The Supreme Court of the United States (SCOTUS) again confirmed that labels for generic products must be the same as the innovator drug that they copy. In addition, SCOTUS determined that the claim of design defects claim in a product liability case cannot be asserted against a generic because the generic product must have the same active ingredient(s), dosage form, route of administration and strength as the product that it copies. The full Supreme Court decision in the Mutual Pharmaceutical v Bartlett can be found here.
One other interesting twist in the case relates to the argument as to how one court suggested a firm could act to avoid a design-defect claim. As stated in the decision “A jury found Mutual liable on respondent’s design-defect claim and awarded her over $21 million. The First Circuit affirmed. As relevant, it found that neither the FDCA nor the FDA’s regulations pre-empted respondent’s design-defect claim. It distinguished PLIVA, Inc. v. Mensing, 564 U. S. ___—in which the Court held that failure-to-warn claims against generic manufacturers are pre-empted by the FDCA’s prohibition on changes to generic drug labels—by arguing that generic manufacturers facing design-defect claims could comply with both federal and state law simply by choosing not to make the drug at all. ” Luckily for all concerned, this dog did not fly. And the court noted: “The First Circuit’s rationale—that Mutual could escape the impossibility of complying with both its federal- and state-law duties by choosing to stop selling sulindac—is incompatible with this Court’s pre-emption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether.” Had this rationale been accepted, this certainly would have thrown the pharmaceutical industry into a no win situation and would also have likely been an extreme detriment to the many thousands of patients that might otherwise benefit from a particular drug.
The Court’s decision also, in my opinion, leaves the decision on the safety and efficacy of drug products in the FDA’s hands where it belongs, and not in the hands of jurors, where it does not.
As noted in my post of February 5, 2013 (here), the DOJ hinted that FDA might be looking to change its regulations to permit certain changes to generic drug warnings. However, now we have two Supreme Court decisions that expressly state that Federal law (as we have always maintained) requires the generic labeling to be the same as that of the reference listed drug upon which it relies for its basis of approval. Even FDA cannot change the law simply by changing a regulation. We need to see where this one goes.