—Diana Winn Levine
I lost my right hand due to a faulty prescription drug label. Now we may all be on the brink of losing our rights to hold drug companies accountable through the state court system when things go horribly wrong due to their products.
Wyeth v. Levine, which the U.S. Supreme Court has agreed to hear in November, is a case that has forced me into the position of defending the rights of all consumers against a pharmaceutical giant. Wyeth wants the court to decide that drug companies cannot be held accountable for their products – even when they hurt or kill someone – so long as those products have received FDA approval. If the Supreme Court accepts Wyeth’s claims that the approval of the FDA, however ill-informed in this instance, trumps the judgment of a citizen jury regarding corporate negligence, it will be upending a very basic foundation of justice in this country. Such a result could make the big drug companies — and, by extension, all other regulated companies — immune to all future claims by injured parties.
How It All Came To This
In April 2000, I went to my local health clinic in Plainfield, Vermont, suffering from a severe migraine. There a physician’s assistant gave me a shot of Demerol for the pain and, to curb the nausea, an IV injection of Phenergan, a drug made by the major pharmaceutical company Wyeth. While it was administered in a way allowed by Wyeth, per the instructions on their labeling for the drug, the Phenergan entered my artery rather than my vein. The consequence of this simple mishap? — within six weeks my right hand had turned black, swollen up, and died. I went through two amputations and ended up losing my right hand and forearm.
This would have been devastating for anybody. It was catastrophic for me. I had played bass, guitar and piano, and had been a professional musician for over 30 years. Up until that day I had an active performing career and a successful music production business. Music was my life.
It turns out that what happened to me was completely avoidable. Wyeth knew that Phenergan — the sole benefit of which is to prevent vomiting — can cause gangrene and tissue death if it is accidentally injected into an artery. This is possible if the drug is administered via the “IV-Push” method, as it was with me. And yet, inexplicably, the instructions that Wyeth provides with their product include this method as an option, along with other perfectly safe modes of administration. The company knew that a simple change in their instructions on how to administer the drug would prevent an injury like mine... knew it, and did nothing.
As a result of the loss of my hand, I suffered huge medical bills and a crippling blow to my music business. I decided to sue to try to recover some measure of compensation for all I had lost. Wyeth sent in five lawyers to defend themselves from my claim, but I and my local attorney helped the jury see that Wyeth was negligent and my loss avoidable; that they were knowingly providing their product with a label that could lead it to being administered in an extremely dangerous — and utterly unnecessary — manner.
Following the jury trial, Wyeth did not appeal the amount of the award or even the decision that it was at fault. Nor did they pay so much as a penny to help me recover from my injury. Instead, they pursued their position that, because the federal Food and Drug Administration had approved the informational label they were using for their drug, they could not be held accountable for any damages that resulted from following that label. Our Supreme Court in Vermont, like every other appeals court in America that has faced such a claim, rejected it. They affirmed that Wyeth is responsible for its own negligence, and that people can sue drug companies when their products cause injuries. Nevertheless, Wyeth appealed this decision to the U. S. Supreme Court. And stunningly, although the Court takes up just a tiny fraction of the cases that are submitted to it, they have decided to hear Wyeth’s appeal this fall.
This is deeply disturbing to me. For 70 years individuals have been able to seek compensation in cases like mine, and neither Congress nor the Courts have ever considered changing this fundamental rule. But now I am afraid that, in their willingness to review this case, the Supreme Court may be prepared to take a very radical step...
The FDA clearly did not appreciate the risks when it approved the label that Wyeth includes with Phenergan. But Wyeth did, which is why the jury found them responsible for the very real damage that resulted. I lost my right hand and my livelihood because of Wyeth — and if the mere fact of FDA oversight means that a company like Wyeth does not have to face the consequences of its own failings, that does not bode well for the future safety of any of us. I hope that the Court will reject this attempt to strip us of our rights, and leave intact the jury system for determining justice in matters of corporate negligence. And I hope my own disfigurement may serve as a reminder of what’s at stake.
Diana with sister Liz, daughter Jessamine, and attorney David Frederick at the Supreme Court, November 3, 2008
(photo by Gerald Herbert, Associated Press)
