Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations for Off-Label Marketing and Promotion of Drug Mycamine®
Philadelphia, PA -- (ReleaseWire) -- 04/16/2014 --The Pharmaceutical company Astellas Pharma US, Inc. has agreed to pay the United States a total of $7.3 million to resolve allegations that it violated the False Claims Act by illegally marketing and promoting the drug Mycamine® for pediatric use and to pediatric institutions.
The settlement resolves allegations brought in a whistleblower action filed in the Eastern District of Pennsylvania in March 2010 under the False Claims Act, which permits private citizens to bring lawsuits alleging violations of the Act on behalf of the United States and to share in any recovery. The settlement resolves claims that, between 2005 and 2010, Astellas knowingly marketed and promoted the sale of Mycamine® for pediatric use, which was not a medically accepted indication and, therefore, not covered by federal health care programs. During this timeframe, the FDA approved Mycamine® to treat adult patients suffering from serious and invasive infections caused by the fungus Candida, including infections in the esophagus, the blood and the abdomen, and to prevent Candida infections in adults undergoing stem cell transplants. Up until June 2013, however, Mycamine® was not approved to treat pediatric patients for any use.
The whistleblower suit was filed by Relator Frank Smith, who worked as a sales representative for the company. Mr. Smith alleged that Astellas promoted and sold Mycamine to children’s hospitals for use in children without warning of certain health risks, including the risk of liver tumors.
Relator Smith claimed that particular pressure was placed on sales persons with children’s hospitals in their sales territories (including duPont Hospital for Children in Wilmington, DE, The Children’s Hospital of Philadelphia, and Saint Christopher’s Hospital for Children) to market Mycamine®, as not only safe for children but superior to its counterpart Cancidas®, even though Mycamine®, did not have a pediatric indication like its competitor.
Relator also alleged that sales representatives were instructed to use the Micafungin-Liposomal Study to respond to dosing questions from pediatric oncologists and other doctors at pediatric hospitals, by turning the first page of the study over and using page 2 as the dosing standard for children. Relator claimed that this was done even though Mycamine®, dosing in children has not been adequately studied or FDA-approved.
Whistleblower Attorney Claudine Q. Homolash, founder of the newly formed CQH Firm, was the lead attorney on the case while at her previous law firm which she left in December 2013. Ms. Homolash was responsible for managing the case, its investigation, compilation of the evidence, drafting the pleadings, and working with the government, the client and other members of the team towards ultimate resolution. “It was a pleasure representing Frank Smith and working with Assistant United States Attorney Susan R. Becker. I am pleased to be a part of this success and honored to have been afforded the opportunity to work on this matter.” Working on the case since 2010, Ms. Homolash commented that she delighted that the attorneys involved were able to achieve such a fantastic result and protect children. She is glad that the company took responsibility.
The lawsuit is captioned United States ex rel. Smith v. Astellas Pharma, US Inc. et al., No. 10-999 (E.D. Pa.).
Government teams have recovered $4.3 Billion in the fiscal year 2013 and $19.2 billion over the last five years in health care fraud. This is the highest three-year average return on investment in the 17-year history of the Health Care Fraud and Abuse Control Program.
About Claudine Q. Homolash
Claudine Q. Homolash, Esquire is a whistleblower lawyer who focuses on healthcare and pharmaceutical company fraud. If you have questions regarding a case, she can be reached at 800.975.8834 or 215.965.1320 for a free legal consultation.
Visit us on the web at http://www.cqhfirm.com.
Please note that this press release has been revised from its original content.