On the same day the Seventh Circuit overturned the verdict in Dolin v. GSK, the court handling the coordinated New York state court Plavix Litigation dismissed the claims of all remaining plaintiffs on the grounds of conflict preemption. Oh happy day!
Plavix is a drug prescribed to inhibit the formation of blood clots. As such, ever since it has been on the market, its label has included warnings regarding the risk of bleeding. In re: Plavix Products Liability Litigation, 2018 WL 4005859, at *2 (N.Y. Sup. Aug. 22, 2018). It is that same risk which plaintiffs in the litigation allege was insufficient. Defendants moved for summary judgment arguing plaintiffs’ failure to warn claims were preempted because defendants could not independently have changed the Plavix warning and plaintiffs’ design defect claims were preempted because defendants could not have changed the design (i.e., the chemical composition) of an FDA approved drug. Id. at *3.
Since we led with the result, you know already that defendants’ arguments held the day. So, usually at this point in our posts we comment on plaintiffs’ arguments and why they failed. In this instance, however, plaintiffs didn’t make any substantive arguments. They instead only made a procedural argument about whether the New York plaintiffs’ generally had designated Dr. Randall Tackett and Dr. Lemuel Moyé as generic experts for all cases. It really isn’t worth delving into other than to say that the court wasn’t swayed by plaintiffs’ counsel’s attempt to disassociate themselves from the “the “Dynamic Duo” since they relied on the experts’ reports and defended them at deposition. Id. at *6. And, since now was the time for plaintiffs “to either prove it or lose it,” id., relying on a “mere procedural technicality” was insufficient to meet a substantive challenge to all of plaintiffs’ remaining claims. Id.
So, we’ll get right to the court’s analysis which starts with the holding that “federal preemption presents a question of law.” Id. at *7. We like checking off that box. The court then dove into whether the plaintiffs’ failure to warn claims were preempted under Wyeth v. Levine. Wyeth said no preemption where a defendant can unilaterally, without the permission of the FDA, change its label via CBE regulations. When is that possible? When the manufacturer has “newly acquired information.” But,
NY Plaintiffs have not produced any evidence that Defendant was in possession of “newly acquired information” after the FDA approved Plavix in 1997 which would have enabled Defendant to make any unilateral changes to the Plavix warning label without further FDA approval.
Id. at *8. The court also observed that plaintiffs did not challenge that defendants fully complied with FDA regulations in obtaining the approval of Plavix. Id. at *7. In other words, there is no allegation that defendants concealed any information from the FDA when it submitted its New Drug Application (“NDA”) or at any time thereafter during the course of the drug approval process. Id. at *6. FDA had all available information in 1997 and nothing new has developed since. And post-approval label changes, if they are based on information known to the FDA prior to approval of the label are preempted. For more on this issue see our posts on In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015) and Utts v. Bristol-Myers Squibb Co. here, here, and here.
As to design defect, the court looked at the opinion of plaintiffs’ expert, Dr. Moyé which was essentially that Plavix was defectively designed from its inception and that defendants either had to re-design the drug post-FDA approval or stop selling it. Id. We already know the Supreme Court has rejected these arguments as the answers to conflict preemption. Mutual Pharm. Co., Inc. v Bartlett, 570 US 472 (2013). Which the court summed up nicely here:
If Defendant did the former to avoid state tort liability, it would be creating a new drug requiring an NDA and FDA approval. Moreover, to have stopped selling Plavix, as this generic expert suggests, to “escape the impossibility of complying with both its federal and state law duties . . . [would be] incompatible with . . . [US Supreme Court] pre-emption jurisprudence.
Id. (citations omitted).
As if preemption wasn’t enough, the court also pointed out that Dr. Moyé’s conclusion that Plavix does more harm than good had to be excluded as it “achieved no consensus in relevant medical and scientific communities.” Id. at *9. His opinion was “grounded on a consensus of one.” Id.