Tag Archives: Drug Label Failure To Warn

Courts Lag Behind Science In Recognizing How Regular Tylenol Use Causes Liver Damage

One of the more sobering parts of being a trial lawyer is reviewing intakes of potential cases. We routinely talk with people who have just lost a spouse or child or who have recently suffered an injury that will leave them permanently disabled. Many of these accidents happened in the course of activities we all know to have an element of danger, but many involve doing the same thing a million other people do every day. No one expects that giving their kid Motrin will cause a horrific skin disease or that their tap water might be so polluted that it's ... Continue Reading

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Why Merck Still Doesn’t Warn About Propecia Causing Impotence

The pharmaceutical industry is plagued by the same problem as the entertainment industries: their business models are too reliant on blockbusters.  I'm certainly not the first person to notice that — even drug company CEOs have openly fretted about it — but the problem persists and grows each year. As the pharmaceutical consulting company L.E.K. pointed out a few months ago, "Blockbusters have become the centerpiece of the biopharma industry, growing from 16% of global drug revenue in 1995 to 35% in 2010." In the entertainment industry, the consequences of that reliance on blockbusters is merely a string of bad sequels ... 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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Pennsylvania’s Defective Drug Design Laws Hang In The Balance

It's no secret that pharmaceutical companies are among the more litigious businesses in America. Up until 2003, when Congress stepped in, the big drug makers had a good thing going: whenever the patent was about to expire on one of their blockbuster drugs, they would file a new patent for trivial modifications to the medicine, and thereafter would sue generic drug manufacturers claiming that the generic version of the old drug somehow infringed on the new patent. Here’s the kicker: the big drug makers knew these patent infringement claims were frivolous, so they would enter into a “settlement” in which ... Continue Reading

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Failure To Warn Quiz: Do You Know Children’s Motrin Side Effects?

They say you learn something new every day. Here’s what you’re going to learn today: Over-the-counter Motrin can burn the skin off your face. Commonly prescribed drugs like the yeast-infection treatment Nystatin and the antibiotic Azithromycin can do the same. All of them, and over a dozen other drugs, can also cause ulcers and lesions to develop on the membranes in your mouth and on your lips, making it impossible to eat. Take a step back and think of how many of those you took in the last year. Who didn’t take Motrin or some other ibuprofen in the past ... Continue Reading

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Wyeth v. Levine: The Supreme Court Rejects Judicial Activism for Drug Makers

As you've probably heard at sites like Overlawyered and Drug & Device Law, the sky is falling upon us because the Supreme Court didn't override Congress and the FDA and decide to pre-empt state failure-to-warn tort suits against prescription drug manufacturers. If you don't know the basic facts, see SCOTUSBlog. Some initial commentary at the WSJ. Wyeth manufactures pharmaceuticals, subject to FDA regulation. The FDA sets a minimum standard for the use of these drugs and their labeling; it does not dictate the text of warning labels, though it does have to approve them, which it does after intense lobbying by the manufacturers, lobbying ... Continue Reading

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