The topic of preemption comes up regularly in our posts, because it is such an important issue in products liability litigation. As you can imagine, most of the cases come out of the drug context – the design, manufacture, and labeling of prescription drugs, so heavily regulated and controlled by the Food and Drug Administration, makes the drug industry a perfect forum to litigate preemption issues in products cases.
Recently, the U.S. District Court for the District of South Carolina heard a case in which the primary issue was preemption. In Fisher v. Pelstring, et al., No. 4:09-cv-00252, 2011 WL 4552464 (D.S.C. Sept. 30, 2011), the court considered the case of William Fisher, who was diagnosed with a neurological condition after taking the generic version of a prescription drug used to treat acid reflux that was manufactured by a company called PLIVA. Mr. Fisher and his wife brought medical malpractice causes of action against the doctor who prescribed the drug, as well as products liability causes of action against Pliva and two makers of the prescription brand of the drug, including strict liability, breach of express warranty, negligent misrepresentation, breach of undertaking special duty, fraud and misrepresentation, and constructive fraud.
There is something very important to note about the labeling of prescription drugs versus the labeling of generic drugs, as the court noted in its decision. Brand name manufacturers are responsible for “the accuracy and adequacy of [a drug's] label,” meaning that they must go through the expensive and lengthy process of getting FDA approval for its label. Generic manufacturers, on the other hand, are only responsible for making sure that the label they use is the same as the one used for the brand-name drug.
The plaintiffs argued that PLIVA failed to adequately warn consumers of the risk of neurological disease on its label, and that such a failure constituted a violation of state products liability laws. Now, while the Fisher case was moving along, the U.S. Supreme Court was considering the case of PLIVA, Inc. v. Mensing, —U.S.—, 131 S. Ct. 2567 (2011). In Mensing, the Court sided with PLIVA, which argued that if it were to unilaterally change its label to comply with state law as the plaintiffs in that case argued, it would violate federal law as prescribed by the FDA.
Good news for PLIVA in the Fisher case, right? Well, it would have been, except for the fact that the plaintiffs were able to show that PLIVA’s generic label did not comply with the label on the brand name drug, and that the correct label would have warned the consumer to limit use of the drug to 12 weeks. As the court noted, “[o]nce the FDA approved the addition of these warnings to the [brand-name] label, PLIVA has not indicated that any federal law prevented PLIVA from also adding these warnings to its generic . . . products.”
Based on this fact, the district court denied PLIVA’s motion to dismiss based on preemption. The court did, however, base its decision to grant summary judgment for PLIVA on several causes of action on preemption analysis, including the causes of action for design defect, breach of express warranty, negligent misrepresentation, breach of undertaking a special duty, fraud and misrepresentation, and constructive fraud.