Can I bring a medical malpractice lawsuit if my medical device implant was recalled?

In August 2010, Johnson & Johnson recalled tens of thousands of their DePuy Orthopaedic ASR metal-on-metal hip implants.  Now they are recalling another 7500 implants from their “Adept,” their line of metal-on-metal implants sold outside the United States.  This included the U.K., Australia and Germany between 2004 and 2011.

Data gathered in the U.K. and in Australia indicate that a significant number of patients were experiencing early failure of their Adept hip implants, requiring replacement much earlier than anticipated.  A registry in the U.K. found that 12.1% of patients with Adept implants needed a replacement within 7 years, while a registry in Australia found that 7.1% of patients required replacement within 3 years.

When a medical device or prosthetic implant fails due to negligence there are two separate legal theories one might choose to explore: medical malpractice and/or product liability.

Medical Malpractice is a legal claim that results from the negligence or error of a healthcare provider.  When a medical device or prosthetic implant fails one theory may be that the doctor who installed it made a mistake.  When hip implants are involved, it is possible the orthopedic surgeon placed the implant incorrectly or did not secure it properly to the bone.  If that is the case, one might bring a medical malpractice claim against the doctor, a claim which must be brought within 2 ½ years of the date of the malpractice.

Product Liability is a legal claim that results when a product is designed or manufactured improperly.  A design defect occurs when they very plan for a product has some error or flaw in it which results in a problem with the product.  When Johnson & Johnson recalled their ASR system they admitted that the material they used to make the femoral head and liner was not appropriate for the use for which the product was intended.   It had a tendency to flake off and cause metal poisoning and an early failure rate of the implant.  This would be a design defect because the product failed to function as intended, but was manufactured in accordance with the design.  A manufacturing defect occurs when a product is designed properly, but there was a problem with the process by which it was created and assembled.  For instance, Johnson & Johnson recalled a number of over-the-counter medications such as Benadryl and Sudafed for manufacturing defects that resulted  in foreign particles such as dust, glass and other contaminants to become mixed and packaged with the medication.  Product Liability claims must be brought within 3 years of the date of the injury caused by the defective product is discovered or should have been discovered.

If you believe you may have been injured by a medical device or prosthetic implant give us a call to speak with one of our attorneys.

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