The ongoing off-label marketing debate has given rise to several False Claims Act lawsuits commenced by a single whistleblower. In a qui tam cause of action filed in November, 2009, whistleblower Frank Solis has alleged that Millennium Pharmaceuticals and Merck, Inc. engaged in the controversial sales technique known as off-label marketing with regard to several prescription medications.
Off-label marketing is a contentious practice wherein drug companies advertise to and encourage practitioners to prescribe drugs for uses not approved by the FDA. Currently, the practice is not per se illegal; however, engaging in off-label marketing with Medicaid or Medicare parents may result in liability under the False Claims Act.
The case at hand also presents a unique legal inquiry with regard to the intersection between the first amendment and a drug company’s right to market its products as it wishes. In a closely-watched whistleblower lawsuit, several amicus curiae have offered their position on the issue, with many pharmaceutical advocates contending that limiting off-label marketing efforts amounts to unconstitutional restraints on free speech.
California judge tosses FCA claim against Millennium
In March, 2015, California District Court judge Morrison C. England Jr. dismissed the False Claims Act allegations put forth by Solis with regard to Millennium’s alleged off-label marketing of the blood-thinning drug Integrilin. Citing the public disclosure bar, Judge England held that as many as five other federal and state False Claims Act cases have been filed already, all of which plainly detail the alleged off-label marketing of the drug. The judge further concluded that there was no reason to believe Mr. Solis was involved in any of the other cases, a factor which could have helped to protect his case, under Ninth Circuit case law, had he been the original source of information.
The court, however, opted not to go into the ongoing first amendment debate, opting only to dismiss the case on procedural grounds. The free speech debate has been closely monitored by both advocates of the pharmaceutical industry and the Department of Justice, which maintains an interest in eradicating off-label marketing to public health insurance enrollees.
The Department of Justice framed the issue as one of distinguishability and has not necessary outlawed off-label marketing unless it results in the intentional submission of false claims to the government. The DOJ concluded in its amicus brief that it only objects to off-label marketing when the practice leads to subsequent claims for reimbursement from Medicare or Medicaid, and it does not condone off-label marketing from a free speech perspective.
Advocates for the pharmaceutical industry obviously see the issue in a different light, arguing that a private sector business should be able to promote and market its own products without government intrusion and penalty.
The free speech aspect of the case has yet to be decided. In 2012, the Second Circuit held that a pharmaceutical representative had been improperly restrained in his speech due to off-label marketing restrictions, prompting a nationwide debate over the issue. Other circuits have not yet ruled on the issue.
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