Healthcare giant St. Jude Medical (NYSE:STJ) revealed in a recent regulatory filing that U.S. Justice Dept. investigators closed a probe of the recalled Riata and Riata ST defibrillators leads.
The "civil investigative demand," initially launched in August 2012 by the Civil Division of the DoJ, seems to have closed without incident or allegations of misconduct related to the Riata leads.
"The CID appeared to relate to a review of whether circumstances surrounding the company’s Riata and Riata ST defibrillator lead products caused the submission of false claims to federal healthcare programs," according to a St. Jude regulatory filing. "The company provided the DoJ with material responsive to the CID in the fall 2012, and in March 2013, the DoJ informed the company that it had closed its investigation."
St. Jude’s Riata leads have been at the center of a high-profile recall that has drawn federal investigations, negative press and patient and shareholder lawsuits.
St. Jude pulled the devices off of shelves in 2010, citing issues with "externalized conductors as a result of inside-out abrasion." The FDA did not issue a recall notice on the device at the time, but has since given the measure Class I recall status, a category usually reserved for the highest-risk devices that pose a threat to patients.
Just last month the medical device maker was slapped with multiple lawsuits in California courts yesterday over the Riata defibrillator lead, alleging that the heart wires were defective and led to injuries or death for more than 30 patients.
St. Jude has been attempting to shield its newer Durata leads from the high-profile recall since the company was forced to concede that the Riata revision rates were higher than previously reported. The device maker has been busy ever since calming fears about the next-generation Durata leads.
Wall Street investors are keeping their eyes peeled for any sign of a problem with the Durata leads. In June 2012, a single report (later debunked) of a Durata lead failure similar to the kind that sank the Riata sent STJ shares plunging 6% in a single day.
