Evidence is mounting showing
manufacturers of St. Jude Riata leads knew their device was unsafe, but failed to inform patients of the faulty device for years. Unfortunately, this news is not surprising in a post-Riegel environment.
In 2008, the U.S. Supreme Court decided the case Riegel v. Medtronic, which held manufacturers of medical devices approved by the FDA’s premarket approval process (PMA) cannot be held liable in court for their product’s defects.
St. Jude had been informed by doctors with concerns about the safety of the Riata leads as early as 2006, and St. Jude itself had found problems with the leads in an internal audit in 2008.
The Wall Street Journal writes:
St. Jude's internal audit concluded in 2008 that Riata had potentially serious insulation problems including inside-out abrasion. It's not clear how many cases of inside-out abrasion St. Jude's engineers had identified by 2008, though St. Jude had confirmed 246 cases of any type of insulation breach, including normal wear and tear, according to the audit.
It wasn’t until December 2010 St. Jude sent warning letters to doctors informing them of possible defects with its leads. Finally, in December 2011 the FDA recalled these dangerous leads.
The St. Jude Riata lead is a perfect example that FDA approval does not make a device safe, and without legal accountability device manufacturers have little incentive to put the safety of patients over their profits.