In mid-January, we discussed a troubling decision from the Alabama Supreme Court, Weeks v. Wyeth. In Weeks, 8 of the Court’s 9 justices agreed that a plaintiff allegedly harmed by a generic drug can sue the manufacturer of the branded drug on which the generic is based. The opinion noted a dissent by Justice Murdock would be forthcoming.
That dissent came out on February 4. In 45 well-reasoned pages, Justice Murdock illuminates how far the Weeks majority strayed from, as he put it, “bedrock principles of tort law,” and how dramatically out of line the decision is with an overwhelming majority of analogous state and federal court decisions.
The opinion begins by expressing an overarching principle that courts must consider when assessing legal controversies that affect commerce and industry. It’s a statement that WLF should etch into the front of our headquarters:
The law must protect the fruits of enterprise and create a climate in which trade and business innovation can flourish. Concomitantly, the law must justly allocate risks that are a function of that free trade and innovation.”
One fundamental principle of tort law which advances this allocation of risks is that businesses should only be responsible for injuries caused by their own products. There must be some relationship between plaintiff and defendant which gives rise to a duty of care to which businesses must conform.
The Weeks majority argued, and Justice Murdock agreed, that adherence to this basic tort principle in the context of generic drugs creates unfairness for plaintiffs. Congress created the generic drug industry with the Hatch-Waxman Act, and FDA issued rules requiring generic drug labels to conform entirely to the branded drug’s label. Because of the U.S. Supreme Court’s decisions in Wyeth v. Levine and PLIVA v. Mensing, plaintiffs alleging state failure to warn or misrepresentation claims can sue branded drug makers (Levine), but federal law preempts state suits against generic drug makers (Mensing).
The Weeks majority, as Justice Murdock put it, “attempt[s] to make this unfairness ‘right’ by creating a second unfairness.” The majority utilized the slippery, subjective concept of foreseeability to right the apparent wrong Congress and FDA created. Under their theory, branded companies should foresee that their labeling information would be provided to doctors who prescribe drugs; that pharmacies would substitute the cheaper generic; and that if some unforeseen risk arises that is not warned for on the label, patients could be harmed.
Case after case in situations analogous or identical to that in Weeks have held that “foreseeability alone is not enough to create a duty.” As a WLF Legal Opinion Letter released today (and drafted prior to the release of Justice Murdock’s dissent) explains, “over seventy court decisions, including four federal courts of appeal rulings, have rejected this expansion of tort law.” Justice Murdock details many of these cases in his dissent.
The Weeks dissent should be required reading for anyone possessing the misguided belief that laws and legal principles can be twisted to satisfy an amorphous sense of “justice.” Actually, they should first read WARNING: Alabama Court’s Blame-Shifting Pharma Decision Will Have Serious Side Effects, WLF’s Legal Opinion Letter. Its authors, Shook, Hardy & Bacon’s Victor Schwartz, Phil Goldberg, and Cary Silverman, were certainly on the same wavelength as Justice Murdock on preserving not only traditional tort principles, but also America’s free enterprise system.