Pharmaceutical Company Astellas Settles False Claims Act Allegations With States

In an all-too-familiar scenario, pharmaceutical company Astellas, Inc. has agreed to settle all allegations against it involving the anti-fungal medication Mycamine. Earlier this year, the U.S. Department of Justice announced that it had reached an agreement with the company wherein it would remit over $7 million to the government pursuant […]

Pharmacy Company Astellas to Pay $7.3 Million in False Claims Act Settlement

The Department of Justice, in concert with several states’ attorneys general, recently announced a settlement against Astellas Pharma U.S., Inc., based in Northbrook, Illinois. The case involved substantial allegations of off-label marketing practices aimed at pediatric federal healthcare patients. As you well know, it is considered a violation of the […]

Pfizer Unsuccessful in Avoiding Off-Label Marketing False Claims Act Case

In a recent False Claims Act case involving the mental health drug Geodon, Pfizer reportedly lost its bid to have the case dismissed after unsuccessfully arguing, among other claims, that relators failed the “first-to-file” and “public disclosure” requirements contained within the language of the FCA. Specifically, the FCA precludes whistleblowers […]

Off-Label Marketing and the First Amendment: Are Pharmaceutical Companies Protected?

The issue of off-label marketing raises a compelling question as to the relationship between the First Amendment’s protection of free speech and the various federal regulations prohibiting the practice of unlawful marketing of prescription drugs. As a review, off-label marketing occurs when a pharmaceutical company markets its product for use […]

U.S. Solicitor General Explains the Inapplicability of Rule 9(b) in the False Claims Act

As we reported yesterday, the U.S. Solicitor General, upon request by the Supreme Court, submitted its amicus curiae brief in the hotly-contested False Claims Act case Nathan v. Takeda Pharmaceuticals. As a bit of background, this case involves the practice of off-label marketing, which occurs when a drug company promotes […]