St. Jude Faces Fresh Crop of Riata Suits

By Damian Garde/Fierce Medical Devices

St Jude Medical is staring down another pair of lawsuits from patients claiming injury by the now-recalled Riata CD leads and the outcome could affect how devicemakers shield themselves from liability suits in the future. 

As The Wall Street Journal reports, two plaintiffs claim their Riata leads were faultily designed and manufactured, leading to inappropriate shocks and device failure. However, the suits stand out because they accuse St. Jude of skirting both FDA requirements and state product liability laws in effort to get around a 2008 Supreme Court ruling that has hamstrung patients trying to litigate against device manufacturers. 


The Court has upheld that FDA regulations supersede disparate state laws on product quality, making it very difficult to successfully sue a company that has complied with the agency’s PMA process and gotten its device on the market, even if the product was later found to be defective. 

For the full article, see Fierce Medical Devices online. 

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