A ruling for consumers today by the U.S. Supreme Court means patients can sue drugmakers for failing to warn about a drug’s safety.
The case stems around Diana Levine. She’s the musician from Marshfield, Vermont who went into a local clinic for treatment of a migraine headache.
Her story is available in video form, produced by the Alliance for Justice and on Injuryboard.
In the past she had received medication, but this time she also got a dose of phenergen, made by Wyeth, for nausea, which was delivered through an IV push, a more aggressive way of delivering drugs immediately into the bloodstream.
The drug was delivered in such a way that it penetrated her artery, destroying it and causing her right arm to become gangrenous. It had to be amputated up to her elbow.
The package insert or label, did not specifically warn against using phenergan in an IV push method.
While Levine had won a $7 million judgment in the lower court, Wyeth took the issue to the highest court arguing that the drug's approval by the federal government meant state court decisions could be preempted.
The justices voted 6-3 that drug companies are not shielded from lawsuits by the Food and Drug Administration’s approval of a treatment and the included label.
“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” wrong Justice John Paul Stevens for the court.
Thousands of lawsuits against pharmaceutical companies had been waiting for the outcome of this case to clarify the muddy issue of federal preemption. AstraZeneca's Seroquel, Wyeth’s Prempro and Premarin drugs are facing litigation which drug makers claimed was preempted by federal immunity.
Diana Levine’s lawyer, David Frederick sasys this is a, “broad victory for consumers”.
A broad decision
But it may not be. The justices left open the possibility that lawsuits might still be barred by injured persons if the FDA had considered a requirement for a stronger warning, but researched the change and then rejected the necessity for change. That would mean a tougher label received extra consideration by the FDA.
Justices John Roberts, Antonin Scalia and Samuel Alito were the disssenting votes. Alito believes that state filed lawsuits will interfere with the federal drug approval system.
The Bush administration had also backed federal preemption arguing that a jury can interfere with the FDA’s work approving drug.
FDA commissioners write along with medical experts in the New England Journal of Medine (NEJM) in a brief to the U.S. Supreme Court, (as friends of Levine) that the FDA does not have the ability to carefully regulate and monitor the safety of all drugs before they are approved. #