Pharma Fraud

Supreme Court Further Limits Liability of Generics for Faulty Drugs

By Gordon Schnell In what is being hailed as a major victory for generic drug makers (but not necessarily for consumers), the Supreme Court ruled last week that these companies cannot be held liable for defects in the design of their products.  The decision follows from the Court's 2011 ruling that similarly shielded the generics from liability for inadequate safety warnings on their drug labels.  Taken together,...

Pharmaceutical Case Presents Novel Use of False Claims Act

(As reported in Thomson Reuters) When you think of a whistleblower, you might think of an employee reporting on the misconduct of some giant corporate employer -- a David versus Goliath scenario.  On Friday, Reuters reminded us that this is not always the case, reporting on a False Claims Act lawsuit brought by a very different kind of whistleblower -- a corporate competitor.  In this case, Amphastar...

High Court to Hear Argument on Whether Injured Patients Can Hold Generic Drug Makers Accountable for Their Defective Drugs

By Jason Enzler Next Tuesday the Supreme Court is scheduled to hear oral argument on Mutual Pharmaceutical’s appeal of a $21 million jury award for serious injuries caused by one of its generic drugs.  Much more is at stake than the money, however, with many expecting the Justices to set out a broad rule on whether any patient can sue a generic drug maker for defects in the design of its drug. The underlying...

Stiff Amgen Fine Shows No Slowing Down in Government Prosecution of Off-Label Marketing

By Gordon Schnell It was only two weeks ago that the Second Circuit Court of Appeals came down with its groundbreaking decision in U.S. v. Caronia.  In a 2-to-1 ruling by a three-judge panel, the appeals court overturned the conviction of a drug company sales representative for promoting a prescription drug for uses not approved by the FDA.  The majority reasoned that banning such off-label marketing violated the...

CVS Sub Caught Duping Consumers in Prescription Drug Purchases

By Marlene Koury In one of the first False Claims Act settlements involving Medicare's "Part D" prescription drug program, CVS Caremark subsidiary, RxAmerica, agreed to pony up $5.25 million to resolve charges that it submitted false pricing information to the Centers for Medicare & Medicaid Services (CMS).  This is the government body that oversees the Medicare and Medicaid programs.  It also makes available the...

The Fraud Behind the Fraud of Off-Label Drug Marketing

By Gordon Schnell It has been one of the most common means for drug companies to get around what can be the very rigorous and time-consuming process of securing FDA approval for selling drugs.  That is, taking drugs that the FDA has approved as safe and effective for one particular use and marketing them to the medical community and the public for an entirely different set of uses.  This so-called off-label...