Off-Label Marketing

Off-Label Marketing Becomes Global Issue as World Health Organization Encourages Cost-Effectiveness

Amid global shortages of life-saving medical resources, the United Nations’ World Health Organization has released a report focusing on various cost-saving tactics for member nations to consider while strategizing medical policy. At the heart of the matter, the WHO found that most nations do not have procedures in place to evaluate cost-effectiveness of current [...]

By | 2018-09-14T14:11:42+00:00 April 16th, 2015|Healthcare Fraud|

Millennium Pharmaceuticals Escapes False Claims Act Allegations; Judge Leaves First Amendment Arguments Intact

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 [...]

By | 2018-09-13T11:57:27+00:00 April 10th, 2015|Healthcare Fraud|

Shire Pharmaceuticals to Pay $56 Million to Settle False Claims Act Allegations

According to a recent announcement by the Department of Justice, Shire Pharmaceuticals has agreed to pay $56 million to settle claims it fraudulently marketed the popular attention-deficit drug Adderall and thereafter submitted claims to U.S. government healthcare programs for reimbursement. The allegations differ from the oft-cited problem of “off-label marketing,” which occurs when a [...]

By | 2018-09-24T15:09:33+00:00 October 14th, 2014|Healthcare Fraud|

Off-Label Marketing Case Involving Calgene Survives Despite Defendants’ Motion to Dismiss

Earlier this month, a False Claims Act case against drug maker Calgene was unsealed, revealing allegations of off-label marketing with regard to its controversial cancer drug Thalomid. The case, in which the government opted not to intervene, has been subject to several months’ worth of procedural wrangling by both parties. [...]

By | 2018-03-27T10:13:13+00:00 July 30th, 2014|Healthcare Fraud|

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 [...]

By | 2018-03-27T10:17:25+00:00 July 25th, 2014|Healthcare Fraud|

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 False Claims Act – a [...]

By | 2018-09-21T14:44:34+00:00 May 2nd, 2014|Healthcare Fraud|

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 from attempting to file cases [...]

By | 2018-09-21T14:37:20+00:00 April 25th, 2014|Healthcare Fraud|

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 to treat conditions in a [...]

By | 2018-09-14T14:09:51+00:00 March 25th, 2014|Healthcare Fraud|

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 a product for the treatment [...]

By | 2019-02-18T14:40:20+00:00 March 13th, 2014|False Claims Act Legal News|
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