Defective Devices

Surgical Warming Blanket May Increase Risk of Serious Infections

August 12, 2022

If you or a loved one developed a serious infection within one year of hip or knee surgery between 2014 and present that required additional surgical procedures to remove and clean or replace the hip or knee implant, you may be entitled to significant compensation without ever going to court.

What is a Bair Hugger?

The Bair Hugger is a forced air warming blanket system manufactured and sold by 3M. Medical personnel primarily use this disposable device to combat the risk of hypothermia in orthopedic surgeries, particularly knee and hip replacement surgery. Hypothermia occurs when the body loses heat faster than it can produce it.  Usually, anesthetized patients lose body heat quickly during a surgery. Hypothermia during surgeries can lead to blood loss, more extended hospitalization, and infections. Keeping the body at proper temperature has proven to reduce bleeding, speed up recovery time, and provide other benefits.

3M manufactures and sells the Bair Hugger system to thousands of hospitals all over the United States. Millions have been used in hospitals since the US Food and Drug Administration first approved the warming device in 1987.  In fact, the Bair Hugger system is the preferred patient warming device in 8 out of the top 10orthopedic hospitals in the United States and has been used in an estimated 180million procedures since 1987.

What’s the Problem with the Bair Hugger?

The Bair Hugger system pushes warm air through a hose into a blanket covering a patient. The device releases warm air over a patient’s body, but also releases air under the surgical table. Plaintiffs claim the system caused them to develop infections after undergoing surgical procedures.

Research published in the Journal of Bone and Joint Surgery found that air circulated by a forced hot air warming blanket system contained 2,000 times more potentially contaminated particles when compared to air circulated by a similar device, greatly increasing the risk of infection.Patients may require additional surgeries to treat these infections. A patient may also require antibiotic therapy.  If a patient’s condition cannot tolerate subsequent surgeries, they may need to stay on long term antibiotic treatment. In the worst cases, patients may need joint fusion, device removal or even limb amputation.  

Back in 2010, Dr. Scott Augustine, the inventor of the Bair Hugger device, warned about potential problems with the system. He stated that the forced air released under the table had the potential to cause germs and bacteria to spread throughout the room, landing on a patient's surgical site.This could cause an infection in the patient’s hip or knee, such as sepsis andMethicillin-resistant Staphylococcus aureus (MRSA). Unfortunately, these infections are very difficult to treat when they occur deep in a patient's joint or tissue. For example, one woman claimed the Bair Hugger caused a drug-resistant infection that required her leg to be amputated.


Factors That Increase the Risk of Infections

Some of factors that increase the risk of infections after knee and hip replacement surgeries include:

  • Diabetes
  • Obesity
  • Immunosuppressive treatments such as chemotherapy
  • Peripheral vascular disease
  • Immune deficiencies, including HIV

Symptoms of An Infection

Early detection of a possible infection is critical. Some symptoms include:

  • Fatigue
  • Swellings
  • Warmth and wound redness
  • Wound drainage
  • Fevers and night sweats

What Is the Current Status of Bair Hugger Lawsuits?

District Court Tosses all Suits in 2019. Thousands of lawsuits were filed against 3M by individuals who claimed they suffered serious infections because of this medical device. These plaintiffs claimed that the device was defective because it transferred antibiotic-resistant bacteria into open surgical wounds, either by disrupting airflow in the operating room or through contamination of the device itself. Plaintiffs further claimed that 3M knew about the potential increased risk of joint infections linked to the use of this medical device during hip and knee replacement surgeries. Yet, the company failed to warn of these dangers or to redesign the product to make it safer.

In 2018, the lawsuits were combined into one multi-district litigation (MDL) before U.S. District Judge Joan Ericksen in Minnesota to handle all of the national discovery and evidence gathering before one court.However, in August 2019, Judge Ericksen determined that plaintiffs’ allegations lacked scientific support and proceeded to dismiss virtually all of the cases finding that the plaintiffs' experts did not present enough reliable medical evidence that the Bair Hugger increased the risk of surgical infections.

Appellate Court “Revives” Plaintiffs’ Claims. The 8th U.S. Circuit Court of Appeals recently said that Judge Ericksen had wrongly excluded testimony from medical experts supporting the plaintiffs’ claims. Its ruling revived nearly 6,000 lawsuits alleging that 3M’s device intended to keep surgical patients warm caused them to develop infections.

Although the appeals court conceded that there were weaknesses in the medical experts’ opinions, it concluded that the opinions weren’t “so fundamentally unsupported that they had to be excluded.”  “Thousands of individuals who were injured by this defective and dangerous device will now have their day in court,” said Michael Sacchet, a lawyer for the plaintiffs.

Bellwethers Trials Scheduled in MDL. In March of 2022, the lead MDL plaintiff and defense attorneys began to identify bellwether cases for trial in the MDL. Bellwether trials are sample jury trials conducted to gauge how jurors react to the evidence and arguments. They are intended to give plaintiffs and defendants an idea of how judges and juries respond to the common issues in a representative sample of cases. Bellwether trials can often promote open and informed settlement discussions that can lead to a global resolution of cases in the MDL. 

The parties have each identified 16 cases from the 150 randomly selected by the MDL court. One of the cases was chosen by both sides, bringing the total number of federal cases nominated as bellwethers to 31. The parties had also agreed to include some cases filed in Ramsey County,Minnesota, and each identified two such cases. One was chosen by both sides, resulting in three total Ramsey County cases nominated as bellwethers. The nominations were selected from cases in which the plaintiffs underwent either a hip or knee implant procedure. The case is In re: Bair Hugger Forced Air Warming Products Liability Litigation, case number 0:15-md-02666, in the U.S. District Court for the District of Minnesota.


You may be entitled to compensation

If you or a loved one developed a serious infection within one year of hip or knee surgery between 2014 and present that required additional surgical procedures to remove and clean or replace the hip or knee implant, you may be entitled to significant compensation without ever going to court. Potential damages include reimbursement of medical expenses, lost work income and significantly, non-economic damages such as pain and suffering and emotional distress.

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