McGarity: Court takes up pre-emption doctrine
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The day before Americans went to the polls to choose a new
president and Congress, the Supreme Court took up one of the
most significant cases of its term. As part of its broad initiative tolimit lawsuits against product manufacturers, the Bush
administration has aggressively asserted the power of federalregulatory agencies to pre-empt lawsuits brought under state law.
Most courts have disagreed, but the Supreme Court will soon have
the final word. Although obscured by the election coverage, the
case is highly significant for consumers of prescription drugs.
The specific case involves a lawsuit brought by Diana Levine, a
professional guitarist from Vermont. Eight years ago, she went to a
clinic complaining of a migraine. She received an injection of an
The label on the drug, manufactured by Wyeth, cautioned that the
method for administering the drug — the so-called "Push IV" method
of direct injection into a vein — was risky because of the dangerthat the drug would be injected into an artery instead of a vein. Butthe label did not instruct doctors not to use the direct injectiontechnique.
Unfortunately, the method made all the difference. The drugapparently missed the vein, reached an artery, and began killingtissue in her arm — a hazard known to the manufacturer when themedicine is introduced by direct injection, rather than the saferapproach of an intravenous drip. In Levine's case, the inadequatelabeling resulted in the amputation of her arm.
Litigation ensued. In court, Levine's lawyers argued that the labelshould either have either "counterindicated" direct injection orincluded a stronger warning against that dangerous technique. Thejury agreed and awarded $7.4 million in damages.
The question before the Supreme Court deals with an abstract legalrule called the pre-emption doctrine. The Constitution says that astate law that conflicts with federal law is null and void. Wyethargues that because its label was approved by the U.S. Food andDrug Administration, Vermont's more protective common law ispre-empted.
Wyeth maintains that the common law duty to warn conflicts withthe company's obligation to use FDA-approved labels. Since thePhenergan label specifically allows doctors to use the directinjection technique and cautions against injecting into arteries, thecompany maintains, complying with a common law duty to telldoctors to avoid that technique or provide a more powerful warningwould violate the federal law or at least pose an obstacle to FDA'simplementation of federal drug labeling policy. Levine's lawsuit istherefore pre-empted by federal law, Wyeth argues.
Levine's lawyers see no such conflict between FDA's requirementsand Vermont's laws. FDA regulations permit manufacturers tochange the label at any time to contraindicate a previouslypermitted use or to contain a more stringent warning. And thoughFDA has the power to disapprove a company's label change, it hasnever done so.
Wyeth's obligation to comply with the federally approved label cameup at trial. The common law rules allowed the company to arguethat FDA approval demonstrated that the label was not defective. But the jury was unconvinced and ruled for Levine.
If allowed to stand, Levine's suit will encourage Wyeth and otherdrug companies to change their labels when they obtain new dataor reanalyses of existing data showing that a drug presents greaterrisks than the company anticipated when it sought FDA approval.
More importantly, the common law is ordinarily the only vehicle forensuring that injured victims can be compensated for harm causedby defective products. Federal regulations are designed to protectthe public, not compensate victims.
If regulatory agencies were perfect, common law liability might beunnecessary. But by all accounts, FDA and other federal agenciesare starved for resources and often more concerned with meetingindustry demands for expeditious approvals than with protecting thepublic.
Of course, pharmaceutical litigation is hardly the only area in which
McGarity: Court takes up pre-emption doctrine
pre-emption would shield manufacturers from liability fordangerously defective products. A broad victory for Wyeth will makeit harder to hold manufacturers of other products to account, too,including manufacturers of defective toys, poorly designedautomobiles and flammable clothing.
The court's eventual ruling, which should come early next year,could shape the law for years to come.
McGarity is a member scholar of the Center for Progressive Reformand the author of 'The Preemption War: When FederalBureaucracies Trump Local Juries.'
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