It is looking very much as if the U.S. Supreme Court will hear a case this upcoming October term that will permit it, at long last, to inter the Chevron doctrine. Under that doctrine, if there is ambiguity about the scope of rule making powers provided to an agency by Congress, courts will defer to the agency with respect to that scope. As a matter of separation of powers, the Chevron doctrine was always problematic. At the same time, some deference to agencies made sense because agencies possess two things that Congress lacks: expertise and energy. If the executive branch, including agencies, expanded its powers, such expansion was aided and abetted by a legislative branch that succumbed to partisan gridlock, know-nothingism, and torpor.
Preemption is not the same thing as Chevron deference. But it is also supported by agency expertise and energy. The FDA, for all of the criticisms leveled against it, has a lot of expertise and energy when it comes to approving drugs and devices. And then there is the Supremacy Clause. It is simply unworkable, even nonsensical, to permit the states to impose varying, contradictory requirements on FDA-approved products. We generally salute the concept of states as laboratories, but jury verdicts in product liability cases are often rotten laboratory experiments gone awry. As a matter of science and interstate commerce, it is well and good that FDA regulations preempt inconsistent state tort laws.
Speaking of separation of powers, now we commence another love letter to the judicial branch – specifically, a court applying preemption against a tort claim that would countermand FDA regulation of drugs. In Heslin v. New Jersey CVS Pharmacy, LLC, 2023 WL 3249820 (D.N.J May 4, 2023), the plaintiff asserted a wrongful death claim based on the decedent’s abusive overuse of a generic over the counter (OTC) anti-diarrhea medicine. The plaintiff initially filed the complaint against only the pharmacy where the decedent allegedly purchased the medicine. The plaintiff’s theory was the pharmacy should have restricted the sale of the anti-diarrhea medicine once it was on notice that some customers were buying too much. This theory sounds a bit like the opioid litigation. Hello, nannyocracy. Anyway, the pharmacy was the only, no doubt lonely, defendant for approximately 20 months, until the plaintiff got the bright idea of amending the complaint to join the manufacturer. Why leave the deepest pockets out of the party? Except it really was not such a bright idea, because the amendment ran straight into preemption. The manufacturer filed a motion to dismiss, and the court granted the motion.
The plaintiff filed two causes of action against the manufacturer under the New Jersey Wrongful Death and Survival Acts. One cause of action was for negligence and the other was for willful and wanton disregard for the manufacturer’s “invitees and customers.” The plaintiff claimed that the manufacturer failed to comply with state and federal laws, including FDA safety announcements regarding the dangers of taking too much of the anti-diarrhea medicine. What was the manufacturer supposed to do? Simply stop selling the medicine? Find a way to restrict its sale of the drug by limiting the amount that could be sold to that mentioned in an FDA safety announcement? Warn abusers to stop abusing?
The Heslin court sorted through the preemption issues in a clear, logical, and blissfully succinct fashion. The court interpreted both claims against the manufacturer to amount to failure to warn claims, violations of the Food, Drug, and Cosmetics Act (FDCA), and “failure to restrict sale” claims.
First, the warning claim against the generic manufacturer was preempted by the sameness requirement of the FDCA. The generic manufacturer must use the same label as the brand manufacturer even when its product is OTC. “The FDA’s duty of sameness preempts any state law duty that would require a generic drug manufacturer to change its label.” See Mensing.
Second, the demand that the manufacturer comply with an FDA safety announcement was a preempted private attempt to enforce the FDCA because it existed “solely by virtue” of the FDA safety announcement. There is, of course, no private enforcement of the FDCA. See Buckman. Moreover, the safety announcement did not change any of the FDA requirements regarding dosage form, strength, or labeling.
Third, the Mensing sameness requirement would extend to the manufacturer’s inability to restrict sales by changing the maximum approved daily dose. Generic drugs must have the same dosage form, strength, and labeling as the name brand versions.
The Heslin court dismissed the claims against the manufacturer with prejudice. In addition to the preemption grounds, the court also pointed out that claims that the manufacturer should have known of the particular plaintiff’s overuse, and that disregard of such fact constituted “willful and wanton” conduct, made no sense in light of the fact that the manufacturer sold the medicine to the pharmacy, not the plaintiff.
The pharmacy is still in the case. We wish the pharmacy good luck, because this case looks to us like one in which all the bad behavior was on the left side of the v.