Pre-emption in drug warnings is implied

On Monday, the U.S. Supreme Court heard oral arguments on a product liability suit that could affect thousands of other potential lawsuits by consumers against drug manufacturers.

The case at bar started with a migraine and ended with an amputated arm instead. In April 2000, Diane Levine, a professional guitarist in Vermont, had gone to a medical clinic for a severe migraine headache and nausea. A physician prescribed Demerol for the migraine and the drug Phenergan for the nausea, and the physician’s assistant administered the injections.

Phenergan can cause rapid and irreversible gangrene if injected into arteries. Its label contains a warning about this danger. Still, direct injection into a vein, called the “IV-push” technique, is permitted by the FDA, provided warning is given in the label. The IV-push was the method followed in Levine’s case, but the assistant missed the vein and injected the drug into the artery. Thus, in

A state court accepted the argument that the drug manufacturer, Wyeth, had not provided sufficient warnings about the risks of using the IV injection to administer Phenergan, and the Vermont Supreme Court upheld this decision.

The fundamental issue in the case concerns an implied interpretation of the doctrine of pre-emption, which bars lawsuits at state courts filed by people injured by products that have been approved by federal agencies charged with safety standards.

Attorneys for Wyeth would argue that the FDA’s approval powers, including their approval on product labels, pre-empt the state court lawsuits that claim the labels should provide stricter warnings.

In February, the Court ruled in a separate case that suits arising from injuries caused by medical devices were pre-empted by a 1976 federal law. This underlying federal law involved an “express pre-emption.”

But the specific drug law in the case at bar does not mention anything about explicit pre-emption. The question before the US Supreme Court was whether the FDA approval should override all legal challenges once government approval has been granted — in short, that pre-emption in drug warnings is implied.

Wyeth and its supporters also contend that if they make changes in the contents of the FDA-approved level to comply with state law, they would be breaking federal law.

In fact, the FDA has previously welcomed companies to improve its risk disclosures immediately. Consumer groups argue that drug manufacturers are responsible for providing updated and accurate warnings to the public. FDA rules do allow them to propose such enhancements.

There may be a larger issue involved. Do federal regulators, like the FDA, set minimum safety standards that states are at liberty to improve upon, or do their judgments constitute the optimal balance between risks and benefits that states must then follow.

There is much at stake in the argument of implied pre-emption — that is, regulatory action already carries the right of pre-emption without requiring specific statements in laws enacted by Congress. A Supreme Court ruling that favors this argument would effectively bar countless personal injury suits involving products approved by federal agencies — drugs, certainly, but also cars and other motor vehicles, household goods, chemicals and agricultural products.

This is one legal issue where consumer interests are hanging in the balance.