Blog Archives

Prosecutors See Case Shift From Pharma To Devices, Park Doctrine Cases Coming

Prosecutors told a conference audience June 7 that U.S. enforcement trends show a shifting from pharmaceutical drugs to biologics, biotechnology, and medical devices and that the Food and Drug Administration and the Department of Justice are actively pursuing cases involving the individual liability of executives.
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Alleged Kickbacks for Using Medical Devices Set Stage for FCA Suit Against Manufacturer

Blackstone Medical Inc., the maker of devices used in spinal surgeries, is not entitled to dismissal of a former employee’s whistleblower suit alleging that kickbacks the company paid to doctors for using its products resulted in fraudulent Medicare claims in violation of the False Claims Act, the U.S. Court of Appeals for the First Circuit determined June 1 (United States ex rel. Hutcheson v. Blackstone Medical Inc., 1st Cir., No. 10-1505, 6/1/11).
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Maker of Epilepsy Drug Pleads Guilty In Off-Label Case, Resolves FCA Charges

The U.S. subsidiary of Belgian pharmaceutical manufacturer UCB SA has pleaded guilty to the off-label promotion of its epilepsy drug Keppra and will pay more than $34 million to resolve criminal and civil liability, the Department of Justice said June 9 (United States v. UCB Inc., D.D.C., No. 1:11-375-RMU, guilty plea 6/9/11).
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High Court Rules Data From FOIA Request Constitutes Public Disclosure Under False Claims Act

 In a ruling with implications for the health care industry, the U.S. Supreme Court May 16 ruled that information gathered through Freedom of Information Act (FOIA) requests constituted “public disclosures” and precluded recovery…

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Drugmaker Serono Agrees to Pay $44.3 Million to Settle Fraud Charges

Pharmaceutical manufacturer EMD Serono Inc. has agreed to pay $44.3 million to settle allegations it paid providers kickbacks to induce them to prescribe or promote its multiple sclerosis drug Rebif and that these payments resulted in the…

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SEC cool to corporate demands on whistleblowers

(Reuters) – U.S. securities regulators are resisting corporate America’s demands to force whistleblowers to report possible wrongdoing internally before they can be considered for compensation from regulators. The Securities and Exchange Commission’s whistleblower proposal, one of many rules required by the Dodd-Frank Wall Street overhaul law, would financially reward people who provide original substantive tips leading to enforcement actions that result in sanctions exceeding $1 million.

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