Preemption: What is it good for?

For more than a decade, drug manufacturers in the US have been inadvertently protected from product liability claims thanks to preemption - the precedence of federal law over that of state law.

So what happens when a patient takes a generic version of a drug that results in an adverse event (or death) due to inadequate warnings? Surely the consumer is protected by being able to sue the manufacturer, correct? Apparently not. Generic manufacturers have successfully argued that they were unable to provide sufficient warning as their labels are required to be the same as the labeling approved for the original innovators drug. Additionally, a generic drug manufacturer may not unilaterally strengthen a label without prior approval of the FDA. Therefore, it "would be impossible" for the manufacturers to abide by federal law requiring that the generic have the same label as the innovator and the state-law requirements for stronger warnings. Surely then the onus falls on the innovator companies for not originally having sufficient warnings, correct? The uninformed patient may be shocked to learn that most state courts have ruled that the name-brand manufacturers could not be held liable for injuries caused by another manufacturer's product.

This is the conundrum posed by preemption. Preemption prevents plaintiffs from pursuing their claims against defendants whom they allege caused their injuries, and yet the preemption doctrine is based on a choice of the superior method for regulation. The distinct lack of a legal remedy in such cases may explain the California Court of Appeal's decision in Conte v. Wyeth.

In Conte v. Wyeth, Elizabeth Conte alleged she developed an irreversible neurological condition after long-term use of generic versions of Wyeth’s Reglan. Although she only took the generic version of the drug, she argued that Wyeth negligently misrepresented the serious risks associated with long-term use of the brand-name version of the drug and should be held liable. Conte filed a lawsuit against Wyeth as well as generic manufacturers Purepac, Teva, and Pliva. After obtaining summary judgement in trial court, Wyeth & the generic manufacturers succesfully argued that Wyeth's product information had no causal relationship to Conte’s injuries and the Conte's claims against the generics were preempted under the Food, Drug and Cosmetic Act.
The California Court of Appeals, First Appellate District, reversed in part and reinstated Conte’s action against Wyeth. Ignoring decades of products liability precedent, the Court concluded Conte could proceed against Wyeth on her negligent misrepresentation claim on the basis of common law.

Preemption is a classic example of instances where enforcing an optimal regulatory strategy does not necessarily translate into protection of the public. In the search for a one size fits all approach to streamline a process, several caveats can be left which prevent legislation from meshing with the justice system. This year, in Levine v. Wyeth, the Supreme Court will address the issue of preemption of claims against name-brand manufacturers' in what could be a landmark victory for consumers. The judgement may very well impact consumer confidence in public agencies such as the FDA and further tarnish the image of drug manufacturers.