We’ll have a full review of Robinson v. McNeil Consumer Healthcare, No. 09-4011, slip op. (7th Cir. Aug. 11, 2010), on Monday, but there’s one part of it that’s too important to wait for then. In Robinson, which involved the OTC drug Motrin, the plaintiff argued that the label should have been revised to include a warning about Stevens/Johnson Syndrome (technically “SJS/TEN”). But after this particular incident the FDA rejected such a warning, determining that “the addition [of such a warning] would confuse rather than enlighten.” Slip op. at 15.
The court, Judge Posner writing for a unanimous panel, held that this FDA decision was preemptive:
The FDA decided not to require such a warning because it would confuse rather than inform; and a court cannot order a drug company to place on a label a warning if there is “clear evidence” that the FDA would not approve it. Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp. 2d 662, 678 (N.D. Tex. 2010). The “clear evidence” in this case is the agency’s refusal to require a reference to SJS/TEN on the label of over-the-counter drugs containing ibuprofen, when it had been asked to do so in the submission to which the agency was responding.
Slip op. 22.
Since this is precisely the claim that plaintiffs make against a number of products, most notably SSRI anti-depressants – and the 360 report on the case completely missed this – we thought it a good idea to pass it along as breaking news.
More on Monday.