One slushy morning this week, we found ourselves searching for our favorite black duck boots. We found one and put in on, then, after much rummaging in the dark recesses of our closet, found a second. At this point, we were on the edge of missing our train, so we put on the second shoe
We just returned from our annual “girl trip” to a lovely spa in the mountains of Pennsylvania. And we stared our decrepitude full in the face. For the first time, we set off enthusiastically on a bike ride (cool “fat tire” bikes we’d never seen before) and found ourselves falling behind on hills and struggling…
If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court…
Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while…
Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us…
Today, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). You can read our discussion of the district court opinion in Cerveny here.
While any decision with a description of “affirmed in…
Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016). With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date. The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.
Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury. Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury). The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue. Id. at 699.
[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.
Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).
We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard all of the incredulous “how could you??” exclamations. Yes, there was lots of violence. There was the ursine animatronic latter-day cousin of “Bruce,” who, like his predecessor, failed to engage or convince us. Bottom line for us was that there was plenty of dramatic stuff going on, but none of it added up to a compelling story.
Without meaning to be flip about the truly tragic facts of today’s case, that was essentially what the court held. In Batoh v. McNeil-PPC, Inc., et al., — F. Supp. 3d –, 2016 WL 922779 (D. Conn. Mar. 10, 2016), the plaintiff’s decedent, her adult son, developed SJS/TEN (Stevens Johnson Syndrome/Toxic Epidermal Necrolysis) after taking over-the-counter Motrin. SJS and TEN are “severe cutaneous adverse reactions” (“SCAR events”) in which skin becomes inflamed, blistered, and necrotic, and sloughs off. The results can be catastrophic. In the plaintiff’s decedent’s case, the SJS/TEN left him with “significant wounds and scarring throughout his body, and damage to his nervous system, eyes, genitals, and feet.” Batoh, 2016 WL 922779 at *4 (citation omitted). A year later, he committed suicide, telling relatives that he could not tolerate living with these residual injuries.
The plaintiff sued the drug’s manufacturer, alleging violations of the Connecticut Products Liability Act based on theories of failure to warn, design defect, breach of warranty, and fraud/misrepresentation. The defendant moved for summary judgment on all of the plaintiff’s claims, and the plaintiff cross-moved on the defendant’s preemption defenses.
This post is from the non-Reed Smith side of the blog.
Today we laud an excellent prescription drug preemption ruling finding “clear evidence” that the FDA would not have permitted the warning of the sort plaintiff demanded – Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016).
At issue is the prescription drug Clomid. Clomid has been FDA approved and on the market since 1967. Id. at *2. It is prescribed to women to induce ovulation. The drug is taken for 5 consecutive days with ovulation typically occurring within 5 to 10 days. Id. at *5. Since the drug has been on the market it has carried a warning that Clomid should not be taken while pregnant due to the potential risk of harm to the fetus. Id. at *2-5. While the warnings have been modified over time, the risk of ingestion while pregnant has always been present, along with warnings about carefully monitoring ovulation so as to avoid becoming pregnant while taking the drug. Id.
Plaintiff used two rounds of Clomid in 1992. Following her second round she became pregnant. Her son was born with birth defects. Id. at *12-13. Plaintiff alleges that those defects were the result of the Clomid she took prior to becoming pregnant remaining present in her system during and after conception. And that therefore, defendant had a duty to warn of the risks of birth defects from Clomid taken prior to pregnancy. Id. at *13-14. Defendant filed a motion for summary judgment on the ground that plaintiff’s claims were barred by federal conflict preemption. Defendant argued that the FDA would not have allowed it to include the warning sought by plaintiff and therefore plaintiff’s state law tort claim conflicts with federal law and is preempted. Id. at *16-17. Under the standard announced in Wyeth v. Levine, 555 U.S. 555 (2009), defendant has to demonstrate the conflict between state and federal law by “clear evidence.” Since that decision, courts have been grappling with what “clear evidence” means. In this case, the court didn’t have to look too hard.
This post is from the non-Reed Smith side of the blog.
Last week we posted about the decision in In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.) dismissing plaintiffs’ failure to warn claims as preempted based on the Wyeth v. Levine “clear evidence” standard. That is “clear evidence” that the FDA would have rejected the warning sought by plaintiffs, which leads to implied preemption based on impossibility.
At that time we had heard that the judge presiding over the consolidated incretin litigation in state court in California would be issuing a similar ruling. That turned out to be correct. Here is a link to the decision, In re: Byetta Cases, Case No. JCCP 4574 (Cal. Super. Nov. 13, 2015). The ultimate conclusion is the same: the evidence demonstrates that on multiple occasions the FDA considered and rejected a causal association between incretin and pancreatic cancer and likewise concluded that the drug’s labeling did not require revision. In re: Byetta Cases, slip op. at 15-18.
We aren’t going to re-hash the impossibility preemption analysis again; we think the federal court decision handled the issue more than well enough. But, we will point out a few interesting points made in the state court decision.