by Nolan and Auerbach on August 29, 2011
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.
by Nolan and Auerbach on July 8, 2011
The FDA recently touted figures from its Bad Ad Campaign, a campaign designed to encourage doctors, patients and sales professionals to report misleading advertising and promotions in the healthcare industry. The 328 reports submitted over the last year are three times as many as the average of 104 reports submitted in previous years.
The FDA has pledged ongoing support for the program that will take aim at young professionals entering the healthcare industry and continuing to educate groups at hospitals and trade shows.
Of the reports submitted most were turned in by doctors, sending a message to the pharma sales force, “Docs are now the eyes and ears of the FDA.”
Unfortunately, in the past, the FDA has been very slow to take action on reports of wayward marketing promotions. Indeed, all too often, providers’ concerns have been simply lost in the morass of government bureaucracy.
The good news is that the False Claims Act provides a viable alternative. This fraud-fighting law not only provides substantial rewards for whistleblowers, but it includes an action-enforcing mechanism that statutorily requires the government to investigate allegations of fraud. In other words, if providers want to ensure that the government will at least consider their concerns, they should file a False Claims Act qui tam action.
If a provider is aware of egregious off-label promotions, they are strongly encouraged to seek out an experienced law firm that focuses its practice on health care False Claims Act actions.
For more information about qui tam law and healthcare fraud, contact Nolan & Auerbach, P.A.
by Nolan and Auerbach on September 17, 2010
A salesman for a medical device manufacturer expressed concerns to his supervisors that the company was illegally marketing its products to physicians. After the company fired the salesman, he brought a lawsuit against the company, alleging retaliatory discharge in violation of the False Claims Act’s anti-retaliation provision. In Smith v. C.R. Bard, Inc., 2010 WL 3122793 (M.D. Tenn. Aug. 9, 2010), the court dismissed the case, ruling that the salesman did not engage in protected activity under the False Claims Act, for his internal complaints did not seek to “expose” fraud on the government.
Narrow readings of the FCA, such as this decision, were the driving force behind several recent FCA amendments. Under the amended False Claims Act, employees who now raise concerns within the confines of the corporation are protected by the FCA’s anti-retaliation provision. Unfortunately, the courts have ruled that these amendments do not apply to cases that were filed prior to the enactment of the amendments.
For more information about qui tam law and health care fraud, contact Nolan & Auerbach, P.A.
