Supreme Court Refuses Appeal in Lawsuit Over Recalled Stryker Trident Hip
The U.S. Supreme Court has rejected an attempt to throw out a product liability lawsuit over a recalled Stryker Trident hip implant.
Earlier this week, the Supreme Court announced that it was refusing to hear an appeal filed by Stryker over a 7th Circuit Court of Appeals ruling last December, which allowed plaintiff Margaret Bausch to pursue a lawsuit against the company for violating FDA regulations in the production of an allegedly defective medical device. The decision will allow Bausch’s lawsuit to go forward in a lower court.
The decision will allow Bausch to proceed with her case against the company, despite a 2008 Supreme Court decision, Riegel v. Medtronic, which ruled that patients cannot sue medical device manufacturers over products that were approved through the FDA’s pre-market approval process, the most stringent process a medical device can undergo before being sold in the U.S. That ruling has been interpreted as applying only to medical devices that were not fast-tracked through the agency’s 510(k) expedited approval process.
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Bausch’s suit, however, points out that just days before she received her Trident hip implant in 2007, the FDA issued a warning letter to Strkyer saying that the company was violating federal regulations at its manufacturing plant in Cork, Ireland.
According to the letter, the company failed to adequately address “continual” reports of problems with Stryker Trident hip replacement parts that were received by the manufacturer between January 2005 and April 2007.
As a result of a subsequent internal investigation, Stryker discovered additional problems with products manufactured at a plant in Ireland and issued a hip recall on January 22, 2008 for the Trident Acetabular PSL Cup and the Trident Hemispherical Cup, after it was discovered that contamination levels at the plant resulted in parts not meeting the proper standards for sterility.
A number of Stryker Trident hip lawsuits have been filed by individuals who experienced problems with the recalled implants. The complaints allege that Stryker manufactured and sold defective devices, failed to properly research their product, and failed to adequately warn about the risk that individuals may experience serious complications, which often require additional hip surgery to replace components.
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