[U] A Long-Term Friday Follow-Up: Merck Files Its Brief In Third Circuit For Another Go-'Round, On Fosamax® And Brittle Bone Warnings...

This Fosamax^® (alendronate sodium) litigation, involving (in part) non-impact hip fractures, and jawbone death (both alleged to be the result of long term alendronate sodium regimens, without at least annual drug holidays) has been to the Third Circuit at least twice before, and once, to the US Supreme Court. It returns now on the issue of whether Merck could have, or should have warned earlier. Merck's brief runs over 50 pages. It argues that the FDA's rules and letters prohibited it from changing its warning labels any earlier than it did.

And as long term readers know, of course, we have followed this litigation morass since 2008. [Earlier, if one counts the Wyeth pre-emption body of law, at the Supremes.] Here is some of the latest, from the Merck brief just filed:

. . .[T]he FDA told the Supreme Court it rejected Merck’s warning based on “lack of adequate data to support a warning,” not “because of the warning’s use of the term ‘stress fractures.’” A1524. Judge Wolfson reasonably “credit[ed]” the FDA’s representation about its own rationale. A102.

Plaintiffs claim the court erred by giving credence to “the government’s litigation position expressed years later in an amicus brief.” Br.58. That misstates the law. It is proper to “defer[]” to an agency’s amicus brief if, as here, “the agency was not a party to the litigation, and had expressed its views only in response to the Court’s request.” Kisor v. Wilkie, 139 S. Ct. 2400, 2417 n.6 (2019). Of course, courts do not “defer[] to an agency’s conclusion that state law is pre-empted,” but they do respect agencies’ “unique understanding of the statutes they administer.” Wyeth, 555 U.S. at 576-77. The FDA’s briefs explained its earlier actions in view of the statutory and regulatory background. That certainly warranted at least “some measure of deference. . . .”

Ironically, Plaintiffs urge the Court to instead defer to the view of a single, former FDA official, Dr. Sharfstein, who joined an amicus brief on Plaintiffs’ side. Br.58. But, unlike the FDA’s briefs, Dr. Sharfstein does not speak for the agency; played no role in the underlying events; and did not file his amicus brief at the Supreme Court’s request. Plaintiffs also pretend the Supreme Court itself somehow resolved this issue in their favor in the facts section of its opinion. See Br.53, 58. As Judge Wolfson appreciated, that is not a plausible understanding of the Court’s decision. . . .

Updated: As a largely insipid housekeeping note, it seems Elon Musk's cavalier attitude about the inner tech that runs on Twitter has once again. . . rendered official Twitter feed links, like that of NASA Social, imaged at left. . . as a 404 link. We shall see if he can fix it, or if we will all end up migrating to Mastodon, CounterSocial or least likely. . . the Instagram version, just opening. Yikes. We will leave the link at left through next week, in hopes Musk can get his act together, though I wouldn't bet the ranch on it. It seems to have to do with his decision (over the Fourth) to limit non-premium-paying account privileges, to link material off the site (like yours truly). So it may be a "feature" -- not a bug. Ugh.

Onward, with my eldest headed back to London for another three months this evening (though we may vacation together in Colorado in September again). . . even so, with a sad smile, then.

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