9 февр. 2012 г.

A 5th Circuit judge in Texas rules that preemption does not apply in a product liability lawsuit over a Stryker Corp. hip implant.

A federal judge in Texas ruled that preemption does not apply in the case of a product liability lawsuit over an allegedly defective Stryker Corp. (NYSE:SYK) hip implant.

Alton Bass sued Stryker in October 2009, 2 years after receiving undergoing hip replacement surgery involving 4 Stryker devices: a shell, an Accolate TMZ Plus hip stem, a V40 alumina femoral head and a Trident 0 alumina insert.

Following the implant Bass began experiencing pain and underwent a second surgery, during which a surgeon discovered that the shell was too loose and revised it.

Bass alleged that the loosening was caused by "manufacturing residuals on the shell which prevented bony ingrowth," according to court documents.

Bass sued Stryker in the Northern District of Texas for a number of claims under state law, including strict liability, negligence, breach of warranty and violation of the Texas Deceptive Trade Practices

Stryker won a motion to dismiss the case, claiming that Bass's claims were preempted by the Medical Device Amendments of the Food, Drug, and Cosmetics Act.

The case hinged on an interpretation of a 2008 U.S. Supreme Court decision in Riegel vs. Medtronic. In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing – in other words, the federal approval preempts state law, provided that the device was cleared via the more-rigorous pre-market approval process rather than via the 510(k) predicate device protocol.

But preemption does not apply if the plaintiff can prove that the claims under state law parallel FDA requirements.

In re-opening the case, Bass argued that the lower court had inappropriately concluded that his shell implant was subject to PMA testing. The court agreed, but noted that the component was part of a larger PMA bid that covered the entire hip system.

Fifth Circuit Chief Judge Catharina Haynes agreed that Bass demonstrated that his claims were parallel to FDA requirements because he alleged that Stryker violated federal regulations in distributing substandard shell devices.

Bass also argued that Stryker recalled the shell products, including the specific model he received, and that the company received FDA warnings on the device 5 months prior to his surgery, including a notice that Stryker failed to verify regarding changes to reduce the "Final Rinse Tank bioburden," according to legal filings.

The recall prompted an FDA investigation, during which the agency concluded that "manufacturing residuals in excess of those permitted by the FDA were found on the shells," court documents show.

The court granted Bass to move forward with claims of strict liability, as long as they are based on manufacturing defects and not on failure to warn or marketing, negligent manufacturing, breach of an implied warranty and violation of the Texas Deceptive Trade Practices

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