Hip replacement and knee replacement patients exposed to the Bair Hugger forced-air warming blanket have experienced post-operative infections. Many of those patients have filed Bair Hugger lawsuits in order to recover damages for medical expenses and other losses.
Anyone who believes he or she may have suffered from an infection related to the use of the Bair Hugger may call 1-866-LAW-2400 for a free evaluation of whether there is an entitlement to compensation.
The two primary defendants in Bair Hugger lawsuits are 3M Company and Arizant Healthcare Inc. They manufactured and marketed the device for more than 15 years, according to an August motion to transfer numerous federal Bair Hugger lawsuits to a single trial court in Minnesota for pretrial coordination.
The transfer motion described the device this way: "The Bair Hugger consists of a portable heater/blower connected by a flexible hose to a disposable blanket that is positioned over (or in some cases under) surgical patients [and] warms patients during surgery by blowing hot air through the blanket and on a patient's exposed skin."
So what went wrong? What caused the infection in the patient who filed the transfer motion a couple of months ago? Allegedly the defendants didn't tell the whole truth to the U.S. Food and Drug Administration.
"In June of 1997, in sworn filings submitted to the FDA in connection with Section 510k of the Food and Drug Act, the Defendants admitted that 'air blown intra-operatively across the surgical wound may result in airborne contamination,'" according to court documents. "The Defendants addressed this flaw in their products by making further misrepresentations to the FDA when they stated that the risk of contamination by air flow is obviated because all 'Bair Hugger Blankets designed for use in the operating room feature a tape barrier which prevent [sic] air from migrating toward the surgical site.'"
The motion concludes, "That statement by the Defendants was false and misleading, and it remains uncorrected to this day. A number of Bair Hugger blankets marketed as safe for use in surgeries do not utilize a taped edge at all. Instead, these forced air warming systems cause contaminated air to enter the surgical field. Also, representing that a taped barrier would contain the contaminated air is false; it ignores the fact that cooler downward airflow in the operating room causes the heated air from the Bair Hugger to rise up. The presence of a tape edge does not prevent the Bair Hugger from facilitating the movement of pathogens from the floor of the operating room to the surgical site."
These defendants' statements and related acts, according the patient's brief, fooled a lot of people, to the detriment of patient safety.
"The effect of these misrepresentations was to mislead healthcare providers about the safety of the Bair Hugger for use in surgical procedures," the plaintiff's motion reads. "The Defendants were aware of the falsity of their misrepresentations. Rather than alter the design of their product or warn physicians of the dangers associated with the Bair Hugger, as numerous studies confirm, the Defendants have chosen to 'double down' on their efforts to promote their defective product."
When medical devices are known to pose unreasonable risks and the manufacturer should have known about it and done something about it, injured patients may be entitled to compensation. Here is where an experienced attorney can be a valuable asset. Since 1984, the pharmaceutical injury and product liability attorneys at Reich & Binstock have been fighting for the rights of victims of defective medical devices and dangerous drugs. And, at Reich & Binstock, the consultation is free.