Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

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.

(Dechert is involved in the diacetyl litigation, but not this case.)

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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.

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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. 

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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?

 

 

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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.

 

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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.”).

 

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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.

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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.


 

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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.

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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.
 

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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.
 

 

 

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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.

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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.

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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.”
 

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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.   

 

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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.

 

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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.”

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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.
 

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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.
 

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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! 

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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).

 

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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.
 

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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.
 

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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.

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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.

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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.

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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.

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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.

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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?

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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.

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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.

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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.

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