News & Commentary on Prescription Drug & Medical Device Lawsuits
This is promising:
Drugmaker executives whose companies promote unauthorized uses of their medicines may be targeted by U.S. regulators for misdemeanor prosecutions, Food and Drug Administration Deputy Chief for Litigation Eric Blumberg said.
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‘“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows
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As I’ve mentioned before, the game plan for most pharmaceutical companies these days seems to be to (a) get a drug approved for a limited indication, and then (b) promote it as a cure for every ailment known to man. I thought the figures below were interesting:
The Justice Department on Tuesday joined a whistle-blower
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Drug marketing 101: The FDA approves drugs for specific ailments. Drug companies may not market the drug to treat any other type of ailment. If they do, it’s called off-label marketing and it is illegal.
Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than…
Some people don’t understand why pharmaceutical companies shouldn’t be allowed to engage in off-label marketing. Here’s one reason:
Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the
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I’ll be honest with you. I don’t trust pharmaceutical sales reps. Few of them are medical doctors, but they tell doctors which drugs should be prescribed for which patients. Traditionally, their compensation is based in part upon how many drugs the doctors they visit prescribe. This leads to a gigantic incentive to engage in off-label…
I sure hope so. Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use.
Washington Bureau – When your doctors writes you a prescription, that’s just between you, your
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Another good article from Duff Wilson at the New York times.
The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.
One of the investigations related to “selected physicians who participated
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I’d love to get my hands on the transcripts for this case.
Oct. 28 (Bloomberg) — A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses.
Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said
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If Allergan is successful in challenging this rule, then FDA approval will become meaningless. Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use. Some would say that’s the world we already live in…
Oct. 2 (Bloomberg)
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The AM Law Daily was kind enough to post the transcript of Mark Lanier's opening statement in the Neurontin trial that was called off. I read this passage and had to share it.
"Please understand, you're not going to have a lot of documents on this stuff because you will hear David Franklin explain that
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