A whistleblower lawsuit unsealed in federal court last week alleges Medtronic Inc. illegally marketed a relatively obscure medical device called a biliary stent in ways not approved by federal regulators.
The complaint was filed in U.S. District Court in Boston by two former employees who claim they were harassed and then fired by the Fridley-based medical technology giant when they complained to their managers that so-called "off-label" use of the stent could be harmful to patients. It is not illegal for doctors to use a medical device off-label, however, it is illegal for companies to promote off-label use.
Tricia Nowak, a former sales representative, and Enda Dodd, a former senior research manager, also allege in the 102-page complaint that Medtronic submitted false information to the Food and Drug Administration in order to circumvent government safeguards and gain clearance to market the stents.
Both plaintiffs worked out of Medtronic's CardioVascular headquarters in Santa Rosa, Calif.
Biliary stents are typically implanted in patients suffering from late-stage cancer who have malignant tumors in the pancreas, liver or stomach. Instead, the suit alleges Medtronic "pressured and incentivized" its sales force to target doctors who would use the stents to treat common vascular conditions such as renal stenosis, a narrowing of a major artery that supplies blood to the kidneys, peripheral vascular disease in the superficial femoral artery, a disease of blood vessels in the groin area, and conditions requiring stents in the arteries branching off the aorta.
The lawsuit claims that 90 percent of the Medtronic biliary stents are used off-label, putting patients at "serious risk." Medtronic sales of endovascular stents increased 21 percent to $120 million in the fiscal third quarter, which ended Jan. 29.
The suit alleges that Bill Hawkins, Medtronic's current CEO, who headed the vascular division at the time of the alleged marketing push, exerted "great pressure on the organization to build new revenue from peripheral vascular products."
In a statement, Medtronic said 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, but Mr. Hawkins has long been well-known in the industry for his leadership in advocating and supporting ethical business practices."
The suit is brought under the federal False Claims Act, which allows a person with knowledge of alleged fraud against the government to file a lawsuit to recover funds owed.
In the case, the whistleblowers allege fraud against federal insurance programs such as Medicare and Medicaid that may have paid for illegal stenting procedures. Plaintiffs can receive a portion of any penalties paid to the government.
Janet Moore • 612-673-7752