St. Jude Medical (NYSE:STJ) knew of potential problems with its Riata pacemaker lead, which it recalled in 2011, as early as 2005, according to FDA documents reviewed by the Wall Street Journal.
The Riata leads, which deliver rhythm-restoring shocks to heart muscles, are prone to so-called "inside-out" abrasion, in which the wires wear through their insulation and can extrude into the blood vessel that carries them. That creates a risk of malfunction or unintended shocks; some 80,000 patients are estimated to have the Riata leads, from about 120,000 sold before they were pulled from the shelves.
But St. Jude first received reports of inside-out abrasion with Riata leads in October 2005, according to the Journal, with an internal probe concluding in 2008 that the medical devices had "potentially serious insulation problems including inside-out abrasion," the newspaper reported. More than 13,000 patients have been implanted with Riata leads since July 2008.
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St. Jude spokeswoman Amy Jo Meyer told the newspaper in an emailed statement that it dealt "proactively" with doctors over the issue, promptly reporting individual cases to the FDA’s MAUDE database. The St. Paul-based medical device company evaluates malfunctions and complaints and reviews potential issues with its independent medical advisory board, Meyer told the Journal.
Company documents reviewed by the WSJ‘s Christopher Weaver describe a case of inside-out abrasion discovered after a California patient received unneeded shocks in 2005. St. Jude launched a probe to evaluate the insulation problems in 2006 and a second in March 2010 specifically on inside-out abrasion, according to Weaver. After 4 case reports were published on the problem between 2008 and 2010, he wrote, St. Jude issued a warning to physicians about inside-out abrasion in 2010. The FDA classified a 2nd, November 2011 warning as a Class I recall, leaving patients with the Riata leads and their doctors in a quandary: Pull the leads, which involves a potentially even riskier surgery, or leave them in?
The Riata debacle also exposes a structural problem in the regulatory pathway. How did such a potentially defective device (Weaver reports that a St. Jude audit released last July found a 19% failure rate for Riata) hit the U.S. market, given that St. Jude didn’t break any rules or regulations in introducing it and followed standard industry procedure in its reaction? Physicians told Weaver that the FDA and the medtech industry need to improve the tracking of potentially faulty devices.
The FDA inspected St. Jude lead-making facility in 2006, when gave then all-clear, and 2009, when it flagged an unrelated problem with Riata, according to the Journal. Sarah Clark-Lynn, spokeswoman for the federal watchdog agency, said the FDA routinely examines adverse events "when device problems could cause serious injuries, appear to violate regulations or agency officials feel initial reports require more information," according to the newspaper.
That means it’s done on a case-by-case basis, according to "a senior FDA official who has been involved in talks with St. Jude over the past 2 years" who told Weaver that there’s "not a magic number, there’s not a line in the sand. We look at the available data."
The agency has mandated post-market surveillance of defibrillator leads since 2008 and is developing a universal device identification system to track medical devices.
