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.

 

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.)

 

Failure of General Causation Proof Leads to Summary Judgment in Chemical Case

The Ohio appeals court ruled recently that a plaintiff could not pursue her chemical exposure toxic tort suit since her sole general causation expert's testimony was properly deemed unreliable by the lower court.  See Cooper v. BASF Inc., No. 26324 (Ohio Ct. App. 6/28/13).

The plaintiffs alleged they contacted a defendant Pest Control Company due to a termite infestation in various parts of their home, and the company applied Termidor SC, which contains the chemical fipronil, inside an open wall in the Coopers' bedroom, underneath a bathroom drain which is accessed through an opening under a sink cabinet, and around the perimeter of the house. A few months later, Mrs. Cooper was hospitalized complaining of various symptoms and was diagnosed with hypothyroidism and related encephalopathy, of unknown etiology. The plaintiffs claimed that the symptoms were caused by alleged exposure to pesticides.  The Coopers filed a complaint alleging: (1) negligence against the chemical manufacturer and the Pest Control Company; (2) strict products liability claims; and (3) fraud against the Pest Control Company.

The trial court ordered the Coopers to identify one or more expert witnesses who would support their theory of general and specific causation in this matter, and to make a submission that the expert was prepared to testify that  the chemical generally is capable of causing the medical conditions about which plaintiff complained and that in this specific instance there was a good faith basis for believing that her conditions were caused by her exposure to this chemical.  The Coopers identified Richard L. Lipsey, Ph.D., as their general causation expert.  Defendants moved to exclude the expert and for summary judgment.

The trial court granted the motions, finding that the expert had not based his opinion regarding general medical causation on reliable scientific, technical, or other specialized information. None of the articles or studies he reviewed showed a causal connection between Fipronil exposure and plaintiff's disease. The key epidemiological study of 103 workers exposed to Fipronil in the factory manufacturing flea collars found that symptoms associated with Fipronil exposure were temporary, and workers' conditions improved when no longer exposed. The animal studies cited by Dr. Lipsey failed to establish any correlation across species, and the expert had to admit that the animals used were not appropriate models for humans.

The court of appeals affirmed.  Ohio follows the Daubert test. And here the expert reached this conclusion without adequate scientific proof of a causal link between fipronil and hypothyroidism in humans. The record contained no evidence of any generally accepted methodology that has been adopted by the scientific community to establish a causal link between fipronil and hypothyroidism in humans. The court also noted, beyond the factors stressed by the lower court, that the expert testified that: (1) he had never written any peer-reviewed articles concerning the effects of pesticides on the human thyroid, (2) he had not done a dose reconstruction as to the amount of fipronil Mrs. Cooper was allegedly exposed to, and (3) there was no biological sampling done on Mrs. Cooper's blood or fatty tissue to prove that she had been exposed to a significant level of the chemical.

Without an expert opinion, summary judgment was appropriate as plaintiff could not prove the causation element of each cause of action.

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.

Daubert Decision to Watch in Ninth Circuit

Here's one to watch. The Ninth Circuit last week said it will rehear the case of a paper mill employee whose $9.4 million mesothelioma verdict was vacated by a panel of the appeals court. The court noted in a one-page order that it will rehear the case en banc, but did not provide any specifics. See Henry Barabin. et al. v. AstenJohnson Inc., No. 10-36142 (9th Cir.); Henry Barabin, et al. v. AstenJohnson Inc. and Scapa Dryer Fabrics Inc., No. 11-35020 (9th Cir.). 

We can certainly speculate, of course, and our guess is that the reason for the decision does not relate directly to the evidentiary issue the panel had when, in November, it overturned the award after finding that the trial court failed to adequately assess the reliability of the plaintiffs' expert testimony.

Readers may recall that plaintiff sued alleging that his 2006 diagnosis of mesothelioma was caused by occupational exposure to asbestos during the more than 30 years he worked at the Crown-Zellerbach paper mill.  The trial court originally excluded Kenneth Cohen, one of the plaintiffs’ expert witnesses, because of his “dubious credentials and his lack of expertise with regard to dryer felts and paper mills.”  But the court later reversed that ruling, after the plaintiff supplemented the record on the expert's credentials, including that he had testified in other cases (in Frye jurisdictions though). The jury found in favor of plaintiffs.

On appeal, the Ninth Circuit determined that the lower court had not properly considered all the Daubert factors, and instead had allowed the plaintiff to submit the expert’s "unfiltered testimony" to the jury.  “Once presented with the additional information in the Barabins’ response to the motion in limine, at a minimum the district court was required to assess the scientific reliability of the proffered expert testimony ...  In failing to do so, the district court neglected to perform its gatekeeping role.”

Our guess is that the court is 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).  One of the concurring opinions questioned the rule from that case that requires the court to vacate and remand for a new trial, as opposed to deciding on the need for a new trial after making a new Daubert determination.  From where we sit, the court had it right in 2003 and this time too. To remand for an evidentiary hearing post-jury verdict undermines Daubert's requirement that some 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 with impunity. 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 in Mukhtar gives trial courts a real and important incentive to be proper, active gatekeepers. 

 

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.
 

 

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.

 

 

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. 

 

Fifth Circuit Affirms Exclusion of Plaintiff Causation Experts in Chemical Case

The Fifth Circuit recently affirmed the dismissal of most of a plaintiff's personal injury claims against a chemical company, based on the conclusion that certain expert witness testimony was inadmissible. See Johnson v. Arkema Inc., No.11-50193 (5th Cir. June, 2012).

Plaintiff Johnson worked as a machine repairman at a glass bottling plant in Waco, Texas from May 1998 to the end of 2008. On two separate occasions, first in early June 2007 and again in July 2007, Johnson claims he was directed to perform work in close proximity to a device known as a C-4 Hood, which was designed, manufactured, and installed by defendant. C-4 Hoods are
utilized to apply a chemical coating to the glass bottles as the bottles are transported along a conveyor belt. According to Johnson, the C-4 Hood he worked near to on those two occasions failed to perform its proper functions, resulting in his alleged exposure to harmful chemicals.

Plaintiff sued. Arkema then filed motions to exclude the opinions of Dr. Richard Schlesinger, Johnson’s expert toxicologist, and Dr. Charles Grodzin, Johnson’s expert pulmonologist, under Federal Rule of Evidence 702 and the Supreme Court’s decision in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). Arkema also filed a motion for summary judgment, contending that absent those experts, Johnson was unable to present scientifically reliable evidence establishing that exposure to the chemicals can cause restrictive lung disease and pulmonary
fibrosis (his alleged injury types). The district court granted the motions, and plaintiff appealed. 

On appeal, plaintiff contended that the district court abused its discretion in excluding Dr. Schlesinger’s expert opinion on general causation.  The district court excluded Dr. Schlesinger’s testimony after determining, inter alia, that: (1) Dr. Schlesinger could not cite to one epidemiological or controlled study of humans indicating that exposure to the relevant chemicals could cause restrictive lung disease and pulmonary fibrosis; (2) the scientific literature was devoid of any data or peer reviewed articles indicating that exposure to the two chemicals will result in chronic lung disease, and such a proposition is not generally accepted in the scientific community.

Plaintiff argued that the two fell into a "class" of chemicals that have been shown to cause these injuries. In forming a reliable opinion regarding the effects of exposure to a particular chemical, an expert may extrapolate data from studies of similar chemicals. BUT to support a conclusion based on such reasoning, the extrapolation or leap from one chemical to another must be reasonable and scientifically valid.  Thus, courts are free to reject a theory based on extrapolation when there is simply too great an analytical gap between the data and the opinion proffered. Here, save for highlighting their shared classifications as "irritants," the expert did not attempt to explain any direct correlation or “fit” between the chemicals at issue and the known scientific data concerning exposure to, for example, chlorine, ammonia, or nitric acid vapor. Accordingly, given the diverse chemical structures and toxicities of irritants, which plaintiff acknowledged, the district court did not abuse its discretion in concluding that Dr. Schlesinger’s “class of chemicals” theory presented “too great an analytical gap between the data and the opinion proffered.

The next issue was reliance on language in an MSDS, which is useful for many of our readers in toxic tort cases.  The district court found the "warning" language in a competitor's MSDS to be irrelevant and unreliable because: it did not clearly state a causation conclusion, and, most importantly, Johnson did not provide any science behind the MSDS, such as the duration or concentration of exposure needed to produce the noted effects, or the scientific literature relied upon by the drafter for the statements contained in the MSDS.  Under such circumstances, the MSDS, standing alone, need not have been accorded any weight. Plaintiff also relied on general hazard language in defendant's own MSDS. But could cite no authority for the proposition that material safety data sheets constitute per se reliable support for an expert’s opinion. To the contrary, in exercising its discretion as a gatekeeper, a court may refrain from treating a MSDS as reliable until it is presented with scientific evidence justifying the relevant statements found within the MSDS.

Finally, Johnson contended that he was exposed to amounts of one of the chemicals (HCl) that were between two and ten times the permissible exposure levels set by OSHA, NIOSH, and the Acute Exposure Guideline Levels set by the National Research Council. Regulatory and advisory bodies such as IARC, OSHA and EPA utilize a “weight of the evidence” method to assess the carcinogenicity or toxicity of various substances in human beings and suggest or make prophylactic rules governing human exposure. This methodology results from the preventive perspective that the agencies adopt in order to reduce potential public exposure to possibly harmful substances. The agencies’ threshold of proof is lower (for policy reasons) than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect, and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm. See generally Wright v. Willamette Industries, Inc., 91 F.3d 1105, 1107 (8th Cir.1996). Thus, such regulatory chemical guidelines are not necessarily reliable in all toxic tort cases. And a court should confirm the underlying basis for their  proscriptions before an expert’s reliance on them can pass Daubert muster. Here, plaintiff did not provide any scientific data or literature to explain how or why the various exposure limits and guidelines were established for the chemicals. Similarly, he had no evidence that the guidelines and exposure limits existed to protect people from developing severe restrictive lung disease and pulmonary fibrosis, his diseases. Thus, the court concluded that the OSHA, NIOSH, and NRC guidelines and exposure limits, standing alone, were insufficient to demonstrate abuse of discretion on the part of the district court.

As to the other expert, Dr. Grodzin’s research and analysis essentially mirrored Dr. Schlesinger’s save for one key distinction: Dr. Grodzin performed a so-called “differential diagnosis” of Johnson. A reliable differential diagnosis typically, though not invariably, is performed after physical examinations, the taking of medical histories, and the review of clinical tests, including laboratory tests, and generally is accomplished by determining the possible causes for the patient’s symptoms and then eliminating each of these potential causes until reaching one that cannot be ruled out.  Even in jurisdictions that accept this questionable approach to causation, the results of a differential diagnosis are far from reliable per se. For example, before courts can admit an expert’s differential diagnosis, which, by its nature, only addresses the issue of specific causation, the expert must first demonstrate that the chemical at issue is actually capable of harming individuals in the general population, thereby satisfying the general causation standard. In other words, the suspect has to be reasonably and reliably "ruled in."

Here, Dr. Grodzin’s differential diagnosis was based on the presumption that the two chemicals  were actually capable of causing restrictive lung disease and pulmonary fibrosis in the general population. Dr. Grodzin did not present any reliable or relevant scientific evidence to bolster this assumption. Consequently, the fact that Dr. Grodzin claimed he conducted a differential
diagnosis did not save his opinion from the same fate as Dr. Schlesinger’s opinion.

 (Note, the court concluded that plaintiff did not need expert witnesses to demonstrate that his immediate acute injuries after exposure and which allegedly sent him to the emergency room, could have been caused by the chemical.  Thus, this part of the case was remanded.)

 

 

 

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.

 

Amicus Urges Supreme Court to Reverse Causation Junk Science Decision

DRI (the Defense Research Institute) last week submitted an amicus brief urging the Supreme Court to review a federal appeals court decision that threatens to undermine the gatekeeper role of the trial courts on expert testimony. United States Steel Corp. v. Milward v. Acuity Specialty Products Group Inc., No. 11-316 ( U.S., amicus petition filed 10/12/2011).

Most of our readers know that DRI is an international organization that includes more than 23,000 attorneys involved in the defense of civil litigation.  DRI has long been a voice in the ongoing effort to make the civil justice system more fair, efficient, and—where national issues are involved—consistent. (Your humble blogger is a member.)

In this case, the plaintiff alleged that he contracted a rare form of cancer, acute promyelocytic leukemia (APL), through exposure to benzene or benzene contaminants. The plaintiff’s expert acknowledged that science has not determined what causes or can cause APL, but opined that, based on his own "judgment," the "weight of evidence" supported a conclusion that APL could be caused by benzene exposure. After a four-day hearing, the district court excluded the expert testimony as unreliable under Daubert, and Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997)(district courts need to exclude proof that is connected to the data only by the ipse dixit of an expert), finding that it amounted to no more than a plausible hypothesis. The U.S. Court of Appeals for the First Circuit reversed and reinstated the case, holding that it was an abuse discretion to exclude this evidence as to possible causation.

The First Circuit in this case appeared to think that district courts not only may but must admit speculative expert testimony that rests on nothing more than the expert’s subjective judgment that an untested hypothesis is supported by the “weight of the evidence.”  That decision conflicts with Supreme Court guidance and with the decisions of other circuits holding that expert testimony is admissible only when it rests on a reliable scientific foundation, and that a district court is not required to accept an expert’s ipse dixit but must instead carefully examine the methods and data underlying the expert’s opinion to ensure that the expert has reliably applied valid scientific principles. Without such an inquiry, the “gatekeeper” function the Federal Rules of Evidence envision for the district court judge becomes meaningless.

DRI correctly points out that the weight-of-the-evidence methodology the court of appeals endorsed does not satisfy the criteria Daubert adopted for assessing the reliability of expert testimony. It is neither testable nor falsifiable; it is not governed by any objective standards; and it has not been generally accepted by the scientific community as a means to assess medical causation absent an observed association between the substance and disease at issue. The fact that some regulatory agencies use an arguably similar, lower bar, methodology to assess risks to public health based on the available data does not mean that it yields “scientific knowledge” admissible under the very different standards governing a court proceeding.

Moreover, the district court’s essential gate-keeping role is particularly important on the issue of medical causation. That issue is often dispositive in toxic tort and product liability cases, which can involve enormous stakes not only for the parties, but also for the national economy. The lay jurors who decide these complicated issues are likely to be greatly influenced by testimony that appears to be scientific in nature coming from a witness whom the court has admitted as an "expert." The decision by the First Circuit undermines the critical screening function district courts perform to prevent juries from being misled by speculation masquerading as scientific knowledge.

 

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.

 

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).  

Court of Appeals Vacates Premature Class Certification

The 11th Circuit earlier this month vacated the district court's premature certification of a class of property owners allegedly harmed by releases from a nearby industrial facility.  Sher v. Raytheon Corp., No. 09-15798 (11th Cir. 3/9/11).

Plaintiffs alleged that Raytheon, through improper disposal and/or storage of hazardous waste at its St. Petersburg, Florida facility, was responsible for the release of toxic waste into the  groundwater of surrounding neighborhoods.

To demonstrate the predominance of common issues under Rule 23(b)(3), plaintiffs’ offered a groundwater expert, Dr. Philip Bedient, who identified the impacted area as a toxic underground plume stretching approximately one mile long and 1.7  miles wide from the Raytheon facility. The need to show on an individual basis the impact of the pollution on each property is a major reason these kinds of property damage class claims are not certified. To try to show here that damages for alleged property injury to 1000 class members could be appropriately resolved in a single class action, plaintiffs presented the affidavit of their damages expert, Dr. John A.  Kilpatrick, who stated that he could develop a hedonic multiple regression model to determine diminution-in-value damages without resorting to an individualized consideration of each of the various properties.

Defendants, in turn, challenged Dr. Bedient’s methodology for defining the impacted area, or really the putative class, as “inconsistent with applicable professional standards.”  Dr. Bedient’s area of impact apparently encompassed many properties on which no contamination had been detected at all.  Raytheon also introduced its damages expert, Dr. Thomas O. Jackson. Dr. Jackson’s report stated that the Plaintiffs’ expert’s “proposed method of analysis of property value diminution using mass appraisal/regression modeling would be unacceptable for this purpose, and would not eliminate the need to evaluate each property in the proposed class area on an individual basis.”

So, notwithstanding the general rule that the court should not delve too deeply into the merits at the class certification stage, the court was confronted with dueling experts, and, more importantly, a serious challenge to the methodology of plaintiffs' experts.

As a threshold matter, the district court punted-- finding that it was not necessary at this stage of the litigation to declare a "proverbial winner in the parties’ war of the battling experts" or choose between the dueling statistics and chemical concentrations. This type of determination would require the court to weigh the evidence presented and engage in a Daubert-style critique of the proffered experts qualifications, which would be "inappropriate" at this stage of the litigation.  More specifically, an inquiry into the admissibility of plaintiffs’ proposed expert testimony as set forth in Daubert would be inappropriate, "because such an analysis delves too far into the merits of Plaintiffs’ case."

On appeal of the certification order, the court of appeals found the Seventh Circuit’s opinion in American Honda Motor Co., Inc., 600 F.3d 813 (7th Cir. 2010), to be persuasive. We posted on that before. The issue before the Seventh Circuit in American Honda was whether or not the district court should have conclusively ruled on the admissibility (versus the weight of, as also in this case) of expert opinion prior to certifying the class. In American Honda, the Seventh Circuit found that “when an expert’s report or testimony is critical to class certification, as it is here . . . , a district court must conclusively rule on any challenge to the expert’s qualifications or submissions prior to ruling on a class certification motion.” Id. at 815-16. The American Honda court found that, if the situation warrants, the district court must perform a full Daubert analysis before certifying the class. Id. at 816. “A district court is the gatekeeper. It must determine the reliability of the expert’s experience and training as well as the methodology used." Id. “The [district] 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.” Id.

Accordingly, here, in its Rule 23 analysis, the district court erred as a matter of law by not sufficiently evaluating and weighing conflicting expert testimony on class certification. It was error
for the district court to decline to declare a proverbial, yet tentative winner of the Daubert issue. Plaintiffs are required to prove, at the class certification stage, more than just a prima facie case, i.e., more than just a “pretty good case.” A district court must make the necessary factual and legal inquiries and decide all relevant contested issues prior to certification. Thus, the court erred in granting class certification prematurely. Tough questions must be faced and squarely decided, said the court, not side-stepped in an overly cautious attempt to avoid the merits. 

 

  

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.

 

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.

 

 
 

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. 


 

Federal Court Grants Daubert Motion and Summary Judgment in Toxic Tort Cases

A federal court last week dismissed consolidated toxic tort suits brought against Alcoa Inc. and other defendants brought by employees of Lockheed Martin Corp. who claimed they were exposed to beryllium used in the manufacture of airplanes. Neal Parker et al. v. Brush Wellman Inc. et al., No. 04-cv-606; Timothy Berube et al. v. Brush Wellman Inc. et al., No. 08-cv-2725(N.D. Ga. 9/17/10).

The dozen plaintiffs in the cases were current or former employees of Lockheed Martin Corp.at its Marietta, Georgia plant site; plaintiffs alleged they had a variety of job responsibilities, time periods of employment, and work areas at the Lockheed facility. Lockheed’s Marietta Facility was purchased by the U.S. Government in 1942 and is leased and operated by Lockheed. Since 1952, Lockheed has produced the beryllium-containing C-130 Hercules airlifter, the C-5 Galaxy, the C-141 Starlifter, and the F/A-22 Raptor Air Dominance Fighter at its Marietta location. Each defendant was alleged to have manufactured component parts for Lockheed using copper-beryllium or aluminum-beryllium alloys.  Plaintiffs alleged that defendants failed to provide Lockheed with sufficient and accurate warnings pertaining to the beryllium contained in the manufactured products. Specifically, plaintiffs asserted a failure to warn claim, arguing that the warning materials that the defendants provided did not adequately communicate the health risks associated with the use of beryllium nor did they describe the methods that would reduce such risks.

Defendants filed a Daubert motion to exclude the testimony of Dr. John Martyny, plaintiffs' causation expert, and a companion motion for summary judgment. The Court ordered a Daubert hearing to clarify the evidentiary and factual background for the expert witness’s opinion and an evidentiary hearing regarding the motions to compel and summary judgment.

Since beryllium is generally recognized in the medical community as being able to cause the type of harm plaintiffs alleged –beryllium-related sickness– the Daubert analysis here focused on specific or individual causation to the plaintiffs, the plaintiff-specific questions: was plaintiff exposed to the toxin, was plaintiff exposed to enough of the toxin to cause the alleged injury, and did the toxin in fact cause the injury? The Eleventh Circuit has recognized that in order to carry
this causation burden in a toxic tort case, a plaintiff must demonstrate the levels of exposure that are hazardous to human beings as well as the plaintiff’s actual level of exposure to the defendant’s toxic substances before he or she may recover.

Here, the link between the expert’s opinion and the dose relationship was a key element of the analysis. Indeed, the hallmark of the science of toxic torts is the dose-response  relationship.  Exposure is only the opportunity for contact. Dose is what enters the body. While Dr. Marytny indicated, based on his experience and anecdotal evidence, that plaintiffs may have been exposed to beryllium at the plant, he did not indicate the level, frequency, duration or particle size of this exposure which would indicate the dose from these defendants’ products.  Importantly, Dr. Marytny did not produce any evidence that even a low-dose exposure resulted from defendants’ products. In fact, Dr. Martyny admitted that he could not opine as to the individual product or products that were the source of the alleged exposure.

Secondly, Dr. Martyny’s theory had not been appropriately tested.  The company itself did some sampling, and every air sample indicated that airborne beryllium concentrations were below the analytical reporting limit (<0.001 μg/sample) and thus also less than the OSHA PEL for beryllium.  Theoretically, defendants’ products could have been placed in an environmental chamber and the various machining procedures could have been reenacted to determine the particle production and size. While clearly this would not be as conclusive as personal sampling data for each plaintiff, this evidence would at least minimally indicate that bio-available beryllium from defendants’ products was possible, said the court.  But plaintiffs did no such testing.  Furthermore, no published studies documented levels of beryllium released by workers working with beryllium-aluminum in the aircraft industry.

Without such data, the expert's opinion merely assumed that plaintiffs’ injuries must have been caused by defendants’ products because the defendants produced  beryllium parts which were sold to Lockheed. However, nothing in his opinion linked these products to the alleged exposure of the plaintiffs nor ruled out other manufacturers’ products that were also present at the Marietta facility. 

Thus, the expert's opinion was excluded, and absent a reliable causation opinion, summary judgment was also appropriate.

The court the offered an alternative basis for the summary judgment on the failure to warn claim -- the sophisticated user doctrine. If a sophisticated user’s employees have knowledge that a particular risk of harm exists and yet allow the harm to occur, this knowledge may bar other employees’ claims against the product manufacturer. The supervising employees’ knowledge –the knowledge of the sophisticated user– can bar other employee’s claims against the product manufacturer. And the user’s knowledge does not need to encompass the precise, physical nature of the hazard presented by his use of the product; it is sufficient if he is aware generally that the use being made of the product is dangerous.

Here, Lockheed was a sophisticated user of beryllium alloys. Lockheed, as a part of the beryllium
industry, had as much access to information regarding beryllium safety as anyone else. For more than forty years, Lockheed  used the Department of Defense’s “Handbook for Metallic Materials and Elements for Aerospace Vehicle Structures” which provides guidelines for proper beryllium use. Lockheed issued its own “Safety and Industrial Hygiene Standard" which recognized that beryllium dust and vapors can cause respiratory problems. Lockheed recognized that it should order “medical monitoring” for those within the exposed worker population. The record made clear that the employer was a sophisticated user; summary judgment was appropriate on this basis as well.

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.)

Causation Expert Opinions Excluded in Toxic Tort Case

A federal judge has issued an opinion explaining her Daubert and summary judgment rulings in a case brought by a consumer who alleged he contracted lung disease from the fumes of microwave popcorn. Newkirk et al. v. ConAgra Foods Inc., No. 2:08-cv-00273 (E.D. Wash. 7/2/2010).

Readers of MassTortDefense may be familiar with the so-called "popcorn lung" litigation in which plaintiffs have alleged they contracted a series of diseases, including Bronchiolitis obliterans, from inhaling the chemical diacetyl which had been used in the artificial butter on microwave popcorn.  Most of the claims have been made by workers with alleged industrial-level exposures on a daily basis in popcorn factories several years ago.  There are, however, a handful of cases by consumers claiming they somehow had sufficient exposure in their homes to have the same respiratory injuries.  These latter cases raise significant issues of general and specific causation, arising from the central tenet of toxicology: the dose makes the poison.  The studies relied on by plaintiffs noted that the cumulative exposure to diacetyl was correlated with chronic effects on lung function in plant workers.

Plaintiff Newkirk claimed that the natural and artificial butter flavoring in ConAgra's Act II Butter and Act II Butter Lovers popcorn products caused him severe and progressive damage to the respiratory system, extreme shortness of breath, and reduced life expectancy.  He claimed that he ate between five and seven bags of ConAgra's popcorn every day for more than a decade.

The motions centered around plaintiff's burden to prove causation. Plaintiffs in toxic tort cases must establish both general and specific causation. Golden v. CH2M Hill Hanford Group, Inc., 528 F.3d 681, 683 (9th Cir.2008). Evidence supporting general causation addresses “whether the substance at issue had the capacity to cause the harm alleged.” In re Hanford Nuclear Reservation Litigation, 292 F.3d 1124, 1133 (9th Cir.2002). Specific causation, by contrast, concerns whether a particular individual suffers from a particular ailment as a result of exposure to the substance. Defendants challenged plaintiff's proof of both under Daubert.

Plaintiffs retained Dr. Egilman to offer an opinion on general causation, as well as to examine Mr. Newkirk, diagnose him, and offer an opinion regarding the specific cause of his condition. The expert opinion testimony of Dr. Egilman was the plaintiffs’ primary evidence supporting general causation. (All of the Newkirks’ other causation expert witnesses assumed that general causation already has been established.)  He opined that,  “There is no known safe level of diacetyl exposure. Existing scientific studies also suggest that levels of diacetyl exposure below and around 1 ppm can cause BO and other respiratory illnesses.”


The court found, however, that Dr. Egilman's attempt to analogize kitchen to industrial exposures failed. He offered no sufficient basis or methodology for support for the conclusion that there is no important (medically relevant) qualitative difference between the vapor from butter flavoring slurry in a mixing vat in a popcorn plant and the vapor from butter flavoring that is emitted from microwave popcorn in the home. There was nothing to support Dr. Egilman’s conclusions that were at the heart of this case: that the vapors emitted from a microwave popcorn bag contain the same proportion of chemicals or in sufficient doses or that all of the substances in the two instances are identical. In other parts of his reports and testimony, the court found, Dr. Egilman relied on some existing data, mostly in the form of published studies, but drew conclusions far beyond what the study authors concluded.

Or, Dr. Egilman manipulated the data from those studies to reach misleading conclusions of his own. Slip opin. at 25. For example, he relied on statements by a Dr. Cecile Rose, on a patient (and another consumer plaintiff), Mr. Watson, who allegedly contracted disease from popcorn fumes. But this was in the nature of a single case report, and in it even Dr. Rose did not assert that her conclusions could be extrapolated to other consumers in the absence of publication or peer review; Dr. Egilman acknowledged that Dr. Rose did not publish the exposure levels measured in Mr. Watson’s home -- so no such comparison was possible.  Dr. Rose herself qualified her conclusions: “It is difficult to make a causal connection based on a single case report. We cannot be sure that this patient’s exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease.” 
 

The expert also relied on testing conducted by Dr. John Martyny in a kitchen (not of a consumer), despite that doctor's own reflections that the methodology underlying the work could not support extrapolating to general causation for a broader group of consumers.  The expert also relied on animal studies. Expert opinion relying on animal studies to reach an opinion on causation in humans is usually admissible only when the expert explains how and why the results of the animal toxicological study can reliably be extrapolated to humans. General Electric Co. v. Joiner, 522 U.S. 136, 143-45 (1997).  Dr. Egilman offered no such analytical bridge between the animal studies finding harm from high levels of diacetyl exposure to lab rats and his conclusion that those studies demonstrate that diacetyl exposure causes decreased lung function in humans. He offered no sufficient explanation for how and why the results of those studies could be extrapolated to humans, let alone low-dose consumer contexts.

Without Dr. Egilman's testimony to support causation, the plaintiffs' other expert witnesses couldn't establish this element either.

Note also that the court excluded Dr. Egilman's "legal conclusions" from his expert report and affidavits, since the witness was no more capable than the fact-finder to draw such a conclusion. See Nationwide Transp. Fin. v. Cass Info. Sys., 523 F.3d 1051, 1059-60 (9th Cir.2008) (expert witness cannot give an opinion as to her legal conclusion, i.e., an opinion on an ultimate issue of law). For example, Dr. Egilman tried to opine that about what the defendant "knew" and "failed to warn" consumers. This is another useful precedent against plaintiffs' mis-use of the conduct "expert" who provides mere legal conclusions and invades the province of the jury.

(Your humble blogger is involved in the diacetyl litigation, but not this case.)

General Causation Opinion Excluded by Eleventh Circuit in Autism Case

The Eleventh Circuit recently  affirmed a judgment for defendant Evenflo Co. in a suit by a plaintiff who had alleged that the car seat manufacturer was responsible for her son's autism. Hendrix v. Evenflo Co., 2010 WL 2490760 (11th Cir., 6/22/10).

Plaintiff alleged that her son sustained traumatic brain injuries when a child restraint system manufactured by Evenflo allegedly malfunctioned during a minor traffic accident. Hendrix further alleged that those brain injuries caused the son to develop autism spectrum disorder (“ASD”). The district court excluded testimony from two of Hendrix's expert witnesses that the accident caused the ASD, concluding that the methods used by Hendrix's experts were not sufficiently reliable under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). See Hendrix v. Evenflo Co., Inc., 255 F.R.D. 568 (N.D.Fla. 2009). The lower court then granted partial summary judgment to Evenflo on Hendrix's ASD claim, determining that without the excluded testimony there was no reliable evidence to support Hendrix's theory that the accident caused the ASD. Hendrix voluntarily dismissed, with prejudice, her remaining damages claims and filed a notice of appeal.

Hendrix's experts relied primarily on the controversial differential etiology method to link the child's traumatic brain injury to his ASD diagnosis. Differential etiology, said the court, is a medical process of elimination whereby the possible causes of a condition are considered and ruled out one-by-one, leaving only one cause remaining. It is a questionable extension of the method by which doctors diagnose a disease into the area of what caused the disease.

The Eleventh Circuit has previously held that, when applied under certain circumstances that it thinks will ensure reliability, the differential etiology method can provide a valid basis for medical causation opinions. The reliability of the method must be judged by considering the reasonableness of applying the differential etiology approach to the facts of this case and the validity of the experts' particular method of analyzing the data and drawing conclusions therefrom. According to the court, a reliable differential etiology analysis is performed in two steps. First, the expert must compile a comprehensive list of hypotheses that might explain the set of salient clinical findings under consideration; the issue at this point in the process is which of the competing causes are generally capable of causing the patient's symptoms. See Clausen v. M/V New Carissa, 339 F.3d 1049, 1057-58 (9th Cir.2003). Second, the expert must eliminate all causes but one.

With regard to the first step, the district court must ensure that, for each possible cause the expert “rules in” at the first stage of the analysis, the expert's opinion on general causation is derived from scientifically valid methodology.  Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1211 (10th Cir.2002); Siharath v. Sandoz Pharms. Corp., 131 F.Supp.2d 1347, 1362-63 (N.D.Ga.2001). This is because a fundamental assumption underlying differential etiology is that the final, suspected cause must actually be capable of causing the injury. Thus, here, the experts' purported use of the differential etiology method will not overcome a fundamental failure to lay the scientific groundwork for the theory that traumatic brain injury can, in general, cause autism.

The Eleventh Circuit has distinguished cases in which the medical community generally recognizes that a certain chemical or product can cause the injury the plaintiff alleges from those in which the medical community has not reached such a consensus. In the second category of cases, the district court must apply the Daubert analysis not only to the expert's methodology for figuring out whether the agent caused the plaintiff's specific injury, but also to the question of whether the drug or chemical or product can, in general, cause the harm plaintiff alleges. Thus, the district court must assess the reliability of the expert's opinion on general, as well as specific, causation.  In this regard, the court (like most) rejects the “post hoc ergo propter hoc fallacy" which assumes causality from temporal sequence; a mere temporal relationship between an event and a patient's disease or symptoms does not allow an expert to place that event on a list of possible causes of the disease or symptoms. Case studies and clinical experience, used alone and not merely to bolster other evidence, are also insufficient to show general causation.

Here, none of the medical textbooks and epidemiological studies submitted by the expert came close to providing useful evidence of a definitive causal link between traumatic head injuries and autistic disorders, and none provided even marginal support for plaintiff's theory of a relationship between abnormal cerebral spinal fluid pressure and problems with cerebellum pressure, leading to autism. For example, the text chapter listing the known etiological factors involved in ASD does not mention acquired trauma in the perinatal brain.

Plaintiff also attempted to sidestep the deficiencies in the medical literature by focusing on the expert's experience and training. Merely demonstrating that an expert has experience, however, does not automatically render every opinion and statement by that expert reliable. The witness must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts. The trial court's gatekeeping function requires more than simply “taking the expert's word for it.”

Judgment for defendant affirmed.

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.”).

 

Daubert Webinar Worth Checking Out

Readers are invited to consider the upcoming webinar, "Daubert Standards for Expert Witness Testimony: Effective Strategies for Bringing and Defending Daubert Challenges."  Your humble blogger will be a co-presenter. 

This is a live 90-minute webinar program with interactive Q&A, set for Thursday, February 25, 2010, at 1:00 p.m. Eastern Time / 12:00 p.m. Central Time / 11:00 a.m. Mountain Time / and 10:00 a.m. Pacific Time.  You can check it out or register.

 

Readers know that Daubert motions are one of the most critical pre-trial aspects of a case involving expert witness testimony because exclusion of a plaintiff's expert can effectively end a lawsuit. A  strong Daubert challenge can also have an impact on settlement. 

This seminar will discuss effective strategies for Daubert motions, and I will talk about when you might want to NOT file one.

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.


 

British Journal Finally Retracts Autism Article

The British medical journal "The Lancet" has  finally issued a full retraction of a study it ran in 1998 purporting to link the measles-mumps-rubella (MMR) vaccines to autism.  Wakefield, et al., "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children," Lancet 1998; 351: 637-641.

The journal noted that following the judgment of the U.K. General Medical Council's "Fitness to Practice Panel" concerning the lead author, it had become clear to the journal that several elements of the 1998 paper by Wakefield, et al., were "incorrect," and contrary to the findings of an earlier investigation. Therefore, the journal "fully retracted" this paper from the published record.

Readers of MassTortDefense know how one article purporting to link a drug to a side effect, a chemical to an adverse effect, a product to an illness, can spawn significant products litigation, and even a mass tort.  Here, the study not only influenced a decade of litigation, it spurred a public health crisis by sending parents in the U.K. and the U.S. into confusion over the safety of having their children vaccinated.  The overwhelming scientific evidence shows vaccines to be safe, but The Lancet stuck by its article even when it was revealed that the study was connected to plaintiff lawyers' pursuit of litigation. In the meantime, all children were put at risk as Great Britain's child vaccination rates plummeted to below 70% in some areas, and by 2008 there were more than 1000 cases of measles, including fatalities, in  England and Wales.

The Lancet article issues demonstrate how even reputable publications can become conduits for plaintiffs' junk science and political junk science.  It's hard to fathom why it took so long for the retraction.  It calls again for an overhaul of the peer review process, which the Supreme Court in Daubert noted as a hallmark of good science.  Most importantly, it reminds the defense bar and their clients how important it is to have a thorough, searching examination of the science that plaintiffs rely on for general or specific causation.  Nothing can be taken at face value, and sometimes only a dogged pursuit of discovery will uncover the many flaws in a seemingly well-regarded study.

Autism and related developmental disorders are an extremely challenging medical issue, deserving of time and resources.  But the questions cannot be answered by junk science.

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.
 

Digitek MDL Update

Recent developments in the Digitek MDL.  The presiding judge in the federal Digitek multidistrict litigation has selected five bellwether cases to be tried.  Readers of MassTortDefense know that an increasingly common case management technique in consolidated or coordinated litigation is the use of bellwether trials, with the hope that early verdicts will impact the resolution of cases down the line.  Judge Goodwin issued Pretrial Order (PTO) No. 47, which assigned the following five cases for trial, in this order:

 • David Kelch, et al. v. Actavis Totowa, LLC, et al., 2:08-cv-01282

 • William J. Young, et al. v. Actavis Totowa, LLC, et al., 2:09-cv-00498

 • Jacquelyn K. Fox, et al. v. Actavis Totowa, LLC, et al., 2:09-cv-00389

 • Karen Sheahan, et al. v. Actavis Group, et al., 2:08-cv-01051

 • Scottie Vega, et al. v. Actavis Group hf., et al., 2:09-cv-00768

Readers may recall that the federal Digitek product liability cases, alleging that Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC released Digitek tablets containing more than the appropriate dosage to the public in 2008, were transferred to an MDL  last August. The plaintiffs allege that the tablets can cause digitalis toxicity in patients with renal failure. This condition can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

The MDL court also recently ordered the plaintiffs to file their class certification motion and brief in support of their "economic loss" class by Jan. 20, 2010.  Defendants’ response brief shall be filed and served thirty days after the filing of such class certification motion and accompanying brief, said the order.

The court also entered amended PTO #48 (Joint Hearing to Address Challenges to Scientific and Technical Evidence). In the spirit of cooperation and collegiality evident since the inception of this MDL, said the court, several distinguished state judicial officers presiding over certain consolidated Digitek actions have graciously agreed to conduct a joint hearing to address the scientific and technical issues presented in this litigation for resolution pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its federal and state progeny. Those issues are best addressed, said the MDL court,  through coordinated proceedings, albeit with each presiding judicial officer giving separate and individualized attention, and disposition, to the evidence and arguments as they relate to his or her assigned consolidated civil actions. The court recognized that each state may have its own standards and procedures for expert testimony designed to ensure the reliability and relevance of evidence based upon scientific, technical and other specialized knowledge.  That joint hearing is scheduled for October, 2010.

This is just the latest step in efforts for such coordination. Pretrial Order (PTO) No. 11 concerned state and federal coordination. It ordered lead and liaison counsel for the plaintiffs and defense to endeavor to coordinate activities between the federal and state litigation. It also ordered the creation of a joint document depository for use by parties in the federal-state litigation. The Order provided a mechanism for cross-noticing depositions. The next status conference is scheduled for Thursday, February 11, 2010 at 9:00 a.m.
 

 

 

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.   


 

Defense Experts Pass Daubert Test in Stand 'n Seal MDL

In the multidistrict product liability litigation over "Stand ‘n Seal," a federal judge is allowing, over plaintiffs' objections, testimony from the defendants' causation experts.  Judge Thomas W. Thrash of the U.S. District Court for the Northern District of Georgia has ruled that three experts, who opined that Stand ‘n Seal does not emit sufficient amounts of the chemical which plaintiffs allege caused their injuries, including chemical pneumonitis, may testify. In Re Stand ‘N Seal Products Liability Litigation, MDL NO. 1804 (N.D. Ga.).

Plaintiffs in the roughly 200 personal injury actions in the MDL assert that Stand ‘n Seal  manufactured with Flexipel S-22WS caused respiratory problems. Stand ‘n Seal is a consumer product used to seal ceramic tile grout in kitchens, bathrooms, and similar areas. The advertised advantage of Stand ‘n Seal was that users can easily stand and spray the sealant onto the grout without the strain of using a brush and manually applying the sealant. The plaintiffs say that the
problems with Stand ‘n Seal began when the manufacturer changed its chemical components to include Flexipel.

Part of the defense has been the dose-response issue that plaintiffs could not have inhaled a harmful amount of the chemical while using Stand ‘n Seal as directed. The plaintiffs urged the court to exclude this expert testimony of Drs. Mark Rigler, William Longo, and Mitchell Sauerhoff.  Rigler and Longo, industrial hygiene experts, tested samples of Stand ‘n Seal and concluded that plaintiffs did not inhale an “analytically detectable” concentration of Flexipel, the specific chemical at issue.  They did not, contrary to plaintiffs' arguments, opine that users of Stand ‘n Seal had absolutely no exposure to Flexipel.  Instead, they have said that users of Stand ‘n Seal were not exposed to “any significant” or “analytically detectable” amounts of Flexipel. In other words, there is a range between zero and the detection limit of their testing, but they believe that range is insignificant.

Instead, said the defense experts, the users of Stand ‘n Seal had a much higher probability of inhaling significant levels of Isopar-G, a solvent used in various formulations of grouting. Defendants intend to offer expert testimony from Mitchell Sauerhoff that overexposure to Isopar-G can cause respiratory injury.  Judge Thrash concluded that the experts’ opinions were admissible. 

“The plaintiffs' experts disagree with Sauerhoff’s opinions, but that disagreement by itself does not make Sauerhoff’s or Rigler and Longo’s testimony inadmissible.”  The court noted that "none of these [potential alternative] explanations seems especially conclusive."  But the alleged generality of the defense experts’ alternate explanations for the cause of the plaintiffs’ injuries affect the weight, not the admissibility, of the expert testimony.”   MassTortDefense notes that plaintiffs often forget that the defendant does not have the burden to disprove causation.  So defense evidence of alternative causes can be admissible even if such evidence would be insufficient when offered by a plaintiff who has the burden of proof on causation.

 

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.”

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.
 

MDL Court Issues Daubert and Summary Judgement Ruling

The MDL court in the Human Tissue mass tort litigation has issued a noteworthy Daubert and summary judgment decision. In re Human Tissue Products Liability Litigation, MDL No. 1763, 2008 WL 4665765 (D.N.J. Oct. 22, 2008). This multidistrict litigation arises from an alleged criminal enterprise to harvest tissue from human corpses without obtaining proper consents and without following appropriate regulations. The plaintiffs in this litigation include the recipients of processed tissue who allegedly suffered harm from the processed tissue product, as well as relatives of the deceased donors.

Certain defendants moved for summary judgment on the issue of general causation of the relevant infectious diseases of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, cancer, and prion disease. General causation, of course, refers to whether a substance is capable of causing a particular injury or condition in the general population. See Perry v. Novartis Pharms. Corp., 564 F.Supp.2d 452, 463 (E.D.Pa.2008); Reference Guide on Medical Testimony, in Reference Manual On Scientific Evidence 439, 444 (Fed. Jud. Ctr., 2d ed.2000).

Defendants argued generally that the tissue at issue was incapable of infecting recipients with certain diseases due to the methods employed by the processing companies to disinfect and sterilize the allografts. But the motion only attacked the potential for the transmission of diseases short of sterilization.

Defendants also moved to exclude the proposed testimonies of several of plaintiffs’ experts. The central conflict among the experts involved time, not capacity. There appeared to be no genuine conflict among the parties that unprocessed bone tissue stored at room temperature can transmit HIV, HBV, HCV, syphilis, and cancer. Rather, the real issue was for what period of time can such bone tissue transmit these diseases-- is it a matter of hours, days, months, or years? Defendants contend that the transmission of disease cannot occur after thirty days, and plaintiffs have sought to extend the period of transmission beyond thirty days. After a comprehensive review of the scientific literature, including epidemiology, animal, and in vitro studies, the court struck plaintiffs' proposed expert testimony where they sought to opine that: (1) unprocessed bone tissue kept at room temperature for thirty days or longer can transmit HIV, HBV, HCV, syphilis, or cancer; (2) unprocessed bone tissue is a transmitter of prion diseases; and (3) the incubation periods of hepatitis and HIV are longer than six months.

Plaintiffs’ expert opinions regarding unprocessed bone tissue stored at room temperature for thirty days or more did not appear to meet the second and third parts of the Daubert and Fed.R.Evid. 702 inquiry-- reliability of methodology and “fit.” The court noted that the opinions were derived from a literature review. When proposed expert testimony is not based upon the expert's own independent research, but instead on such a literature review, the party proffering such testimony must come forward with other objective, verifiable evidence that the testimony is based on scientifically valid principles. The court did not question the reliability of the underlying studies, but rather the plaintiffs’ extrapolations from those studies to the ultimate conclusion. The extrapolations from these studies were not tested, were not subject to peer review, and had no known rate of error. The theory that these studies suggest the existence of general causation as framed in this litigation has not been generally accepted. Without plaintiff's expert evidence, there was no evidence supporting plaintiffs' theories of causation.

In an observation of special interest to readers of MassTortDefense, the court addressed the claim that the science was still evolving and an MDL court should not truncate the mass litigation before it develops. Multidistrict litigation courts are often confronted with evaluating limited or evolving scientific and medical theories and evidence. The absence of definitive scientific or medical knowledge is, said the court, a reality in some cases. Nevertheless, district courts are charged with the role of gatekeeper and can only allow presently reliable evidence. As courts have recognized, the Rules of Evidence may, on occasion, prevent the jury from learning about promising or potential clinically relevant information. See In re Reuzulin Products Liability Litigation, 369 F.Supp.2d 398, 438 (S.D.N.Y.2005). The Rules of Evidence, however, cannot be disregarded even if at a future date, medical and scientific literature proves the contrary. As Judge Richard Posner put it, “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).
 

While MassTortDefense does not typically blog about non-legal or personal issues, we cannot help but say Congratulations to our Philadelphia Phillies, 2008 World Series Champions

"Science Day" In Mass Torts

Many mass torts involve complex medical and scientific issues.  Typically, general causation (can the product cause the injury alleged) and/or specific causation (did the product cause this injury) are debated.  Such questions often spawn Daubert or Frye challenges to expert opinion testimony,  motions in limine, and summary judgment motions that the trial court must wrestle with.

Accordingly, the notion of "educating the court" on the foundation of scientific issues often looms as an important task for defense counsel in mass torts.  One solution to this dilemma may be the "science day" on which the parties present an overview of the issues for the court.

The ABA CIVIL TRIAL PRACTICE STANDARDS note that in cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court. Tutorials are intended to provide the court with background information to assist the court in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex scientific subject matter.


In any case in which the court believes one or more tutorials might be useful in assisting it in understanding the complex technology or other scientific subject matter, the court should invite the parties to express their views on the desirability of one or more tutorials. Once the court decides to permit or require one or more tutorials, it should invite the parties to suggest the subject matter and format of each tutorial, notes the ABA.


If the parties cannot agree on the subject matter and format, the court should invite each party to submit a description of any tutorial it proposes and to explain how that tutorial will assist the court and why it is preferable to the tutorial proposed by another party. The court may approve one or more tutorials proposed by the parties, or the court may fashion its own tutorial after providing the parties with an opportunity to comment on the court's proposed subject matter and format.


A court may consider the following procedures for the presentation of tutorials:

  • An in-court or recorded presentation by an expert jointly selected by the parties;
  • an in-court or recorded presentation by one or more experts on behalf of each party;
  • an in-court or recorded presentation by counsel for each party;
  • a combined in-court or recorded presentation by counsel and one or more experts on behalf of each party;
  • an in-court or recorded presentation by an expert appointed by the court, which may include cross-examination by counsel for each party;
  • recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial Center.


In the context of patent cases, it is well recognized that the court may conduct a tutorial, the purpose of which is to receive expert testimony for background and education on the technology implicated by the presented claim construction issues in assisting the court in the task of construing the patent. See, e.g., Starpay.com L.L.C. v. Visa Int'l Serv. Assoc., 2005 WL 1552769, at *1 (N.D. Tex.).

The use of tutorials is not, however, limited to patent cases, or even to technology cases. See, e.g., In Re Pharmaceutical Industry Average Wholesale Price Litigation, 230 F.R.D. 61, 67 (D. Mass. 2005).

Some courts will use them as a pre-curser to Daubert hearings. Generally, they are with no cross-examination; no-transcripts and an agreement that no testimony can be used in subsequent Daubert hearings.

Courts may find them very helpful. See Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387 (at the outset of proceedings after remand from the MDL, counsel for all sides presented an all-day “tutorial” to the court on the complex science involved in these cases. The tutorial demonstrated the need for and prompted the court to appoint the technical advisors).

 

Third Circuit Rejects Vaccine Plaintiffs' General Causation Expert Opinion

The Third Circuit recently upheld a judgment for the U.S. following a bench trial, in a suit by a couple who alleged that contaminated polio vaccine caused the husband's brain cancer. Gannon v. United States, 2008 WL 4151665 (3d Cir. 2008).

Plaintiffs alleged that an oral polio vaccine (OPV) received between 1973 and 1976 was contaminated with SV40, a simian virus found in both monkeys and humans. The Gannons claimed that the government was negligent in failing to prevent the manufacturer from making the OPV available to the public, and as a result, the contaminated vaccine caused Mr. Gannon to develop a form of brain cancer. Gannon and his wife filed an administrative claim against the government under the Federal Tort Claims Act and, later, a suit in the Eastern District of Pennsylvania.

The Court, for the convenience of the witnesses and to prevent recalling the experts later in the trial, decided to combine a Daubert hearing with the expert bench trial testimony on the issue of causation. Thus, the trial began with the Daubert examination of plaintiffs' expert, Dr. Adi Gazdar, who presented his full testimony on the issue of causation. He testified that SV40 plays a causal role in this type of cancer.

The district court denied the Daubert motion, but rejected the testimony as insufficient on the issue of general causation.  Safe approach in a bench trial, here it and then decide. The ruling came pursuant to Rule 52(c), which states that a trial court can enter judgment after hearing evidence on only one issue, provided the party against whom judgment has been entered is fully heard. (The appeals court rejected the plaintiffs' argument that they were not fully heard on causation: The plaintiffs asserted they would have called two other witnesses to testify, but those witnesses were not relevant to causation because their testimony would principally address the issue of contamination.) Interestingly, the United States did not offer an alternate source of causation but merely asserted that SV40 did not cause brain tumors and offered expert testimony to that effect.

Although Dr. Gazdar testified that it was his opinion that to a reasonable degree of medical certainty SV40 plays a causal role in the formation of medulloblastomas, the Court decided that the plaintiffs had not met their burden of proof on causation. Specifically, the Court found that Dr. Gazdar's testimony failed to satisfy the “Bradford Hill” criteria. The Bradford Hill criteria are broadly accepted criteria for evaluating general causation based on epidemiology;  they are: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biologic Gradient, (6) Plausibility, (7) Coherence, (8) Experimental Evidence, and (9) Analogy.

On appeal, the Third Circuit observed that causation is an essential part of the plaintiffs' negligence claim. Based upon its thorough consideration of the record evidence, the Third Circuit could not say that the district court clearly erred in its findings of fact or that it erred in concluding that the Gannons had not met their burden of proof on the issue of causation.
 

  • The Court relied upon the fact that all three defense experts used established scientific frameworks and cited both biological and epidemiological evidence. Each of those experts opined that the evidence did not support the conclusion that SV40 causes human cancer.
  • The Court relied upon a 2003 Institute of Medicine report, which concluded that “ ‘the evidence is inadequate to accept or reject a causal relationship’ “ between SV40 and cancer.
  • Dr. Gazdar, the plaintiffs' expert, testified that he agreed that current epidemiological evidence does not support the conclusion that SV40 causes brain cancer.
  • He relied upon testing on rodents, which defense experts stated were not a good brain model for humans; even Dr. Gazdar admitted the results could not necessarily be extrapolated to humans.

Most importantly, the court considered each of the nine Bradford Hill criteria for causation and found that Dr. Gazdar's opinion did not meet the criteria.  The general causation opinion was thus rejected on the merits.
 

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.

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.

MDL Judge Excludes Plaintiffs' Real Estate Expert Opinion in MTBE Litigation

The MDL judge overseeing the federal MTBE litigation, In re Methyl Tertiary Butyl Ether (MTBE) Products Liability Litigation, MDL 1358, recently issued a ruling excluding a plaintiff expert’s opinion that the gasoline additive's alleged contamination of private wells caused home values to drop 15%. In Tonneson v. Sunoco Inc., 2008 WL 2324112 (S.D.N.Y. 6/6/08), Judge Shira A. Scheindlin held that the real estate expert, Gregory Langer, failed to offer any valid methodology for his devaluation conclusion.

In property damage cases, the injury/damages expert issues can be crucial. While plaintiffs prefer to focus attention as much as possible on defendant’s conduct, whether it be the alleged creation of a nuisance, strict liability for ultrahazardous activities, negligence, etc., in reality the plaintiffs’ ability to prove impact, injury, and damages from the conduct is a central issue in these cases.

Expert Opinions

The expert proposed to offer several opinions:

1. Contamination of the exclusive source of drinking water for residents with a chemical such as MTBE, which received widespread local publicity, has a significant impact on the market value of the property.

2. There is credible evidence that publicity concerning MTBE contamination in the relevant area has materially impacted the ability of residential property owners to sell their homes within a reasonable period of time.

3. A reasonable seller of real estate would disclose to any prospective buyer the presence of MTBE contamination in the domestic well servicing the property to be sold.

4. The value of plaintiffs' property in the affected area decreased by 15% due to the effective MTBE contamination.

The expert admitted that there were not enough sales to generate the data for a regression analysis. Thus, it was necessary to provide trend data on sales by sub-markets, sales/list price analysis, and days on the market comparisons. Langer's report compared the real estate market in the County as a whole and the relevant local community, on such variables as average list price, percentage sale price/list price, average days on the market, and median price.

Daubert Analysis

The court noted that under Rule 702, if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

In this case, the court concluded it was unable to discern any method -- much less a reliable method -- that Langer used to reach his conclusion that the value of plaintiffs' property decreased by 15% because of MTBE contamination. Langer merely compiled market data and then offered his conclusions, without any sufficient explanation of the relationship between the two. The expert provided a litany of “important factors” that can affect the value, without any explanation how these factors did affect the value of plaintiffs' property, beyond the obvious conclusion that it would better to have properly that has not been contaminated with MTBE.

Other problems included the fact that the expert also selectively chose data to highlight. For instance, Langer stressed days on market, without addressing the fact that the median price went up at the same time. Obviously, the average days on the market may have shot up because sellers were unwilling to negotiate downward on their selling price in such a hot market. Without good explanations, courts cannot assess the reliability of any conclusion drawn by an expert, even if he possesses relevant experience. The expert cited, but did not follow, suggested standards of the relevant appraisal industry group, the USPAP.

The ultimate problem with Langer's opinion was not his conclusion but the fact that he failed to identify any methodology. A court cannot assess the reliability of reasoning or methodology that is unexplained. The ipse dixit of the expert is insufficient.

Fact Testimony

While Langer's expert testimony did not satisfy Rule 702, the statistics that he gathered on retail property were deemed relevant to plaintiffs' action. Plaintiffs might argue to the jury that they should find, based on all of the evidence, that the sales figure statistics demonstrate that MTBE contamination was a cause of the alleged diminished value of plaintiffs' homes. Thus, he would be permitted to offer certain statistics as a fact witness.

State Supreme Court Upholds Reversal of Benzene Verdict on Daubert Grounds

The Mississippi Supreme Court earlier today upheld the reversal of a $2 million benzene verdict. In Watts v. Radiator Specialty Co., et al., No. 2006-CA-01128-SCT (Miss. June 12, 2008), the Court's opinion focused on the absence of scientific evidence linking non-Hodgkin’s lymphoma, plaintiff’s condition, to benzene exposure.

Plaintiff alleged that his use of the product “Liquid Wrench” during his employment as a mechanic exposed him to benzene, and in turn caused his non-Hodgkin’s lymphoma. Plaintiff was diagnosed with small-cell lymphocytic lymphoma, a subtype of non-Hodgkin’s lymphoma in 1999. Liquid Wrench is a liquid solvent used for cleaning tools and engine parts and loosening nuts and bolts. Beginning in 1947, and throughout much of his career, Watts allegedly used Liquid Wrench as many as five times a day. It was undisputed that during at least 18 years of his usage Liquid Wrench did contain benzene.  In the 2004 trial, a jury found defendants Radiator Specialty and U.S. Steel liable.

In May 2006, however, the trial court granted the defendants’ motion for judgment notwithstanding the verdict after finding that the testimony of the plaintiff’s expert on the issue of causation should have been excluded as scientifically unreliable. Dr. Levy testified as to general causation (that benzene causes non-Hodgkin’s lymphoma) and specific causation (that benzene-containing Liquid Wrench caused Mr. Watts’s non-Hodgkin’s lymphoma). In particular, the trial court found that neither the cohort studies nor the case control studies relied upon by Dr. Levy at trial supported his opinion that a causal connection exists between benzene exposure and non-Hodgkin’s lymphoma. (Cohort studies identify and study a group of people exposed to a certain element as compared to another group not exposed to the element to see if there is a higher incidence of disease in the group exposed.; case-control studies identify and study a group of people who have a disease as compared to a group of people who do not have that disease to see if there is a higher incidence of exposure to a certain element in the group that has the disease.) The trial court entered an order dismissing the plaintiff’s case with prejudice, and the plaintiff appealed.

The State Supreme Court’s Analysis

The high court noted the defendants’ central contention that there is no evidence of a link between benzene exposure and small-cell lymphocytic lymphoma. The defendants claimed that Dr. Levy thus had insufficient support for his testimony that a demonstrable causal association exists between benzene exposure and non-Hodgkin’s lymphoma.

Mississippi follows the standard for expert testimony described in Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993). Trial judges are expected to assume the role of gatekeeper on questions of admissibility of expert testimony. There was no dispute that Dr. Levy was properly qualified as an expert in epidemiology and occupational medicine, but there was an issue regarding the reliability of his causation testimony.

The methodology used in forming his opinion as to general causation was the review of eighteen case studies done by different researchers between 1979 and 2004 (nine cohort studies and nine case-control studies). While this type of epidemiological study review is certainly an accepted methodology in the state, an analysis of these case studies supported the trial court’s finding that Dr. Levy’s testimony as to the content of the studies and their relevance to the facts of this case could easily have misled the jury. (The Court believed that juries are often in awe of expert witnesses and their impressive lists of honors, education and experience.)

Dr. Levy admitted that only half the studies showed a statistically significant increase in risk due to benzene exposure. None of the studies specifically looked at the possible risks associated with use of Liquid Wrench. None specifically studied the risks of development of non-Hodgkin’s lymphoma in mechanics, Watts’s profession. (The studied occupations included oil refinery workers, gas station attendants, general chemical workers, and seamen on tankers. ) One of the studies suggested that the reported increase in risk of non-Hodgkin’s lymphoma was not occupationally related. Several of the studies did not provide a dose-response ratio. In short, the Court believed, none of these studies provide a basis for the conclusion that there is a causal connection between benzene exposure and non-Hodgkin’s lymphoma, much less small-cell lymphocytic lymphoma, the particular type from which plaintiff suffered. The Court also emphasized the fact that the expert’s testimony gave very little detail, if any, as to the specific findings of each case study and why it might be relevant.

While experts need not rely on studies that explicitly support their testimony, it is significant that none of the studies relied upon by Dr. Levy found a conclusive link between benzene exposure and non-Hodgkin’s lymphoma.

Dissent Misses the Mark

Three justices in dissent disagreed with this conclusion, arguing that the trial court abused its discretion in excluding Dr. Levy’s testimony. Specifically, the dissent took issue with the emphasis on the conclusion that none of the studies found a link between benzene exposure and non-Hodgkin’s lymphoma. But the majority found it crucial that the few positive findings were not statistically significant, and/or did not relate to the relevant type of lymphoma, and/or that the higher risk of non-Hodgkin’s lymphoma was found among chemical workers who were exposed to a number of chemicals other than benzene and thus the observed risks could be due to some other exposure.

The Court drew upon the language of the United States Supreme Court in General Electric Co. v. Joiner, 522 U.S. 136 (1997), in which the Court observed that an expert’s conclusions and methodology are not entirely distinct from one another. Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.

The dissent also asserted that the majority’s decision would effectively resurrect the Frye standard requiring an expert’s opinion to be generally accepted in the scientific community. Frye v. United States, 54 App. D.C. 46, 47, 293 F. 1013, 1014 (1923). Quite to the contrary, this case is a good example of how courts should apply Daubert. Acceptance remains a relevant factor for trial courts to consider under Daubert. And the gap between the data and the conclusion was simply too great.

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.

Peer Review (Part II)

In yesterday’s post, MassTortDefense began discussion of a peer review issue commented on in this week's New England Journal of Medicine. The editorial comments on two cases in which Pfizer served discovery on the journal, seeking peer-review and other editorial documents on manuscripts concerning Pfizer's Bextra and Celebrex, which of course have been the subject of litigation. Pfizer sought peer-review documents, including the critiques prepared by reviewers for the authors. The logic is that the critiques might help reveal flaws in methodology in the research. This was seen as particularly important given significant imprimatur of the NEJM and the use of its published studies in the cases.

In the case In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation,
2008 WL 859207 (D.Mass. March 31, 2008) the court rejected the discovery, and granted the journal’s motion for a protective order. The court began by noting that the NEJM is the world's oldest and most frequently-cited medical journal. Physicians rely on information presented in the NEJM to follow medical developments and improve patient care. Manuscripts submitted for publication by the NEJM are subject to “peer review,” i.e., to screening and analysis conducted by experts in the subject matter discussed within the submitted articles. Peer reviewers are given a draft manuscript and are asked to provide a confidential, frank, honest evaluation of the manuscript's scientific validity and to provide an overall opinion with respect to a manuscript's “worthiness for publication.” Information from peer reviewers which is communicated to the authors does not reveal the identity of the peer reviewer. The NEJM informs prospective peer reviewers that it will maintain the confidentiality of their identities, unless the reviewer grants specific permission to the contrary. None of the peer reviewers for the eleven Bextra and Celebrex articles published had given the NEJM permission to disclose his or her identity.


The published articles were relevant to the MDL litigation and to plaintiffs’ allegations that Pfizer failed to act upon the results of studies described in the scientific literature, and that it was on notice from those studies of the alleged risks presented by the drugs.

 
At a hearing on the motion, Pfizer apparently narrowed the scope of its request, and withdrew its requests seeking certain documents reflecting the peer reviewer comments which were not shared with the authors, internal editorial comments or processes

Rule 26 and Rule 45 require application of a balancing test looking at whether the information can be obtained from some other source that is more convenient, less burdensome, or less expensive, the burden or expense of the proposed discovery, and its likely benefit, considering the needs of the case, the amount in controversy, the parties' resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues. Specifically here that would include the objector's interest in confidentiality and the potential injury to the free flow of information that disclosure may create. Another factor entitled, said the court, to special weight in conducting this balancing test is that the NEJM was a non-party to the MDL.

The district court concluded that the materials were relevant, but their probative value was limited. The reasoning was that plaintiffs' claims focus on what Pfizer knew, or should have known, via published articles in the scholarly literature. The peer reviewers' confidential comments don’t speak directly to that issue, the court thought. Of course, what a product seller should take from a published article does depend in great measure on the quality of the article, its methodology, is biases, its power, and other aspect peer reviewers are likely to comment upon. But the court felt that Pfizer's own experts were able to review and analyze the articles for flaws in methodology, and the peer reviewer comments contain no new data.


Peer review comments could also potentially be useful to impeach any causation experts of plaintiffs who rely on the studies, and to provide ammunition for defense causation experts. The court however, worried that this reflected a “growing problem” with the use of subpoenas to compel the giving of evidence and information by unretained experts. That seems a somewhat narrow and uniformed view of what defendants typically do when confronted with a mass tort or MDL: they retain as many of the best experts they can find.

Balancing against that probative value, the court analogized the peer review process to the level of protection offered academics engaged in pre-publication research. Because the peer review contributes to the advancement of medicine and science by helping to ensure that faulty, incomplete, or misleading results are not published, and because a journal’s ability to advance medical knowledge in this way might be impaired, resulting in adverse consequences for physicians, patient care, and for society as a whole, the Journal’s objections seemed persuasive to the court. If reviewers thought their names or reviews would be subject to disclosure in unrelated litigation, there would be “chilling effect” on the peer review process and as a result, upon the medical community. The comments are both part of scholarly research efforts as well as part of the editorial process of a print publication. The court concluded that any wholesale disclosure by the NEJM of the peer reviewer comments communicated to authors will be harmful to the NEJM's ability to fulfill both its journalistic and scholarly missions, and by extension harmful to the medical and scientific communities, and to the public interest. Thus the subpoena was quashed.

The Northern District of Illinois, similarly, declined to compel compliance with similar subpoenas served by Pfizer in the same MDL on the Journal of the American Medical Association and the Archives of Internal Medicine. In re Bextra and Celebrex, C.A. No. 08C 402 (N.D.Ill. March 14, 2008). The district court there found that the any probative value of the requested information was outweighed by the burden imposed on the journals in invading the sanctity of the peer review process. In short, it was not unreasonable to believe that compelling production of peer review documents would compromise the process.

But it raises an interesting, perhaps test-able, question whether disclosure of comments would discourage people from submitting articles to the journal, or peer reviewers from commenting on manuscripts.  Isn't a prestigious thing to be able to say "I am a peer reviewer for the NEJM"? After all, a large part of the the academic world involves defending one's scholarly work in public, in symposia, in class rooms, etc.  And scientists frequently publish comments, letters to the editor, publicly critiquing others' work. Wonder if any respected journal conduct peer review in which complete confidentiality is not promised the reviewers?

Yesterday’s editorial commented that confidential peer review is a key component of the manuscript selection process. The Journal’s stand was consistent with the views of the International Committee of Medical Journal Editors. The ICMJE is a group of about 500 general medical journal editors whose participants meet annually and has produced a number of editions of uniform requirements for manuscripts submitted to biomedical journals. See Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication.


In its Uniform Requirements, the ICMJE states that unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Reviewers have rights to confidentiality, which must be respected by the editor. Editors must not disclose information about manuscripts (including their receipt, content, status in the reviewing process, criticism by reviewers, or ultimate fate) to anyone other than the authors and reviewers. “This includes requests to use the materials for legal proceedings.”

It will be interesting to watch and see if the issue arises again in a case in which the party seeking the information -- and might it be plaintiffs under the proper facts? -- can show a higher degree of probative value.

Peer Review, Daubert, and the New England Journal of Medicine

The new England Journal of Medicine weighed in today with an editorial on a topic that should be important for readers of MassTortDefense – peer review. Curfman, et al., Peer Review in the Balance, 358 NEJM 2276 (May 22, 2208).

The editorial weighs in on two recent decisions in the Celebrex litigation involving product liability defendant’s attempts to go beyond the veil of the published article and obtain discovery on information created in the peer review process as manuscripts were assessed. Those manuscripts related to studies of science relevant to the litigation, and the argument was advanced that commentary, discussion, and analysis of those studies by expert peer reviewers likely also contained relevant information about that pertinent science.

Legal Setting

Expert testimony is essential in virtually every mass tort or complex product liability litigation. Under the gate-keeping function of the trial judge, designed to keep junk science out of the courtroom, the Daubert opinion lists important factors to consider in admission of expert testimony, including whether the theory or technique has been subjected to peer review and publication. This factor is relevant, but not dispositive, because sometimes well-grounded but innovative theories will not yet have been published, and sometimes a topic may be of too limited interest to be published. But the Court believed that peer review increases likelihood that substantive flaws will be detected in an article, and publication places the work within the test of the marketplace of ideas. The theory is available to be scrutinized, and has been scrutinized by experts in the relevant field. In essence, submission of the method, theory, reasoning, to scrutiny of scientific community is considered component of good science.


The Daubert Court was aware from amicus briefing of another view of peer review, emphasizing that the peer review system is not a litmus test for truth, not a guarantor of scientific certainty, and does not guarantee that the particular data, research and analytical methodologies, or conclusions of the accepted papers represent the consensus opinion of the relevant community. Brief of Amici Curiae Chubin et al., Daubert, 1992 U.S. S.Ct. Briefs LEXIS 938. But the Court generally rejected this view.


There is some lower court variation in application of Daubert and Frye on peer review; some courts emphasize the mere fact of peer review, Doe v. Ortho-Clinical Diagnostics Inc., 440 F.Supp. 2d 465 (M.D.N.C. 2006)(thimerosal), with others offering a more nuanced view of peer reviewed publication serving as a validity enhancer. The presence of the limited view encourages plaintiffs to seek to get theory published somewhere to “check the box” of peer reviewed publication. The more rigorous view reads the Supreme Court as clearly intending that judges use their own evaluation of peer review and publication as a tool for exploring whether substantive flaws in an expert's methodology have been or could have been exposed. Black v. Rhone-Poulenc, Inc., 19 F.Supp.2d 592 (S.D.W.Va. 1998) (depends upon how the peer review was performed; who did it; plaintiffs failed to provide sufficient information to assess).

Now, before getting into the two recent decisions and the editorial, a brief background on peer review.

Brief History of Peer Review

Modern medical journals came into existence during the 19th century. They were originally a vehicle for personal journalism, with the models for medical editors including the crusading newspaper writer. Publication was a personal vehicle for the editor. Over time, newspapers came to resemble newspapers, with correspondents to cover medicine in different geographic and specialty areas. But in many medical journals, the editors wrote much or all of content. A second type of journal also arose, in addition to those journals that followed the newspaper model, and that was the official publications of research institutes, typically specializing in one kind of research.


In the 19th century editors often could not fill their columns. The problem was finding publishable manuscripts, not turning down original contributions. Editorial board members would help round up material for the editor to publish, rather than review and reject manuscripts. In the 20th century, the supply/demand ratio gradually reversed. The number of passable manuscripts began to increase greatly, so that choosing among good articles became an option. Between 1913 and 1925, the Journal of the American Medical Association received 1500-2000 manuscripts for consideration. And the end of World War II marked the beginning of a dramatic increase in the volume of research and the subsequent reporting of research results. So by the 1990’s, JAMA was receiving 4500 papers/year, plus 5500 letters to editor. Yet JAMA publishes about 500 articles a year. Or the NEJM, which was getting more than 4000 article submissions/year, and publishing less than 10%.

Today there are more than 10,000 medical and scientific journals, and more than 2 million scientific and medical articles published each year. Most are never cited again.

There are examples of historical scientific journals in France and England with well thought-out peer review process to select reports to be published in journals and memoirs. In 1752, the Royal Society of London, a medical society, began publishing Philosophical Transactions and established a "Committee on Papers" to review articles submitted for publication. But in the U.S., most journals were personal fiefdoms of editors. (E.g., James McKeen Cattell, who for 50 years edited (and owned) Science and other major journals at the same time. ) As noted, editors wrote much of the content; they considered themselves as expert as anyone to assess content. The only mechanism that resembled modern peer review, perhaps, was book publishers seeking outside advice regarding textbook manuscripts in technical fields.


Peer review developed in part to deal with situations in which an editor lacked the specialized knowledge to make decisions about highly technical articles. Particularly after WWII, more specialists in subject matter, in terms of technique and, especially, in medicine, and laboratory materials were needed. And when physicians began to specialize in particular fields, it also spawned a demand for specialized journals catering to that specialty.  The supply/demand ratio gradually reversed and there was a growing need to discriminate high-quality articles and turn down others in the growing volume of at least plausibly good submissions that they had to consider.

Fast Forward to Today
An example of rigorous peer review is the New England Journal of Medicine, which publishes less than 10% of the unsolicited manuscripts it receives. There is a multi-step process including an initial screen by and editor; and internal review by an associate editor; submission to at least 2 peer reviewers/referees; presentation of the article to an editorial meeting; a statistical/math review, etc. There is a step for an additional review and revision by the author.


Today, scientific and medical journal have a significant role in shaping the views and behavior of scientists, clinicians, and policy makers. Contrary to the theory that journals act as passive conduits for scientific content, studies show the impact of an article is strongly influenced by which journal published it, and authors know that. There is a potential for a few high-impact journals to shape heavily the use of scientific information. At the same time, the increasing number of biomedical journals, the advent of online publication, and the increasingly interdisciplinary nature and impact of research, are forcing journals to compete for the best research.

With that background, the current controversy in the next posting.