Off-Label Marketing

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

The WHO is examining the benefits of off-label marketing and has urged corporations to work together to lower the costs of medication overall.Image source: Wikimedia Commons Amid global shortages of life-saving medical resources, the United Nations’ World Health Organization has released a report focusing on various cost-saving tactics [...]

By | 2018-03-26T04:34:19+00:00 April 16th, 2015|Healthcare Fraud|

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

In a closely-watched False Claims Act off-label marketing lawsuit, one of three defendants – Millennium Pharmaceuticals – has escaped liability. Image source: Wikimedia Commons 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 [...]

By | 2018-03-26T10:00:33+00:00 April 10th, 2015|Healthcare Fraud|

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

Shire Pharmaceuticals, maker of popular ADHD drug Adderall, has paid over $56 million to settle claims it improperly marketed the drug.Image source: Wikimedia Commons According to a recent announcement by the Department of Justice, Shire Pharmaceuticals has agreed to pay $56 million to settle claims it fraudulently marketed [...]

By | 2018-03-26T00:27:37+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

Drug maker Astellas has agreed to pay over $7 million to federal and state agencies to settle claims it unlawfully marketed a powerful anti-fungal drug to treat pediatric patients.Image source: Wikimedia Commons The Department of Justice, in concert with several states’ attorneys general, recently announced a settlement against Astellas Pharma U.S., Inc., based [...]

By | 2018-03-27T08:58:23+00:00 May 2nd, 2014|Healthcare Fraud|

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

Pfizer is allegedly continuing its practice of fraudulent marketing tactics for its antipsychotic schizophrenia drug Geodon despite settling with the government on this matter in 2009 for $2.3 billion. At that time, Pfizer was allegedly touting Geodon for unapproved uses, including post-traumatic stress disorder, anxiety and autism. Image source: In a recent [...]

By | 2018-03-27T09:00:50+00:00 April 25th, 2014|Healthcare Fraud|

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

The FDA is responsible for the parameters of pharmaceutical drug approvals and any marketing of a product for purposes beyond its approved use is known as “off-label marketing.”Image source: Wikimedia Commons The issue of off-label marketing raises a compelling question as to the relationship between the First Amendment’s protection of free speech and [...]

By | 2018-03-26T04:34:57+00:00 March 25th, 2014|Healthcare Fraud|

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

The U.S. Supreme Court is expected to issue a ruling on Nathan v. Takeda once oral arguments conclude. Image source: Wikimedia Commons 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 [...]

By | 2018-03-25T14:59:58+00:00 March 13th, 2014|False Claims Act Legal News, Healthcare Fraud|
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