Particularly since Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), we have written numerous posts about preemption and "newly acquired information" in prescription drug product liability litigation. None of them, however, has involved federal appellate authority - until now.
In Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., ___ F.3d ___, 2021 WL 41897 (4th Cir. Jan. 6, 2021), the court overturned a plaintiff's verdict on preemption grounds and specifically addressed the portion of 21 C.F.R. §314.70(c)(6)(iii) predicating the availability of changes being effected ("CBE") warning supplementation on the existence of "newly acquired information" that provides "evidence of a causal association" meeting FDA standards. Those standards are set in 21 C.F.R. §314.3(b), which defines "newly acquired information" as that which "reveal[s] risks of a different type or greater severity or frequency than previously included in submissions to [the] FDA."
Knight holds, first, that information already known to the FDA cannot be "newly acquired," and second that preliminary results still subject to investigation do not meet FDA standards. Since plaintiffs had nothing else in Knight, the Fourth Circuit required entry of judgment as a matter of law.
On the first point, "the FDA was already aware of" plaintiff's purported "new analysis" "when it approved [the product]." 2021 WL 41897, at *6. Indeed, "the physician label in place" at the relevant time "warned of these risks." Id. at *7. The scientific conclusion at issue was only "that there is no single . . . concentration range that provides optimal benefit-risk for all patients." Id. (citation and quotation marks omitted). That conclusion "plainly does not establish any new risk" at all. Id. It merely "tracked" what the drug's warnings already stated. Id. Well, duh. "Newly" acquired information at least has to be "new," and this plainly wasn't.
The second point is more interesting. Plaintiffs also asserted that a scientific article's pre-publication "preliminary conclusions" should be considered newly acquired information. In a notable defense of the scientific method, Knight rejected the proposition that legal liability can be based on a mere scientific dispute about what data meant. The Fourth Circuit pointed out:
[A]fter circulating a draft version that concluded such a range existed, [defendant] continued to analyze the data and work on the paper. Almost two years later, [defendant] came to a different conclusion. Importantly, the scientific and regulatory community accepted [defendant's] final conclusion. The final version of the paper was published, peer-reviewed and submitted to the FDA.
2021 WL 41897, at *7.
Thus, "the new analysis did not 'reveal' the conclusion" plaintiffs claimed it did, so that "preliminary thoughts and draft conclusions were not 'newly acquired information.'" Id. (citing 21 C.F.R. §314.3(b)). Knight lauded several trial courts for for "reach[ing] the same result . . . despite the lack of preceential guidance. Id. at *7 n.9 ("commend[ing]" Silverstein v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 6110909 *33-36 (S.D. Fla. Oct. 7, 2020), Lyons v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 1:18-cv-04624-WMR, 2020 WL 5835125 *8-9 (N.D. Ga. Sept. 29, 2020), and Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, at *16 (Conn. Super. Sept. 11, 2019)).
Indeed, it could not be otherwise and still be science. "[T]he fact that some findings in an analysis may be revealed instantly does not mean that all are." Id. at *8.
[W]e caution against a quick trigger in determining the existence of newly acquired information. It is imperative for the scientific process that open dialogue and exchange of ideas take place during an analysis and drafting of a paper. That, along with airing and testing opposing opinions, results in better decisions. That is why hypotheses, differing viewpoints and even preliminary conclusions are not reliable evidence of new risks. If they were, companies might discourage the open dialogue needed to reach the best results. Or, unnecessary warnings might flood labels and distract from real risks. Accordingly, preliminary thoughts and discussions are not "reasonable evidence of a causal association with a drug" and cannot, without more, reveal "newly acquired information."
Id. (citations and quotation marks omitted) (emphasis added). We can use a ringing defense of science right now, and the Fourth Circuit gave us one.
Originally Published by Reed Smith, January 2021
This article is presented for informational purposes only and is not intended to constitute legal advice.