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In re 3M Bair Hugger Litigation

Court of Appeals of Minnesota

January 14, 2019

In re: 3M Bair Hugger Litigation

          Ramsey County District Court File No. 62-CV-15-6432

          Wilbur W. Fluegel, Fluegel Law Office, Minneapolis, Minnesota; and Genevieve M. Zimmerman, Meshbesher & Spence, Ltd., Minneapolis, Minnesota; and Michael V. Ciresi, Jan M. Conlin, Michael Sacchet, Ciresi Conlin LLP, Minneapolis, Minnesota (for appellant Scott Sehnert)

          Jerry W. Blackwell, Benjamin W. Hulse, Monica L. Davies, Blackwell Burke, P.A., Minneapolis, Minnesota; and Aaron D. VanOort, Jeffrey P. Justman, Dadri-Anne A. Graham, Faegre Baker Daniels LLP, Minneapolis, Minnesota (for respondent 3M)

          Considered and decided by Larkin, Presiding Judge; Connolly, Judge; and Reyes, Judge.

         SYLLABUS

         To determine whether the general-acceptance standard of Minn. R. Evid. 702 has been met, a court relies on evidence of the relevant scientific community's acceptance or nonacceptance of the novel scientific theory.

          OPINION

          CONNOLLY, Judge.

         Appellants brought product-liability actions in state and federal courts, alleging that respondent's forced-air warming device (FAWD) used to maintain patients' normal body temperature during surgery increased the risk of surgical-site infection (SSI). Each party moved to exclude the other party's experts; appellants moved to add a claim for punitive damages; and respondent moved for summary judgment with respect to general causation. The district court granted respondent's motions and denied appellants' motions. Appellants challenge these decisions. Because we see no error in the decisions to exclude appellants' experts, to grant summary judgment to respondent, and to deny appellants' motion for punitive damages, we affirm.

         FACTS

         In 1987, appellant Scott Augustine, an anesthesiologist and the CEO of Augustine Medical, Inc., invented a FAWD to maintain patients' normal body temperature during surgery. Known as the Bair Hugger, it became the leading warming device in the world. In 2002, Augustine was notified that he was under investigation for Medicare fraud. He resigned from Augustine Medical Inc., which was reorganized as Arizant Healthcare Inc. (Arizant), and Arizant retained the rights to the Bair Hugger.

         In 2003, Augustine formed appellant Augustine Biomedical Design and invented an electric-conduction warming device (ECWD) known as the HotDog. In 2004, he pleaded guilty to Medicare fraud, was fined $2 million, and was prohibited from participating in federal health-care programs for five years.

         During those years, he deprecated the Bair Hugger in other countries, leading the UK National Institute for Health and Clinical Excellence to reject his claim that FAWDs increase the risk of SSI and a German court to enjoin him from making false claims that the Bair Hugger increased bacterial contamination in operating rooms.

         In 2009, Augustine hired a law firm to promote the use of his ECWD and agreed to work with the law firm as a nontestifying expert for individuals who brought lawsuits against Arizant. The U.S. Food and Drug Administration (FDA) investigated Augustine's claims that the Bair Hugger increased the risk of bacterial contamination and rejected them.

         In 2010, Arizant was acquired by respondent 3M Company (3M). Augustine repeatedly and unsuccessfully attempted to induce 3M to purchase the HotDog system, which he claimed reduced the rate of SSI compared to FAWDs such as the Bair Hugger. The FDA warned Augustine that his claim lacked clinical support.

         In 2013, the law firm that Augustine had hired began filing lawsuits against Arizant and 3M, claiming that the Bair Hugger was unsafe. In 2014, Augustine funded the McGovern Study, [1] which purported to find an association between the Bair Hugger and increased SSIs. One of the study's authors, a former employee of Augustine, testified that "[t]he study does not establish a causal basis" and characterized it as marketing rather than research.

         In 2017, the FDA sent a Safety Alert to healthcare providers "reminding [them] that using thermoregulation devices during surgery, including [FAWDs], ha[s] been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients"; advising them that "[a]fter a thorough review of available data, [the FDA was] unable to identify a consistently reported association between the use of [FAWDs] and [SSIs]"; and recommending "the use of thermoregulating devices (including [FAWDs]) for surgical procedures."

         To support the claims in their lawsuits, appellants retained three general-causation[2]medical experts, none of whom had previously studied the efficacy of FAWDs or published peer-reviewed articles relevant to the claims in this litigation and none of whom claimed that their general-causation opinions were generally accepted within the relevant scientific community. On respondent's motion, the district court excluded the testimony of appellants' experts and consequently granted respondent summary judgment with respect to general causation. The district court also denied appellants' motion to amend their complaint by adding a claim for punitive damages. Appellants challenge these decisions.

         ISSUES

         1. Did the district court err in applying Minn. R. Evid. 702 to exclude ...


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