Photo of Rachel B. Weil

Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  As that post described in detail, Reckis involved devastating injuries to a 7-year-old child whose toxic epidermal necrolysis (“TEN”) was allegedly caused by Children’s Motrin   The jury awarded $50 million in compensatory damages, and awarded $6.5 million in loss-of-consortium damages to each of the child’s parents.

After trial, defendants moved for JNOV, arguing, inter alia, that they were entitled to judgment as a matter of law because plaintiffs’ warnings claim was preempted, under principles of implied conflict preemption.  Under Wyeth v. Levine, defendants’ argument seemed airtight. Under Levine, 555 U.S. 555, 571 (2009), there is “impossibility preemption” – preemption because it is impossible to comply with both state and federal requirements – when there is “clear evidence that the FDA would not have approved” the labeling change the plaintiffs seek.  Plaintiffs’ failure-to-warn claim argued that the Children’s Motrin label should have contained certain specific language related to TEN. But the FDA had already rejected identical language when that language was the subject of a Citizen Petition.   Could there be any clearer evidence than an FDA decision rejecting the very language plaintiffs identified?   The Reckis court apparently thought so, since “actually did not” wasn’t “clear” enough for that court.  Even though the substantive FDCA standards were identical, the court speculated that it could have made a difference if the FDA had considered a manufacturer’s request instead of a third party’s petition, 471 Mass. at 290, a rationale that impermissibly assumes that the FDA doesn’t always adhere to its own evidentiary standards.  The Reckis court’s refusal to recognize preemption under any set of facts was so blatant that we concluded, “If the Supreme Court meant what it said in Levine, evidently it will have to say so again.”And the Court will have that opportunity, if it chooses to seize it. On August 18, defendants filed their Petition for a Writ of Certiorari, posing this question:  “Whether the Massachusetts Supreme Judicial Court erred when it held, in direct conflict with the Seventh Circuit, that FDA’s rejection of warning language proposed in a Citizen Petition is not “clear evidence” sufficient to preempt state tort claims that the manufacturer was obligated to add the FDA-rejected language to its drug’s labeling.” Johnson & Johnson v. Reckis, 2015 WL 6083499 (U.S.) at *i.

Defendants pointed out that, “[f]aced with the same allegations targeting the precise drug warnings at issue here, the Seventh Circuit held that FDA’s prior rejection of a so-called Citizen Petition proposing additional warnings constituted the “clear evidence” [Levine] said was needed to preempt such claims.” Id., at *3 (citing Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010)).  That’s a direct conflict between a federal court of appeals and a state court of last resort on a question of federal law–something squarely in the Supreme Court’s job description. In declining to follow Robinson, defendants argued, the Massachusetts court “erected hurdles so high that it is hard to imagine any case satisfying the “clear evidence” standard it articulated,” creating a rule that has no “basis in [Levine] or common sense.” Id.

Defendants concluded, “Particularly given the record here, this case is an ideal vehicle for providing much-needed guidance to the lower courts and restoring content to the “clear evidence” standard.”  Id. at *5.  We agree, and so do a host of advocacy groups – PLAC, the Chamber of Commerce of the United States, the Washington Legal Foundation , and the Biotechnology Industry Organization, the Consumer Healthcare Products Association, and the Pharmaceutical Research and Manufacturers of America — that have filed amicus curiae briefs.  We recommend them.  They say practically everything that can be said about Levine and implied FDCA preemption.

And so it is up to SCOTUS to determine whether Levine’s legacy is to be anything other than complete evisceration of the doctrine of impossibility preemption (at least as to branded prescription drugs). We will keep you posted.