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May 19, 2014 by |

Pharmaceutical Manufacturer Pays $7.3 Million to Settle Qui Tam Lawsuit


The manufacturer of the antifungal medication Mycamine has agreed to pay $7.3 million to settle a whistleblower lawsuit. The lawsuit was filed in 2010 by Frank Smith in a United States District court. The defendant in the case is Astellas Pharma US Inc. and allegations involve False Claims Act violations. San Francisco whistleblower and securities attorneys are seeing more whistleblower complaints.

According to the settlement agreement, the defendant will pay approximately $4.2 million to the federal government and $3.1 million to certain states who participate in the Medicaid program. The whistleblower who filed the lawsuit will receive approximately $708,000.

It was alleged that the defendant engaged in off label marketing when they sold Mycamine for non- approved uses. Mycamine is approved to treat fungal infections of the esophagus in adults. It was alleged that the drug was sold for use by children, which is not allowed. According to the settlement agreement, from 2005 to 2013 Mycamine was not approved to treat children for any use. San Francisco whistleblower and securities attorneys are glad that whistleblower complaints are being investigated.

The federal government alleged that the defendant 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. Thus, when bills were submitted to Medicare and Medicaid to pay for the drug, the False Claims Act was violated. Medicare and Medicaid only reimburse for approved uses of pharmaceutical products. San Francisco whistleblower and securities attorneys say that False Claims Act violations cost taxpayers dollars.

The defendant in the case denied the allegations but agreed to settle the case. The whistleblower alleged that the defendant aggressively marketed Mycamine to children’s hospitals and pediatric centers and that the product presented an increased risk of harm to children. The defendant cooperated with the government investigation into the allegations. Evans Law Firm, Inc. was not involved with this case but will investigate whistleblower claims.

Evans Law Firm, Inc. handles whistleblower/false claims, consumer fraud class actions, insurance and banking fraud, consumer product liability, elder abuse, and personal injury cases. If you think that you have witnessed or are the victim of financial fraud by an insurance company, bank or individual then, contact Evans Law Firm, Inc. at (415) 441-8669 for a free and confidential consultation, or email

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