Bair Hugger Warming Blanket Lawsuits

Lawsuits claim Bair Hugger brand surgical warming blankets led to serious infections that required additional surgery or amputations. As of September 2018, there were 4,882 active lawsuits in federal court over the blankets. Manufacturer 3M won the first bellwether trial in May 2018. A second case was scheduled for trial in December 2018.

Bair Hugger lawsuits claim the surgical warming blankets affected airflows in operating rooms, allowing contaminants to get into patients’ incisions and cause infections. A judicial panel combined federal lawsuits from across the U.S. in a Minnesota federal court.

Models named in lawsuits include Model 500, Model 505, Model 750 and Model 775. Companies being sued are Arizant Healthcare, which has produced Bair Hugger warming blankets since 1987, and 3M Company, which acquired Arizant for $810 million in 2010.

Timeline of Bair Hugger Lawsuits
  • 1987
    FDA approved Bair Hugger as a surgical warming device.
  • 2013
    Patient Tommy Walton filed the first Bair Hugger lawsuit, asked for $1 million.
  • 2013 – 2015
    More than a dozen other patients filed lawsuits in federal courts.
  • December 2015
    A federal panel combined the first 14 Bair Hugger lawsuits into a multidistrict litigation.
  • August 2017
    The MDL judge selected five cases for bellwether trials.
  • May 2018
    Manufacturer 3M won the first bellwether trial in Minneapolis.
  • November 2018
    5,455 Bair Hugger lawsuits had been filed and 4,944 remained pending in the MDL.
  • December 2018
    The second bellwether case was scheduled for trial.

Lawsuits Claim Infections Led to Amputations and Deaths

The lawsuits focus on the most serious Bair Hugger complications. They claim people developed serious infections after surgeries involving the devices.

Some people lost limbs to infection or had a loved one die. Many of the patients suing had knee and/or hip replacement surgeries resulting in deep-joint infections that were difficult to treat. Patients say they developed MRSA (methicillin-resistant Staphylococcus aureus), which is an antibiotic-resistant infection that can lead to skin infection, sepsis, pneumonia and bloodstream infections.

Bair Hugger lawsuits claim infections caused:
  • Additional surgeries
  • Hospitalization
  • Amputation
  • Death

Bellwether Trials Started in May 2018

One Bair Hugger lawsuit has gone to trial so far. It ended in May 2018 with a verdict in favor of 3M.

Louis Gareis filed the lawsuit. His lawyers sought more than $200,000 in damages. They promised to appeal the verdict.

Gareis underwent hip replacement surgery in which doctors used a Bair Hugger device. Gareis blamed the device for infections.

There have been no publicized settlements. People who have filed suit have asked for as much as $1 million in damages from 3M and Arizant.

Lawsuit Examples
Tommy Walton
Tommy Walton had hip replacement surgery in March 2011 and filed the first Bair Hugger lawsuit in 2013. Walton developed a deep-joint infection after his surgery and required 15 follow-up surgeries to remove the infection.
Barbara Libby
Barbara Libby claimed she developed a deep-joint infection and required seven additional surgeries because of a Bair Hugger device. Libby says she now suffers from permanent disability and decreased mobility.
Rosie Bartel
Rosie Bartel developed a MRSA infection requiring 27 additional surgeries following a knee replacement in 2009. Eventually doctors amputated her right leg below the hip. In addition to her physical suffering, her medical problems caused her to lose her job and her home.
Timothy Johnson
Timothy Johnson claimed he developed a deep-joint infection after total knee arthroplasty in 2010. His leg had to be amputated when multiple revision surgeries failed to remove the infection. In addition to compensation for pain and suffering and medical expenses, Johnson is seeking punitive damages.
Ruth Childers
Ruth Childers claimed that use of a Bair Hugger device gave her an antibiotic-resistant infection following knee replacement surgery in 2013. She had to have her leg amputated above the knee. She is seeking $1 million in damages.

FDA Is Aware of Infection Concerns

The U.S. Food and Drug Administration (FDA) has received hundreds of adverse event reports, including multiple reports about patient deaths, relating to Bair Hugger devices since 2013.

In August 2017, the FDA said it was aware of infection concerns with the blankets. But the agency recommended that health care providers continue using them.

The FDA sent a letter to health care providers highlighting the benefits of patient warming devices during surgery. These included less blood loss, faster recovery and decreased infection risk.

The letter said the agency reviewed medical research and data. The FDA also pledged to “actively monitor this situation.”

Since approving the first Bair Hugger warming device in 1987, the FDA has issued at least 14 additional clearances for changes or new versions of the devices.

3M Recalled 165,000 Bair Hugger Warming Blankets

In January 2018, 3M recalled 165,000 Bair Hugger warming blankets for a design defect. Some blankets failed to fully inflate after the company redesigned the system’s underbody blankets. 3M warned in its recall letter that partial inflation could prevent proper warming.

An adverse event report to the FDA claimed a patient suffered hypothermia during surgery in which a blanket failed to fully inflate. The device was among the lots later recalled. The patient required intensive care unit treatment to regain normal body temperature.

Neither 3M nor Arizant has issued a recall of the blankets due to reported infections.

3M’s Lawsuit Response

After 3M won the first bellwether trial in 2018, the company released a statement saying it was “grateful the jury put science first.”

“This verdict affirms the science behind the 3M Bair Hugger system, which has been proven to be a safe and effective way to warm patients during surgery,” the statement said.

3M and Arizant continue to advertise the blankets as safe and effective in all surgeries, including orthopedic procedures. The manufacturers contend that 170 studies have found forced-air warming to be safe.

However, Dr. Scott Augustine — the inventor of Bair Hugger products — claims those studies are misleading and measured the wrong things. He has urged 3M and Arizant to recall the devices.

Augustine designed and sells a competing medical device called the HotDog. In 2010, 3M said in a statement: “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”

Please seek the advice of a medical professional before making health care decisions.

Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By
Kevin Connolly
Kevin Connolly Managing Editor
Medically Reviewed By
Dr. John A. Daller
Dr. John A. Daller American Board of Surgery

18 Cited Research Articles

  1. Meier, B. (2010, Dec. 24). Doctor says a device he invented poses risks. The New York Times. Retrieved from:http://www.nytimes.com/2010/12/25/business/25invent.html
  2. Timothy Johnson v. 3M Company and Arizant Health Care. Case No. 2:14-cv-02044-KHV-KGS. Retrieved from:http://www.clg.org/pdf/7/1/8/U.S.-Complaint---Kansas.pdf
  3. Welbes, J. (2013, March 28). Texas patient suing 3M for Bair Hugger injury. TwinCities.com Pioneer Press. Retrieved from:http://www.twincities.com/ci_22894244/texas-patient-suing-3m-bair-hugger-injury
  4. U.S. Judicial Panel on Multidistrict Litigation. (2015, December 11). In Re: Bair Hugger Forced Air Warming Devices Products Liability Litigation; Transfer Order. Retrieved from: http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2666-Initial_Transfer-12-15.pdf
  5. U.S. District Court, District of Minnesota. (2017, August 29). Pretrial Order No. 22. Retrieved from http://www.mnd.uscourts.gov/MDL-Bair-Hugger/Orders/2017/2017-0829-PTO22.pdf
  6. Centers for Disease Control and Prevention. (2016, May 16). Methicillin-resistant Staphylococcus aureus (MRSA). Retrieved from https://www.cdc.gov/mrsa/index.html
  7. 3M. (2010, October 13). 3M Completes Acquisition of Arizant Inc. Retrieved from http://news.3m.com/press-release/company/3m-completes-acquisition-arizant-inc
  8. Anesthesiology News. (n.d.). Arizant Healthcare, Inc., a 3M Company. Retrieved from http://www.anesthesiologynews.com/ancp/0813/content/ANCP13_020a.html
  9. U.S. District Court for the District of Minnesota. (2017, October 20). Order; In Re: Bair Hugger Forced Air Warming Devices Products Liability Litigation. Retrieved from http://newyork.legalexaminer.com/wp-content/uploads/sites/196/2017/11/bair-hugger-order-10-20-2017.pdf
  10. 3M Company. (2018, January 25, 2018). Field Safety Notice. Federal Institute for Drugs and Medical Devices (Germany). Retrieved from https://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2018/01008-18_kundeninfo_en.pdf?__blob=publicationFile&v=1
  11. U.S. Food and Drug Administration. (2018, February 12). Class 2 Device Recall 3M Bair Hugger Normothermia System, Full Access Underbody Warming Blanket. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=161064
  12. Carlson, J. (2018, February 13). 3M Recalls Some Bair Hugger Underbody Warming Blankets. Minneapolis StarTribune. Retrieved from http://www.startribune.com/3m-recalls-bair-hugger-underbody-warming-blankets/473963843/
  13. U.S. Food and Drug Administration. (2018, January 30). MAUDE Adverse Event Report: 3M Health Care 3M Bair Hugger Full Access Underbody Warming Blanket Disposable Thermal Blanket. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7229320&pc=DWJ
  14. U.S. District Court, District of Minnesota. (2018, April 4). Pretrial Order No. 25. In re: Bair Hugger Forced Air Warming Products Liability Litigation. Retrieved from http://www.mnd.uscourts.gov/MDL-Bair-Hugger/Orders/2018/2018-0404-PTO25.pdf
  15. U.S. District Court, District of Minnesota. (2018, January 19). Pretrial Order N0. 24. In re: Bair Hugger Forced Air Warming Products Liability Litigation. Retrieved from http://www.mnd.uscourts.gov/MDL-Bair-Hugger/Orders/2018/2018-0119-PTO24.pdf
  16. Carlson, J. (2018, May 13). 3M’s Patient Warming Device Goes on Trial in Minneapolis. Minneapolis Star Tribune. Retrieved from http://www.startribune.com/3m-s-patient-warming-device-goes-on-trial-in-minneapolis/482501552/
  17. U.S. Food and Drug Administration. ( 2017, August 30). Information About the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers. Retrieved from https://www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm573837.htm
  18. U.S. Judicial Panel on Multidistrict Litigation. (2018, November 15). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-November-15-2018.pdf
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