A Texas woman has sued 3M (a medical device company) in Texas alleging the company sold defective surgical equipment that gave her a drug-resistant infection and required her leg to be amputated. This lawsuit is the latest in a string of cases that argue 3M’s patient-warming Bair Hugger device causes dangerous infections. Bair Hugger devices are meant to help people recover from surgery by trapping a layer of warm air around the site of the operation but has been accused of blowing bacteria into the surgical site.
In this lawsuit, Ruth Childers said 3M Co. and three other defendants owe her more than $1 million for selling and using the Bair Hugger. Childers’ suit also includes claims against a Houston medical center, the doctor who allegedly conducted surgery in the presence of bacteria, and Arizant Healthcare Inc., which created the Bair Hugger and was bought by 3M in 2010.
The Bair Hugger is the subject of dozens of lawsuits and 3M is currently pushing to have the suits transferred to Minnesota for multidistrict litigation. Charles Houssiere III, who is co-counsel for Childers, said the case was filed in Texas partly out of convenience, and includes local defendants in case 3M and Arizant argue that other parties are liable for Childers’s infection and amputation.
Childers claims she suffered from a drug-resistant infection after receiving knee replacement surgery in December 2013. As a result of the infection, her leg was amputated above the knee, according to her lawsuit, which also alleges the defendants changed the design of the Bair Hugger in a way that increased the risk of pathogens being blown into the surgical site.
“Any 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,” the suit said. “However, through misrepresentations to the public, the medical community, and the FDA, the defendants actively and knowingly concealed the propensity of these devices to cause infection in orthopedic implant surgeries.”
3M’s response to the allegations are the following: “In over 25 years and more than 200 million patients warmed successfully by 3M’s patient warming products, there is not a single confirmed incident of infection caused by the Bair Hugger system,” Donna Fleming Runyon, a 3M spokeswoman, said in an email.
Even though the Bair Hugger and similar products are marketed for increasing patient comfort, reducing bleeding and reducing the risk of infections and post-operative heart attacks, there are at least 43 federal cases and 12 state cases that 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.