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Bair Hugger Warming Blanket Lawsuits

The first lawsuit alleging links between a Bair Hugger device and infection failed in May 2018. A second trial against Bair Hugger manufacturer 3M is scheduled for December 2018. More than 5,000 people have filed lawsuits over the devices. They claim that Bair Huggers used in surgery led to serious infections. The infections required another surgery or amputations.

Bair Hugger Lawsuit Facts
  1. Number of Lawsuits 5,028 (4,623 still pending)
  2. Plaintiff Injuries Serious infections, Methicillin-resistant Staphylococcus aureus (MRSA)
  3. Defendants 3M Company and Arizant Healthcare
  4. Litigation Status Active
  5. Settlement No publicized settlements
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As of July 2018, there were 4,623 active lawsuits over Bair Hugger warming blankets in a multidistrict litigation (MDL).

MDLs combine similar lawsuits to move them more quickly and cost-effectively through the legal system.

Bair Hugger’s manufacturer, 3M, won the first bellwether trial in May 2018. Bellwethers are “test cases” that are tried before juries. A second bellwether case is scheduled for trial in December 2018.

Bellwether trial verdicts can help both sides gauge how other lawsuits will do at trial.

The outcome of bellwethers can sometimes help determine if other cases will proceed to court. It can also influence settlements.

The cases in the Bair Hugger MDL are from across the U.S. A federal panel combined them in a Minnesota federal court in December 2015. The court has added new lawsuits since then.

Timeline of Bair Hugger Lawsuits
  • 1987
    FDA approved Bair Hugger as a surgical warming device
  • 2011
    Patient Tommy Walton developed infection following surgery, requires 15 follow up surgeries
  • 2013
    Walton filed first Bair Hugger lawsuit seeking $1 million in damages
  • 2013 – 2015
    More than a dozen other patients filed lawsuits in federal courts
  • December 2015
    A federal panel combined first 14 Bair Hugger lawsuits into a multidistrict litigation
  • August 2017
    MDL judge selected five cases for bellwether trials
  • May 2018
    Manufacturer 3M won first Bair Hugger bellwether trial in Minneapolis
  • July 2018
    5,028 Bair Hugger lawsuits had been filed, 4,623 remained pending in the MDL
  • December 2018
    Second bellwether case ready for trial

Bair Hugger Injuries People Sue Over

People claim in their lawsuits that they or close relatives developed serious infections after surgeries involving Bair Hugger warming blankets. Many had knee and/or hip replacement surgeries resulting in difficult to treat deep joint infections.

Bair Hugger Lawsuits Claim Infections Caused:
  • Additional surgeries
  • Hospitalization
  • Amputation
  • Death

Lawsuits claim infections following use of Bair Hugger devices have included MRSA (methicillin-resistant Staphylococcus aureus). MSRA is an antibiotic-resistant infection that can cause severe complications.

MRSA Can Lead To:
  • Skin infections
  • Sepsis – a life-threatening response to infection
  • Pneumonia
  • Bloodstream infections

Bair Hugger lawsuits claim that the devices affected the airflow in operating rooms. They allege this allowed contaminants to get into patients’ incisions and cause infections. 3M says Bair Huggers are not responsible for infections. The company claims that more than 200 studies and clinical trials show the devices are safe and effective.

Bair Hugger 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. He is seeking more than $1 million in damages.
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 an MRSA infection requiring 27 additional surgeries following a knee replacement in 2009. Eventually her right leg was amputated below the hip. In addition to her physical suffering, her medical problems caused her to lose her job and eventually 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.

Accusations Against Bair Hugger Manufacturers

Lawsuits against 3M Company and Arizant Healthcare, Bair Hugger’s manufacturers, claim that the companies marketed an unsafe product and didn’t do enough to warn the public of its dangers.

Bair Hugger Lawsuits Claim Manufacturers:
  • Failed to properly and thoroughly test Bair Hugger warming devices
  • Did not conduct effective testing and surveillance of Bair Hugger devices after they were on the market
  • Knew or should have known of Bair Hugger risks
  • Failed to warn the public of the risks from the devices
  • Continued to market Bair Hugger warming blankets after risks were discovered

Arizant, Inc. has produced the Bair Hugger since 1987. In 2010, 3M acquired Arizant for $810 million.

Bair Hugger Models Named in Lawsuits:
  • Model 500 (no longer in service)
  • Model 505
  • Model 750
  • Model 775

Bair Hugger Verdicts and Settlements

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. Doctors used a Bair Hugger device during the surgery. Gareis blamed the device for infections.

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

Any verdicts or settlements in the Bair Hugger lawsuits may depend on the nature of each individual’s injuries or losses.

Factors That May Determine Bair Hugger Verdicts Or Settlements:
  • Medical bills
  • Disability
  • Death of a relative
  • Lost wages
  • Pain and suffering

Class Action Lawsuits over Bair Hugger Warming Blankets

There are currently no class action lawsuits over Bair Hugger warming blankets. New lawsuits filed over the devices have generally been combined into the MDL currently underway in Minnesota.

Generally, lawsuits over medical devices are better suited to MDLs than to class-action lawsuits. Both combine the resources of several — even thousands — of plaintiffs, but there are important differences. One of the most important is that class actions can only be filed in cases where the damages involved would make an individual lawsuit impractical. The amounts of damages injured people are seeking in the Bair Hugger lawsuits are likely too high to qualify as a class action.

Recalls and FDA Action on Bair Hugger Devices

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.

Neither 3M nor Arizant has issued a recall of Bair Hugger due to reported infections.

In August 2017, the FDA said it was aware of infection concerns with Bair Huggers. But the agency recommended that health care providers continue using Bair Huggers. The FDA sent out a letter to health care providers. It highlighted 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 in making its decision. The letter also said that the FDA would continue 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.

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 Bair Hugger 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.

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

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15 Cited Research Articles

  1. 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
  2. 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
  3. Centers for Disease Control and Prevention. (2016, May 16). Methicillin-resistant Staphylococcus aureus (MRSA). Retrieved from https://www.cdc.gov/mrsa/index.html
  4. 3M. (2010, October 13). 3M Completes Acquisition of Arizant Inc. Retrieved from http://news.3m.com/press-release/company/3m-completes-acquisition-arizant-inc
  5. Anesthesiology News. (n.d.). Arizant Healthcare, Inc., a 3M Company. Retrieved from http://www.anesthesiologynews.com/ancp/0813/content/ANCP13_020a.html
  6. 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
  7. 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
  8. 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
  9. 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/
  10. 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
  11. 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
  12. 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
  13. 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/
  14. 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
  15. U.S. Judicial Panel on Multidistrict Litigation. (2018, July 16). 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-July-16-2018.pdf
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