3M Bair Hugger Lawsuit
During joint-replacement surgery, it’s important to maintain the patient’s body temperature sufficiently warm. Patients can get cold before, during, or even after a surgical procedure because of a number of factors, including the effects of anesthetic drugs, the presence of uncovered skin, and the intravenous administration of cold fluids. If the patient becomes too cold because of a dangerous drop in body temperature, they risk becoming hypothermic.
This sort of cold can negatively affect surgical outcomes. It can increase the risk of infection and heart problems, slows healing, and may lengthen recovery time. Keeping a patient warm, on the other hand, results in reduced risk of heart attack and infection, and may shorten the length of the hospital stay.
The 3M Bair Hugger warming blankets were designed to help keep patients warm during surgery. More than 50,000 of these units are currently in use across the country, but individuals who have filed Bair Hugger lawsuits argue that the blankets have a design flaw that increases the patient’s risk of developing a serious infection.
Over 1,000 patients who had knee and hip replacement surgery in which Bair Hugger warming blankets were used have filed lawsuits against the manufacturer. These plaintiffs allege that after their surgeries, they were diagnosed with serious and life-threatening infections that required extensive treatment with antibiotics, hospitalization, and even additional surgeries.
What is the Bair Hugger Warming Blanket?
Bair Hugger warming blankets reached the market in 1987 when the FDA approved them for use during surgery. Then between 1990 and 2006, the FDA granted clearances for 14 similar products made by the manufacturer, including different types of blankets and warming units. The units were initially made by Arizant Healthcare Inc., which was then acquired by 3M in 2010. Arizant continues to operate as a subsidiary of the 3M companies.
The Bair Hugger warming blankets are inflatable blankets that connect to a portable heater/blower that gently blows warm air through a hose into the blanket. In surgery, the blanket can be positioned over or sometimes under the patient. The airflow that flows into the blanket is supposed to help keep the patient warm by regulating body temperature to prevent hypothermia.
Bair Hugger Warming Blankets May Increase Risk of Infections
Plaintiffs who have filed Bair Hugger lawsuits claim that the design of the product allows bacteria and other contaminants on the floor of the operating room to become airborne, where they can land on a patient’s exposed joints and tissues during surgery. These contaminants can then cause serious deep joint infections after the surgery is complete.
In 2010, the New York Times reported that Dr. Scott D. Augustine, an anesthesiologist and the inventor of the Bair Hugger warming blanket, no longer supported the use of the device because of his concerns that it posed a danger to patients. According to Dr. Augustine, the blanket can spread bacteria that has been linked to serious, sometimes life-threatening hospital-acquired infections. The doctor has designed a new warming device that doesn’t use forced air (and is more like an electric blanket). He is promoting the new device as a safer alternative to the Bair Hugger warming blanket.
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 FDA has received reports of serious patient injuries following the use of Bair Hugger warming blanket, including:
- Serious deep-joint and deep-tissue infections
- MRSA (Methicillin-resistant Staphylococcus auerus) infections
- Sepsis infections
- Other serious infections
Patients who had joint replacement surgery in which a Bair Hugger warming blanket was used are advised to watch for symptoms of joint 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
Plaintiffs who have filed Bair Hugger warming blanket lawsuits claim that the device manufacturers have long known about the risk for potential infections, but failed to provide adequate warnings about these risks to surgeons, hospitals, and patients.
They also claim that the Bair Hugger blankets are defectively designed in two ways:
- they affect airflow in the operating room, increasing the risk that bacteria from the floor will be deposited on the surgical site; and
- the airflow paths inside the units can become contaminated with pathogens that can then make their way into the operating area.
In December 2015, all federally-filed Bair Hugger Lawsuits were consolidated in the District of Minnesota. U.S. District Judge Joan Ericksen was assigned to oversee the proceedings. Currently, about 1,300 cases are pending nationwide. The initial bellwether trials are scheduled to begin in early 2018.
Patients may be unaware of whether or not a Bair Hugger warming blanket was used in their surgeries. Chaffin Luhana provides consultations and case evaluations to help determine which product used and whether patients may have a case against Arizant and 3M companies. Call today at 1-888-480-1123 for your free consultation.