Washington, D.C., United States (AHN) – The U.S. Supreme Court upheld a 2008 decision that allowed patients to file a parallel claim against manufacturers of medical devices.
With the ruling, the court rejected an appeal by Stryker Corporation against a lawsuit foiled by Illinois resident Margaret Bausch who got a replacement hip six days after the Food and Drugs Administration (FDA) issued a warning about problems at Stryker’s manufacturing plant.
In seeking to dismiss Bausch’s lawsuit, Stryker cited a 2008 Supreme Court ruling that patients cannot file state-law product liability suits over products that went through FDA review.
However, a Chicago Federal Appeals court allowed Bausch’s suit based on the exception made the Supreme Court which allowed parallel claims.
The FDA investigated Stryker’s facility in Ireland and informed the company in March 2007 that it must correct manufacturing deficiencies. In 2008, Stryker recalled hip and knee replacements manufactured at its Ireland plant, including the one implanted on Bausch, requiring her to undergo a second surgery to have the defective device replaced.
Stryker, based in Kalamazoo, Michigan, reported last month that its profit went down 3 percent in the third quarter due to cost related to recent acquisitions. As a result, Stryker’s earnings went down to $327 million from $337 million after it purchased former rival Orthovita, the neurovascular business of Boston Scientific Corporation and Memometal Technologies, which makes foot and hand implants.
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