Stent maker Boston Scientific violated FDA regulations

By Austin Kirk
Posted September 10, 2007

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Boston Scientific, manufacturer of the popular Taxus Express Drug Eluting Stent, has been reprimanded by the FDA for violating federal regulations when they failed to report two deaths in a clinical trial for a different type of stent.  This is not the first warning for the company, which has a history of failing to properly report problems with their devices.  The medical product manufacturer also recently agreed to pay $195 million to settle lawsuits filed due to problems with their recalled pacemakers and defibrillators, and they face thousands of potential drug eluting stent lawsuits from individuals who suffered a heart attack, death or reclogging of their artery after having the dangerous device implanted into their artery.

The Wall Street Journal reports that a letter was sent by the FDA on August 30, warning Boston Scientific that they committed “serious violations” of federal regulations designed to ensure the safety of consumers,  The violations stem from a small study involving an abdominal aorta stent which the company later abandoned after it was discovered that a large number of the stents were fracturing, and at least five of those involved in the study died.

According to the FDA, two deaths which occurred on December 14, 2005 and December 8, 2006 were not reported to federal regulators in an adverse event listing provided to the agency on June 8, 2007.  The warning followed an inspection conducted between May 9 and May 16, 2007.  The inspection was performed to ensure that data and information provided by the company were valid and accurate, as well as to ensure that human subjects were protected from undue hazard.

The FDA called Boston Scientific’s attempts at corrective actions “inadequate” since their decision to provide a “refresher training course”  on adverse event reporting requirements for their project team did not address the underlying issue of ensuring timely follow up and evaluating adverse events.

>>LINK: Boston Scientific Warning Letter from FDA

The company has been in hot water with the FDA on at least two prior occasions in recent years.  In January 2007, a warning was issued due the company’s failure to properly report problems in their medical devices.  In addition, an earlier warning issued due to complaints of sloppy manufacturing was just lifted in April 2007 after the company addressed the problems.

BOSTON SCIENTIFIC STENT LAWSUITS

The heart stent lawyers at Saiontz & Kirk, P.A. are reviewing potential Boston Scientific lawsuits for individuals who had a Taxus Express Drug Eluting Stent implanted into a previously blocked artery, and subsequently suffered a heart attack, death or reclogging of the artery.  Recent studies have demonstrated that medicated stent problems increase the risk of potentially fatal blood clots which can develop years after the stent is implanted.

If you, a friend or family member experienced heart stent problems, request a free claim evaluation.