Nuanced Judicial Hurdles for Off-Label Marketing Medical Device Cases

While the pharmaceutical industry is slowly starting to appreciate the legal and regulatory constraints to illegal off-label promotions, the medical device industry still appears light years away from fully embracing ethical marketing practices. A prime example of the industry’s wayward behavior is evident in several ongoing False Claims Act cases involving the promotion of biliary stents.

A number of device makers have received FDA clearance to market their biliary stents as palliative and short-term fixes to relieve pain caused by bile blockages experienced by a limited number of late-state cancer patients. Because these devices were positioned to the FDA as short-term and not life-sustaining, they were subjected to less rigorous clinical studies.

However, once the devices received the FDA’s seal of approval, several device makers allegedly started promoting the devices as suitable vascular stents, which are implanted for permanent use and undergo far longer-term and variable stresses than biliary stents due to their location in the body.

The industry-wide pervasiveness of these promotions was chronicled in a recent court decision out of the District of Massachusetts. In this case, United States ex rel. Nowak v. Medtronic, Inc., the judge observed that the off-label promotions of bilary stents are so rampant in the industry that the vast majority of bilary stent sales are for off-label uses.

Here, the court distinguished off-label pharmaceutical promotions from off-label medical device promotions. Notably, the court concluded, “Off-label promotion cases involving medical devices are uniquely complicated by the relatively more permissive and undefined nature of Medicare and Medicaid coverage of ‘off-label’ medical devices.” For support, the court reaches for a quote from a recent Texas district court decision: “While Medicare and Medicaid typically do not reimburse off-label prescriptions for drugs, . . . eligibility for reimbursement [of Category B medical devices] depends on whether the procedure performed is ‘medically necessary’ or ‘reasonable and necessary.’” United States ex rel. Bennett v. Medtronic, Inc., 747 F. Supp. 2d 745, 747 (S.D. Tex. 2010).

For more information about qui tam law and healthcare fraud, contact Nolan & Auerbach, P.A.