In April 2000, musician Diana Levine of Marshfield, Vermont was rushed to an emergency room with a severe migraine. It had happened before. She was given a painkiller then another medication to stop the nausea brought on by the drug.
The nausea medication, called Phenergan, was inadvertently injected into an artery which led to gangrene and eventually caused Levine to lose her right arm below the elbow. Ed Silverman of Pharmalot interviewed Levine in February.
Levine filed a lawsuit against drug maker, Wyeth.
The drug’s labeling was inadequate for the particular method of administering the drug, the suit argued. She was awarded $6.8 million, an award that survived an appeal to the Vermont Supreme Court.
Generally, that’s the end of the story.
The plaintiff takes the money they recover, after paying attorney’s fees and the IRS, they then figure out how to remake their lives, pay any past and ongoing medical bells and move on. Rarely does a jury award mean one has struck the lottery jackpot.
But Wyeth, not content with the ruling, has appealed to an even higher court – the U.S. Supreme Court – which will hear the Levine case November 3.
The outcome has the potential to impact millions of Americans who take prescription drugs or use FDA-approved medical devices.
Wyeth reasons that since its drug (and the warning label) went through FDA approval, it should receive blanket immunity from state law claims challenging safety, efficacy or labeling.
That is the reasoning behind federal preemption, an increasingly convenient way for drug makers to avert the cost of damages from a drug or medical device that causes harm.
The Levine case is being watched by many because it’s as much about preemption as it is about Wyeth. It’s about state rights versus federal rights, and ultimately it’s about the rights of citizens versus the rights of corporations.
Without the FDA mandate, chaos would prevail, some argue. States (in the form of lawsuits) should not be allowed to challenge the wisdom and consistency of a federal binding standard for drug approvals. The FDA should be the final word on safety and effectiveness.
Wyeth argues in its brief, that it is impossible to comply with both state law and FDA requirements. Perhaps not surprisingly, the White House supports a federal preemption.
A court challenge does nothing to prevent Wyeth from making a drug label clearer, Levine argued. And what happens when the FDA is repeatedly shown to be incapable of keeping dangerous drugs and medical devices off the market? Anti preemption sentiment argues that to take away the ability to hold corporations accountable could have cataclysmic consequences for public health and patients’ rights.
The New England Journal of Medicine is against preemption, though many doctors feel it protects them from lawsuits. Also filing briefs against federal preemption are 47 state attorneys general, former FDA commissioners, members of Congress and constitutional experts, all urging the high court to uphold the $6.8 million ruling.
The question before the U.S. Supreme Court will be this – Whether the prescription drug labeling judgments imposed by the FDA under the federal Food, Drug and Cosmetic Act, preempts state-law product liability claims premised on the theory that different labeling judgments were necessary to make the drugs reasonably safe for use.
Levine tells Pharmalot about Wyeth that, “They should’ve taken responsibility for changing the label…. I just have to have faith. If people like me are denied the ability to sue a drug company, well, a drug company has a mind of its own. They know when something is dangerous and they can change it. Think of all the little clinics and emergency rooms that may know as a result of my case. Hopefully, that’ll lead to change. It’s a shame we have to take this upon ourselves. Why should I have to be the savior? It’s astonishing to me that the Supreme Court took this, but I’m going to make the best of it.”
Diana Levine’s case will set the future ground rules for lawsuits against an FDA approved drug or device. A loss in the high court and arguments will be made to the White House and Congress guaranteeing the right to sue, according to the Wall Street Journal legal blog
Many eyes are watching. Stay tuned. #