Simplifying Global Compliance
The QMN Weekly Bulletin
Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter
March 16, 2012
Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials. The elderly patients died in 2003 and 2004 after bone cement made by Synthes’ Norian subsidiary was injected into their spines, allegedly causing their blood pressure to plummet. Their families filed suit in Contra Costa [Calif.] County Superior Court on Feb. 27.
Devices & Diagnostics Letter
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