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Page 13 of 14

Does the FDA Hide Evidence of Clinical Fraud?

Posted  02/13/15
By Marlene Koury The FDA protects the public health and assures all drugs are proven safe and effective by reputable scientific trials before they are licensed for sale.  Or do they?  An investigative reporting class at NYU found evidence showing when the FDA finds scientific fraud or misconduct, it does not notify the public, doctors, or the scientific community.  Rather, the FDA "has shown a pattern of burying...

Tagged in: FDA Fraud,

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DOJ Catch of the Week – Vascular Solutions

Posted  08/1/14
By the C|C Whistleblower Lawyer Team This week's Department of Justice "catch of the week" goes to Vascular Solutions Inc (VSI).  On Monday, the Minneapolis-based medical device maker agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval.  Specifically, the government charged that VSI marketed and sold its "Vari-Lase...

Tagged in: Catch of the Week, FCA Federal, FDA Fraud, Healthcare Fraud, Medical Devices and DME, Medicare, Off-Label and Unapproved Use,

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Another Preemption Decision Sheltering Drug Makers from Liability

Posted  07/24/13
By Marlene Koury Pharmaceutical companies are on a roll.  They continue to prevail in court by relying on the preemption doctrine to block injured consumers from suing over defective drugs.  First, in the recent Mutual Pharmaceutical v. Bartlett and PLIVA v. Mensing decisions, the Supreme Court held that federal law bars suits against generic drug companies for defects in the design or labeling of their...

Tagged in: Court Decision, Healthcare Fraud, Pharma Fraud,

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Supreme Court Further Limits Liability of Generics for Faulty Drugs

Posted  07/3/13
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,...

Tagged in: Defective Products, Healthcare Fraud, Pharma Fraud,

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Pharmaceutical Case Presents Novel Use of False Claims Act

Posted  05/1/13
(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...

Tagged in: FCA Federal, Pharma Fraud,

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

Posted  03/13/13
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...

Tagged in: Defective Products, Healthcare Fraud, Pharma Fraud,

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

Posted  12/20/12
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...

Tagged in: Off-Label and Unapproved Use, Pharma Fraud,

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Another Bad Report Card for the Beleaguered FDA

Posted  11/29/12
By Gordon Schnell The Food and Drug Administration (FDA) admittedly has a lot on its plate.  Tasked with regulating the country’s food and medicine supply, not to mention the ever-evolving array of medical devices and procedures, the FDA is the federal agency perhaps most responsible for ensuring our health and well-being.  If the agency does not perform up to task, a lot of people are affected.  So it is no...

Tagged in: FDA Fraud,

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CVS Sub Caught Duping Consumers in Prescription Drug Purchases

Posted  10/22/12
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...

Tagged in: FCA Federal, Part D, Pharma Fraud,

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The Fraud Behind the Fraud of Off-Label Drug Marketing

Posted  10/5/12
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...

Tagged in: Healthcare Fraud, Off-Label and Unapproved Use, Pharma Fraud,

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