We have expressed our opinion on “failure to update” claims and have not hidden that we don’t think much of them. Failure to update claims were manufactured by plaintiffs in response to PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) which basically
Search results for: failure to update
Warning Causation Sinks Another Generic “Failure To Update” Claim
It’s Delaware week here at the DDL Blog. A couple of days ago we brought you a particularly clear-minded order rejecting innovator liability in the First State (so nicknamed because Delaware was the first of the original 13 colonies to ratify the Constitution in 1787), and yesterday we reported on a pair of Delaware orders…
Warnings Causation Sinks “Failure to Update” Claim
This post is not from the Dechert side of the blog.
“Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers distribute their products with drug labeling that is the same as their innovator counterparts—the so-called “duty of sameness.” A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury. Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as we pointed out here.
In addition to the preemption issues, “failure to update” claims are highly contrived. We never saw them before the Supreme Court found most claims against generic drug manufacturers preempted by federal law, and the key principle under tort law is whether drug labeling adequately warns of known and reasonably knowable risks. Sameness might be relevant to adequacy, but it also might not. In this regard, “failure to update” claims are nothing more than plaintiffs’ lawyers trying to thread the eye of a needle after Mensing and Bartlett.
True, the duty of sameness does not seem all that onerous to our uneducated eyes: Just follow the leader. And it is not like we are talking about absolute liability. As we have discussed, the plaintiffs still have to prove all the elements of their claims, including (but not limited to) causation. On days when we are in this generous frame of mind, “failure to update” claims are something we can live with.…
Continue Reading Warnings Causation Sinks “Failure to Update” Claim
S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim
Today’s post comes from the non-Dechert side of the DDL blog.
This week is the anniversary of the beginning of Facebook. The question of whether Zuckerberg et al. could successfully “monetize” that platform has apparently been answered. There are almost as many ads and push notifications as there are things that we actually care about, such as pictures and updates from friends and family. Even worse than the ads are the political rants, stalker high school classmates, and suggestions to join stupid games. After a nephew invited us to play Farmville for the fifth time, we unfriended him. It was an easy call, especially since most of his entries involved home-made backyard mixed martial arts films and his f-bomb quotient would have made the makers of Scarface and Midnight Run blush. Why isn’t there a “Dislike” button we can click?
But today we will “Like” a pair of decisions out of the Southern District of Texas. The cases are Jackson v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9286 (S.D. Tex. Jan. 27, 2015), and Garza v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9292 (S.D. Tex. Jan. 27, 2015). The cases involve the same judge, the same defendants, and the same claim that ingestion of Reglan/metoclopramide caused tardive dyskinesia. They were issued on the same date. Both opinions are short, well-reasoned, and follow settled Fifth Circuit law.…
Continue Reading S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim
Learned Intermediary Doctrine Gets an Assist in Preempting a Failure to Update Claim
Last week, the Eighth Circuit put the final seal on Pliva’s victory in Brinkley v. Pfizer, Inc., 2014 U.S. App. LEXIS 22742 (8th Cir. Dec. 2., 2014), upholding the district court’s dismissal with prejudice under Mensing and Bartlett. The case involved a doctor who prescribed Reglan and a pharmacist who, when filling the prescription, switched it out for Pliva’s generic metoclopramide. Id. at *2. While the Reglan label had been changed in 2004 to add a warning on long-term use, Pliva, plaintiff claimed, failed to make the corresponding update to its label. So she pursued a failure to update claim.
In some sense, that’s a good starting point. By styling her failure to warn claim as a “failure to update,” Plaintiff was conceding that she could not bring a standard failure to warn claim.” Generic manufacturers can only change their label to match a corresponding change in the branded label, and plaintiff hoped that her “failure to update” claim would avoid Mensing preemption.
But this claim had problems too, and they centered on the learned intermediary doctrine. Pliva’s duty to warn, if any, ran to plaintiff’s prescribing doctor. But, as plaintiff alleged, her doctor prescribed Reglan, not Pliva’s generic metoclopramide. Consistent with that, the doctor consulted the Reglan label, not the Pliva label. Id. at 2-3. In short, the doctor never read Pliva’s label. So no matter what Pliva put there, it could not have affected the doctor’s decision to prescribe the drug to plaintiff. We lawyers call that a failure of proximate causation.…
Continue Reading Learned Intermediary Doctrine Gets an Assist in Preempting a Failure to Update Claim
Breaking News – Sixth Circuit Allows “Failure to Update” Claims
It’s only a small piece of what product liability claims are all about, but the Sixth Circuit in Fulgenzi v. PLIVA, Inc., No. 12-3504, slip op. (6th Cir. March 13, 2013), has ruled (creating something of a circuit split with the 5th Circuit’s nonprecedential Morris decision from last month), that “failure to update” claims…
Yet Another Failure-To-Update Claim Bites the Dust
In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).
Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:
Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.
Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.
OK, so take generic preemption out of the mix entirely – what happens with Woods?
Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.…
Continue Reading Yet Another Failure-To-Update Claim Bites the Dust
Partial Update On Medical Abortion Litigation
Lawyers really like to be right. This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions. Back when the Dobbs decision had been leaked but not yet issued, we…
2021 Updates to Ediscovery for Defendants Cheat Sheet
It’s been a while (since mid-2020) since we last updated our cheat sheet devoted to ediscovery for defendants. That’s because, unlike most of our other cheat sheets and scorecards, cases involving defense discovery of plaintiffs’ social media can be found in a wide variety of non-drug/device contexts – other personal injury, employment, civil…
Illinois Appellate Court Affirms Summary Judgment on Failure-to-Warn and “Voluntary Undertaking” Claims in Programmable Pump Case
Before we turn to today’s case, a quick update: when last we spoke, we were about to board a plane for Peoria – our first work trip in sixteen months. We were excited about it. We regret to report that we stepped out of the plane into something resembling a weird post-apocalyptic Mad Max movie. …