The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). A couple of anonymous, obviously plaintiff-side, comments to our “breaking news” Amarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside. Both comments raised the same issue: what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?
One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over. The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964). “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.” Id. at 277. See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action). Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:
The publication here was not a ‘commercial’ advertisement. . . . That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . . To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.
376 U.S. at 266 (citations and quotation marks omitted).
That makes sense, since most litigation over pharmaceutical labeling is, at bottom, a fight over science – both sides’ experts battle over whether drug X causes adverse condition Y. Scientific speech has long been fully First Amendment protected. “Under the First Amendment there is no such thing as a false idea.” Gertz v. Robert Welch, Inc., 418 U.S. 323, 339 (1974). See, e.g., Miller v. California, 413 U.S. 15, 23 (1973) (listing “scientific speech” as a category of fully protected speech); American School of Magnetic Healing v. McAnnulty, 187 U.S. 94, 106 (1902) (government may not decide that one side of medical controversy, such as the benefits of smallpox vaccination or homeopathy, is “fraudulent”); Universal City Studios, Inc. v. Corley, 273 F.3d 429, 446-47 (2d Cir. 2001) (“it is settled that the First Amendment protects scientific expression and debate just as it protects political and artistic expression”). We could cite a dozen more cases standing for the fully First Amendment protected nature of scientific speech, but that’s not the point of this post.
Back in August, we also noticed the same point being made by Lou Bograd, one of the more creative plaintiff-side lawyers around. He was quoted by 360 in this story as saying:
If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products.
So we wrote a post about all that, on the assumption that the comments were directed against the concept of “impossibility” preemption in product liability litigation involving generic drugs. Where else would plaintiffs’ lawyers be so desperate as to advance an argument predicated on the absolute First Amendment-protected status of the very speech that they simultaneously have to claim is somehow “defective”?
Now, Mr. Bograd has taken pen to paper and fleshed out his musings in an article in a widely circulated ATLA publication. L. Bograd, “Be Careful What You Wish for: Drugmakers, the First Amendment, & Preemption,” 51 Trial 24 (Nov. 2015). It’s available on Westlaw, but oddly doesn’t seem to have a separate WL citation.
Sure enough, we were dead in the red as to where we thought that argument was directed. It’s an attempt to set up the First Amendment protection as some sort of defense to impossibility preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). The article’s thesis is, “[i]f the First Amendment protects [FDA regulated entities’] right to truthfully promote the drugs they sell, it also must protect their constitutional right to provide truthful warnings about their products’ risks, even if the FDA has not approved those warnings.” Id. (no internal pagination provided). Therefore, according to the article, “federal law cannot prohibit generic drug companies from providing truthful warnings about the risks of the products they sell.” Id.
If ATLA is publishing this, we on the defense side can expect to see the argument start popping up in litigation. Thus, we’ve decided to revisit our prior post in a little more depth.
Our response to the thesis being put forward is, first (as already stated) that the initial statement being true, the First Amendment precludes courts from litigating the subsequent propositions under Sullivan. The First Amendment precludes state (or federal) law from seeking adjudication of the “truth” of fully protected speech. Plaintiffs don’t get to have courts enforce their version of the “truth” against our clients as protected speakers – no more than creationists can sue scientists into submission, or Christians can sue Jews. The premise that pharmaceutical speech is fully First Amendment protected ends the discussion, except for, “here, plaintiff, please sign the stipulation of dismissal, and we won’t seek costs against you based on your concession.”
Our second response is that, assuming all the statements are true, the article’s premise that Mensing/Bartlett is somehow called into question is false. Keep in mind the Supreme Court’s basis for impossibility preemption. It’s what we’ve previously called the “independence principle.” It is impossible to comply with an immediate common-law tort duty to change a warning where, procedurally, an FDA-regulated manufacturer must first receive permission from the FDA permission which cannot possibly be granted instantaneously) before making that change.
[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.
Mensing, 131 S. Ct. at 2581. That point was not only reiterated in Bartlett, 133 S. Ct. at 2470 (warning-based design claim preempted because “federal law prohibits generic drug manufacturers from independently changing their drugs’ labels”), but also extended to design claims. Id. at 2475 (“redesign was not possible” because any redesigned substance...
