Timeline of the Bair Hugger Lawsuit
Warming blankets are widely used during surgeries in the United States because consistently maintaining a patient’s body temperature throughout the procedure has been found to decrease bleeding, as well as reduce the time needed for recovery. The Bair Hugger warming system, manufactured by 3M, forces warm air underneath a special blanket that is placed over a patient during surgery. Operating rooms typically have a special ventilation system that directs the airflow from the ceiling to the floor in order to prevent contamination of the surgical site. It has been demonstrated that excess warm air from the warming blankets can create convection currents that draw contaminated air from the floor up to the patient, possibly corrupting the incision site.
Some patients who have undergone knee or hip replacement surgeries in which Bair Hugger warming blankets were used have reported suffering from deep joint infections. This type of infection is extremely difficult to treat, and the artificial joint can form a protective barrier against the body’s natural immune response.
The timeline of the Bair Hugger lawsuit extends from the first reports of adverse events through the current stage of litigation. If you or a loved one suffered an injury from a surgical procedure in which a Bair Hugger warming blanket was used, please contact an experienced defective product attorney to arrange a complimentary case evaluation.
In 1987, the first Bair Hugger warming system was given premarket clearance for use by the U.S. Food and Drug Administration (FDA). Since that time, numerous adverse events concerning Bair Hugger devices have been reported to the FDA. Most of the early adverse event reports have involved patients who were burned from exposure to heat during the surgery or equipment malfunctions that allowed cold air to circulate underneath the blanket.
Dr. Scott Augustine, the inventor of the Bair Hugger system, has spoken out regarding the safety of the products.
Between 1990 and 2006, the FDA granted additional clearances for 14 similar products made by the manufacturer of the Bair Hugger system. The premarket clearance program is used by the FDA to approve medical devices that are similar to existing products without extensive clinical testing for safety.
The Inventor Speaks Out
Dr. Scott Augustine, the inventor of the Bair Hugger system, has spoken out regarding the safety of the products. After resigning from Arizant (which was subsequently purchased by the 3M corporation) in 2002, he has pointed to over 170 scientific studies that have shown the device to be beneficial to maintaining a patient’s body temperature during surgery. However, Dr. Augustine emphasizes that none of these studies analyzed the effects of forced air in orthopedic surgeries, specifically in joint replacement procedures. He claims that forced air from the device can spread bacteria that is associated with hospital-acquired infections.
FDA Warning Letter
In June 2010, the FDA sent a letter to the manufacturer of Bair Hugger devices indicating that the company had violated several sections of the Federal Food, Drug, and Cosmetic Act, including:
- Failure to report to the FDA a recent malfunction of the device and that the device may likely cause serious injury.
- Failure to report to the FDA that the device had caused serious injury.
- Failure to develop, maintain, and execute FDA reporting procedures.
- Failure to make and maintain sufficient adverse event files.
Scientific Studies Concerning Bair Hugger Devices
A study published in The Bone & Joint Journal in February 2013 looked at a team of researchers who investigated how forced-air warming blankets, like the Bair Hugger system, can increase the concentration of airborne particles near the incision site. The study found that the warm air waste from the blankets can create convection currents that interact with the one-directional ventilation flow in the surgical suite, causing turbulence over the patient. The convection currents can pull potentially contaminated air from underneath the surgical table to the incision site and increase the particle concentration over the patient by 1,000 times.
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Another study, published in Anesthesia & Analgesia in August 2013, examined the effects of forced-air warming blankets and convective warming blankets on ventilation performance in an operating room. The study concluded that excess heat from forced-air warming devices disrupted the ventilation airflow over the surgical site, whereas convective devices did not. The study also recommended further studies into the effects that forced-air warming devices have on the outcomes of surgeries that are contaminant-sensitive, such as orthopedic joint replacement procedures.
A November 2014 article was published in the Journal of Hospital Infection that reviewed published experimental and clinical research concerning the infection control dangers of using forced-air warming devices, such as the Bair Hugger system.
The study concluded that forced-air warming devices do contaminate the ventilation of the incision site. Although the authors of the article stated that there was no definite link of increased surgical site infections with the use of forced-air warming devices, they recommend that surgeons consider alternative types of warming devices when contamination of the surgical site could be critical to patient safety.
Claims Filed in the Bair Hugger Lawsuit
In 2013, a lawsuit was filed by a Texas man who had hip replacement surgery in 2011. He claims that the Bair Hugger device used during his surgery caused an infection in his hip that required 15 additional surgeries, including the eventual removal of the artificial joint.
In 2014, a man filed a lawsuit stemming from his knee replacement surgery at the University of Kansas Hospital in September 2010. Following the surgery, he developed a MRSA (Methicillin-Resistant Staphylococcus Aureus) infection and his leg needed to be amputated. His lawsuit also claims that 3M was aware of the dangers associated with Bair Hugger devices by 2009, yet the company continued to produce the devices and market them as safe for general and orthopedic surgeries.
In a separate 2014 Bair Hugger lawsuit, a woman claims that she developed a MRSA infection after knee replacement surgery and had to undergo 11 additional surgeries. Part of her leg was amputated and she is now confined to a wheelchair.
Consolidating Cases in Multidistrict Litigation
As of September 2015, at least 14 Bair Hugger lawsuits had been filed in five federal district courts across the country. One plaintiff filed a motion to centralize all of the cases before a single federal judge in Minnesota.
By November 2015 over 50 Bair Hugger lawsuits were filed in the United States by patients who claimed that the device was the cause of serious infections. In December 2015, the cases were centralized in multidistrict litigation (MDL) before a federal court in Minnesota. In January 2016, the judge issued its first pre-trial order stating that the court would begin holding regular status conferences beginning in February.
On January 15, 2016, at least 82 Bair Hugger lawsuits were pending in court. As of February 16, 2016, at least 112 Bair Hugger claims had been filed by plaintiffs who had sustained injuries. As more cases are filed regarding the use of Bair Hugger warming systems during surgery, the individual claims will be included in the current MDL.
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Each state has its own statute of limitations that determines the time constraints that victims have to file a claim before the manufacturer is released from liability. If you or a loved one experienced a deep joint infection after surgery in which a Bair Hugger device was used, please contact a defective medical device attorney today to explore your legal rights.