JAMA Favors Consumers In Upcoming Levine Pre-emption Case
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Coming up next week before the U.S. Supreme Court is an issue that affects all Americans who take any kind of prescription drug from time to time – that would be virtually all of us.
The case before the court on November 3 is Wyeth v. Levine and the decision will help clarify one of the fiercest battles between consumers and corporations to date, known as federal pre-emption.
Now a prestigious medical journal is taking the side of consumers, which puts them squarely against the pharmaceutical industry, which is a rare position for doctors.
Background on the case - Diana Levine, 62, is rushed to a Vermont emergency room with a migraine. She was given demerol for the pain and a Wyeth drug Phenergan, for the nausea. Levine wishes she had opted for the nausea.
Wyeth’s label doesn’t warn against administering the drug through something called an IV push. The drug turned her arm gangrenous then she lost most of her right arm below the elbow, a terrible tragedy for a musician.
Wyeth was sued by Levine who won in court almost $7 million. Wyeth said, wait a minute in its brief (Wyeth brief)and appealed. Levine won that too.
Now Wyeth it taking the issue to the highest court in the land hoping to have a favorable outcome arguing essentially that a federal authority which approved the drug's label pre-empts a state lawsuit.
The endorsement from the medical community comes from the editors of the Journal of the American Medical Association (JAMA).
They say, in a nutshell that the government cannot possibly protect the public from the potential downsides of drugs that enter the market. Some have not had sufficient testing, while some have had negative test results withheld from regulators. The FDA can’t possibly screen for every dangerous drug.
What’s most interesting is the doctors and editors credit the power of a subpoena and an order to produce documentation as the most likely way to find out what is really happening behind the boardroom doors of pharmaceutical giants.
“Thus, tort law serves in effect as a way to close regulatory gaps in the FDA premarketing approval process and to provide a mechanism for postmarketing surveillance. Moreover, litigation has been a rich source of information about how drug and device manufacturing companies behave, such as with off-label promotion, guest and ghost authorship, and reporting of safety findings.”
Without information gathered in court, much of the behaviors by drug companies would stay hidden.
As the Diana Levine case goes, so likely will the pendulum swing – either toward consumer rights in court, or the rights of corporations to hide behind a blanket immunity.