Yesterday while the national news was fixated on the prediction of Election Day results, the U.S. Supreme Court heard arguments in a case which has the potential for impacting people’s lives far more than most of the ballot measures being considered today across the nation.
Wyeth v. Levine went before the Supreme Court, with the pharmaceutical giant arguing, with the support of the Bush administration, that the lawsuit should be thrown out because federal law preempts such state court claims. At issue is whether the federal government can limit lawsuits by consumers like Diana Levine who have been harmed by prescription medications.
Wyeth is asking the court to rule that drug makers may not make changes to labels without the approval of the Food and Drug Administration and that people cannot sue under state law for harm caused by an FDA-approved drug. But in broader terms, it may herald the application of dozens of new regulations promulgated under Bush appointees which would act to “pre-empt” state law allowing injured consumers to bring negligence claims against all types of businesses and manufacturers. During President Bush’s administration, it is estimated that over 60 proposed or final regulations put out by government agencies include language aimed at shielding companies from product liability claims.
In recent years, the administration, the U.S. Chamber of Commerce and other business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption – asserting the primacy of federal regulation over rules that might differ from state to state.
Diana Levine, a professional guitarist and pianist, sought treatment for a migraine and nausea at a Vermont clinic in 2000. A physician’s assistant wrongly injected the anti-nausea drug Phenergan made by Wyeth Pharmaceuticals into an artery, rather than a vein. A few weeks later, her right hand and forearm had to be amputated because of the onset of irreversible gangrene, a risk known to Wyeth arising from the injection method of administration.
Ms. Levine settled her claims against the clinic. She also filed suit against the drug’s manufacturer, Wyeth, claiming that the company was negligent and failed to warn about the heightened dangers of administering the drug intravenously using a syringe, rather than by means of an IV drip. A Vermont jury awarded Ms. Levine almost $7 million in compensatory damages. Wyeth appealed and the Vermont Supreme Court upheld the verdict.
The company argues that allowing a state jury to second-guess the FDA labeling requirements undermines the carefully crafted rules and expert determinations of federal regulators. Last term, the U.S. Supreme Court justices overwhelming sided with manufacturers of medical devices in a similar matter. The companies also argued that they could not be sued by consumers for products that had been approved by the FDA. But in that case an eight-justice majority determined that Congress had explicitly written that immunity into the law. See Safety Not a State Concern?
In the law that governs drug manufacturers, there is no expressed immunity. Lawmakers have amended the food and drug laws many times without inserting any immunity provision. Congress’s silence speaks volumes, and the justices should respect that determination. If Wyeth and other pharmaceuticals want change, they should take their case to Congress. In reauthorization legislation for the Consumer Product Safety Commission, Congress nullified the preemption language by inserting a section that preserves the right of consumers to seek restitution from those who caused them harm.”
And the justices did not appear posed to make a sweeping generalization in the expected opinion. Several justices indicated that if the U.S. Food and Drug Administration had clear information about the risks of Wyeth Pharmaceuticals’ anti-nausea drug Phenergan, and approved its warning label anyway, then Wyeth probably would prevail in its court fight against Diana Levine of Vermont, but , there was skepticism among the justices and disagreement between the opposing lawyers that the FDA had a clear picture of the disastrous consequences of improperly giving Phenergan by IV push. Justices Ruth Bader Ginsburg and Samuel Alito raised questions of patient safety and the adequacy of FDA review of the drug label, with Justice Alito questioning how the FDA approved a drug “as ‘safe and effective’ when ‘you have the risk of gangrene.’
Yet both Chief Justice John Roberts and Justice Antonin Scalia focused on drugmakers’ ability to meet federal requirements without further demands from the states. Most legal experts predict that a narrow ruling will be made.