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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,

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,

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,

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,

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,

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,

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,

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,

FDAGate -- The Latest Lapse in Government Enforcement

Posted 07/20/12

By Gordon Schnell In what quickly has become the most recent "gate" scandal in Washington, the evidence continues to mount that the FDA acted to stifle whistleblowers within its own ranks. It all began several years ago when a half-dozen FDA scientists and doctors objected to certain imaging devices for mammograms and colonoscopies because of the high levels of radiation they believed the equipment emitted. The...

Tagged in: FDA Fraud,

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Another Preemption Decision Sheltering Drug Makers from Liability

Supreme Court Further Limits Liability of Generics for Faulty Drugs

Pharmaceutical Case Presents Novel Use of False Claims Act

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

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

Another Bad Report Card for the Beleaguered FDA

CVS Sub Caught Duping Consumers in Prescription Drug Purchases

The Fraud Behind the Fraud of Off-Label Drug Marketing

FDAGate -- The Latest Lapse in Government Enforcement

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