Search results for: failure to update

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

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

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

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

Another two years have elapsed (since October, 2023) since we last updated our cheat sheet devoted to ediscovery for defendants.  That’s because finding good, pro-defense ediscovery decisions is a hard and time-consuming task – and getting harder.  Unlike most of our other cheat sheets and scorecards, cases involving defense discovery of plaintiffs’ social media…

As defense lawyers, we have dealt many a time with plaintiffs’ attorneys who get away with just about everything. Failing to appear for hearings. Failing to oppose motions. Ignoring court orders. Ignoring discovery requests.

When unjustified, such acts of neglect should not be excused, but they often are. Courts are predisposed to decide cases on…

Recently, when putting together our “Staple Suit Cropped” blogpost about Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), we realized that, while we had a comprehensive 50-state survey on the questionable status of failure-to-report claims under state law, we did not have a similarly complete reference for preemption of the same reporting-based claims.

We’re rectifying that here.

Failure-to-report claims have been asserted against every product that has a preemption defense – branded drugs, generic drugs, and PMA medical devices.  Thus, there are different ways that failure-to-report claims end up preempted.

  • First, reporting-based claims against drugs or medical devices are impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. §337(a), because they would not exist without the FDA reporting obligations that they claim were violated.  Therefore, “the existence of these federal enactments is a critical element” of the cause of action, and implied preemption applies.  531 U.S. at 353.
  • Second, and relatedly, in the majority of states where no state-law claim exists for failure to make mandatory reports to a governmental agency (see the 50-state survey), Buckman further precludes such claims as purely private attempts to enforce the FDCA/FDA regulations concerning adverse event reporting.
  • Third, in cases involving pre-market approved medical devices, the same absence of any state-law reporting-based claims leads to express, as well as implied, preemption because there is no recognized “parallel” state-law theory of liability that could support a “parallel claim” exception to express preemption under 21 U.S.C. §360k(a).
  • Fourth, generic drugs enjoy their own implied preemption defenses under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and can take similar advantage of Buckman-based preemption precedent.

Obviously, there can be overlap between these three categories, and not all courts keep them separate.

Since the issue is preemption, a federal issue, our primary division of cases is by federal circuit rather than by state.  Of the circuits, the Second, Third, Sixth, Eighth, Tenth, and Eleventh all have precedential decisions holding failure-to-report claims preempted, although the Second has only dealt with express preemption.  The Second, Fifth and Ninth allow “parallel” failure to warn claims to escape preemption if state common law allows them, with the Second being stricter than the others.  The Seventh Circuit has been hostile generally to FDCA-based preemption, but hasn’t decided a reporting-based case.  The First, Fourth, and District of Columbia circuits have yet to decide the question.  We note that no precedential decision from any federal court of appeals has flatly denied preemption in a failure-to-report case since 2013, the 2013 decision was repudiated by the highest court of the state in question (see Ninth Circuit, below), and the United States Supreme Court abolished any “presumption against preemption” in express preemption cases in 2016.  See Commonwealth of Puerto Rico v. Franklin California Tax-free Trust, 579 U.S. 115, 125 (2016).  Thus, defendants have good grounds to seek reconsideration of what adverse appellate authority exists.

Finally, we don’t do the other side’s research for them, so be advised, that while we try to be comprehensive in collecting favorable cases, we aren’t including all adverse decisions. Continue Reading Preemption Round Up – Failure to Report

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