On Feb. 19, the Court unsealed a qui tam lawsuit brought by Hagens Berman against Medtronic (NYSE: MDT), one of the world's largest medical technology companies, for fraudulent medical device applications to the FDA and off-label promotion of its biliary devices. The consolidated complaint, filed in the U.S. District Court in Boston, also charges the medical technology giant with wrongfully retaliating against and terminating former employee Tricia Nowak after her repeated objections to the promotion of stents for uses not approved by the Food and Drug Administration (FDA).
Tricia Nowak, a former sales representative, along with Enda Dodd, a former senior research manager also fired in retaliation by Medtronic, claim the medical device maker defrauded the FDA, federal and state healthcare programs by fraudulently designing and marketing its biliary stents for peripheral vascular use. Representing Plaintiff Ms. Nowak in the case, Hagens Berman, along with co-counsel Chris Dolan of the Dolan Law Firm, representing Mr. Dodd, seek to recover damages and civil penalties arising from Medtronic's unlawful and off-label promotion of its biliary stents.
According to the complaint, the $15 billion medical company submitted false certifications and statements to the FDA in order to circumvent government regulations and FDA safeguards for approval of high-risk medical devices. By doing so, the lawsuit claims Medtronic deceptively gained easy marketing clearance from the FDA for biliary stents which it promoted exclusively as vascular stents. FDA approval of vascular stents requires a more rigorous analysis of the device which Medtronic sought to avoid.
Medtronic then pressured and incentivized its vast sales force to sell biliary stents for peripheral vascular use, the lawsuit charges. The medical device maker is accused of illegally selling biliary devices to treat common vascular conditions including renal stenosis, peripheral vascular disease in the superficial femoral artery (so-called SFA) and conditions requiring iliac artery stenting.
Former employees Nowak and Dodd raised numerous concerns to senior executives surrounding the off-label design and marketing of these stents. Both whistleblowers were allegedly harassed by management and eventually terminated as a result of their protected whistle blowing activity. All the while, Medtronic attempted to conceal its illegal promotional efforts for biliary stents while continuing to actively promote these devices for off-label use, the lawsuit charges.
According to the lawsuit, off-label sales represent virtually all, if not all, of Medtronic's biliary device sales, generating millions in revenue for the company.
The medical device giant's unlawful activities have caused federal and state healthcare programs, including Medicare, Medicaid, the Veterans Administration and the Federal Employee Health Benefits Program, to reimburse off-label for medical insurance claims related to Medtronic's biliary stents, the lawsuit claims.
The lawsuit also points out that a variety of serious adverse events continue to surface among patients who receive biliary stents for off-label use. More and more patients require additional surgeries to retrieve defective devices or repair a ruptured vessel while others experience more severe complications including strokes, heart attacks, and death, the lawsuit states. Furthermore, the complaint alleges that the FDA repeatedly warned Medtronic to cease its unlawful activities, which it refused to do.
In response to the lawsuit, Medtronic told The Wall Street Journal it "is aware of the complaint and intends to vigorously dispute its allegations, including filing a motion to dismiss at the outset of the case. We don't comment on any specific allegations." The Wall Street Journal went on to report that "the lawsuit appears to parallel a federal investigation by the Department of Justice in Boston into marketing of the biliary stents. Various prosecutorial and congressional offices have been investigating the medical-device industry's marketing practices, and the Justice Department's biliary-stent investigation appears to be part of that overall inquiry."
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