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You are here: Home / Medical Devices / Bair Hugger / Bair Hugger

Bair Hugger

March 3, 2016 By US Recall News Leave a Comment

The Bair Hugger is composed of a blanket connected to a heater/blower and a hose, that is placed over and under a patient to keep the patient’s exposed skin warm during knee or hip replacement surgery. On February 1, 2016, a Louisiana man filed a lawsuit in federal court against defendants 3M Co. and Arizant Healthcare, Inc., claiming that his surgical wound became contaminated and infected because of a defect in the design in the device.

Plaintiff’s Claim

The plaintiff asserted that a the redesign of the Bair Hugger’s air filtration blowers caused it to suck in contaminated air, thereby allowing microorganisms to incubate and multiply inside the internal airflow mechanism. These microorganisms, alleged the plaintiff, were blown into his open surgical wound during knee surgery, causing an infection that caused him to have to undergo 15 additional surgeries.

The plaintiff alleged three distinct wrongful acts against the defendant:

  1. Continuing to market the device even after its defect became apparent in 1997.
  2. Failing to warn against the dangers arising from the design defect.
  3. Actively deceiving the U.S. Food and Drug Administration in 2009 concerning the safety of its air flow system.

Legal Theories

The plaintiff relied on a variety of legal theories to press his claim, including:

  • Negligence (in the product redesign process)
  • Misrepresentation (of the dangers of the product)
  • Fraud and deceit (on the FDA)
  • Breach of express warranty
  • Breach of implied warranty
  • Product liability (due to the presence of the design defect)

The success of any one of these legal theories may be enough to justify an award of damages against the defendants. The product liability claim does not even require the plaintiff to prove misconduct on the part of the defendants – the plaintiff must prove only that a design defect in the device rendered it unreasonably dangerous, and that the plaintiff was harmed by the defect.

Damages

The general measure of damages in this case (assuming that liability is eventually established) is how much worse off the plaintiff was than he would have been if his knee had never become infected. Any expenses or pain relating to the surgery that prompted the use of the Bair Hugger in the first place would not factor into the calculation of damages.

More specifically, if the plaintiff prevails, he may be entitled to damages for:

  • Medical expenses arising from his 15 subsequent surgeries and other medical care
  • Pain and suffering caused by his subsequent surgeries and other medical care
  • Loss of enjoyment of life due to long-term disability (including impaired mobility caused by knee problems)
  • Economic losses (due to occupational disability)
  • Emotional distress

Although the plaintiff is also demanding compensation for attorney’s fees as well as punitive damages, these are less likely to be included in a damages award even if he wins the case. Damages awards totaling hundreds of thousands or even millions of dollars are not unheard of in cases such as this one.

The Bair Hugger device has become the subject of an increasing number of lawsuits. Even its inventor, Dr. Scott Augustine, has confirmed reports that Arizant Healthcare, Inc. concealed dangers of the device.

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Filed Under: Bair Hugger, Featured, Medical Devices Tagged With: Bair Hugger

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