Wall Street Journal Reports St. Jude Heart Device Flaws were Known for Years before Recall

Florida Defective Rialta DefibrillatorAn article published by The Wall Street Journal (WSJ) is claiming that St. Jude, manufacturer of recalled Riata defibrillator leads, knew about problems with the defective product long before it sent a warning letter to doctors in 2010.

The Riata leads were ultimately pulled from the market last year after it was found that they could cause defibrillators to send unnecessary shocks to the heart or fail to deliver life saving jolts to normalize heart rhythms.

WSJ reports that several doctors had let St. Jude know about “inside-out abrasion” problems with the devices from 2006 to 2009, but were told by representatives of the company that the incidents were isolated. In 2008, a St. Jude internal audit looked into Riata’s potentially serious insulation problems and found that 32 of the devices were damaged enough to inhibit lifesaving shocks; but by that time, the company had sold more than 120,000 of the leads and concluded the risk of abrasion-related failures was “remote.”

Although St. Jude has not been accused of wrongdoing – it’s generally agreed that this is “business as usual” when it comes post-market tracking of potentially defective medical devices – physicians and device-safety experts point out that if the company had acknowledged the failures earlier, doctors may have been able to spot a growing trend and been able to identify the scope of the problem earlier.

Despite the Nov. 2011 recall, nearly 80,000 U.S. patients still have the potentially dangerous implanted Riata leads.

If you have been injured by a defective medical product or device, contact a Tampa defective medical device attorney at Farah & Farah today. Our lawyers aren’t afraid of large medical device manufacturers and will fight tirelessly to see that you receive the compensation you deserve. Call us at (800) 533-3555 for a free and discreet review of your case.

Badges