Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, January 15, 2019

Exclusion of expert testimony in surgical warming device suit affirmed under Frye-Mack standard

By Kathleen Bianco, J.D.

Testimonies by purported experts asserting that forced-air warming devices (FAWDs) used to maintain patients’ body temperature during surgery increased the risk of surgical-site infection (SSI) were properly excluded from products liability actions against the manufacturer of such a device because the opinions put forth by the experts were based upon novel scientific theory not generally accepted in the relevant scientific community, the Minnesota Court of Appeals held. Moreover, the court ruled that the denial of the plaintiffs’ request to amend their complaint to add a punitive-damages claim was not an abuse of discretion because they failed to show by clear and convincing evidence that the manufacturer acted with a deliberate disregard for the safety of others (In re: 3M Bair Hugger Litigation, January 14, 2019, Connolly, F.).

The suit alleged that the Bair Hugger device, a FAWD manufactured by 3M, was unsafe because it increased the risk of surgical-site infections. Each party moved to exclude the other party’s experts, the manufacturer moved for summary judgment, and the plaintiffs sought to add a claim for punitive damages. The state court excluded the plaintiffs’ experts for failing to satisfy the Frye-Mack standard, granted the manufacturer’s motion for summary judgment, and rejected the plaintiffs’ motions. The plaintiffs filed a timely appeal, arguing that the court erred in excluding their experts and denying their motion to amend.

Admissibility of expert testimony. In analyzing the admissibility of the expert opinions, the appellate court premised its decision on the fact that Minnesota is a Frye-Mack state. The Frye-Mack standard requires that when an opinion is based upon a novel scientific theory, the proponents of the theory must establish that the underlying scientific evidence is generally accepted in the relevant scientific community. The plaintiffs argued that this standard was not applicable because the science used was not "novel." The court rejected that assertion, concluding that because the scientific theory espoused had not been considered by any court, it was novel. In reaching its conclusion that the relevant scientific community had not accepted the novel scientific opinion that FAWDs caused an increase in SSIs, the court examined several scientific papers and studies. Furthermore, based on the fact that the plaintiffs’ experts had not previously studied the efficacy of the FAWDs, published peer-reviewed articles relevant to the claims, or asserted that their general-causation opinions were generally accepted within the relevant scientific community, the appellate panel found no error in the lower court’s decisions as to the admissibility of the plaintiffs’ experts and the manufacturer’s motion for summary judgment.

Punitive damages. As to the request to add a punitive-damages claim, the denial of the plaintiffs’ motion was not an abuse of discretion because they failed to establish by clear and convincing evidence that the device manufacturer had acted with a deliberate disregard for the rights and safety of others or that the device presented a high probability of injury.

The case is No. A18-0473.

Attorneys: Wilbur W. Fluegel (Fluegel Law Office) for Scott Sehnert. Jerry W. Blackwell (Blackwell Burke, PA) and Jeffrey P. Justman (Faegre Baker Daniels LLP) for 3M.

Companies: 3M

MainStory: TopStory ExpertEvidenceNews CausationNews DamagesNews MinnesotaNews

Back to Top

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.