Astellas Pharma US Settles Mycamine Whistleblower Lawsuit with Federal Government
The settlement was unsealed on Wednesday, April 16th. Whistleblower Frank Smith filed the lawsuit against the company in 2010, alleging that Astellas violated the False Claims Act by promoting off-label use of Mycamine in children.
Mycamine was approved by the FDA in 2005, and was designed specifically to treat fungal infections of the esophagus. In 2008, it was approved for adult use in candidemia, acute disseminated candidiasis, and candida peritonitis and abscesses. However, Mycamine was not approved for any use in children until 2013.
Based on the whistleblower lawsuit, the Justice Department investigated Astellas for off-label marketing practices between 2005, when Mycamine was approved, and 2010, when the whistleblower lawsuit was filed. Relator Frank Smith, a former sales rep for the pharmaceutical company, claimed that Astellas “aggressively marketed” Mycamine to children’s hospitals well before the FDA ever approved it for use in children.
“Particular pressure was placed on salespersons with children’s hospitals in their sales territories (including duPont Hospital for Children in Wilmington, Del., the Children’s Hospital of Philadelphia, and St. Christopher’s Hospital for Children) to market Mycamine as not only safe for children but superior to its counterpart Cancidas, even though Mycamine has no pediatric indication,” the complaint said.
The U.S. government concluded that Astellas “knowingly marketed and promoted the sale and use of Mycamine for pediatric patients, when the drug had not been approved as safe and effective by the Food and Drug Administration (FDA) for such patients,” the agreement said, “and the United States and state Medicaid programs did not provide coverage for such use of Mycamine.”
Per the whistleblower lawsuit’s settlement, Astellas admits no wrongdoing, but pays a total of $7.3 million – $4.2 million to the federal government, $3.1 million to Medicaid-participating states, and $708,852 to Smith.
“The settlement in this case further demonstrates our commitment to hold responsible any pharmaceutical company that disregards the FDA drug approval process and promotes drugs for uses before they have been deemed safe and effective,” said U.S. Attorney Zane D. Memeger of the Eastern District of Pennsylvania in the press release. “It’s a message that should resonate with all drug companies: There are consequences for violating the False Claims Act and putting profit ahead of government safeguards.”
The Strom Law Firm Can Help Protect Whistleblowers with the False Claims Act
The False Claims Act, also known as the Whistleblower Act or a qui tam lawsuit, is intended to encourage people to come forward with information and assist the government in stopping the waste of Government funds.
Common whistle blower actions include:
- Medicare fraud,
- defense contractor fraud, and
- other kinds of fraud.
If you are personally aware of a fraud that has been committed by your current or former employer, a competitor or otherwise, contact the Qui Tam attorneys at the Strom Law Firm today for a no cost consultation to discuss the facts of your case and whether filing a whistleblower lawsuit may be appropriate. We understand the complexity of the False Claims Act, and can help you with your case. We offer free, confidential consultations so contact us for help today. 803.252.4800.