Bair Hugger Warming Blanket Lawsuits

Thousands of people who developed serious infections have filed lawsuits over Bair Hugger warming blankets. The devices play a critical role in keeping patients’ body temperature stable during surgery, but a design flaw may allow the blankets to spread hard to treat bacteria.

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Fast Facts:

  • People claim infections caused by Bair Hugger devices led to additional surgeries, amputations or death
  • More than 4,000 people have files lawsuits over Bair Hugger warming devices
  • The first Bair Hugger lawsuit should be ready for trial in mid-2018

The Bair Hugger Normothermia System uses forced-air to keep patients warm during orthopedic surgery. But studies have found the devices may lift bacteria or other debris from below operating tables and carry these contaminants into open surgical wounds, increasing the risk of infections.

Some patients have suffered serious infections leading to complications including amputation and death following surgeries using the devices. The first of more than 4,200 lawsuits against Bair Hugger’s manufacturers was filed in 2011.

Status of Bair Hugger Lawsuits

As of January 2018, there were 4,215 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.

The cases in the Bair Hugger MDL are from across the U.S. and were first combined in a Minnesota federal court in December 2015. New lawsuits have been added since then.

5 bellwether trials will test arguments in Bair Hugger Lawsuits starting in 2018.

The MDL court has selected five cases to serve as bellwether trials. Bellwethers are “test cases” that are tried before juries. The 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 or the amount of settlements.

The first Bair Hugger trial is scheduled to begin in 2018.

Timeline of Bair Hugger Lawsuits:

  • 1987

    FDA approves Bair Hugger as a surgical warming device

  • 2011

    Patient Tommy Walton develops infection following surgery, requires 15 follow up surgeries

  • 2013

    Walton files first Bair Hugger lawsuit seeking $1 million in damages

  • 2013 – 2015

    More than a dozen other patients file lawsuits in federal courts

  • December 2015

    A federal panel combines first 14 Bair Hugger lawsuits into a multidistrict litigation

  • August 2017

    MDL judge selects five cases for bellwether trials

  • January 2018

    4,414 Bair Hugger lawsuits have been filed, 4,215 are still pending in the MDL

  • April 30, 2018

    First two Bair Hugger bellwether cases are to be ready for trial

Bair Hugger Injuries People Are Suing Over

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

Oftentimes, these infections led to other complications including:

  • Additional surgeries
  • Hospitalization
  • Amputation
  • Death

Infections following use of Bair Hugger devices have included MRSA, methicillin-resistant Staphylococcus aureus, 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

Many of the people who have filed lawsuits against 3M claim that the airflow from Bair Hugger products led to their infections during surgery.

Here are details about a few of their cases:

  • 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 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 following 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

    Timothy Johnson claimed he developed a deep-joint infection after total-knee arthroplasty in 2010. His leg had to be amputated following multiple revision surgeries failed to remove the infection. In addition to compensation for pain and suffering and medical expenses, Johnson is seeking punitive damages.

Accusations Against Bair Hugger’s Manufacturer

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

People filing Bair Hugger lawsuits claim its 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

Verdicts and Settlements in Bair Hugger Lawsuits

There have been no verdicts and 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 may include:

  • 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.

Complications from a Bair Hugger warming device? We can help.

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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 Warming Devices

The U.S. Food and Drug Administration (FDA) has received hundreds of adverse event reports, including at least 11 reports relating to patient deaths, relating to Bair Hugger devices since 2013.

Neither 3M nor Arizant has issued a recall of the devices over reported infections related to the Bair Hugger units.

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.

Author

Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.


Hide Sources

  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. U.S. Judicial Panel on Multidistrict Litigation. (2018, January 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-January-16-2018.pdf
  8. 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
  9. 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
  10. 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/
  11. 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

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