St. Jude Medical ($STJ) began to face reports of safety problems with its Riata defibrillator leads back in 2005, years before the company notified physicians and the FDA, and a recall finally hit last year. What's more, The Wall Street Journal reports, a number of doctors claim they notified the company about Riata malfunctions, only to be rebuffed that the problems reflected "isolated incidents."
According to the story, physicians from Johns Hopkins, the University of Pittsburgh Medical Center, Royal Victoria Hospital in Belfast Ireland and others reported problems in some of their patients between 2006 and 2009 regarding malfunctioning Riata defibrillator wires (no one died), only to be told that the incidents were isolated and they shouldn't worry. (Some didn't report problems right away, however, because they themselves believed the Riata problems were one-time incidents).
It turns out, of course, that the Riata problems were not isolated incidents. St. Jude did not break any laws and followed practices typical in the industry, the story reminds us. But doctors and device safety experts have said that a sooner acknowledgement of Riata problems could have helped define how serious the problem was much earlier, according to the article. The FDA, of course is developing a bar code system to help track device failures, though an online database that posts reports of problems isn't detailed enough, critics argue. St. Jude itself says it is doing more rigorous testing with its Durata leads, which replaced Riata in the marketplace.
A Wall Street Journal review of FDA documents collected in the case shows that St. Jude had begun facing problems with Riata as early as 2005. St. Jude said in response that it reported individual cases to the FDA and reiterated that it "proactively" notified doctors and regulators of the extent of the Riata problems, once fully known.
- read the WSJ story