Company Shells Out $7.3 Million In False Claim Whistleblower Case: Drug Company Reportedly Put Children At Risk For Heart Attack And Liver Failure (Picture And Video)

An Astellas pharmaceutical sales representative, the whistleblower in the case, contacted Sheller, P.C. who filed a qui tam complaint with the U.S. Attorney’s Office in 2010. Led by founding partner of the firm Stephen Sheller, former Assistant U.S. Attorney Joseph Trautwein,  Jamie Sheller and Claudine Homolash worked with the relator/whistleblower to prepare the case, submit evidence and file the complaint under seal with the government according to court documents.  

The lawsuit alleges that Astellas marketed Mycamine for off-label use in children, thereby increasing sales while making illegal claims for reimbursement from the government.  “Children were put at risk of cardiac arrest, liver failure, kidney and blood disorders and other adverse effects,” said Stephen Sheller in an interview with The American Law Journal television program. “There are children out there that may have these problems whose parents don’t know that the drug may have caused serious, potentially life-threatening conditions.”

At the time, Mycamine was approved only for adults and not for use in children by the U.S. Food and Drug Administration for intravenous (IV) use to treat the yeast fungus candida and thrush infections in the throat, stomach, in abscesses and other areas of the body. 

According to the complaint, more than two dozen states joined the Sheller lawsuit to recover the funds improperly paid the pharmaceutical company by Medicare, Medicaid, TRICARE and other programs. Astellas denied the allegations; the agreement states the settlement is “neither an admission of liability . . . nor a concession by the Unites States that its claims are not well founded.” 

“Pharmaceutical companies that place their financial interests above the well-being of their patients will be held accountable,” said Sheller. “We’ve been fighting these battles for many years, and we cannot, and should not, tolerate those who abuse federal and state health care programs and put the beneficiaries of these programs at risk.”

“No matter how big or small the case, the government has a system in place to protect the public” said Trautwein in an American Law Journal interview. “If you don’t follow the system, they’re going to come after you. Hopefully that message is getting across.”

The relator first became acquainted with the Sheller, P.C. law firm’s whistleblower practice after being represented by attorney Jamie Sheller in an auto accident. “The genesis of this claim is that the whistleblower was rear-ended while driving in 2009 and was successfully represented by our firm” said Jamie Sheller in an interview with The American Law Journal. “Upon learning our firm was involved in pharmaceutical fraud cases, he expressed concern about the conduct of his employer and as a father, he wanted to be sure there was no potential injury to children prescribed this drug for unapproved use. He wanted to do the right thing.”

The relator is the first-to-file whistleblower in this claim, which under qui tam provisions of the False Claims Act allows private persons to bring a lawsuit on behalf of the government and share in the proceeds.

The settlement was achieved through the coordinated efforts of the Sheller team and the U.S. Department of Justice and U.S. Attorney’s Office for the Eastern District of Pennsylvania including Margaret L. Hutchinson, Assistant U.S. Attorney and Chief of the Civil Division, Assistant U.S. Attorney Susan R. Becker, Health Care Fraud Analyst Ray Uhlhorn and auditor Dawn M. Wiggins.

The lawsuit is captioned United States ex rel. F.S., et al. v. Astellas Pharma US, Inc., et al., No.10-999.