It is an issue that is discussed behind law school doors, but it is an issue that citizens in a democracy need to understand.
NPR, National Public Radio, provides one of the best explanations of the Diana Levine case before the court this morning and if you think some obscure legal notions have nothing to do with you - think again.
Basically the U.S. Supreme Court, the highest court in the land, will render the final decision on whether corporations that make devices and products we use every day have immunity from prosecution, if those products harm us.
That is the far reaching implication. Wyeth, the drug company that brought the issue to the high court, says the decision will just affect Wyeth and Levine, a departure from what the company said in its legal brief to the high court.
Injuryboard has provided extensive coverage of Diana Levine and the issue of federal pre-emption.
Here are the basics to consider.
John Adams, one of our founding fathers writes in 1774, “Representative government and trial by jury are the heart and lungs of liberty. Without them we have no other fortification against being ridden like horses, fleeced like sheep, worked like cattle, and fed and clothed like swine and hounds.”
In other words, being able to take a defective product to trial is an important American right. (Adams is also referring to the court system to right any wrong, such as being accused of a crime when you are innocent).
Diana Levine, a Vermont musician lost part of her right arm after a botched drug injection. The drug, Phenergan, is made by Wyeth and nowhere on its label does it say it should not be administered by IV push, a rather forceful way to inject medication. In this case, the IV push punctured the vein and caused her arm to turn gangrenous.
Levine, and her attorneys say that Wyeth should have carried the warning against IV push on its label.
Her story convinced a Vermont jury that awarded her $6.7 million. Wyeth appealed to the Vermont Supreme Court, which upheld the jury award.
Not satisfied, Wyeth took the issue before the court. Many eyes are watching their argument.
Basically, Wyeth says its hands are tied when it comes to any label changes. The Food and Drug Administration must decide on label changes, therefore consumers should not be able to sue under state law.
Even FDA officials of late, as well as medical editors of the New England Journal of Medicine,have stated that the FDA is not capable of guaranteeing the safety of drugs.
There are too many drugs approved; often drug makers do no disclose all adverse findings in bringing a drug to the FDA to market; and the majority of the post-marketing negative reports are issued to the drug companies, therefore they have the better vantage point when it comes to label changes and formulation changes to make drugs and devices safer.
Even past FDA regulators, such as David Kessler, say that lawsuits are a vital part of the balance of issuing new drugs and consumer safety.
Vermont and 46 states are urging the court to uphold the Vermont Supreme Court ruling favoring Levine and consumers rights to sue.
Diana Levine, meanwhile still hasn’t seen a dime. Levine, who still lives in Marshfield, Vermont, survives on Social Security disability and has to play a guitar with the help of her sister strumming the strings.