During many types of surgery, a special blanket is placed over the patient with the purpose of delivering heat to a patient’s body. One such device is the Bair Hugger™ surgical warming blanket made by 3M and its subsidiary, Arizant, Inc.
Knowing the benefits of maintaining body temperature, a doctor came up with the Bair Hugger back in the eighties. The blanket allows body temperature to remain at 98.6 degrees Fahrenheit and has become extremely popular in the United States. In fact, it is used in approximately 90% of all major surgeries, as well as to treat hypothermia and exposure.
The purpose of the Bair Hugger is to help maintain a safe environment for the patient during surgery and to promote better healing and lessen bleeding. However, the Bair Hugger works differently than others by distributing warm air over the patient’s body.
Traditional surgical operating rooms use advanced systems, like the Laminar Air Flow System, which are constantly circulating clean, filtered air throughout the OR. Their purpose is to prevent airborne particles and contaminants from making their way into an open incision and triggering an infection.
There are concerns the blanket’s process of forcing warm air can interfere with these systems and cause contaminated particles from the floor to land in the open surgical site of the patient. These contaminated particles can cause severe infections that threaten both life and limb and even cause worse issues than the initial surgery was supposed to treat.
This contaminated air from the floor can quickly cause a serious infection, especially in patients who have undergone a surgery involving joints or an artificial heart valve. In fact, the inventor of this piece of technology said in a statement to the New York Times back in 2010 that he wants hospitals and other healthcare providers to cease using the blanket during certain operations and even admitted that the medical device poses a danger to patients.
In 2014, a man from Texas undergoing a routine hip replacement surgery alleged that the Bair Hugger warming system used during his surgery caused him to get an infection of antibiotic-resistant Methicillin-resistant Staphylococous aureus (MRDSA). The man required two additional surgeries to clean out the hip and remove the implant, but still suffers limited mobility. More than 700 current and ongoing lawsuits allege that the makers of the blanket knew of the infection risks, yet failed to properly warn patients and healthcare providers of these risks.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.