Flaws in the Preemption Defense to Liability Claims Against Generic Drug Manufacturers

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. In their rush to criticize the Court for its uneven application of the Supremacy Clause in these cases, commentators have failed to notice that the whole edifice sprang from basic misconceptions about the operation and interplay of tort doctrine and FDA rules.

A proper appreciation of these details reveals just how flimsy a case exists for continuing to recognize this particular version of the federal preemption defense to strict products liability claims.