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Posts Tagged Injury

Legislating Ignorance

Child-GUN

Science is under attack, and not just from anti-vaccine celebrities and parents with degrees from Google University. Scientific illiteracy is being woven into the very fabric of our society through legislative assault. If you dismiss this as alarmist hyperbole, you haven’t been paying close enough attention.

Every day thousands of pediatric health care providers throughout the country provide safety advice to patients and their parents during routine health maintenance visits. As part of this important routine we ask a series of standard questions to assess the safety of our patients’ environment. Some of these questions are easy and straightforward, and some are more personal and potentially awkward for patients and their parents, including questions pertaining to sexual practices and preferences and psychosocial history. An important series of questions focuses on potential hazards in the home, such as how toxins and medicines are stored, how pools are secured against curious toddlers, and whether there are guns in the home and how they are stored and secured. Parents are usually appreciative of the advice we provide, and thankful for our concern and attention to these issues. Occasionally patients or parents are taken aback by some of these questions, and very rarely they prefer not to answer them (in my 20 years in practice, I can recall only one time this has occurred). We ask these questions because accidental injuries and deaths are common occurrences in the pediatric population, and there is good evidence that patients tend to follow the advice we provide our patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine

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Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

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Posted in: Pharmaceuticals, Politics and Regulation

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