Sunday, July 1, 2018
The Sixth Circuit ruled last week in McDaniel v. Upsher-Smith Labs, Inc., that the Federal Food, Drug, and Cosmetic Act preempted a plaintiff's state failure-to-warn claims against a generic drug manufacturer for failure to include a Medication Guide with the prescription drugs.
The case narrows the already wee-bit window left open for plaintiff claims against generic manufacturers by the Supreme Court in PLIVA v. Mensing. That case held that the FDCA preempted state tort law that required manufacturers to use a stronger label. As the McDaniel majority explained:
In Mensing, patients who had taken generic metoclopramide and developed tardive dyskinesia sued the generic manufacturers for failing to update the warning labels to adequately advise of the medication's risks. They claimed that state tort law obligated these manufacturers to use a stronger label. But FDA regulations require sameness between the warning labels of a brand-name drug and its generic counterpart. The generic manufacturers were in a bind. If they strengthened the label to satisfy state law, they'd run afoul of their federal duty of sameness; if they retained the label to satisfy federal law, they'd fall short of their state-law duty to provide adequate labeling. Finding it impossible for the generic manufacturers to comply with state and federal law, the Supreme Court held that state law must give way and the tort claims were preempted.
Mensing left a narrow opening for plaintiffs' state failure-to-warn claims: They have to be based on conduct that violates the FDCA, but can't be a critical element of the claim. Chief Judge Cole explained in partial concurrence, partial dissent:
Implied preemption leaves open a narrow gap for state failure-to-warn claims against generic drug manufacturers that resides between its two forms--impossibility and obstacle preemption. The claim must be premised on conduct that violates the FDCA to avoid impossibility preemption. This is so because the FDCA requires a generic drug to have the same warnings as its brand-name counterpart (under the federal duty of sameness), so that simultaneous compliance with any state duty to supply different warnings would be impossible. At the same time, to avoid obstacle preemption, the violation of the FDCA cannot be "a critical element" of the claim [because the FDCA authorizes only the federal government, not individual plaintiffs, to enforce the FDCA].
Circuit law recognizes that a plaintiff can thread this needle: in Fulgenzi v. PLIVA, the court held that a plaintiff's failure-to-warn claim survived preemption, because the claim "relie[d] upon the adequacy of the warnings and the causation of her injuries," and not the "[f]ailure to update from one adequate warning to another." "On the merits, whether PLIVA ha[d] violated its federal duties [was] irrelevant to the adequacy of its warnings."
But the court distinguished Fulgenzi here: "But here, as explained above, adequacy of the warnings is not the issue. Rather, it is Upsher-Smith's alleged failure to ensure the amiodarone Medication Guide's availability for distribution--the failure to comply with a federal regulation that only the Federal Government may enforce--that is the ballast steadying McDaniel's claim." The court pointed to repeated references in McDaniel's complaint that the defendant failed to meet FDCA standards.
Chief Judge Cole argued that Fulgenzi applied:
McDaniel's Tennessee failure-to-warn claims are no different. In her complaint, she alleges that Upsher-Smith violated the federal duty of sameness by failing to provide warnings in the form of a medication guide. But she cannot be faulted for doing so [in order to avoid impossibility preemption, described above]. . . .
McDaniel's claims are premised on a violation of an independent Tennessee duty to warn, not federal law. "The alleged breach arises from the same act"--namely, the failure to provide a medication guide. Indeed, it must arise from the same act to avoid impossibility preemption. "[B]ut the legal basis is different." McDaniel's claims depend on whether the warnings provided were inadequate and proximately caused her late husband's death. Because the fact of a federal-law violation is not a necessary element of those claims, they are not subject to obstacle preemption . . . .