Corporations from all industries and their insurance representatives are crying foul.
They are upset because the Alabama Supreme Court affirmed the right of a man who developed a permanent muscle-control disorder from taking generic versions of the prescription severe heartburn and nausea medication Reglan to sue the maker of the brand name product, Specifically, critics of the decision are complaining that allowing the lawsuit brought by the man whose tardive dyskinesia resulted from long-term use of metoclopramide to proceed will open the door for all kinds of product liability lawsuits against manufacturers who did not actually make the products that caused harm.
The decision, however, rests solely on the determination that the maker of an innovator drug has a duty to ensure revisions to FDA-approved labeling are made known, even if doing so requires distributing information that producers of nonbranded products with the exact same active pharmaceutical ingredient do not. The ruling came in the course of a larger federal lawsuit that could set a precedent regarding duty to warn about medication side effects. That higher-level case has yet to be decided, but the state court's ruling could strengthen the plaintiffs' position.
A strong warning about the risk of developing tardive dyskensia was added to the Reglan label in 2009, but generic metoclopramide has been available to U.S. patients for decades. This timeline matters because generic drugmakers are only required to use the labeling that exists when their nonbranded products enter the market. The result is that when the FDA-approved label for a branded product gets updated, new warnings, uses and instructions do not always appear on labels for generics.
The Alabama justices determined that patients could have a reasonable expectation that brand manufacturers would inform prescribers and pharmacists about label changes. They also concluded that the plaintiffs in Wyeth v. Weeks could make the case that the defendants' inaction in this regard constituted a failure to meet the duty to warn.
No one can know whether the plaintiffs will prevail, but my Virginia personal injury law firm colleagues know that every person harmed by a dangerous or defective product deserves their day in court. When companies do not meet their legal and ethical obligations to inform users about risks for injuries or death, or when they act too slowly to issue recalls and correct problems, those companies must be held liable.
Manufacturers, chambers of commerce and their insurance lawyers who argue that the Alabama Supreme Court's decision is too broad and likely to open them up to lawsuits from anyone harmed by any similar problem are wrong. The ruling clearly applies only to FDA-approved generic equivalents of brand name drugs that lack up-to-date labeling. I'd expand on this point, but a strong defense of the limited nature of the ruling appears in the decision itself:
We are not turning products-liability law (or tort law for that matter) on its head, nor are we creating a new tort of "innovator liability" as has been suggested. Instead, we are answering a question of law involving a product that, unlike any other product on the market, has unprecedented federal regulation. Nothing in this opinion suggests that a plaintiff can sue Black & Decker for injuries caused by a power tool manufactured by Skil based on labeling or otherwise. The unique relationship between brand-name and generic drugs as a result of federal law and FDA regulations, combined with the learned-intermediary doctrine and the fact that representations regarding prescription drugs are made not to the plaintiff but to a third party, create the sui generis context in which we find prescription medication.
What does bear mentioning is that product manufacturers cannot be excused from their duty to warn simply because making sure warnings get communicated clearly and completely is time-consuming or likely to impose additional expense. At root, this is what Wyeth and its parent company are arguing -- that they do not need to take the extra effort required to get updated drug labels into the hands of generics makers, prescribers, pharmacists and patients because they do want to do so.