A Texas woman has sued 3M, accusing the company of selling defective surgical equipment responsible for a drug-resistant infection that led to a leg amputation.
This case is the latest in a series of cases that argue 3M’s patient-warming Bair Hugger device causes dangerous infections, Law360 reports.
The suit was filed on December 9, 2015 in Harris County (Texas) court. The woman is asking for more than $1 million from 3M Co. and three other defendants for selling and using the Bair Hugger. The Bair Hugger is meant to help people recover from surgery by trapping a layer of warm air around the site of the operation but patients say the device blows bacteria into those sites, causing infections. The lawsuit also includes claims against the Houston medical center where the surgery took place, the doctor who allegedly conducted surgery in the presence of bacteria, and Arizant Healthcare Inc., which created the Bair Hugger. (3M bought the device in 2010.)
Dozens of lawsuits have been brought against the Bair Hugger and 3M has asked to have the lawsuits transferred to Minnesota for multidistrict litigation (MDL).
The Bair Hugger and similar products—forced-air warmers—are intended to increase patient comfort, reduce bleeding, and reduce the risk of infections and post-operative heart attacks, according to Law360. But at least 43 federal cases and 12 state cases have been filed against 3M claiming the device increases infections, according to a document the company filed last month with the Joint Panel on Multidistrict Litigation. According to the (Minneapolis) StarTribune, the warming unit can disrupt the flow of sterile air inside an operating room. Waste heat from the unit builds up under the operating table, creating convection currents that can stir up contaminants from the floor and embed them on the surface of a knee or hip implant.
The Texas woman says she suffered a drug-resistant infection after knee replacement surgery in December 2013. As a result of the infection, she had to have her leg amputated above the knee. The lawsuit alleges the defendants changed the design of the Bair Hugger in a way that increased the risk of bacteria being blown into the surgical site. The lawsuit says that a “reasonable and competent physician would not use a Bair Hugger in an orthopedic implant surgery if they were fully apprised of the dangers and risks associated with doing so,” according to Law360. The lawsuit claims the company misrepresented the Bair Hugger to “the public, the medical community, and the FDA,” and “actively and knowingly concealed the propensity of these devices to cause infection in orthopedic implant surgeries.”