We’ve reviewed the transcript of the oral argument in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S.), e.g., the United States Supreme Court appeal from the horrible decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), which we ranked as the worst case in all of 2017. Our one sentence reaction – We’d rather be us than them.
The Fosamax plaintiffs have a lot of problems with their position in Albrecht, chief among them that the FDA itself, as amicus curiae in this case, disputes their interpretation of what the Agency knew and did.
Briefly, plaintiffs argued that: (1) the FDA’s rejection of the defendant’s “stress fracture” warning was because stress fractures and the injury at issue in the litigation – now called “atypical femur fractures” (or “AFF” for short) − were two different things; (2) the FDA only rejected the imprecise term “stress fracture,” and didn’t reject an AFF warning, and (3) the rest of the regulatory record consists of FDA “musings” that plaintiffs are free to contradict and juries would be free to disregard. Albrecht Tr. at 35-38, 42-44, 61-63.
Equally briefly, defendant argued that: (1) its rejected “stress fractures” warning encompassed AFF (a term only created later), demonstrated by language about “complete” and “non-traumatic” fractures; (2) the FDA’s rejection was based on insufficient data about AFF, since a short time later the Agency set up a task force to study AFF before changing labels for this drug class (bisphosphonates); and (3) the FDA does not simply reject scientifically valid warnings for grammatical reasons. Albrecht Tr. at 3-5, 10-12, 16-19, 65-66.
The FDA, represented by the Solicitor General’s office, agreed with the defendant’s depiction of its regulatory actions regarding AFF, arguing that the Agency obeyed the law and did not reject the defendant’s label for imprecise language, but rather because the link between AFF and bisphosphonates was not supported by sufficient scientific data at the time Albrecht Tr. at 20-22, 27-30.
At the oral argument another problem for the plaintiffs was evident: Justice Stephen Breyer. A member of the majority in Wyeth v. Levine, 555 U.S. 555 (2009), and an anti-preemption dissenter in the more recent PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), decisions, Justice Breyer is a “must get” vote for plaintiffs in Albrecht. They don’t have him:
JUSTICE BREYER: I’m leading to this, that, when you talk about the standard, drugs are important to people. They cure millions, or thousands, anyway, of people who need to be cured or helped.
Now, when you put on, and at the same time there will be a...
