MASSDEVICE ON CALL — Medtronic (NYSE:MDT) is mired in some 700 lawsuits over its Infuse bone growth protein, representing complaints from about 1,000 patients, the company revealed in recent regulatory filings.
Medtronic provided few details on those lawsuits, but company spokeswoman Cindy Resman told reporters that the lawsuits are still in early phases and that Medtronic has not been found liable in any, MedPage Today reported. Some lawsuits have been dismissed and others are pending in a limited fashion, according to the report, but it’s likely that more are on the way.
"Certain law firms have advised the company that they may bring a large number of similar claims against the company in the future," according to a Medtronic filing.
The high-profile Infuse lawsuits generally accuse Medtronic of illegally marketing the product for uses not approved by the FDA. A years-long federal investigation into Medtronic’s practices closed in May 2012 without finding evidence of wrongdoing.
The controversy, including a shareholder lawsuit accusing Medtronic and its leadership of misleading investors, blew up over the summer of 2011 when the Spine Journal dedicated its entire June issue (PDF) to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.
The ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks. In the fall of 2012 a U.S. Senate report blasted Medtronic over its handling of the Infuse product, saying the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies, charges that the company "vigorously" denied.
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