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For your delectation and delight, desultory dicta on the law of delicts.

Viagra, Part II — MDL Court Sees The Light – Bad Data Trump Nuances of Statistical Inference

July 8th, 2012

In the Viagra vision loss MDL, the first Daubert hearing did not end well for the defense. Judge Magnuson refused to go beyond conclusory statements by the plaintiffs’ expert witness, Gerald McGwin, and to examine the qualitative and quantitative evaluative errors invoked to support plaintiffs’ health claims. The weakness of McGwin’s evidence, however, appeared to encourage Judge Magnuson to authorize extensive discovery into McGwin’s study. In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1090 (D. Minn. 2008).

The discovery into McGwin’s study had already been underway, with subpoenas to him and to his academic institution. As it turned out, defendant’s discovery into the data and documents underlying McGwin’s study won the day. Although Judge Magnuson struggled with inferential statistics, he understood the direct attack on the integrity of McGwin’s data. Over a year after denying defendant’s Rule 702 motion to exclude Gerald McGwin, the MDL court reconsidered and granted the motion. In re Viagra Products Liab. Litig., 658 F. Supp. 2d 936, 945 (D. Minn. 2009).

The basic data on prior exposures and risk factors for the McGwin study was collected by telephone surveys, from which the information was coded into an electronic dataset. In analyzing the data, McGwin used the electronic dataset and not the survey forms. Id. at 939. The transfer from survey forms to electronic dataset did not go smoothly; about 11 patients were miscoded as “exposed“ when their use of Viagra post-dated the onset of NAION. Id. at 942. Furthermore, the published article incorrectly stated personal history of heart attack as a “risk factor ”; the survey inquired about family not personal history of heart attack. Id. at 944.

The plaintiffs threw several bombs in response, but without legal effect. First, the plaintiffs claimed that the study participants had been recontacted and the database had been corrected, but they were unable to document this process or the alleged corrections. Id. at 433. Furthermore, the plaintiffs could not explain how, if their contention had been true, McGwin would have not committed serious violations of his university’s institutional review board’s regulations with respect to deviations from the original protocol. Id. at 943 n.7.

Second, the plaintiffs argued that the underlying survey forms were “inadmissible ” and thus the defense could not use them to impeach the McGwin study. Some might think this a duplicitous argument, utterly at odds with Rule 703 – rely upon a study but prevent use of underlying data and documents to explain that the study does not show what it purports to show. The MDL court spared the plaintiffs the embarrassment of ruling that the documents on which McGwin had based his study were inadmissible, and found that the forms were business records and admissible under Federal Rule of evidence 803(6). The court could have gone further to point out that McGwin’s reliance upon hearsay in the form of his study, McGwin 2006, opened the door to impeaching the hearsay relied upon with other hearsay. See Rule 806.

When defense counsel sat down with McGwin in a deposition, they found that he had not undertaken any new analyses of corrected data. Plaintiffs’ counsel directed him not to do so. Id. at 940-41. But then after the deposition was over, McGwin submitted a letter to the journal to report a corrected analysis. Pfizer’s counsel obtained the letter in response to their subpoena to McGwin’s university, the University of Alabama, Birmingham. Mirabile dictu; now the increase risk appeared limited to only to the defendant’s medication, Viagra!

The trial court was not amused. First, the new analysis was no longer peer reviewed, and the court had placed a great deal of emphasis on peer review in denying the first challenge to McGwin. Second, the new analysis was no longer that of an independent scientist, but was conducted and submitted as a letter to the editor, while McGwin was working for plaintiffs’ counsel. Third, the plaintiffs and McGwin conceded that the data were not accurate. Last, but not least, the trial court clearly was not pleased that the plaintiffs’ counsel had deliberately delayed McGwin’s further analyses until after the deposition, and then tried to submit yet another supplemental report with those further analyses. In sum:

“the Court finds good reason to vacate its original Daubert Order permitting Dr. McGwin to testify as a general causation expert based on the McGwin Study as published. 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. Likewise, the known rate of error is also meaningless if it is based on inaccurate data. Even if the McGwin Study as published was conducted according to generally accepted epidemiologic research and did not result from post-litigation research, the fact that the McGwin Study appears to have been based on data that cannot now be documented or supported renders it inadmissibly unreliable. The Court concludes that under Daubert, Dr. McGwin’s opinion, to the extent that it is based on the McGwin Study as published, lacks sufficient indicia of reliability to be admitted as a general causation opinion.”

Id. at 945-46. The remaining evidence was the Margo & French study, but McGwin had previously criticized that study as lacking data that ensured that Viagra use preceded onset of NAION. In the end, McGwin was left with bupkes, and the plaintiffs were left with even less.

*******************

McGwin 2006 Was Also A Pain in the Rear End for McGwin

The Rule 702 motions and hearings on McGwin’s proposed testimony had consequences in the scientific world itself. In 2011, the British Journal of Ophthalmology retracted McGwin’s 2006 paper. “Retraction: Non-arteritic anterior ischaemic optic neuropathy and the treatment of erectile dysfunction, ” 95 Brit. J. Ophthalmol. 595 (2011).

Interestingly, the retraction was reported in the Retraction Watch blog, “Retractile dysfunction? Author says journal yanked paper linking Viagra, Cialis to vision problem after legal threats.” The blog treated the retraction as routine except for the hint of “legal pressure”:

“One of the authors of the paper, a researcher at the University of Alabama named Gerald McGwin Jr., told us that the journal retracted the article because it had become a tool in a lawsuit involving Pfizer, which makes Viagra, and, presumably, men who’d developed blindness after taking the drug:

‘The article just became too much of a pain in the rear end. It became one of those things where we couldn’t provide all the relevant documentation [to the university, which had to provide records for attorneys].’

Ultimately, however, McGwin said that the BJO pulled the plug on the paper.”

Id. The legal threat is hard to discern other than the fact that lawyers wanted to see something that peer reviewers almost never see – the documentation underlying the published paper. So now, the study that formed the basis for the original ruling against Pfizer floats aimlessly as a derelict on the sea of science. McGwin is, however, still at his craft. In a study he published in 2010, he claimed that Viagra but not Cialis use was associated with hearing impairment. Gerald McGwin, Jr, “Phosphodiesterase Type 5 Inhibitor Use and Hearing Impairment,” 136 Arch. Otolaryngol. Head & Neck Surgery 488 (2010).

Where are Senator Grassley and Congressman Waxman when you need them?

Posted in Causation, Data Sharing, Expert Witnesses, Rule 702, statistical evidence, Underlying Data | Comments Off on Viagra, Part II — MDL Court Sees The Light – Bad Data Trump Nuances of Statistical Inference

Maryland Puts the Brakes on Each and Every Asbestos Exposure

July 3rd, 2012

Last week, the Maryland Court of Special Appeals reversed a plaintiffs’ verdict in Dixon v. Ford Motor Company, 2012 WL 2483315 (Md. App. June 29, 2012). Jane Dixon died of pleural mesothelioma. The plaintiffs, her survivors, claimed that her last illness and death were caused by her household improvement projects, which involved exposure to spackling/joint compound, and by her husband’s work with car parts and brake linings, which involved “take home” exposure on his clothes. Id. at *1.

All the expert witnesses appeared to agree that mesothelioma is a “dose-response disease,” meaning that the more the exposure, the greater the likelihood that a person exposed will develop the disease. Id. at *2. Plaintiffs’ expert witness, Dr. Laura Welch, testified that “every exposure to asbestos is a substantial contributing cause and so brake exposure would be a substantial cause even if [Mrs. Dixon] had other exposures.” On cross-examination, Dr. Welch elaborated upon her opinion to explain that any “discrete” exposure would be a contributing factor. Id.

Welch, of course, criticized the entire body of epidemiology of car mechanics and brake repairmen, which generally finds no increased risk of mesothelioma above overall population rates. With respect to the take-home exposure, Welch had to acknowledge that there were no epidemiologic studies that investigated the risk of wives of brake mechanics. Welch argued that the studies of car mechanics did not involve exposure to brake shoes as would have been experienced by brake repairmen, but her argument only served to make her attribution based upon take-home exposure to brake linings seem more preposterous. Id. at *3. The court recognized that Dr. Welch’s opinion may have been trivially true, but still unhelpful. Each discrete exposure, even as attenuated as a take-home exposure from having repaired a single brake shoe may have “contributed,” but that opinion did not help the jury assess whether the contribution was substantial.

The court sidestepped the issue of fiber type, and threshold, and honed in on the agreement that mesothelioma risk showed a dose-response relationship with asbestos exposure. (There is a sense that the court confused the dose-response concept to mean no threshold.) The court credited hyperbolic risk assessment figures from the United States Environmental Protection Agency, which suggested that even ambient air exposure to asbestos leads to an increase in mesothelioma risk, but then realized that such claims made the legal need to characterize the risk from the defendant’s product all the more important before the jury could reasonably have concluded that any particular exposure experienced by Ms. Dixon was “a substantial contributing factor.” Id. at *5.

Having recognized that the best the plaintiffs could offer was a claim of increased risk, and perhaps crude quantification of the relative risks resulting from each product’s exposure, the court could not escape that the conclusion that Dr. Welch’s empty recitation of “every exposure” is substantial was nothing more than an unscientific and empty assertion. Welch’s claim was either tautologically true or empirical nonsense. The court also recognized that risk substituting for causation opened the door to essentially probabilistic evidence:

“If risk is our measure of causation, and substantiality is a threshold for risk, then it follows—as intimated above—that ‘substantiality’ is essentially a burden of proof. Moreover, we can explicitly derive the probability of causation from the statistical measure known as ‘relative risk’ … . For reasons we need not explore in detail, it is not prudent to set a singular minimum ‘relative risk’ value as a legal standard.¹² But even if there were some legal threshold, Dr. Welch provided no information that could help the finder of fact to decide whether the elevated risk in this case was ‘substantial’.”

Id. at *7. The court’s discussion here of “the elevated risk” seems wrong unless we understand it to mean the elevated risk attributable to the particular defendant’s product, in the context of an overall exposure that we accept as having been sufficient to cause the decedent’s mesothelioma. Despite the lack of any quantification of relative risks in the case, overall or from particular products, and the court’s own admonition against setting a minimum relative risk as a legal standard, the court proceeded to discuss relative risks at length. For instance, the court criticized Judge Kozinski’s opinion in Daubert, upon remand from the Supreme Court, for not going far enough:

“In other words, the Daubert court held that a plaintiff’s risk of injury must have at least doubled in order to hold that the defendant’s action was ‘more likely than not’ the actual cause of the plaintiff’s injury. The problem with this holding is that relative risk does not behave like a ‘binary’ hypothesis that can be deemed ‘true’ or ‘false’ with some degree of confidence; instead, the un-certainty inherent in any statistical measure means that relative risk does not resolve to a certain probability of specific causation. In order for a study of relative risk to truly fulfill the preponderance standard, it would have to result in 100% confidence that the relative risk exceeds two, which is a statistical impossibility. In short, the Daubert approach to relative risk fails to account for the twin statistical uncertainty inherent in any scientific estimation of causation.”

Id. at *7 n.12 (citing Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1320-21 (9th Cir.1995) (holding that that a preponderance standard requires causation to be shown by probabilistic evidence of relative risk greater than two) (opinion on remand from Daubert v. Merrell Dow Pharms., 509 U.S. 579 (1993)). The statistical impossibility derives from the asymptotic nature of the normal distribution, but the court failed to explain why a relative risk of two must be excluded as statistically implausible based upon the sample statistic. After all, a relative risk greater than two, with a lower bound of a 95% confidence interval above one, based upon an unbiased sampling, suggests that our best evidence is that the population parameter is greater than two, as well. The court, however, insisted upon stating the relative-risk-greater-than-two rule with a vengeance:

“All of this is not to say, however, that any and all attempts to establish a burden of proof of causation using relative risk will fail. Decisions can be – and in science or medicine are – premised on the lower limit of the relative risk ratio at a requisite confidence level. The point of this minor discussion is that one cannot apply the usual, singular ‘preponderance’ burden to the probability of causation when the only estimate of that probability is statistical relative risk. Instead, a statistical burden of proof of causation must consist of two interdependent parts: a requisite confidence of some minimum relative risk. As we explain in the body of our discussion, the flaws in Dr. Welch’s testimony mean we need not explore this issue any further.⁴⁴”

Id. (emphasis in original).

And despite having declared the improvidence of addressing the relative risk issue, and then the lack of necessity for addressing the issue given Dr. Welch’s flawed testimony, the court nevertheless tackled the issue once more, a couple of pages later:

“It would be folly to require an expert to testify with absolute certainty that a plaintiff was exposed to a specific dose or suffered a specific risk. Dose and risk fall on a spectrum and are not ‘true or false’. As such, any scientific estimate of those values must be expressed as one or more possible intervals and, for each interval, a corresponding confidence that the true value is within that interval.”

Id. at 9 (emphasis in original; internal citations omitted). The court captured the frequentist concept of the confidence interval as being defined operationally by repeated samplings and their random variability, but the confidence of the confidence interval means that the specified coefficient represents the percentage of all such intervals that include the “true” value, not the probability that a particular interval, calculated from a given sample, contains the true value. The true value is either in or not in the interval generated from a single sample risk statistic. Again, it is unclear why the court was weighing in on this aspect of probabilistic evidence when plaintiffs’ expert witness, Welch, offered no quantitation of the overall risk or of the risk attributable to a specific product exposure.

The court indulged the plaintiffs’ no-threshold fantasy but recognized that the risks of low-level asbestos exposure were low, and likely below a doubling of risk, an issue that the court stressed it wanted to avoid. The court cited one study that suggested a risk (odds) ratio of 1.1 for exposures less than 0.5 fiber/ml – years. See id. at *5 (citing Y. Iwatsubo et al., “Pleural mesothelioma: dose-response relation at low levels of asbestos exposure in a French population-based case-control study,” 148 Am. J. Epidemiol. 133 (1998) (estimating an odds ratio of 1.1 for exposures less than 0.5 fibers/ml-years). But the court, which tried to be precise elsewhere, appears to have lost its way in citing Iwatsubo here. After all, how can a single odds ratio of 1.1 describe all exposures from 0 all the way up to 0.5 f/ml-years? How can a single odds ratio describe all exposures in this range, regardless of fiber type, when chrystotile asbestos carries little to no risk for mesothelioma, and certainly orders of magnitude risk less than amphibole fibers such as amosite and crocidolite. And if a low-level exposure has a risk ratio of 1.1, how can plaintiffs’ hired expert witness, Welch, even make the attribution of Dixon’s mesothelioma to the entirety of her exposure, let alone the speculative take-home chrysotile exposure involved from Ford’s brake linings? Obviously, had the court posed these questions, it would it would have realized that “it is not possible” to permit Welch’s testimony at all.

The court further lost its way in addressing the exculpatory epidemiology put forward by the defense expert witnesses:

“Furthermore, the leading epidemiological report cited by Ford and its amici that specifically studied ‘brake mechanics’, P.A. Hessel et al., ‘Meso-thelioma Among Brake Mechanics: An Expanded Analysis of a Case-control Study’, 24 Risk Analysis 547 (2004), does not at all dispel the notion that this population faced an increased risk of mesothelioma due to their industrial asbestos exposure. … When calculated at the 95% confidence level, Hessel et al. estimated that the odds ratio of mesothelioma could have been as low as 0.01 or as high as 4.71, implying a nearly quintupled risk of mesothelioma among the population of brake mechanics. 24 Risk Analysis at 550–51.”

Id. at *8. Again, the court is fixated with the confidence interval, to the exclusion of the estimated magnitude of the association! This time, after earlier shouting that it was the lower bound of the interval that matters scientifically, the court emphasizes the upper bound. The court here has strayed far from the actual data, and any plausible interpretation of them:

“The odds ratio (OR) for employment in brake installation or repair was 0.71 (95% CI: 0.30-1.60) when controlled for insulation or shipbuilding. When a history of employment in any of the eight occupations with potential asbestos exposure was controlled, the OR was 0.82 (95% CI: 0.36-1.80). ORs did not increase with increasing duration of brake work. Exclusion of those with any of the eight exposures resulted in an OR of 0.62 (95% CI: 0.01-4.71) for occupational brake work.”

P.A. Hessel et al., “Mesothelioma Among Brake Mechanics: An Expanded Analysis of a Case-control Study,” 24 Risk Analysis 547, 547 (2004). All of Dr. Hessel’s estimates of effect sizes were below 1.0, and he found no trend for duration of brake work. Cherry picking out the upper bound of a single subgroup analysis for emphasis was unwarranted, and hardly did justice to the facts or the science.

Dr. Welch’s conclusion that the exposure and risk in this case were “substantial” simply was not a scientific conclusion, and without it her testimony did not provide information for the jury to use in reaching its conclusion as to substantial factor causation. Id. at *7. The court noted that Welch, and the plaintiffs, may have lacked scientific data to provide estimates of Dixon’s exposure to asbestos or relative risk of mesothelioma, but ignorance or uncertainty was hardly the basis to warrant an expert witness’s belief that the relevant exposures and risks are “substantial.” Id. at *10. The court was well justified in being discomforted by the conclusory, unscientific opinion rendered by Laura Welch.

In the final puzzle of the Dixon case, the court vacated the judgment, and remanded for a new trial, “either without her opinion on substantiality or else with some quantitative testimony that will help the jury fulfill its charge.” Id. at *10. The court thus seemed to imply that an expert witness need not utter the magic word, “substantial,” for the case to be submitted to the jury against a brake defendant in a take-home exposure case. Given the state of the record, the court should have simply reversed and rendered judgment for Ford.

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Johnson v. Arkema Inc. – The Fifth Circuit Proves to Be Sophisticated Consumer of Science

June 21st, 2012

Yesterday, in celebration of the first day of summer, the Fifth Circuit handed down a decision in a case that looks like a laundry list of expert witness fallacies. Fortunately, the district judge and two of the three appellate judges kept their analytical faculties intact. Johnson v. Arkema Inc., Slip op., 2012 WL ___ (5th Cir. June 20, 2012) (per curiam) (affirming exclusion of expert witnesses).

The plaintiff had worked in a glass bottling plant, where on two occasions in 2007, he was in close proximity to the defendant’s ventilation hood, designed to be used with a chemical, Certincoat, composed of monobutyltin trichloride (MBTC), an organometallic compound. Plaintiff claimed that the ventilation was inadequate and that as a result he was exposed to MBTC as well as hydrochloric acid.

The plaintiff sustained some acute symptoms and ultimately was diagnosed with a “chemical pneumonia,” by his treating physician. The plaintiff further claimed that his condition progressively worsened, and that he was ultimately diagnosed with “pulmonary fibrosis,” a “severe restrictive lung disease.” The plaintiff filed reports from two expert witnesses – Richard Schlesinger, a toxicologist, and Charles Grodzin, a pulmonary physician – in support of his claim that his pulmonary fibrosis was caused by overexposure to MBTC and hydrochloric acid (HCl).

Plaintiff’s claim led to defendant’s Rule 702 challenge, which the trial court sustained, and the appellate court affirmed.

A basic problem faced by plaintiff is that there was virtually no evidence that MBTC or HCl causes pulmonary fibrosis. Undaunted, the plaintiff and his expert witnesses pushed on, but the lack of epidemiologic evidence associating MBTC or HCl with pulmonary fibrosis proved reliably harmful to plaintiff’s case.

General Acceptance

Plaintiff could point to no evidence that MBTC or HCl causes pulmonary fibrosis. Slip op. at 7. Given the delay in manifestation of the fibrosis after the plaintiff’s rather limited, discrete exposures, the court recognized that epidemiologic evidence was important, if not essential, to plaintiff’s case. Without epidemiology, the plaintiff retreated to generalities – the chemicals cause lung irritation, lung injury, etc. One concurring judge was taken in, but the majority of the panel saw through the dodge.

Anecdotal Evidence

Without epidemiologic evidence, the plaintiff invoked anecdotal evidence that other employees sustained similar lung injuries. The problem, however, for even this low-level evidence was that other employees experienced only transitory symptoms, which quickly resolved. Id. at 4 -5, 27.

Post Hoc, Ergo Propter Hoc

Focusing only on himself as an anecdote with n =1, the plaintiff, and his expert witnesses, argued that temporal sequence of his exposure and his pulmonary fibrosis was itself evidence of causality. Neither the trial court nor the appellate court found this much of an argument. Id. at 16 n.13, 18.

Mechanism in Search of Data – Schlesinger’s irritant theory

Schlesinger argued that both MBTC and HCl are pulmonary irritants, which can cause inflammation, and pulmonary fibrosis results from inflammation. Id. at 8. True, but not all irritants cause pulmonary fibrosis. Chronicity and dose are important considerations. Whether these chemicals, under exposure conditions experienced by plaintiff, were capable of causing pulmonary fibrosis, cried out for evidence.

The Material Safety Data Sheets (MSDS)

The plaintiff argued that the MSDS for HCl established that this chemical was “severely corrosive to the respiratory system.” Id. at 11-12. The defendant’s own MSDS for MBTC stated that MBTC “causes respiratory tract irritation.” Id. at 16. The courts saw these arguments as transparently absent evidence. None of the MSDS identified pulmonary fibrosis; nor did they specify (1) the underlying scientific support, or (2) the relevant duration and exposure needed to induce any particular adverse outcome.

Animal Studies

For both MBTC and HCl, plaintiff adverted to animal studies, but the courts found that the animal studies failed to support the plaintiff’s expert witnesses’ opinions and the plaintiff’s claims. The studies were readily distinguishable in terms of dose, duration, and disease outcome. In particular, none of the studies showed that the chemicals caused pulmonary fibrosis. Id. at 7, 12 (baboon study of HCl showed impairment but not fibrosis at 10,000ppm for one year, quite unlike plaintiff’s exposure), 16-17 (rat inhalation study of MBTC, six hrs/day, five days/wk, up to 30 mg/m³, with toxicity but no mention of lung fibrosis).

Regulatory Limits

Plaintiff argued that HCl levels were multiples of the OSHA limits, but the courts would not credit regulatory exposure limits are evidence of harmfulness because of the precautionary nature of many regulations. Id. at 14. Furthermore, the disease outcomes of regulatory concern did not appear to be pulmonary fibrosis for the chemicals involved.

Res Ipsa Loquitur

The plaintiff argued that causation was a matter of common sense and general experience. Even if his expert witnesses did not have valid, reliable evidence, the jury could make the causal determination without scientific evidence. Id. at 26. Rejected.

Chemical Analogies

The defendant’s expert witness acknowledged that tin oxide can cause pulmonary fibrosis. Id. at 28. This admission, however, came without any qualification about what exposure or duration data might be needed to support a conclusion about specific causation in the plaintiff. Id. Furthermore, tin pneumoconiosis, or stannosis, is known as a benign lung disease, unassociated with impairment or disability. Like simple silicosis, stannosis is a picture change on chest radiograph, without diminution of performance on pulmonary function tests. Agency for Toxic Substances and Disease Registry, A Toxicological Profile for Tin and Tin Compounds at 30 (2005).

Differential Diagnosis

Plaintiff’s pulmonary expert witness, Dr. Grodzin, tried to bootstrap specific causation by assuming general and putting it in the “differentials” for him to embrace. Id. at 19. A fallacious form of reasoning, but the courts here were on top of it.

* * * * *

The panel did reverse the trial court’s grant of summary judgment. The gate closed a little too fast to permit scrutiny of plaintiff’s claim of acute injuries and symptoms, which were less dependent upon epidemiologic evidence.

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Expert Witness Guru

June 20th, 2012

In my casting about on the internet, I came across an interesting site dedicated to expert witness issues: The Expert Witness Guru (EWG).

As you might expect, the Expert Witness Guru is an India-based “expert witness consulting and publishing firm, with a distinct focus on helping experts build a robust practice and providing attorneys with the right tools to locate and engage the right experts.” The website is a blend of marketing and scholarship, which is designed to be helpful to both expert witnesses and to lawyers who depend so much upon their experts in litigation. The EWG offers a variety of litigation support services, including preparation of expert witness profiles and deposition summaries.

The website features a blog, the Expert Witness Marketing and News Blog, which is designed with the mixed readership of both expert witnesses and lawyers in mind. The EWG blog publishes the work of the folks at EWG, as well as invited guest posts. Expert Witness Guru also publishes an electronic monthly magazine, Expert Witness Chronicle, with coverage of the law, practice, and marketing of expert witness testimony. To date, two issues have been released, which are available at the EWG website.

The editorial staff of Expert Witness Chronicle includes Ashish Arun (Editor), Shweta Nawani (Co-Editor), and contributors John F. Fielder, Myles Levin, and Gil Zamora.

The second issue of the Expert Witness Chronicle announced the formation of a capable editorial board, of well-respected scholars and practictioners:

Joseph P. Sanders, the A. A. White Professor of Law at University of Houston Law Center

Edward K. Cheng, Professor of Law at Vanderbilt Law School, and

John F. Fielder, clinical and forensic psychologist, and CEO, Daubert Institute of Forensic Psychology

The first two issues feature interesting coverage of the whole range of expert witness issues, from practice issues involving retention to the wide spectrum of types of expert witness testimony (forensic, economic, engineering, scientific, etc.). The website, blog, magazine, and the outsourced services are all worth a closer look.

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Politics of Expert Witnesses – The Treating Physician

June 7th, 2012

If a party retains an expert witness who has actually conducted research on the issue in controversy, the witnesses’ underlying data and analyses will be sought in discovery. Of course, litigants are entitled to every man’s (and woman’s) evidence, and independent research, but the involvement of an investigator-author as an expert witness will almost certainly increase the scope of discovery. Counsel will seek manuscript drafts, emails with co-authors, interim data, protocols and protocol amendments, preliminary analyses, among other documents. Many would-be expert witnesses are reluctant to put their own research into issue. The result is that expert witnesses frequently do not have “hands-on” experience with respect to the exact issue raised by the litigation in which they serve.

The combination of these factors creates vulnerabilities for witnesses. Expert witnesses who have not conducted research or written about the issue end up being more attractive to lawyers. But even these witnesses will be flawed in the eyes of a jury or trial judge: they have been paid for their time in reviewing literature, preparing reports, sitting for depositions, traveling, appearing at trial. The compensation of a highly skilled and experienced professional can lead to large amounts of money, amounts sufficient to make juries skeptical and lawyers’ uncomfortable.

Physicians, who care and treat a claimant, represent a litigation Holy Grail: the prospect of having a neutral, disinterested, and caring expert witness opine about causation, diagnosis, damages, or prognosis, without the baggage of having been selected and paid by lawyers. A lot of sharp elbows are thrown in the process of trying to align treating physicians with one side or the other’s litigation positions.

In some litigations, in some states, ex parte interviews by defense counsel are forbidden, but similar interviews by plaintiffs’ counsel are allowed. Much mischief results. The practice of trying to turn the treating physician into a “causation” or “damages” witness runs amuck, especially when trial courts do not require full Federal Rules of Civil Procedure Rule 26 disclosures from the treating physicians.

Jurors will want to know what treating physicians said, and may regard them as disinterested. Indeed, the supposed neutrality and beneficence of the treating physician is often emphasized by counsel in their addresses to juries. See, e.g., Simmons v. Novartis Pharm. Corp., 2012 WL 2016246, *2, *7 (6th Cir. 2012)((affirming exclusion of retained expert witness, as well as a treating physician who relied solely upon a limited selection of medical studies given to him by plaintiffs’ counsel); Tamraz v. BOC Group Inc., No. 1:04-CV-18948, 2008 WL 2796726 (N.D.Ohio July 18, 2008)(denying Rule 702 challenge to treating physician’s causation opinion), rev’d sub nom. Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (6th Cir. 2010)(carefully reviewing record of trial testimony of plaintiffs’ treating physician; reversing judgment for plaintiff based in substantial part upon treating physician’s speculative causal assessment created by plaintiffs’ counsel), cert. denied, ___ U.S. ___ , 131 S. Ct. 2454, 2011 WL 863879 (2011). See generally Robert Ambrogi, “A ‘Masterly’ Opinion on Expert Testimony,” Bullseye: October 2010; David Walk, “A masterly Daubert opinion” (Sept. 15, 2010); Ellen Melville, “Comment, Gating the Gatekeeper: Tamraz v. Lincoln Electric Co. and the Expansion of Daubert Reviewing Authority,” 53 B.C. L. Rev. 195 (2012) (student review that mistakenly equates current Rule 702 law with the Supreme Court’s 1993 Daubert decision, while ignoring subsequent precedent and revision of Rule 702).

In the silicone gel breast implant litigation, plaintiffs corralled a herd of rheumatologists who were sympathetic to their claims of connective tissue disease, and who would support their “creative” causation theories. As a result, defense rheumatologists were not likely to have seen many of the claimants in their practice. The plaintiffs’ counsel capitalized upon this “deficiency” in their experience, by attacking the defense experts’ expertise and their experience with the newly emergent phenomenon of “silicone-associated disease” (SAD). The treating physicians were involved early on in the SAD litigation exploit.

In New Jersey, defense counsel have a limited right to ex parte interviews of treating physicians. Stempler v. Speidell, 100 N.J. 368, 495 A.2d 857 (1985). Certain New Jersey state trial judges, however, have ignored the Stempler holding in mass tort contexts, and have severely limited defendants’ ability to get information from treating physicians. Last week, the New Jersey Appellate Division waded into this contentious area, by reversing an aberrant trial judge’s decision that severely restricted defendants’ retention of any physician who had treated a plaintiff in the mass tort. In Re Pelvic Mesh/Gynecare Litig., No. A-5685-10T4 (N.J. Super. App. Div. June 1, 2012).

The defendants, Johnson & Johnson and Ethicon, Inc., designed, made, marketed, and sold pelvic mesh medical devices for the treatment of pelvic organ prolapse and stress urinary incontinence. In re Pelvic at 2. Several hundred personal injury cases against the defendants were assigned to the Atlantic County law division. In a pretrial order, the trial court barred “defendants from consulting with or retaining as an expert witness any physician who has at any time treated one or more of the plaintiffs.” Id. Remarkably, the trial court’s order was not limited to attempts to contact a physician for purposes of discussing a particular plaintiff’s case. The trial court’s order had the effect of severely limiting defendants access to expert witnesses, as well as disqualifying expert witnesses already retained. Plaintiffs’ counsel, however, were free to line up their clients’ treating physicians, and other treating physicians with substantial clinical experience with the allegedly defective device.

The Appellate Division reversed the trial court’s asymmetrical rules regarding treating physicians as manifestly inconsistent with the New Jersey Supreme Court’s mandate in Stempler and other cases. The Appellate Division showed little patience for the trial court’s weak attempt to justify the uneven-handed treatment of access to treating physicians. The trial court had invoked the potential for interference with the doctor-patient privilege as a basis for its pretrial order, but hornbook law, in New Jersey and in virtually every state, treats the filing of a lawsuit as a waiver of the privilege. Id. at 11. Similarly, the Appellate Division rejected the trial court’s insistence that a treating physician was obligated to protect and advance patients’ litigation interests by either testifying for patients or refraining from testifying for defendants. Id. at 15. A treating physician has no “duty of loyalty” to help advance a patient’s litigious goals. Id. at 26. The trial court had myopically confused a duty to provide medical care and treatment with helping plaintiffs’ counsel advance their view of the patients’ welfare.

The Appellate Division’s reversal is a welcome return of sanity and equity to New Jersey law of expert witnesses. The over-reaching rationale of the trial court posed some incredible implications. The appellate court noted, as an example, that “radiologists, orthopedists, and neurologists who routinely testify as experts for the defense in numerous personal injury cases in our courts are likely to be treating or consulting physicians for other patients with similar injuries, and some of those patients may also have filed lawsuits or may do so in the future.” Id. at 16. The trial court’s reasoning would strip defendants in virtually all personal injury litigation of access to expert physician opinion. In asbestos litigation, for instance, the defense would find any and all pulmonary physicians who was treating a worker with asbestos-related disease to be off limits to consulting or testifying. The Appellate Division’s strong ruling should be seen as a cloud on the validity of the continuing practice of barring defense counsel from ex parte interviews of treating physicians in mass or other tort litigation.

Posted in Causation, Expert Witnesses, Rule 702, Trial Procedure | Comments Off on Politics of Expert Witnesses – The Treating Physician