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:
- 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)
- 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)
- 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)
- 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)
- 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)
- 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:
- 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:
- 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 https://www.truthaboutbairhugger.com/truth-science-behind-claims-3m-bair-hugger-system-look-augustine-connections-research-studies/.
[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).
