First of 4,300 Bair Hugger Infection Lawsuits Goes to Trial

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3M World Headquarters
3M World Headquarters in Maplewood, MN, USA

A lawsuit that could affect thousands of people went to trial in Minneapolis on Monday.

It is one of 4,300 Bair Hugger warming blanket lawsuits filed in U.S. federal court. The lawsuits claim the devices caused serious infections. The infections led to more surgeries or amputations.

The trial is the first bellwether trial in the Bair Hugger multidistrict litigation (MDL).
Bellwethers are “test cases.” The outcome can sometimes lead to a settlement or dismissal of other lawsuits.

More Bair Hugger bellwethers are likely. The court has ordered both sides in the Bair Hugger lawsuits to select eight more cases to go to trial.

U.S. District Court to Drugwatch: Opening Statements Have Begun

The U.S. District Court for the District of Minnesota told Drugwatch on Tuesday afternoon that opening statements had begun in the first Bair Hugger trial.

Louis Gareis sued manufacturer 3M in the Minnesota case. Gareis had hip replacement surgery in 2010.

He claims a Bair Hugger used during surgery caused a deep wound infection. Doctors had to remove Gareis’ implant two years later to stop the infection.

Lawyers expect the Gareis trial to last three weeks. In April 2018, the court ordered a second Bair Hugger lawsuit ready for trial in December 2018. The court did not set an exact date.

What Are Bair Hugger Warming Blankets?

Bair Huggers stabilize patient’s temperatures during surgery. Four in five U.S. hospitals use the devices.

Bair Huggers force air into inflatable warming blankets. The air never touches the patient. And the blankets are disposable.

But four studies suggest the devices stir up air in operating rooms. Researchers claim the devices can lift bacteria from below operating tables. It then floats on air currents into open surgical wounds.

Joint replacement surgeries often include Bair Huggers. Joint implants are susceptible to bacteria.

A single bacterium can live and grow on the devices. It can create a “biofilm” leading to infection months after surgery.

3M claims the devices are safe after 200 million surgeries. The U.S. Food and Drug Administration reviewed the research last year. The agency said it was “unable to identify” the link between Bair Huggers and infection.

Thousands Filed Bair Hugger Lawsuits

People have filed about 4,700 lawsuits over Bair Hugger infections. A federal panel combined Bair Hugger lawsuits into an MDL in 2015. More than 4,300 remained pending as of April 2018.

MDLs help several similar lawsuits move through the legal process more efficiently.

People who filed Bair Hugger lawsuits claim the devices spread infections during surgery. They claim they needed surgery or hospital stays to stop infections they developed.

Some people needed amputations. Others claim a Bair Hugger-related infection killed a loved one.

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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

8 Cited Research Articles

  1. 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
  2. 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
  3. 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/
  4. U.S. Judicial Panel on Multidistrict Litigation. (2018, April 16). MDL Statistics Report. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-April-16-2018.pdf
  5. McGovern, PD. (2011, November). Forced-air warming and ultra-clean ventilation do not mix: an investigation of theatre ventilation, patient warming and joint replacement infection in orthopaedics. The Journal of Bone and Joint Surgery. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/22058308
  6. Belani, KG et al. (2012, July 19). Patient Warming Excess Heat: The Effects on Orthopedic Operating Room Ventilation Performance. Anesthesia & Analgesia. Retrieved from https://www.ncbi.nlm.nih.gov/labs/articles/22822191/
  7. Legg, AJ. (2013). Forced-Air Patient Warming Blankets Disrupt Unidirectional Airflow. The Journal of Bone and Joint Surgery. Retrieved from https://www.ncbi.nlm.nih.gov/labs/articles/23450029/
  8. Dasari, KB. (2012 March). Effect of forced-air warming on the performance of operating theatre laminar flow ventilation. Anaesthesia. Retrieved from http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2044.2011.06983.x/full
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