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Legal Remedies for Suspect Medical Science in Products Cases – Part One

June 2nd, 2020

Expert witness opinions about the nature and cause of plaintiffs’ medical conditions, are the linchpin of mass tort cases involving claims of bodily injury from allegedly harmful products. The quality of these expert witness opinions has long been the subject of debate, but the explosion of products liability cases has brought increasing scrutiny, especially in cases involving asbestos, silica, and pharmaceutical claims.[1]

Courts, Congress, and commentators have raised concerns about the scientific and medical validity of the opinions offered in support of certain product liability claims, whether certain of the individuals who offer such opinions have a proper degree of independence from the lawyers representing the plaintiffs, and whether there is any way to address these questions apart from a rejection of the individual claims in which the bogus opinions are offered. Famously, Judge Janis Jack of the United States District Court for the Southern District of Texas addressed these issues in a lengthy decision in which she excoriated physicians, medical screeners, and plaintiffs’ lawyers who she concluded had transgressed basic ground rules of medical and legal propriety in connection with silicosis claims.[2]

The stakes generated by the availability of these medical/technical opinions are especially high in mass torts that involve medical assessments of thousands of claimants. The pendency of asbestos claims has driven well over 100 companies into bankruptcy, and with that example, any industry facing a substantial wave of repetitive liability claims must be concerned about how to respond to what it believes are false or unfounded claims. Clients ask whether there are remedies for the promotion of false, fraudulent, or just inadequate medical science under the banner of seeking compensation in products liability cases. The answers remain less than clear.

Some Past Attempts to Remedy the Harm from Dubious Science in Products Cases

GAF’s Litigation against the Asbestos Lawsuit Industry

On January 10, 2001, G-I Holdings Inc., the successor to GAF Corporation (“GAF”), filed suit against a group of asbestos personal injury lawyers who it alleged had “orchestrated a scheme to inundate the judicial system with hundreds of thousands of asbestos cases without regard to their merit.”[3] Among the allegations were claims that the plaintiffs’ firms had “suborned perjury and fabricated evidence” and “induced expert witnesses to provide false and misleading testimony, all for the purpose of extracting unwarranted and inflated settlements, judgments and, correspondingly, attorneys’ fees, from GAF and other asbestos defendants.” The complaint alleged that, in 1978, a group of

“approximately 125 plaintiffs’ asbestos contingency fee attorneys banded together to form and fund the Asbestos Litigation Group (“ALG”) in order to further their scheme of promoting asbestos litigation.” GAF asserted that “acting jointly through the ALG, and through less formal asbestos-related organizations, defendants, upon information and belief, solicited tens of thousands of asbestos claimants and sued manufacturers without regard for, or in conscious disregard of, the merits of their claims against particular individual defendants such as GAF. . . . .pursuant to agreements with each network [of local counsel] member, a share of the fees . . . .is typically channeled back to the referring ALG member, and ultimately to the ALG, to be invested in future claimant solicitations, including mailed advertisements in newsletters. This has resulted in the filing of further claims, thereby continuing the scheme, and increasing the network, which spirals ever larger.”

GAF’s complaint specifically included claims relating to the alleged “fabricat[ion]” of “medical evidence.” In this regard, GAF alleged, upon information and belief, that the plaintiffs’ lawyers had:[4]

. . . .induced medical “experts” to testify falsely. As set forth in the “Toxic Justice” report, [the plaintiffs’ law firm] paid off what one of the firm’s paralegals described as “whore docs” i.e., doctors who for money eagerly attributed virtually any lung abnormality to asbestos exposure, regardless of what medical evidence actually showed.

And GAF complained that:

. . . . these practices induced false and misleading testimony to be given by expert witnesses in support of claims brought against GAF and others, which resulted in GAF’s payment of inflated verdicts and settlements in a number of cases.

While much of GAF’s complaint did not focus specifically on the quality of the medical evidence, it is nonetheless instructive as an overall perspective on the factual framework within which these medical issues arise. GAF’s complaint understandably focused heavily on defendant’s Baron & Budd’s memorandum, entitled “Preparing for Your Deposition.” GAF alleged that this

“memorandum, apparently created for use in preparing asbestos plaintiffs for deposition, improperly exhorts witnesses to testify in a pre-scripted manner, regardless of the truth.”

For particularity’s sake, GAF alleged, with extensive quotations from the Baron & Budd memorandum, that the memorandum told

“witnesses to identify only those products listed on the Work History Sheets prepared by Baron & Budd (lest the witness identify the product of a bankrupt entity from whom no damages or attorneys’ fees could be collected). . . .and to memorize the product names provided by Baron & Budd on the “Work History Sheets” and to testify that they actually saw those names on containers where they worked. . . .”[5]

The complaint alleges that the memorandum gave further improper instructions to plaintiffs about their testimony, including directions to omit any mention of exposures resulting “from the replacement or removal of old product that could not be identified by brand”; making false claims of “equal exposure to all products”; denying “that they ever saw any warnings or had knowledge concerning the harmful effects of asbestos.”

GAF alleged a variety of other concerted actions to file false asbestos claims. These activities allegedly included withholding “from production in discovery death certificates for asbestos claimants that did not support the conclusion that the individual had died as a result of an asbestos-related disease”; conducting “periodic in-house training sessions to teach other attorneys and/or paralegals how to prepare all asbestos claimants to give scripted testimony in their depositions. . . . .without regard for whether or not the testimony was true”; participating in a scheme to falsify Court records to indicate that complaints were filed before the running of the statute of limitations; and submitting affidavits containing false information concerning the identity of products.

The complaint also contained a number of allegations to the effect that the defendant law firms had “used their considerable resources and power in an attempt to intimidate and deter GAF (and others) from exercising their constitutionally protected rights to petition Congress in support of legislation that would establish a fair and efficient administrative facility for resolving legitimate asbestos claims without the years of delay and wasteful fees and transaction costs that are characteristic of the current system. Defendants have waged a full-scale, multi-front war against those seeking passage of a Congressional bill entitled the “Fairness in Asbestos Compensation Act.”

The suit pled claims under the Racketeer Influenced and Corrupt Organizations Act (“RICO”),[6] and under numerous other headings of state, and federal, law.[7] The lawsuit industry defendants brought a series of motions to dismiss on the pleadings, with successive amended complaints filed, until there was nothing left of GAF’s complaint.[8] For example, part of the case – relating to the Baron & Budd memorandum discussed above — pleaded fraud based on information and belief. Judge Sweet dismissed that aspect of the fraud claims on the grounds that Federal Rule of Civil Procedure 9(b) requires that allegations of fraud be pleaded with specificity and that the plaintiff must provide a statement of facts upon which the belief of the existence of fraud is founded. Judge Sweet concluded that GAF had repeatedly failed to meet this requirement.

Federal and State Prosecutions against Physicians and Screening Companies

After Judge Jack’s exposé of fraudulent and false diagnoses in the silicosis MDL, various news media reported that the United States Attorney’s office in the Southern District of New York was investigating possible criminal charges against the physicians and lawyers who orchestrated the screenings. Historically, there has been little interest among prosecutors in the questionable activities of screening physicians, with some notable exceptions. In 1990, the United States Attorney’s office, for the Eastern District of Philadelphia, filed a civil RICO against several Philadelphia-area physicians for their role in submitting false and fraudulent Medicare claims.[9] As pleaded by the government, the fraudulent scheme consisted of soliciting industrial workers for “free” lung screening, at the behest of lawyer clients, for asbestos-related diseases. The physicians conducted radiologic and pulmonary function examinations, and submitted requests to Medicare for reimbursement of inflated costs for these services and falsely stated that the services were reasonably medically necessary because of diagnoses of chronic obstructive pulmonary disease.[10] This matter appears to have been resolved before trial, although the docket fails to reveal the exact nature of the resolution.

The false claim problem continues, although the silicosis screenings have abated, and most asbestos plaintiffs’ lawyers have shifted their efforts to the high-yield mesothelioma and lung cancer cases, for which diagnostic accuracy is not typically the dominant issue. Some within the lawsuit industry appear to continue the practice of referring clients to friendly physicians for an examination that will form the basis of a lawsuit, with the consulting physician in turn filing a request for reimbursement with the claimant’s private or public health insurer. For most insurers, such a claim for reimbursement impliedly represents that the services were reasonably medically necessary, and sometimes the services may well be necessary. At other times, the services are redundant and provided only for purposes of preparing the examining physician to serve as an expert witness. In a case I tried early in my career, the testifying expert witness first saw the plaintiff two weeks before trial for no purpose other than to serve as a witness. The plaintiff had a regular treating physician, and had been examined by another testifying witness, but the plaintiff’s lawyer wanted to have a second testifying witness for trial. The “Saturday-night” expert witness conducted his examination, and then requested reimbursement for the examination from the plaintiff’s health insurer, and indicated the name of the plaintiff’s counsel as the “referring physician” on the insurance forms. The trial judge remarkably would not permit cross-examination of the testifying expert witness on the fraud, and suggested that such cross-examination was prohibited by the collateral source rule! The health insurance industry will occasionally act vigilantly to enforce a lien against a tort recovery, but there has been little evidence of civil or criminal litigation arising from the practice of billing insurers for examinations by physicians who are essentially expert witnesses and not treating physicians.

The Pennsylvania Silicosis Litigation Cock Up

In February 2002, Texas invaded Pennsylvania. No conventional weapons were fired. The Texans took up positions in mobile vans in motel parking lots across eastern Pennsylvania. Without prescriptions, physicians’ orders, or regulatory approval, the Texans directed unlawful X-ray radiation at Pennsylvania workers in the hopes of creating evidence to be used in lawsuits for silicosis. To help establish their litigation beachhead, the Texans hired local mercenaries – a New Jersey company in the business of providing mobile X-ray screenings. Dozens of silicosis lawsuits were created and filed in Philadelphia as a result of the invasion.

On January 25, 2007, the Commonwealth of Pennsylvania, through its Department of Environmental Protection (DEP), responded by fining the New Jersey company, MOST Health Services, Inc. The DEP found that MOST violated Pennsylvania law by conducting X-ray screenings without physician or regulatory approval. For having unlawfully exposed 161 persons to ionizing radiation, DEP assessed a civil penalty of $80,500.00, against MOST. The DEP did not charge the plaintiffs’ lawyers with any violation of Commonwealth regulations.

MOST’s participation in unlawful litigation screenings was not a momentary lapse in judgment. Back in 2000, defense counsel in asbestos cases compelled the testimony of MOST principal Kenneth Warner, who acknowledged then that MOST had not been in the practice of complying with screening regulations. Mr. Warner, however, claimed that the company was in the process of filing appropriate applications to comply.

Workers were invited to the February 2002 MOST screenings by their unions, but the invitation letters were written by Texas lawyers. To participate in the screenings, the workers had to sign a retainer agreement to engage the Texas-based law firm. The workers were told that “legal ethics” required that they hire the sponsoring law firm to represent them before “the attorneys can provide [them] with medical tests.”

Of course, the law in no state permits attorneys to provide medical tests, and especially not X-rays. DEP, like most other states’ regulatory agencies, has promulgated comprehensive regulations that govern virtually every aspect of the use of medical radiation. In Pennsylvania, anyone proposing a “healing arts screening” with X-rays must submit, in advance, a comprehensive, written proposal with details of the proposed screening, the description of the population to be examined, the qualifications of the radiation technician and operator, the quality control to be used, the qualifications of the supervising physician, and the identity and qualifications of the physician who will interpret the radiographs.

The MOST screenings, commissioned by the Texas lawyers, were never authorized by the DEP. No physician was present on site. None of the workers presented prescriptions or physicians’ orders before being unlawfully exposed to radiation. The identity of the physician slated to receive the chest radiographs was never disclosed to DEP.

Ultimately, the films created by MOST were sent to a West Virginia physician, well known and well compensated in dust-disease litigation. This off-site physician diagnosed virtually all of the workers with either asbestosis or silicosis, and a majority of litigants with both asbestosis and silicosis, although he never examined the workers, never interviewed them, and never reviewed their medical records.

In December 2005, the defendants in the silicosis cases that arose from the MOST screenings moved to dismiss on grounds that the claims were the direct result of unlawful activities that violated Pennsylvania public policy. The trial court denied the motion without opinion. Despite the obvious conspiracy between the plaintiffs’ lawyers and MOST to violate Pennsylvania health regulations, no disciplinary actions were brought against the plaintiffs’ lawyers in the cases.

The Pennsylvania fine against MOST seems to have been an exceptional finding. Although the predatory screening practices decried in federal Judge Janis Graham Jack’s now judicial opinion, In re Silica Products Liability Litigation, no other states to my knowledge have taken action against the conspiracies among lawyers, physicians, and mobile screening companies, to violate state health regulations. These conspiracies thrived for some time, in part because of the entrepreneurial enthusiasm of the conspirators, and the failure of courts, bar associations, adversary counsel, state and federal regulators, and medical societies to condemn the screening practices. In the context of silicosis litigation, the “red flags of fraud,” go beyond the manufacturing of diagnoses for money; they mark as dubious the entire enterprise of suing sand suppliers for failure to warn about hazards that were well known to government, industry, labor, and academia from the 1930s, forward.

[1] The following commentary flows from a joint project that the late R. Nicholas (Nick) Gimbel and I worked on some years ago. Nick’s illness and tragic death prevented us from publishing this work, but I believe it still bears some sort of public airing. Nick Gimbel and I presented some of this commentary in a paper, “Legal Remedies to Address Suspect Medical Science in Product Liability Cases,” for Mealey’s Advanced Insurance Coverage Conference, in Philadelphia, Pennsylvania (Jan. 23, 2006).

[2] In re Silica Products Liability Litigation, 398 F.Supp. 2d 563 (S.D.Tex. 2005) (“In re Silica”). Although Judge Jack’s deconstruction of the silicosis “epidemic” is famous among defense counsel, Her Honor’s work has been met with willful ignorance by the lawsuit industry. See, e.g., David Michaels, “Deadly Dust,” chap. 8, in The Triumph of Doubt: Dark Money and the Science of Deception (2020) (exhibiting amnesia about one of the largest litigation frauds in the 21^st century, so far.)

[3] For a more complete, scholarly exposition of this case, see Lester Brickman, “Civil RICO: An Effective Deterrent to Fraudulent Asbestos Litigation?” 40 Cardozo L. Rev. 2301, 2344-2402 (2019).

[4] Fourth Amended Complaint dated August 19, 2002.

[5] Fourth Amended Complaint, ¶ 61.

[6] 18 U.S.C. § 1961, et seq.

[7] Other claims in the GAF complaint asserted tortious interference with contract and economic advantage, breach of contract, common law fraud and falsification of documents. Claims that were dismissed include malicious interference with GAF’s right to petition Congress, violation of 15 U.S.C. § 1 (antitrust laws) and fraudulent inducement.

[8] See G-I Holdings, Inc. v. Baron & Budd, No. 01-Civ. 0216, 2005 WL 1653623 (S.D.N.Y.); G-I Holdings, Inc. v. Baron & Budd, No. 01-Civ. 0216, 2004 WL 638141 (S.D.N.Y. Mar. 30, 2004); G-I Holdings, Inc. v. Baron & Budd, 2004 WL 540456 (S.D.N.Y. Mar. 17, 2004); G-I Holdings, Inc. v. Baron & Budd, 2004 WL 374450 (S.D.N.Y. Feb. 27, 2004); G-I Holdings, Inc. v. Baron & Budd, 218 F.R.D. 409 (S.D.N.Y. 2003); G-I Holdings, Inc. v. Baron & Budd, 213 F.R.D. 146 (S.D.N.Y. 2003); G-I Holdings, Inc. v. Baron & Budd, 01 Civ. 0216, 2002 WL 31251702 (S.D.N.Y. Oct. 8, 2002); G-I Holdings, Inc. v. Baron & Budd, 238 F.Supp.2d 521 (S.D.N.Y. 2002); and G-I Holdings, Inc. v. Baron & Budd, 179 F.Supp.2d 233 (S.D.N.Y. 2001).

[9] U.S. v. MRS Diagnostics, Inc., Civil Action No. 90-3517 (E.D.Pa. May 23, 1990), Complaint.

[10] Id. at Complaint para. 1(a)-(i).

Posted in Asbestos, Scientific Misconduct, Silica | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part One

ACGIH TLVs Lack Scientific Integrity & Transparency – The Mica NIC

June 2nd, 2020

The American Conference of Governmental Industrial Hygienists (ACGIH®) is a non-profit corporation established in 1938, to advance occupational and environmental health. The corporation’s motto, included in its logo, hubristically announces: “Defining the Science of Occupational and Environmental Health.”

Philosophers of science may demur from “the” in “the Science,” as well as from the intellectual arrogance in suggesting that this private organization has any such ability to commandeer the complex social nature of scientific knowledge. And yet, in the small area of setting permissible exposure limits to potential environmental or occupational toxic substances, the ACGIH is in the business of “defining” safety. Starting in 1941, the group started to review and recommend “exposure limits.” In 1956, the group coined (literally and figuratively) the term “threshold limit values” (TLVs®), and started to publish documentation for its recommended values.

From the beginning, the ACGIH has asserted that TLVs® are not standards; rather they are guidelines for use, with other information, in determining safe levels of workplace and environmental exposure. The ACGIH maintains that its TLVs are based upon published, peer-reviewed scientific studies in industrial hygiene, toxicology, occupational medicine, and epidemiology, without consideration for economic or technical feasibility.

Beginning in the 1980s, “the Lobby”[1] started to throw brushback pitches at the ACGIH to bully the organization out of positions that the Lobby thought were too comforting to manufacturing industry.[2] The result was a dramatic shift in the ACGIH’s perspective. The bullying created a “white-hat” bias that operates as a one-way ratchet to push the ACGIH always to lower TLVs, regardless whether there was a scientific warrant for doing so. Efforts to curb ACGIH overreach by litigation have generally failed. The TLVs have becoming increasingly controversial and non-evidence-based.[3]

What follows is what a hypothetical stakeholder might submit in response to a recent ACGIH Notice of Intended change for its TLV for mica dust. Like other mineral dusts, mica when inhaled in large quantities over long time periods, causes a pneumoconiosis. Documenting a “reasonable safe” level requires studies with adequate quantification of exposure. I will leave the reader to decide whether the ACGIH has that evidence in hand, based upon the following.

[1] F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997); see “The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013).

[2] Barry I. Castleman & Grace E. Ziem, “Corporate influence on threshold limit values,” 13 Am. J. Indus. Med. 531 (1988); Grace Ziem & Barry I. Castleman, “Threshold limit values: historical perspectives and current practice,” 31 J. Occup. Med. 910 (1989); S.A. Roach & S.M. Rappaport, “But they are not thresholds: a critical analysis of the documentation of Threshold Limit Values,” 17 Am. J. Indus. Med. 727 (1990).

[3] Philip E. Karmel, “The Threshold Limit Values Controversy,” N.Y. L. J. (Jan. 3, 2008).

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

These comments are in response to the proposed change in the ACGIH® TLV® for Mica, as explained in the ACGIH “Mica: TLV® Chemical Substances Draft Documentation, Notice of Intended Change” (“NIC”). For the reasons stated below, the change in the Mica TLV-TWA (time-weighted average) in the NIC is not warranted and the existing Mica TLV should not be changed.

The ACGIH® TLVs® are important non-governmental standards, largely because a number of government entities incorporate TLVs by reference into regulations and thus give TLVs the force of law.[4] For example, some states and Canadian provinces simply adopt TLVs as state or provincial occupational exposures levels, and some states have established “maximum allowable ambient concentrations” or similar limits on “toxic air contaminants” based entirely or in part on TLVs. The U.S. Mine Safety and Health Administration (MSHA) uses the 1973 ACGIH TLV for crystalline silica (quartz) as a legally enforceable permissible exposure level.[5] The U.S. Occupational Health and Safety Administration (OSHA) Hazard Communication Standard requires that ACGIH TLVs be disclosed in required Safety Data Sheets. The process by which the ACGIH develops TLVs is critically important, and furthermore, given the regulatory and legal significance of the ACGIH TLVs, the ACGIH has the burden to support proposed changes in TLVs by an adequate process, which includes transparency and evidence sufficient to support any proposed change.

The flaws in the ACGIH TLV setting process are well known and the subject of several publications, most recently in paper titled “142 ACGIH Threshold Limit Values® established from 2008-2018 lack consistency and transparency.”

The following specific comments address the ACGIH’s process disclosed in the ACGIH’s NIC in support of its proposed change for the TLV-TWA for mica, which illustrate the process problem — the ACGIH NIC for the proposed Mica TLV-TWA change does not support the change proposed by the ACGIH. Again, the ACGIH TLVs have regulatory and legal significance; therefore, the ACGIH should not make TLV changes arbitrarily and capriciously. Instead, the changes should be made pursuant to a transparent process, and the ACGIH should support the proposed changes with the weight of the available evidence, and the evidence in support of and the reasons for the proposed change should be publicly disclosed. It has not done that in this case, and its own NIC makes it clear that it has not:

There is no evidence that “mica is an important cause of disabling occupational pneumoconiosis” as stated in the NIC.

The NIC provides no citation or other supporting evidence for this conclusion; it merely states the conclusion as “fact” and a premise for the proposed change.[6] The NIC fails to estimate the number of workers currently potentially exposed to mica in the U.S. (or elsewhere), what industries these workers work in, what forms of mica these workers may be exposed to, what levels of respirable mica these workers may be exposed to, and to what extent pneumoconiosis caused by the inhalation of respirable mica exists.[7]

The NIC proposes to materially lower the TLV for mica, but, other than noting that there are “nine different major species”, does not adequately address the mineralogical differences between the different species of mica, makes no attempt to assess the potential adverse health effects for the different species of mica, does not examine the “dose-response” data (as inadequate as it is) for the different species of mica, and so on.

The “Chemical and Physical Properties” section of the NIC suggests the wide variety of materials that fall within the general term “mica”. In spite of this, the ACGIH appears to have ignored differences and concluded that the TLV for “mica” as a general category of substances should be applicable to all forms of mica, with no support for this conclusion in the NIC.[8]

The human studies (sic) cited in the NIC are inadequate to support a decision to change the mica TLV and do not support the mica TLV proposed.

The first cited study involved four employees in a muscovite milling plant, with an alleged exposure to respirable mica (as muscovite) dust between 1.86 and 5.77 mg/m³.

The second cited study involved a (one) South African man who worked in a mica milling factory. As noted in the NIC, “[q]uantitative exposure data were not reported.”

The third cited study involved a (one) 65-year old who worked in the rubber industry for 40 years, where he was exposed to numerous dusts, including mica. There was no exposure data reported.

The fourth study involved a (one) 62-year old woman allegedly exposed to “pure mica” for seven years; no quantitative exposure data were available.

The NIC cites the case of a worker who bagged mica flake for 36 years. In this case, there were, apparently, two dust samples taken – one at the time of a medical exam of the worker at age 54, total dust of 0.2 mg/m³ — and one taken 17 years earlier – 0.7 mg/m³. The bulk mica samples disclosed 7.1% to 8.4% silica (presumably, respirable crystalline silica as quartz). The reference to the silica content of the “bulk samples” suggests that there was no analysis of the material collected in the two air samples taken.

The NIC cites the case of two British men who worked as “grinders of imported muscovite,” one starting in 1957. The “workplace dust concentrations were not quantified.”

The next paper cited in the NIC was from 1940 and involved employees who were exposed to the dust caused by “mica-scrap” grinding. There was actually an attempt to quantify mica exposures (the data from before 1940), but it was done by particle count. The NIC notes that the available information regarding mica health effects may be “limited by potential uncertainty converting from mppcf (million particles per cubic foot) to mg/m³ (which might not apply to all dust exposure scenarios).” The difficulties associated with converting from mppcf to mg/m³ are well known in the cases of minerals far more extensively studied than mica (e.g., crystalline silica as quartz). In addition to the conversion factor issue, there are other concerns raised by relying upon a paper published in 1940 to support a TLV today, such as, the quality of the sampling, the quality of the chest x-rays, and issues with the classification of the chest x-rays. With that said, the NIC noted that “[n]one of the workers exposed at less than 10 mppcf (1.8 mg/m³), irrespective of employment duration, developed pneumoconiosis.”

The remaining studies cited in the NIC are similar. But, to close this section of the comments, I will refer to the last study, a study of 71 South African workers employed in mica milling. Twelve personal and static samples were taken during the course of the study. The results of the personal samples indicated a range of respirable dust (or was it mica?) between 0.4 to 1.68 mg/m³. The radiologic examination disclosed that 19 of the 71 workers had changes consistent with one or more of asbestos, silica and/or mica. “The specific dust concentrations to which the individuals presenting with lung changes were exposed were not reported.”

The ACGIH is proposing a reduction in the mica TLV based on the studies as described in the NIC. We submit that this is a process and transparency problem – there is simply no way to conclude that a reduction in the mica TLV is warranted based on the Human Studies (the “evidence”) cited in the NIC. In most cases, the Human Studies are simply case reports involving one, two, or a few people, with no quantitative exposure data. The studies with exposure data are inadequate, i.e., date from before 1940, and among other things measured exposure as mppcf, with one study literally including two samples. Given the legal and regulatory significance of ACGIH TLVs, the evidence cited in support of the change in the mica TLV, and the reasonable conclusion that can be drawn from the evidence cited, should exceed some threshold and meet some burden. The evidence in the NIC is grossly insufficient to support the proposed change.

The NIC for mica does not disclose any evidence to support the proposed TLV of a TWA of 0.1 mg/m³.

The comparison to OSHA’s notice of proposed rulemaking for occupational exposure to respirable crystalline silica (RCS) is instructive. The supporting documentation sets forth a preliminary quantitative risk assessment outlining life-time risks for various disease end points associated with occupational exposure to RCS at various levels. The preliminary quantitative risk assessment disclosed all of the underlying studies and methodology, sufficient to allow a reader to understand the basis for the risk assessment conclusions and agree or disagree with the conclusions. Based on the risks (and other factors not considered by the ACGIH) set forth in the documentation, OSHA proposed a PEL (permissible exposure level) for RCS.

By contrast, the ACGIH simply contends for its proposed mica TLV: “Consequently, a TLV-TWA of 0.1 mg/m³ measured as respirable fraction (containing no asbestos and <1% crystalline silica) is recommended.” The materials preceding “[c]consequently”, which in normal reading would be expected to support the conclusion following, are not a risk assessment or anything similar to one, and in no way even superficially support the conclusion – the recommendation – stated.[9] Therefore, the ACGIH proposed a TLV-TWA of 0.1. The NIC materials do not support a TLV of 0.1 mg/m³, any more than they support a TLV of 0.0001 or 10. It cannot be stated too emphatically that the NIC is devoid of any evidence to support any TLV, including the recommended TLV-TWA of 0.1 mg/m³.

Of course, the ACGIH TLV process is not a federal rulemaking. And readers should be aware of the ACGIH Position Statement regarding TLVs (“TLVs … are not quantitative levels of risk at different exposure levels…”). But the same Position Statement notes that “TLVs^®…represent conditions under which ACGIH^® believes that nearly all workers may be repeatedly exposed without adverse health effects.” So, presumably, the ACGIH concluded that its proposed mica TLV was that level, and yet there is simply no evidence in the NIC to support that conclusion. Given the regulatory and legal significance of TLVs, the process of establishing TLVs should have some basis in science and evidence.

References

ACGIH® TLV/BEI® Position Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-position-statement

ACGIH® TLV/BEI® Policy Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-policy-statement

30 C.F.R. § 56.5001 (MSHA exposure to airborne contaminants)

29 C.F.R. § 1910.1200 (OSHA Hazard Communications)

D. Davies & R. Cotton, “Mica pneumoconiosis,” 40 Br. J. Indus. Med. 22 (1983)

Subhabrata Moitra, “Mica pneumoconiosis: a neglected occupational lung disease – letter,” 6 The Lancet Respir. Med. e39 (2018), available at: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30178-4/fulltext

Notice of Proposed Rule Making (NPRM) for Occupational Exposure to Respirable Crystalline Silica, 56 Fed. Reg. 56273 (Sept. 12, 2013)

Knut R. Skulburg, “Mica pneumoconiosis – a literature review,” 11 Scand. J. Work & Envt’l Health 65 (1985)

Carl J. Smith & Thomas A. Perfetti, “142 ACGIH Threshold Limit Values® (TLV®s) established from 2008-2018 lack consistency and transparency,” 3 Toxicol. Research & Application 1 (2019)

[4] ACGIH states that TLVs are not intended to be legal standards, but the ACGIH recognizes the broad use of TLVs and should reasonably anticipate that TLVs will be used in ways beyond the scope of the legal disclaimers that the ACGIH publishes.

[5] 30 C.F.R. 56.5001

[6] The problems cited by Moitra — illegally operated mica mines exploiting vulnerable populations to work without protections in India and some African countries — speak to the need to eliminate illegal mining and protect vulnerable populations from exploitation, not the adequacy or inadequacy of any TLV.

[7] By comparison, see the OSHA documentation for the NPRM for Occupational Exposure to Respirable Crystalline Silica published September 12, 2013. The citation to the 1985 Skulberg article (in “Major Sources of Exposure”) is inadequate on its face in 2020; the article summarizes world mica use from 1905-1981, and provides no information regarding use post-1981. Likewise, the citation to the “Campaign for Safe Cosmetics” does not provide information on occupational exposure.

[8] The case of crystalline silica again provides a useful contrast. There is no ACGIH TLV for “crystalline silica,” which as a general term includes many polymorphs.

[9] Actually, the materials that precede “consequently” explicitly refute the conclusion stated by the ACGIH (the TLV-TWA of 0.1 mg/m³) — “the published literature has established an association between mica exposure and pneumoconiosis typically at concentrations in the range of 1-6 mg/m³,” and “no cases were observed among workers exposed to mica dusts at concentrations of 1.8 mg/m³ or less….”

Posted in Cognitive Biases, Scientific Evidence | Comments Off on ACGIH TLVs Lack Scientific Integrity & Transparency – The Mica NIC

Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent

June 2nd, 2020

The Advisory Committee notes to the year 2000 amendment to Federal Rule of Evidence 702 included a comment:

“A review of the case law after Daubert shows that the rejection of expert testimony is the exception rather than the rule. Daubert did not work a ‘seachange over federal evidence law’, and ‘the trial court’s role as gatekeeper is not intended to serve as a replacement for the adversary system’.”[internal citation omitted]

In stating its review of the caselaw, perhaps the Committee was attempting to allay the anxiety of technophobic judges. But was the Committee also attempting to derive an “ought” from an “is”? Before the Supreme Court decided Daubert in 1993, virtually every admissibility challenge to expert witness opinion testimony failed. The trial courts were slow to adapt and to adopt the reframed admissibility standard. As the Joiner case illustrated, some Circuits were even slower to permit trial judges the discretion to assess the validity vel non of expert witnesses’ opinions.

The Committee’s observation about the “exceptional” nature of exclusions was thus unexceptional as a description of the case law before and shortly after Daubert was decided. And even if the Committee were describing a normative view, it is not at all clear how that view should translate into a ruling in a given case, without a very close analysis of the opinions at issue, under the Rule 702 criteria. In baseball, most hitters are thrown out at first base, but that fact does not help an umpire one whit in calling a specific runner “safe” or “out.” Nonetheless, courts have repeatedly offered the observation about the exceptional nature of exclusion as both an explanation and a justification of their opinions to admit testimony.[1] The Advisory Committee note has thus mutated into a mandate to err on the side of admissibility, as though deliberately committing error was a good thing for any judge to do.[2] First rule: courts shall not err, not intentionally, recklessly, or negligently.

Close Calls and Resolving Doubts

Another mutant offspring of the “exception, not the rule” mantra is that “[a]ny doubts regarding the admissibility of an expert’s testimony should be resolved in favor of admissibility.”[3] Why not resolve the doubts and rule in accordance with the law? Or, if doubts remain, then charge them against the proponent who has the burden of showing admissibility? Unlike baseball, in which a tie goes to the runner, in expert witness law, a tie goes to the challenger because the defender of the motion has failed to show a preponderance in favor of admissibility. A better mantra: “exclusion when it is the Rule.”

Some courts re-imagine the Advisory Committee’s about exceptional exclusions as a recommendation for admitting Rule 702 expert witness opinion testimony as a preferred outcome. Again, that interpretation reverses the burden of proof and makes a mockery of equal justice and scientific due process.

Yet another similar judicial mutation is the notion that courts should refuse Rule 702 motions when they are “close calls.”[4] Telling the litigants that the call was close might help assuage the loser and temper the litigation enthusiasms of the winner, but it does not answer the key question: Did the proponent carry the burden of showing admissibility? Residual doubts would seem to weigh against the proponent.

Not all is lost. In one case, decided by a trial court within the Ninth Circuit, the trial judge explicitly pointed to the proponent’s failure to identify his findings and methodology as part of the basis for exclusion, not admission, of the challenged witness’s opinion testimony.[5] Difficulty in resolving whether the Rule 702 predicates were satisfied worked against, not for, the proponent, whose burden it was to show those predicates.

In another case, Judge David G. Campbell, of the District of Arizona, who has participated in the Rules Committee’s deliberations, showed the way by clearly stating that the exclusion of opinion testimony was required when the Rule 702 conditions were not met:

“Plaintiffs have not shown by a preponderance of the evidence that [the expert witness’s] causation opinions are based on sufficient facts or data to which reliable principles and methods have been applied reliably… .”[6]

Exclusion followed because the absent showings were “conditions for admissibility,” and not “mere” credibility considerations.

Trust Me, I’m a Liberal

One of the reasons that the Daubert Court rejected incorporating the Frye standard into Rule 702 was its view that a rigid “general acceptance” standard “would be at odds with the ‘liberal thrust’ of the Federal Rules.”[7] Some courts have cited this “liberal thrust” as though it explained or justified a particular decision to admit expert witness opinion testimony.[8]

The word “liberal” does not appear in the Federal Rules of Evidence. Instead, the Rules contain an explicit statement of how judges must construe and apply the evidentiary provisions:

“These rules shall be construed to secure fairness in administration, elimination of unjustifiable expense and delay, and promotion of growth and development of the law of evidence to the end that the truth may be ascertained and proceedings justly determined.”[9]

A “liberal” approach, construed as a “let it all in” approach would be ill-designed to secure fairness, eliminate unjustifiable expense and time of trial, or lead to just and correct outcomes. The “liberal” approach of letting in opinion testimony and let the jury guess at questions of scientific validiy would be a most illiberal result. The truth will not be readily ascertained if expert witnesses are permitted to pass off hypotheses and ill-founded conclusions as scientific knowledge.

Avoiding the rigidity of the Frye standard, which was so rigid that it was virtually never applied, certainly seems like a worthwhile judicial goal. But how do courts go from the Justice Blackmun’s “liberal thrust” to infer a libertine “anything goes”? And why does liberal not connote seeking of the truth, free of superstitions? Can it be liberal to permit opinions that are based upon fallacious or flawed inferences, invalid studies, or cherry-picked data sets?

In reviewing the many judicial dodges that are used to avoid engaging in meaningful Rule 702 gatekeeping, I am mindful of Reporter Daniel Capra’s caveat that the ill-advised locutions used by judges do not necessarily mean that their decisions might not be completely justifiable on a carefully worded and reasoned opinion that showed that Rule 702 and all its subparts were met. Of course, we could infer that the conditions for admissibility were met whenever an expert witness’s opinions were admitted, and ditch the whole process of having judges offer reasoned explanations. Due process, however, requires more. Judges need to specify why they denied Rule 702 challenges in terms of the statutory requirements for admissibility so that other courts and the Bar can develop a principled jurisprudence of expert witness opinion testimony.

[1] See, e.g., In re Scrap Metal Antitrust Litig., 527 F.3d 517, 530 (6th Cir. 2008) (“‘[R]ejection of expert testimony is the exception, rather than the rule,’ and we will generally permit testimony based on allegedly erroneous facts when there is some support for those facts in the record.”) (quoting Advisory Committee Note to 2000 Amendments to Rule 702); Citizens State Bank v. Leslie, No. 6-18-CV-00237-ADA, 2020 WL 1065723, at *4 (W.D. Tex. Mar. 5, 2020) (rejecting challenge to expert witness opinion “not based on sufficient facts”; excusing failure to assess factual basis with statement that “the rejection of expert testimony is the exception rather than the rule.”); In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., No. 2:18-CV-00136, 2019 WL 6894069, at *2 (S.D. Ohio Dec. 18, 2019) (committing naturalistic fallacy; “[A] review of the case law … shows that rejection of the expert testimony is the exception rather than the rule.”): Frankenmuth Mutual Insur. Co. v. Ohio Edison Co., No. 5:17CV2013, 2018 WL 9870044, at *2 (N.D. Ohio Oct. 9, 2018) (quoting Advisory Committee Note “exception”); Wright v. Stern, 450 F. Supp. 2d 335, 359–60 (S.D.N.Y. 2006)(“Rejection of expert testimony, however, is still ‘the exception rather than the rule,’ Fed.R.Evid. 702 advisory committee’s note (2000 Amendments)[.] . . . Thus, in a close case the testimony should be allowed for the jury’s consideration.”) (internal quotation omitted).

[2] Lombardo v. Saint Louis, No. 4:16-CV-01637-NCC, 2019 WL 414773, at *12 (E.D. Mo. Feb. 1, 2019) (“[T]he Court will err on the side of admissibility.”).

[3] Mason v. CVS Health, 384 F. Supp. 3d 882, 891 (S.D. Ohio 2019).

[4] Frankenmuth Mutual Insur. Co. v. Ohio Edison Co., No. 5:17CV2013, 2018 WL 9870044, at *2 (N.D. Ohio Oct. 9, 2018) (concluding “[a]lthough it is a very close call, the Court declines to exclude Churchwell’s expert opinions under Rule 702.”); In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., No. 2:18-CV-00136, 2019 WL 6894069, at *2 (S.D. Ohio Dec. 18, 2019) (suggesting doubts should be resolved in favor of admissibility).

[5] Rovid v. Graco Children’s Prod. Inc., No. 17-CV-01506-PJH, 2018 WL 5906075, at *13 (N.D. Cal. Nov. 9, 2018), app. dism’d, No. 19-15033, 2019 WL 1522786 (9th Cir. Mar. 7, 2019).

[6] Alsadi v. Intel Corp., No. CV-16-03738-PHX-DGC, 2019 WL 4849482, at *4 -*5 (D. Ariz. Sept. 30, 2019).

[7] Daubert v. Merrell Dow Pharms., Inc. 509 U.S. 579, 588 (1993).

[8] In re ResCap Liquidating Trust Litig., No. 13-CV-3451 (SRN/HB), 2020 WL 209790, at *3 (D. Minn. Jan. 14, 2020) (“Courts generally support an attempt to liberalize the rules governing the admission of expert testimony, and favor admissibility over exclusion.”)(internal quotation omitted); Collie v. Wal-Mart Stores East, L.P., No. 1:16-CV-227, 2017 WL 2264351, at *1 (M.D. Pa. May 24, 2017) (“Rule 702 embraces a ‘liberal policy of admissibility’, under which it is preferable to admit any evidence that may assist the factfinder[.]”); In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007); Billone v. Sulzer Orthopedics, Inc., No. 99-CV-6132, 2005 WL 2044554, at *3 (W.D.N.Y. Aug. 25, 2005) (“[T]he Supreme Court has emphasized the ‘liberal thrust’ of Rule 702, favoring the admissibility of expert testimony.”).

[9] Federal Rule of Evidence Rule 102 (“Purpose and Construction”) (emphasis added).

Posted in Evidence, Rule 702, Scientific Evidence | Comments Off on Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent

Judicial Dodgers – Weight not Admissibility

May 28th, 2020

Another vacuous response to a methodological challenge under Rule 702 is to label the challenge as “going to the weight, not the admissibility” of the challenged expert witness’s testimony. Of course, a challenge may be solely focused upon the expert witness’s credibility, such as when an expert witness testifies on many occasions only for one side in similar disputes, or for one whose political commitments render him unable to acknowledge the bona fides of any studies conducted by the adversarial parties.[1] If, however, the Rule 702 challenge stated an objection to the witness’s methodology, then the objection would count against both the opinion’s weight and its admissibility. The judicial “weight not admissibility” label conveys the denial of the challenge, but it hardly explains how and why the challenge failed under Rule 702. Applying such a label without addressing the elements of Rule 702, and how the challenged expert witness satisfied those elements, is often nothing less than a failure of judging.

The Flawed Application of a Generally Accepted Methodology

If a meretricious expert witness by pretense or ignorance invokes a standard methodology but does so in a flawed or distorted, or in an invalid way, then there will be a clear break in the chain of inferences from data to conclusion. The clear language of Rule 702 should render such an expert witness’s conclusion inadmissible. Some courts, however, retreat into a high level of generality about the method used rather than inspecting the method as applied. For example, a court might look at an expert witness’s opinion and correctly find that it relied upon epidemiology, and that epidemiology is a generally accepted discipline concerned with identifying causes. The specific detail of the challenge may have shown that the witness had relied upon a study that was thoroughly flawed,[2] or that the witness relied upon an epidemiologic study of a type that cannot support a causal inference.[3]

Rule 702 and the Supreme Court’s decision in Joiner make clear that the trial court must evaluate the expert witness’s application of methodology and whether it actually supports valid inferences leading to the witness’s claims and conclusions.[4] And yet, lower courts continue to characterize the gatekeeping process as “hands off” the application of methodology and conclusions:

“Where the court has determined that plaintiffs have met their burden of showing that the methodology is reliable, the expert’s application of the methodology and his or her conclusions are issues of credibility for the jury.”[5]

This rejection of the clear demands of a statute has infected even the intermediate appellate United States Court of Appeals. In a muddled application of Rule 702, the Third Circuit approved admitting expert witness testimony in a case, explaining “because [the objecting party / plaintiff] objected to the application rather than the legitimacy of [the expert’s] methodology, such objections were more appropriately addressed on cross-examination and no Daubert hearing was required”).[6] Such a ruling in the Third Circuit is especially jarring because it violates not only the clear language of Rule 702, but also established precedent within the Circuit that holds that “any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.”[7]

The Eight Circuit seems to have set itself up stridently against the law by distinguishing between scientific methodologies and their applications, and holding that “when the application of a scientific methodology is challenged as unreliable under Daubert and the methodology itself is otherwise sufficiently reliable, outright exclusion of the evidence in question is warranted only if the methodology was so altered by a deficient application as to skew the methodology itself.”[8]

The Ninth Circuit similarly has followed this dubious distinction between methodology in the abstract and methodology as applied. In City of Pomona, the Circuit addressed the admissibility of an expert witness whose testing deviated from protocols. Relying upon pre-2000 Ninth Circuit case law, decided before the statutory language of Rule 702 was adopted, the court found that:

“expert evidence is inadmissible where the analysis is the result of a faulty methodology or theory as opposed to imperfect execution of laboratory techniques whose theoretical foundation is sufficiently accepted in the scientific community to pass muster under Daubert.”[9]

The Eleventh Circuit has similarly disregarded Rule 702 by adverting to an improvised distinction between validity of methodology and flawed application of methodology.[10]

Cherry Picking and Inadequate Bases

Most of the Circuits of the United States Court of Appeals have contributed to the mistaken belief that “[a]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility.”[11] Clearly, such questions can undermine the admissibility of an expert witness’s opinion under Rule 702, and courts need to say why they have found the challenged opinion to have had a “sufficient basis.” For example, in the notorious Milward case, the First Circuit, citing legally invalid pre-Daubert decisions, stated that “when the factual underpinning of an expert’s opinion is weak it is a matter affecting the weight and credibility of the testimony − a question to be resolved by the jury.”[12]

After Milward, the Eighth Circuit followed suit in a hormone replacement therapy case. An expert who ignored studies was excluded by the district court, but the Court of Appeals found an abuse of discretion, holding that the sufficiency of an expert’s basis is a question of weight and not admissibility.[13]

These rulings elevate form over substance by halting the gatekeeping inquiry at an irrelevant, high level of abstraction, and finding that the challenged expert witness was doing something “sciencey,” which is good enough for government work. The courts involved evaded their gatekeeping duties and ignored the undue selectivity in reliance materials and the inadequacy and insufficiency of the challenged expert witness’s factual predicate. The question is not whether expert witnesses relied upon “scientific studies,” but whether their causal conclusions and claims are well supported, under scientific standards, by the studies upon which they relied.

Like the covert shifting of the burden of proof, or the glib assessment that the loser can still cross-examine in front of the jury,[14] the rulings discussed represent another way that judges kick the can on Rule 702 motions. Despite the confusing verbiage, these judicial rulings are a serious deviation from the text of Rule 702, as well as the Advisory Committee Note to the 2000 Amendments, which embraced the standard articulated in In re Paoli, that

“any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.”[15]

On a positive note, some courts have recognized that responding with the conclusory assessment of a challenge’s going to weight not admissibility is a delegation of the court’s gatekeeping duty to the jury.[16]

In 2018, Professor Daniel Capra, the Reporter to the Rules Committee addressed the “weight not admissibility dodge” at length in his memorandum to the Rules Committee:

“Rule 702 clearly states that these are questions of admissibility, but many courts treat them as questions of weight. The issue for the Committee is whether something/anything can be done about these wayward decisions.”[17]

The Reporter charitably noted that the problem could be in the infelicitous expression of some courts that short-circuit their analyses by saying “I see the problems, but they go to the weight of the evidence.”[18] Perhaps these courts meant to say that they had found that the proponent of the challenged expert witness testimony had shown admissibility by a preponderance, and that what non-disqualifying problems remained should be taken up on cross-examination.[19] The principle of charity, however, cannot exonerate federal judges from exercising the dodge repeatedly in the face of clear statutory language. Indeed, the Reporter reaffirmed the Rules Committee’s substantive judgment that questions of sufficient basis and reliable application of methodology are admissibility issues:[20]

“It is hard to see how expert testimony is reliable if the expert has not done sufficient investigation, or has cherry-picked the data, or has misapplied the methodology. The same ‘white lab coat’ problem − that the jury will not be able to figure out the expert’s missteps − would seem to apply equally to basis, methodology and application.”

Although the Reporter opined that some authors may have overstated judicial waywardness, he found the judicial disregard of the requirements of Rule 702(b) and (d) incontrovertible.[21]

Professor Capra restated his conclusions a year later, in 2019, when he characterized broad statements such as such as “challenges to the sufficiency of an expert’s basis raise questions of weight and not admissibility” as “misstatement[s] made by circuit courts in a disturbing number of cases… .”[22] Factual insufficiency and unreliable application of methodology are, of course, also credibility and ethical considerations, but they are the fact finders’ concern only after the proponent has shown admissibility by a preponderance of the evidence. Principled adjudication requires judges to say what they mean and mean what they say.

[1] See also Cruz-Vazquez v. Mennonite Gen. Hosp. Inc., 613 F.3d 54 (1st Cir. 2010) (reversing exclusion of an expert witness who was biased in favor of plaintiffs in medical cases and who was generally affiliated with plaintiffs’ lawyers; such issues of personal bias are for the jury in assessing the weight of the expert witness’s testimony). Another example would be those expert witnesses whose commitment to Marxist ideology is such that they reject any evidence proffered by manufacturing industry as inherently corrupt, while embracing any evidence proffered by labor or the lawsuit industry without critical scrutiny.

[2] In re Phenylpropanolamine (PPA) Prods. Liab. Litig., MDL No. 1407, 289 F. Supp. 2d 1230 (W.D. Wash. 2003) (Yale Hemorrhagic Stroke Project).

[3] Cook v. Rockwell Internat’l Corp., 580 F. Supp. 2d 1071, 1098 (D. Colo. 2006) (“Defendants next claim that Dr. Clapp’s study and the conclusions he drew from it are unreliable because they failed to comply with four factors or criteria for drawing causal interferences from epidemiological studies: accounting for known confounders … .”), rev’d and remanded on other grounds, 618 F.3d 1127 (10th Cir. 2010), cert. denied, ___ U.S. ___, 133 S.Ct. 22 (2012). For another example of a trial court refusing to see through important qualitative differences between and among epidemiologic studies, see In re Welding Fume Prods. Liab. Litig., 2006 WL 4507859, *33 (N.D. Ohio 2006) (reducing all studies to one level, and treating all criticisms as though they rendered all studies invalid)

[4] General Electric Co. v. Joiner, 522 U.S. 136 (1997).

[5] Proctor & Gamble Co. v. Haugen, 2007 WL 709298, at *2 (D. Utah 2007); see also United States v. McCluskey, 954 F.Supp.2d 1227, 1247-48 (D.N.M. 2013) (“the trial judge decides the scientific validity of underlying principles and methodology” and “once that validity is demonstrated, other reliability issues go to the weight − not the admissibility − of the evidence”); Murphy-Sims v. Owners Ins. Co., No. 16-CV-0759-CMA-MLC, 2018 WL 8838811, at *7 (D. Colo. Feb. 27, 2018) (“Concerns surrounding the proper application of the methodology typically go to the weight and not admissibility[.]”).

[6] Walker v. Gordon, 46 F. App’x 691, 696 (3rd Cir. 2002).

[7] In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994).

[8] United States v. Gipson, 383 F.3d 689, 696 (8th Cir. 2004)(relying upon pre-2000 authority for this proposition).

[9] City of Pomona v. SQM N.Am. Corp. 750 F.3d 1036, 1047 (9th Cir. 2014).

[10] Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1343 (11th Cir. 2003).

[11] Puga v. RCX Sols., Inc., 922 F.3d 285, 294 (5th Cir. 2019). See also United States v. Hodge, 933 F.3d 468, 478 (5th Cir. 2019)(“As a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility and should be left for the jury’s consideration.”); MCI Communications Service Inc. v. KC Trucking & Equip. LLC, 403 F. Supp. 3d 548, 556 (W.D. La. 2019); Coleman v. United States, No. SA-16-CA-00817-DAE, 2017 WL 9360840, at *4 (W.D. Tex. Aug. 16, 2017); Alvarez v. State Farm Lloyds, No. SA-18-CV-01191-XR, 2020 WL 734482, at *3 (W.D. Tex. Feb. 13, 2020)(“To the extent State Farm wishes to attack the ‘bases and sources’ of Dr. Hall’s opinion, such questions affect the weight to be assigned to that opinion rather than its admissibility and should also be left for the jury’s consideration.”)(internal quotation and citation omitted); Patenaude v. Dick’s Sporting Goods, Inc., No. 9:18-CV-3151-RMG, 2019 WL 5288077, at *2 (D.S.C. Oct. 18, 2019) (“More fundamentally, each of these arguments goes to the factual basis of the report, … and it is well settled that the factual basis for an expert opinion generally goes to weight, not admissibility.”); Wischermann Partners, Inc. v. Nashville Hosp. Capital LLC, No. 3:17-CV-00849, 2019 WL 3802121, at *3 (M.D. Tenn. Aug. 13, 2019) (“[A]rguments that Pinkowski’s opinions are unreliable because he failed to review other relevant information and ignored certain facts bear on the factual basis for Pinkowski’s opinions, and, therefore, go to the weight, rather than the admissibility, of Pinkowski’s testimony.”).

[12] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 22 (1st Cir. 2011) (internal citations omitted), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012).

[13] Kuhn v. Wyeth, Inc., 686 F.3d 618, 633 (8th Cir. 2012): Kuhn v. Wyeth, Inc., 686 F.3d 618, 633 (8th Cir. 2012), rev’g Beylin v. Wyeth, 738 F.Supp. 2d 887, 892 (E.D.Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.) (excluding proffered testimony of Dr. Jasenka Demirovic who appeared to have “selected study data that best supported her opinion, while downplaying contrary findings or conclusions.”); see United States v. Finch, 630 F.3d 1057 (8th Cir. 2011) (the sufficiency of the factual basis for an expert’s testimony goes to credibility rather than admissibility, and only where the testimony “is so fundamentally unsupported that it can offer no assistance to the jury must such testimony be excluded”); Katzenmeier v. Blackpowder Prods., Inc., 628 F.3d 948, 952 (8th Cir. 2010)(“As a general rule, the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination.”); Paul Beverage Co. v. American Bottling Co., No. 4:17CV2672 JCH, 2019 WL 1044057, at *2 (E.D. Mo. Mar. 5, 2019) (admitting challenged opinion testimony without addressing the expert witness’s basis or application of methodology, following Eighth Circuit’s incorrect statement in Nebraska Plastics, Inc. v. Holland Colors Americas, Inc., 408 F.3d 410, 416 (8th Cir. 2005) that “[a]s a general rule, the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination[,]”). See also “The Fallacy of Cherry Picking As Seen in American Courtrooms” (May 3, 2014).

[14] See “Judicial Dodgers – Reassigning the Burden of Proof on Rule 702” (May 13, 2020); “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020).

[15] Fed. R. Evid. 702, Advisory Note (quoting In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994)).

[16] See Nease v. Ford Motor Co., 848 F.3d 219, 231 (4th Cir. 2017) (“For the district court to conclude that Ford’s reliability arguments simply ‘go to the weight the jury should afford Mr. Sero’s testimony’ is to delegate the court’s gatekeeping responsibility to the jury.”).

[17] Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702, at 1-2 (Apr. 1, 2018)

[18] Id. at 43.

[19] Id. at 43, 49-50.

[20] Id. at 49-50.

[21] Id. at 52.

[22] Daniel J. Capra, Reporter, Reporter’s Memorandum re Possible Amendments to Rule 702, Advisory Comm. on Evidence Rules, Minutes of Meeting at 23 (May 3, 2019).

Posted in Rule 702, Uncategorized | Comments Off on Judicial Dodgers – Weight not Admissibility

SKAPPOLOGY

May 26th, 2020

The Genetic Literacy Project (GLP) asks:

“Who is David and who is Goliath in the lobbying battle over agricultural biotechnology? Activists? Agro-business? In a commitment to transparency, the GLP has mined 5 years of data to help the public understand the funding network that shapes the biotechnology debate.”

The amount of money flowing into the campaign against genetically modified organisms (GMOs) is astonishing, but it does not stop the hypocritical complaints against industry’s sponsorship of studies to help show the safety of GMOs. In a recent on-line article, the GLP has published charts to map contributions from not-for-profit non-governmental organizations to anti-biotechnology advocacy groups. Close to a billion dollars ($850M) flowed into the coffers of these organizations from 2012 to 2016. The GLP’s work on tracking this funding is commendable for bringing balance to the debate about the effect of corporate money on health and environmental issues. Corporate includes the lawsuit industry and the advocacy industries.

Well actually, it would be a wonderful world if the GLP’s tracking were unnecessary. In one such alternative universe, people would ask to examine the evidence for and against claims, and they would have a healthy respect for uncertainty.

Studies funded by parties are routinely relied upon in litigation, and they are often pivotal in how courts decide significant claims of environmental or occupational harm.[1] Unfortunately, the sponsorship of studies by plaintiffs’ counsel, third-party litigation funding entities, and advocacy groups is often obscured or hidden.

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

I recently happened upon an article of interest in an obscure journal, by a well-known author.[2] The author, John C. Bailar, formerly an Editor-in-Chief of the Journal of the National Cancer Institute, was professor emeritus in the University of Chicago’s Department of Public Health Sciences. He died in September 2016. Bailar was a graduate of the Yale University medical school, and also held a doctorate in statistics.

There is nothing ground breaking in Bailar’s article, but it is a nice summary of the ways that errors can creep into the scientific literature, short of actual fabrication or falsification of data.[3] It is also worth reading because it is an article that comes from one of the several Coronado Conferences, sponsored by an advocacy organization that has fraudulently concealed its funding, The Project on Scientific Knowledge and Public Policy, aka SKAPP.

To be sure, authors of SKAPP-funded articles have invariably cited their funding from SKAPP, and Bailar was no exception. Bailar made the following acknowledgements:

“Support for this paper was provided by The Project on Scientific Knowledge and Public Policy (SKAPP) at The George Washington University School of Public Health and Health Services. It is revised from a paper presented at SKAPP’s March 2006 Coronado Conference “Truth and Advocacy: The Quality and Nature of Litigation and Regulatory Science.” The papers from that conference will be published elsewhere.”[4]

The acknowledgement of support was rather anemic by SKAPP standards. Most SKAPP-funded articles recited something closer to the following provided by David Michaels, who headed up SKAPP and worked as an expert witness for the litigation industry, until becoming the Administrator of the Occupational Health & Safety Administration, in President Obama’s administration:[5]

“DM [David Michaels] and CM [Celeste Monforton] are employed by the George Washington University School of Public Health and Health Services as part of the Project on Scientific Knowledge and Public Policy (SKAPP). Their salaries, in part, are funded by the Common Benefit Litigation Expense Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation. SKAPP’s funding is unrestricted; its funders are not given advance notice or the opportunity to review or approve any documents produced by the project. PL [Peter Lurie] is with Public Citizen’s Health Research Group.”

Michaels’ statement was perhaps a little more forthcoming, but few scientists or lay persons would know that his salary, and support, came from plaintiffs’ lawyers as part of an active litigation effort. Although Michaels claimed that the funding was unrestricted, like Big Tobacco funding, the sponsor, plaintiffs’ counsel, created a substantial selection effect in choosing beneficiaries who would deliver its pre-approved message. The Common Benefit Trust may sound like an eleemosynary, public-spirited, organization, with the imprimatur of the federal court system. It was not.

Was Bailar influenced by his source of funding? His topic would have permitted him many examples from the annals of science or litigation, but interestingly one of the few examples Bailar chose to give details about was a scientific dispute between the semiconductor industry and Richard Clapp, who was acting as an expert witness in litigation against that industry. Although Clapp used a study design known to be inaccurate and biased, Bailar touted Clapp’s research over that sponsored by members of the industry. Richard Clapp, in addition to have been an expert witness for the litigation industry on many occasions, also happened to have been a member of the SKAPP’s advisory committee. Hmmm.

Whence comes SKAPP funding? SKAPP trades on most readers’ lack of familiarity with how “common benefit funds” are established. They sound like some sort of disembodied charitable trust, such as the Pew. In fact, the silicone common benefit trust was nothing more than a funding device for mass federal litigation involving silicone breast implants. Ironically, the funding came from a litigation in which one leading judge described plaintiffs’ expert witnesses as “charlatans,” and the litigation claims as largely based upon fraud.[6] Cynics might believe that Bailar’s choice of Clapp versus the semiconductor industry, regardless of the merits, was driven by a desire to please SKAPP & Clapp.

The common benefit fund for the silicone-gel breast implant litigation was created by Order 13, “Establishing Plaintiffs’ Litigation Expense Fund to Compensate and Reimburse Attorneys for Services Performed and Expenses Incurred for Common Benefit.” The late Judge Sam Pointer, appointed to preside over MDL 926, In re Silicone Gel Breast Implants Products Liability Litigation, Master File No. CV 92-P-10000-S, entered the order on July 23, 1993. Some of the pertinent terms of Order 13 illustrate how it was supposed to operate:

This order is entered in order to provide for the fair and equitable sharing among plaintiffs of the cost of special services performed and expenses incurred by attorneys acting for the common benefit of all plaintiffs.

Plaintiffs’ Litigation Expense Fund to be Established. Plaintiffs’ National Liaison Counsel … are directed to establish an interest-bearing account to receive and disburse funds as provided in this order.

***

Assessment.

(a)    All plaintiffs and their attorneys who, after this date, either agree — for a monetary consideration — to settle, compromise, dismiss, or reduce the amount of a claim or, with or without a trial, recover a judgment for monetary damages or other monetary relief, including both compensatory and punitive damages, with respect to a breast implant claim are hereby assessed:

(1)    5% of the “gross monetary recovery,” if the agreement is made or the judgment is entered after this date and before November 1, 1993, or

(2)    6% of the “gross monetary recovery,” if the agreement is made or the judgment is entered after October 31, 1993.

Defendants are directed to withhold this assessment from amounts paid to plaintiffs and their counsel, and to pay the assessment into the fund as a credit against the settlement or judgment. ***

Disbursements.

(a)    Payments may be made from the fund to attorneys who provide services or incur expenses for the joint and common benefit of plaintiffs in addition to their own client or clients. Attorneys eligible are not limited to Plaintiffs’ National Liaison Counsel and members of Plaintiffs’ National Steering Committee, but include, for example, other attorneys called upon by them to assist in performing their responsibilities, State Liaison Counsel, and other attorneys performing similar responsibilities in state court actions in which the presiding state-court judge has imposed similar obligations upon plaintiffs to contribute to the fund.

(b)    Payments will be allowed only to compensate for special services performed, and to reimburse for special expenses incurred, for the joint and common benefit of all plaintiffs.

***

(c)    No amounts will be disbursed without review and approval by a committee of federal and state judicial officers to be designated by the court. The committee may, however, utilize the services of a special master to assist in this review, and may authorize one or more of its members to act for the committee in approving particular types of applications for disbursement.

(d)    If the fund exceeds the amount needed to make payments as provided in this order, the court will order an refund to those who have contributed to the fund. Any such refund will be made in proportion to the amount of the contributions.”

For a while, a defense lawyer, representing the defendants in the silicone MDL, participated in discussions concerning MDL 926 Order 13 funds, until the plaintiffs’ lawyers decided that his services were not needed, and excluded him from discussions of the use of the monies. The reality is that the plaintiffs’ lawyers in the silicone litigation were able to bamboozle the slim oversight committee into approving a propaganda campaign against Daubert gatekeeping, and that recipients of the plaintiffs’ lawyers’ largesse were able to misrepresent their funding as though it were from a federal court.

There are further ironies connected with the silicone common benefit trust. First, the silicone litigation was effectively over when the court-appointed expert witnesses’ reports that announced that the plaintiffs’ expert witnesses lacked sound scientific evidence to support conclusions of causation. SKAPP’s website reports that its activities started around 2002, by which time both the court-appointed witnesses, as well as the British Ministry of Health, and the Institute of Medicine’s select committee had reported that there was no basis for the plaintiffs’ causal claims in litigation.[7] The second irony is that SKAPP, through its sponsorship of various research and writing projects, had made the recipients of SKAPP money, by the terms of Order 13, agents of the silicone plaintiffs’ lawyers and their clients. Recipients of SKAPP funding who did not disclose that their support or salaries come from the coffers of plaintiffs’ counsel were engaged in misleading their readers and the scientific and legal communities.

I have written often in the past about SKAPP as an agent of plaintiffs’ counsel in mass tort litigation.[8] The concern is not new, but it has continuing significance because of the asymmetrical standard advanced by the lawsuit industry and its scientific advisors who seek to disqualify manufacturing industry and its scientific advisors from participating in scientific debate and argument about various health claims.[9]

[1] See, e.g., Leaf River Forest Prods. v. Ferguson, 662 So. 2d 648, 657 (Miss. 1995) (litigation involving defense expert witness’s reliance upon dioxin studies funded by defendant paper mills); Maurer v. Heyer-Schulte Corp., No. Civ. A. 92-3485, 2002 WL 31819160 at *3 (E.D. La. Dec. 13, 2002) (granting defendant’s summary judgment against plaintiff’s claim that breast implants caused her harm; citing defendants’ sponsored epidemiologic studies showing no causal link, including epidemiologic study conducted in Sweden); Nat’l Res. Def. Council v. Evans, 232 F. Supp. 2d 1003, 1013 (N.D. Cal. 2002) (“commend[ing] defendants’ sponsorship of independent scientific research…”); FTC v. Pantron I, Corp., 1991 U.S. Dist. LEXIS 21858 (C.D. Cal. Sept 6, 1991) (finding study funded by defendants met “basic and fundamental requirements for scientific validity and reliability”).

[2] John C. Bailar, “How to distort the scientific record without actually lying: truth, and the arts of science,” 11 European J. Oncol. 217 (2006).

[3] Id. at 218.

[4] Id. at 223.

[5] David Michaels, Celeste Monforton & Peter Lurie, “Selected science: an industry campaign to undermine an OSHA hexavalent chromium standard,” 65 Envt’l Health 5 (2006).

[6] Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009).

[7] Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8, 22-23 (July 1998) (concluding that there was no demonstrable risk of connective tissue disease from silicone breast implants); Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999) (rejecting plaintiffs’ theories and litigation claims of systemic disease).

[8] “SKAPP A LOT” (April 30, 2010); “Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013). See also Walter Olson, Schools for Misrule: Legal Academia and an Overlawyered America 121-22 (2011); David E. Bernstein & Eric G. Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1, 39 & n.211 (2015); Ted Frank, “Daubert Debate,” Overlawyered (July 5, 2003); Peter Nordberg, “Bernstein on SKAPP (part 1),” Daubert on the Web (Jul)y 02, 2003).

[9] Consider the media hysteria over former President Obama’s nomination of Dr. Robert Califf, to serve as Chair of the Food and Drug Administration.[9] The criticism was based upon his having served as the founding director of the Duke Clinical Research Institute, which received funding directly from pharmaceutical companies. The Senate confirmed Califf (89 to 4), but the controversy highlights the hypocrisy in play. Brady Dennis, “Senate confirms Robert Califf as new FDA commissioner,” Wash. Post (Feb. 24, 2016).

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Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

May 13th, 2020

Explaining the denial of a Rule 702 motion in terms of the availability of cross-examination is just one among several dodges that judges use to avoid fully engaging with Rule 702’s requirements.[1] Another dodge involves shifting the burden of proof on admissibility from the proponent of the challenged expert witness to the challenger. This dodgewould appear to violate well-established law.

The Supreme Court, in deciding Daubert, made clear that the question whether an expert witness’s opinion was admissible was governed under the procedure set out in Federal Rule of Evidence 104(a).[2] The significance of placing the Rule 702 issues under the procedures set out in Rule 104(a) is that the trial judge must make the admissibility determination, and that he or she is not bound by the rules of evidence. The exclusion of the admissibility determination from the other rules of evidence means that trial judges can look at challenged expert witnesses’ relied-upon materials, and other facts, data, and opinions, regardless of these materials’ admissibility. The Supreme Court also made clear that the admissibility of an expert witness’s opinion testimony should be shown “by a preponderance of proof.”[3] Every court that has directly addressed the burden of proof issue in a Rule 702 challenge to expert witness testimony has clearly assigned that burden to the proponent of the testimony.[4]

Trial courts intent upon evading gatekeeping responsibility, however, have created a presumption of admissibility. When called upon to explain why they have denied Rule 702 challenges, these courts advert to the presumption as an explanation and justification for the denial.[5] Some courts even manage to discuss the burden of proof upon the proponent, and a presumption of admissibility, in almost the same breath.[6]

In his policy brief for amending Rule 702, Lee Mickus traces the presumption innovation to Borawick v. Shay, a 1995 Second Circuit decision that involved a challenge to hypnotically refreshed (or created) memory.[7] In Borawick, the Court of Appeals held that the plaintiff’s challenge turned upon whether Borawick’s testimony was competent or admissible, and that it did not involve the “the admissibility of data derived from scientific techniques or expert opinions.”[8] Nevertheless, in dicta, the court observed that “by loosening the strictures on scientific evidence set by Frye, Daubert reinforces the idea that there should be a presumption of admissibility of evidence.”[9]

Presumptions come in different forms and operate differently, and this casual reference to a presumption in dictum could mean any number of things. A presumption of admissibility could mean simply that unless there is a challenge to an expert witness’s opinion, the opinion is admissible.[10] The presumption could be a bursting-bubble (Thayer) presumption, which disappears once the opponent of the evidence credibly raises questions about the evidence’s admissibility. The presumption might be something that does not disappear, but once the admissibility is challenged, the presumption continues to provide some evidence for the proponent. And in the most extreme forms, the (Morgan) presumption might be nothing less than a judicially artful way of saying that the burden of proof is shifted to the opponent of the evidence to show inadmissibility.[11]

Although Borawick suggested that there should be a presumption, it did not exactly hold that one existed. A presumption in favor of the admissibility of evidence raises many questions about the nature, definition, and operation of the presumption. It throws open the question what evidence is needed to rebut the presumption. For instance, may a party whose expert witness is challenged not defend the witness’s compliance with Rule 702, stand on the presumption, and still prevail?

There is no mention of a presumption in Rule 702 itself, or in any Supreme Court decision on Rule 702, or in the advisory committee notes. Inventing a presumption, especially a poorly described one, turns the judicial discretion to grant or deny a Rule 702 challenge into an arbitrary decision.

Most importantly, given the ambiguity of “presumption,” a judicial opinion that denies a Rule 702 challenge by invoking a legal fiction fails to answer the question whether the proponent of the expert witness has carried the burden of showing that all the subparts of Rule 702 were satisfied by a preponderance of the evidence. While judges may prefer not to endorse or disavow the methodology of an otherwise “qualified” expert witness, their office requires them to do so, and not hide behind fictional presumptions.

1

[1] “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020).

[2] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592 n.10 (1993).

[3] Id., citing Bourjaily v. United States, 483 U. S. 171, 175-176 (1987).

[4] Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir. 2010) (quoting Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir. 2006)); Beylin v. Wyeth, 738 F. Supp. 2d 887 (E.D. Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.); Pride v. BIC Corp., 218 F.3d 566, 578 (6th Cir. 2000); Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 742 (S.D. Ohio 2007).

[5] See, e.g., Cates v. Trustees of Columbia Univ. in City of New York, No. 16CIV6524GBDSDA, 2020 WL 1528124, at *6 (S.D.N.Y. Mar. 30, 2020) (discussing presumptive admissibility); Price v. General Motors, LLC, No. CIV-17-156-R, 2018 WL 8333415, at *1 (W.D. Okla. Oct. 3, 2018) (“[T]here is a presumption under the Rules that expert testimony is admissible.”)(internetal citation omitted); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“The Second Circuit has made clear that Daubert contemplates liberal admissibility standards, and reinforces the idea that there should be a presumption of admissibility of evidence.”); Advanced Fiber Technologies (AFT) Trust v. J & L Fiber Services, Inc., No. 1:07-CV-1191, 2015 WL 1472015, at *20 (N.D.N.Y. Mar. 31, 2015) (“In assuming this [gatekeeper] role, the Court applies a presumption of admissibility.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *2 (S.D.N.Y. Jan. 22, 2015) (“[T]he court should apply ‘a presumption of admissibility’ of evidence” in carrying out the gatekeeper function.); Martinez v. Porta, 598 F. Supp. 2d 807, 812 (N.D. Tex. 2009) (“Expert testimony is presumed admissible”).

[6] S.E.C. v. Yorkville Advisors, LLC, 305 F. Supp. 3d 486, 503-04 (S.D.N.Y. 2018) (“The party seeking to introduce the expert testimony bears the burden of establishing by a preponderance of the evidence that the proffered testimony is admissible. There is a presumption that expert testimony is admissible … .”) (internal citations omitted).

[7] Borawick v. Shay, 68 F.3d 597, 610 (2d Cir. 1995), cert. denied, 517 U.S. 1229 (1996).

[8] Id.

[9] Id. (referring to Frye v. United States, 293 F. 1013 (D.C.Cir.1923)).

[10] In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007) (Weinstein, J.) (“Since Rule 702 embodies a liberal standard of admissibility for expert opinions, the assumption the court starts with is that a well-qualified expert’s testimony is admissible.”).

[11] See, e.g., Orion Drilling Co., LLC v. EQT Prod. Co., No. CV 16-1516, 2019 WL 4273861, at *34 (W.D. Pa. Sept. 10, 2019) (after declaring that “[e]xclusion is disfavored” under Rule 702, the court flipped the burden of production and declared the opinion testimony admissible, stating “Orion has not established that incorporation of the data renders Ray’s opinion unreliable.”).

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Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions

May 11th, 2020

In my last post,[1] I praised Lee Mickus’s recent policy paper on amending Rule 702 for its persuasive force on the need for an amendment, as well as a source for helping lawyers anticipate common judicial dodges to a faithful application of the rule.[2] There are multiple dodges used by judicial dodgers, and it behooves litigants to recognize and anticipate them. In this post, and perhaps future ones, I elaborate upon the concerns that Mickus documents.

One prevalent judicial response to the Rule 702 motion is to kick the can and announce that the challenge to an expert witness’s methodological shenanigans can and should be addressed by crossexamination. This judicial response was, of course, the standard one before the 1993 Daubert decision, but Justice Blackmun’s opinion kept it alive in frequently quote dicta:

“Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.”[3]

Justice Blackmun, no doubt, believed he was offering a “helpful” observation here, but the reality is quite different. Traditionally, courts allowed qualified expert witnesses to opine with wild abandon, after showing that they had the very minimal qualifications required to do so in court. In the face of this traditional judicial lassitude, “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof” were all a litigant could hope to accomplish in litigation. Furthermore, the litany of remedies for “shaky but admissible evidence” fails to help lower court judges and lawyers sort shaky but admissible evidence from shaky and inadmissible evidence.

Perhaps even more to the point, cases at common law “traditionally” did not involve multivariate logistic regression, structural equation models, propensity score weighting, and the like. Juries did just fine on whether Farmer Brown had exercised due care when he ran over his neighbor’s cow with his tractor, or even when a physician opined that a child was born 350 days after the putative father’s death was sired by the testator and entitled to inherit from “dad.”

Mickus is correct that a trial judge’s comment that the loser of a Rule 702 motion is free to cross-examine is often a dodge, an evasion, or an outright failure to engage with the intricacies of a complex methodological challenge.[4] Stating that the “traditional and appropriate means of attacking shaky but admissible evidence” remain available is a truism, and might be offered as judicial balm to the motion loser, but the availability of such means is hardly an explanation or justification for denying the Rule 702 motion. Furthermore, Justice Blackmun’s observation about traditional means was looking back at an era when in most state and federal court, a person found to be minimally qualified, could pretty much say anything regardless of scientific validity. That was the tradition that stood in active need of reform when Daubert was decided in 1993.

Mickus is also certainly correct that the whole point of judicial gatekeeping is that the presentation of vive voce testimony before juries is not an effective method for revealing shaky, inadmissible opinion testimony. A few courts have acknowledged that cross-examination in front of a jury is not an appropriate justification for admitting methodologically infirm expert witness opinion testimony. In the words of Judge Jed Rakoff, who served on the President’s Council of Advisors on Science and Technology,[5] addressed the limited ability of cross-examination in the context of forensic evidence:

“Although effective cross-examination may mitigate some of these dangers, the explicit premise of Daubert and Kumho Tire is that, when it comes to expert testimony, cross-examination is inherently handicapped by the jury’s own lack of background knowledge, so that the Court must play a greater role, not only in excluding unreliable testimony, but also in alerting the jury to the limitations of what is presented.”[6]

Judge Rakoff’s point is by no means limited to forensic evidence, and it has been acknowledged more generally by Professor Daniel Capra, the Reporter to the Advisory Committee on Evidence Rules:

“the key to Daubert is that cross-examination alone is ineffective in revealing nuanced defects in expert opinion testimony and that the trial judge must act as a gatekeeper to ensure that unreliable opinions don’t get to the jury in the first place.”[7]

Juries do not arrive at the court house knowledgeable about statistical and scientific methods; nor are they prepared to spend weeks going over studies to assess their quality, and whether an expert witness engaged in cherry picking, misapplying methodologies, or insufficient investigation.[8] In discussing the problem of expert witnesses’ overstating the strength of their opinions, beyond what is supported by evidence, the Reporter stressed the limits and ineffectiveness of remedial adversarial cross-examination:

“Perhaps another way to think about cross-examination as a remedy is to compare the overstatement issue to the issues of sufficiency of basis, reliability of methodology, and reliable application of that methodology. As we know, those three factors must be shown by a preponderance of the evidence. The whole point of Rule 702 — and the Daubert-Rule 104(a) gatekeeping function — is that these issues cannot be left to cross-examination. The underpinning of Daubert is that an expert’s opinion could be unreliable and the jury could not figure that out, even given cross-examination and argument, because the jurors are deferent to a qualified expert (i.e., the white lab coat effect). The premise is that cross-examination cannot undo the damage that has been done by the expert who has power over the jury. This is because, for the very reason that an expert is needed (because lay jurors need assistance) the jury may well be unable to figure out whether the expert is providing real information or junk. The real question, then, is whether the dangers of overstatement are any different from the dangers of insufficient basis, unreliability of methodology, and unreliable application. Why would cross-examination be insufficient for the latter yet sufficient for the former?

It is hard to see any difference between the risk of overstatement and the other risks that are regulated by Rule 702. When an expert says that they are certain of a result — when they cannot be — how is that easier for the jury to figure out than if an expert says something like ‘I relied on four scientifically valid studies concluding that PCB’s cause small lung cancer’. When an expert says he employed a ‘scientific methodology’ when that is not so, how is that different from an expert saying “I employed a reliable methodology” when that is not so?”[9]

The Reporter’s example of PCBs and small lung cancer was an obvious reference to the Joiner case, in which the Supreme Court held that the trial judge had properly excluded causation opinions. The Reporter’s point goes directly to the cross-examination excuse for not shirking the gatekeeping function. In Joiner, the Court held that gatekeeping was necessitated when cross-examination was insufficient in the face of an analytical gap between methodology and conclusion.[10] Indeed, such gaps are or should be present in most well-conceived Rule 702 challenges.

The problem is not only that juries defer to expert witnesses. Juries lack the competence to assess scientific validity. Although many judges are lacking in such competence, at least litigants can expect them to read the Reference Manual on Scientific Evidence before they read the parties’ briefs and the expert witnesses’ reports. If the trial judge’s opinion evidences ignorance of the Manual, then at least there is the possibility of an appeal. It will be a strange day in a stranger world, when a jury summons arrives in the mail with a copy of the Manual!

The rules of evidence permit expert witnesses to rely upon inadmissible evidence, at least when experts in their field would do so reasonably. To decide whether the reliance is reasonable requires the decision maker go outside the “proofs” that would typically be offered at trial. Furthermore, the decision maker – gatekeeper – will have to read the relied-upon study and data to evaluate the reasonableness of the reliance. In a jury trial, the actual studies relied upon are rarely admissible, and so the jury almost never has the opportunity to read them to make its own determination of reasonableness of reliance, or of whether the study and its data really support what the expert witness draws from it.

Of course, juries do not have to write opinions about their findings. They need neither explain nor justify their verdicts, once the trial court has deemed that there is the minimally sufficient evidence to support a verdict. Juries, with whatever help cross-examination provides, in the absence of gatekeeping, cannot deliver anything approaching scientific due process of law.

Despite Supreme Court holdings, a substantially revised and amended Rule 702, and clear direction from the Advisory Committee, some lower courts have actively resisted enforcing the requirements of Rule. 702 Part of this resistance consists in pushing the assessment of the reliability of the data and assumptions used in applying a given methodology out of the gatekeeping column and into the jury’s column. Despite the clear language of Rule 702, and the Advisory Committee Note,[11] some Circuits of the Court of Appeals have declared that assessing the reliability of assumptions and data is not judges’ work (outside of a bench trial).[12]

As Seinfeld has taught us, rules are like reservations. It is not enough to make the rules, you have to keep and follow them. Indeed, following the rule is really the important part.[13] Although an amended Rule 702 might include a provision that “we really mean this,” perhaps it is worth a stop at the Supreme Court first to put down the resistance.

[1] “Should Federal Rule of Evidence 702 Be Amended?” (May 8, 2020).

[2] Lee Mickus, “Gatekeeping Reorientation: Amend Rule 702 to Correct Judicial Misunderstanding about Expert Evidence,” Washington Legal Foundation Critical Legal Issues Working Paper No. 217 (May 2020).

[3] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 596 (1993).

[4] See, e.g., AmGuard Ins. Co. v. Lone Star Legal Aid, No. CV H-18-2139, 2020 WL 60247, at *8 (S.D. Tex. Jan. 6, 2020) (“[O]bjections [that the expert could not link her experienced-based methodology to her conclusions] are better left for cross examination, not a basis for exclusion.”); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“To the extent Defendant argues that Mr. McPartland’s conclusions are unreliable, it may attack his report through cross examination.”); Wright v. Stern, 450 F. Supp. 2d 335, 359–60 (S.D.N.Y. 2006) (“In a close case, a court should permit the testimony to be presented at trial, where it can be tested by cross-examination and measured against the other evidence in the case.”) (internal citation omitted). See also Adams v. Toyota Motor Corp., 867 F.3d 903, 916 (8th Cir. 2017) (affirming admission of expert testimony, reiterating the flexibility of the Daubert inquiry and emphasizing that defendant’s concerns could all be addressed with “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof”); Liquid Dynamics Corp. v. Vaughan Corp., 449 F.3d 1209, 1221 (Fed. Cir. 2006) (“The identification of such flaws in generally reliable scientific evidence is precisely the role of cross-examination.” (internal citation omitted)); Carmichael v. Verso Paper, LLC, 679 F. Supp. 2d 109, 119 (D. Me. 2010) (“[W]hen the adequacy of the foundation for the expert testimony is at issue, the law favors vigorous cross-examination over exclusion.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *6 (S.D.N.Y. Jan. 22, 2015) (“In light of the ‘presumption of admissibility of evidence,’ that opportunity [for cross-examination] is sufficient to ensure that the jury receives testimony that is both relevant and reliable.”) (internal citation omitted).

Even the most explicitly methodological challenges are transmuted into cross-examination issues by refusnik courts. For instance, cherry picking is reduced to a credibility issue for the jury and not germane to the court’s Rule 702 determination. In re Chantix Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1288 (N.D. Ala. 2012) (finding that an expert witness’s deliberate decision not to rely upon clinical trial data merely “is a matter for cross-examination, not exclusion under Daubert”); In re Urethane Antitrust Litig., 2012 WL 6681783, at *3 (D.Kan.) (“The extent to which [an expert] considered the entirety of the evidence in the case is a matter for cross-examination.”); Bouchard v. Am. Home Prods. Corp., 2002 WL 32597992, at *7 (N.D. Ohio) (“If the plaintiff believes that the expert ignored evidence that would have required him to substantially change his opinion, that is a fit subject for cross-examination.”). Similarly, courts have by ipse dixit made flawed application of what a standard methodological into merely a credibility issue to be explore by cross-examination rather than by judicial gatekeeping. United States v. Adam Bros. Farming, 2005 WL 5957827, at *5 (C.D. Cal. 2005) (“Defendants’ objections are to the accuracy of the expert’s application of the methodology, not the methodology itself, and as such are properly reserved for cross-examination.”); Oshana v. Coca-Cola Co., 2005 WL 1661999, at *4 (N.D. Ill.) (“Challenges addressing flaws in an expert’s application of reliable methodology may be raised on cross-examination.”).

[5] President’s Council of Advisors on Science and Technology, Report to the President on Forensic Science in Criminal Courts: Ensuring Scientific Validity of Feature-Comparison Methods (Sept. 2016).

[6] United States v. Glynn, 578 F. Supp. 2d 567, 574 (S.D.N.Y. 2008) (Rakoff, J.)

[7] Daniel J. Capra, Reporter, Advisory Comm. on Evidence Rules, Minutes of Meeting at 23 (May 3, 2019) (comments of the Reporter).

[8] Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702 at 50 (April 1, 2018) (identifying issues such as insufficient investigation, cherry-picking data, or misapplying standard methodologies, as examples of a “white lab coat” problem resulting from juries’ inability to evaluate expert witnesses’ factual bases, methodologies, and applications of methods).

[9] Daniel J. Capra, Reporter, Advisory Comm. on Evidence Rules, Minutes of Meeting at 10-11 (Oct. 1, 2019) (comments of the Reporter on possible amendment of Rule 702) (internal citation to Joiner omitted).

[10] Id. at 11 n.5.

[11] See In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994) (calling for a close, careful analysis of the application of a proper methodology to every step in the case; “any step that renders the analysis unreliable renders the expert’s testimony inadmissible whether the step completely changes a reliable methodology or merely misapplies that methodology”).

[12] See, e.g., City of Pomona v. SQM North Am. Corp., 750 F.3d 1036, 1047 (9th Cir. 2014) (rejecting the Paoli any-step approach without careful analysis of the statute, the advisory committee note, or Supreme Court decisions); Manpower, Inc. v. Ins. Co. of Pa., 732 F.3d 796, 808 (7th Cir. 2013) (“[t]he reliability of data and assumptions used in applying a methodology is tested by the adversarial process and determined by the jury; the court’s role is generally limited to assessing the reliability of the methodology – the framework – of the expert’s analysis”); Bonner v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir. 2001) (“the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination”).

[13] Despite the clarity of the revised Rule 702, and the intent to synthesize Daubert, Joiner, Kumho Tire, and Weisgram, some courts have insisted that nothing changed with the amended rule. See, e.g., Pappas v. Sony Elec., Inc., 136 F. Supp. 2d 413, 420 & n.11 (W.D. Pa. 2000) (opining that Rule 702 as amended did not change the application of Daubert within the Third Circuit) (“The Committee Notes to the amended Rule 702 cite and discuss several Court of Appeals decisions that have properly applied Daubert and its progeny. Among these decisions are numerous cases from the Third Circuit. See Committee Note to 2000 Amendments to Fed. R.Evid. 702. Accordingly, I conclude that amended Rule 702 does not effect a change in the application of Daubert in the Third Circuit.”). Of course, if nothing changed, then the courts that take this position should be able to square their decisions with text of Rule 702, as amended in 2000.

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Should Federal Rule of Evidence 702 Be Amended?

May 8th, 2020

Almost 27 years have passed since the United States Supreme Court issued its opinion in Daubert.[1] The holding was narrow. The Court reminded the Bar that Federal Rule of Evidence 702 was a statute, and that courts were thus bound to read it as a statute. The plain language of Rule 702 had been adopted by the Court in 1972, and then enacted by Congress, to be effective on July 1, 1975. Absent from the enacted Rule 702 was the “twilight zone” test articulated by a lower federal court in 1923.[2] In the Daubert case, the defense erroneously urged the application of the twilight zone test. In the post-modern way, the plaintiffs urged the application of no test.[3] The Court held simply that the twilight zone test had not been incorporated in the statutory language of Rule 702. Instead, the Court observed that the plain language of the statute imposed “helpfulness” and epistemic requirements for admitting expert witness opinion testimony.

It took another two Supreme Court decisions to flesh out the epistemic requirements for expert witnesses’ opinions,[4] and a third decision in which the Court told the Bench and Bar that the requirements of Rule 702 are “exacting.”[5] After the Supreme Court had added significantly to Rule 702’s helpfulness and knowledge requirements, the Advisory Committee revised the rule in 2000, to synthesize and incorporate these four Supreme Court decisions, and scholarly thinking about the patho-epistemology of expert witness opinion testimony. The Committee revised Rule 702 again in 2011, but only on “stylistic” issues, without any intent to add to or subtract from the 2000 rule.

Not all judges got the memo, or bothered to read and implement the revised Rule 702, in 2000. At both the District Court and the Circuit levels, courts persisted, and continue to persist, in citing retrograde decisions that predate the 2000 amendment, and even predate the 1993 decision in Daubert. Even the Supreme Court, in a 2011 opinion that did not involve the interpretation of Rule 702, was misled by a Solicitor General’s amicus brief, into citing one of the most anti-science, anti-method, post-modern, pre-Daubert, anything-goes decisions.[6] The judicial resistance to Rule 702 is well documented in many scholarly articles,[7] by the Reporter to the Advisory Committee,[8] and in the pages of this and other blogs.

In 2015, when evidence scholar David Bernstein argued that Rule 702 required amending,[9] I acknowledged the strength of his argument, but resisted because of what I perceived to be the danger of opening up the debate in Congress.[10] Professor Bernstein and lawyer Eric Lasker detailed and documented the many judicial dodges and evasions engaged in by many judges intent upon ignoring the clear requirements of Rule 702.

A paper published this week by the Washington Legal Foundation has updated and expanded the case for reform made by Professor Bernstein five years ago. In his advocacy paper, lawyer Lee Mickus has collated and analyzed some of the more recent dodges, which will depress the spirits of anyone who believes in evidence-based decision making.[11] My resistance to reform by amendment is waning. The meaning and intent of Rule 702 has been scarred over by precedent based upon judicial ipse dixit, and not Rule 702.

Mickus’s paper, like Professor Bernstein’s articles before, makes a persuasive case for reform, but this new paper does not evaluate the vagaries of navigating an amendment through the Advisory Committee, the Supreme Court, and Congress. Even if the reader is not interested in the amendment process, the paper can be helpful to the advocate in anticipating dodgy rule denialism.

[1] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

[2] Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923).

[3] See “The Advocates’ Errors in Daubert” (Dec. 28, 2018).

[4] General Electric Co. v. Joiner, 522 U.S. 136 (1997); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).

[5] Weisgram v. Marley Co., 528 U.S. 440, 455 (2000) (Ginsberg, J.) (unanimous decision).

[6] Matrixx Initiatives, Inc. v. Siracusano, 563 US 27, 131 S.Ct. 1309, 1319 (2011) (citing Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262, 298 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986)). See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; “Part 2”; “Part 3”; “Part 4”; “Part 5”; and “Part 6”.

[7] David E. Bernstein & Eric Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 Wm. & Mary L. Rev. 1 (2015); David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2014).

[8] See Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702 at 52 (April 1, 2018) (“[T]he fact remains that some courts are ignoring the requirements of Rule 702(b) and (d). That is frustrating.”).

[9] David E. Bernstein & Eric Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 Wm. & Mary L. Rev. 1 (2015).

[10] “On Amending Rule 702 of the Federal Rules of Evidence” (Oct. 17, 2015).

[11] Lee Mickus, “Gatekeeping Reorientation: Amend Rule 702 to Correct Judicial Misunderstanding about Expert Evidence,” Washington Legal Foundation Critical Legal Issues Working Paper No. 217 (May 2020).

Posted in Expert Witnesses, Rule 702 | Comments Off on Should Federal Rule of Evidence 702 Be Amended?

Data Games – A Techno Thriller

April 22nd, 2020

Data Games – A Techno Thriller

Sherlock Holmes, Hercule Poirot, Miss Marple, Father Brown, Harry Bosch, Nancy Drew, Joe and Frank Hardy, Sam Spade, Columbo, Lennie Briscoe, Inspector Clouseau, and Dominic Da Vinci:

Move over; there is a new super sleuth in town.

Meet Professor Ken Wheeler.

Ken is a statistician, and so by profession, he is a data detective. In his day job, he teaches at a northeastern university, where his biggest challenges are managing the expectations of students and administrators, while trying to impart statistical learning. At home, Ken rarely manages to meet the expectations of his wife and son. But as some statisticians are wont to do, Ken sometimes takes on consulting gigs that require him to use his statistical skills to help litigants sort out the role of chance in cases that run from discrimination claims to rare health effects. In this contentious, sharp-elbowed environment, Ken excels. And truth be told, Ken actually finds great satisfaction in identifying the egregious errors and distortions of adversary statisticians

Wheeler’s sleuthing usually involves ascertaining random error or uncovering a lurking variable, but in Herberg I. Weisberg’s just-published novel, Data Games: A Techno Thriller, Wheeler is drawn into a high-stakes conspiracy of intrigue, violence, and fraud that goes way beyond the run-of-the-mine p-hacking and data dredging.

An urgent call from a scientific consulting firm puts Ken Wheeler in the midst of imminent disaster for a pharmaceutical manufacturer, whose immunotherapy anti-cancer wonder drug, Verbana, is under attack. A group of apparently legitimate scientists have obtained the dataset from Verbana’s pivotal clinical trial, and they appear on the verge of blowing Verbana out of the formulary with a devastating analysis that will show that the drug causes early dementia. Wheeler’s mission is to debunk the debunking analysis when it comes.

For those readers who are engaged in the litigation defense of products liability claims against medications, the scenario is familiar enough. The scientific group studying Verbana’s alleged side effect seems on the up-and-up, but they appear to engaged in a cherry-picking exercise, guided by a dubious theory of biological plausibility, known as the “Kreutzfeld hypothesis.”

It is not often that mystery novels turn on surrogate outcomes, biomarkers, genomic medicine, and predictive analytics, but Data Games is no ordinary mystery. And Wheeler is no ordinary detective. To be sure, the middle-aged Wheeler drives a middle-aged BMW, not a Bond car, and certainly not a Bonferroni. And Wheeler’s toolkit may not include a Glock, but he can handle the lasso, the jacknife, and the logit, and serve them up with SAS. Wheeler sees patterns where others see only chaos.

Unlike the typical Hollywood rubbish about stereotyped evil pharmaceutical companies, the hero of Data Games finds that there are sinister forces behind what looks like an honest attempt to uncover safety problems with Verbana. These sinister forces will use anything to achieve their illicit ends, including superficially honest academics with white hats. The attack on Verbana gets the FDA’s attention and an urgent hearing in White Oak, where Wheeler shines.

The author of Data Games, Herbert I. Weisberg, is himself a statistician, and a veteran of some of the dramatic data games he writes about in this novel. Weisberg is perhaps better known for his “homework” books, such asWillful Ignorance: The Mismeasure of Uncertainty (2014), and Bias and Causation: Models and Judgment for Valid Comparisons (2010). If, however, you ever find yourself in a pandemic lockdown, Weisberg’s Data Games: A Techno Thriller is a perfect way to escape. For under $3, you will be entertained, and you might even learn something about probability and statistics.

Posted in Data Sharing, Scientific Misconduct, Scientific Publishing, Underlying Data | Comments Off on Data Games – A Techno Thriller

Disproportionality Analyses Misused by Lawsuit Industry

April 20th, 2020

Adverse event reporting is a recognized, important component of pharmacovigilence. Regulatory agencies around the world further acknowledge that an increased rate of reporting of a specific adverse event may signal the possible existence of an association. In the last two decades, pharmacoepidemiologists have developed techniques for mining databases of adverse event reports for evidence of a disproportionate level of reporting for a particular medication – adverse event pair. Such studies can help identify “signals” of potential issues for further study with properly controlled epidemiologic studies.[1]

Most sane and sensible epidemiologists recognize that the low quality, inconsistences, and biases of the data in adverse event reporting databases render studies of disproportionate reporting “poor surrogates for controlled epidemiologic studies.” In the face of incomplete and inconsistent reporting, so-called disproportionality analyses (“DPA”) assume that incomplete reporting will be constant for all events for a specific medication. Regulatory attention, product labeling, lawyer advertising and client recruitment, social media and publicity, and time since launch are all known to affect reporting rates, and to ensure that reporting rates for some event types for a specific medication will be higher. Thus, the DPA assumptions are virtually always false and unverifiable.[2]

DPAs are non-analytical epidemiologic studies that cannot rise in quality or probativeness above the level of the anecdote upon which they are based. DPAs may generate signals or hypotheses, but they cannot test hypotheses of causality. Although simple in concept, DPAs involve some complicated computations that embue them with an aura of “proofiness.” As would-be studies that lack probativeness for causality, they are thus ideal tools for the lawsuit industry to support litigation campaigns against drugs and medical devices. Indeed, if a statistical technique is difficult to understand but relatively easy to perform and even easier to pass off to unsuspecting courts and juries, then you can count on its metastatic use in litigation. The DPA has become one of the favorite tools of the lawsuit industry’s statisticians. This litigation use, however, cannot obscure the simple fact that the relative reporting risk provided by a DPA can never rise to the level of a relative risk.

In one case in which a Parkinson’s disease patient claimed that his compulsive gambling was caused by his use of the drug Requip, the plaintiff’s expert witness attempted to invoke a DPA in support of his causal claim. In granting a Rule 702 motion to exclude the expert witnesses who relied upon a DPA, the trial judge rejected the probativeness of DPAs, based upon the FDA’s rejection of such analyses for anything other than signal detection.[3]

In the Accutane litigation, statistician David Madigan attempted to support his fatally weak causation opinion with a DPA for Crohn’s disease and Accutane adverse event reports. According to the New Jersey Supreme Court, Madigan claimed that his DPA showed “striking signal of disproportionality” indicative of a “strong association” between Accutane use and Crohn’s disease.[4] With the benefit of a thorough review by the trial court, the New Jersey Supreme Court found other indicia of unreliability in Madigan’s opinions, such that it was not fooled by Madigan’s shenanigans. In any event, no signal of disproportionality could ever show an association between medication use and a disease; at best the DPA can show only an association between reporting of the medication use and the outcome of interest.

In litigation over Mirena and intracranial hypertension, one of the lawsuit industry’s regulars, Mayhar Etminan, published a DPA based upon the FDA’s Adverse Event Reporting System, which purported to find an increased reporting odds ratio.[5] Unthinkingly, the plaintiffs’ other testifying expert witnesses relied upon Etminan’s study. When a defense expert witness pointed out that Etminan had failed to adjust for age and gender in his multivariate analysis,[6] he repudiated his findings.[7] Remarkably, when Etminan published his original DPA in 2015, he declared that he had no conflicts, but when he published his repudiation, he disclosed that he “has been an expert witness in Mirena litigation in the past but is no longer part of the litigation.” The Etminan kerfuffle helped scuttle the plaintiffs’ assault on Mirena.[8]

DPAs have, on occasion, bamboozled federal judges into treating them as analytical epidemiology that can support causal claims. For instance, misrepresentations or misunderstandings of what DPAs can and cannot do carried the day in a Rule 702 contest on the admissibility of opinion testimony by statistician Rebecca Betensky. In multidistrict litigation over the safety of inferior vena cava (“IVC”) filters, plaintiffs’ counsel retained Rebecca Betensky, to prepare a DPA of adverse events reported for the defendants’ retrievable filters. The MDL judge’s description of Betensky’s opinion demonstrates that her DPA was either misrepresented or misunderstood:

“In this MDL, Dr. Betensky opines generally that there is a higher risk of adverse events for Bard’s retrievable IVC filters than for its permanent SNF.”[9]

The court clearly took Betensky to be opining about risk and not the risk of reporting. The court’s opinion goes on to describe Betensky’s calculation of a “reporting risk ratio,” but found that she could testify that the retrievable IVC filters increased the risk of the claimed adverse events, and not merely that there was an increase in reporting risk ratios.

Betensky acknowledged that the reporting risk ratios were “imperfect estimates of the actual risk ratios,”[10] but nevertheless dismissed all caveats about the inability of DPAs to assess actual increased risk. The trial court quoted Dr. Betensky’s attempt to infuse analytical rigor into a data mining exercise:

“[A]dverse events are generally considered to be underreported to the databases, and potentially differentially by severity of adverse event and by drug or medical device. . . . It is important to recognize that underreporting in and of itself is not problematic. Rather, differential underreporting of the higher risk device is what leads to bias. And even if there was differential underreporting of the higher risk device, given the variation in reporting relative risks across adverse events, the differential reporting would have had to have been highly variable across adverse events. This does not seem plausible given the severity of the adverse events considered. Given the magnitude of the RRR’s [relative reporting ratios], and their variability across adverse events, it seems implausible that differential underreporting by filter could fully explain the deviation of the observed RRR’s from 1.”[11]

Of course, this explanation fails to account for differential over-reporting for the newer, but less risky or equally risk device. Betensky dismissed notoriety bias as having caused an increase in reporting adverse events because her DPA ended with 2014, before the FDA had issued a warning letter. The lawsuit industry, however, was on the attack against IVC filers, years before 2014.[12] Similarly, Betensky dismissed consideration of the Weber effect, but her analysis apparently failed to acknowledge that notoriety and Weber effect are just two of many possible biases in DPAs.

In the face of her credentials, the MDL trial judge retreated to the usual chestnuts that are served up when a Rule 702 challenge is denied. Judge Campbell thus observed that “[i]t is not the job of the court to insure that the evidence heard by the jury is error-free, but to insure that it is sufficiently reliable to be considered by the jury.”[13] The trial judge professed a need to be “be careful not to conflate questions of admissibility of expert testimony with the weight appropriately to be accorded to such testimony by the fact finder.”[14] The court denied the claim that Betensky had engaged in an ipse dixit, by engaging in its own ipse dixit. Judge Campbell found that Betensky had explained her assumptions, had acknowledged shortcomings, and had engaged in various sensitivity tests of the validity of her DPA; and so he concluded that Betensky did not present “a case where ‘there is simply too great an analytical gap between the data and the opinion proffered’.”[15]

By closing off inquiry into the limits of the DPA methodology, Judge Campbell managed to stumble into a huge analytical gap he blindly ignored, or was unaware of. Even the best DPAs cannot substitute for analytical epidemiology in a scientific methodology of determining causation. The ipse dixit becomes apparent when we consider that the MDL gatekeeping opinion on Rebecca Betensky fails to mention the extensive body of regulatory and scientific opinion about the distinct methodologic limitations of DPA. The U.S. FDA’s official guidance on good pharmacovigilance practices, for example, instructs us that

“[d]ata mining is not a tool for establishing causal attributions between products and adverse events.”[16]

The FDA specifically cautions that the signals detected by data mining techniques should be acknowledged to be “inherently exploratory or hypothesis generating.”[17] The agency exercises caution when making its own comparisons of adverse events between products in the same class because of the low quality of the data themselves, and uncontrollable and unpredictable biases in how the data are collected.[18] Because of the uncertainties in DPAs,

“FDA suggests that a comparison of two or more reporting rates be viewed with extreme caution and generally considered exploratory or hypothesis-generating. Reporting rates can by no means be considered incidence rates, for either absolute or comparative purposes.”[19]

The European Medicines Agency offers similar advice and caution:

“Therefore, the concept of SDR [Signal of Disproportionate Reporting] is applied in this guideline to describe a ‘statistical signal’ that has originated from a statistical method. The underlying principle of this method is that a drug–event pair is reported more often than expected relative to an independence model, based on the frequency of ICSRs on the reported drug and the frequency of ICSRs of a specific adverse event. This statistical association does not imply any kind of causal relationship between the administration of the drug and the occurrence of the adverse event.”[20]

The current version of perhaps the leading textbook on pharmacoepidemiology is completely in accord with the above regulatory guidances. In addition to emphasizing the limitations on data quality from adverse event reporting, and the inability to interpret temporal trends, the textbook authors clearly characterize DPAs as generating signals, and unable to serve as hypothesis tests:

“a signal of disproportionality is a measure of a statistical association within a collection of AE/ADR reports (rather than in a population), and it is not a measure of causality. In this regard, it is important to underscore that the use of data mining is for signal detection – that is, for hypothesis generation – and that further work is needed to evaluate the signal.”[21]

Reporting ratios are not, and cannot serve as, measures of incidence or prevalence, because adverse event databases do not capture all the events of interest, and so these ratios “it must be interpreted cautiously.”[22] The authors further emphasize that “well-designed pharmacoepidemiology or clinical studies are needed to assess the signal.”[23]

The authors of this chapter are all scientists and officials at the FDA’s Center for Drug Evaluation and Research, and the World Health Organization. Although they properly disclaimed to have been writing for their agencies, their agencies have independently embraced their concepts in other agency publications. The consensus view of the hypothesis generating nature of DPAs can easily be seen in surveying the relevant literature.[24] Passing off a DPA as a study that supports causal inference is not a mere matter of “weight,” or excluding any opinion that has some potential for error. The misuse of Betensky’s DPA is a methodological error that goes to the heart of what Congress intended to be screened and excluded by Rule 702.

[1] Sean Hennessy, “Disproportionality analyses of spontaneous reports,” 13 Pharmacoepidemiology & Drug Safety 503, 503 (2004).

[2] Id. See, e.g., Patrick Waller & Mira Harrison-Woolrych, An Introduction to Pharmacovigilance 68-69 (2^nd ed. 2017) (noting the example of the WHO’s DPA that found a 10-fold reporting rate increase for statins and ALS, which reporting association turned out to be spurious).

[3] Wells v. SmithKline Beecham Corp., 2009 WL 564303, at *12 (W.D. Tex. 2009) (citing and quoting from the FDA’s Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (2005)), aff’d, 601 F.3d 375 (5th Cir. 2010). But see In re Abilify (Aripiprazole) Prods. Liab. Litig., 299 F.Supp. 3d 1291. 1324 (N.D. Fla. 2018) (noting that the finding of a DPA that compared Abilify with other anti-psychotics helped to show that a traditional epidemiologic study was not confounded by the indication for depressive symptoms).

[4] In re Accutane Litig., 234 N.J. 340, 191 A.3d 560, 574 (2018).

[5] See Mahyar Etminan, Hao Luo, and Paul Gustafson, et al., “Risk of intracranial hypertension with intrauterine levonorgestrel,” 6 Therapeutic Advances in Drug Safety 110 (2015).

[6] Deborah Friedman, “Risk of intracranial hypertension with intrauterine levonorgestrel,” 7 Therapeutic Advances in Drug Safety 23 (2016).

[7] Mahyar Etminan, “Revised disproportionality analysis of Mirena and benign intracranial hypertension,” 8 Therapeutic Advances in Drug Safety 299 (2017).

[8] In re Mirena IUS Levonorgestrel-Relaated Prods. Liab. Litig. (No. II), 387 F. Supp. 3d 323, 331 (S.D.N.Y. 2019) (Engelmayer, J.).

[9] In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, Order Denying Motion to Exclude Rebecca Betensky at 2 (D. Ariz. Jan. 22, 2018) (Campbell, J.) (emphasis added) [Order]

[10] Id. at 4.

[11] Id.

[12] See Matt Fair, “C.R. Bard’s Faulty Filters Pose Health Risks, Suit Says,” Law360 (Aug. 10, 2012); See, e.g., Derrick J. Stobaugh, Parakkal Deepak, & Eli D. Ehrenpreis, “Alleged isotretinoin-associated inflammatory bowel disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System,” 69 J. Am. Acad. Dermatol. 393 (2013) (documenting stimulated reporting from litigation activities).

[13] Order at 6, quoting from Southwire Co. v. J.P. Morgan Chase & Co., 528 F. Supp. 2d 908, 928 (W.D. Wis. 2007).

[14] Id., citing In re Trasylol Prods. Liab. Litig., No. 08-MD-01928, 2010 WL 1489793, at *7 (S.D. Fla. Feb. 24, 2010).

[15] Id., citing and quoting from In re Trasylol Prods. Liab. Litig., No. 08-MD-01928, 2010 WL 1489793, at *7 (S.D. Fla. Feb. 24, 2010) ((quoting General Electric v. Joiner, 522 U.S. 136, 146 (1997)).

[16] FDA, “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance for Industry” at 8 (2005) (emphasis added).

[17] Id. at 9.

[18] Id.

[19] Id. at 11 (emphasis added).

[20] EUDRAVigilance Expert Working Group, European Medicines Agency, “Guideline on the Use of Statistical Signal Detection Methods in the EUDRAVigilance Data Analysis System,” at 3 (2006) (emphasis added).

[21] Gerald J. Dal Pan, Marie Lindquist & Kate Gelperin, “Postmarketing Spontaneous Pharmacovigilance Reporting Systems,” in Brian L. Strom & Stephen E. Kimmel and Sean Hennessy, Pharmacoepidemiology at 185 (6^th ed. 2020) (emphasis added).

[22] Id. at 187.

[23] Id. See also Andrew Bate, Gianluca Trifirò, Paul Avillach & Stephen J.W. Evans, “Data Mining and Other Informatics Approaches to Pharmacoepidemiology,” chap. 27, in Brian L. Strom & Stephen E. Kimmel and Sean Hennessy, Pharmacoepidemiology at 685-88 (6^th ed. 2020) (acknowledging the importance of DPAs for detecting signals that must then be tested with analytical epidemiology) (authors from industry, Pfizer, and academia, including NYU School of Medicine, Harvard Medical School, and London School of Hygiene and Tropical Medicine).

[24] See, e.g., Patrick Waller & Mira Harrison-Woolrych, An Introduction to Pharmacovigilance 61 (2^nd ed. 2017) (“[A]lthough the numbers are calculated in a similar way to relative risks, they do not represent a meaningful calculation of risk.” *** “Indicators of disproportionality are measures of association and even quite extreme results may not be causal.”); Ronald D. Mann & Elizabeth B. Andrews, Pharmacovigilance 240 (2d ed. 2007) (“Importantly, data mining cannot prove or refute causal associations between drugs and events. Data mining simply identifies disproportionality of drugevent reporting patterns in databases. The absence of a signal does not rule out a safety problem. Similarly, the presence of a signal is not a proof of a causal relationship between a drug and an adverse event.”); Patrick Waller, An Introduction to Pharmacovigilance 49 (2010) (“[A]lthough the numbers are calculated in a similar way to relative risks, they do not represent a meaningful calculation of risk. Whilst it is true that the greater the degree of disproportionality, the more reason there is to look further, the only real utility of the numbers is to decide whether or not there are more cases than might reasonably have been expected. Indicators of disproportionality are measures of association and even quite extreme results may not be causal.”); Sidney N. Kahn, “You’ve found a safety signal–now what? Regulatory implications of industry signal detection activities,” 30 Drug Safety 615 (2007).

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