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

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]

  1. . . . .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:

  1. . . . . 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 21st 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).

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.

Dark Money, Scott Augustine, and Hot Air

April 11th, 2020

Fraud by the litigation industry takes many different forms. In the massive silicosis litigation unleashed in Mississippi and Texas in the early 2000s, plaintiffs’ lawyers colluded with physicians to concoct dubious diagnoses of silicosis. Fraudulent diagnoses of silicosis led to dismissals of thousands of cases, as well as the professional defrocking of some physician witnesses.[1] For those trying to keep up with lawsuit industry’s publishing arm, discussion of the Great Silicosis Fraud is completely absent from David Michaels’ recent book, The Triumph of Doubt.[2] So too is any mention of “dark money” that propelled the recently concluded Bair Hugger litigation.

Back in 2017, I wrote about the denial of a Rule 702 motion in the Bair Hugger litigation.[3] At the time, I viewed the trial court’s denial, on the facts of the case, to be a typical failure of gatekeeping.[4] Events in the Bair Hugger cases were only warming up in 2017.

After the court’s ruling, 3M took the first bellwether case to trial and won the case with jury, on May 30, 2018. Perhaps this jury verdict encouraged the MDL trial judge to take 3M’s motion for reconsideration of the Rule 702 motion seriously. In July 2019, the MDL court granted 3M’s motion to exclude the opinion testimony of plaintiffs’ general causation and mechanism expert witnesses, Drs. Jarvis, Samet, Stonnington, and Elghobashi.[5] Without these witnesses, over 5,000 plaintiffs, who had been misled about the merits of their cases, were stranded and set up for dismissal. On August 2, 2019, the MDL cases were dismissed for want of evidentiary support on causation. On August 29, 2019, plaintiffs filed a joint notice of appeal to the Eight Circuit.

The two Bair Hugger Rule 702 federal court decisions focused (or failed to focus) on scientific considerations. Most of the story of “dark money” and the manufacturing of science to support the litigation were suppressed in the Rule 702 motion practice, and in the federal jury trial. In her second Rule 702 reconsideration opinion, the MDL judge did mention undisclosed conflicts of interest by authors of the key studies relied upon by plaintiffs’ witnesses.[6]

To understand how the Bair Hugger litigation got started, and to obtain a full understanding of the nature of the scientific evidence was, a disinterested observer will have to read the state court decisions. Defendant 3M moved to exclude plaintiffs’ causation expert witnesses, in its Minnesota state court cases, under the so-called Frye standard. In response, the state judge excluded plaintiffs’ witnesses for advancing a novel scientific theory that lacked acceptance in the relevant scientific community. The Minnesota Court of Appeals affirmed, with a decision that talked rather more freely about the plaintiffs’ counsel’s dark money. In re 3M Bair Hugger Litig., 924 N.W.2d 16 (Minn. App. 2019) [cited as Bair Hugger].

As the Minnesota Court of Appeals explained, a forced-air warming device (FAWD) is a very important, useful device to keep patients’ body temperatures normal during surgery. The “Bair Hugger” is a FAWD, which was invented in 1987, by Dr. Scott Augustine, an anesthesiologist, who at the time was the chief executive officer of Augustine Medical, Inc. Bair Hugger at 19.

In the following 15 years, the Bair Hugger became the leading FAWD in the world. In 2002, the federal government notified Augustine that it was investigating him for Medicare fraud. Augustine resigned from the company that bore his name, and the company purged the taint by reorganizing as Arizant Healthcare Inc. (Arizant), which continued to make the Bair Hugger. In the following year, 2003, Augustine pleaded guilty to fraud and paid a $2 million fine. His sentence included a five-year ban from involvement in federal health-care programs.

During the years of his banishment, fraudfeasor Augustine developed a rival product and then embarked upon a global attack on the safety of his own earlier invention, the Bair Hugger. In the United Kingdom, his claim that the Bair Hugger increased risks of surgical site infections attacks was rejected by the UK National Institute for Health and Clinical Excellence. A German court enjoined Augustine from falsely claiming that the Bair Hugger led to increased bacterial contamination.[7] The United States FDA considered and rejected Augustine’s claims, and recommended the use of FAWDs.

In 2009, Augustine began to work as a non-testifying expert witness with the Houston, Texas, plaintiffs’ law firm of Kennedy Hodges LLP. A series of publications resulted in which the authors attempted to raise questions about the safety of the Bair Hugger. By 2013, with the medical literature “seeded” with several studies attacking the Bair Hugger, the Kennedy Hodges law firm began to manufacture law suits against Arizant and 3M (which had bought the Bair Hugger product line from Arizant in 2010). Bair Hugger at 20.

The seeding studies were marketing and litigation propaganda used by Augustine to encourage the all-too-complicit lawsuit industry to ramp up production of complaints against 3M over the Bair Hugger. Several of the plaintiffs’ studies included as an author a young statistician, Mark Albrecht, an employee of, or a contractor for, Augustine’s new companies, Augustine Temperature Management and Augustine Medical. Even when disclosures were made, they were at best “anemic”:

“The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.”[8]

Some of these studies generally included a disclosure that Albrecht was funded or employed by Augustine, but they did not disclose the protracted, bitter feud or Augustine’s confessed fraudulent conduct. Another author of some of the plaintiffs’ studies included David Leaper, who was a highly paid “consultant’’ to Augustine at the time of the work on the study. None of the studies disclosed Leaper’s consultancy for Augustin:

  1. Mark Albrecht, Robert Gauthier, and David Leaper, “Forced air warming, a source of airborne contamination in the operating room?” 1 Orthopedic Rev. (Pavia) e28 (2009)
  2. Mark Albrecht, Robert L. Gauthier, Kumar Belani, Mark Litchy, and David Leaper, “Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room,” 39 Am. J. Infection Control 321 (2011)
  3. P.D. McGovern, Mark Albrecht, Kumar Belani, C. Nachtsheim, “Forced-air warming and ultra-clean ventilation do not mix,” 93 J. Bone & Joint Surg. – British 1537 (2011)
  4. K.B. Dasari, Mark Albrecht, and M. Harper, “Effect of forced-air warming on the performance of operating-theatre laminar-flow ventilation,” 67 Anaesthesia 244 (2012)
  5. Mike Reed, Oliver Kimberger, Paul D. McGovern, and Mark C. Albrecht, “Forced-Air Warming Design: Evaluation of Intake Filtration, Internal Microbial Buildup, and Airborne-Contamination Emissions,” 81 Am. Ass’n Nurse Anesthetists 275 (2013)
  6. Kumar Belani, Mark Albrecht, Paul McGovern, Mike Reed, and Christopher Nachtsheim, “Patient warming excess heat: the effects on orthopedic operating room ventilation performance,” 117 Anesthesia & Analgesia 406 (2013)

In one study, Augustine’s employee Mark Albrecht conducted the experiment with one of the authors, but was not listed as an author although he wrote an early draft of the study. Augustine provided all the equipment used in the experiment. The published paper failed to disclose any of these questionable activities:

  1. A.J. Legg & A.J. Hammer, “Forced-air patient warming blankets disrupt unidirectional flow,” 95 Bone & Joint J. 407 (2013)

Another study had more peripheral but still questionable involvement of Augustine, whose company lent the authors equipment used to conduct the study, without proper acknowledgment and disclosure:

  1. A.J. Legg, T. Cannon, and A. J. Hamer, “Do forced-air warming devices disrupt unidirectional downward airflow?” 94 J. Bone & Joint Surg. – British 254 (2012)

In addition to the defects in the authors’ disclosures, 3M discovered that two of the studies had investigated whether the Bair Hugger spread bacteria in the surgical area. Although the experiments found no spread with the Bair Hugger, the researchers never publicly disclosed their exculpatory evidence.[9]

Augustine’s marketing campaign, through these studies, ultimately fell flat at the FDA, which denied his citizen’s petition and recommended that surgeons continue to use FAWDs such as the Bair Hugger.[10] Augustine’s proxy litigation war against 3M also fizzled, unless the 8th Circuit revives his vendetta. Nonetheless, the Augustine saga raises serious questions about how litigation funding of “scientific studies” will vex the search for the truth in pharmaceutical products litigation. The Augustine attempt to pollute the medical literature was relatively apparent, but dark money from undisclosed financiers may require greater attention from litigants and from journal editors.

[1]  In re Silica Products Liab. Litig., MDL No. 1553, 398 F. Supp. 2d 563 (S.D.Tex. 2005).

[2]  David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020).

[3]  In re Bair Hugger Forced Air Warming, MDL No. 15-2666, 2017 WL 6397721 (D. Minn. Dec. 13, 2017).

[4]  “Gatekeeping of Expert Witnesses Needs a Bair Hug” (Dec. 20, 2017).

[5]  In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., MDL No. 15-2666, 2019 WL 4394812 (D. Minn. July 31, 2019). See Joe G. Hollingsworth & Caroline Barker, “Exclusion of Junk Science in ‘Bair Hugger’ MDL Shows Daubert Is Still Breathing,” Wash. Leg. Foundation (Jan 23, 2020); Christine Kain, Patrick Reilly, Hannah Anderson and Isabelle Chammas, “Top 5 Drug And Medical Device Developments Of 2019,” Law360 (Jan. 9, 2020).

[6]  In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., 2019 WL 4394812, at *10 n.13 (D. Minn. July 31, 2019) (observing that “[i]n the published study, the authors originally declared no conflicts of interest”).

[7]  Dr. Augustine has never been a stranger to the judicial system. See, e.g., Augustine Medical, Inc. v. Gaymar Industries, Inc., 181 F.3d 1291 (Fed. Cir. 1999); Augustine Medical, Inc. v. Progressive Dynamics, Inc., 194 F.3d 1367 (Fed. Cir. 1999); Cincinnati Sub-Zero Products, Inc. v. Augustine Medical, Inc., 800 F. Supp. 1549 (S.D. Ohio 1992).

[8]  P.D. McGovern, Mark Albrecht, Kumar Belani, and C. Nachtsheim, “Forced-air warming and ultra-clean ventilation do not mix,” 93 J. Bone & Joint Surg. – British 1537, 1544 (2011).

[9]  See

[10]  William Maisel, “Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers”; Center for Devices and Radiological Health, U.S. Food and Drug Administration (Aug. 30, 2017).

April Fool – Zambelli-Weiner Must Disclose

April 2nd, 2020

Back in the summer of 2019, Judge Saylor, the MDL judge presiding over the Zofran birth defect cases, ordered epidemiologist, Dr. Zambelli-Weiner to produce documents relating to an epidemiologic study of Zofran,[1] as well as her claimed confidential consulting relationship with plaintiffs’ counsel.[2]

This previous round of motion practice and discovery established that Zambelli-Weiner was a paid consultant in advance of litigation, that her Zofran study was funded by plaintiffs’ counsel, and that she presented at a Las Vegas conference, for plaintiffs’ counsel only, on [sic] how to make mass torts perfect. Furthermore, she had made false statements to the court about her activities.[3]

Zambelli-Weiner ultimately responded to the discovery requests but she and plaintiffs’ counsel withheld several documents as confidential, pursuant to the MDL’s procedure for protective orders. Yesterday, April 1, 2020, Judge Saylor entered granted GlaxoSmithKline’s motion to de-designate four documents that plaintiffs claimed to be confidential.[4]

Zambelli-Weiner sought to resist GSK’s motion to compel disclosure of the documents on a claim that GSK was seeking the documents to advance its own litigation strategy. Judge Saylor acknowledged that Zambelli-Weiner’s psycho-analysis might be correct, but that GSK’s motive was not the critical issue. According to Judge Saylor, the proper inquiry was whether the claim of confidentiality was proper in the first place, and whether removing the cloak of secrecy was appropriate under the facts and circumstances of the case. Indeed, the court found “persuasive public-interest reasons” to support disclosure, including providing the FDA and the EMA a complete, unvarnished view of Zambelli-Weiner’s research.[5] Of course, the plaintiffs’ counsel, in close concert with Zambelli-Weiner, had created GSK’s need for the documents.

This discovery battle has no doubt been fought because plaintiffs and their testifying expert witnesses rely heavily upon the Zambelli-Weiner study to support their claim that Zofran causes birth defects. The present issue is whether four of the documents produced by Dr. Zambelli-Weiner pursuant to subpoena should continue to enjoy confidential status under the court’s protective order. GSK argued that the documents were never properly designated as confidential, and alternatively, the court should de-designate the documents because, among other things, the documents would disclose information important to medical researchers and regulators.

Judge Saylor’s Order considered GSK’s objections to plaintiffs’ and Zambelli-Weiner’s withholding four documents:

(1) Zambelli-Weiner’s Zofran study protocol;

(2) Undisclosed, hidden analyses that compared birth defects rates for children born to mothers who used Zofran with the rates seen with the use of other anti-emetic medications;

(3) An earlier draft Zambelli-Weiner’s Zofran study, which she had prepared to submit to the New England Journal of Medicine; and

(4) Zambelli-Weiner’s advocacy document, a “Causation Briefing Document,” which she prepared for plaintiffs’ lawyers.

Judge Saylor noted that none of the withheld documents would typically be viewed as confidential. None contained “sensitive personal, financial, or medical information.”[6]  The court dismissed Zambelli-Weiner’s contention that the documents all contained “business and proprietary information,” as conclusory and meritless. Neither she nor plaintiffs’ counsel explained how the requested documents implicated proprietary information when Zambelli-Weiner’s only business at issue is to assist in making lawsuits. The court observed that she is not “engaged in the business of conducting research to develop a pharmaceutical drug or other proprietary medical product or device,” and is related solely to her paid consultancy to plaintiffs’ lawyers. Neither she nor the plaintiffs’ lawyers showed how public disclosure would hurt her proprietary or business interests. Of course, if Zambelli-Weiner had been dishonest in carrying out the Zofran study, as reflected in study deviations from its protocol, her professional credibility and her business of conducting such studies might well suffer. Zambelli-Weiner, however, was not prepared to affirm the antecedent of that hypothetical. In any event, the court found that whatever right Zambelli-Weiner might have enjoyed to avoid discovery evaporated with her previous dishonest representations to the MDL court.[7]

The Zofran Study Protocol

GSK sought production of the Zofran study protocol, which in theory contained the research plan for the Zofran study and the analyses the researchers intended to conduct. Zambelli-Weiner attempted to resist production on the specious theory that she had not published the protocol, but the court found this “non-publication” irrelevant to the claim of confidentiality. Most professional organizations, such as the International Society of Pharmacoepidemiology (“ISPE”), which ultimately published Zambelli-Weiner’s study, encourage the publication and sharing of study protocols.[8] Disclosure of protocols helps ensure the integrity of studies by allowing readers to assess whether the researchers have adhered to their study plan, or have engaged in ad hoc data dredging in search for a desired result.[9]

The Secret, Undisclosed Analyses

Perhaps even more egregious than withholding the study protocol was the refusal to disclose unpublished analyses comparing the rate of birth defects among children born to mothers who used Zofran with the birth defect rates of children with in utero exposure to other anti-emetic medications.  In ruling that Zambelli-Weiner must produce the unpublished analyses, the court expressed its skepticism over whether these analyses could ever have been confidential. Under ISPE guidelines, researchers must report findings that significantly affect public health, and the relative safety of Zofran is essential to its evaluation by regulators and prescribing physicians.

Not only was Zambelli-Weiner’s failure to include these analyses in her published article ethically problematic, but she apparently hid these analyses from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, which specifically inquired of Zambelli-Weiner whether she had performed such analyses. As a result, the PRAC recommended a label change based upon Zambelli-Weiner’s failure to disclosure material information. Furthermore, the plaintiffs’ counsel represented they intended to oppose GSK’s citizen petition to the FDA, based upon the Zambelli-Weiner study. The apparently fraudulent non-disclosure of relevant analyses could not have been more fraught for public health significance. The MDL court found that the public health need trumped any (doubtful) claim to confidentiality.[10] Against the obvious public interest, Zambelli-Weiner offered no “compelling countervailing interest” in keeping her secret analyses confidential.

There were other aspects to the data-dredging rationale not discussed in the court’s order. Without seeing the secret analyses of other anti-emetics, readers were deprive of an important opportunity to assess actual and potential confounding in her study. Perhaps even more important, the statistical tools that Zambelli-Weiner used, including any measurements of p-values and confidence intervals, and any declarations of “statistical significance,” were rendered meaningless by her secret, undisclosed, multiple testing. As noted by the American Statistical Association (ASA) in its 2016 position statement, “4. Proper inference requires full reporting and transparency.”

The ASA explains that the proper inference from a p-value can be completely undermined by “multiple analyses” of study data, with selective reporting of sample statistics that have attractively low p-values, or cherry picking of suggestive study findings. The ASA points out that common practices of selective reporting compromises valid interpretation. Hence the correlative recommendation:

“Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”[11]

The Draft Manuscript for the New England Journal of Medicine

The MDL court wasted little time and ink in dispatching Zambelli-Weiner’s claim of confidentiality for her draft New England Journal of Medicine manuscript. The court found that she failed to explain how any differences in content between this manuscript and the published version constituted “proprietary business information,” or how disclosure would cause her any actual prejudice.

Zambelli-Weiner’s Litigation Road Map

In a world where social justice warriors complain about organizations such as Exponent, for its litigation support of defense efforts, the revelation that Zambelli-Weiner was helping to quarterback the plaintiffs’ offense deserves greater recognition. Zambelli-Weiner’s litigation road map was clearly created to help Grant & Eisenhofer, P.A., the plaintiffs’ lawyers,, create a causation strategy (to which she would add her Zofran study). Such a document from a consulting expert witness is typically the sort of document that enjoys confidentiality and protection from litigation discovery. The MDL court, however, looked beyond Zambelli-Weiner’s role as a “consulting witness” to her involvement in designing and conducting research. The broader extent of her involvement in producing studies and communicating with regulators made her litigation “strategery” “almost certainly relevant to scientists and regulatory authorities” charged with evaluating her study.”[12]

Despite Zambelli-Weiner’s protestations that she had made a disclosure of conflict of interest, the MDL court found her disclosure anemic and the public interest in knowing the full extent of her involvement in advising plaintiffs’ counsel, long before the study was conducted, great.[13]

The legal media has been uncommonly quiet about the rulings on April Zambelli-Weiner, in the Zofran litigation. From the Union of Concerned Scientists, and other industry scolds such as David Egilman, David Michaels, and Carl Cranor – crickets. Meanwhile, while the appeal over the admissibility of her testimony is pending before the Pennsylvania Supreme Court,[14] Zambelli-Weiner continues to create an unenviable record in Zofran, Accutane,[15] Mirena,[16] and other litigations.

[1]  April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019).

[2]  See In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657) [cited as In re Zofran].

[3]  “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[4]  In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) [Order].

[5]  Order at n.3

[6]  Order at 3.

[7]  See In re Zofran, 392 F. Supp. 3d at 186.

[8]  Order at 4. See also Xavier Kurz, Susana Perez-Gutthann, the ENCePP Steering Group, “Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP),” 27 Pharmacoepidemiology & Drug Safety 245 (2018).

[9]  Order at note 2 (citing Charles J. Walsh & Marc S. Klein, “From Dog Food to Prescription Drug Advertising: Litigating False Scientific Establishment Claims Under the Lanham Act,” 22 Seton Hall L. Rev. 389, 431 (1992) (noting that adherence to study protocol “is essential to avoid ‘data dredging’—looking through results without a predetermined plan until one finds data to support a claim”).

[10]  Order at 5, citing Anderson v. Cryovac, Inc., 805 F.2d 1, 8 (1st Cir. 1986) (describing public-health concerns as “compelling justification” for requiring disclosing of confidential information).

[11]  Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The American Statistician 129 (2016)

See alsoThe American Statistical Association’s Statement on and of Significance” (March 17, 2016).“Courts Can and Must Acknowledge Multiple Comparisons in Statistical Analyses (Oct. 14, 2014).

[12]  Order at 6.

[13]  Cf. Elizabeth J. Cabraser, Fabrice Vincent & Alexandra Foote, “Ethics and Admissibility: Failure to Disclose Conflicts of Interest in and/or Funding of Scientific Studies and/or Data May Warrant Evidentiary Exclusions,” Mealey’s Emerging Drugs Reporter (Dec. 2002) (arguing that failure to disclose conflicts of interest and study funding should result in evidentiary exclusions).

[14]  Walsh v. BASF Corp., GD #10-018588 (Oct. 5, 2016, Pa. Ct. C.P. Allegheny Cty., Pa.) (finding that Zambelli-Weiner’s and Nachman Brautbar’s opinions that pesticides generally cause acute myelogenous leukemia, that even the smallest exposure to benzene increases the risk of leukemia offended generally accepted scientific methodology), rev’d, 2018 Pa. Super. 174, 191 A.3d 838, 842-43 (Pa. Super. 2018), appeal granted, 203 A.3d 976 (Pa. 2019).

[15]  In re Accutane Litig., No. A-4952-16T1, (Jan. 17, 2020 N.J. App. Div.) (affirming exclusion of Zambelli-Weiner as an expert witness).

[16]  In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396 (S.D.N.Y. 2016) (excluding Zambelli-Weiner in part).