Tag Archives: Off Label Prescription

Taxpayers Spend Billions Giving Children Antipsychotic Medications

  Can you guess the best-selling class of drugs? It may be that a fifth of Americans suffer gastroesophageal reflux disease at least once a week, over 30% have hypertension, and over a third of U.S. adults have high LDL cholesterol, but the best-selling class of drugs isn’t proton-pump inhibitors for reflux, or angiotensin II receptor antagonists for blood pressure, or statins. It’s anti-psychotics.   The best-selling drug in America is Abilify, the prescribing information for which says it is only approved for:   Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have ... Continue Reading

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The Big Pharma Business Model: Deception And Bribery

It’s déjà vu all over again. Remember how, three years ago, Pfizer paid $2.3 billion to the Department of Justice to settle off-label claims relating to Bextra and other drugs, and Eli Lilly paid $1.4 billion for Zyprexa marketing? If so, then last week was no surprise: GlaxoSmithKline agreed to pay a whopping $3 billion to settle criminal and civil charges brought against it by the Department of Justice. Quoting from the DOJ press release, GlaxoSmithKline was accused of: distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression ... Continue Reading

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The Learned Intermediary Doctrine And Dollars For Docs

Have you ever seen a commercial on TV, or heard a commercial on the radio, or read an advertisement in a magazine, or saw a commercial on a website, for a prescription drug? Of course you have, if you're in the United States (or New Zealand — the rest of the modern world bans the practice). You see them all the time. Why? Because, as io9 profiled extensively, "For every dollar spent on ads for drugs, over four dollars in retail sales are garnered. A May 2011 study showed that new drugs that feature direct-to-consumer advertising are prescribed nine times more than their new counterparts ... Continue Reading

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The Most Unfair Prescription Drug And Medical Device Opinions Of 2011

A few days ago I reviewed the list of "worst" pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the "best" prescription drug and medical device decisions. The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries' factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn't find a federal statute or regulation in support of ... Continue Reading

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Off Label Drug Use Should Be Regulated For Patient Safety

[Update: the American Medical Association recently posted an article about how "off-label" marketing is so pervasive that many doctors don't even know what the approved purposes of the prescription drugs and medical devices are, exposing them to malpractice liability.] The pharmaceutical defense lawyers at Drug & Device Law, one of my favorite blogs to throw rocks at (we went Jersey Shore over the Wellbutrin litigation a year ago), are at it again, this time attacking a legal theory they refer to as ‘FDA regulatory informed consent.’ Although drug companies aren’t allowed to market drugs for any purpose other than those ... Continue Reading

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