False Claims Act, Medical Fraud

“Dermagraft” manufacturer, Shire Pharmaceuticals LLC (Shire) agreed to pay $350 million to settle False Claims Act allegations. The federal government alleged that Shire employed kickbacks and other unlawful methods to induce clinics and physicians to use or overuse its product. Shire entered into a $350 million settlement agreement to settle both federal and state False Claims Act allegations. “Dermagraft,” is a bioengineered human skin substitute approved by the FDA for the treatment of diabetic foot ulcers.

The allegations resolved by the settlement were brought in six lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private parties to sue on behalf of the government for false claims and to receive a share of any recovery. The whistleblower shares to be awarded in this case have not yet been determined.

“Giving kickbacks and gratuities to healthcare providers corrupts medical treatment by interjecting personal financial incentives into decisions that should focus on what is best for a particular patient,” said U.S. Attorney Channing D. Phillips for the District of Columbia. “These types of unlawful incentives are particularly troubling when they seek to corrupt the medical treatment provided to our nation’s veterans. We will aggressively pursue any company that engages in such reprehensible and unlawful conduct, which seeks to put a company’s financial gains ahead of providing the best medical treatment for those who bravely served in our Armed Forces.”

One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $31.4 billion through False Claims Act cases, with nearly $19.6 billion of that amount recovered in cases involving fraud against federal health care programs.

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