Since the US Supreme Court decision in Pliva v. Mensing barred most lawsuits against generic drug manufacturers, it seemed that people injured by generic drugs that lacked adequate labeling may have no right to compensation. On Friday January 11, though, the Alabama Supreme Court proposed a logical solution to the problem: people injured by generic drugs can sue the name brand manufacturer who is responsible for the inadequate label.
Who Can You Sue for Drug Injuries?
Two recent US Supreme Court decisions have clarified the rules for bringing defective product lawsuits against drug manufacturers. The 2008 decision in Wyeth v. Levine stated that name brand drug manufacturers alone bore responsibility for the adequacy of their labeling. Although Wyeth had claimed that it could not change its labeling without the approval of the FDA, the Court noted that the Changes Being Effected (CBE) rule allowed manufacturers to change their labels first and ask for approval afterward. This made it the manufacturers’ responsibility to ensure that the public was informed of potential risks as soon as they became known.
Then in 2011, the Court revisited the issue with its decision in Pliva v. Mensing. In this decision, the Court decided that generic drug manufacturers could not be sued for failure to warn or similar inadequate labeling claims because the law required that generic drug labels must exactly match the label for the name-brand drug. Therefore generic drug manufacturers did not have the power to warn the public about new risks. This apparently made generic drug manufacturers nearly immune to failure to warn lawsuits and left people injured by generic drugs without a legal option for compensation.
A New Precedent?
The current case centers on the same drug as the Pliva v. Mensing decision, metoclopramide, the generic drug based on the name brand Reglan. Metoclopramide is used to treat a number of digestive tract disorders, most commonly acid reflux, but in 2009 the FDA ordered all manufacturers to alter labeling for metoclopramide to include the risk of tardive dyskinesia, a movement disorder.
Alabama resident Danny Weeks claims that he developed tardive dyskinesia after taking generic forms of metoclopramide. He filed lawsuits against Actavis and Teva, the generic drug manufacturers who made the drugs he actually took, and Wyeth, the manufacturer of the name-brand drug Reglan.
The decision was filed in a federal court in Alabama because the drug companies in question are based out of state. The federal court asked the Alabama Supreme Court whether Wyeth could be sued in this case, and the court said, “Yes.”
Name Brand Drug Manufacturers Responsible for Labels
In its decision (draft available here), the Alabama Supreme Court cited both Pliva v. Mensing and Wyeth v. Levine. The Alabama Court cited the ruling from Mensing to stress the protection afforded to generic drug manufacturers: “rather than a duty to warn, ‘generic manufacturers have an ongoing federal duty of sameness’ regarding their warning labels” (indirect citation via Phelps v. Wyeth). The Alabama Court emphasized that this labeling restriction extended to all possible methods for a generic manufacturer to warn doctors, patients, and the public.
From Wyeth v. Levine, the Alabama Court cited language supporting the need for state-based tort claims in promoting the public good:
State tort suits uncover unknown drug hazards ad provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the [Federal Food, Drug, and Cosmetic Act]’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.
The Alabama Court then stated that it was “not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant” when the actual issue is the warning label, which the brand-name manufacturer did produce.
Only in Alabama?
A lawyer for Pfizer, who acquired Wyeth in 2009, quickly dismissed the significance of the ruling, citing more than 70 court decisions in which brand-name manufacturers were protected from lawsuits related to generic products. He did note that two other decisions came to the same conclusion as the Alabama Court’s. He did not, however, note that the bulk of these decisions were made before Pliva v. Mensing, a fact that heavily influenced the Alabama Court’s decision.
Whether the significance of this case will have nationwide influence or if it will remain an Alabama phenomenon remains to be seen.