Today is the birthday of Gilbert O'Sullivan, who scored a hit back in 1972 with "Alone Again, Naturally," the saddest song we can think of this side of Albinoni's Adagio. That is fitting, given our postscript.
December 1 is also the birthday of Sarah Silverman and Bette Midler, two women who consistently bring smiles, so we'll discuss a good case out of the Eleventh Circuit, though probably not good enough to crack our upcoming top ten list. In Tsavaris v. Pfizer, Inc., 2017 WL 5593488 (11th Cir. Nov. 21, 2017), the plaintiff claimed that she developed breast cancer after ingesting a generic version of a hormone replacement drug. She sued both the brand and generic manufacturers. We don't know what happened regarding the brand manufacturer (they should certainly have secured a dismissal), but we know that the district court dismissed the claims against the generic manufacturer on preemption grounds well-established in the Mensing and Bartlett SCOTUS decisions and the Guarino Eleventh Circuit decision. The district court entered final judgment for the defendant.
The plaintiff filed an amended complaint against the generic manufacturer, asserting that she would not have been harmed had the manufacturer not "failed in its federally mandated duty" under 21 U.S.C. section 355 to notify the FDA of certain scientific studies relevant to the cancer risk. The district court denied the amendment on both procedural and substantive grounds, and the Eleventh Circuit affirmed, holding that the district court had not abused its discretion. The procedural grounds were enough to bar the amendment: the plaintiff identified no newly-discovered evidence or manifest error of law, as required by Federal Rule of Civil Procedure 59(e). That is all well and good.
But it is the substantive decision that is more interesting to us. The plaintiff was complaining of a violation of a federal reporting duty owed to a federal agency, not to her. More specifically, she premised her complaint on a provision of the federal Drug Price Competition and Patent Term Restoration Act that requires companies to submit "data relating to clinical experience and other data or information ... about the safety, effectiveness, or labeling of its drug" to the FDA. Because the plaintiff was seeking "to enforce a duty owed to a federal agency and her cause of action would not exist in the absence of that duty, her proposed second amended complaint is preempted."
The Tsavaris decision was not selected by the Eleventh Circuit for publication in the Federal Reporter, perhaps because this was a pro se appeal. But the proposed amended complaint was drafted "with the assistance of counsel," and is fairly typical of the way some plaintiff lawyers seek to evade preemption. Thus, the Eleventh Circuit's finding that the amendment would have been futile provides some comfort to practitioners on the right side of the v.
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We mourn the passing earlier this week of beloved Reed Smith colleague Chuck Pagliotti. Chuck was what all of us in the legal profession should aspire to be – a problem solver. Chuck was a genius when it came to fixing messes we made on our computers, iPhones, or anything else that could occasionally baffle us. He always did so with patience and a smile. We shared a love for anything relating to Star Wars. Chuck was a sweet, gentle soul. Our grief exceeds our poor power of expression.
This article is presented for informational purposes only and is not intended to constitute legal advice.
