Wyeth Concedes that Levine Case is not suitable to rule on broad preemption
Thursday, September 18, 2008
In a stunning legal turn of events, attorneys representing pharmaceutical maker Wyeth in a lawsuit brought by a Vermont woman who lost an arm after being given a Wyeth nausea drug have apparently thrown in the towel on the argument that makers of all FDA-approved drugs should be shielded from state personal-injury claims.
Legal scholars, plaintiff's attorneys, and injured parties across the country have been closely watching developments in the United States Supreme Court case between Wyeth and Diana Levine. Many had been bracing for a landmark legal ruling that would have far-reaching effects on the rights of all patients who are injured by FDA-approved drugs to sue the drug makers in state courts.
However, in what appears to be a shift in legal posture by Wyeth, the company now contends that in its view, the Levine case is not about barring all injured people from suing the makers of FDA-approved drugs in state courts. While Wyeth insists that preemption is appropriate in Levine's case and should prevent her from receiving damages, the company said the case should not be used by the Supreme Court to issue a broader interpretation of preemption and prohibit all state cases involving FDA-approved drugs. Read Wyeth's newly filed reply brief here.
Facts of the Case
Levine, a professional musician who played guitar, bass, and piano, lost her right arm below the elbow when a hospital worker improperly administered an injection of Phenergan, a Wyeth product used to control nausea. Levine sued Wyeth in her state court and a jury awarded her $6.7 million in damages after finding Wyeth had failed to include proper warnings on Phenergan's packaging about the risks of infection. Wyeth eventually appealed the Vermont jury award to the United States Supreme Court.
The court is slated to hear attorneys' arguments on November 3, 2008. A ruling is not expected until Spring 2009.
The Preemption Argument
The Wyeth-Levine case hinges on the legal concept of preemption, which holds that federal laws and regulations supersede, or come before, conflicting state laws. Wyeth argues that since the FDA - a federal regulatory agency -- approved Phenergan, the company is protected from state personal-injury claims like Levine's. According to Wyeth, the drug maker should be able to rely on the FDA stamp of approval without having to worry about being sued by patients who are injured when the drug is used as directed and approved.
A Change in Position
However, in its legal brief filed with the Supreme Court, Wyeth clearly differentiates Levine's case from others. Wyeth said the Levine case is different than instances where drug manufacturers withhold crucial information about a drug's risks from the FDA during the approval process, only to try and hide behind the FDA-approval when the drug causes injuries.
"Whatever might be said about preemption in those situations, they are most definitely not this case," Wyeth conceded. "Respondent never argued that Wyeth concealed information from FDA, and never contended that Wyeth should have changed its labeling to reflect information that came to light after its labeling was approved."
Those two sentences contained in the introduction of a lengthy legal filing gave plaintiff's attorneys and their injured clients reason to shout for joy. Many had feared the court would use the Wyeth-Levine case to extend federal preemption and impose a sweeping ban on state claims for injuries caused by FDA-approved drugs.
Earlier this year, the court ruled that makers of FDA-approved medical devices are, in fact, immune from state personal-injury lawsuits. However, that ruling relied on an entirely different body of law than is in play in the Wyeth-Levine case. Nonetheless, injured parties and their attorneys had been nervously holding their breaths awaiting word from the Supreme Court.
We Shouldn't Reward Deception
In many cases where patients are killed or injured by FDA-approved drugs, it turns out that in reviewing and approving the drug for use, the FDA didn't have all the information from the drug maker. Studies are hidden, statistics are misused, and other sleights of hand are employed by drug makers in order to gain FDA approval.
Plaintiff's attorneys and injured patients have been saying that such corporate trickery should not be rewarded with immunity from state personal-injury claims. By holding drug companies fully accountable in state courts for their deceptive acts, we can ensure that only safe drugs gain FDA approval.
Now, it appears that one of the world's largest drug makers agrees.
Posted under: Dangerous Drugs • Medical Devices