Long-standing Case Arising from Hurricane Rejected

Readers know we don't have the resources here to update every case we post on, but here is an update on a case we posted about nearly six years ago.    See Henry v. St. Croix Alumina, LLC, No. 12-1844 (3rd Cir. 7/10/14)(unpublished).

The case arose out of the effects of Hurricane Georges, which hit the Virgin Islands in 1998. The plaintiffs filed suit in1999, alleging that during the storm two materials, bauxite and red mud, were distributed around the island. Bauxite is a red colored ore with the consistency of dirt or dust from which alumina is extracted and used to produce aluminum. A by-product of the alumina extraction process is a substance called red mud, which was stored in piles outside the refinery using a method known as dry-stacking.  Appellants allegedly sustained property damage and also mild illnesses/injuries as a result of contact with the red dust during and after the hurricane. Generally, Appellants experienced rashes, irritation of the eyes and skin, and itching. All but one of the seventeen Appellants had their symptoms disappear completely in the weeks and months following the hurricane.

The case had a long procedural history, with class certification, decertification, and partial certifications. Eventually the property damage claims settled, and the personal injury claims were dismissed. The dismissal of Appellants' personal injury claims was founded in large part on the court's rejection of their four proposed experts. The experts did not satisfy the requirements of Fed. R. Evid. 702 and the accompanying test enunciated in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Without any expert testimony as to the cause of Appellants' injuries, the District Court ruled that the personal injury claims could not proceed and granted summary judgment to Appellees on those counts.

Three of the experts had opined on the amount of red mud that escaped the refinery and reached Appellants. Tarr concluded that some 160,000 pounds of particulates escaped from the refinery, and experts Bock and Kleppinger each stated that red mud was a "preponderance" or large component of the red dust that contacted Appellants.  However, as the District Court noted, each of the experts relied upon unique, qualitative methodologies to reach these conclusions. The District Court properly found that none of these methods had any of the hallmarks of reliable expert testimony under Daubert. The experts did not utilize a peer-reviewed methodology, subject to any known rate of error, which is generally accepted in the scientific community, or has otherwise been utilized outside the judicial context.

Much of the remaining opinion submitted by these experts was then excluded by the District Court as it did not "fit" with the case. For instance, Kleppinger and Bock testified as to the pH and toxicity of red mud stored at the refinery. The District Court held that this did not bear on the danger posed by the material that actually came into contact with Appellants. Critically, as the Court pointed out, Appellants offered no reliable testimony as to the amount and toxicity of the red dust which came into contact with Appellants. Finally, the District Court found Dr. Brautbar's testimony inadmissible, as it relied on the excluded expert opinions to establish that Appellants had come into contact with sufficient quantities of red mud to cause their claimed symptoms.

In sum, the District Court performed an exhaustive analysis of the proposed expert testimony, and determined that it was inadmissible. The court of appeals agreed with the reasoning and conclusions of the District Court, and affirmed its evidentiary rulings.
 

State Supreme Court Rejects Fishing Expedition of Experts' Employer

The Texas Supreme Court rejected plaintiffs' attempt to engage in a "fishing expedition"  of the employer of two experts retained in a product liability dispute. See In re Ford Motor Co., No. 12-1000 (Tex., 3/28/14).

In this design-defect case, the plaintiff sought to discover alleged  potential bias of the defendant’s two testifying experts by seeking to depose a corporate representative of each expert’s employer. This suit arose from injuries plaintiff Saul Morales allegedly sustained after a Ford vehicle allegedly struck him. Morales had been in his own vehicle, fleeing police who suspected he was driving drunk, said the court. Eventually, Morales stopped his vehicle and continued his flight on foot. One of the police officers likewise left his 2004 Ford Crown Victoria Police Interceptor, then pursued and apprehended Morales. While the officer attempted to handcuff Morales, the officer’s vehicle allegedly began rolling backward toward the pair. The vehicle allegedly struck the plaintiff, injuring him. 

Morales sued Ford Motor Company, which designed and manufactured the police car, and the car’s seller, Ken Stoepel Ford, Inc. Morales alleged the vehicle had a design defect that allowed the officer unintentionally to place the gear-shift selector between park and reverse, which then caused the vehicle to go into an idle-powered reverse. To defend the lawsuit, Ford retained two expert witnesses: Erin Harley, of Exponent, Inc., and Hugh Mauldin, of Carr Engineering, Inc. After deposing both Harley and Mauldin, Morales sought corporate-representative depositions from Exponent and Carr Engineering on seventeen topics, arguing the additional depositions were necessary to prove each testifying expert’s bias in favor of Ford and other automobile manufacturers.

The courts have expressed concerns about allowing overly expansive discovery about testifying experts that can “permit witnesses to be subjected to harassment and might well discourage reputable experts” from participating in the litigation process. Ex parte Shepperd, 513 S.W.2d 813, 816 (Tex. 1974). The particular deposition notices in this case. said the court,  highlighted the danger of permitting such expansive discovery. In his deposition notices to Carr Engineering and Exponent, Morales sought detailed financial and business information for all cases the companies have handled for Ford or any other automobile manufacturer from 2000 to 2011. Such a "fishing expedition," said the court, seeking sensitive information covering twelve years, is just the type of overbroad discovery the rules are intended to prevent.

In any event, the most probative information regarding the bias of a testifying expert comes from
the expert herself. In this case, for example, Harley testified that 5% of the cases she handles
are for plaintiffs and that she has never testified against an automobile manufacturer. Similarly,
Mauldin testified that historically about 50% of Carr Engineering’s work is done for Ford.  That was all plaintiff was entitled to, and the lower court order was quashed.

 

 

 

Appeals Court Affirms Summary Judgment for Cart Manufacturer

The Second Circuit affirmed the grant of summary judgment for a golf cart maker who challenged plaintiff's expert opinion in a design defect suit by a teenager injured in a 2007 golf cart accident. See Valente v. Textron, Inc., No. 13-1456 (2d Cir., 3/10/14).

Plaintiffs appealed from an award of summary judgment in favor of defendants on Valente’s strict liability and negligence design defect claims for damages allegedly sustained when Valente was operating a golf car manufactured by defendants. Valente contended that the district court erred in precluding the testimony of his expert (K. Seluga) after a hearing pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

Specifically, the district court excluded Seluga’s testimony that yaw instability—resulting from a design defect in the use of a two-wheel rear braking system as opposed to a four-wheel braking system—was responsible for Valente’s accident. In fact, the court of appeals concluded, the district court’s thoughtful and thorough explanation for excluding Seluga’s testimony convincingly demonstrated that it acted well within its discretion.

There is no dispute that the coefficient of friction term in the relevant calculations was the determining factor in the expert's opinion that yaw instability was responsible for Valente’s accident. But the coefficient of friction used by Seluga, based on flat surface testing, was approximately 40% lower than the coefficient measured by Seluga and defendants' expert on the actual path of the accident, as well as that used by the expert in a published peer reviewed article on the topic.

 

Even assuming the reliability of the coefficient, Seluga testified that his simulation would predict a
rollover due to yaw instability somewhere between 25% and 50% of the time.  The purpose for which Valente sought to offer Seluga’s testimony, however, was not that under certain circumstances there was a 25% chance that the accident could have occurred as a result of the defect in the golf car, but rather that the design defect actually caused the accident “to a reasonable degree of engineering certainty.” Where, as here, data is simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion
testimony.

 

With Seluga’s testimony properly excluded, the record was devoid of any evidence supporting Valente’s theory that the golf car had a design defect or that such a design defect likely caused his accident.

Affirmed.

 

State Mass Tort Court Rejects General Causation Experts

A Pennsylvania state court excluded plaintiffs' expert testimony offered in coordinated cases alleging a denture adhesive caused personal injuries.  See  In re: Denture Adhesive Cream Litigation, No. 090604534 (Phila, Ct. Common Pleas)(J.New).

In 2009 the court had created the mass tort docket for these product cases. Defendants include manufacturers and retailers. Defendants moved to exclude under the Frye test the plaintiffs' four main general causation experts, who opined that the product's zinc conduct led to neurological complications; the court heard live testimony and oral argument. 

The court had considered some of the issues before, excluding the general causation opinions because they were based on inadequate data, including with regard to how much zinc is absorbed in the body.  Plaintiffs then submitted supplemental information which they alleged filled in the various analytical gaps. One item involved a publish Scottish study of 22 patients to which one of the experts applied a further analysis he termed a "cohort study", and another was a study by one of the experts of 24 subjects using denture products over a 30 day period.

The court concluded that the opinions involved "novel" science because the alleged link between zinc and neuropathy is reported in literature only in the past few years.  In analyzing the new data, the court stressed that the issue was not just the alleged link between zinc exposures and neuropathy, but the ability of a specific product to cause specific injuries. Not all zinc-containing dental creams are equal, said the court.

 The so-called cohort study did not describe the actual exposure dose of each subject. It didn't describe the type of adhesive used, the frequency it was used, or the duration between use and symptoms. Thus it is based on a method that is not generally accepted. Furthermore, it was not published and subject to peer review.

The experts alleged that zinc in the denture adhesive had blocked the users' bodies from being able to absorb copper, causing copper deficiency myeloneuropathy.  The second study, at best, linked product use to a short-term reduction in copper.  It did not say anything about severe copper deficiency or allegedly resultant neurological symptoms.  The court found it to be a "blatant, litigation driven attempt to remediate" the deficiencies in the prior expert testimony.

In sum, even with the "new" data, plaintiffs had failed to provide a sound and generally accepted methodology linking the product to the alleged injury.  Expert opinions excluded.

Ninth Circuit En Banc Decision on Daubert Errors

Readers may recall we posted about a Ninth Circuit case involving a worker at a paper mill who claimed asbestos exposure from various products used there.  The trial court admitted testimony from three experts over defendants’ objections, without conducting an adequate Daubert review, resulting in a trial verdict of $10.2 million. The Ninth Circuit reversed the trial verdict, and the panel remanded the case to the trial judge for a new hearing and trial. See Henry Barabin. et al. v. AstenJohnson Inc., No. 10-36142 (9th Cir.) The Ninth Circuit then agreed to hear the case en banc, and our guess was that the court was thinking more about the fact that the panel remanded the case for a new trial in light of the court’s 2003 decision in Mukhtar v. California State University, 299 F.3d 1053 (9th Cir. 2002), amended by 319 F.3d 1073 (9th Cir. 2003).

The court has now issued its en banc opinion, upholding the reversal of the verdict; agreeing with the original panel that the trial court had conducted an improper Daubert review; and rejecting two key arguments that plaintiffs made in trying to save the case. Plaintiffs, first, wanted a remand for purposes of the Daubert hearing only. They argued that an appeals court did not have the authority to exclude the experts on its own (even after the inadequate job by the trial judge) and must remand that decision. The en banc court disagreed, said that it did have such authority, although here the record was insufficient to allow the panel to make that decision. The en banc court thus held that a reviewing court has the authority to make Daubert findings based on the record established by the district court, and overruled Mukhtar v.California State University, 299 F.3d 1053, 1066 n.12 (9th
Cir. 2002), amended by 319 F.3d 1073 (9th Cir. 2003), to the extent that it required that Daubert findings always be made by the district court.

Second, plaintiffs argued that on remand the trial judge should get another shot at a Daubert decision without necessarily holding a complete new trial. But, the court held that if expert admissibility error occurred and was prejudicial, the only recourse was an entire new trial. Thus, the plaintiffs now have to first get past a real Daubert analysis, and if they do, then win an entire new trial in front of a new jury.

We have argued here that to remand for an evidentiary hearing post-jury verdict undermines Daubert's requirement that a reliability determination must be made by the trial court before the jury is permitted to hear the evidence. Otherwise, instead of fulfilling its mandatory role as a gatekeeper, the district court clouds its duty to ensure that only reliable evidence is presented. A post-verdict analysis does not protect the purity of the trial, but instead creates an undue risk of post-hoc rationalization. This is hardly the gatekeeping role the Supreme Court envisioned in Daubert and its progeny. The rule recognized here gives trial courts a real and important incentive to be proper, active gatekeepers.

(Note that my partner Mark Behrens was asked to submit an amicus brief on behalf of the Coalition For Litigation Justice, Inc., Chamber Of Commerce Of The United States Of America, NFIB Small Business Legal Center, American Insurance Association, Property Casualty Insurers Association Of America, American Chemistry Council, And National Association Of Manufacturers.)

 

State Appeals Court Rejects Expert Testimony In Toxic Tort Case

The Superior Court of Pennsylvania recently rejected the plaintiff's expert's opinion on causation, in an interesting Frye decision.  See Snizavich v. Rohm and Haas Co., No. 1383 EDA 2012, (Pa. Super. Ct. Dec. 6, 2013).

Plaintiff's decedent filed suit against Rohm and Haas in April 2009, asserting causes of action under the Wrongful Death and Survival Acts, in which she alleged that decedent’s brain cancer was caused by exposure to chemicals while working at Spring House, and that Rohm and Haas was allegedly liable.  Plaintiffs submitted an expert report, which defendant challenged in a Frye motion and then hearing.  The trial court rejected the expert opinion and then granted defendant summary judgment. Plaintiff appealed.

The trial court was especially troubled by the plaintiff's expert, Dr. Milby’s, reliance on a report from the University of Minnesota (“Minnesota Report”), finding an association between brain cancer and working at the Spring House, PA facility where thousands of chemicals had been used. The Minnesota Report was inconclusive as to both the cause of the brain cancer found in the Spring
House workers and the relationship between the chemicals and increased incidence of brain cancer. Nevertheless, as the court stated, Dr. “Milby somehow comes to the exact opposite conclusion . . . Milby, however, does not state any scientific methodology that he used nor does he call into question the [study’s] methodology that might make its findings incorrect, rather he simply stated his own opposite conclusions without any further support.”  Ultimately, the Milby expert report seemed to be little more than an unscientific lay opinion given by someone who happened to be a medical doctor. As such, Dr. Milby’s testimony would not assist the trier of fact, because it contained no evidence, causal or otherwise, linking the decedent’s brain cancer to the Spring House facility.

Under Pennsylvania law, admissible expert testimony that reflects the application of expertise requires more than simply having an expert offer a lay opinion.  Testimony does not become scientific knowledge merely because it was proffered by a scientist.  Wack v. Farmland Industries, Inc., 744 A.2d 265, 271 (Pa. Super. 1999) abrogated on other grounds by Trach v. Fellin, 817 A.2d
1102 (Pa. Super. 2003). Likewise, expert testimony must be based on more than mere personal belief, Commonwealth v. Stringer, 678 A.2d 1200, 1202 (Pa. Super. 1999), and must be supported by reference to facts, testimony or empirical data.  Downey v. Crozer-Chester Medical Center, 817 A.2d 517, 528 (Pa. Super. 2003) (en banc).

The exercise of scientific expertise requires inclusion of scientific authority and application of the authority to the specific facts at hand. Thus, the minimal threshold that expert testimony must meet to qualify as an expert opinion rather than merely an opinion expressed by an expert, is this, observed the court: the proffered expert testimony must point to, rely on or cite some scientific authority – whether facts, empirical studies, or the expert’s own research – that the expert has applied to the facts at hand and which supports the expert’s ultimate conclusion. When an expert opinion fails to include such authority, the trial court has no choice but to conclude that the expert
opinion reflects nothing more than mere personal belief.

Here, the appellate court agreed that Dr. Milby failed to demonstrate any scientific basis, other than his own subjective beliefs, that the chemicals used at Spring House caused brain cancer. He basically reviewed plaintiff's medical records, work history, and work conditions, and then relied on the Minnesota Report.  However, the Minnesota Report was inconclusive as to the cause of the brain cancer found in the Spring House workers and the relationship between the chemicals used at Spring House and brain cancer. Although Dr. Milby references and seems to rely on the Minnesota Report, he ignored the fact that it specifically and intentionally disclaims that exact conclusion that he himself reaches.  Dr. Milby did not offer any other scientific authority that even suggested a causal relationship between possible exposure to chemicals at Spring House and brain cancer, or any reason to doubt the scientific veracity of the Minnesota Report. The Milby expert opinion was, therefore, more aptly described as scrupulously avoiding the medical literature, and based entirely on subjective assessments of both cause and effect.

Thus, the Superior Court concluded that Dr. Milby’s opinion was nothing more than lay opinion offered by an expert and therefore was inadmissible. The decision reinforces the burden facing plaintiffs in toxic tort cases to proffer expert testimony with a sufficient scientific basis, especially where there are numerous idiopathic cases, where the scientific and medical literature has not found a conclusive causal link between a given product and the alleged injury.

 

State High Court Rejects Mold Expert Opinion

Here's an interesting expert analysis that arises in the less common Frye context.  In Chesson v. Montgomery Mut. Ins. Co., No. 97 (Md., 9/24/13), the Maryland high court affirmed the exclusion of an expert's methodology for linking alleged mold exposure and the plaintiffs' illness; among other things, the approach failed to take into account the level of mold exposure plaintiffs experienced.

The case at hand originated in workers’ compensation claims filed by six employees of the Baltimore Washington Conference of the United Methodist Church. The employees claimed that they had sustained physical injury, specifically neurocognitive and musculoskeletal symptoms, as a result of exposure to mold in the Baltimore Washington Conference’s office. To prove causation, the employees proffered Dr. Ritchie Shoemaker as their expert. Montgomery Mutual, however,
sought to exclude Dr. Shoemaker under Frye (called Reed in this state), arguing that his methodology to determine causation was not generally accepted in the relevant scientific community.

After some procedural events, the lower court eventually held a Frye-Reed hearing, in which the judge considered whether the relevant scientific community generally accepted as reliable and
valid Dr. Shoemaker’s methodologies and theory that identified mold exposure as the cause
for the neurocognitive and musculoskeletal symptoms allegedly suffered by the employees.  At the hearing, Dr. Shoemaker testified that the indoor air of a water-damaged building known to contain mold caused neurocognitive and muscuoloskeletal symptoms. He based his opinion on something he called his “Repetitive Exposure Protocol,” in which he would identify the presence of mold in the building, through visual identification of mold, detecting a musty smell, or lab testing of a sample, such as a piece of drywall. The individual at issue would then be removed from the subject building and, for two weeks, receive a treatment to relieve the symptoms allegedly related to mold exposure, and then be returned to the subject building for three days, during which, he
opined, the individual would report that the symptoms had redeveloped.

The trial court allowed the testimony but the Court of Appeals held that Dr. Shoemaker’s testimony was not admissible under Frye-Reed, reasoning that his methodology was flawed and not generally accepted because it failed to account for the levels of mold exposure. The Court, moreover, concluded that based on an examination of relevant scientific journal articles that the scientific community remained uncertain as to Dr. Shoemaker’s techniques and conclusions.  The plaintiffs appealed.

The high court noted that in Maryland when an expert opinion is offered to support the existence of new or novel scientific theory or methodology, “the basis of that opinion must be shown to be generally accepted as reliable within the expert’s particular scientific field.” Reed v. State, 283 Md. 374, 381, 391 A.2d 364, 368 (1978), citing Frye v. United States, 293 F. 1013, 1014 (1923). The general acceptance test imposes a significant gate-keeping role on the judge to determine whether a scientific theory or methodology should be admitted for consideration by jury.  Moreover, validity and reliability are the linchpins of  the scientific method: validity, having been defined as the extent to which something measures what it purports to measure, and reliability, characterized as the ability of a measure to produce the same result each time it is applied to the same thing.

The court stressed that on cross-examination, Dr. Shoemaker admitted that he did not test any of the buildings, either the Baltimore Washington Conference’s office or any others in which an
individual resided or worked who underwent his “Repetitive Exposure Protocol,” to determine the level of mold exposure that an individual working or residing therein would have experienced. According to Dr. Shoemaker, the mere "identification" of mold in a building, even by the presence of a musty smell alone, was sufficient to conclude that an individual residing or working in that building inhaled mold that caused neurocognitive and musculoskeletal symptoms, without any further assessment of not only the level of mold, but also what other chemicals the plaintiff may have been exposed to.

Defendants called a Dr. Cheung who testified that Dr. Shoemaker’s “Repetitive Exposure Protocol”
was not generally accepted as valid in the relevant scientific community, not only because it was experimental as well as controversial in its “second tier” of biological markers approach and use of treatment drugs in an off-label fashion, as well as in its failure to account for stress levels in individuals, but also primarily because it failed to measure the levels of mold exposures by individuals in the water-damaged buildings. Mold exposure can be low to medium to high, he testified, and should include consideration of the pathways that mold must travel to reach an individual, such as the building’s ventilation system, walls, or ceiling, as well as the pressure or air flow of the building.  Dr. Cheung also testified to a survey that he had commissioned relative to whether Dr. Shoemaker’s diagnosis was generally accepted and found it was not.  Most importantly, Dr. Cheung testified regarding the absence of any study utilizing the scientific method that confirmed the relationship of mold exposure to neurocognitive and musculoskeletal symptoms.

The court also noted that other jurisdictions have determined that Dr. Shoemaker’s theory, based on his “Repetitive Exposure Protocol,” is neither generally accepted nor reliable. See Young v. Burton, 567 F. Supp. 2d 121, 130-31 (D.D.C. 2008) (also listing Virginia, Florida, and Alabama as jurisdictions rejecting Dr. Shoemaker’s theory).

The Court of Appeals agreed with the intermediate appeals court, finding that the expert's failure to account for the level of mold exposure was a fundamental flaw in his methodology .Without an expert's admissible opinion on causation, plaintiffs were unable to prove that mold in the walls of their office building was the cause of their neurocognitive and musculoskeletal symptoms.

 

State Supreme Court Reaffirms Death of Single Fiber Theory

The Pennsylvania Supreme Court recently reaffirmed several important principles in toxic tort exposure, specifically asbestos, cases. See Howard, et al. v. A.W. Chesterton Co., et al., Nos. 48 EAP 2012, 49 EAP 2012 and 50 EAP 2012 (Pa. Sept. 26,2013).

Plaintiff alleged personal injury from exposure to dust from defendant's asbestos-containing products. The common pleas court awarded summary judgment in favor of defendants/appellants, reasoning that plaintiff's deposition testimony failed to establish that he breathed asbestos-containing dust from the products manufactured or distributed by appellants, and the court also found expert affidavits submitted by plaintiffs represented insufficient proof of actual exposure.  On appeal, the Superior Court reversed on the basis that dust may have been invisible to the naked eye, and the expert affidavits were sufficient to establish exposure to dust which was a substantial causal factor in plaintiff's injury.

The Supreme Court reversed the intermediate appeals court, and in so doing reaffirmed several key principles of state law:

--The theory that each and every exposure, no matter how small, is substantially causative of disease may not be relied upon as a basis to establish substantial-factor causation for diseases that are dose-responsive. See Betz v. Pneumo Abex, LLC, 44 A.3d 27, 55-58 (Pa. 2012). 

-- Relatedly, in cases involving dose-responsive diseases, expert witnesses may not ignore or refuse to consider dose as a factor in their opinions. See id.

-- Bare proof of some de minimus exposure to a defendant’s product is insufficient to establish substantial-factor causation for dose-responsive diseases. See Gregg v. V-J Auto Parts, Inc., 943 A.2d 216, 225-26 (Pa. 2007).

-- Relative to the testimony of an expert witness addressing substantial-factor causation in a dose-responsive disease case, some reasoned, individualized assessment of a plaintiff’s or decedent’s exposure history is necessary. See Betz, 44 A.3d at 55-58.

-- Summary judgment is an available vehicle to address cases in which only bare de minimus exposure can be demonstrated and where the basis for the experts testimony concerning substantial-factor causation is the any-exposure theory. See Betz, 44 A.3d at 55-58; Gregg, 943 A.2d at 227.

In an interesting procedural twist, during arguments before the Supreme Court, plaintiff conceded that the Superior Court had erred in its ruling -- an apparent attempt to have the Supreme Court not reiterate the points that some lower courts in the state inexplicably continued to not apply.  Nevertheless, in light of the intensely protracted nature of asbestos litigation, the Court decided to provide at least some limited guidance.  Indeed, as explained in detail in the unanimous decision in Betz, the any-exposure opinion is simply unsupportable both as a matter law and science.

 

(Note that my colleague Mark Behrens was involved in the amicus briefing on behalf of the Coalition for Litigation Justice.)

Florida Adopts Daubert Test

Last month, Florida Gov. Rick Scott (R) signed into law legislation (H.B. 7015) concerning the qualifications of expert witnesses and replacing the the state admissibility standard under Frye to the Daubert standard. The law kicks in this month.


Currently, Florida courts employ the standard articulated in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) and progeny, to determine whether to admit expert testimony. Under the Frye standard, the methodology or principle on which expert opinion testimony is based must be generally accepted in the field in which it belongs.  The bill replaces the Frye standard with the Daubert standard. Under the Daubert test, when there is a proffer of expert testimony, the trial judge as a gatekeeper must make a preliminary assessment of whether the reasoning or methodology properly can be applied to the underlying facts at issue. The bill adopts the Daubert standard by amending Florida law to prohibit an expert witness from testifying in the form of an opinion or otherwise, including pure opinion testimony, unless:

The testimony is based on sufficient facts or data;
The testimony is the product of reliable principles and methods; and
The witness has applied the principles and methods reliably to the facts of the case.


Additionally, the preamble further states that the Legislature intended to adopt the standards provided in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), General Electric Co. v. Joiner, 522 U.S. 136 (1997), and Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) and to prohibit pure opinion testimony as provided in Marsh v. Valyou, 997 So. 2d 543 (Fla. 2007).


The vote in the Senate was 30-9; in the state House 70-41.  Florida business groups supported the change as one making the state's legal climate more friendly to businesses by helping to keep junk science out of the court room.

Discovery of Expert Communications At Issue

 Here is one to watch for our readers who practice in Pennsylvania.  The state Supreme Court has before it the issue of discovery of communications between lawyers and their expert witnesses. See Carl Barrick v. Holy Spirit Hospital of the Sisters of Christian Charity, et al., No. 76 MAP 2012 (S.Ct. Pa.).

Barrick filed suit against Holy Spirit Hospital and Sodexho Management Inc. alleging personal injuries in the cafeteria of Holy Spirit Hospital.  An orthopedic surgeon who treated Barrick for injuries sustained from the accident was also named as an expert witness.  One of the defendants subpoenaed Barrick’s medical chart and other records, but the Doctor's medical center withheld some records which allegedly were trial preparation materials under Pennsylvania Rules of Civil Procedure.

The defendant filed a motion to compel, and after the trial court conducted an in camera review, the court ordered the release of the materials to the defendants.  This was in line with some state cases that suggested work product protections in Pennsylvania are not as strong as under the federal rules. The plaintiff appealed, and a panel of the Superior Court upheld the ruling in 2010. The issue was then reconsidered by the Superior Court sitting en banc, which ruled that the Pennsylvania Rules of Civil Procedure did not compel the disclosure of such communications between attorneys and their expert witnesses. Arguably this ruling offered more protection than the federal rules do.  It also made an interesting contrast with Rule 4003.5 which, upon cause shown, gives state courts some ability to compel experts to do more than the basic response to interrogatories regarding their anticipated testimony at trial.

The 8-1 majority reasoned that Pa.R.C.P. 4003.5 controls discovery regarding expert testimony, and it specifies that a party cannot directly serve discovery requests upon a non-party expert witness. Discovery regarding testimony of an expert other than through a defined set of interrogatories must be made upon the showing of good cause to the court, not through a subpoena. Here, the correspondence sought by the defendant did not fall into the area of interrogatory permitted under Rule 4003.5(a)(1).  

Following the en banc ruling, defendants appealed.  The issue before the supreme court now is whether the superior court’s holding “improperly provides absolute work-product protection to all communications between a party’s counsel and their trial expert.”

Ninth Circuit Vacates Asbestos Verdict on Daubert Basis

The Ninth Circuit earlier this month vacated a $9 million award for a plaintiff who allegedly contracted mesothelioma working for decades at a paper mill, because the trial court failed to assess the reliability of expert testimony for the plaintiffs under Daubert v. Merrell Dow Pharm.,
Inc
., 509 U.S. 579 (1993). See Henry Barabin et al. v. AstenJohnson Inc., et al., Nos. 10-36142 and 11-35020 (9th Cir.). 

Plaintiff's employer used dryer felts containing asbestos allegedly made or sold by defendants. During his employment, he allegedly worked in various jobs that exposed him to the dryer felts that defendants had provided. He also took pieces of dryer felt home to use in his garden.  In November, 2006, Plaintiff was diagnosed with pleural malignant epithelial mesothelioma.  It was undisputed that exposure to respirable asbestos can cause mesothelioma (general causation).

Defendants filed a motion in limine to exclude plaintiff's expert witnesses on specific causation. The district court excluded one (Dr. Cohen) as an expert because of his “dubious credentials and his lack of expertise with regard to dryer felts and paper mills. . . ” Additionally, the district court limited a second (Dr. Millette), requiring disclosure to the jury that Dr. Millette’s tests were “performed under laboratory conditions which are not the same as conditions at [plaintiff's workplace].”  However, during a pre-trial conference, the district court reversed its decision to exclude Dr. Cohen’s testimony. The district court explained that plaintiffs had clarified Dr. Cohen’s credentials, including that he had testified in other cases. The district court did not hold a Daubert hearing.

After the jury verdict and post-trial motions, defendants appealed.  The court of appeals noted that in its role as gatekeeper, the district court determines the relevance and reliability of expert testimony and its subsequent admission or exclusion. See Ellis v. Costco Wholesale Corp., 657 F.3d 970, 982 (9th Cir. 2011). Admission or exclusion under Daubert rests on the scientific reliability and relevance of the expert testimony.  The expert’s opinion must be deduced from a “scientific method” to be admissible. The test under Daubert is not the correctness of the expert’s conclusions but the soundness of his methodology. Compliance with Rule 702 is gauged by the district court’s assessment of the reliability of the proffered expert testimony. Specifically, the district court is charged with determining whether the proffered expert testimony is trustworthy. In a case involving scientific evidence, evidentiary reliability will be based upon scientific validity. Scientific validity is, in turn, assessed in large part by the degree to which the theories propounded by the expert have been subjected to and survived scrutiny in the relevant scientific community.  The "decision to admit or exclude expert testimony is often the difference between winning and losing a case."

Since the decision to permit the testimony was based on reconsideration, the record was limited. Once presented with the additional information in the response to the motion in limine, at a minimum the district court was required to assess the scientific reliability of the proffered expert testimony.  Unfortunately, said the court of appeals, because no Daubert hearing was conducted as requested, the district court failed to assess the scientific methodologies, reasoning, or principles Dr. Cohen applied. None of the Daubert factors was considered. "Instead, the court allowed the parties to submit the experts’ unfiltered testimony to the jury."  In failing to do so, the district court neglected to perform its gatekeeping role.  Rather than making the required determinations, the district court left it to the jury to determine the relevance and reliability of the proffered expert testimony in the first instance, said the panel. The 9th Circuit panel seemed influenced in part by the fact that, in its order, the district court wrote: In the interest of allowing each party to try its case to the jury, the Court deems admissible expert testimony that every exposure can cause an asbestos-related disease. (emphasis added).

"Let the parties try their cases; let the jury sort it out" is not what Daubert allows or requires.  The district court committed reversible error when it failed to assess the proferred expert testimony for relevance and reliability, concluded the court. Prior decisions dictated that a new trial be provided in this circumstance.

Amicus Weighs In On Daubert Issue in Court of Appeals

The Product Liability Advisory Council weighed in as amicus earlier this month, asking the Eleventh Circuit to reverse a district court ruling that had allowed unreliable expert testimony in a case involving Jet Skis. See Megan Sands v. Kawasaki Motors Corp. U.S.A. et al., No.12-14667 (11th Cir.).

The PLAC brief  is part of the litigation arising from a complaint originally filed in Florida in 2007 by Georgia college student Megan Sands, who was riding as a passenger on a Kawasaki 2003 Ultra 150 Jet Ski in the Bahamas when she was thrown backward from her seat into the water.  She alleged this caused her to suffer severe, extensive and permanent damage to her lower extremities. Sands alleged that the device was defective because it did not have either a raised seat back or a “sissy bar” to prevent passengers from falling backward, or a kill switch that would allow an ejected passenger to cut off the engine.The case went to trial, resulting in a favorable verdict for Kawasaki on strict liability and negligent failure to warn claims but a finding in favor of Sands on design defect claims. Defendant appealed.

The amicus brief focused on the trial court's gate-keeping obligations under the Daubert standard, and the testimony of plaintiff's expert Burleson concerning an alternative seat design for the jet ski. PLAC argued that he presented no testing or engineering analysis to show that the alternative design would have improved the overall safety and utility of the product. Instead, his opinion rested
solely on an unsupported, conclusory statement in his report, which was precisely the kind of "analytical leap" and ipse dixit condemned in prior cases.  Kawasaki did not challenge the
admissibility of Burleson's assertion that his seat back concept, if used, might have eliminated or reduced the risk of injury to this plaintiff. Rather, as Kawasaki had argued below, Burleson had not tested whether a seatback would pose other dangers of equal or greater magnitude to the danger it would supposedly address.

The trial court appeared to describe the issue merely as whether "adequate testing" was conducted, but the testing evidence was not responsive to the specific objection that Kawasaki had raised. Neither the Plaintiff nor the trial court, said PLAC, ever identified any test or other engineering data supporting Burleson's conclusory assertion about the overall safety of the alternative design.

PLAC also focused on the trial court's statement that it was "unable to say that Mr. Burleson's testimony regarding a fixed seatback is unreliable," which sounded like the court switched the burden to show unreliability to Kawasaki. The absence of an admission by Burleson that the
alternative design would introduce a risk of other hazards should not have permitted the jury to
conclude that the alternative design was reasonable. Substantive tort law places the burden on the plaintiff to establish that the proposed alternative design would have greater overall safety than the existing design, and procedural law  imposes the burden on the proponent of expert testimony to establish its reliability. PLAC argued that a trial court does not have discretion to switch the burden under Rule 702 from the proponent of expert evidence to the opponent of such evidence. 

One to keep an eye on.

 

Supreme Court Denies Cert in Case Excluding Treater Opinions

Readers may recall our post about Simmons v. Novartis Pharmaceutical Corp., a case in which the Sixth Circuit affirmed the exclusion of plaintiff's expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. The issue was specific causation, and the court helpfully noted that a treating physician’s testimony is subject to Daubert; that an expert's statement that he found “a very close association” between ONJ and the class of drugs is not enough; and that while a treater may be qualified to diagnose a patient, a diagnosis is merely a hypothesis, which does not by itself satisfy Daubert and Rule 702.

The Supreme Court earlier this month denied the plaintiff's cert petition. See Simmons v. Novartis Pharmaceutical Corp., U.S., No. 12-283, cert. denied 11/5/12).

Plaintiff had argued that when a case involves medication that has not been widely studied, and thus published about, a different standard should apply.  She also argued that the opinions would have been admissible under the law of Maryland which, she said, requires only that expert opinions be expressed “to within a reasonable degree of medical/dental probability.”

Novartis has had a number of victories in similar cases, challenging treating physicians who seek to offer expert causation opinions. 

Supreme Court Hears Arguments in Comcast

We alerted readers before about the Supreme Court consideration of the role of Daubert at the class certification stage.   See Comcast Corp. v. Behrend, U.S., No. 11-864 (cert. granted 6/25/12). The Court had indicated it was interested in the question "whether a district court may certify a class action without resolving whether the plaintiff class has introduced admissible evidence, including expert testimony, to show that the case is susceptible to awarding damages on a classwide basis." Readers will recall that in Wal-Mart Stores Inc. v. Dukes, 131 S. Ct. 2541 (2011) the Supreme Court in dicta referenced the question. Justice Scalia observed that the district court had "concluded that Daubert did not apply to expert testimony at the certification stage of class-action proceedings," but the majority replied that "we doubt that is so." 131 S. Ct. at 2554. Thus, Dukes strongly suggested that it was appropriate for defendants to make the expert challenge at the class certification stage, and important for the court to resolve the issue then.

The justices heard arguments from both sides November 5th.  The district court in Comcast originally certified a class; following the court of appeals' decision in Hydrogen Peroxide, 552 F.3d 305, the district court granted in part Comcast‘s motion to reconsider its certification decision. After further briefing, plaintiffs got the case re-certified after convincing the district court that they could show that they had an expert methodology to prove damages on a classwide basis. On the current appeal, the Third Circuit agreed that the lower court had applied the "rigorous analysis," adding that at the class certification stage, "we are precluded from addressing any merits inquiry unnecessary to making a Rule 23 determination.” The Petitioners argued that the Third Circuit affirmed the certification order after expressly declining to consider several “merits” issues necessary to determine whether, as required by Rule 23(b)(3), common questions predominate over individual ones. The focus on damages, which some have viewed as narrowing the issue presented, still is a question that arises not just in antitrust cases, but also in mass torts, which are front and center for our readers.

Plaintiffs seemed to get more questions from the bench than did defendant, especially about any problem with allowing potentially inadmissible evidence to form the basis for the crucial class certification decision. 

Comcast emphasized flaws in the expert's damages model, including that the damage model was not linked to the class theory certified by the lower court, that the alleged monopolization of the Philadelphia area through clustering deterred competitors, or “overbuilders,” from competing. The district court should not have relied on it to certify the class. Plaintiffs argued waiver, that the company failed to bring up Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 469 (1993), until it was too late. That focus led Justice Kagan to note, “I am still in search of a legal question that anybody disagrees about here.” Justice Elena Kagan observed it seemed the parties apparently agreed that if the Daubert question was not waived, the lower court should have held a hearing on the admissibility of the expert opinions. Comcast emphasized it had argued to the trial court that this model did not work, ought to be precluded, and was not a valid methodology.

Plaintiffs argued that allowing district courts to defer admissibility determinations under Daubert  until after the class certification stage is consistent with the broad discretion given judges on evidentiary issues.  But that failed to address the pressure that class certification puts on defendants to settle, a point that was not a focus of the arguments. Plaintiffs also seemed to be arguing for a standard in which the district court has to decide simply that it is more likely than not that the damages model/expert opinion will be admissible at trial, and will meet the standard that’s required to get to a verdict.  But Justice Sotomayor asked "can a district court ever say that it’s persuaded by unreliable or not probative evidence.” Justice Alito similarly asked how could this expert "report be probative if it did not satisfy Daubert?”
 

Comcast argued that the trial court needed to conduct more than a limited Daubert hearing, agreeing with what defendant called the holding of the Seventh Circuit in American Honda that the question at the class cert hearing is not solely one of whether the evidence would be admissible, but also  -- keeping in mind that the focus of the class certification hearing is to decide whether the case should be tried as a class --  whether it is a methodology that sufficiently fits the facts and is reliably based on a scientific method so that plaintiffs will be capable of proving, class-wide, this issue at trial.

Justice Scalia asked about a hybrid approach where the court would focus at the class stage on reliability, and leave other Daubert inquiries (like fit)  for trial. But a focus of Justice Ginsburg's questions right out of the box was whether any finding of reliability was necessary on damages. She noted that in discrimination law contexts, courts may, if the liability questions can be adjudicated on a class basis, have the damages question adjudicated individually.  Of course, that view of class actions seems to slight the manageability requirement in a (b)(3) context, and invites truncated procedures that violate a defendant's due process rights.

One to watch for sure.
 

 

Report Issued on Use of Science in Regulatory Decisions

Scientists and policy experts from industry, government, and various nonprofit sectors worked on a report released recently by the Research Integrity Roundtable, designed to offer ways to improve the scientific analysis and independent expert reviews which underpin many important regulatory decisions. The primary audience for the report is federal agencies and their scientific advisory committees, but the ideas in the report may be relevant to others who work at the intersection of science and regulatory policy, including in Congress, the judiciary, and readers of MassTortDefense.  These issues can have important implications for persons interested in issues associated with chemicals, energy, land use, natural resources, agriculture, pharmaceuticals, and other areas in which science informs public policy.

Critics of the manner in which science is used in regulatory decision-making processes tend to raise two kinds of concerns. They question the composition of committees that are empaneled to recommend or review the science behind a possible regulatory decision and they question the way an agency or committee has reviewed the relevant scientific literature, charging that the reviewers used or omitted the wrong studies, and/or that the studies were not appraised appropriately. Obviously, some disputes over the "politicization" of science actually arise over differences about policy choices that science can inform, but not determine.

With that in mind, this report attempts to lay out some broad principles, guidelines, and practices designed in the view of the authors to limit the battling over conflict of interest and bias, and systematic reviews.  Accordingly, this report focuses on:

 How should panels be composed and the qualifications of prospective advisory panelists be vetted?
 How should concerns about biases and conflicts of interest of advisory panelists be handled?
 Which studies should agencies review when examining the scientific literature related to a regulatory policy issue?
 How should contending views regarding the relevance of particular scientific results to a regulatory issue and the credibility of those results be addressed?

For panel formation, the report concludes that a reasonable balance must be established between transparency and privacy. In the realm of qualifications, for example, balancing how much personal information should be revealed to the public by a prospective panelist who may be willing to serve in an advisory capacity, but may not want every aspect of his or her personal life or financial status released to the public.

In dealing with scientific studies, the report suggests a balance must be established in developing and applying objective and transparent criteria for establishing data relevance and reliability between the desire for complete data-sets and the reality that the relevant scientific literature is populated with studies from a wide variety of sources with varying degrees of data availability. In some cases, when proprietary information is involved, an appropriate balance must be struck between the public’s right to know and the legally based need to protect proprietary formulas, production processes, and related intellectual property. 

State Supreme Court Affirms Exclusion of Experts' Inferential Opinions

Follow our train of thought: we have posted about the misuse of the differential diagnosis concept, as plaintiff experts morph it from an accepted tool for deciding what is wrong with a patient to a method for explaining why and how the patient suffered his injury/illness.  Now, three computer experts sought to opine that a software flaw prevented a health monitor alarm from sounding, claiming their methodology was just "like a medical differential diagnosis"!  Fortunately, the South Carolina Supreme Court rejected that attempt last week.  See Graves v. CAS Medical Systems Inc., No. 27168 (S.C., 8/29/12).

Their doctor ordered that the plaintiffs use a monitor manufactured by CAS to track their infant child's breathing and heart rates as a precaution. The monitor was designed to sound an alarm, if the subject were to experience an apneic, bradycardia, or tachycardia event. Once the breathing or heart rate returns to normal, the alarm stops. Each machine also keeps a log of any events, which is the term for when the alarm sounds, and records the pertinent data and vital signs. As an additional safety measure, CAS installed not only a back-up alarm, but also a feature that records whether the alarm sounded. This system operates primarily through an independent and separate microphone specifically designed to listen for the alarm. If it hears the alarm, it then makes a notation in the monitor's internal log. If it does not hear the alarm, then it records "Front alarm not heard," and the monitor will sound the backup alarm. A microphone listens for this back-up alarm as well and records whether it was heard. If the back-up alarm fails, all the lights on the front of the monitor flash.

Tragically, the child died from Sudden Infant Death Syndrome (SIDS), which essentially means that no attributable cause of death exists. Plaintiffs claimed the monitor's alarm never sounded that night. Additionally, they testified that all the lights on the front of the monitor were on, although they were solid and not flashing. Another family member who was asleep downstairs also allegedly could not recall hearing the alarm go off.  Plaintiffs further testified the machine was not turned off until the next day, when the monitor was removed for testing.

Plaintiffs filed a strict liability design defect claim against CAS, contending the monitor's software design caused the alarm to fail.  Their claim revolved around what is known as "spaghetti code," which is when computer code is unstructured and can result from the overuse of "goto" or "unconditional branch" statements, which causes a signal working its way through the code to jump around instead of following a linear path.  This in turn caused the signal to be pushed off course and never reach its destination.

To support this theory, the Graves designated three software experts to testify regarding the alarm's alleged failure. In arriving at their conclusions that a software defect caused the alarm to fail, none of the experts did much actual testing of the software. Instead, they used a "reasoning to the best inference" analysis, which was "similar to a differential diagnosis" in the medical field. In this case, three potential causes were identified: hardware error, complaint error, and software error. Complaint error means that the monitor was misused or the alarm did sound and the Graves failed to hear it.  All the experts were able to dismiss hardware error as a cause because the machine was tested and shown to be functioning properly. Thus, the question became whether complaint error or a software error occurred.

The experts excluded complaint error because the machine was hooked up properly, and they did not believe anyone would sleep through the alarm. In other words, because the Graves claimed the alarm did not wake them, that means it must not have gone off. After being confronted with the fact that the monitor listens for the alarm and separately records whether it was sounded, the experts opined that it must be "certain" the internal logs showing the alarm actually did sound were not reliable "in light of the undisputed testimony that the alarm did not function." That left software error as the most likely cause of the alleged failure, they opined.

Defendant moved to have all these experts excluded, arguing none of them met the reliability factors for scientific testimony set forth in State v. Council, 335 S.C. 1, 515 S.E.2d 508 (1999). CAS also moved for summary judgment, contending that without this expert testimony plaintiffs had no evidence of a design defect. The trial court agreed that their opinions were unreliable both as scientific evidence and as nonscientific evidence and thus were inadmissible. Having excluded the opinions of all the Graves' experts, the lower court granted CAS's motion for summary judgment.

The state Supreme Court noted that this was its first opportunity to assess the reliability of an opinion rendered using the "reasoning to the best inference" methodology, so looked for guidance to the analysis of the United States Court of Appeals for the Tenth Circuit, which had already done so. In Bitler v. A.O. Smith Corp., 400 F.3d 1227 (10th Cir. 2004), the court held that "[e]xperts must provide objective reasons for eliminating alternative causes" when engaging in this analysis. Id. at 1237. Furthermore, "an inference to the best explanation for the cause of an accident must eliminate other possible sources as highly improbable, and must demonstrate that the cause identified is highly probable." Id. at 1238. Although the expert need not categorically exclude all alternate causes, that does not relieve the expert of his burden to prove the alternate cause is at least highly improbable based on an objective analysis. See id. at 1237–38 & n.6. The court found this objectivity requirement consistent with the quality control element of State v. Council.

Here, there was evidence that the alarm worked properly and the plaintiffs failed to hear it. In addition to the monitor's recordation of hearing the alarm sound, the family pediatrician testified he believed plaintiffs slept through it, the court noted. The doctor was aware of just how exhausted the parents were. Although the alarm is loud, if one is tired enough, he testified that it is possible to sleep through it. His opinion was bolstered by the fact that the machine seems to have worked just as it was supposed to and recorded the breathing issues perfectly. The log also seems to show the alarm managed to stimulate the baby into breathing normally at times.

This evidence does not mean that is exactly what happened.  But there was enough that an expert needed to take it into account.. Instead, the experts simply assumed the alarm did not sound and provided no reason for discounting the evidence to the contrary other than the assertion of the persons alleging a failure. Thus, they did not objectively discount the evidence of complaint error as required. See Clark v. Takata Corp., 192 F.3d 750, 757 (7th Cir. 1999) ("Simply put, an expert does not assist the trier of fact in determining whether a product failed if he starts his analysis based upon the assumption that the product failed (the very question that he was called upon to resolve), and thus, the court's refusal to accept and give credence to [the expert's] opinion was proper.").

The trial court did not abuse its discretion in excluding the opinions, and summary judgment was warranted. 

Court of Appeals Reverses Daubert Decision

A tip of the hat to our DRI colleague Mike Weston for alerting us to an interesting 10th Circuit opinion from a couple weeks ago, Hoffman v. Ford Motor Co., 2012 WL 3518997 (10th Cir. Aug. 16, 2012).

Plaintiff was injured in a rollover car accident, and sued the car manufacturer alleging that a defect in the seat belt buckle caused it to release during the accident and allow her to be ejected from the vehicle.  In support of this theory, plaintiff presented the opinion of Dr. Good, a mechanical engineer, who theorized that the buckle most probably inertially unlatched during the accident due to an alleged design defect.  He ran a series of tests on buckles allegedly similar to the one in the accident, but ran into issues when he needed to make a comparison of the data from his lab tests to data from crash rollover tests to determine if the situation measured in the lab could actually occur in the real world.  Specifically, there was an absence of available data from relevant rollover crash tests (which present dynamic, multi-dimensional forces working on the component), and so he compared his results to data from planar crash data -- ones focused on only the horizontal plane (for example, a frontal car crash).

Ford moved to exclude the opinions as unreliable under Daubert, but the district court  (without a hearing) denied the motion, concluding Ford had failed to prove that the differences between the lab test results and the real world rollover accidents were significant.  Defendant appealed. (Note, whether she was even wearing her seat belt at all was hotly contested at trial. For purposes of the Daubert issue, the court assumed she was.) 

The court of appeals concluded that in permitting the testimony, the district court had not been "a sufficiently exacting gatekeeper; Daubert requires more precision."  Plaintiff failed to present a sufficient scientific connection between the accelerations and forces the expert found necessary to unlatch the buckles in the lab, and the acceleration and forces that would have occurred in the actual accident on the street. 

Specifically, the court of appeals held that the trial court should NOT have chastised the defendant for failing to show how the deficiency mattered, the failure to use rollover crash data. And the trial court should not have deemed it "unfair" for Ford to criticize the plaintiff because of the limited amount of rollover crash data available to the expert.  The state of the science is what it is.  And Ford did more than point out a deficiency in the method; it also explained why the deficiency rendered the testing and comparison suspect.  More importantly for our readers, "it was not Ford's burden to show Good's inertial unlatch opinion was unreliable and irrelevant.  Rather, it was plaintiff's burden to show reliability and relevancy."

It was undisputed engineering science that once a component is tested, the results must be applied to the whole vehicle setting; the lab results must be compared to data from the real world. Merely showing that similar buckles can be made to unlatch under certain lab conditions is irrelevant to whether the buckle at issue unlatched in the accident absent proof that the lab conditions were present and can be adequately and accurately related to the actual rollover-type accident.  Plaintiff's expert failed to explain adequately how the acceleration and forces present in the planar crash tests were similar enough to those present in a rollover accident. Nowhere did he show how his comparison was scientifically valid. Thus, his opinion was based on mere speculation, or on the assumption, that the levels of forces he found necessary to unlatch buckles in the lab were substantially similar to those that occurred in the subject accident.

Absent such evidence, plaintiff could not meet her burden.  Since plaintiff had a full and fair opportunity to present the case, and made no attempt to add or substitute other evidence, the court of appeals remanded with instruction for the district court to enter judgment as a matter of law for defendant.

 

 

Failure of Expert Testimony on Alternative Designs Dooms Claim

A New Jersey appeals court ruled recently that plaintiffs' expert testimony was indeed insufficient in a suit over a fire and explosion involving a furnace used to manufacture super alloys for aerospace uses. See Leonard et al. v. Consarc Corp., No. A-1413-10T4, (N.J. Superior Court,  Appellate Division).

Plaintiffs were employed by Howmet Dover Alloy, which uses a vacuum induction melting furnace (VIM) to manufacture super alloys for aerospace uses. Howmet contracted with Consarc to retrofit and upgrade a VIM located at its Dover facility. As part of that project, Consarc manufactured a new vacuum chamber and dome, an industrial crucible to fit inside the vacuum chamber, and controls for the device.  Allegedly, while Howmet employees were melting super alloys in the VIM's interior crucible, it tipped and spilled molten super alloy onto the floor, causing such extreme conditions of heat that fires broke out in adjacent areas. The fire department responded and got the blaze under control.

Allegedly, Howmet workers then began to assess the situation for clean-up. In an effort to get a better view of the condition of the crucible and chamber, the workers removed the glass from sight ports, opened various valves, and turned on the vacuum pumps to extract the smoke from the fire. The pumps expelled the smoke but also the argon gas used to suppress the fire. As the argon gas was removed, it was replaced by air drawn in through the sight ports, the now open valve, and, possibly, a hole in the chamber resulting from the original fire.

However, a substantial quantity of unburned oil and resulting vapor remained in the chamber, and  molten metal or still hot walls ignited the air-oil mixture and caused an explosion. Plaintiffs were allegedly injured.

They sued alleging defective product design. Plaintiffs retained a mechanical engineer as an expert in the analysis of "industrial accidents, mechanical malfunctions, fires and explosions." He issued a report which concluded that (1) the hydraulic hose used to deliver hydraulic fluid required to tilt the crucible containing the molten metal alloys was touching or extremely close to the interior floor of the chamber at the time of the accident, which constituted a defect in the design because the hose could not withstand coming into contact with molten alloy; and (2) the dome of the chamber was defectively designed because it should have been protected by exterior shields to repel any hazardous gases emerging from inside the furnace.

Defendant moved to exclude the expert as unqualified, but the trial judge concluded that he was qualified as an expert under Rule 702, and denied Consarc's motion. He held that, while the witness did "not have specific experience in the field of vacuum induction furnaces, [or] melting furnaces, [he] certainly has overall experience in the analysis of industrial accidents, mechanical malfunctions, fires and explosions."

At the conclusion of plaintiffs' case at trial, Consarc moved for an involuntary dismissal pursuant to NJ Rule 4:37-2(b).  Although the trial judge did not agree with all of Consarc's arguments in support of an involuntary dismissal, he granted the motion to dismiss on the following grounds: (1) the expert gave a net opinion as to the inadequacy of any existing hose and the proposed relocation of the connections for the interior hydraulic hose; (2) he gave a net opinion as to the
feasibility of placing protective shields around the dome of the furnace; and (3) Howmet's conduct after the explosion (the inspection actions) served as an intervening and superseding cause that precluded Consarc's liability.

In New Jersey, design defect is defined by the Products Liability Act, N.J.S.A. 2A:58C-1 to -11,
as something that renders a product not "reasonably fit, suitable, or safe for its intended purpose." N.J.S.A. 2A:58C-2. A design defect is further defined as a danger inherent in a product that has been manufactured as intended when that danger, as a public policy matter, is greater than can be justified by the product's utility.  When a product is manufactured as intended but the design renders the product unsafe, the first element of a design defect case exists.  In addition, the defect must have existed when the product left the hands of the manufacturer. If the plaintiff contends that an alternative design would have rendered the product safe, the plaintiff must also prove that a practical and feasible alternative design existed that would have reduced or prevented the harm.  Lewis v. Am. Cyanamid Co., 155 N.J. 544, 560 (1998).

A claim that there could have been an alternative design requires support by expert opinion that the proposed alternative design was available at the time of manufacture and that it was practical,
feasible and safer. Expert testimony in conclusory terms is insufficient to meet that burden. N.J.R.E. 703 requires an expert to give the why and wherefore of his or her opinion rather than a mere conclusion.  Jimenez v. GNOC, Corp., 286 N.J. Super. 533, 540 (App. Div.), certif. denied, 145 N.J. 374 (1996). Therefore, experts must be able to identify the factual bases for their conclusions, explain their methodology, and demonstrate that both the factual bases and the methodology are scientifically reliable.

Plaintiffs appealed, and the court of appeals affirmed.  The witness did not have the expertise or the factual basis for opining that there was a feasible alternate design for the hose connection points. As a consequence, his opinion amounted to nothing more than a net opinion. The same problems apply to his opinion with respect to the dome. He testified that there should have been shields around the top of the dome to prevent discharged material from injuring anyone standing nearby. He also asserted that it would have been very simple to do so. However, he was not aware of any such design in actual use and he provided no details to demonstrate that his proposed design was actually feasible. The witness had no expertise in the field of vacuum
induction furnaces. His qualifications were, at best, minimal with respect to the type of  sophisticated machinery involved in this case. More importantly, he offered no specifics with respect to the details and feasibility of the alternative designs upon which he relied. For that reason, plaintiffs failed to meet their burden to prove that alternate designs were available, feasible, and practical at the time of manufacture.

Supreme Court to Review Issue of Daubert at Class Certification Stage

The U.S. Supreme Court agreed last week to hear argument in a case in which the lower courts wrestled with the issue whether, at the class certification stage, a district court must resolve Daubert issues. See Comcast Corp. v. Behrend, U.S., No. 11-864 (cert. granted 6/25/12). The Court indicated it was interested in the question "whether a district court may certify a class action without resolving whether the plaintiff class has introduced admissible evidence, including expert testimony, to show that the case is susceptible to awarding damages on a classwide basis."

Readers will recall that in Wal-Mart Stores Inc. v. Dukes, 131 S. Ct. 2541 (2011)  the Supreme Court in dicta referenced the question. Justice Scalia observed that the district court had "concluded that Daubert did not apply to expert testimony at the certification stage of class-action proceedings," but the majority replied that "we doubt that is so." 131 S. Ct. at 2554. Thus, Dukes strongly suggested that it was appropriate for defendants to make the expert challenge at the class certification stage, and important for the court to resolve the issue then; the Comcast litigation may see the Court turn that persuasive dicta into binding precedent. 

Most district courts have been following the dicta. Historically, the Circuits have split.  The 8th and 9th Circuits call for an expert inquiry at this stage, and in American Honda, which we commented on here, the Seventh Circuit previously held that where an expert’s report or testimony is critical to class certification, a district court must conclusively rule on any challenge to the expert’s qualifications or submissions prior to ruling on the class certification motion. 600 F.3d at 815–16. Later, the Seventh Circuit reaffirmed its holding from American Honda, ruling that it was error for a district court to decline to rule on a Daubert motion at the class certification stage. Messner v. Northshore Univ. Healthsystem, 2012 U.S. App. LEXIS 731, *17 (7th Cir. Jan. 13, 2012).

The 3rd Circuit went in another direction. The district court in Comcast originally certified a class; following the court of appeals' decision in Hydrogen Peroxide, 552 F.3d 305, the district court granted in part Comcast‘s motion to reconsider its certification decision.  After further briefing, plaintiffs got the case re-certified after convincing the district court that they could show that they had an expert methodology to prove damages on a classwide basis. On the current appeal, the Third Circuit agreed that the lower court had applied the "rigorous analysis,"  adding that at the class certification stage, "we are precluded from addressing any merits inquiry unnecessary to making a Rule 23 determination.”  The Petitioners argued that the Third Circuit affirmed the certification order after expressly declining to consider several “merits” issues necessary to determine whether, as required by Rule 23(b)(3), common questions predominate over individual ones.

So the Comcast case may give the Supreme Court a chance to further explain what exactly a rigorous analysis should entail, especially with respect to alleged class-wide damages. The focus on damages, which some have viewed as narrowing the issue presented, still is a question that arises not just in antitrust cases, but also in mass torts, which are front and center for our readers. 

 

Court of Appeals Affirms Exclusion of Plaintiff Expert Testimony

The Sixth Circuit earlier this month affirmed the exclusion of plaintiff expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. See Simmons v. Novartis Pharmaceuticals Corp., No. 11-5053 (6th Cir., 6/5/12).

Simmons developed osteonecrosis of the jaw (ONJ), a bone disease affecting the jaw, allegedly as a result of using the prescription medications Zometa and Aredia. He sued and the Judicial Panel on Multidistrict Litigation transferred the action under 28 U.S.C. § 1407 to the United States District Court for the Middle District of Tennessee and assigned it to Chief Judge Todd Campbell.

To prove specific causation, plaintiff offered two experts. Plaintiff offered Dr. Obeid, a board-certified oral and maxillofacial surgeon who saw the plaintiff, and Dr. Edward Gutman an experienced oral surgeon. Defendant moved to exclude, inter alia, the testimony of Drs. Obeid and Gutman, on the issue of causation. The MDL court granted the motion to exclude any testimony by Dr. Obeid as
to the cause of Simmons’s injury, and by a separate order the district court granted defendant’s motion to exclude Dr. Gutman’s causation testimony. The court then granted defendant’s motion for summary judgment on all of plaintiff’s claims because plaintiff no longer had proof of an essential element of a product-liability claim under Maryland law, i.e., specific causation. Plaintiff appealed.

The court of appeals noted that a treating physician’s testimony is subject to Daubert. See Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419, 426 (6th Cir. 2009). Plaintiff was therefore required to demonstrate that Dr. Obeid’s reasoning or methodology was scientifically valid and that he properly applied that reasoning or methodology to the facts at issue. Plaintiff relied on Dr. Obeid’s statement that he found “a very close association” between ONJ and the class of drugs. However, Dr. Obeid also specifically acknowledged that he “didn’t establish causation” in evaluating Simmons’s ONJ.  Readers know that association is not causation.  Furthermore, Dr. Obeid agreed that the current level of evidence did not support a cause-and-effect relationship between bisphosphonate exposure and ONJ. While there were references to the medication in Dr. Obeid’s medical records, even if this was a "diagnosis," a diagnosis is merely a hypothesis, which does not satisfy Daubert and Rule 702. Moreover, nowhere in his testimony did Dr. Obeid rule out other conditions as the sole cause of Simmons' ONJ.

As to Dr. Gutman, the court noted that he had no knowledge of the etiologies of ONJ prior to meeting Simmons, and then gained only a limited familiarity based on literature supplied to him by plaintiff’s counsel. He had never treated any patients who were taking Aredia or Zometa or any other bisphosphonate, had never diagnosed a patient with ONJ, or determined a cause of
a patient’s ONJ.  Dr. Gutman admitted that he was not an expert on Zometa, Aredia, bisphosphonates, or ONJ, except as to Simmons’s case. He had no independent expertise from any other source other than six medical articles plaintiff’s counsel gave him; other than these
articles, there was no other "methodology" supporting his opinion.

The district court also did not abuse its discretion in excluding Dr. Gutman’s specific causation
opinion as unreliable because it was not derived from scientifically valid principles but
rather relied exclusively on the scientific literature provided by counsel. Dr. Gutman
made no attempt to verify this information, such as by doing his own research for other articles, and then drawing an independent conclusion. Courts view with special caution expert testimony prepared solely for purposes of litigation, rather than flowing from an expert’s line of scientific or technical work.  

Exclusions upheld; summary judgment affirmed.

Federal Court Denies Class Certification After Daubert Analysis

A  federal court late last month declined to certify three classes of consumers in litigation claiming that a defect in Harley-Davidson Motor Co. Inc.'s motorcycles caused severe wobbling and instability. See Steven C. Bruce, et al. v. Harley-Davidson Motor Co., Inc., et al., No. 2:09-cv-06588 (C.D. Cal.).

Plaintiffs were owners of Harley-Davidson motorcycles. According to plaintiffs, beginning in or before 2002, Harley-Davidson manufactured and sold touring motorcycles that had an alleged design defect in the form of an excessively flexible chassis. According to plaintiffs, the alleged defect caused “severe wobbling, weaving and/or instability,” especially occurring when riders made sweeping turns, and traveled at speeds above 55 miles per hour. Plaintiffs alleged that had they and other class members known of the defective nature of the vehicles, they would not have purchased or leased their motorcycles, or at least would have reduced the amount they were willing to pay for them. Hence, the classic alleged consumer fraud class action.

Plaintiffs moved for class certification, and relied on expert testimony to establish some of the Rule 23 elements.  Specifically, plaintiffs’ expert opined that a rider of a properly-designed
motorcycle should not experience a weave-mode instability event when riding within the
range of expected speeds.  He asserted that the class-purchased cycles shared a common design defect in the form of an “excessively flexible” chassis. The vehicles allegedly failed to “damp out,” or reduce, weave-mode oscillations to one half of their original amplitude within the time frame (a couple seconds) necessary to prevent them from becoming perceptible to the riders.

Defendants challenged the admissibility of that expert testimony under Daubert, contending that Rule 702 and Daubert apply with “full force” at the class certification stage. In support of this
position, Harley-Davidson relied primarily on Wal-Mart Stores, Inc., v. Dukes, 131 S. Ct. 2541 (2011), and Am. Honda Motor Co. v. Allen, 600 F.3d 813, 815–16 (7th Cir. 2010) (per curiam).  In Dukes, the Supreme Court noted that it doubted that Daubert did not apply at the certification stage of class-action proceedings. 131 S. Ct. at 2554. In American Honda, which we commented on here, the Seventh Circuit held that where an expert’s report or testimony is critical to class certification, a district court must conclusively rule on any challenge to the expert’s qualifications or submissions prior to ruling on the class certification motion. 600 F.3d at 815–16. Earlier this month, the Seventh Circuit reaffirmed its holding in American Honda, ruling that it was error for a district court to decline to rule on a Daubert motion at the class certification stage. Messner v. Northshore Univ. Healthsystem, 2012 U.S. App. LEXIS 731, *17 (7th Cir. Jan. 13, 2012).

Plaintiffs argued that a full Daubert inquiry into the reliability of expert opinions is not required or appropriate at the class certification stage. They cited In In re Zurn Pex Plumbing Prods. Liability Litig., 644 F.3d 604, 613 (8th Cir. 2011),which we criticized here, and in which the Eighth Circuit reasoned that an “exhaustive and conclusive Daubert inquiry before the completion of merits discovery” is not necessary due to the “inherently preliminary nature of pretrial evidentiary and
class certification rulings.”  See also Behrend v. Comcast Corp., 655 F. 3d 182, 204 n. 13 (3d Cir. 2011) (district court need not turn class certification into a "mini-trial”).

Here the district court found the approach adopted by the Eighth Circuit to be the appropriate application of Daubert at the class certification stage. Thus, a “tailored” or “focused” inquiry, to assess whether the experts’ opinions, based on their areas of expertise and the reliability of their analysis of the available evidence, should be considered in deciding the issues relating to class certification, said the court. Especially where discovery has been bifurcated into a class phase and a merits phase, an expert’s analysis may have to later adapt, as gaps in the available
evidence are filled in by merits discovery. Here, the court had granted defendants’ request for bifurcated discovery. Accordingly, the expert opinions would be assessed in light of the evidence currently available.

Even with a less than full inquiry, the court found that the proposed expert testimony must be excluded. In reaching this conclusion, the court decided the expert had not adequately
explained the scientific basis for his proposed standard, which also had not been accepted in
the field of motorcycle dynamics. While the evidence supported that the damping out of weave-mode oscillations may be an important factor for motorcycle stability, it did not establish that the expert's "rule" requiring the reduction of weave-mode oscillations to one half of their original amplitude within two seconds was scientifically valid.

The expert formed his opinions exclusively for the purposes of litigation and had not published his "rule" for peer review, providing further support for his exclusion.

Additionally, the court believed that he had not sufficiently accounted for other potential causes of the instability. He failed to consider and test for other possible causes including the use of non-specified tires and leaky shocks. See, e.g., Clausen v. M/V NEW CARISSA, 339 F. 3d 1049, 1058
(9th Cir. 2003) (“The expert must provide reasons for rejecting alternative hypotheses using scientific methods and procedures and elimination of those hypotheses must be founded on more than ‘subjective beliefs or unsupported speculation.’”).

Thus, plaintiffs failed to establish that common questions of law and fact predominated over individual inquiries. Once the opinions were excluded, plaintiffs failed to show that they had the ability to use common evidence by which they could demonstrate the defect. The fact that the chassis was the same for each vehicle ignored the failure to show how common evidence would ultimately be admissible to prove that they shared a common defect, and also was unavailing because it overlooked the Supreme Court’s admonition that a “rigorous analysis” will often “entail some overlap with the merits of the plaintiff’s underlying claim.” Dukes, 131 S. Ct. 2551.

Two Summary Judgments for Ladder Defendants Affirmed

Ladders and scaffolds are two of the most valuable tools we know.  And as the season for decorating approaches, we know MassTortDefense will soon be utilizing some, with due care of course.

Two federal courts of appeal have separately affirmed the dismissal of claims about personal injuries caused by allegedly defective Louisville Ladder Inc. products, because plaintiffs failed to offer sufficient expert testimony.

In Raymond B. Bielskis v. Louisville Ladder Inc., No. 10-1194 (7th Cir.), the court considered the appeal of a claim resulting from an accident that occurred when a Louisville Ladder mini-scaffold allegedly collapsed while plaintiff on an acoustical ceiling project.  Following the accident that injured his hand and knee, Bielskis filed suit alleging the ladder company had been negligent in failing to properly test and inspect the threaded stud of the caster stem that allegedly caused the collapse and in failing to warn consumers of the alleged manufacturing defect.

The mini-scaffold is approximately four feet long with a hinged side that allows it to collapse for storage. The sides of the scaffold have rungs which are used to place planks where the user may stand. The entire unit is mobile: it has four wheels that may be locked while the user is working and unlocked when moving the unit. Plaintiff alleged that it had collapsed because the caster stem above one of the wheels had broken. Bielskis retained an expert (Mizen) to provide expert testimony at trial as to what caused the caster stem to break. He opined that the fracture was caused by excess tensile stress brought on by over-tightening the threaded stem. Mizen concluded that the brittle fracture could have been avoided by either attaching the wheel with a different
mechanism than the threaded stud or by not tightening the stud “beyond making it simply snug to the leg base.” Louisville Ladder also retained an expert who also concluded that the caster stem had sustained a brittle fracture. Unlike Mizen, however, he determined that the caster stem ultimately failed because it was too loose, not because it was too tight.

Louisville Ladder moved to bar Mizen’s testimony, arguing that it was insufficiently reliable under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). In particular, Louisville Ladder faulted Mizen for his failure to utilize any recognized scientific methodology to reach his conclusions. The district court granted Louisville Ladder’s motion, concluding that the methodology underlying
Mizen’s opinion was insufficiently reliable. The primary problem the court identified with Mizen’s opinion was his leap, without data or testing, from the accepted premise that a crack without plastic deformation is a brittle fracture to his ultimate conclusion that the caster was too tight. When questioned as to what scientific methodology he used to reach this conclusion, Mizen replied that he had relied on “basic engineering intelligence” and “solid engineering principles that any other engineer would use.”

After Louisville Ladder moved to exclude his testimony, Mizen supplemented his opinion with several articles that he claimed supported his conclusion. He located the articles by using the Internet search engine Google and typing in the phrase “brittle fracture.”

The court of appeals agreed the district court was within its discretion to conclude that Mizen’s methodology sounded more like the sort of talking off the cuff—without sufficient data or analysis—that courts have repeatedly rejected.

Mizen made no attempt to test his hypothesis. His theory was certainly capable of being tested. He did not take the time to measure the caster stem; he had no idea what alloy was used to construct the caster stem and made no effort to quantify its tensile strength or yield strength. In contrast, Louisville Ladder’s expert used digital calipers to measure the various components, created positive and negative replicas of the fracture surfaces so that the fractographic appearance of the surfaces could be examined in detail and then performed stress analysis calculations with the caster installed in two different configurations in order to assess the stresses present
at the stud site with different degrees of tightness.

Likewise, Mizen’s proposed design alternatives did not survive scrutiny.  When asked if those design alternatives had been tested, Mizen stated, “I don’t have to test it.” Likewise, he dismissed the question of whether any of his proposed design alternatives were used in the marketplace
on scaffolds or had been recommended or required by any industry-wide standards for climbing equipment.  Without more, there is no way to assure that Mizen’s proposed alternatives are “the product of reliable principles and methods.”

Absent expert testimony, summary judgment would follow, but plaintiffs argued res ipsa.  While plaintiff showed a scaffold could be expected not to break and collapse under the weight of a single individual working on it, he failed to prove that the scaffold was defective at the time it left Louisville Ladder’s control. The mini-scaffold was already assembled when Bielskis’s employer gave it to him.   Plaintiff did not present any evidence about who assembled the scaffold and whether it was assembled in conformity with the manufacturer’s warnings or specifications. Plaintiff's expert had neither reviewed the scaffold assembly instructions nor ascertained who had assembled the scaffold.

In Robert Cannioto et al. v. Louisville Ladder Inc., et al., No. 11-12885 (11th Cir.), the court concluded that the district court did not abuse its discretion in excluding the expert testimony
of the plaintiffs’ principal expert witness.  The court rejected plaintiffs "malfunction theory" under Cassisi v. Maytag Company, 396 So.2d 1140 (Fla. 1st DCA 1981).  There, the Florida appellate court held that a legal inference is created that a product was defective at the time of injury or the time of sale when it malfunctions during normal use. The district court correctly concluded that the Cassisi inference was not applicable to this case because the ladder in question still existed and had been inspected by the plaintiffs’ expert. The record also demonstrated that the plaintiff failed to subject the ladder to a normal operation. The ladder was set up at too steep an angle at the time of plaintiff's fall.  The court affirmed the grant of summary judgment in favor of the defendants.

 

Substantial Cause Explored in Case of Multiple Exposures

The Sixth Circuit issues and interesting opinion last week, exploring plaintiff's burden to prove that exposure to defendant's product caused his injury in the context in which plaintiff was exposed to numerous other similar products. See Moeller v. Garlock Sealing Technologies LLC, No. 09-5670, (6th Cir., 9/28/11).

Plaintiff was a pipefitter who worked with asbestos-containing gaskets made by Garlock from about 1962 until about 1970. But from 1962 until about 1975, he also sustained significant exposure to asbestos insulation. He contracted mesothelioma and sued, alleging that his exposure to Garlock’s asbestos-containing gaskets was a substantial factor in causing his injuries.

At trial, plaintiff's expert testified that exposure to asbestos from Garlock gaskets, along with his other exposures, contributed to the mesothelioma. And one of the treating oncologists opined  that if plaintiff had worked for many years (as he did) scraping and grinding asbestos gaskets, and if plaintiff breathed those fibers, then that exposure would have caused his cancer. In rebuttal, Garlock presented evidence that plaintiff had sustained substantial exposure to asbestos insulation products for 13 years. It also presented evidence that whereas asbestos insulation was banned in the 1970s, leading asbestos safety authorities believed that gaskets, such as those sold by Garlock, posed “no health hazard,” and were sold lawfully in the United States. Garlock also suggested that the plaintiff had only installed Garlock gaskets (an activity that both parties agree did not create a risk of injury), and had not ever removed them (the activity that the plaintiff alleges caused the injuries).

The jury returned a verdict for plaintiff, and defendant appealed.

To prevail on a negligence claim, Kentucky law requires a plaintiff to prove that a defendant’s conduct was a substantial factor in bringing about the harm. Deutsch v. Shein, 597 S.W.2d 141, 144 (Ky. 1980). Causation requires a link between the specific defendant’s conduct and the plaintiff’s injuries. See Estes v. Gibson, 257 S.W.2d 604, 607 (Ky. 1953) . Substantial causation refers to the probable cause, as opposed to a possible cause. One measure of whether an action is a substantial factor is the number of other factors which contribute in producing the harm and the extent of the effect which they have in producing it.

The appeals court concluded that the plaintiff failed to prove that Garlock’s product was a substantial factor in bringing about the harm. The plaintiff presented various witnesses to support the claim that the mesothelioma was caused by his exposure to Garlock gaskets. But one expert never actually said that the exposure to Garlock gaskets was a substantial factor in causing the  cancer; the others testified that all types of asbestos can cause mesothelioma and that any asbestos exposure counts as a “contributing factor.”  That testimony does not establish that exposure to Garlock gaskets in and of itself was a substantial factor.

Moreover, the evidence presented was insufficient to allow a jury to infer that exposure to Garlock gaskets was a substantial cause of the cancer. Plaintiff here presented no evidence quantifying  exposure to asbestos from Garlock gaskets. There was testimony that he removed gaskets for several years, and that some of those gaskets were Garlock’s. But the plaintiff failed to establish how many Garlock gaskets he removed, or how frequently he removed—as opposed to installed—them. The record also shows that plaintiff regularly tore out asbestos insulation during the relevant years, and that his exposure to asbestos from insulation would have been thousands of times greater than his exposure from removing gaskets.

Thus, while his exposure to Garlock gaskets may have contributed to his mesothelioma, the record simply does not support an inference that it was a substantial cause of his mesothelioma. Given that the Plaintiff failed to quantify his exposure to asbestos from Garlock gaskets and that the Plaintiff concedes that he sustained massive exposure to asbestos from non-Garlock sources, there is simply insufficient evidence to infer that Garlock gaskets probably, as opposed to possibly, were a substantial cause of the injury.

The court summed it up: saying that exposure to Garlock gaskets was a substantial cause of plaintiff’s mesothelioma would be akin to saying that one who pours a bucket of water into the
ocean has substantially contributed to the ocean’s volume.

 

Medical Monitoring Claim Rejected in Rail Spill

The Sixth Circuit recently rejected the medical monitoring claims of a putative class of residents of a small Ohio town who alleged exposure to chemicals released after a CSX Transportation Inc. train accidentally derailed. Jonathan Hirsch et al. v. CSX Transportation Inc., No. 09-4548 (6th Cir. Sept. 8, 2011).

On October 10, 2007, thirty-one cars of a CSX train derailed and caught fire near the town of Painesville, Ohio. As a precaution, emergency personnel removed about 1,300 people from the surrounding half-mile radius. Most of what burned in this fire was non-toxic, but nine of the cars were carrying potentially hazardous materials. The plaintiffs claimed that 2,800 tons of burning material were sent into the surrounding atmosphere, and that, as a result, the level of dioxin in their town was significantly elevated.

While the fire was still burning, several residents of the town brought suit against CSX;  the district court did not allow the plaintiffs to pursue an independent cause of action for medical monitoring, but decided a court-supervised medical monitoring was available as an equitable remedy under Ohio law. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63-65 (Ohio 2004); see also Day v. NLO, 851 F. Supp. 869, 880 (S.D. Ohio 1994).  Defendant then moved for summary judgment, which was granted. The district court held that the plaintiffs had failed to meet their burden to show that (1) the dioxin released into the air by the fire is a known cause of human disease; and (2) that the named plaintiffs were exposed to dioxin in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring. The plaintiffs timely appealed.

The court of appeals focused on the issues of causation and injury. Rather than traditional personal injuries, the alleged injuries consisted solely of the increased risk of—and corresponding cost of screening for—certain diseases that, according to plaintiffs, were more likely to occur as a result of the train crash. Assuming that Ohio would recognize such an injury, the remedy would be a medical monitoring program that would spare the Plaintiffs these expenses. But were plaintiffs actually at such an increased risk of disease that they were entitled to a medical monitoring program? Not every exposure, not every increased risk risk of disease warrants increased medical scrutiny. For the plaintiffs to prevail, there must be evidence that a reasonable physician would order medical monitoring for them.

Plaintiffs hired several experts to try to meet this burden. (No Daubert issue raised; the issue was sufficiency, not admissibility.). They offered a chemical engineer who tested the community for levels of dioxin. He assumed a normal background level of dioxin at 4 parts per trillion and took measurements around Painesville to compare with this baseline. His measurements
showed elevated levels near the crash site.  Plaintiffs had a chemist who speculated about train cargo, nature and amounts; then, a physicist who plotted the dispersion and concentration of the chemicals from the fire on a map for the purpose of showing which members of the community were exposed to what levels of dioxin. Then a medical doctor used this map to determine who in the community was likely exposed to levels of dioxin above what the EPA considers acceptable—levels at which the risk of cancer increases by "one case in one million exposed persons."

The court of appeals saw at least two problems with this offer.  One issue was the use of the regulatory level. The expert not only accepted the risk of one in a million as the threshold for monitoring, but appeared to have halved it. “One should be afforded the benefit of medical
monitoring, if one has sustained a dose equal to or in excess of 50% of the EPA maximum.” There was little explanation as to why he believed that reasonable physicians would order expensive and burdensome testing for such a small risk, but he explained he wanted "to err on the side of patient safety.”  However, a one-in-a-million chance is small. Indeed, it is proverbially small. If something has a one-in-a-million chance of causing cancer in an individual, then it will not cause cancer in 999,999. For some perspective, the National Safety Council estimates a person’s lifetime risk of dying in a motor vehicle accident as 1 in 88. The lifetime risk of dying in “air and space transport accidents” is roughly 1 in 7,000. The risk of being killed by lightning
is roughly 1 in 84,000, while the risk of being killed in a “fireworks discharge” stands at around 1 in 386,000. So, a small risk and no basis to say it called for medical monitoring.  Certainly the EPA didn't base its standard on any medical monitoring analysis.

Second, the doctor based based his assessment on the exposure map.  But the map was unreliable. The estimate of the total material burned was speculative. The expert admitted that “the fire temperature, particle size distribution, and fire area were not established.” And there were other sources of exposure not accounted for.

Plaintiffs thus alleged only a risk that bordered on legal insignificance, and failed to produce evidence establishing with any degree of certainty that they had even this hypothetical risk.

Summary judgment affirmed.

Third Circuit Upholds Exclusion of Plaintiff's Causation Expert

The Third Circuit last week affirmed the exclusion of expert testimony in a toxic tort suit in which plaintiff alleged defendants' insecticide products gave him non-Hodgkin's lymphoma. Pritchard v. Dow AgroSciences, et al., No.10-2168 (3d Cir. 2011).

Plaintiff claimed that he contracted cancer from a pesticide produced by defendant Dow AgroSciences. His wife claimed to have suffered derivative injuries. In support of their complaint, the Pritchards solicited the expert testimony of Dr. Bennet I. Omalu, who provided the District Court with a report and, later, a declaration, stating that Dursban caused the cancer.  Although the trial court found Dr. Omalu to be a qualified expert, it ruled (on Dow's motion) that his proposed testimony was unreliable and therefore inadmissible at trial under Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The exclusion of Dr. Omalu's testimony doomed the lawsuit, because plaintiffs had no other evidence of causation.  Plaintiffs appealed.

The appeal tried to raise the issues surrounding the intersection of federal law, rules of evidence underlying Daubert, and state law, which supplies the elements of a claim (including causation) in a diversity case. Plaintiffs argued that in the course of finding that Dr. Omalu's testimony was unreliable, the District Court erroneously relied on principles that were supposedly at odds with state (Pennsylvania) substantive law governing the level of certainty required to establish causation, having to do with idiopathic disease and epidemiological studies.

It is true that the trial court noted that Dr. Omalu did not rule out unknown or idiopathic causes; that the court considered the fact that the epidemiological study on which the doctor wished to rely showed only a relative risk of 2.0; and that the court observed that the proposed testimony was not grounded in science as Dr. Omalu has not presented any statistically significant evidence showing an association between the chemical agent at issue and non-Hodgkins lymphoma. See Pritchard v. Dow Agro Sciences, 705 F. Supp. 2d 471, 492, 486, 493 (W.D. Pa. 2010).

However, the trial court considered these factors among “a host of other deficiencies,” as components of a determination that the proffered testimony failed to satisfy the admissibility standard. The trial court did not adopt any bright-line rules, but instead evaluated the plaintiffs' proffer using a flexible approach as directed by the Court of Appeals in Heller v. Shaw Industries, 167 F.3d 146 (3d Cir. 1999).  This was an evidentiary ruling, separate and distinct from any substantive question regarding causation (which the court never had reason to reach).

Plaintiffs also argued that the court had engaged in some kind of improper balancing of plaintiffs' scientific evidence vs. defendants'. But the district court engaged in no such balancing. Instead, it rightly concluded that Dr. Omalu's proposed testimony was unreliable due to numerous cracks in its scientific foundation.  He cited only one specific study in support of his general causation conclusion that Dursban causes cancer — and in fact, he relied not on the study itself but on his own reinterpretation of the study's findings using a lower confidence interval. (That is, he recalculated the study's conclusions so as to serve plaintiff's litigation needs, said the court.)   Moreover, the plaintiffs offered no clear explanation of the methods through which he recalculated the study's results, leaving the court unable to evaluate the reliability of his methodology.

And the expert's specific causation conclusion that Dursban had caused Mr. Pritchard's illness was not supported by evidence in the medical records, discovery responses, deposition testimony, application records, or any other information regarding Mr. Pritchard's exposure to pesticides.  Significantly, Dr. Omalu also failed to adequately address possible alternative causes of the cancer.

Accordingly, the trial committed no error in excluding the expert testimony, and in the absence of proof of causation, the case was properly dismissed. Affirmed.

 

Appeals Court Upholds Summary Judgment Based on Daubert in Benzene Case

The Sixth Circuit last week upheld the dismissal of a plaintiff''s claim that benzene exposure caused her cancer. Pluck v. BP Oil Pipeline Co., No. 09-4572 (6th Cir.,  5/12/11).  The central issue was the exclusion of plaintiff's causation expert's opinion based on a "differential diagnosis" that failed to reliably rule in benzene exposure as a potential cause of plaintiff's cancer, and to rule out some other potential exposures.

This case arose from benzene contamination allegedly caused by gas-pipeline releases allegedly resulting in the seepage of gasoline into the surrounding soil and groundwater. Benzene, a component of gasoline, is a known carcinogen in sufficient doses under certain exposure circumstances, and is also ubiquitous in the ambient air and is a component or constituent of vehicle exhaust and cigarette smoke, said the court. Plaintiffs purchased a home in the area,  and used well water to drink, wash, shower, and irrigate their yard and garden. In October,  1996, plaintiffs say they noticed a gasoline odor in their home and water, and benzene was first detected in the well on their property in the amount of 3.6 parts per billion (“ppb”).  They began drinking bottled water in lieu of tap water, although they claim to have resumed drinking tap water upon the drilling of a new, deeper well. Between 1997 and May 2002, the new well tested negative for benzene twenty-two times.

Mrs. Pluck was diagnosed with Non-Hodgkins lymphoma (“NHL”) in 2002 at age forty-eight. She filed suit, alleging claims of strict liability for hazardous activity, negligence, and loss of consortium. To support their claims, plaintiff and spouse retained Drs. Joseph Landolph and James Dahlgren as experts on causation to demonstrate that benzene is generally capable of causing NHL and specifically caused Mrs. Pluck’s NHL. Defendant filed motions in limine to exclude the testimony of Dahlgren and Landolph on the grounds that their testimony failed to satisfy the standard for reliability set forth in Daubert. In particular, BP argued that Dr. Dahlgren’s testimony on specific causation was unreliable because he formulated a specific causation opinion without evidence of dose, and subsequently performed an unreliable dose reconstruction in an attempt to support his opinion.  Dahlgren then submitted a supplemental declaration in which he evaluated Mrs. Pluck’s illness under a "differential-diagnosis" methodology. The district court granted the motions, and plaintiff appealed.

In a toxic tort case, as here, the plaintiff must establish both general and specific causation through proof that the toxic substance is capable of causing, and did cause, the plaintiff’s alleged injury.  As to specific causation, the plaintiff must show that she was exposed to the toxic substance and that the level of exposure was sufficient to induce the complained-of medical condition (based on a dose-response relationship). Both causation inquiries involve scientific assessments that must be established through the testimony of a medical expert. Without this testimony, a plaintiff’s toxic tort claim will fail.

The Plucks had to concede that the expert Dr. Dahlgren did not establish dose; they instead argued that Dahlgren used differential diagnosis to determine specific causation. Defendant argued that Dr. Dahlgren did not apply differential diagnosis in either his expert opinion or his deposition, but did so only in an untimely supplemental declaration filed five months after the deadline for expert reports. And in any event, his approach was flawed. The Sixth Circuit has recognized differential diagnosis, properly done, as an appropriate method for making a determination of causation for an individual instance of disease. Differential diagnosis -- originally a standard technique for determining what disease caused a patient's symptoms -- has been adapted in some courts as an acceptable scientific technique for identifying the cause of a medical problem by eliminating the likely causes until the most probable one is isolated. A physician who applies differential diagnosis to determine causation considers all ("rules in") relevant potential causes of the symptoms and then eliminates ("rules out") alternative causes based on a physical examination, clinical tests, and a thorough case history.

Even in courts that accept this adapted method, not every opinion that is reached via a differential-diagnosis method will meet the standard of reliability required by Daubert.  Calling something a “differential diagnosis” or “differential etiology” does not by itself answer the reliability question but prompts at least three more:

(1) Did the expert make an accurate diagnosis of the nature of the disease?

(2) Did the expert reliably rule in the possible causes of it?

(3) Did the expert reliably rule out the rejected causes?

If the court answers “no” to any of these questions, the court must exclude the ultimate conclusion reached.

Here the court agreed that Dahlgren could not reliably “rule in” benzene exposure as the cause of Mrs. Pluck’s NHL. In recognition of the fact that benzene poses a health concern at certain levels of exposure, the EPA has stated that the maximum permissible contaminant level for benzene in
drinking water is 5 ppb. 40 C.F.R. § 141.61(a)(2). Dahlgren, however, did not ascertain Mrs. Pluck’s level of benzene exposure, nor did he determine even whether she was exposed to quantities of benzene exceeding the EPA’s safety regulations. The levels of benzene in the Plucks’ wells never exceeded the maximum permissible contaminant level of 5 ppb designated by the EPA.

Dahlgren’s opinion that Mrs. Pluck’s “low-level exposure” to benzene caused her NHL was thus not grounded in “sufficient facts or data,”  nor did it reflect the “reliable principles and methods” required by Rule 702. It was, instead, pure conjecture.  Although the Plucks argued that the district court required too much specificity regarding Mrs. Pluck’s dose, this argument was also without merit. The mere existence of a toxin in the environment is insufficient to establish causation without proof that the level of exposure incurred could cause the plaintiff’s symptoms. See also McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1242 (11th Cir. 2005) (causation “requires not simply proof of exposure to the substance, but proof of enough exposure to cause the plaintiff’s specific illness”).

Finally, even if Dr. Dahlgren had properly “ruled in” benzene exposure as the cause plaintiff's NHL, he failed to “rule out” alternative causes of her illness, as is required under the differential-diagnosis methodology. See also Wills v. Amerada Hess Corp., 379 F.3d 32, 50 (2d Cir. 2004) (expert’s opinion suffered from a “fatal flaw” when he acknowledged that cigarettes and alcohol were risk factors for developing squamous-cell carcinoma but failed to account for these variables in concluding that decedent’s cancer was caused by exposure to toxic chemicals such as benzene and PAHs).  In this case, Dahlgren acknowledged in his deposition that Mrs. Pluck was
exposed to other sources of benzene, from her extensive smoking habit and from other organic solvents.  Yet, Dr. Dahlgren neither identified these other solvents nor determined Mrs. Pluck’s potential level of exposure to these other possible sources of benzene.Thus, Dahlgren failed to “rule out” alternative causes of Mrs. Pluck’s NHL.

The court of appeals determined that the district court did not abuse its discretion in concluding that the expert did not perform a reliable differential diagnosis.  And summary judgment properly followed.

 

Observations from Judges on Scientific Evidence

I spoke last week at a CLE seminar on "Chemical Products Liability and Environmental Litigation."  One of the panels included an array of federal and state court judges who offered their thoughts on a number of interesting topics, including Daubert/Frye issues.

No surprise for the savvy readers of MassTortDefense, but one clear takeaway is that judges have differing views and approaches on a variety of expert-related issues, including when they hold a hearing vs. deciding on the paper, and when they want the experts to appear live vs. argument.

There were a few areas of consensus. 

  • The panel agreed you need to know your judge, learn his or her preferences, and know how busy their docket is. 
  • In Daubert or Frye hearings, don't waste time on Rule 56 or Rule 702 black letter law.
  • In filings, always cite to the record so the judge or clerk can find the basis of factual assertions. This was called a "lost art."
  • A stipulated joint glossary of key terms is appreciated when possible.

The judges agreed that they are not overly impressed with arguments noting the expert was excluded by other courts on other cases.  If the facts are nearly identical, and they respect the other judge, and there is an opinion or order with some reasoning, they may give it some weight.  But if the expert opinion was also admitted in some other cases, this may cancel out the influence of prior exclusions.

Finally, while many lawyers talk about filing an iffy or uncertain motion to "educate" the court as to important science issues, the panel suggested this often doesn't help. There may be a time lag between the motion and trial; and the loss of momentum from losing a motion may have carry-over effects in the litigation.

 

Interesting Case Management Issue in Welding MDL

We have posted about the welding fumes MDL before. Call it case management by option-- as the court has worked through the bellwether trials, it is interesting that the MDL court gave the next-up plaintiff (in the Street trial) a choice.  Plaintiff could either (1) maintain his existing trial date of June 1, 2011, at which trial he may not offer the opinions of his expert Dr. Sanchez-Ramos; or (2) postpone the starting date for trial of his case until on or about November 1, 2011, and the Court would conduct a Daubert hearing on the admissibility of Dr. Sanchez-Ramos’s opinions during the summer of 2011.

Plaintiff Street chose the second option. Accordingly, the MDL Court has set the Daubert hearing to begin on August 24, 2011, with the expectation the hearing will last two days. The parties were directed to negotiate a schedule for briefing, expert depositions, and so on, and provide it to the Special Master as soon as possible. The schedule will include a deadline of April 5, 2011, for provision by Dr. Sanchez-Ramos of a supplemental expert report and literature review list.


Trial of the Street case was accordingly postponed to November 1, 2011. The Court said it will
discuss trial preparation deadlines with the parties during the next case management teleconference.  In re Welding Fume Products Liability Litigation,  No. 1:03-CV-17000 (N.D. Ohio, 3/25/11).  

Appeals Court Applies Sophisticated User Doctrine

A California appeals court earlier this month affirmed a trial court's dismissal of a product liability failure to warn claim, based on the sophisticated user doctrine. Walkowiak v. MP Associates, No. B220494, (Cal. Ct. App., 2d App. Dist., 3/9/11)(not published).

Plaintiff Christopher Walkowiak began working for a special effects company in the movie industry in 1994. His boss had a Class 1 Pyrotechnic Operator license, and Walkowiak received on-the-job training in special effects. He obtained a Class 3 Pyrotechnic Operator license in 1995 and a Class 2 license in 1998. In order to obtain these licenses, Walkowiak had to obtain references from pyrotechnicians and pass a written examination. The written examination was general in nature and did not cover every specific types of explosive device used in productions.

Defendant MP Associates (MP) manufactures pyrotechnic devices. Defendant Roger George Rentals (RGR) rents and sells special effects supplies, including pyrotechnic devices manufactured by MP. Its primary clientele is the entertainment industry. One of the products they sold was a simulated stinger missile (SSM). The SSM consists of a cardboard tube with a red plastic cap on one end and a white plastic cap on the other end. The tube contains pyrotechnic materials near the end with the red plastic cap. Prior to ignition, the white plastic cap is to be removed. Upon ignition, a pellet of pyrotechnic material is propelled out of the end of the tube by gunpowder. It produces bright white light and smoke, and it travels about 200 feet. It simulates the appearance of a missile. Pretty clever, and can fool the camera.

The SSM had a sticker on the side of the cardboard tube which read, “Dangerous. Handle With Care. Keep Fire Away.” This was a standard warning that MP placed on all of the pyrotechnic devices it sold. The SSM also had a piece of tape over the white plastic cap which read, “Remove Before Ignition. This Side Up.” Once the tape was removed, there was nothing on the SSM to indicate which end was to face up. Packaging materials which came with the SSM included a list of “Dos and Don’ts” which applied to pyrotechnic devices in general. The list included the warning not to “use any explosive material unless completely familiar with safe procedures for their use, or under the direction of competent, experienced persons.” However, the packaging materials did not include any specific instructions for use of the SSM.  The manufacturer sold SSMs only to purchasers with a Class 1 or Class 2 Pyrotechnic Operator license. And the company would personally discuss use of the SSM with the purchaser. Since 1998, MP had reportedly sold over 20,000 SSMs. Until the accident in this case, there had been no misfires or injuries resulting from the use of an SSM.

On January 18, 2007, Walkowiak was working on the movie set for “Charlie Wilson’s War.”  His supervisor instructed Walkowiak to test fire an SSM that had been leftover from a previous production, using the same shoulder launcher that had been used in “Over There.” The shoulder launcher consisted of a steel tube bolted to a rifle stock. The steel tube was closed at the end bolted to the rifle stock. The SSM was loaded into the open end of the steel tube. It was fired by means of a battery-operated power switch which was connected to the SSM by wires. Walkowiak’s Class 2 license allowed him to use the SSM fired from a shoulder launcher under the supervision of a Class 1 license holder.

But Walkowiak had not worked on “Over There.” He had never fired an SSM before or seen an SSM loaded into a shoulder launcher. He had not seen any instructions for using the SSM. What he did know was that the SSM was a controlled pyrotechnic device that was potentially dangerous. He knew that he should get questions regarding its use answered before using it. Walkowiak called one of the defendants and asked how to operate the shoulder launcher. Defendant told him how to wire and prepare the launcher. He did not tell Walkowiak how to load the SSM into the launcher, however. Before loading the SSM into the shoulder launcher, Walkowiak saw tape with printing on one end of the SSM. He did not recall seeing the words “Remove Before Ignition” or “This Side Up” on the tape. However, he understood these words to mean that the cap and tape should be removed before discharging the SSM, and “This Side Up” referred to the discharge end of the SSM.

Walkowiak removed the cap and the tape from the SSM. Walkowiak made the decision as to how to load the SSM into the shoulder launcher. Walkowiak loaded the SSM into the shoulder launcher and connected the wires. He believed he was loading the device safely and correctly. He knelt down and pointed the shoulder launcher toward a wall. After a countdown, Walkowiak fired the device. There was an explosion and a bright flash of light. The SSM exploded in the steel tube. The steel tube broke off the rifle stock and hit Walkowiak in the face, causing severe injury. It was determined that he had loaded the SSM in backwards.

Plaintiff sued the various parties in the chain of distribution of the SSM.  The trial court dismissed the claim.  The trial court explained that merely because an accident has occurred, there is no presumption of a defect or negligence.  In this case, Walkowiak had not shown that the device had any physical, manufacturing or design defect. There was no evidence of even a single incident where the device was used properly but caused this kind of injury.  Therefore, the trial court noted, the only potential basis for imposing liability on defendants was the breach of a duty to warn of a danger. The court added, however, that product liability cannot be based on failure to warn of a danger that is known or obvious to a user, under California law. Failure to warn of a danger that is generally known and recognized does not, by itself, render a product dangerous.

Plaintiff appealed. The court of appeals discussed the doctrine of sophisticated user. In explaining the development of the sophisticated user defense, the state Supreme Court had begun with the general principle that manufacturers have a duty to warn consumers about the hazards inherent in their products. This enables consumers to avoid the hazards through careful use of the products or refraining from using the products altogether.  However, the sophisticated user defense exempts manufacturers from their typical obligation to provide product users with warnings about the products’ potential hazards. It provides that sophisticated users need not be warned about dangers of which they are already aware or should be aware. Because these sophisticated users are charged with knowing the particular product’s dangers, the failure to warn about those dangers is not the legal cause of any harm that product may cause. The rationale supporting the defense is that the failure to provide warnings about risks already known to a sophisticated purchaser usually is not a proximate cause of harm resulting from those risks suffered by the buyer’s employees or downstream purchasers. This is because the user’s knowledge of the dangers is the equivalent of prior notice.

In California, a manufacturer is not liable to a sophisticated user of its product for failure to warn of a risk, harm, or danger, if the sophisticated user knew or should have known of that risk, harm, or danger. An objective test applies, because it would be nearly impossible for a manufacturer to predict or determine whether a given user or member of the sophisticated group actually has knowledge of the dangers because of the infinite number of user idiosyncrasies. Hence, even if a user was truly unaware of a product’s hazards, that fact is irrelevant if the danger was objectively obvious to the expert user.  And, the defense applies to both negligence and strict liability causes of action.

Here, Walkowiak’s own deposition testimony supported the finding that he was a sophisticated user of pyrotechnics. He had a Class 2 Pyrotechnic Operator license and years of experience in special effects. He knew that the SSM was a controlled pyrotechnic device and potentially dangerous. He understood the nature of the warnings provided on and with the SSM. He knew to ask for instructions on how to operate the device, and in fact asked for some information. In other words, said the court, Walkowiak knew or should have known of the risk involved in use of the SSM.

That Walkowiak did not have experience using the SSM and could only use it under supervision did not establish that he was unaware of the risks associated with its use. His testimony established that he was aware of the risks: he knew the SSM was dangerous, and he understood the nature of the warnings on the device, “Remove Before Ignition” and “This Side Up.” He simply did not know how to use the SSM with the shoulder launcher. Plaintiff could cite no authority, however, that would require a manufacturer not only to apprise a user of the risks associated with use of its product but also to provide instruction on how to use the product in a device it did not manufacture. 

(The court remanded the design defect claim, under the risk benefit test, as the trial court had jumped the gun on its conclusion that an alternate design would make the SSM unsuitable for other uses.)


 

State Supreme Court Affirms Exclusion of Unsound Expert Opinion

The Arkansas Supreme Court upheld recently the decision of a state trial court to bar a methodologically unsound expert report that sought to link fertilizer to a child's cancer.  Green v. George's Farms Inc., No. 10-26 (Ark. 2/17/11).

Defendants/Appellees were engaged in the poultry-production business in northwest Arkansas. For decades, their feeds have included the additive 3-Nitro, an FDA-approved product that is used to promote growth and prevent disease. Feed turns into excrement. Growers typically remove the chicken litter from poultry houses once a year, and the litter is then applied as fertilizer -- in this case to the fields surrounding plaintiffs' home, including areas near several schools. The chicken litter is spread primarily in the spring and fall, commonly at a ratio of two tons per acre. Sounds like good recycling.  But, said the court, roxarsone, an organic derivative of arsenic, comprises twenty percent of the ingredients contained in 3-Nitro. Arsenic, said the court, is a carcinogen and is considered both a cancer-causing agent and a promoter of cancer. The roxarsone that is fed to the chickens degrades into an inorganic form of arsenic that is excreted by the chickens.

Plaintiff Michael Green, was born and raised in the neighborhood near the schools and fields. In the fall of 1999, he experienced unexplained bruising, and was eventually diagnosed with a rare form of leukemia called chronic myelogenous leukemia (CML). He sued, alleging that the arsenic-laced litter produced by roxarsone-fed chickens polluted the air as a result of ventilating the chicken houses, and that dust clouds formed when the litter is spread, and that exposure to this inorganic arsenic caused his leukemia. (Other plaintiffs joined in the complaint, but the trial court severed the claims of the other plaintiffs.)  

In pretrial rulings, the circuit court granted summary judgment in favor of defendants on the issue of causation. Additionally, the court excluded under the Daubert rule all testimony pertaining to certain parts of a report entitled “Exposures to Carcinogenic Arsenicals and Other Toxic Substances in Washington County, Arkansas,” prepared by plaintiffs’ expert, Dr. Rod O’Connor.

On the (first) appeal the supreme court held that a question of fact remained on the issue of causation. Green I, 373 Ark. at 396, 284 S.W.3d at 42–43. However, the court found no abuse of discretion in the circuit court’s decision to exclude the testimony. Id. at 408, 284 S.W.3d at 51. On remand, the trial court granted a directed verdict, and this, the second appeal, ensued.

Noting that the lack of publication and peer review had influenced the court’s earlier decision, appellants asserted that Dr. O’Connor’s work had since been peer reviewed and published, and thus it should have been admitted on remand. Defendants responded that the law-of-the-case
doctrine precluded reconsideration of this issue. The trial court found that the published article utilized the same unreliable methodology to estimate peak air exposure concentration that it had previously ruled inadmissible. The trial court also stated that the expert's calculations were based on unreasonable assumptions and scientifically unsound mathematical extrapolations from dust samples collected in the area, and that Dr. O’Connor continued to use a formula that the EPA had warned should only be used to determine air levels of lead. The trial court found that the theory advanced by the expert had never been tested and still had not been sufficiently tested by any other scientist.

The doctrine of law of the case prohibits a court from reconsidering issues of law and fact that have already been decided in a case. The doctrine also provides that a decision of an appellate court establishes the law of the case for the trial upon remand and for the appellate court itself upon subsequent review. The law-of-the-case doctrine in some forms also prevents consideration of an argument that could have been raised at the first appeal and is not made until a subsequent appeal.  The doctrine serves to effectuate efficiency and finality in the judicial process, and its purpose is to maintain consistency.  The law-of-the-case doctrine is conclusive only where the facts on the second case/appeal are substantially the same as those involved in the prior appeal, and it does not apply if there was a material change in the facts.

And that was one of the issues here. The record reflected that the rejected parts of Dr. O’Connor’s report included his calculations relating to inhalation exposure reconstruction that were based on a formula for converting measurements of arsenic in dust to measurements of arsenic in air.  Plaintiffs argued that publication and peer review of his methodology represented a material change in circumstances that would permit reconsideration of this issue. However, the court recognized that publication is not a talisman or "get out of jail free" card from our favorite old board game. It was not apparent to the court whether the specific inhalation exposure reconstruction reflected in the report was indeed subjected to peer review in the article. The fact of publication (or lack thereof) in a peer reviewed journal thus is a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised. 

Here, the absence of peer review and publication was but one factor in the overall assessment of the validity of Dr. O’Connor’s methodology. Given the serious flaws exposed in the expert's methods, the court was not persuaded that the publication of the article in a peer-reviewed journal constitutes a new fact that is sufficiently material to overcome the law-of- the-case doctrine. Further, plaintiffs’ argument that criticisms of his methods should only affect the weight but not the admissibility of the evidence was also barred by law of the case.

 

State Supreme Court Vacates Plaintiff Verdict After Trial By Ambush

The Mississippi Supreme Court has vacated a $4.5 million verdict in favor of plaintiffs in a case against defendant Hyundai over a serious car accident. Hyundai Motor America v. Applewhite, No. 2008-CA-01101-SCT (Miss., 2/10/11).

Casino co- workers Dorothy Applewhite, Cecilia Cooper, and Anthony Stewart were traveling in Applewhite's 1993 Hyundai Excel after work.  It is unclear who was driving, but the two women were in the front seats, and Stewart was in the rear seat. A co-worker traveling ahead of them testified that he noticed the car weaving, drifting onto the shoulder, and finally swerving into the northbound lane, where it collided with another vehicle. The Excel separated into two pieces. All three passengers in the Excel died at the scene of the accident. 

Family members of the three decedents sued Hyundai. At trial, the plaintiffs undertook to prove that the Excel was not crashworthy due to alleged defects in both its design and manufacture, including the welds in the vehicle. Plaintiffs offered the testimony of several expert witnesses, including Andrew Webb, an accident reconstructionist.  Webb testified that he had used a computer program to reconstruct the accident and concluded that, had the Excel remained intact, the occupants would have experienced a change in velocity of thirty-five miles per hour. Another expert then testified that at thirty-five miles per hour, it was more likely than not that the occupants would have survived the crash.

The jury awarded the plaintiffs $4.5 million, or $1.5 million for each of three decedents, finding that the automobile at issue was defective in both its design and manufacture.

On appeal, Hyundai argued that it was entitled to a new trial because it was ambushed by changes
to Webb’s opinion. As noted, one of Webb’s main contentions was that, had the Excel remained
intact, the vehicle would have experienced a change in velocity (delta-v) of no more than thirty-five miles per hour. Hyundai deposed Webb before trial, at which time Webb gave a detailed
explanation of his calculations. Months after the deposition, Webb signed an errata sheet concerning his deposition testimony, changing four key variables that he had used to make his calculations. Most notably, Webb changed the angle of the Excel from 22 degrees to 44 degrees and increased the closing speed of the Excel from 68 miles per hour to 78 miles per hour. Despite these dramatic changes, Webb did not alter his ultimate conclusion that the car would have sustained a delta-v of only thirty-five miles per hour had it remained intact.

At trial, Webb testified about the errata sheet, claiming that he had to change several variables because he realized after he had been deposed that he had made some mistakes in his initial analysis. It is undisputed that Webb’s errata sheet was not done to correct errors made by the court reporter or to clarify his testimony. On the sheet itself, Webb listed the reason for the changes simply as “range not asked.”

Hyundai moved to strike Webb’s testimony at trial, alleging that it had never received the errata sheet during discovery and that these changes were a surprise. In response, the plaintiffs argued that the changes were not material because they did not alter Webb’s ultimate conclusion. The plaintiffs also produced a letter trying to demonstrate that they had forwarded Webb’s errata sheet to the defendant. The trial court heard extensive arguments on the issue and denied the defendant’s motion.

The Supreme Court did not agree.  The discovery rules impose a duty on the parties to amend a prior response when the party knows that the response, though correct when made, is no longer
true and the circumstances are such that a failure to amend the response is in substance a
knowing concealment. The failure seasonably to supplement or amend a response is a discovery violation that may warrant sanctions, including exclusion of evidence. Whether the plaintiffs did or did not send the errata sheet was unnecessary and irrelevant to a proper analysis. Even if Hyundai did receive the errata sheet, simply giving the defendant this document did not relieve the plaintiffs of their duties under the rules. The purpose of an errata sheet is to correct scrivener’s errors or provide minor clarification; it is not a means of making material, substantive changes to a witness’s testimony. See e.g., Garcia v. Pueblo Country Club, 399 F.3d 1233, 1242 n.5 (10th Cir. 2002) (“A deposition is not a take home examination.”) If a witness changes his testimony in a manner that conflicts with prior discovery responses, the sponsoring party has a duty under the rules (Rule 26(f) in this state) seasonably and formally to amend or supplement the response -- not try to sneak it through in an errata sheet. This the responsibility of the party sponsoring the witness, not the responsibility of the witness.

The plaintiffs argued that Webb’s changes were not material because they did not alter his opinion that, had the car not separated, the occupants would have experienced a delta-v of only thirty-five miles per hour. The Court did not agree. The changes in Webb’s calculations were material changes because they were essential components of the basis for his opinion. When Hyundai attempted to cross-examine Webb about his calculations, Webb referred to his errata sheet at least seven times to demonstrate that he had corrected his mistakes. It is clear from Webb’s own trial testimony that the figures on the errata sheet were important to his calculations. Moreover, when Hyundai’s experts performed crash testing, they relied on and used the figures given by Webb in his deposition in an attempt to test his opinions and refute his testimony. When Webb changed his calculations, the entire crash test using Webb’s initial calculations lost much of its relevance.  

The Court found that the trial judge abused his discretion by not enforcing the rules, noting "we do
not condone trial by ambush." Hyundai was entitled to full and complete disclosure of the plaintiffs’ expert testimony, and neither these plaintiffs nor any other party litigant may rely on a witness’s notations on a deposition errata sheet as a substitute for formal and timely supplementation. 

Court of Appeals Affirms Exclusion of Plaintiff Causation Experts in Toxic Tort Case

Insecticide manufacturers held on to summary judgment as the Eight Circuit affirmed the lower court's causation ruling under DaubertJunk v. Terminix International Co., No. 08-3811 (8th Cir., 12/9/10).

The plaintiffs'  home had been infested with spiders during the mother's pregnancy, and she contacted Terminix about the problem.  Defendant thereafter sprayed a pesticide inside and outside the Junks' home, approximately 20 times, the last occurring two years after her son's birth. Junk alleged that the child's multiple medical conditions were caused by exposure to ingredients in Dursban, an insecticide manufactured by Dow, distributed by Terminix.

The defendants moved to exclude the causation testimony of plaintiffs' two medical experts, and for summary judgment.  The trial court first excluded the testimony of Dr. Richard Fenske, who had been retained to determine whether the son had been exposed to an unsafe level of the insecticide during his mother's pregnancy and after his birth. Dr. Fenske testified that when making toxic exposure and dosage estimates he usually relied on a "deterministic modeling" method in which he creates an exposure model that accounts for numerous variables. In this case, however, he did not have sufficient data to perform such an analysis. Instead, he compared what he knew about the circumstances of the child's exposure with those in published studies. This comparative analysis led him to conclude that plaintiff had been exposed to an unsafe level. Observing that Dr. Fenske had not followed his own usual methodology and concluding that he had relied on a number of ungrounded assumptions in his comparative approach, the district court excluded his opinion on the ground that his methodology was not sufficiently reliable.

Dr. Cynthia Bearer's testimony was also excluded. She was a neonatologist and board certified pediatrician whom Junk retained to give her opinion on general and specific causation.  Because Dr. Bearer's opinion on specific causation relied on Dr. Fenske's conclusions, after the court excluded Dr. Fenske's testimony, it found Dr. Bearer's opinion on specific causation also lacked a scientific factual basis and declined to admit it.

Plaintiffs appealed.

The court of appeals agreed that Dr. Fenske's comparative analysis depended on various unsupported assumptions. He did not account for differences between conditions in the Junk household and those described in the articles he consulted. In one instance, his only basis for comparison was the fact that the Junk household and those in a particular study were all treated with the Dursban ingredient chlorpyrifos. In another, he relied on a study where the only common variable between the Junks' experience and the homes studied was the total amount of chlorpyrifos applied. Dr. Fenske thus disregarded other important variables such as where and how chlorpyrifos was applied in the household and whether the homes in a comparison study were the same size as the Junks' home.


While Dr. Fenske was not required to produce a mathematically precise table equating levels of exposure with levels of harm, he was required to have a "scientifically valid" method to estimate that plaintiff's exposure exceeded a safe level. The expert's failure to follow his own general practice and his reliance on unfounded assumptions in his comparative method created "too great an analytical gap" between his opinion and the data on which it relied.

Because Dr. Bearer's differential diagnosis depended on Dr. Fenske's opinion on exposure, the district court did not abuse its discretion in excluding it. A differential diagnosis begins with an expert's "ruling in" plausible causes of an injury. See Kudabeck v. Kroger Co., 338 F.3d 856, 860–61 (8th Cir. 2003). Then the expert "rules out" less likely causes until the most likely cause remains. Without a scientific basis for including unsafe chlorpyrifos exposure in her differential, her opinion amounted to speculation.

To succeed in her claims, Junk needed to present expert testimony showing that the chlorpyfiros could have caused the son's injuries and that it did in fact cause those injuries. Junk's  experts did not survive the district court's Daubert analysis. After the court properly excluded Dr. Bearer's
testimony, Junk could not prove specific causation as required under Iowa law. As there was no longer a genuine issue of material fact as to that necessary element, Dow and Terminix were entitled to judgment.

 

 
 

Proof of General Causation in Drug Case Not Automatic

A West Virginia federal court has granted summary judgment against a plaintiff alleging that the heartburn drug metoclopramide caused her tardive dyskinesia.  Meade v. Parsley, et al., 2010 WL 4909435 (S.D.W.Va.,  11/24/10).

Since its approval by the Food and Drug Administration in 1980, metoclopramide has been widely used to treat gastroesophageal reflux disease (“GRD”), nausea, and gastroparesis.  Plaintiff's treater, Dr. Deidre Parsley, prescribed metoclopramide to Mrs. Meade in order to treat her
GRD, nausea, and loss of appetite. Plaintiff  never read any written materials accompanying her metoclopramide prescriptions, which included a statement that therapy longer than 12 weeks has not been evaluated and cannot be recommended.  Dr. Parsley likewise did not read the metoclopramide package insert or any other written materials produced by PLIVA before prescribing the drug to Mrs. Meade. After the drug usage, the FDA added a black box warning about tardive dyskinesia.  But, save for the placement of the warning in a black box, the previous warning seemed not too different.

Plaintiffs contended that the warnings were inadequate in that they misleadingly invited long term use that has never been approved by the FDA, despite the fact that the warning did state that therapy longer than 12 weeks has not been evaluated and cannot be recommended. In addition,
plaintiffs claim that the warnings downplayed the seriousness and potential irreversibility of the risk of tardive dyskinesia in long term use, but the warning did state that the risk is highest among the elderly, especially elderly women (like this plaintiff), and that the likelihood of irreversibility is believed to increase with the duration of treatment and the total cumulative dose. 

Defendant moved for summary judgment, contending that there were no genuine issues of material fact inasmuch as (1) plaintiffs could not establish causation; (2) Dr. Parsley was aware of the risks of using metoclopramide when she prescribed the drug to Mrs. Meade; (3) PLIVA satisfied any alleged duty to warn by providing a package insert explaining potential side effects of
metoclopramide.  The court never had to reach the third argument.

In a pharmaceutical products liability action, a plaintiff must initially establish both general and specific causation for his injuries. Bourne ex rel. Bourne v. E.I. Dupont de Nemours & Co., 189 F. Supp. 2d 482, 485 (S.D. W. Va. 2002).  General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. In re Rezulin Prods. Liab. Litig., 369 F.
Supp. 2d 398, 402 (S.D.N.Y. 2005); In re Hanford Nuclear Reservation Litig., 292 F.3d 1124, 1129 (9th Cir. 2002). General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease.

In addition to general and specific causation, plaintiffs must establish proximate causation.To
show proximate causation in a failure-to-warn case based on an allegedly inadequate drug label, a plaintiff must show that a different label or warning would have avoided the plaintiff’s injuries. The court noted that the West Virginia Supreme Court has not had occasion to clarify whether a drug manufacturer must warn both the patient and the physician, or just the patient.  But it did not need to resolve this issue in evaluating proximate causation, however, because the undisputed evidence shows that an adequate warning would not have changed either Mrs. Meade’s or Dr. Parsley’s behavior in a manner which would have avoided Mrs. Meade’s injury.  Rather than merely showing that “adequate warnings would have changed behavior,”  as plaintiff argued, plaintiffs must
establish that an adequate warning would have changed behavior in a manner which would have avoided the plaintiff’s injury.  Mrs. Meade testified that she never read the package insert or any other documents accompanying her metoclopramide prescription.  Dr. Parsley likewise testified that she did not read the metoclopramide warning. And while Dr. Parsley did read the PDR for
the brand name version of the drug, it is undisputed that the defendant did not create that PDR.

The more interesting part of the opinion for our readers is the treatment of the issue of general causation.  It seems that none of plaintiffs’ retained experts offered any opinions regarding general
causation. So plaintiffs were left to argue that several of Mrs. Meade’s treating physicians (whom plaintiffs began referring to as “non-retained experts”) testified regarding the causal link between metoclopramide and tardive dyskinesia. None of these non-retained experts provided written
reports, and in deposition none of these physicians testified directly as to general causation. They assumed causation as a prelude to a specific causation opinion, but this mere assumption does not establish general causation. The law is clear that a mere possibility of causation and, more
specifically, indeterminate expert testimony on causation that is based solely on possibility is not sufficient to allow a reasonable juror to find causation. 

As an alternative basis for general causation, plaintiffs tried to rely on the fact that defendant's own package inserts and brand name warnings refer to a "causal link” between metoclopramide and tardive dyskinesia. Plaintiffs could cite no authority for the proposition that a plaintiff in a pharmaceutical products liability case can satisfy his or her burden of proving general causation by relying on the defendant manufacturer’s drug label warnings. Moreover, this contention was undermined by the general principle that causation evidence in toxic tort cases must be in the form of expert scientific testimony.  PLIVA’s drug label, which merely warns of metoclopramide’s potential side-effects without explaining the scientific basis for the warning, was no substitute for expert testimony that establishes causation in terms of reasonable probability.

Third, plaintiffs also tried to cite, as evidence of general causation, the subsequent FDA directive requiring drug manufacturers to insert a black box warning on metoclopramide labels to convey a
greater risk of tardive dyskinesia. The court, as have several other courts have, however, rejected reliance on agency determinations as a basis for general causation. Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concluded that the FDA-mandated tardive dyskinesia warning cannot establish general causation.

 Summary judgment granted.

Claim Against Starbucks For Hot Tea Rejected

A federal appeals court has upheld the exclusion of plaintiffs' experts in a design defect case alleging Starbucks Coffee Co.'s tea/coffee cup design caused severe burns to an elderly customer. See Moltner v. Starbucks Coffee Co., No. 09-4943 (2d Cir. 11/2/10).

Plaintiff alleged she purchased a venti-sized cup of tea, served double-cupped and lidded. She had difficulty removing the lid, and in the course of her attempts to pry it off, she alleged that the tea spilled onto her left leg, causing severe burns.

In support of her design defect claim, she presented the reports of four experts. The District Court for the Southern District of New York excluded the experts under Daubert and granted the coffee maker summary judgment.

The Second Circuit unanimously agreed that proof from Moltner's these design defect experts failed to meet the standards of Federal Rule of Evidence 702.  As the district court discussed, and the court of appeals affirmed, the first (Diller) report was unreliable because its conclusions were conclusory, devoid of any factual or analytical basis, and this report thus did not demonstrate a sufficient level of intellectual rigor. The second (Dr. Gerstman) report likewise was unreliable because it does not state the basis or analysis from which its conclusions were derived.  Third, the (Anders) report was the product of a method of testing that was insufficiently reliable and lacked “the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” The report by a fourth expert (DiMaria), which supported Moltner's negligence claim, was properly barred because it would not assist the jury in determining whether Starbucks breached its duty of care to the plaintiff.

We note this decision not so much for the Daubert analysis (which is not lengthy), but because it strikes us as another good example of what is wrong with so much product liability litigation today.  An elderly woman with serious injury is a sympathetic plaintiff in front of a jury.  But such a case should never get to a jury. The panel also rejected Moltner’s theory of negligence as infirm as a matter of law under Fung-Yee Ng v. Barnes & Noble, Inc., 764 N.Y.S.2d 183, 183-84 (1st Dep’t 2003) (“‘Double cupping’ is a method well known in the industry as a way of preventing a cup of hot tea from burning one’s hand.”).  Products are not defective just because they are capable of being involved in an injury.  Products need not be designed to prevent any injury no matter what the consumer does with the product.   Almost every design choice, including something as simple as double cupping, may have potential impact on the relative risks of injury.   A proper negligence analysis supports the decision to minimize the risk of injuries, yet juries are often incapable of confirming that analysis when confronted with a sympathetic plaintiff.  And while they should, juries confronted with a seriously injured plaintiff may find it difficult to recognize the proper role of personal responsibility in cases like this: regardless of the design of the cup or lid, when you are dealing with a very hot beverage, you must exercise precaution; it's a matter of common sense, common knowledge, common awareness. Hence the need for rules keeping out junk science and the need for courts to grant summary judgment. 


 

Court of Appeals Vacates Jury Verdict for Plaintiff in Welding Case

The Sixth Circuit last week vacated one of the rare plaintiff verdicts in the welding rod litigation.  Tamraz  v. Lincoln Electric Co., et al., 2010 WL  3489002 (6th Cir. 9/8/10).  The key issue in the appeal was the trial court's decision to allow a causation expert, Dr. Walter Carlini, to testify on behalf of the plaintiff Jeff Tamraz over defendants' Daubert challenge.

From roughly 1979 to 2004, Jeff Tamraz worked as an independent-contracting welder in California, on bridges and buildings.  Plaintiffs contended that Mr. Tamraz suffers from manganese-induced Parkinsonism as a result of exposure to manganese-containing welding fumes on these jobs.

The case went to trial in 2007, and the jury in the Northern District of Ohio (plaintiffs are from Oregon) returned a plaintiff verdict, awarding $17.5 million to Jeff Tamraz in compensatory damages and $3 million to his wife, Terry Tamraz, for loss of consortium.

Defendants, including Lincoln Electric, Hobart Brothers Co. and ESAB Group Inc., appealed on various grounds, including the trial court's decision to permit the testimony of Dr. Carlini on causation issues despite the Daubert challenge.

The opinion offers a number of useful observations for toxic tort litigation, especially on the almost-always central issue of causation.

It begins with a nice overview of the science on the spectrum of movement disorders often termed "parkinsonism" that have different causes and different but overlapping symptoms.  No one disputed that plaintiff here suffered from parkinsonism; the questions were what kind and from what cause. Apparently, every doctor to examine Tamraz reached a different conclusion about one or both of those issues.  Plaintiff's expert concluded that Tamraz suffers from “manganese-induced parkinsonism,” but not in the sense of a manifestation of the disease "manganism," as that phrase is sometimes used in these welding cases. Rather, he believed that manganese exposure caused something closely akin to traditional Parkinson's Disease in Tamraz.  Dr. Carlini hypothesized that Tamraz might have a genetic predisposition to Parkinson's Disease, and that manganese in lower levels than necessary to cause true manganism might nevertheless “trigger” the symptoms of Parkinson's Disease, like “the straw that broke the camel's back.” He did not believe that Tamraz has Parkinson's Disease in the strict medical sense, but manganese caused a disease that he believed to be otherwise similar to Parkinson's Disease. 

Defendants disputed this conclusion that manganese exposure caused the illness; that is, they challenged Dr. Carlini's etiology (what caused the disorder diagnosed?), not the methodology to arrive at his general spectrum diagnosis (what disorder caused the set of symptoms observed?).  And the Sixth Circuit agreed there were serious issues here. The problem here was that, when Dr. Carlini testified that manganese exposure caused Tamraz's condition, he went beyond the boundaries of allowable testimony under Rule 702.

The opinion was at most a working hypothesis, not admissible scientific “knowledge.” Fed.R.Evid. 702. His theory was a "plausible hypothesis. It may even be right. But it is no more than a hypothesis."  For example, the expert admitted that the literature hypothesizing a link between environmental toxins and latent genetic Parkinson's Disease was “all theoretical.”  He also conceded there were no studies finding a link between manganese and true Parkinson's Disease.  He further he conceded that he was speculating that Tamraz had an underlying predisposition to Parkinson's Disease, even though Tamraz had no family history of Parkinson's Disease. 

And finally, even if manganese could cause Parkinson's Disease in someone like Tamraz, that did not show that manganese did cause Tamraz's Parkinson's Disease. Parkinson's Disease occurs commonly in the general population and usually without any known cause. Any given case of Parkinson's Disease thus might have occurred regardless of the manganese exposure, making it hard to attribute one case to manganese exposure over all of the other possible causes.

Plaintiffs stressed on appeal that Dr. Carlini opined “with a reasonable degree of medical certainty,” but the court of appeals correctly noted that the phrase --the conclusion by itself-- does not make a causation opinion admissible. The “ipse dixit of the expert” alone is not sufficient to permit the admission of an opinion. General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). Minus that one phrase, nothing in this testimony took the opinion beyond speculation, theory, hypothesis. 

Plaintiffs, understandably, also tried to bolster the opinion by emphasizing areas of agreement among experts on the general diagnosis of some parkinsonism disorder.  But in conflating “manganese-induced parkinsonism” with manganism, plaintiff conflated diagnosis with etiology, erasing the distinction between Tamraz's disease and what caused it. Diagnosis and etiology, however, both were in play in this case. Because Dr. Carlini diagnosed Tamraz with something akin to Parkinson's Disease, not manganism, and because Parkinson's Disease unlike manganism has no standard etiology and lots of idiopathic cases, Dr. Carlini's etiology opinion had to rise or fall on its own.

Plaintiffs also trotted out the standard "differential diagnosis" argument, the tent that supposedly (and too often does) covers all kinds of unreliable causation opinions from medical experts.  The court here made some very useful observations about this issue. 

1) Most treating physicians have more training in and experience with diagnosis than etiology. See D. Faigman, Judges as “Amateur Scientists”, 86 B . U. L.Rev. 1207, 1221-22 (2006); E. Imwinkelried, The Admissibility and Legal Sufficiency of Testimony About Differential Diagnosis (Etiology), 56 Baylor L.Rev. 391, 405 (2004); M. Henefin, Reference Guide on Medical Testimony, in Reference Manual on Scientific Evidence 439, 471-72 (2d ed.2000). 

2) When physicians think about etiology in a clinical setting, moreover, they may think about it in a different way from the way judges and juries think about it in a courtroom. 

3) Getting the diagnosis right matters greatly to a treating physician, as a bungled diagnosis can lead to unnecessary procedures at best and death at worst. See Bowers v. Norfolk S. Corp., 537 F.Supp.2d 1343, 1361 (M.D.Ga.2007). But with etiology, the same physician may often follow a precautionary principle: If a particular factor might cause a disease, and the factor is readily avoidable, why not advise the patient to avoid it? Such advice  --telling a worker, say, to use a respirator-- can do little harm, think the doctors, and might do some good. See J. Hollingsworth & E. Lasker, The Case Against Differential Diagnosis: Daubert, Medical Causation Testimony, and the Scientific Method, 37 J. Health L. 85, 98 (2004). A lower threshold for making a causation decision serves well in the clinic but not in the courtroom, said the court. 

Of course, some courts permit the physician to testify as to etiology using this methodology, e.g., Hardyman v. Norfolk & W. Ry. Co., 243 F.3d 255, 260-67 (6th Cir.2001), but even these courts must apply the Daubert principles carefully in considering it. The ability to diagnose medical conditions is not remotely the same as the ability to deduce, in a scientifically reliable manner, the causes of those medical conditions. Gass v. Marriott Hotel Servs., Inc., 501 F.Supp.2d 1011, 1019 (W.D.Mich.2007), rev'd on other grounds, 558 F.3d 419 (6th Cir.2009). Doctors thus may testify to both, at least in the Sixth Circuit, but the reliability of one does not guarantee the reliability of the other. 

Thus, whether plaintiffs described Dr. Carlini's causation methodology as “differential etiology” or “differential diagnosis,” that label does not make it reliable. Using the differential diagnosis method is not some "incantation that opens the Daubert gate.”  The issues remain, did the expert make an accurate diagnosis of the nature of the disease? Did the expert reliably rule in the possible causes of it? Did the expert reliably rule out the rejected causes? If the court answers “no” to any of these questions, the court must exclude the ultimate conclusion reached. See Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 179 (6th Cir .2009).

Here, Dr. Carlini's opinion failed the last two prongs because his efforts to “rule in” manganese exposure as a possible cause, or to “rule out” other possible causes, turned on speculation and theory and hypothesis, not a valid methodology. 

While expressing sympathy for the plaintiffs, the court observed that ignoring Rule 702 — allowing the law to "get ahead of science" — would be just as unfair. Such an approach eventually would destroy jobs and stifle innovation unnecessarily, because it would impose liability on business based on speculation, not science.

Case remanded for new trial, with different evidence obviously. 

(The dissent would have found the challenge going to the weight, not admissibility of the testimony, and the trial court's decision not an abuse of discretion.)

Lone Pine Ruling Affirmed in Vioxx

The Sergeant Joe Friday character on Dragnet was created and played by actor Jack Webb.  Like so many famous lines, the immortal words, "Just the facts, ma'am," were apparently never uttered by the character.  What Friday actually said in early episodes is "All we want are the facts, ma'am."  

Either way, that's our motto when we post about litigation the firm has been involved in.  But with that limitation, a noteworthy decision is In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010).

After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement (MSA).  PTO 28 required non-settling plaintiffs to notify their healthcare providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply could result in dismissal of the plaintiffs' claims with prejudice.

PTO 28 is characterized as a Lone Pine order, named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986). Lone Pine orders are designed to handle the complex issues and potential burdens on the aprties and the court in mass tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).

The trial court extended deadlines, but eventually defendant Merck moved for an Order to Show Cause as to sixty-one plaintiffs for alleged failure to provide a case-specific expert report as required by PTO 28. The plaintiffs filed responses, arguing that they were in substantial compliance with PTO 28 and that state substantive law only required general forms of causation proof. In April 2009, the district court dismissed these plaintiffs' complaints with prejudice for failure to comply with PTO 28.

A district court's adoption of a Lone Pine order and decision to dismiss a case for failing to comply with a Lone Pine order are reviewed for abuse of discretion. Acuna, 200 F.3d at 340-41. The district court stated that “it is not too much to ask a plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury.”

The court of appeals had previously held that such orders are issued under the wide discretion afforded district judges over the management of discovery under Federal Rule 16. The court had held that the Lone Pine orders essentially required information which plaintiffs should have had before filing their claims pursuant to Rule 11.  Each plaintiff should have at least some information regarding the nature of his injuries, the circumstances under which he could have been exposed to harmful substances, and the basis for believing that the named defendants were responsible for his injuries.

The Fifth Circuit reaffirmed its view that it is within a trial court's discretion to take steps to manage the complex and potentially very burdensome discovery that these mass tort cases would require. The court of appeals thus affirmed the judgment of the district court.
 

Plaintiff Expert Must Exclude Other Plausible Causation Theories

In an interesting products/fire case, the Texas Supreme Court confirmed last week that a plaintiff's expert must explain or disprove alternative causation theories to establish plaintiff's causation theory. See Wal-Mart Stores Inc. v. MerrellNo. 09-0224  (Tex. 6/18/10).

Plaintiffs' decedents died from smoke inhalation in the bedroom of their rented home. When police officers arrived, they found in the living room a badly burned recliner, a damaged pole-style floor lamp, and other furniture covered in soot and smoke. There were candles, melted wax, an ashtray, and smoking paraphernalia throughout the house, including ash trays, a "bong," and marijuana cigarette butts. The fire marshal declared the fire accidental and of unknown origin. Then, plaintiffs brought wrongful death and survival claims against Wal-Mart, alleging that a halogen lamp in the apartment, purchased from Wal-Mart, caused the fire.

Merrell’s expert, Dr. Beyler, attributed the fire to “nonpassive failure" of the lamp igniting the recliner below it.  He opined that the lamp’s halogen bulb exploded, sending burning glass shards onto the recliner, which smoldered for several hours. Beyer admitted there were possible other mechanisms.  But he purported to rule out smoking materials as the cause because none
were found in the immediate “area of origin” of the fire. He also purported to rule out the candles as the cause of the fire because, had the candles been the source of ignition, the candle wax on the
table allegedly would not have survived the exposure.

Wal-Mart’s expert, John Lentini, testified that the more likely cause of this fire was careless disposal of smoking materials.

Wal-Mart contended on appeal that even if Beyler’s testimony was properly admitted, it constituted no evidence of causation because his opinion lacked factual substantiation and therefor was too
conclusory.  Specifically, Wal-Mart contended that Beyler’s testimony did not show that the lamp was more likely to have caused the fire than any other obvious potential sources.

The general rule here is that opinion testimony that is conclusory or speculative is not relevant evidence, because it does not tend to make the existence of a material fact more probable
or less probable. Such conclusory statements cannot support a judgment. 

The Court conducted a careful review of the record, reminding readers how important the details, nuances, language of expert reports and testimony can be, especially in close cases. While much attention is given to the support the expert has for the chosen theory, equal attention should be given to the expert's attempt to rule out other possible mechanisms.

The Court concluded that Beyler did not really answer why a burning cigarette could not have caused the fire. He dismissed as irrelevant the fact that post-mortem toxicology reports revealed that the decedents had been smoking the very night of the fire because, according to Beyler, that
evidence did not provide data relevant to the investigation of causes available in the area of
origin.  But, relating to the recliner, it was unexplained why not having found evidence of burnt cigarettes right there was significant when there was likewise no evidence of charred or exploded glass either in the recliner or anywhere else in the house -- which was his adopted theory. So, while Beyler did undertake to eliminate one potential cause of the fire that might otherwise seem on a par with the lamp theory, the melted candle wax, he provided no coherent explanation for why lit smoking materials could not have been the source.

An expert’s failure to explain or adequately disprove alternative theories of causation makes his or her own theory speculative and conclusory. See Gen. Motors Corp. v. Iracheta, 161 S.W.3d 462, 470 (Tex. 2005) (expert eliminated the obvious possibility that fuel or vapors from the tank filler neck ignited only by saying so, offering no other basis for his opinion. Such a bare opinion was not
enough.).

Causation opinion insufficient. Judgment for defendant.

Expert on "Ethics" Rejected in Device MDL

The federal court overseeing the MDL concerning an allegedly defective stress urinary incontinence device has issued a number of rulings on defendant Mentor Corp.'s motions to exclude various plaintiff experts. The one we want to focus our readers on is the order granting the company's motion to exclude the testimony of a so-called "business ethicist," who was proffered to testify about the supposed inappropriateness of Mentor's conduct relating to the warnings about the ObTape device.  In re Mentor Corp. ObTape TransObdurator Sling Prods. Liab. Litig., 2010 WL 1727828 (M.D. Ga. Apr. 27, 2010).

Mentor developed a device called ObTape Transobturator Tape (“ObTape”), which was used to treat women with stress urinary incontinence. Plaintiffs contended that the allegedly defective design of ObTape caused complications that resulted in significant injuries, including serious infections and erosion of the tape. Of course, every ObTape package included an FDA-approved Product Insert Data Sheet which listed vaginal erosion, urethral erosion, and infection as possible complications associated with ObTape. The Judicial Panel on Multidistrict Litigation transferred the several federal products liability cases to the Middle District of Georgia in 2008. Ahead of the upcoming trials in the bellwether cases, both parties filed various motions in limine to exclude the other's expert  witnesses.

Plaintiffs intended to offer Professor Ann Buchholtz, Ph.D., as an "ethics" expert. Prof. Buchholtz proposed to opine about defendant's alleged ethical duty to protect the safety of patients and its ethical duty to provide information to physicians and patients. Specifically, she asserted, based on a review of selected internal Mentor documents, that certain information about ObTape should have been reported to the FDA and to physicians and patients. Mentor contended that Prof. Buchholtz’s ethics opinions should not be permitted because (1) the opinions would not assist the jury, (2) the opinions are unreliable, and (3) Prof. Buchholtz is not qualified to render the opinions.

For an expert’s testimony to “assist” the trier of fact, the evidence must have a valid scientific connection to the disputed facts in the case. A court may exclude expert testimony that is imprecise and unspecific, or whose factual basis is not adequately explained. Cook ex rel. Tessier v. Sheriff of Monroe County, Fla., 402 F.3d 1092, 1111 (11th Cir. 2005).  Expert testimony is generally only admissible if it concerns matters that are beyond the understanding of the average lay person. Proffered expert testimony generally will not help the trier of fact when it offers nothing more than what lawyers for the parties can argue in closing arguments.

And that is the precise problem with so-called business ethics experts who testify merely to highlight plaintiff counsel's interpretation of cherry-picked internal documents; to testify as to ethical standards that are not legal standards at issue in the case; to invade the province of the jury by substituting the witness' conclusions about the appropriateness of the defendant's conduct; and to work the jury into a lather with a subjective, supposedly expert view of that conduct. See generally In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531 (S.D.N.Y. 2004). Personal views on corporate ethics and morality are not expert opinions. See In re: Diet Drugs Prod. Liab. Litig., 2001 WL 454586 at *9 (E.D.Pa. Feb. 1, 2001); see also In re Trasylol Products Liab. Litig., MDL-1928, 2010 WL 1489793 (S.D.Fla.Feb. 24, 2010).  Expert testimony about a company's "intent" is merely conjecture based on the expert's impressions of the physical evidence, and must be excluded as not based on any reliable methodology or scientific principle. J.B. Hunt Transport, Inc. v. Gen. Motors Corp., 243 F.3d 441, 444-45 (8th Cir.2001); In re Baycol Products Litigation, 532 F.Supp.2d 1029.  Similarly, an expert cannot be presented to the jury solely for the purpose of constructing a factual narrative based upon record evidence.  In re Diet Drugs Prods. Liab. Litig., MDL No. 1203, 2000 WL 876900, at *9 (E.D.Pa. June 20, 2000); see also In re Fosamax Products Liab. Litig., MDL 1789, 645 F.Supp.2d 164 (S.D.N.Y.July 27, 2009).

Here, the court found the expert was not qualified to render an opinion regarding what information Mentor should have disclosed to the FDA or to physicians and patients. Prof. Buchholtz is not a physician, a medical researcher, or a medical ethicist. She had no expertise in the fields that would
qualify a witness to testify about what scientific information should be reported to the FDA or to testify about medical device industry standards for warning physicians and patients about potential adverse effects of a medical device.  Therefore, she was not qualified to offer an opinion about the appropriateness of Mentor’s conduct regarding its alleged failure to warn the FDA, physicians, and
patients about certain risks associated with ObTape.

Beyond the qualification issue, the court went on to note that even if the “Code of Ethics” that Prof. Buchholtz relied on was somehow relevant to a medical device company’s standard of care in the context of product development and marketing, anyone who reads and understands the English language can interpret and apply the principles underlying that “Code of Ethics.” So Prof. Buchholtz’s testimony on the subject was unnecessary, and not beyond the understanding of a lay jury. 

Decision to Not Conduct Daubert Inquiry Leads to Class Certification

A federal court recently certified a class of Minnesota building owners in litigation over issues with plumbing systems. See In re: Zurn Pex Plumbing Products Liability Litigation, MDL No. 08-1958, 2010 WL 1839278 (D.Minn. 5/6/10).

The issue for our readers is not so much what happened, but what should have happened but did not.  I recently posted about the7th Circuit decision in American Honda Motor Co., Inc. v. Allen, 2010 WL 1332781 (7th Cir., April 7, 2010), mandating that trial courts rule on the admissibility of expert testimony at the certification stage of litigation when the testimony is critical to certification.  That is the only approach that makes any sense. Otherwise, the court risks certifying a class -- and engaging the parties in  the massive discovery and notice process that accompanies it  -- based on testimony that fails the Daubert test, is unreliable, and eventually inadmissible under the Federal Rules.  Here, the court refused to exclude the testimony of two plaintiff experts at the certification stage.  The court noted that the 8th Circuit had not yet adopted the approach of the 7th Circuit. 

Historically, potable water plumbing systems used copper pipes. In the 1990's, some companies designed plumbing systems using polybutylene plastic. After a wave of litigation involving allegedly failed polybutylene plumbing systems, defendant Zurn designed a cross-linked polyethylene plumbing system, commonly referred to as “pex,” as an alternative to polybutylene systems and copper plumbing systems. Plaintiffs were individuals who owned a home with a Zurn pex plumbing system. in several lawsuits, plaintiffs alleged that defective fittings used in the pex system caused their plumbing systems to leak resulting in damage to their properties. Plaintiffs also alleged that Zurn failed to adequately test the brass crimp fittings in their anticipated environments before marketing its product. In 2008, the Judicial Panel on Multi-District Litigation determined that the pex plumbing cases met the MDL test, and that centralization of the cases in Minnesota was appropriate.

Plaintiffs moved for certification of a class of all persons and entities that own a structure located within the State of Minnesota that contains a Zurn Pex plumbing system with brass crimp fittings.  Defendants, in turn, moved to exclude portions of the testimony of plaintiffs' experts, Dr. Wallace Blischke and Dr. Roger Staehle.  

Dr. Blischke, a statistician, performed an analysis of Zurn's warranty claims data and estimated that millions of Zurn's brass fittings will fail within the twenty-five year warranty period; he concluded that the fittings have a mean time to failure of 40 years.  Defendants offered evidence that the 40 years was based on unsupported assumption, not data.  The court admitted that as merits discovery unfolded and more information becomes available, Dr. Blischke's 40 year estimate for the mean time to failure "may or may not be admissible," but it would consider the expert testimony in support of class certification anyway and "has given such testimony proper weight."

Dr. Staehle then conducted a round of testing known as the U-bend test of brass specimens from Zurn's fittings. Defendants offered evidence that the reliability of Dr. Staehle's U-bend testing was undermined by his use of an artificially inflated level of strain, and they challenged the correctness of Dr. Staehle's calculation of the strain. The court concluded that "at this point" it would not exclude the testimony, which could be the subject of cross examination.

The certification battleground was 23(b)(3) predominance.  Defendants stressed that there were lots of possible causes of the failure of any particular plumbing system, and thus individual issues predominated.  Plaintiffs -- and here we see where the denial of a Daubert inquiry has its pernicious effect -- responded that the brass crimp fittings used in the pex plumbing system suffer from an inherent design and manufacturing defect, and that the parts were substantially certain to fail within the 25 year express warranty provided by Zurn and/or the useful life of the fittings.  And this was a set of predominating common issues, they said.  But they only get there through the testimony of the experts, not only on the merits, but on the presentation that the defects and useful life were demonstrable on a common basis through expert testimony about testing and time-to-failure.  So, for example, in certifying a warranty class for those plaintiffs whose systems had not yet failed, the court readily acknowledged being influenced by the fact that plaintiffs "allege, and intend to prove by expert testimony, that Zurn's brass crimp fittings suffer from a uniform, inherent design and manufacturing defect...."

Similarly, with regard to a class relying on a negligence cause of action, the court concluded that if plaintiffs can prove that the crimp fittings suffer from a uniform, inherent design and manufacturing defect, and that the defect is the only cause of failure in the majority of the cases, then proximate cause will not involve predominately individual determinations, and resolution of that issue would be common the class. For class certification purposes, the court was "convinced that Plaintiffs have adduced sufficient evidence to support their theory of the case."  But, of course, that evidence was arguably inadmissible expert testimony.

Since proof of reliance will likely vary among class members, and since defendants are entitled to present individualized defenses to reliance under Minnesota law, plaintiffs failed to show that the reliance component of their consumer protection claims could be proven by common evidence. Accordingly, class certification as to plaintiffs' consumer protection claims was denied.

But imagine how easy it can be to show "predominance" of common issues when your proof is unreliable, inadmissible, unscientific, expert testimony that just doesn't get screened.  Why should the gatekeeper role not impact entrance to the expensive, protracted world of a class action as much as to trial?

 

 

District Courts May Need to Conduct Full Daubert Inquiry Before Class Certification Decision

The Seventh Circuit issued a very interesting opinion on the interplay of class certification and Daubert issues. American Honda Motor Co., Inc. v. Allen, 2010 WL 1332781 (7th Cir., April 7, 2010).  Specifically, the defendant asked the court to resolve whether the district court  must conclusively rule on the admissibility of an expert opinion prior to class certification when that opinion is essential to the certification decision. Since this is the type of question that Rule 23(f) was designed to address, the court of appeals took the appeal -- and agreed with Honda. 

Plaintiffs were purchasers of Honda's Gold Wing GL1800 motorcycle; they alleged that the motorcycle has a design defect that prevents the adequate dampening of “wobble,” that is, side-to-side oscillation of the front steering assembly. Plaintiffs moved for class certification pursuant to Rule 23(b)(3). To demonstrate the predominance of common issues, they relied heavily on a report prepared by a motorcycle engineering expert, who opined about a "reasonable wobble decay" standard. Honda moved to strike the report pursuant to Daubert, arguing that this wobble decay standard was unreliable because it was not supported by empirical testing, was not developed through a recognized standard-setting procedure, was not generally accepted in the relevant scientific, technical, or professional community, and was not the product of independent research.

The district court said that it had "definite reservations" about the reliability of the expert's wobble decay standard. Nevertheless, the court declined to exclude the report in its entirety "at this early stage of the proceedings.”  The trial court denied Honda's motion to exclude “without prejudice,”  and granted plaintiffs' motion for class certification.

The 7th Circuit has already noted that a district judge may not duck hard questions by observing that each side has some support. Tough questions must be faced and squarely decided, if necessary by holding evidentiary hearings and choosing between competing perspectives. But the court had not yet specifically addressed whether a district court must resolve a Daubert challenge prior to ruling on class certification if the testimony challenged is integral to the plaintiffs' satisfaction of Rule 23' s requirements.  Here, it did hold that when an expert's report or testimony is critical to class certification, as it was in this case, a district court must conclusively rule on any challenge to the expert's qualifications or submissions prior to ruling on a class certification motion. That is, the district court must perform a full Daubert analysis before certifying the class if the situation warrants. If the challenge is to an individual's qualifications, a court must make that determination by comparing the area in which the witness has superior knowledge, skill, experience, or education with the subject matter of the witness's testimony. The court must also resolve any challenge to the reliability of information provided by an expert if that information is relevant to establishing any of the Rule 23 requirements for class certification.

Here, while the trial court began to ask the right questions, it never finished. The court's effective statement of admissibility left open the questions of what portions of the expert's testimony it may have decided (or will decide) to exclude, whether the expert reliably applied the standard to the facts of the case, and, ultimately, whether plaintiffs had actually satisfied Rule 23(b)(3)'s predominance requirement -- because they relied on the expert opinions. As a result, the district court never actually reached a conclusion about whether the expert report was reliable enough to support plaintiffs' class certification request.  This was not sufficient. Indeed, it was an abuse of discretion, according to the court of appeals.

The court went on to examine the record, which revealed to it that exclusion was the inescapable result when the Daubert analysis is carried to its conclusion. The expert originally developed the standard for use in a lawsuit in which he testified as an expert against Honda; despite its publication in one journal, there is no indication that this wobble decay standard had been generally accepted, or indeed, accepted by anyone other than this author. The expert never conducted any rider confidence studies to determine when motorcycle riders perceive wobble, or performed any tests to determine the minimal wobble amplitude at which riders detect oscillation.  He did test a single, used 2006 GL1800, ridden by a single test rider, but then extrapolated his conclusions to the entire fleet of GL1800s produced from 2001 to 2008 -- arguably too small a sample size from which reliable extrapolations can be made. 

The court therefore granted Honda's petition for leave to appeal, vacated the district court's denial of Honda's motion to strike and its order certifying a class, and remanded for proceedings consistent with this opinion.

 

Fifth Circuit Affirms Exclusion of Plaintiff's Causation Experts

A federal appeals court recently affirmed a judgment for the maker of a drug used to treat Parkinson's disease in litigation alleging that the drug caused plaintiff's compulsive gambling.  Wells v. SmithKline Beecham Corp., 2010 WL 1010591 (5th Cir. 2010).

Wells sued GlaxoSmithKline, the manufacturer of Requip, alleging that GSK had failed to warn patients about the alleged side effect of pathological gambling.  For Wells to win under Texas law,  he had to show that the failure to warn caused his injury.  Causation has two levels, general and specific, and a plaintiff must prove both. General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. Sequence matters, said the 5th Circuit: a plaintiff must establish general causation before moving to specific causation. Without the predicate proof of general causation, the tort claim fails.

Wells engaged three expert witnesses to address general causation, that the drug supposedly could cause pathological gambling. In reaching their conclusions, the experts relied upon: (1) published articles documenting case-specific correlations between Requip and gambling; (2) a single unpublished study allegedly showing a nexus between Parkinson's medicines generally and gambling; (3)  internal data supposedly revealing case-specific associations between Requip and gambling; and (4) the fact that GSK has since changed the Requip label to warn about possible gambling side-effects. (Of course, on the last point a regulatory agency can require a warning based on a lesser level of proof than is required to recover in a tort action.) Defendant challenged the evidence under Daubert, and the district court granted summary judgment.  Plaintiff appealed.

Readers know that Daubert requires admissible expert testimony to be both reliable and relevant.  This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.  Although there are “no certainties in science,” the expert must present conclusions grounded in the methods and procedures of science.  In short, the expert must employ in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

The court of appeals found that each of the three experts had, in deposition, in essence conceded that there exists no scientifically reliable evidence of a cause-and-effect relationship between Requip and gambling, that the state of the art was mere association, not cause.  That alone would doom the plaintiff's case.

But more interesting for readers is when the court went on, in the alternative, to address the methodologies and fit. 

The studies relied on were, each expert conceded, not statistically significant epidemiology. They were, in fact, case studies. Although case-control studies are not per se inadmissible evidence on general causation,  the courts have frowned on causative conclusions bereft of statistically significant epidemiological support. While the court agreed that in epidemiology hardly any single study is ever conclusive, and it did not suggest that an expert must back his or her opinion with multiple published studies that unequivocally support his or her conclusions, here there was simply too great an analytical gap between the data and the opinion proffered.  Bottom line-- the bases for the experts' conclusions passed none of the applicable Daubert factors: that Requip causes problem gambling is not generally accepted, has not been subjected to peer review and publication, and is not backed by studies meeting requisite scientific standards.

Without the expert testimony, Wells could not prove general causation.  Here's a useful quote:  "Wells urges the law to lead science -- a sequence not countenanced by Daubert."  See also Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996) (“Law lags science; it does not lead it.”).

 

Seventh Circuit Decides FDCPA Class Claims And Offers Survey Guidance

The Seventh Circuit recently issued an interesting decision in two consolidated consumer cases. Dekoven v. Plaza Associates, Nos. 09-2016, 09-2249 (7th Cir. 3/17/10).  In the two closely related class action suits under the Fair Debt Collection Practices Act, 15 U.S.C. §§ 1692-1692p, which the appeals court had consolidated for decision, the plaintiffs complained about dunning letters sent to them by the a debt collection agency.

What is most interesting to our readers is not the Fair Debt Collection Practices Act issues, perhaps, but the court's guidance on survey evidence. In both cases the district court had entered summary judgment in favor of defendant after rejecting the survey evidence prepared by the plaintiffs’ expert witness, Howard L. Gordon.   Indeed, while the court could see a potential for deception of the unsophisticated debtor in letters sent offering some kind of compromise of their debts, it had no way of determining whether a sufficiently large segment of the unsophisticated were likely to be deceived to enable the court to conclude that the statute had been violated.

For that conclusion, evidence is required, the most useful sort, observed the court, being the kind of consumer survey described in Johnson v. Revenue Management Corp., 169 F.3d 1057, 1060-61 (7th Cir. 1999); see also Hahn v. Triumph  Partnerships LLC, 557 F.3d 755, 757 (7th Cir. 2009); Williams v. OSI Educational Services, Inc., 505 F.3d 675, 678 (7th Cir. 2007). (But see, for criticism of the use of survey evidence, Judge Jolly’s dissenting opinion in Gonzalez v. Kay, 577 F.3d 600, 609-11 (5th Cir. 2009).)

Here, the plaintiffs’ expert did conduct a survey. But both trial court  judges considered it  inadmissible under the standards governing the admission of survey evidence (a form of expert evidence) in federal court. See, e.g., Muha v. Encore Receivable Management, Inc., 558 F.3d 623, 625-26 (7th Cir. 2009); Peaceable Planet, Inc. v. Ty, Inc., 362 F.3d 986, 992 (7th Cir. 2004); United States v. Curtin, 588 F.3d 993, 997-98 (9th Cir. 2009); Vail Associates, Inc. v. Vend-Tel-Co., Ltd., 516 F.3d 853, 864 n. 8 (10th Cir. 2008).

Judge Posner agreed.  One of the issues was the high percentage of people in the control group in the survey who answered "don't know/not sure."   The control approach was thus not adequate and may have confused respondents, maybe even others besides those who answered “don’t know/not sure.”  Therefore the entire survey was no good, as the judges below found.

It was no good for another reason: if the don’t know/not sure respondents were eliminated, the control group would shrink to 27 persons. Determining the minimum sample size from which reliable extrapolations can be made to the sampled population is tricky, said the court. See Fowler, Survey Research Methods 45 (4th ed. 2008). But 27 is too small a sample, concluded the appeals court.  Especially since the sample drawn by the plaintiffs’ expert was what is called a “convenience” sample — convenient to the sampler — as distinct from a “representative” sample —  representative of the population sampled.

A properly designed control group is vital in such a survey, including one intended to reveal whether a debt collector is confusing debtors. Cf. Free v. Peters, 12 F.3d 700, 705-06 (7th Cir. 1993); Penney v. Praxair, Inc., 116 F.3d 330, 333-34 (8th Cir. 1997); United States v. Aguilar, 883 F.2d 662, 706-08 (9th Cir. 1989). The debt collector can’t be blamed if consumers don’t understand his dunning letter unless he should have added or subtracted something to make it clearer. The plaintiff  thus has to show that the additional language of the letters unacceptably increased the level of confusion; many unsophisticated consumers would be confused even if the letters they received contained nothing more than a statement of the debt and the statutory bare bones notice.

Interestingly, the court said that district judges may want to consider exercising the clearly authorized but rarely exercised option of appointing their own expert to conduct a survey in FDCPA cases. Fed. R.Evid. 706(a); General Electric Co. v. Joiner, 522 U.S. 136, 149-50 (1997) (Breyer, J., concurring); In re High Fructose Corn Syrup Antitrust Litigation, 295 F.3d 651, 665 (7th Cir. 2002); Indianapolis Colts, Inc. v. Metropolitan Baltimore Football Club Ltd. Partnership, 34 F.3d 410, 414-15 (7th Cir. 1994).  Judges can assure themselves of the expert’s neutrality by (as in arbitration) asking the parties’ own experts to nominate a third expert to be the court-appointed expert.  The decision to appoint an expert is within the discretion of the trial judge, of course.

State Supreme Court Overturns Verdict In Sudden Acceleration Case

A recent state supreme court decision offers an interesting take on the use of experts in product liability cases. Watson v. Ford Motor Company , No. 26786 (S.C. March 15, 2010).

Plaintiffs filed a products liability suit against Ford, alleging that the cruise control system on the accident vehicle was defective and the cause of a serious accident. Watson testified that when she entered the interstate, she promptly set the cruise control, but shortly thereafter, the vehicle began to suddenly accelerate. Watson testified that she pumped her brakes to no avail before crashing. Plaintiff's theory of the case was that the vehicle's cruise control system was defective because it allowed electromagnetic interference (EMI) to affect the system. To support this theory, they presented Dr. Antony Anderson, an electrical engineer, who testified as to his theory that EMI can interfere with the speed control component of a cruise control system and cause a vehicle to suddenly and uncontrollably accelerate. Dr. Anderson further opined that this was the cause of the accident, and that Ford could have employed a feasible alternative design to prevent EMI.  Plaintiffs also presented testimony from Bill Williams who was qualified as an expert on “cruise control diagnosis.”

The jury found Ford liable on the cruise control products liability claim, and awarded compensatory damages of $15 million to Watson and $3 million to the estate of passenger Patricia Carter.

The appeal presented three issues: did the trial court err in qualifying Bill Williams as an expert in cruise control systems; did the trial court err in allowing Dr. Anderson’s expert testimony regarding EMI and alternative feasible design; did the trial court err in allowing evidence of other incidents of alleged sudden acceleration in Explorers?

On question one, the court found error. Williams testified that he had worked in the automotive industry since the early 1980s and was currently conducting seminars to train automobile technicians who focus on the brake systems in vehicles. While Williams may have been qualified as an expert in other aspects of automobile components, such as the brake system, the trial court failed to properly evaluate Williams’ qualifications specific to cruise control systems. Notwithstanding this error, the court did not believe that this error alone prejudiced Ford’s defense. Williams’ testimony essentially consisted of a description of the system accompanied by models and diagrams of the components. Furthermore, the trial court prohibited Williams from testifying to matters outside of his scope, specifically noting he could not testify as to electrical engineering matters.

On the second issue, the court addressed an issue that reflected the lack of fit between the opinion and the witness' qualifications in the particular area of expertise. Beyond that, Ford claimed that Dr. Anderson's theory regarding EMI as the cause of the sudden acceleration failed to meet the reliability requirements for the admission of expert testimony. The court reiterated several factors that the trial court should consider when determining whether scientific expert evidence is reliable:(1) the publications and peer review of the technique; (2) prior application of the method to the type of evidence involved in the case; (3) the quality control procedures used to ensure reliability; and (4) the consistency of the method with recognized scientific laws and procedures.

Dr. Anderson’s background involved working with massive generators which have entirely different electrical wiring systems and different voltage levels. He had no experience in the automobile industry, never studied a cruise control system, and never designed any component of a cruise control system. Dr. Anderson had not even operated an automobile with a cruise control system before this litigation; yet, he offered testimony regarding EMI and its effect on the cruise control system.  While he was an expert, perhaps not in the area he opined about.

Even assuming Dr. Anderson was properly qualified as an expert in this area, his testimony was found not reliable. Dr. Anderson declared that the alternative design (twisted pair wiring) would have prevented EMI but did not explain how twisted pair wiring could be incorporated in to a cruise control system and did not offer any model comparison. Furthermore, Dr. Anderson concluded that this design was economically feasible, but offered no basis to support this conclusion.

Dr. Anderson admitted that his theory had not been peer reviewed, he had never published papers on his theory, and he had never tested his theory. He also admitted that he would not be able to determine exactly where the EMI (which he opined caused the cruise control to malfunction) originated or what part of the system it affected. He further testified that it would not be possible to replicate the alleged EMI malfunction of a cruise control system in a testing environment.

The court concluded that there was no evidence indicating that Dr. Anderson’s testimony contained "any indicia of reliability." He had never published articles on his theory nor had he tested his theory. Importantly, Dr. Anderson admitted that it was not possible to test for EMI. Furthermore, although it is not a prerequisite in South Carolina that scientific evidence attain general acceptance in the scientific community before it is admitted, the court found it instructive that not only had the underlying science not been generally accepted, Dr. Anderson’s theory was rejected in the scientific community.  Next, the court found that Ford was prejudiced by the admission of this testimony. Indeed, the only evidence plaintiffs presented to support their theory that the vehicle was defective was Dr. Anderson’s testimony.

On the third issue, evidence of similar accidents, transactions, or happenings is admissible in South Carolina where there is some special relation between the accidents tending to prove or disprove some fact in dispute. Typically, a plaintiff must present a factual foundation for the court to determine that the other accidents were substantially similar to the accident at issue. The court will look at whether (1) the products are similar; (2) the alleged defect is similar; (3) causation related to the defect in the other incidents; and (4) exclusion of all reasonable secondary explanations for the cause of the other incidents.

Here, plaintiffs failed to show that the incidents were substantially similar and failed to establish a special relation between the other incidents and the relevant accident. The other incidents involved Explorers that were made in different years and were completely different models with the driver’s seat located on the right side of the vehicle. More importantly, plaintiffs failed to show a similarity of causation between the malfunction in this case and the malfunction in the other incidents. Plaintiffs presented only the testimony of the other drivers and did not present any expert evidence to show that EMI was a factor in the malfunction in the other incidents.

This evidence was highly prejudicial. Courts require a plaintiff to establish a factual foundation to show substantial similarity because evidence of similar incidents may be extremely prejudicial. Plaintiffs' counsel highlighted this improper evidence in closing arguments and thereby possibly induced the jury to speculate as to other causes of the accident not supported by any evidence.

State Court Affirms Exclusion of Expert Evidence in Accutane Case

A New Jersey appellate court recently affirmed a trial court's decision that an Accutane plaintiff's expert's study must be excluded as unreliable. See Palazzolo v. Hoffmann La Roche Inc., 2010 WL 363834 (N.J. Super. Ct., 2/3/10).

Plaintiffs filed a product liability and consumer fraud complaint against defendants claiming that Accutane, a drug used to treat acne, caused their family member to develop depression which led to his suicide. They contended that at the time of his death in 1997, Accutane should have carried a warning label concerning the possibility that the drug could cause depression and suicide.

As one element of their product liability cause of action, plaintiffs needed to establish “general causation,” by showing that Accutane can cause depression and suicide. See Kemp v. State, 174 N.J. 412, 417 (2002); Coffman v. Keene Corp., 133 N.J. 581, 594 (1993). On that issue, plaintiffs retained Dr. James Bremner, as an expert.  Plaintiffs paid Bremner to undertake a study of the issue; there was no dispute that the study was commissioned specifically for use in this litigation.

In the study at issue, Bremner and a team of other scientists used positron emission tomography (PET) technology to compare changes in brain metabolism between two groups of subjects being treated for acne. One group was receiving antibiotic treatment and the other group was being treated with Accutane.  According to Bremner, the PET study demonstrated that the subjects treated with Accutane showed decreased metabolism in the orbital frontal cortex, a portion of the brain associated with depression. He published an article about the study in a scientific journal, describing his methodology and his conclusions. Based largely but not entirely on the PET study, he issued an expert report opining that Accutane can cause depression and suicide.

Defendants challenged the evidence. In deposition and at a hearing, Bremner was repeatedly confronted with potential problems in the PET study, including missing data, inaccurate data, and deviations from the methodology he claimed to have followed. As a result, in the middle of the Rule 104 hearing, the court permitted Bremner to re-work his study data and issue a supplemental expert report and allowed defendant to re-depose him. The trial court then excluded the evidence.

The court of appeals affirmed. First, Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article. Significantly, contrary to representations made in the article, he did not get before-and-after questionnaires from many of the subjects.  Those questionnaires were designed to elicit the extent to which the subjects might be worried about their acne. This was relevant because some scientists were of the view that worrying, as well as depression, could affect activity in the orbital frontal cortex.

Secondly, Bremner also could not document much of the data on which his published results were based. Third, he admitted that some of the statistical analysis was inaccurate. For example, in the hearing session, Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.

The court noted that an expert's scientific peers cannot fairly judge the expert's written work, including whether it is worthy of publication, if his article does not accurately represent either the underlying data or what the author did to produce his results. In essence, Bremner's study was not  soundly and reliably generated.

There also was no error in precluding Bremner from providing supplemental reports or information after the Rule 104 hearing record closed. The judge allowed Bremner multiple opportunities to correct errors in his study before the record closed. The orderly conduct of litigation demands that expert opinions reach closure. See Miller v. Pfizer, Inc., 356 F.3d 1326, 1334 (10th Cir.), cert. denied, 543 U.S. 917 (2004).

The court of appeals remanded the case for consideration whether, even without the PET study, Dr. Bremner can still offer an opinion that Accutane can affect the brain and produce depression.

Seventh Circuit Affirms Exclusion of Plaintiff Expert in Device Case

Just about a year ago, we posted about an interesting device case in which the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product. Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09).

Last week  the federal appeals court affirmed the judgment for the knee implant maker.  Fuesting v. Zimmer Inc., 2010 WL 271728 (7th Cir. 1/25/10).  Fuesting had alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. The expert testimony as to defect also failed.

On appeal, the Seventh Circuit stated that Dr. Rose's testimony did not show that his theory that these knee implants oxidize “in vivo” had sufficient acceptance in the scientific community.  He failed to point to any peer reviewed studies that discuss the oxidation rates of this type of implant in vivo.  Dr. Rose failed to cite any articles or studies that he or any one else conducted regarding how one can discern whether the alleged oxidation occurred before or after implantation.  Dr. Rose also did not rule out possible alternative methods of causation.  Nor did he explain how the device's oxidation caused the device to fail, as the mere presence of oxidation does not prove that the oxidation caused the device to malfunction.

Dr. Rose also failed to “bridge the analytical gap” between the accepted fact that GIA sterilization causes at least some amount of oxidation and his ultimate conclusion that Fuesting's knee implant in particular failed because GIA, rather than another sterilization method, was used. Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He concluded, in one sentence of his report, and without any support, that the industry standard was to sterilize implants in an inert gas instead of air. In fact, no manufacturer at that time employed any of  the proffered methods, and Dr. Rose cited no contemporary articles counseling the use of such methods.  For all these reasons, the district court did not abuse its discretion in excluding Dr. Rose's testimony.


 

Federal Rule of Civil Procedure 26: Amendment Update

We love to hear from our faithful readers, and one recently asked us to update the status of the proposed amendments to Rule 26. We posted on them last year, noting that there would be public comment opportunities throughout 2009.

Below, a review of those comments.  But first a reminder of the proposed changes. The amendments would extend work-product protection to the discovery of draft reports by testifying expert witnesses and, with three important exceptions, to the discovery of communications between testifying expert witnesses and retaining counsel. The amendments also provide that a lawyer relying on a witness who will provide expert testimony but is not required to provide a Rule 26(a)(2)(B) report – because the witness is not retained or specially employed to provide expert testimony and is not an employee who regularly gives expert testimony – must disclose the subject matter of the witness’s testimony and summarize the facts and opinions that the witness is expected to offer. The 1993 amendments to Civil Rule 26 have been interpreted by some courts to allow discovery of all draft expert witness reports and all communications between counsel and testifying expert witnesses. The experience under those amendments revealed significant practical problems in the eyes of many litigators.

The comments? First, the arguments in favor:

• Lawyers and expert witnesses take elaborate and costly steps to avoid creating any discoverable draft report or any discoverable communications between the lawyer and expert. These steps can include hiring two sets of experts, one to testify and one to consult; avoiding any note-taking by the expert; and avoiding the creation of any draft report. At the same time, lawyers take elaborate and
costly steps to attempt to discover all of the other side’s drafts and communications.


• Experience has shown that the elaborate steps to avoid creating discoverable drafts or communications result in inefficient, costly, and wasteful litigation behavior. At the same time, experience has also shown that extensive, time-consuming, and costly efforts to discover every change in draft reports by experts and every communication between experts and retaining counsel rarely produces information that bears on the strengths or weaknesses of the experts’ opinions.

• Many experienced lawyers routinely stipulate that they will not seek to discover draft reports from each other’s experts or communications between the experts and the retaining lawyers. That good lawyers stipulate to avoid the present rule indicates problems with it.

• Some states have implemented procedures similar to the proposed amendments.  State  practitioners representing both plaintiffs and defendants report a degree of consensus about the success of these procedures in improving the ability to use expert witnesses and to discover the basis for their opinions.


• The proposed amendments would not limit discovery into the areas that are genuinely important for learning the strengths and weaknesses of a testifying expert’s opinion. The proposed amendments specifically allow discovery into communications between a lawyer and testifying expert about: (1) the compensation for the expert’s study or testimony; (2) the facts or data provided
by the lawyer that the expert considered in forming opinions; and (3) the assumptions provided by the lawyer that the expert relied upon in forming an opinion.

Opposing Views:

• The proposed amendments limit discovery that could show the extent of the retaining lawyer’s influence on the testifying expert’s opinions. That could make it easier for lawyers to influence the opinions their testifying experts present.

• The proposed amendments only limit discovery of draft reports and certain communications. They do not apply to inquiries into such matters at the trial itself. It may be unclear whether the draft reports and communications will be protected from disclosure at trial. As a result, the amendments may not eliminate the costly and wasteful steps to avoid creating draft reports or records of attorney/expert communications. (MassTortDefense wonders how many lawyers will venture into these issues at trial without the benefit of any discovery.)

Overall, comments received during the notice-and-comment period made it appear that the vast majority of practitioners, on both the plaintiff and defense sides, support the proposed rule amendments. Interestingly, lots of academics spoke up against the rule.

So what's the status? On September 15, 2009, the Judicial Conference met and approved the recommendations of the Committee on Rules of Practice and Procedure and approved the proposed rules. The rules were then transmitted to the Supreme Court in December with a recommendation that they be approved and transmitted to Congress in accordance with the Rules Enabling Act.  The schedule would still have them taking effect, if not rejected by the Court or Congress, on December 1, 2010.

 

Court Excludes Toxic Tort Causation Testimony

A federal court has excluded plaintiffs' expert testimony in litigation alleging personal injury and property damage from releases at a Midwest refinery.  Baker, et al. v. Chevron USA Inc., et al., No. 05-cv-00227 (S.D. Ohio Jan. 6, 2010). In the absence of necessary expert testimony, the claims were subject to summary judgment.

Plaintiffs in this case were residents of the villages of Hooven and Cleves, Ohio, who asserted claims for personal injury and property damage allegedly resulting from the Gulf Oil refinery, now owned by defendant Chevron USA.  Gulf operated a gasoline refinery which was situated on the eastern edge of Hooven from 1930 to 1985. Gulf also refined diesel fuel, jet fuel, and fuel oil at the refinery and operated an asphalt plant at this location. Gulf and Chevron merged in 1985, and Chevron closed the refinery in 1986.

Plaintiffs alleged that Gulf’s operation of the refinery resulted in the release of millions of gallons of gasoline and diesel fuel.  But these plaintiffs did not claim injuries resulting from groundwater contamination. Rather, they asserted injuries allegedly caused by air emissions from the refinery and, in particular, the benzene contained in those emissions. Benzene is ubiquitous in the ambient air and is a component or constituent of vehicle exhaust and cigarette smoke. In the petroleum industry, benzene is found in small amounts in gasoline.

For case management purposes, the matter was bifurcated between personal injury claimants and property damage claimants. The parties were permitted to select bellwether plaintiffs for each trial group. This opinion dealt with the claims of the bellwether personal injury claimants, and a key issue, as is often the case in toxic tort litigation, was causation.

Regarding their alleged benzene exposure, plaintiffs offered a three-step procedure. First, expert Dr. Cheremisinoff calculated a gross amount of benzene released from the refinery through emissions. Then, using those calculations, Dr. Rosenfeld, plaintiffs’ second expert, used an air flow model to calculate the cumulative dose of benzene to which each plaintiff was exposed. Third, using those dose estimates, a third expert, Dr. Dahlgren, submitted opinions that each plaintiff’s dose of benzene was sufficient to cause her illness. 

Chevron moved to exclude Dr. Dahlgren's opinions under Daubert, and for summary judgment contingent  upon the striking of  plaintiffs' causation evidence. The principal argument raised was that Dr. Dahlgren’s opinions were unreliable because there was an insufficient scientific or medical basis to conclude that the doses of benzene to which plaintiffs’ were exposed were large enough to have caused their illnesses. Relatedly, Chevron contended that there is an insufficient scientific or medical basis to conclude that benzene even causes some of the illnesses alleged. The Court held a hearing on Chevron’s Daubert motion during which Dr. Dahlgren and Chevron’s medical expert also testified.

In a toxic tort case, the plaintiff must present evidence of both general causation and specific causation. General causation establishes whether the substance or chemical at issue is capable of causing a particular injury or condition. Specific causation relates to whether the substance or chemical in fact caused this plaintiff’s medical condition. Without expert medical testimony on both general causation and specific causation, a plaintiff’s toxic tort claim will fail.

In this case, Dr. Dahlgren offered causation opinions based largely on epidemiological studies. (Epidemiology is the study of the incidence, distribution, and etiology of disease in human populations.) Epidemiology is usually considered highly probative evidence on general causation in toxic tort cases. The court may nonetheless exclude expert testimony based on epidemiological studies where the studies are insufficient, whether considered individually or collectively, to support the expert’s causation opinion. Nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may thus conclude that there is simply too great an analytical gap between the data and the opinion proffered.

A couple of parts of the court's detailed analysis are worth highlighting for readers of  MassTortDefense:

First, Dr. Dahlgren’s reliance on the “one-hit” or “no threshold” theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer. The court noted that while the one-hit theory has been accepted for purposes of establishing regulatory safety standards, it has not been accepted as a reliable theory for causation under Daubert standards.  See Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 199 (5th Cir. 1996) (“Scientific knowledge of the harmful level of exposure to a chemical, plus knowledge that the plaintiff was exposed to such quantities, are minimal facts necessary to sustain the plaintiffs’ burden in a toxic tort case.”); McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1240 (11th Cir. 2005) (holding that district court erred by not excluding plaintiff’s expert’s causation opinion because he neglected dose-response relationship); Henricksen v. ConocoPhillips Co., 605 F. Supp.2d 1142, 1162 (E.D. Wash. 2009) (excluding expert’s opinion pursuant to Daubert where “he presumed that exposure to benzene in gasoline can cause AML in any dose.”); National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp.2d 942, 961 (E.D.Ark. 1998), aff’d, 191 F.3d 858 (8th Cir. 1999); Sutera v. Perrier Group of Am., Inc., 986 F. Supp. 655, 667 (D. Mass.
1997). Moreover, since benzene is ubiquitous, causation under the one-hit theory could not be established because it would be just as likely that ambient benzene was the cause of plaintiffs’ asserted illnesses.

Second, the court noted that to the extent that Dr. Dahlgren relied on the evidence that plaintiffs were exposed to benzene in excess of regulatory levels, that is insufficient to make his opinions admissible. The mere fact that plaintiffs were exposed to benzene emissions in excess of mandated limits is insufficient to establish causation. Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244, 252-53 (6th Cir. 2001); David L. Eaton, Scientific Judgment and Toxic Torts- A Primer in Toxicology for Judges and Lawyers, 12 J.L. & Pol’y 5, 39 (2003) (“regulatory levels are of substantial value to public health agencies charged with ensuring the protection of the public health, but are of limited value in judging whether a particular exposure was a substantial contributing factor to a particular individual’s disease or illness.”). This is because regulatory agencies are charged with protecting public health and thus reasonably employ a lower threshold of proof in promulgating their regulations than is used in tort cases. Allen, 102 F.3d at 198.

Third, the court focused on the issue of the link between cited literature and the actual specific opinion given. The court recognized that an expert’s opinion does not have to be unequivocally supported by all epidemiological studies in order to be admissible under Daubert. But here, the opinions expressed in Dr. Dahlgren’s revised report were based "on a scattershot of studies and articles which superficially touch on each of the illnesses at issue." The expert had not differentiated the cases in any way and simply assumed that each reference supported his causation opinion on each and every illness. That clearly was not the case. Also, none of the cited studies supported an opinion that benzene can cause the illnesses from which plaintiffs suffer at the extremely low doses or exposures experienced in this case. Even if it is medically accepted that benzene can cause disease at high doses, Dr. Dahlgren could not cite any paper finding that the relevant low cumulative exposure significantly increases the risk of developing the injuries.

The court, therefore, found that the expert's causation opinions were not reliable under the standards enunciated by Daubert and, consequently, inadmissible. Without Dr. Dahlgren's testimony, the plaintiffs were unable to establish that their illnesses were caused by alleged emissions from the plant, the court observed, and so granted Chevron's motion for summary judgment on all four bellwether personal injury plaintiffs.
 

Causation Proof Still Insufficient In Drug Case

A while back we posted about an interesting toxic tort case involving important causation issues. See Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.).  A Minnesota appeals court recently refused to rehear its prior affirmance of summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer.  2009 Minn. LEXIS 648. 

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone replacement therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants. In November 2001, Zandi alleges she was diagnosed with "hormone-dependent breast cancer." She contended that the HRT drugs caused her cancer. 

The trial court found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony. Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to try to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Zandi's claims were based on the following propositions: 1) it is supposedly generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual. The appellate issues revolved around the second.

Plaintiff's experts based their specific causation opinions in part on "differential diagnosis."  As readers of MassTortDefense know,  differential diagnosis, sometimes called “differential etiology”  is a process through which all the scientifically plausible causes of an injury are “ruled in,” and the expert then “rules out” the less plausible causes until reaching the one that theoretically cannot be ruled out.  If you've watched "House" on TV, you have seen the use of differential diagnosis to discover what disease a patient is suffering from.  Less traditional, and more questionable, is the use of the technique to discover what is the cause of the disease in the patient.  Most doctors don't care as much about the cause of the disease as getting the right disease and treating it.  As used by toxic tort plaintiffs, differential diagnosis adopts a process of elimination to identify not just the injury (which may be debated) but also the cause; in theory, it seeks to eliminate the possibility of competing causes or confounding factors. 

Again, in performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains. Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one or a few causes would necessarily implicate another. For differential diagnosis to be sufficiently reliable to even come close to proving causation, even assuming one accepts the method in this context, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable. But additional risk factors that plaintiff failed to adequately account for here in this case included family history. When faced with this dilemma, as is common when a disease has many idiopathic cases, plaintiff's experts simply suggest that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses, as long as "major" or "most" explanations are ruled out.  Courts should be wary of this.

Courts generally recognize that the proffered expert must have a sufficient basis to “rule in” the drug or toxic substance at issue as a plausible cause of plaintiff’s injury. E.g., Jazairi v. Royal Oaks Apts., 217 Fed. Appx. 895 (8th Cir. 2007).  But this case is a good reminder that the plaintiff's expert testimony must also reliably “rule out” the other plausible causes of the injury--  again, especially difficult when its causes are largely unknown.  On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”  See also Perry v. Novartis, 564 F. Supp.2d 452 (E.D. Pa. 2008).

This clear reasoning can be contrasted with the inexplicable finding of the 8th Circuit in Scroggin v. Wyeth, 2009 WL 3518245 (8th Cir. Nov. 2, 2009), which accepted plaintiff's carefully constructed circular reasoning.  Unable to prove that the breast cancer was caused by hormone therapy drugs, plaintiff's expert simply re-diagnosed the disease as hormone-induced breast cancer.  This allowed the expert to engage in a so-called differential diagnosis to determine the cause of the breast cancer simply by ruling out the two possible sources of these hormones: (1) plaintiff produced the hormones herself, or (2) they came from the hormone replacement therapy she had allegedly taken for the past eleven years.  Under this circular reasoning, any form of cancer can easily be linked to the defendant's product because it will be re-characterized as the sub-type of disease caused by the substance at issue. 
 

 

Plaintiffs' Causation Expert Excluded in Viagra MDL

The federal judge overseeing the multidistrict litigation involving the erectile dysfunction drug Viagra has decided to exclude the testimony of the plaintiffs' key expert witness on causation. In re: Viagra Products Liability Litigation, case number 06-md-01724 (D. Minn. 8/19/09).

The litigation stems largely from an announcement in July, 2005 by the FDA that it was updating its labeling requirements for Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to nonarteritic anterior ischemic optic neuropathy (NAION), an eye condition that can result in partial or total blindness.  An MDL consolidated hundreds of product liability lawsuits alleging a link between Viagra and NAION.
 

Judge Paul Magnuson of the U.S. District Court for the District of Minnesota had ruled last year that the general causation opinions of three of  the plaintiffs' experts should be excluded.  This motion related to plaintiffs' sole remaining general causation expert, Dr. Gerald McGwin.  This expert had authored a study, published in the British Journal of Opthalmology, which indicated that male Viagra users with a history of heart attacks had a statistically significant increased risk of suffering NAION. The court had originally denied Pfizer’s Daubert challenge to Dr. McGwin, largely because his study was peer-reviewed, published, contain[ed] known rates of error, and seemingly resulted from generally accepted epidemiological research.  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1081 (2008). In January, Judge Magnuson ruled that Pfizer could seek additional discovery related to McGwin's study, and in July, the judge denied the plaintiffs’ motion to have McGwin provide live testimony at a Daubert rehearing.
 

That additional discovery revealed that the study contained discrepancies that raised “serious concerns” about its reliability. In fact, the study contained numerous “acknowledged inaccuracies,” chief among them the inclusion of numerous patients in McGwin's data-set who had not taken Viagra until after they were diagnosed with NAION.  Dr. McGwin acknowledged that the statistics
in his study would have been different had those individuals (11 of 27 patients who
reported drug use) been coded as unexposed rather than as exposed. The discrepancies between the dates of first use on the original survey forms and in Dr. McGwin’s later electronic data set weaken the McGwin study’s assessment of temporality, thereby impair the study’s ability to contribute meaningfully to Dr. McGwin’s opinion about general causation.

Second, the statistical methods actually used to produce the numbers in the McGwin study as published were not the statistical methods that the study said were used. Even if a later reanalysis purportedly confirmed  the findings of the original study, the fact that the methodologies described in the study were not the actual methodologies used clearly also undermines the reliability of the McGwin study as published.

Third, the study was unreliable because it mischaracterizes one of its main findings—that men with a personal history of myocardial infarction and drug use have a significantly higher risk of NAION. The patients were actually asked whether they had a family history of myocardial infarction; no one was asked about personal history. These mis-codings regarding myocardial infarction added yet another layer of unreliability to the McGwin study as published.

The judge concluded that "Almost every indicia of reliability the Court relied on in its previous
Daubert Order regarding the McGwin Study has been shown now to be unreliable. Peer
review and publication mean little if a study is not based on accurate underlying data."

Lastly, Judge Magnuson denied the plaintiffs' motion for leave to file a supplement to McGwin's expert report, which included a reanalysis of the data, concluding that the report's untimely
submission was neither harmless nor justified. The reanalysis lacked even the basic indications of reliability — peer review and publication — that the original had seemingly had, and it had also been produced simply in response to concerns raised in the litigation.

Can Jury Ignore Uncontroverted Expert Opinion On Causation?

Here at MassTortDefense we often talk about the sufficiency of expert opinions, including on causation, from a legal Daubert or Frye standpoint.  A recent state court case from Texas reminds us about the rules on jury consideration of opinions that survive such legal challenges.

In Rentech Steel LLC v. Teel, No. 11-07-00318-CV (Tex. App., 11th Dist., 8/13/09), the plaintiff, who was working as a summer employee at Rentech's steel fabrication plant, suffered severe bilateral hand injuries while cleaning a power roller machine, a device that draws in steel plates and rolls them into cylinders. Rentech acknowledged some degree of fault but argued that some responsibility also rested with the settled manufacturer of the machine and the supplier.  The jury found Rentech negligent, but found no liability on the part of the other companies. Rentech appealed the finding of sole liability.

Expert William W.R. Purcell, a certified safety professional with degrees in civil and safety engineering and 40 years of experience, was retained by the plaintiff, but actually called by Rentech as an expert at trial.  He blamed the other defendants for inadequate warnings and instruction, and marketing defects, as well as agreeing there was negligence on the part of Rentech. Despite this uncontroverted expert testimony, the jury assigned liability only to Rentech.

The court of appeals noted that in Texas the jury is the sole judge of the witnesses’ credibility and the weight to give to their testimony.  Jurors may choose to believe one witness and disbelieve another and may disregard even uncontradicted and unimpeached testimony from disinterested witnesses.  Furthermore, even uncontroverted expert testimony does not bind the jury unless the subject matter is one for experts alone – one for which jurors “cannot properly be assumed to have or be able to form correct opinions of their own based upon evidence as a whole and aided by their own experience and knowledge of the subject of inquiry.”  Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 338 (Tex. 1998).

In this case, causation was not a matter for experts alone and did not require a technical or
scientific explanation, said the court;  it was within the jury’s ability to determine on its own what caused the accident and resulting injuries. See K-Mart Corp. v. Honeycutt, 24 S.W.3d 357, 361 (Tex. 2000)(holding that it was within jury’s ability to determine on its own whether lack of a railing caused the accident). Because causation was not an issue for experts alone, the jury could have disregarded Purcell’s conclusion as to causation.  The jury was free to conclude based upon the evidence presented at trial that Rentech failed to provide by a preponderance of the evidence (1) that the negligence of the other sellers was a cause of the accident and (2) that a marketing or design defect was a cause of the accident.

Other evidence before the jury included pictures of the actual roller machine and the warnings already located on the machine; testimony from a Rentech employee who operated the machine that a manual containing operating instructions had previously been supplied to Rentech; and testimony indicating that the Rentech employee operating the machine was knowingly violating the safety warnings and company policy at the time of the incident. Furthermore, the jury could have found that evidence proving a safer alternative design was lacking.

State Court Excludes Plaintiff's Causation Expert Under Frye Test

A Minnesota appeals court recently affirmed summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer. Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.)

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone-replacement-therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants.   In November 2001, Zandi was diagnosed with "hormone-dependent breast cancer."  She contended that the HRT drugs caused her cancer.  She brought claims for negligence, strict liability, breach of implied warranty, breach of ex-press warranty, fraud, misrepresentation, and violation of the Minnesota fraudulent advertising act, the Minnesota Prevention of Consumer Fraud Act, and the Minnesota Uniform Deceptive Trade Practices Act.


The trial court  found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony.  Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Goeb v. Tharaldson, 615 N.W.2d 800, 814 (Minn.2000). Under Minnesota's version of this standard, the proponent of scientific evidence must establish that the scientific theory is generally accepted in the relevant medical or scientific community and that the principles and methodology used are reliable.  McDonough v. Allina Health Sys., 685 N.W.2d 688, 694 (Minn.App.2004). When novel scientific evidence is offered, (1) the trial court must determine whether it is generally accepted in the relevant scientific community; (2) the particular scientific evidence in each case must be shown to have foundational reliability.

Zandi's claims were based on the following propositions: 1) it is generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual.  The appellate issues revolved around the second.  Defendants alleged that even if one assumes the relevant scientific community generally accepts that HRT causes hormone-dependent breast cancer, Zandi had failed to establish that the relevant scientific community generally agrees that there is a method of diagnosing the cause of breast cancer in a particular person.

Plaintiff's experts based their specific causation opinions on epidemiological studies and differential diagnosis. But  the science of epidemiology does not address the cause of an individual's disease. Epidemiology is concerned with the incidence of disease in populations and does not address the question of cause of an individual's disease. Epidemiology has its limits at the point where an inference is made that the relationship between an agent and a disease is causal (general causation) and where magnitude of excess risk attributed to the agent has been determined; that is, epidemiology addresses whether an agent can cause disease, not whether an agent did cause a specific plaintiff's disease. See Green et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 333, 381-82 (Fed.Jud.Ctr.2d ed.2000).

Plaintiff's experts also relied on differential diagnosis. As used by plaintiffs, differential diagnosis adopts a process of elimination to identify cause; it  seeks to eliminates the possibility of competing causes or confounding factors. Goeb, 615 N.W.2d at 815.  In performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains.  Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one cause would implicate another. For differential diagnosis to be sufficiently reliable to prove causation, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable.

Additional risk factors that plaintiff failed to adequately account for here included family history. Indeed, plaintiff's experts suggested that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses.

On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”
 

Summary Judgment For Manufacturer in Pain Pump Litigation

In what appears to be the first substantive decision to come out of the multiple suits alleging that a pain pump medical device damages patients, a federal court has granted summary judgment to the defendant. Kilpatrick v. Breg, Inc., No. 4:08-cv-10052 (S.D. Fla. 6/26/09). Judge Michael Moore ruled in favor of medical device manufacturer Breg, finding that the plaintiff, who alleged damage to his shoulder cartilage, did not provide enough reliable expert evidence to link the condition to the defendant's shoulder pain pump.

Plaintiff Kilpatrick underwent arthroscopic shoulder surgery in 2004 after an orthopedic specialist discovered a tear in his shoulder socket.  To help with post-operative pain, the surgeon inserted a pain pump into plaintiff's shoulder, which would allow the doctor to administer an anesthetic via a catheter in the patient's arm. The surgeon injected bupivacaine into the pump's attached catheter and further filled it with 100 cc's of anesthetic, which was to be delivered into Kilpatrick's shoulder over the next 48 hours.  Plaintiff alleges that he began experiencing severe pain in his shoulder in 2006. An orthopedic surgeon diagnosed the pain as glenohumeral chondrolysis, a deterioration of the cartilage, and Kilpatrick underwent shoulder replacement surgery. He then brought suit, alleging negligence, strict products liability, and violations of Florida's Deceptive and Unfair Trade Practices Act.  Kilpatrick claimed that using the Breg pain pump to administer local anesthetic directly into his shoulder joint caused him to develop post-arthroscopic glenohumeral chondrolysis.

The reliability prong of the Rule 702 analysis was the central issue.  Breg argued, and plaintiff apparently did not contest, that the case should be treated like a toxic tort case for purposes of the Daubert inquiry, in that plaintiff had to offer proof of both general and specific causation. “If anything, determining causation in this case requires an even more complex logical chain than the typical toxic tort case, because the key issue is not merely whether a chemical compound could and did cause injury, but whether that compound as delivered via a particular medical device inserted in a particular location (within Kilpatrick's shoulder joint) could and did cause injury,” the court found.

The summary judgment motion focused first on general causation, and the ability of plaintiff's expert to opine adequately under Daubert that the device can cause this type of injury.  The causes of chondrolysis remain disputed, and experts in the medical community have pointed to autoimmune deficiencies, certain kinds of sutures, thermal energy procedures and contrast dyes made from gentian violets as possible risk factors.  Plaintiff's expert admitted it was a still developing science.

Plaintiff's expert relied on several published studies to attempt to show causation, which were not directly on point, and the Court found that his extrapolations from the studies were not warranted either.  None of the articles were based on controlled, randomized epidemiological studies of human beings, which are the best evidence. “Significantly, none of the articles explains the mechanism by which bupivacaine damages cartilage, each has important limitations that Poehling does not take into account, and none of them offers an ultimate conclusion as to the general causation of glenohumeral chondrolysis,” the court noted. At most they suggest a possible association.  Association is not causation.  As for the animal studies, the expert did not explain the possible differences in dose-response relationship between humans and rabbits, an important factor to consider in evaluating whether an alleged exposure caused an adverse effect. 

As to specific causation, as is typical of many plaintiff experts, Poehling described a process of so-called "differential diagnosis," trying to rule out other suspected causes such as thermal energy and gentian violet, the contrast dye sometimes used during arthroscopic surgery. This approach cannot, observed the court, make up for a fundamental lack of adequate proof about the general toxicity of the substance.  To "rule in" one cause, even while ruling out other causes, requires a sufficient general causation proof.  At its base, however, the conclusion on specific causation still would be unreliable, the court said, as it was "ultimately rooted in nothing more than temporal relationship.”   That before/after focus is not the basis of good science, the court said, “and Poehling's dependence upon it further weakens the reliability of his methodology.”  Significantly, the expert had not offered a sufficient explanation of the background risk for genohumeral chondrolysis, casting further doubt on the reliability of the chosen method. He admitted that not only the pain pump — as a kind of drug delivery system — could have caused the injury, but also the anesthetic delivered via the pain pump.  Poehling's concession that the current state of medical literature is still unsettled about the cause of the plaintiff's condition seriously undermines the reliability of his methodology, the court concluded.  His methodology had no known rate of error, and thus all he had was a hypothesis that “may be exactly right,” but that currently is “merely plausible, not proven.”

It will be interesting to see what impact the approximately 300 suits pending against pain pump manufacturers in state and federal courts.   


 

Daubert Ruling In Zyprexa: A Lesson For Mature Mass Torts

Zyprexa is a mature mass tort, as the defendant has settled approximately 31,000 individual product liability lawsuits over the drug, which was widely used in the treatment of psychiatric disorders. The federal court overseeing the multidistrict litigation over Eli Lilly and Co.'s product has made an important ruling on a Daubert challenge to a plaintiff expert in 13 cases involving 20 of the remaining claimants. In re Zyprexa Products Liability Litigation, MDL No. 1596 (E.D.N.Y. May 12, 2009).

Plaintiffs proposed to call an expert to establish the specific causal relationship between the Zyprexa taken and the onset or worsening of their diabetes. After briefing and an extensive evidentiary hearing, Senior Judge Jack B. Weinstein granted Eli Lilly's motion to disqualify Dr. Stephen J. Hamburger, M.D. While the expert met the necessary educational and experiential qualifications warranting the admissibility of his expert opinions, the court found his testimony lacked sufficient scientific reliability.

The court noted that in longstanding and highly complex litigation (read mass tort), particular emphasis must be placed on the reliability and scientific validity of the expert's opinions. Particularly in a mature mass tort ("advanced stage" described the court) when the issues of the benefits and risks of the drug have been a focus of the scientific community for some time, precision with respect to the relevant scientific knowledge and its application to the facts of the individual cases is expected, said the court.

The record demonstrated to the court that this expert's opinions relied on "a subjective methodology, a fast and loose application of his scientific theories to the facts, and conclusion-driven assessments on the issues of causation in the cases on which he proposes to testify,” the order said. In particular, the court pointed to the opinion that Zyprexa supposedly has a direct adverse effect on cells essential to the body's production of insulin, even in cases in which there was no documented weight gain. This opinion was not based on sufficient facts or data, nor was it the product of a reliable method.

In applying this theory to the facts of the cases (the "fit" required by Daubert), the expert had been, in the view of the court, “shockingly careless” about the scientific facts in these cases, including whether weight gain preceded or followed the plaintiffs' use of Zyprexa, and whether there was any weight gain at all. When confronted with these issues, he merely "shrugged off" factual discrepancies in his analyses or shifted to new theories on the fly.

Significantly, the court correctly observed that other mass torts had been subject to a kind of junk science, and it it could not "permit a major pharmaceutical litigation to become the subject of the kind of 'rubber-stamp' expert opinions that have so marred mass litigations such as those involving asbestos and breast implants.”

State Appellate Accutane Decision Reverses Verdict

The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week.  See  McCarrell v. Hoffman-La Roche, Inc., And Roche Laboratories, Inc., 2009 WL 614484 (N.J.Super.A.D.) (March 12, 2009).

Plaintiff alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease ("IBD"). The IBD allegedly led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his product liability claim against Roche, but not on his consumer fraud claim, and awarded him compensatory damages.

By order dated May 2, 2005, the state Supreme Court had designated all pending and future statewide actions involving Accutane as a mass tort.  Thus, all Accutane cases, including plaintiff's lawsuit, were transferred to Atlantic County to be heard on a coordinated basis. Discovery in the state cases proceeded in tandem with discovery in the federal Accutane multidistrict ("MDL") litigation.

On appeal from the jury verdict, Roche specifically argued, inter alia, that the trial court erred in admitting the opinion testimony of plaintiff's causation expert Dr. Sachar because his methodology was unreliable and thus improper under  N.J.R.E. 702; and that the trial court denied Roche a fair trial in admitting the testimony about causality assessments based on Accutane ADEs, but in restricting the defense in presenting competing quantitative proofs to put the ADEs in context, including the actual number of Accutane users.

On the issue whether Dr. Sachar's causation testimony was sufficiently reliable in the field of scientific research to be admitted, the court noted that in New Jersey the standard of review of such
rulings under Rule 702 is a narrow one. "In reviewing a trial court's evidential ruling, an appellate court is limited to examining the decision for abuse of discretion."

On the merits, the defendant objected to the expert's heavy reliance on animal studies. The NJ  Supreme Court has previously recognized that animal studies can be an accepted scientific method to study the safety and efficacy of drugs.  Even though the dose administered in the animal studies was far different than the medicinal dose, "trained experts commonly extrapolate from existing data." Gen. Elec. v. Joiner, 522 U.S. 136, 146 (1997). In assessing the results of animal studies, which frequently involve high doses, experts should be careful to consider the dose-response differential between animals and humans. Magistrini v. One Hour Martinizing
Dry Cleaning
, 180 F. Supp. 2d 584, 593 (D.N.J. 2002), aff'd, 68 Fed. App'x. 356 (3d Cir. 2003). (Readers also know that the biological differences between commonly used animals such as rats and humans make the models inappropriate for many comparisons, regardless of dose.)

Defendants also challenged the use of anecdotal case reports as a basis for the causation opinion. The court recognized that "[c]ausal attribution based on case studies must be regarded with caution." Federal Judicial Center, Reference Manual on Sci. Evidence 497 (2d ed. 2000).
That is so because case reports typically reflect reported observations, and do not themselves contain scientific analyses. For instance, case reports may lack controls, may fail to screen out alternative causes, and may omit relevant facts about the patient's condition that can be pertinent to a causation assessment. Consequently, a number of courts have concluded that anecdotal case reports are not a scientifically reliable basis for an expert's opinion on causation.

Nevertheless, some other courts have allowed consideration of case reports as an acceptable basis for trying to show causation, particularly when accompanied by other reliable scientific evidence. New Jersey courts have previously upheld the admission of expert testimony that has relied, at least in part, upon case reports or comparable anecdotal evidence. The court also found significant that the case reports here included dechallenge and rechallenge reports. Dechallenge and rechallenge reports are a type of case report. Dunn v. Sandoz Pharms. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003). Such reports have limitations, but have been considered useful in some contexts in ascertaining causation because they measure a patient's reaction to a drug, said the appellate court.  (Readers will note that the dechallenge/rechallenge concept appears to make little sense when the effect of the drug is supposedly a permanent disease!)

The New Jersey court recognized it was issuing a causation decision contrary to the ruling in the Accutane MDL.  The state court declined to follow the federal court's decision because (1) the causation expert in the federal case was not Dr. Sachar, and that particular expert's methodology was not as "demonstrably sound" as that of Dr. Sachar; (2) the standards for expert admissibility under N.J.R.E. 702 are not identical to F.R.E. 702; and (3) the testimonial record in this case, having proceeded to trial, was more developed than it was in the Florida case on a pretrial motion, lending greater confidence to a conclusion to sustain the trial judge's decision to admit Dr. Sachar's testimony.

Defendant also challenged the expert's testimony about the company's alleged intent and motive and mind-set, a typical plaintiffs' tactic in mass torts.  Totally improper, highly prejudicial, and ignored by some courts because they seem overwhelmed by the plaintiff's characterization of the defendant's conduct.  Well-reasoned opinions exclude such testimony. See In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1053 (D.Minn. 2007) (observing that "[p]ersonal views on corporate ethics and morality are not expert opinions"); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (holding that the objected-to opinions of expert witnesses on intent, motives, or state of mind of a corporation had no basis in any relevant body of knowledge or expertise).  Here, the court seemed not to understand the impact and purpose of this improper testimony, finding that although Dr. Sachar's testimony sharply criticized Roche, his criticisms did not rise to "such an inflammatory level" that would cause the appeals court to find an abuse of discretion by the trial court in not excluding it.  The issue is not only a Rule 403 prejudice issue; there is a fundamental relevance issue, and a serious issue about fit, foundation, and reliability.

Finally, there was what has been described as the "numbers" issue. The issue refers to the fact that the trial court allowed plaintiff's witnesses and counsel to refer, on repeated occasions, to the number of adverse incidents reported from Accutane users or from other sources while, at the same time, the court restricted Roche's attempt at trial to place those adverse numbers into any larger quantitative context. Specifically, the judge precluded Roche witnesses from more
fully informing the jury about the large number of persons who had taken Accutane before it was prescribed to plaintiff in 1995, and the comparative significance of those figures.

The court ultimately concludes that it was unfair to Roche for the trial court to have precluded such "numbers" counter-proof and that the court abused its discretion on this evidentiary issue. Had Roche been allowed to present the statistics showing five million Accutane users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's actions in changing its label. "Principles of completeness and fairness warranted the presentation of this contextual information to the fact-finder."

 

 

Eleventh Circuit Affirms Exclusion of Expert Testimony on General Causation

The 11th Circuit has affirmed a trial court’s exclusion of key expert causation proof in a suit against the manufacturer of Remicade, finding the expert evidence was not adequately supported by scientific studies or literature. Goldstein v. Centocor Inc., 2009 WL 275322 (11th Cir. 2/05/09).

Plaintiff-appellant contended that the prescription medication Remicade caused his pulmonary fibrosis, requiring a bilateral lung replacement. The trial court excluded plaintiff’s expert testimony on general causation, pursuant to Fed.R.Evid. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). The court of appeals reviews a trial court's Daubert rulings under an abuse of discretion standard. McClain v. Metabolife Intern'l, Inc., 401 F.3d 1233, 1238 (11th Cir.2005).

Plaintiff’s expert did not rely on any epidemiological studies that connect Remicade with pulmonary fibrosis. This is not necessarily fatal, said the 11th Circuit, but it makes a plaintiff’s task to show general causation more difficult. See Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1198 (11th Cir.2002).

In the absence of epidemiological studies, the expert reviewed four sources to make his general causation assessment. The first category, plaintiff's lung and bowel pathology reports, was not relevant to general causation; its focus on the plaintiff made it relevant to specific causation. See McClain, 401 F.3d at 1239 (“General causation is concerned with whether an agent increases the incidence of disease in a group and not whether the agent caused any given individual's disease.”). The second category, MedWatch case reports submitted by doctors who observed possible reactions to Remicade, have a limited weight. Such reports are made without medical controls or scientific assessment, and while they may support other proof of causation, alone they cannot prove causation. Id. at 1199. (putting aside an expert’s reliance on such reports, they are hearsay and do not fall within any of the exceptions to the hearsay rule; also, the prejudicial effect of these reports outweighs their probative value.)

The third category, a review of medical textbooks, revealed no relevant general causation information, only extended analogies. The fourth category, a review of abstracts of four articles linking Remicade with pulmonary fibrosis, is relevant to general causation but provided only very limited information.

A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. General Elec. Co. v. Joiner, 522 U.S. 136, 146, (1997). The district court did so here, and the 11th Circuit found no abuse of discretion in its determination.
 

Daubert Lessons From Two Medical Device Cases

Two recent federal cases illustrate important Daubert principles in the medical device context.

In Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09), the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product.  In contrast, in Jaske v. Zimmer Inc., 2009 WL 150946 (N.D. Ill., 1/20/09), the Northern District of Illinois reversed an earlier decision to exclude two expert witnesses for the plaintiff. On a motion for reconsideration, the court ruled that plaintiff can present testimony from two experts in polymer science as to why his prosthetic knee, manufactured by defendant Zimmer, allegedly failed.


Fuesting alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

Under Rule 702 and the Daubert standard, expert testimony must be both relevant and reliable. The district court must act as a “gatekeeper” making a preliminary assessment of the reasoning or methodology underlying the testimony. Daubert factors include: (1) whether the scientific theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the theory's known or potential rate of error when applied; and (4) whether the technique or theory has been ‘generally accepted’ in the scientific community. 


On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. To bridge the gap, rhe expert needed to show, with respect to Fuesting's implant in particular, what quantum of each variable is required to set the alleged causal chain reaction in motion. That is, the causation opinion must be specific to the plaintiff, and each chain in the causal link must be supported by adequate science. Gaps included how much radiation does it take to cause oxidation, and to what degree? How much oxidation must occur to render polyethylene more susceptible to delamination? And once polyethylene becomes more susceptible to delamination, how then does oxidation affect delamination? Are all forms of polyethylene, including that used by Zimmer (which the company claims to be oxidation-resistant), susceptible to delamination? What effect, if any, does implantation into the human body have on the rate of oxidation?

The expert testimony as to defect also failed. Oxidation can occur in implants sterilized by any method. However, plaintiff’s expert did not know of any peer-reviewed studies or articles that compared oxidation rates for implants sterilized by GIA to those sterilized through other methods. While the prosthesis showed significant oxidation when it was tested, that testing occurred more than six years after the knee joint was explanted, and plaintiff failed to account for oxidation that may have occurred after the joint was removed.

Having granted Zimmer's motion to exclude the expert testimony, the court had no alternative but to also grant the company's motion for summary judgment.

In Jaske, Plaintiff had his left knee replaced with a prosthesis to alleviate recurring pain. When the prosthesis allegedly failed, he filed suit against the manufacturer. Last year, the district court granted defendant's motion to exclude the testimony of two of plaintiff's experts in polymer science, who, while qualified to offer some opinions, used a test as the basis for their opinions that was not reliable. (A Fourier Transform Infrared Spectroscopy (“FTIR”)). Plaintiff moved for reconsideration.


The court had determined that the proffered testimony was unreliable for two reasons. First, the results of the FTIR test may have been skewed because lipids and proteins from Jaske's body had permeated the product. And, second, even if the test results were accurate, they did not determine when the oxidation took place. Originally, plaintiff offered nothing but a naked expert opinion on this issue. On reconsideration, plaintiff presented new evidence that any biological material present would absorb the infrared spectrum used in the FTIR at a different frequency than oxidized polyethylene, and that the FTIR is the accepted standard of the American Society of Testing and Manufacturing for this purpose.

The court had also originally noted that the FTIR test measured the amount of oxidation present in the prosthesis only at the time the test was conducted. It did not provide historical readings. Plaintiff clarified that his experts developed their theory independent of the test results. Instead of relying on the FTIR results to arrive at their theory, they said, the FTIR simply provided support for it. In other words, the results of the FTIR are merely consistent with the theory. The theory that gamma irradiation sterilization in air causes oxidation has been recognized, asserted plaintiff, for some time in the scientific community.


This second case demonstrates one of the potential dangers of the Daubert challenge: if the court is going to give plaintiff a second bite of the apple, the Daubert motion turns into a roadmap for the plaintiff on what holes to fix.  See our post on reasons why you might not file a credible motion.
 

Update on Proposed Amendment to Federal Rules on Expert Discovery

Experts play a vital role in mass tort defense.  Selection, preparation, and discovery of experts are crucial pre-trial tasks of the defense attorney.  Thus, the rules of civil procedure governing those tasks really matter.

The end of the time period for public comment on proposed changes to Federal Rule of Civil Procedure 26 is rapidly approaching. The formal process to amend the rule governing expert discovery began in early 2008 when the Advisory Committee on civil rules met to consider rule changes recommended by the American Bar Association. After drafting a proposed rule, the committee published the changes for public comment. Written comments are due by February 17, 2009.  There will be a final public Judicial Conference hearing in San Francisco, California, on February 2, 2009.  Guidelines for submitting comments can be found here.


After the comment period ends in February, the advisory committee is expected to consider comments and, if needed, redraft the rule.  Under the Rules Enabling Act, the rule will then be forwarded to the Standing Committee on Rules of Practice and Procedure, which must consider the changes. The standing committee would review the rule at a meeting planned for June, and submit it to the Judicial Conference for consideration at its September session. The proposed changes could go to the U.S. Supreme Court in time for the October session. Assuming this timeline holds up, the Supreme Court must act on the changes by May, 2010. The final step will require consideration by Congress, which will have seven months to act on the proposal. By statute, non-action would allow the rule changes to take effect early as December, 2010.

But the first deadline is the looming end to the public comment period.

What would the rule do?

The key changes extend work-product protection to drafts of Rule 26(a)(2)(B) expert reports and 26(a)(2)(C) party disclosures, and also to certain attorney-expert communications. The proposed amendments are designed to reflect what the Standing Committee calls the “lessons of experience” as opposed to theory, and to provide useful discovery while reducing practices that now impede the best use of expert trial witnesses.

Under the proposal, Rule 26(b)(4) would be amended to extend work-product protection to drafts of expert reports, drafts of party disclosures, and communications between expert witnesses and counsel. Exceptions are carved out for discovery of compensation, identification of facts or data the attorney provided to the expert and that the expert considered in forming the opinions to be expressed; and any assumptions that the attorney provided to the expert and that the expert relied upon in forming opinions.

Some courts have interpreted the Advisory Committee note on existing Rule 26(a)(2)(B) to allow parties to inquire into all communications between experts and counsel, multiplying expenses with little benefit to the parties, and impeding the way cases are actually prepared for trial. This approach has also contributed to the practice of retaining two experts, one to testify and the other to consult. Many lawyers will stipulate out of discovery of draft reports and attorney-expert communication because the costs of such discovery seem higher than the infrequent, small benefits that may be gained. The changes thus are needed to create efficiencies and to reduce litigation costs.

Some academics and the plaintiffs’ bar argue, however, that any restriction on inquiry into the expert's relationship with retaining counsel is a bad idea. Some have even started a letter-writing campaign opposing the proposed amendments. Comments from DRI, on the other hand, suggest that the protections should extend to communications between attorneys and the expert's staff as well.
 

Summary Judgment In Benzene Case: Failure To Prove Dose

A federal court has granted summary judgment in a toxic tort suit in which plaintiff alleged he contracted a bone disease because of his long-term exposure to trace amounts of benzene in oil-based paint. Smolowitz v. The Sherwin-Williams Co., 2008 WL 4862981 (E.D.N.Y. Nov. 10, 2008). Plaintiff failed to offer sufficient evidence under New York law of exposure level.


In order to prevail in a toxic tort case, plaintiffs must present sufficient evidence to support a finding that defendants' products caused plaintiffs' injuries. Proof of causation requires establishing both “general” causation and “specific” causation.  General causation bears on whether the type of injury at issue can be caused or exacerbated by the defendant's product. Specific causation bears on whether, in the particular instance, the injury actually was caused or exacerbated by the defendant's product.  The fundamental principle of toxicology is that the dose makes the poison: substances that are benign or even beneficial at a certain level can be toxic at another. Even when general causation is clear, a plaintiff must show that he or she was exposed to a sufficient dose of the substance to have caused the disease. Under New York law, plaintiffs must establish both general and specific causation through expert testimony

Plaintiff Richard Smolowitz worked as a drywall taper and spackler over a thirty year period beginning in the 1950s and ending in the early 1980s. Plaintiff alleges that his exposure to benzene in paints caused him to contract myelodysplastic syndrome (“MDS”).  A central factual issue in this case, said the court, was the level of exposure to which plaintiff was subject, and whether that level of exposure can cause MDS. First, plaintiff was not a painter, but alleged he worked in areas where paint products were regularly used. Second, the solvents used in defendants' oil based paints contained only a trace contamination of benzene due to the fact that the products are based on petroleum, and it is not always possible to remove all of the benzene during the manufacturing process.

In early motion practice, plaintiff's counsel represented that he would provide the testimony of expert witnesses who could prove that plaintiff was exposed to oil based paints with sufficient levels of benzene to cause his illness. Eventually, he relied on the opinions of plaintiff's treating physician, Dr. Silverman, to provide expert testimony on issues of general and specific causation. The doctor reported he was currently treating plaintiff for MDS; that Smolowitz reported a history of exposure to oil based paints, thinners and benzene during a 35-year period; and that in his opinion it was “likely to a reasonable medical probability, that Mr. Smolowitz's exposure to benzene during the years that he worked as a dry-wall mechanic is causative for his current hematologic condition.”

The court concluded that Dr. Silverman's testimony was inadequate to prove either general or specific causation. The conclusory statement that based upon plaintiff's reported history it was likely to a reasonable medical probability that Mr. Smolowitz's exposure to benzene during the years that he worked as a dry-wall mechanic is causative for his current hematologic condition, had substantial deficiencies. First, there was nothing in this statement that suggests that Dr. Silverman was aware of or had quantified the precise amount of benzene to which plaintiff was exposed. No proof of dose. Second, Dr. Silverman did not offer any opinion as to whether that limited level of benzene exposure, whatever it was, can cause the disease. In the absence of sufficient evidence from an expert or a treating physician of the plaintiff's exposure level, plaintiff could not prove the essential causation element of the claim.
 

Eighth Circuit Affirms Exclusion Of Causation Expert In Toxic Tort Case

The 8th Circuit has upheld the trial court’s decision that a plaintiff who alleged she was injured by drinking water from a bottle filled with freon did not have adequate and valid expert evidence of causation. Bland v. Verizon Wireless, 2008 WL 3474178 (8th Cir. August 14, 2008).

Plaintiff alleged that she inadvertently left her water bottle behind in a store, and an employee of defendant sprayed compressed air into her water bottle “as a joke,” believing the water bottle belonged to a fellow employee. At home, plaintiff opened the bottle which “made a-kind of pressurized noise.” She took a drink, then decided to smell the contents, taking a big whiff which made her cough. She then allegedly took another drink.

Plaintiff later reported to her doctor that after drinking from the bottle she coughed, which persisted for nearly an hour. She also described a “sore sensation in her throat” and for the next few days a “raspy sensation in her lungs.” Plaintiff alleged she developed a headache which persisted for about two weeks. Later testing at the University of Iowa Lab determined the bottle contained 820 parts per million (ppm) (.08%) of difluoroethane, a freon compound.

Plaintiff was later seen by a Dr. Sprince, complaining of shortness of breath when running. Her lung function test results were basically normal. Dr. Sprince eventually diagnosed her as having “exercise-induced asthma.” Dr. Sprince later theorized that “[b]ased on the initial clinical findings, [a] strong temporal relationship between the inhalation of freon and the occurrence of respiratory symptoms, and the subsequent response to pre-exercise treatment with inhaled bronchodilator” that plaintiff's exercise-induced asthma was caused by the inhalation of freon.

Plaintiff sought to use the testimony of this treating physician, Dr. Sprince, to establish a causal link between inhalation of freon and the alleged exercise-induced asthma. The district court excluded Dr. Sprince's testimony because Dr. Sprince's proffered testimony as to causation did not satisfy the standards for admission of expert scientific testimony under Daubert.

The 8th Circuit affirmed, noting first that a treating physician's expert opinion on causation is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for purposes of litigation.

The first problem with Dr. Sprince's causation testimony was that she failed scientifically to eliminate other possible causes as part of her differential diagnosis. In particular, her own testimony acknowledged the cause of exercise-induced asthma in the majority of cases is unknown. Where the cause of the condition is unknown in the majority of cases, an expert cannot properly conclude, based upon a simple differential diagnosis, that exposure, here to freon, was the most probable cause of the injury. As a practical matter, Dr. Sprince's causation opinion could not possibly be based upon a reasonable degree of medical certainty. Where the majority of cases of exercise-induced asthma have no known cause, and where Dr. Sprince failed to do an investigation and analysis of plaintiff's home or other environments in search of other possible causes, the district court did not abuse its discretion in determining Dr. Sprince's differential diagnosis did not satisfy Daubert.

Second, plaintiff’s expert did not know what amount of exposure to freon causes, or involves an appreciable risk of causing, asthma, and had no good grounds for determining whether plaintiff  was exposed to a sufficient dose to have caused her asthma. Dr. Sprince could not determine or estimate the amount of freon plaintiff was actually or probably exposed to. The expert could not extrapolate from the existing data because the gap between the data identified (exposure facts) and Dr. Sprince's proffered opinion was simply too great an analytical gap to support admissibility. Critical to a determination of causation is characterizing exposure. In a toxic tort case, the magnitude or concentration of an exposure should be estimated and the temporal aspects of the exposure should be determined --whether the exposure was short-term and lasted a few minutes, days, weeks, or months, or was long-term and lasted for years. Dr. Sprince lacked knowledge regarding what level of exposure to freon constitutes an appreciable risk of causing asthma and the specific concentration and degree of exposure to the freon. Similarly, plaintiff’s expert did not offer as evidence any personal experience with treating other patients following a similar exposure, admitting she had no such experience.

Finally, the expert’s heavy reliance on temporal proximity, without more, was insufficient to establish causation. In the absence of an established scientific connection between exposure and illness, or compelling circumstances, the temporal connection between exposure to chemicals and an onset of symptoms, standing alone, is entitled to little weight in determining causation. See Moore v. Ashland Chem., Inc., 151 F.3d 269, 278 (5th Cir.1998). It is not always irrelevant, said the court. The temporal relationship often will be one of several factors, and the weight to be given to the temporal relationship will differ depending on the strength of that relationship. But in this case, the district court properly discounted all the other factors supporting Dr. Sprince's opinion leaving only temporal proximity to support Dr. Sprince's causation opinion. And that was not enough, especially when plaintiff did not make an appointment with a doctor until two to three weeks after the incident.
 

Daubert Decision in Mold Case

A legal malpractice case is the somewhat surprising setting for an interesting Daubert toxic tort opinion, but we found one. Young, et al. v. Burton, et al, 2008 WL 2810237 (D.D.C. 7/22/08).

Plaintiffs sued a law firm for allegedly failing to file a timely personal injury lawsuit for their alleged mold-induced injuries. The lawsuit would have sought recovery from a landlord for damages suffered by plaintiffs allegedly as a result of exposure to toxic mold while residing in a DC apartment building. In order to succeed on their legal malpractice claim, plaintiffs needed to show their underlying claim was meritorious. Thus, plaintiffs needed admissible expert testimony as to the cause, nature, and extent of their injuries.

Defendants moved to exclude the expert’s testimony, arguing that his opinions were not based on a reliable methodology.

Following a Daubert hearing, the Court concluded that the diagnosis of plaintiffs, as well as the proffered opinions relating to general and specific causation, were not sufficiently grounded in scientifically valid principles and methods to satisfy Daubert.

Exposure Claim

Plaintiffs resided in the apartment for approximately thirty-four days, during which time plaintiffs contend they could smell noxious fumes from raw sewage. They testified they noticed extensive visible mold growth in an adjacent vacant apartment, although they estimated they were in that apartment for no longer than one or two minutes. There was no documentation of any visible mold growth in plaintiffs', and plaintiffs did not believe the two apartments shared a common air source.

Both plaintiffs submitted extensive medical records to document the health problems that they attribute to their mold exposure, but medical records also indicated significant medical problems prior to moving into the apartment

Plaintiffs’ expert, Dr. Shoemaker, used his own differential diagnostic procedure for mold illness. That procedure involves a two-tiered analysis. To satisfy the first tier, all three of the following factors must be met: (1) the potential for exposure; (2) the presence of a distinctive group of symptoms; and (3) the absence of confounding diagnoses and exposures. The second tier looks at levels of certain hormones and enzymes in the blood which the expert believes are altered by exposure to a biotoxin and thus serve as “biomarkers.”

Defense Argument

Defendants requested a Daubert hearing, arguing that there was no evidence as to the exact substance plaintiffs were exposed to or the level at which they were exposed, and thus formal toxicological causation analysis could not be performed. In addition, the tests Dr. Shoemaker used to reach his diagnosis are experimental and “not generally accepted in the toxicology community.” The traditional causation analysis, relying on the nine “Hill Criteria” that are necessary to establish a causal relationship, does not support a causal association between the dark material on the adjacent apartment walls and the plaintiffs' health complaints. (In a nutshell, the Hill Criteria are: 1) strength; 2) consistency; 3) specificity; 4) temporality; 5) biological gradient; 6) plausibility; 7) coherence; 8) experiment; and 9) analogy).

Mold Disease Causation
Courts throughout the country have varied widely with respect to the level of certainty they require with respect to the issue of causation in mold cases. See Jeffrey J. Hayward, The Same Mold Story?: What Toxic Mold is Teaching us about Causation in Toxic Tort Litigation, 83 N.C. L.Rev. 518, 536-38 (2005). One common method of plaintiffs attempting to demonstrate causation is showing a temporal relationship between exposure to a toxin and subsequent adverse health effects. However, while necessary, temporal association between exposure and illness, without more, is generally insufficient to establish causation. Under the traditional approach, in the absence of an established scientific connection between exposure and illness, the temporal connection between exposure to chemicals and an onset of symptoms, standing alone, is entitled to little weight in determining causation.

The most widely-used method of demonstrating causation in toxic tort cases is to present scientifically accepted information about the dose-response curve for the toxin which confirms that the toxin can cause the health effects experienced by the plaintiff at the dosage plaintiff was exposed to. Indeed, scientific knowledge of the harmful level of exposure to a chemical, plus knowledge that the plaintiff was exposed to such quantities, are minimal facts necessary to sustain the plaintiff's burden in a toxic tort case.

Diagnosis Flawed
Dr. Shoemaker could not show that plaintiffs met his own case definition. In the first tier of Dr. Shoemaker's case definition, the patient must have had exposure; clearly, a person cannot be made ill by mold toxins to which she has not actually been exposed. No environmental tests were conducted in plaintiffs' apartment to provide actual proof that plaintiffs did, in fact, inhale toxic substances when they resided there.

Shoemaker attempted to show that plaintiffs had the requisite exposure in two ways, neither of which was convincing to the court. First, Dr. Shoemaker believed that his case definition allowed him to use the diagnosis of the disease as evidence of actual exposure. In short, the symptoms fundamentally become the basis for explaining themselves. Such circular reasoning is not scientifically or medically acceptable. And factually, plaintiffs' complex of symptoms did not begin immediately after exposure. Also, the symptoms did not remain consistent over time. Finally, Dr. Shoemaker was unable to determine which symptoms are actually attributable to the mold. Rather, he testified that roughly 75% of plaintiffs' symptoms were probably attributable to this mold exposure, although he could not say which ones.

The third element of the first tier of Dr. Shoemaker's diagnostic protocol is that there be an absence of confounding diagnoses and exposures. This requirement is critical to a differential diagnosis, which is to conclude that only the chosen diagnosis could be responsible for the symptoms presented. Nevertheless, Dr. Shoemaker glossed over the explanation of how he ruled out all potential confounding explanations for plaintiffs' symptoms. At points, Dr. Shoemaker brushed off discussion of confounding diagnoses as almost irrelevant.

The most fundamental flaw in Dr. Shoemaker's Tier 2 analysis was that not one of his biomarker tests is generally accepted or clinically validated for the purpose of diagnosing “mold illness.” Additionally, the idea that levels of these biomarkers five years after an exposure is in any way related to that exposure is unsupported by generally accepted science.


General Causation

Shoemaker arrived at his opinions on general and specific causation based on novel and unaccepted theories and methodologies. Plaintiffs’ general causation evidence confronted the problem that there was no way of knowing what substance the plaintiffs were in fact exposed to, as Dr. Shoemaker freely admitted he did not know what molds or bacteria were present in plaintiffs' apartment. Second, his own peer-reviewed publication on “mold illness” was far too limited to stand alone as proof of general causation; only twenty-six subjects participated in the study, and the double-blinded, placebo-controlled clinical trial involved only thirteen of those subjects.

Specific Causation

On specific causation, in short, Shoemaker did not perform his five-step protocol on plaintiffs, and indeed could not possibly have done so, as he first met them long after they left the suspected mold environment. Nor was he able to base his causation opinion on the plaintiffs' response to treatment, for both plaintiffs chose not to take the medication that he had prescribed for them. 
 

Defendants did an outstanding job of holding plaintiff's expert to the standards he himself created, but could not attain.

Indiana Appeals Court Upholds Summary Judgment On Causation Issue

The Indiana Court of Appeals has ruled that the trial court correctly granted summary judgment to DaimlerChrysler Corporation in two separate toxic exposure cases involving visiting workers at the company's New Castle, Ind., facility. See Coomer v. DaimlerChrysler Corp., Ind. Ct. App., No. 33A01-0712-CV-582, 7/11/08); and Gregory v. DaimlerChrysler, Ind. Ct. App., No. 33A01-0712-CV-581, 7/11/08). In affirming the rulings of the Indiana Circuit Court, the Court of Appeals held that the expert in both cases, Dr. George Rogers, did not adequately specify the level, concentration, or duration of plaintiffs' alleged exposure to unspecified chemicals. Accordingly, the workers failed to present sufficient expert evidence to establish causation.

Plaintiffs Matthew Gregory and Darrin Coomer were employees of Smoot Construction, and alleged they were doing work at the DaimlerChrysler New Castle Machining and Forging Facility. Three months after starting work, Coomer experienced a seizure while playing video games at home. Coomer’s treating neurologist diagnosed him with juvenile myoclonic epilepsy (JME), the “most common genetic or inherited form of epilepsy . . . [which is] thought to be caused by an abnormal gene on the short arm of chromosome 6.”  About 7 months after he began working, plaintiff Gregory, who was twenty-seven years old, allegedly experienced his first seizure after returning home from work. An IME showed he suffered from idiopathic seizure disorder.

Gregory and Coomer, in two separately filed complaints against Daimler/Chrysler Corp., Methadone Corp., and NC-M Chassis Systems LLC, alleged that the seizures were caused by their exposure to allegedly contaminated soil, water, and toxins at the facility. Defendant moved for summary judgment on the issue of causation. In response, plaintiffs presented their own expert, a professor of pediatrics and pharmacology/toxicology, who concluded that Coomer and Gregory were "clearly'' exposed to a "complex mixture of potentially toxic materials.''  The expert opined that many of the materials identified on the site, including some solvents and metals, can cause seizures with excess exposure. “I think it is reasonable to conclude that [plaintiffs'] occupational exposure to this mix of toxic chemicals may have contributed to the onset" of their disorders.

The Court of Appeals noted that an expert’s opinion is insufficient to establish causation when it is based only upon a temporal relationship between an event and a subsequent medical condition. In particular, when an expert witness testifies in a chemical exposure case that the exposure has caused a particular condition because the plaintiff was exposed and later experienced symptoms, without having analyzed the level, concentration or duration of the exposure to the chemicals in question, and without sufficiently accounting for the possibility of alternative causes, the expert’s opinion is insufficient to establish causation. Dr. Rodgers did not identify which chemicals plaintiffs were allegedly exposed to. He did not specify the level, concentration, or duration of their alleged exposure to the unspecified chemicals. Instead, Dr. Rodgers made vague assertions regarding plaintiffs’ alleged exposure to a mixture of “potentially toxic materials.” MassTortDefense has posted about the importance of evidence of dose here.

In toxic tort cases in Indiana, one way an expert may approach the causation issue is by way of a “differential diagnosis,”  testing to rule out alternative causes of the plaintiff’s ailments. But the expert never addressed the independent medical examiner’s conclusion that Gregory had an idiopathic seizure disorder, and he also failed to address the possible impact of a skull fracture Gregory sustained in an accident as a child. The expert failed to respond to the fact that Coomer’s own physician concluded that Coomer’s seizures were the result of a genetic form of epilepsy.

In sum, because Dr. Rodgers did not identify specific chemicals, analyze the level, concentration, or duration of Coomer’s alleged exposure, or account for the possibility of alternative causes, his opinion was insufficient to establish causation.

Daubert Ruling And Summary Judgment In Lymphoma Case

Judge Stewart Dalzell of the U.S. District Court for the Eastern District of Pennsylvania granted summary judgment to Novartis Pharmaceuticals Corp. in a suit that alleged the company's eczema drug, Elidel, caused plaintiff’s lymphoma. Perry v. Novartis Pharmaceuticals Corp., 2008 WL 2683047 (E.D. Pa. July 09, 2008). Although we typically focus on appellate opinions at MassTortDefense, this well-reasoned opinion is worth a look.

The Perrys filed suit against Novartis in October, 2005 alleging that the company had failed to warn about the risks of Elidel. Their son allegedly developed eczema shortly after his birth, and a pediatrician prescribed Elidel in 2003. He was diagnosed with lymphoma a few months later.

Defendant challenged plaintiffs’ expert evidence on causation. As is frequently the case, if plaintiffs’ expert testimony does not meet the Daubert standard, summary judgment for failure of proof on causation follows. The court noted that the core issue that the jury would have to address in this case is whether Perry's exposure to Elidel was a substantial cause of his disease. Courts in toxic tort cases often separate the causation inquiry into general causation (whether the substance is capable of causing the observed harm in general), and specific causation (whether the substance actually caused the harm a particular individual suffered). Plaintiffs' experts did the same, each drawing conclusions about both the capacity of the drug to cause Non-Hodgkins Lymphoma (NHL) in humans and its particular effect in Perry's case.

An expert's journey from general causation to specific causation need not be just a two-step process. So long as, taken together, the expert is able to draw a chain of scientifically reliable causal links that meets plaintiff's requirements under the substantive tort law, the evidence is admissible, and it will be left to the jury to establish the relative credibility of the parties' competing experts. Where, however, the expert reports leave wide, unexplained gaps in the causal chain, the evidence is not helpful to the trier of fact and must be excluded. In Daubert terms, just as there is no fit where there is simply too great an analytical gap between the data and the opinion offered, see Soldo v. Sandoz Pharms. Corp., 244 F.Supp.2d 434, 527 (W.D. Pa. 2003) (quoting General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997)), “there is also no fit when there is too great an analytical gap between an expert's general causation conclusion and the specific causation question the jury must ultimately answer,” said the court.

One problematic gap concerned epidemiology. Although it has not been held by the Third Circuit that epidemiological studies are an indispensable element in the presentation of a prima facie drug product liability case, Lanzilotti v. Merrell Dow Pharms. Inc., 1986 WL 7832 (E.D.Pa. July 10, 1986) at *2, epidemiology is the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or a disease. See Soldo, 244 F.Supp. at 532 (quoting Conde v. Velsicol Chem. Corp., 804 F.Supp. 972, 1025-26 (S.D. Ohio 1992)). Thus, while an expert's conclusions reached on the basis of other studies could perhaps be sufficiently reliable where no epidemiological studies have been conducted, no reliable scientific approach can simply ignore the epidemiology that does exist.

A second issue concerned the state of the art. The court made clear that the non-existence of good data does not allow expert witnesses to speculate or base their conclusions on inadequate supporting science. In cases where no adequate study shows the link between a substance and a disease, expert testimony will generally be inadmissible, even if there are hints in the data that some link might exist. This may mean that early victims of toxic torts are left without redress because they are unable to prove their cases with the scientific data that currently exists. While this is a “regrettable result in those individual cases,” said the court, it is an unavoidable reality of the structure of our legal system and is necessary to protect the interests of defendants who might otherwise be subject to crippling verdicts on the basis of slender scientific evidence. As the Seventh Circuit has noted, the courtroom is not the place for scientific guesswork, even of the inspired sort. “Law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996).

Focusing next on specific causation, the court noted that each plaintiff expert engaged in a differential diagnosis. MassTortDefense notes the increasing use, and misuse, by plaintiffs of so-called differential diagnosis. The process by which a doctor views symptoms and test results to rule out possible alternative diseases in the diagnostic process to arrive at a conclusion concerning what ails the patient, has morphed into a process by which experts can tell the jury what caused the condition of the plaintiff – a far different thing. Here, after finding that no other risk factor for NHL was present, the experts concluded that because the drug was the only risk factor present and because the disease is rare, plaintiff’s treatment with Elidel was a substantial factor in his presentation with the disease. However, in order to result in an admissible conclusion, a differential diagnosis should reliably rule out reasonable alternative causes of the alleged harm including idiopathic causes. Soldo, 244 F.Supp.2d at 567. Admissible expert testimony need not rule out all alternative causes, but where a defendant points to a plausible alternative cause and the doctor offers no explanation for why he or she has concluded that it was not the sole cause, that doctor's methodology is unreliable.

Here, the differential diagnoses by plaintiff experts failed to exclude the likelihood that Perry's lymphoma had no known cause. Most NHL cases are idiopathic, having no known cause. Courts have excluded experts' differential diagnoses where they failed to adequately account for the likelihood that the disease was caused by an unknown factor. Doe v. Ortho-Clinical Diagnostics, Inc., 440 F.Supp.2d 465, 478 (M.D.N.C. 2006); Whiting v. Boston Edison Co., 891 F.Supp. 12 (D. Mass.1995). This is not to say, cautioned the court, that where most diagnoses of a disease are idiopathic it is impossible to prove specific causation. But in those cases, analysis beyond a differential diagnosis will likely be required.

Plaintiffs' experts' general causation conclusions were primarily based on animal studies and their failure to satisfactorily address epidemiology (and the gap related to dosage levels in the studies vs. plaintiff’s exposure) undermined the usefulness of those conclusions to a jury. Since plaintiffs' experts failed to form a scientifically grounded chain of inference between their general causation finding and their specific causation finding, their opinions were excluded. Summary judgment followed.

MTBE Court Excludes Part, Permits Part Of Plaintiffs' Expert Opinion

In another in a series of rulings on expert issues, the MDL court in the MTBE litigation has excluded parts of the proffered testimony of a plaintiffs' expert, while permitting others. Judge Shira Scheindlin of the U.S. District Court for the Southern District of New York issued an order permitting Dr. Myron Mehlman to testify that MTBE causes adducts to form on DNA and is a probable human carcinogen. Judge Scheindlin found that the plaintiffs proved that this part of his testimony is the product of reliable principles and methods. However, he may not testify that plaintiffs have a reasonable basis for their alleged fear of cancer.

The suits in the MDL generally allege that MTBE, which was added to gasoline at varying levels between 1979 and 2007, has leaked from underground storage tanks and contaminated groundwater. The defendants in this particular case within the MDL are the owners of two gas stations and their suppliers who allegedly contaminated 50 private water wells in the town of Fort Montgomery, N.Y. See In re: Methyl Tertiary Butyl Ether Products Liability Litigation, case number 1:00-cv-01898.

Defendants argued that Mehlman's opinion should be excluded because his methods are not generally accepted in the scientific community and because he hadn't applied those methods reliably to the facts. The absence of general acceptance in the community remains a relevant factor under Daubert.

The court noted that if a method hasn't gained general acceptance, it may be properly viewed with skepticism. But “viewing a method with skepticism is a far cry from the bright-line rule of exclusion.” The expert relied on the peer reviewed MTBE-DNA Adducts study, as well as numerous studies allegedly showing exposure to MTBE has led to cancer in animals. The court held that a vigorous cross examination by defendants at trial was the proper way to handle the issues concerning the expert’s methodology as well as its underlying assumptions. “After evaluating the evidence from both sides, the jury may well agree with defendants that MTBE does not cause cancer in humans,” the court noted.

However, the expert cannot testify that specific plaintiffs suffered subcellular damage or have a reasonable fear of cancer because he did not adequately quantify their alleged exposure. While the levels of exposure to toxic substances is sometimes difficult to precisely quantify, this does not excuse Dr. Mehlman from attempting to analyze plaintiffs' exposure levels if he intended to testify that they have a basis for their fear of cancer.

Why Not File That Daubert Motion?

The typical fodder for MassTortDefense includes a recent case decision, new legislation or regulatory action, and developing science. Today’s post starts in a more local spot: in the midst of a recent strategy discussion, a young colleague asked, “If the motion is not frivolous, and you are not convinced the judge won’t consider it, why would you ever NOT file a Daubert challenge to a plaintiff’s expert?” Not a bad question, and maybe worth sharing the discussion.

Knowing when and when not to file a Daubert motion requires evaluating the risks of filing, and balancing a number of possibly competing relevant factors, even beyond the merits of the motion and the identity of the trial judge.

Our younger colleague knew that Federal Rules of Evidence 701-703 govern the admissibility of expert opinion evidence. And that in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court re-emphasized the trial court’s role as gatekeeper of proper scientific evidence. In a nutshell the Court adopted a new or refined test for admissibility focused on relevancy, reliability, and fit of the proffered expert’s opinion. Important factors may include whether technique has been tested; subjected to peer review and publication; the potential and known error rates; any standards and controls applicable to the science; and the degree of acceptance in scientific community. And he knew that in Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999), the rule was applied not only to “scientific” evidence, but also to technical or other specialized knowledge. Stressing that the Daubert factors are flexible, not rigid, the application and importance of each one may or may not be pertinent, depending on the issues, the expert, and the opinion.

So why not make a seemingly valid motion? What’s the harm? Certain risks may exist. The first set of factors might loosely be thought of as timing issues. By filing the motion, are you showing your hand too soon? You may be losing the element of surprise, and suffer a loss of effectiveness in cross-examination. One of the issues here is whether you are showing a hand they have seen; or will see soon in Motions In Limines; or in defense reports or in the depositions of your experts, or are indeed giving them intelligence. Also, is the timing such that the plaintiff will still have a chance to cure? ATLA teaches young plaintiff attorneys to “ask the court to schedule Daubert motions before the discovery cut-off so that if there is a curable deficiency, there is time to cure it.” Ann.2003 ATLA-CLE 851 (July, 2003).

Whether the expert’s deficiency is correctable (and in time) depends on the specific issues. Arguably an incomplete analysis could be fixed. Viterbo v. Dow Chem. Co., 826 F.2d 420, 423 (5th Cir. 1987)(oral history taken by expert of plaintiff was incomplete). But the absence of peer review probably can’t be fixed in time in most cases. Valentine v. Pioneer Chlor Alkali Co., 921 F. Supp. 666 (D. Nev. 1996)(discussing meaning of peer review). A another type of issue, when the expertise of the witness is too far removed from the proffered area of testimony, arguably can be fixed only by substitution. Whiting v. Boston Edison Co., 891 F. Supp. 12 (D. Mass. 1995) (doctor with epidemiology experience excluded from opining on dose reconstruction). Similarly, ask whether the issue for the motion is an issue on which you can effectively lock in the expert before trial, or whether there is sliding room. It may be helpful to a motion that an expert says she or he has no knowledge on a key issue, but if cured after the unsuccessful motion and before trial, the cross at trial about “well, you know stuff now that you didn’t know then” may be ineffective.

A second set of concerns may relate to the court and judge. Even if the motion is not a “sure winner” (and are any?), how important is it to “educate” the judge? And perhaps it is important to educate the court as to key science and evidentiary issues sooner rather than later. However, there may be other opportunities to do so. Another issue related to the tendencies of the specific judge, is will the judge have expected you to file the motion, so that voir dire, motions in limine, trial objections, or other attacks on the expert will not be well received if you don't? Some issues may be more appropriate for judge than jury, which might push you in one direction. Technical errors in complex statistical analysis may bore the jury to tears, making the motion more valuable; but a doctor who offers a litigation opinion inconsistent with his clinical practice might be more vulnerable in front of the jury. And there may be some kinds of experts you don’t want a jury to hear no matter what the strength of the cross. E.g., In re Welding Fume Products Liab. Litig., MDL No. 1535, 2006 WL 4507859 (Feb. 19, 2008, N.D.Ohio) (plaintiff’s business ethics expert excluded).

A third factor that comes to mind is whether the challenge is to all or part of the opinion? If some opinion will survive, do you want the weak opinion left in to use on cross to discredit the rest of the testimony, which appears stronger? If some opinion will survive, and summary judgment is not available, will exclusion of weak opinion make expert more credible at trial—because what is left is less subject to challenge?


ACSH Releases Paper On Scientific "Conflicts of Interest"

The American Council on Science and Health has recently published an interesting analysis of an issue of potential importance to all MassTortDefense readers involved in the defense of significant product liability claims. See Bailey, Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest (ACSH 2008). The report can be obtained at  their site.

It is virtually impossible to litigate toxic torts or complex products liability litigation without the benefit of scientific experts. Indeed, most of today’s mass torts, whether they be in the drug or medical devices context, chemicals, or consumer products, implicate significant scientific questions on issues of product defect, warnings, specific causation, general causation, injury and damages. Novel claims such as medical monitoring turn as well on scientific issues such as risk levels, and the availability of scientific tests to early detect diseases.

Defendants in mass torts may face the reality of a gap or hole in the existing science, and confront the issue of whether to sponsor research to fill in the gaps.  Outside litigation, in the ordinary course of business, industry spends billions of dollars on research annually, generating scientific data related to their products' safety and efficacy. Within the court room, Daubert and Frye challenges to experts are a common, and important, feature of many such cases as courts seek to exercise a gate-keeping function to exclude junk science from the courtroom. In that context, as well as in cross examination of experts who are permitted to testify, the search for “bias” that may undermine the validity or credibility of opinions offered by the scientific experts is a crucial undertaking. Insulating one’s own experts from the reach of a bias attack, inoculating the finder of fact from the impact of a bias challenge, is often an important task for defense counsel.

But what is bias? And what should properly be viewed by the jury as a “connection” that fundamentally undermines a proffered expert opinion? As the new ACSH publication notes, for approximately a century, industry has been a powerful motivating force in the creation of new technology and the underwriting of scientific research. Yet, the last two decades have seen the development of a sweeping movement aimed at convincing everyone that any connection with industry taints research or the researcher, and also is aimed squarely at curtailing academic/industry (particularly biomedical) research collaborations and restricting membership on government scientific advisory boards from researchers in any way associated with industry.

Conflicts of interest activists assert that ties between researchers and industry are harming patients and consumers, undermining public trust in research, food safety and environmental regulation and boosting the costs of medicine and other products. The activists seek to demonize researchers whose work receives support from commercial sponsors, especially drug companies and the makers of synthetic chemicals used in agriculture, industry and consumer products. Significantly, it may be that the campaign to purge any experts with industry ties—no matter how slender—from advisory panels is chilling scientific debate and depriving regulators and the public of valuable insights. The problem here is that industry often hires the most qualified and experienced researchers for their advice and research acumen. Those are precisely the people who should be advising.

The paper notes that the intense focus on the alleged effects of financial conflicts of interest ignores how other conflicts can bias scientific research and advice to government agencies. People are influenced by all sorts of interests besides money. “Why should having once consulted with Pfizer or DuPont disqualify a scientist from serving on a government advisory board or writing a review article in a scientific journal, while being a lifelong member of Greenpeace does not? And if owning $10,000 in Dow stock represents a potential conflict of interest, surely $10,000 in funding from the Union of Concerned Scientists does too,” observes the ACSH report.

The paper argues that the current obsession with conflicts of interest is not merely wrong yet harmless. The activists have provoked the development of unnecessary and complex academic regulations and restrictions that are interfering with the speedy translation of scientific discoveries into effective treatments and new products and technologies. Instead of improving public health or making the environment safer and cleaner, the activities of conflict of interest activists are harming them. Researchers are abandoning universities and some are even leaving the country for settings in which academic-industry collaboration is encouraged rather than denigrated and penalized. Government agencies are being denied access to sound scientific advice, which distorts regulatory priorities, risks lives and raises costs.

That is not to say that no mistakes have been found, but private solutions including the advent of permanent online peer-review of scientific studies and the requirement by scientific journals that all clinical trials be registered go a long way to deal with such situations.

There appears to be very little evidence that alleged conflicts of interests are significantly distorting scientific research, harming consumers and patients, or misleading public policy. Most conflicts of interest activists clearly have prior strong ideological commitments against free markets and corporations. They view the conflicts of interest campaign as another tool to attack an enterprise which they already despise on other grounds. 

The paper concludes that this crusade is anti-industry ideology masquerading as a patient safety and consumer advocacy campaign.

Texas Appeals Court Affirms Dismissal of Property Damage Claims

At MassTortDefense we are not adverse to spotlighting the occasional interesting, helpful (or even scary) intermediate appellate court decision. Hence, our focus today on Adamcek v. Reynolds Metals Co., Tex. Ct. App. 13th Dist., No. 13-06-240-CV, 2008 WL 1822772 (April 24, 2008), in which the Texas court of appeals ruled that expert testimony for plaintiffs living in an area affected by a hazardous waste plume was insufficient in a toxic tort case.

Those readers confronting toxic tort litigation know the importance of causation: including whether the substance is capable of causing the injury alleged (general) and whether the substance did cause the injury (specific). And a component of the latter is that the plaintiff actually suffered an exposure, and an exposure above background, and an exposure sufficient to have caused the damage alleged. In the property damage context, causation is equally important, and should not be taken for granted by defendants. This opinion is interesting in part because it shows the importance of putting plaintiffs to their proof on every element of a claim in the property damage context, and because it also involves a nuisance claim – which plaintiffs have been trying to expand and distort beyond its historical foundation and policy roots.


Background
The lawsuit involved 1200 consolidated plaintiffs, who filed suit after the discovery of groundwater contamination by a chemical called Trichloroethylene (TCE). Plaintiffs alleged that the TCE originated at an aluminum extrusion facility owned and operated by various defendants at various times. They alleged personal injuries, punitive damages, and this part of the case involved their claims of property damage under the theories of nuisance, negligence, and gross negligence.
Defendants filed a “no evidence” motion, basically a summary judgment motion asserting that there is no evidence of one or more essential elements of a claim on which an plaintiffs have the burden of proof. In order to avoid the no-evidence summary judgment, plaintiffs must produce more than a scintilla of probative evidence that raises an issue of material fact on each element challenged. That is, they need evidence that rises to a level that would enable reasonable and fair-minded people to differ in their conclusions. The trial court granted the motion, and 97 plaintiffs appealed.

Need for Causal Link to Injury 

The court defined a nuisance as a condition that substantially interferes with the use and enjoyment of land by causing unreasonable discomfort or annoyance to persons of ordinary sensibilities attempting to use and enjoy it. Under Texas law, in order to recover on a nuisance claim, the defendant must have generally engaged in one of three kinds of activity: (1) intentional invasion of another's interests; (2) negligent invasion of another's interest; or (3) other conduct, culpable because abnormal and out of place in its surroundings, that invades another's interests. The invasion must cause an injury, an interference. Just as in a claim for negligence which requires that damages were proximately caused by the breach.

Plaintiffs’ “Proof” Insufficient

Plaintiff relied on an affidavit from an expert to meet their burden on causation. The expert identified an “additional plume, which had its genesis in a leak from a sewer line.” In his affidavit, he referred to a map that he alleged showed where the plaintiffs live. However, carefully analyzed, it was clear that the expert did not show that any of the appellants owned an interest in the property within the additional plume he demonstrated. Moreover, he did not designate which properties or whose interests were in fact affected by the TCE under his theory, and how. Thus, the affidavit did not provide any evidence that any particular appellant had an interest that was affected by the TCE contamination. The Texas Court of Appeals upheld dismissal of the nuisance claim, finding the residents failed to assert sufficient evidence of causation of injury.

Think about putting plaintiffs to their proof on each and every element of the toxic tort claim.