County District Court File No. 62-CV-15-6432
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)
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.
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.
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.
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
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.
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.
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.
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
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,  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
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
support the claims in their lawsuits, appellants retained
three general-causationmedical 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
the district court err in applying Minn. R. Evid. 702 to