Stryker Rejected in Bid for U.S. Supreme Court Limits on Patient Suits
The U.S. Supreme Court left intact a ruling that let a woman sue Stryker Corp. (SYK) over a recalled artificial hip, as the justices refused to reinforce the limits on patient lawsuits against medical-device makers.
The high court today rejected Stryker’s appeal in the case of Margaret J. Bausch, an Illinois woman who received a replacement hip six days after federal regulators warned about problems at a company manufacturing facility.
Stryker’s appeal sought to strengthen a 2008 Supreme Court ruling that said patients generally can’t press state-law product liability suits over products that undergo the Food and Drug Administration’s most intensive review process, known as pre-market approval.
In letting Bausch’s suit go forward, a Chicago-based federal appeals pointed to an exception the Supreme Court made in the 2008 decision allowing so-called parallel claims -- state lawsuits alleging a violation of FDA requirements.
The FDA warning stemmed from an investigation of Stryker’s Cork, Ireland, facility. The agency told the company in March 2007 that it needed to correct manufacturing failings at the plant.
The following year, Kalamazoo, Michigan-based Stryker recalled hip and knee replacements made at the Cork plant, allegedly including the device that had been implanted in Bausch. She then underwent a second surgery to have the device replaced.
The case is Stryker v. Bausch, 11-2.
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