$7.3M Astellas Pharma Off-Label Marketing and FCA Settlement

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Digital Journal

2014-04-16

The whistleblower attorney team of Sheller P.C. announced today that Astellas Pharma U.S., Inc. has agreed to pay $7.3 million to resolve allegations by the Sheller whistleblower client that Astellas violated the False Claims Act by submitting fraudulent claims to government healthcare programs while marketing off-label the antifungal drug Mycamine for use in children. Court documents detailing the civil allegations were unsealed today by the Office of the United States Attorney for the Eastern District of Pennsylvania.

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. 

 

About Stephen A. Sheller and Sheller, P.C.

Sheller, P.C. represents plaintiffs injured by defective drugs, devices, and consumer products nationwide as well as whistleblowers reporting corporate and government fraud. Founded by Stephen A. Sheller and in practice since 1977, Sheller, P.C. has challenged some of the largest corporations in the United States, including pharmaceutical and medical device companies, auto, tobacco and others.

The firm’s off-label marketing and federal and state False Claims Act qui tam whistleblower cases have recovered more than $6.25 billion for the U.S. Government and taxpayers to date, including some of the largest in U.S. history.(1,2,3,4,5,6)

About Joseph Trautwein

Founder of Joseph Trautwein & Associates, LLC, Joseph Trautwein has more than sixteen years experience in complex civil litigation including twelve years of service with the U.S. Department of Justice. He was Assistant U.S. Attorney in the civil division of the Philadelphia office until 2010, focusing primarily on health care and defense contractor fraud. Trautwein continues to pursue corporate wrongdoing on behalf of consumers and the government.

Cases cited

(1) United States ex. rel. Victoria Starr, et al. v. Janssen Pharmaceutica Prods., L.P., No. 04-1529

(2) United States ex. rel. Robert Rudolph, et al. v. Eli Lilly and Company, No. 03-943

(3) United States ex. rel. Ronald Rainero, et al. v. Pfizer, Inc., No. 07-11728

(4) United States ex. rel. James Wetta, et al. v. AstraZeneca Corp., No. 04-0379

(5) Price v. Philip Morris USA, 848 N.E.2d 1 (Ill. 2005)

(6) United States ex rel. Gavin v. Sarasota Pain Associates, P.A. and Steven Y. Chun, M.D., 6:11-cv-583-T-23TBM (M.D. Fla. 2014)

DOJ Release

United States Settles False Claims Act Lawsuit Against Astellas Pharma U.S., Inc., U.S. Department of Justice Press Release, April 16, 2014 http://www.justice.gov/opa/pr/2014/April/14-civ-391.html

Astellas Pharma US Release

Astellas Pharma US Reaches Agreement With U.S. Department of Justice, April 16, 2014 http://newsroom.astellas.us/2014-04-16-Astellas-Pharma-US-Inc-reaches-agreement-with-U-S-Department-of-Justice

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