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Is The FDA Ready For Kim Kardashian And Mutant Head Lice?

Posted  08/31/15
(published on the Huffington Post blog) A pharmaceutical company was recently reprimanded by the FDA for its misleading marketing tactics on an unexpected forum—Kim Kardashian's Instagram feed.  The new mother's failure to address the full safety profile of morning sickness drug, Diclegis, prompted the FDA to issue a warning letter to the drug's manufacturer.  This sort of enforcement is representative of the...

Can Data Bring Reason to Drug Pricing?

Posted  07/24/15
As far as purveyors of all things pharmaceutical go, Walter White isn’t looking so bad these days.  Well, at least his prices were competitive.  With major pharmaceutical companies putting astronomical and ever-increasing price tags on frequently life-saving medications, patients and insurers, including state and federal government payers, are finding themselves looking for new options and opportunities to...

Congress Highlights Medicare Part D Plans’ Failure To Prevent Fraud

Posted  07/16/15
Fraud in the Medicare Part D prescription drug program is getting the attention of not only the Department of Health and Human Services’ Office of the Inspector General (HHS OIG) but also watchdogs on Capitol Hill.  On Tuesday, July 14, 2015, the House of Representatives’ Committee on Energy and Commerce held a hearing to examine two recent reports from HHS OIG examining improper spending in the Medicare Part...

DOJ Gives Major Shoutout To Whistleblowers In $450M DaVita False Claims Act Settlement

Posted  06/26/15
By Gordon Schnell On Wednesday, Denver-based provider of dialysis services DaVita Healthcare Partners, Inc. agreed to pay $450 million to resolve charges it violated the False Claims Act by purposely creating and then billing the government for unnecessary waste in administering the drugs Zemplar and Venofer to dialysis patients.  DaVita is the largest provider of dialysis services in the US with dialysis clinics...

DOJ Catch Of The Week -- PharMerica Corporation

Posted  05/15/15
By the C|C Whistleblower Lawyer Team This week's Department of Justice "catch of the week" goes to PharMerica Corporation, an organization of long-term care pharmacies that dispense medications to residents of nursing homes and skilled nursing facilities across the country.  Yesterday, PharMerica agreed to pay $31.5 million to settle charges it violated the Controlled Substances Act by dispensing Schedule II...

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...

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...

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...

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,...

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...
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