The 3M Bair Hugger Forced-Air Warming Blanket is Currently the Subject of Dozens of Bair Hugger Lawsuits Pending Litigation
Southern Med Law, a law firm that represents product liability plaintiffs around the country, notes that the U.S. Food & Drug Administration (FDA) recently issued a safety communication regarding the potential for certain surgical heater-cooler devices to spread dangerous nontuberculous mycobacteria infections. Surgical warming blankets were part of the FDA’s list and will be of interest to the men and women represented in Bair Hugger lawsuits. The warming blanket lawsuits claim patients developed post-operative debilitating deep-joint infections when Bair hugger blankets, used to keep patients warm before surgery, circulated contaminants. The devices mentioned in the FDA’s October 15th alert included:
• warming blankets;
• oxygenator heat exchangers; and
• cardioplegia (paralysis of the heart) heat exchangers
The FDA revealed that it had received 32 reports of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination, 25 of which were reported to the agency this year. Some reports describe infections related to cardiothoracic surgeries, but other reports did not specify the procedure the patient was undergoing. Eight reports were related to 3 events describing patient infections occurring in U.S. health care facilities, while the remaining involved health care facilities outside the U.S.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm, FDA, October 2015]
On October 26th, it was reported by the U.S. Center for Disease Control (CDC) that a small number of the extremely rare bacterial infections had occurred in certain open-heart surgery cases that were performed at WellSpan York Hospital in York, Pennsylvania, between Oct. 1, 2011 and July 24, 2015. At least five deaths have been tied to the infections. Heater-cooler units used to keep blood at the correct temperature during cardiac bypass operations have been cited as a possible cause of the infections.
[fox43.com/2015/10/26/rare-bacterial-infection-at-wellspan-york-hospital-linked-to-heater-cooler-devices-for-open-heart-surgery/, Fox 43, October 2015]
“The FDA warning and the recent report out of Pennsylvania are of great interest to our Firm, as we are currently investigating product liability claims on behalf of hip and knee replacement patients who allegedly develop deep joint infections following implant surgery with the 3M Bair Hugger forced-air warming blanket,” says Dr. François Blaudeau, the founder of Southern Med Law. ‘’Dozens of Bair Hugger lawsuits have already been filed against the 3M Company over this device, which is used during surgery to help patients maintain an optimal body temperature.”
The 3M Bair Hugger utilizes filtered air that flows through a warming unit to gently and evenly disperse the air throughout a disposable warming blanket, which is isolated from the surgical site by an adhesive strip on the blanket and surgical barrier drape. However, a growing number of Bair Hugger lawsuits allege that the device suffers from a design flaw that allows contaminated air from the operating room floor to come into contact with the surgical site. This can cause artificial joint patients to develop serious post-operative infections at the implant site, resulting in additional hospitalizations and surgery, including revision of their hip or knee replacement.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) is currently considering a proposal to consolidate dozens of Bair Hugger lawsuits in the U.S. District Court, District of Minnesota. Plaintiffs pushing for the centralization assert that hundreds of similar cases could soon be filed in federal courts, given the widespread use of the Bair Hugger system in hospitals throughout the U.S. The 3M Company opposes centralization of the pending lawsuits. The JPML heard Oral Arguments on the matter on December 3rd, and its decision is expected soon. (In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666)
Southern Med Law is investigating potential product liability claims on behalf of individuals may have developed post-operative infections due to the Bair Hugger forced-air warming blanket or surgical heater-cooler devices. To arrange for a free, no obligation legal consultation, please call Southern Med Law today, at (205) 547-5525. More information about this issue can be obtained by visiting www.southernmedlaw.com.
About Southern Med Law And Filing A Bair Hugger Lawsuit: Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203