3M Bair Hugger Lawsuits
Several lawsuits have been filed by plaintiffs that claim that the Bair Hugger warming blanket allows microorganisms from the surgical floor to rise and settle on open surgical areas, increasing risk of serious and sometimes life-threatening infections.
Pittsburgh residents who underwent surgery with a Bair Hugger warming blanket and later developed serious infections are advised to speak to the Bair Hugger attorneys at Chaffin Luhana immediately. Hundreds of patients have already filed personal injury lawsuits against manufacturers 3M and subsidiary Arizant.
What is the Bair Hugger Warming Blanket?
The FDA first approved the Bair Hugger warming blanket in 1987. The manufacturers did not have to offer clinical trials as proof of the products’ safety and efficacy, however. Instead, they used the FDA’s “fast-track” 510(k) approval system, which requires only that manufacturers prove their product to be significantly similar to others already on the market.
The Bair Hugger product was first developed and brought to market by Augustine Medical, which later changed its name to Arizant. 3M acquired Arizant in 2010, but Arizant continues to operate as a subsidiary of 3M.
The blanket is intended to help keep patients warm during surgery. A cold environment in the operating room paired with the effects of anesthesia can make it more difficult for a patient to naturally regulate body temperature. Patients who get too cold are at risk of blood loss, infections, and even death.
The Bair Hugger warming blanket consists of a portable heater/blower that is connected by a flexible hose to a disposable, inflatable blanket that is placed either over or under a surgical patient. The system gently blows air through the hose to warm the blanket, keeping the patient warm during surgery.
The blanket also includes drain holes to keep fluid away from the patient’s skin, allowing it to pass through the blanket to the linen underneath it. Since the blanket is disposable, there is no risk of infections passing from one patient to another by the blanket. There have been reports of individual infections linked to these devices, however.
Estimates are that there are currently more than 50,000 Bair Hugger units currently in use across the country. Hospitals often use these warming blankets during hip and knee replacement surgeries.
Original Bair Hugger Designer Speaks Out About Risks
Lawsuits filed against 3M and Arizant allege that the Bair Hugger warming blanket can increase the risk of bacterial infections, particularly in artificial joint surgeries. These infections can be difficult to detect and treat, which can lead to serious and potentially deadly complications, including sepsis.
When the Bair Hugger first came on the market, it was hailed as revolutionary, and quickly gained popularity in hospitals and medical centers. But in 2010, Dr. Scott Augustine, who originally designed and developed the product, spoke out against it, noting that it presented a serious risk of infection during surgery.
In a New York Times article, the doctor noted that hospitals should stop using the Bair Hugger, because of the danger it presented. Though proud of the technology, he told the Times that he had developed a new, safer blanket that worked more like an electric blanket and didn’t used forced air.
What’s wrong with forced air? According to the doctor and to plaintiffs that have filed lawsuits related to the device, it creates air currents that can pick up bacteria from the surgical floor and other nearby areas and redeposit them on vulnerable, open tissues in the surgical site.
The doctor’s statements were somewhat suspect because he no longer had a financial stake in the company at the time, and seemed to be pushing his own new technology. Yet subsequent studies indicated his concerns were warranted.
On August 30, 2017, however, the FDA issued a letter to healthcare providers addressing concerns with thermoregulating devices. The FDA stated that “[a]fter a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection. Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.”
Types of Injuries Associated with Bair Hugger Warming Blankets
The types of injuries reported to the FDA and in personal injury lawsuits related to Bair Hugger warming blankets include the following:
- Serious deep-joint and deep-tissue infections
- MRSA (Methicillin-resistant Staphylococcus auerus) infections
- Sepsis infections
- Other serious infections
Patients who went through joint replacement surgery where a Bair Hugger warming blanket was used are advised to watch for symptoms of infection. These may include:
- Swelling or redness over the joint area
- Warmth around the surgical incision
- Excessive fatigue
- Wound drainage
- Fever, chills, and night sweats
- Pain and stiffness in a joint that was working fine before
- Reduced mobility
Treatments for potential Bair Hugger-related infections often include:
- Extensive hospitalization
- Additional surgeries (often high in number)
- Antibiotic regimens (often administered through IV)
- Removal and replacement of the hip or knee implant
- Insertion of antibiotic spacers in the affected joint
Bair Hugger Warming Blanket Lawsuits
The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally-filed Bair Hugger lawsuits into the District of Minnesota in December 2015. Over 2,000 cases are currently pending, under the direction of U.S. District Judge Joan Ericksen. The first bellwether trials are scheduled to begin in 2018.
If you or a loved had surgery with a Bair Hugger warming blanket and then experienced a serious infection, you may be eligible to file a Bair Hugger warming blanket lawsuit. Chaffin Luhana is now investigating these cases, and invites you to call today at 1-888-316-2311.