Stryker Corp. (NYSE:SYK) won another victory in its ongoing legal travails over the now-recalled Trident hip implant, after a federal appeals upheld the dismissal of a product liability lawsuit.
The U.S. Appeals Court for the Fifth Circuit upheld a lower court’ decision to toss Ronald Funk’s lawsuit against the Kalamazoo, Mich.-based orthopedic medical device maker on preemption grounds. In 2008, the U.S. Supreme Court ruled in Riegel vs. Medtronic 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.
Funk had a total hip replacement in March 2007 with a Trident implant, according to court documents, but suffered from ongoing pain in his right hip after the surgery. His surgeon attributed the pain to a defect in the implant and Funk had another surgery to remove and replace the defective portion of the implant, according to the documents.
It’s the latest legal victory for Stryker, which won other liability lawsuits over allegedly defective Trident implants. A federal judge in Texas tossed a similar case in May 2010, finding that preemption did apply; later that month a federal judge in Alabama dismissed another Trident lawsuit after the plaintiff failed to muster enough expert testimony to bolster her case.
A federal judge in Tennessee, however, ruled in June 2010 that preemption does not apply in a similar liability suit.
In March 2010, Stryker resolved all outstanding issues related to a warning letter it received from the Food & Drug Administration in 2007, which led to a recall of some of the Trident implants.
In the warning letter, FDA officials chastised Stryker for repeatedly failing to perform corrective procedures despite several reports of problems with the implants.
“In some instances these problems have required revision surgeries. In addition, complaints were also received between January of 2005 through April of 2007 for squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments),” according to the letter. “Furthermore, complaints were received between January of 2005 through June of 2007 concerning improper seating of hip implants in broached bones resulting in bone fractures.”
Inspectors said that bacterial contamination in the plant, including reports of Staphylococcus, a bacteria that causes staph infections, were contributing to the problems with the implants.
Company officials have said the problems uncovered in the 2007 warning letters, as well as an additional warning it received over its Hopkinton, Mass.-facility in 2008, led to a renewed focus by the Kalamazoo, Mich.-based company on quality assurance systems.
In September 2009 the company named Lonny Carpenter to the newly created position of group president for global quality and operations, after spending more than $50 million in 2008 on the initiatives and an estimated $75 million in 2009. The company pledged a total of $200 million over three years to clean up its quality systems.
