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FDA: No Association Between 3M Bair Hugger Blankets and Infection

n a potentially damaging blow to plaintiffs in mass tort litigation, the Food and Drug Administration says it "has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection."

Plaintiffs have filed 3,262 lawsuits in federal court against 3M over its Bair Hugger surgical warming blanket.

They include patients who developed hip and knee infections following joint replacement surgery that involved the use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The cases are consolidated before U.S. District Judge Joan N. Ericksen in MDL 2666 in Minnesota, IN RE: Bair Hugger Forced Air Warming Devices Products Liability Litigation.

Blankets regulate patient temperature

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publically available medical literature, operating room guidelines, and ventilation requirements.

In a safety alert, the FDA says it "is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients."

"The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery)."

FDA recommends

It adds, "the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Meanwhile, Judge Ericksen scheduled five bellwether cases involving the 3M Bair Hugger for trial on February 26, 2018:

  • Kamke v. 3M Co., et al. – 16cv1225 (JNE/FLN)
  • Nugier, et al. v. 3M Co., et al. – 16cv4246 (JNE/FLN)
  • Walker v. 3M Co., et al. – Ramsey Cty. Case No. 62-cv-16-1257
  • Skaar, et al. v. 3M Co., et al. – 16cv2969 (JNE/FLN)
  • Gareis v. 3M Co., et al. – 16cv4187 (JNE/FLN)

Experts on specific causation as to Kamke and Nugier must be disclosed under Rule 26(a)(2) by October 9, 2017. Rebuttal expert reports and disclosures of the identity of rebuttal expert witnesses must be exchanged by October 30, 2017. Depositions of expert witnesses must be completed by December 15, 2017.

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