U.S. Attorney’s office for Massachusetts dropped a years-long inquiry into allegations that Medtronic (NYSE:MDT) promoted off-label use for its biliary stents.
The Bay State feds told Medtronic Feb. 9 that the 3-year-old investigation is no longer active, according to a regulatory filing.
The probe began in June 2008, when the Fridley, Minn.-based med-tech company received a subpoena from the U.S. attorney’s office for doucments and data related to possible off-label marketing of the stents.
In February 2010, a similar "qui tam" lawsuit was filed accusing Medtronic of similar violations. Just a month earlier, another qui tam lawsuit filed in the U.S. District Court for Northern Texas accused Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Johnson & Johnson (NYSE:JNJ) of engaging in similar schemes.
The Medtronic case, filed by a pair of former employees-turned-whistleblowers, alleged that Medtronic promoted using the devices to treat obstructions in peripheral blood vessels. The suit also accused the company of retaliating against and ultimately firing the pair after they objected to the alleged misdeeds.
In July 2011, Medtronic notched a partial victory in a Commonwealth federal court, when Judge Douglas Woodlock dismissed 2 of the 3 counts against it on the grounds that 1 of the whistleblowers lacked legal standing to sue under the False Claims Act and that the 2nd failed to specify the time, place, and content of an alleged false representation, as required under the FCA.
In November 2011, the device maker entered into a non-financial settlement with 1 of the whistleblowers, who then abandoned all claims against Medtronic, according to an SEC filing.
Read more medical device legal news from MassDevice.com
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Enzo is seeking either an injunction against future sales of the offending products, or, barring that, a "compulsory ongoing licensing fee." Enzo filed the same complaint against Life Technologies Corp. (NSDQ:LIFE), Gen-Probe (NSDQ:GPRO) and Roche Diagnostics (PINK:RHHBY) last month. Read more
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The pair of lawsuits – Viserta v. St. Jude Medical and Banks v. Coloplast – both involved explanted medical devices, patient injury claims and alleged product defects, and neither had a physical device to demonstrate as evidence.
The St. Jude (NYSE:STJ) lawsuit, however, involved a device that had been cleared via the FDA’s pre-market approval pathway, whereas the Coloplast (CPH:COLO B) device had not. Thanks to preemption laws, the St. Jude case was a textbook ruling in the company’s favor. The Coloplast case went through more rounds of argument before the courts ultimately ruled in favor of the plaintiff. Read more
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