As lawyers, we have to get client approval before we can discuss their litigation substantively. Here are a couple just-in decisions where we’re doing that, but that are important enough our readers would want to know about them right away. In re Incretin-Based Therapies Products Liability Litigation, slip op. (S.D. Cal. Nov. 9, 2015)
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
We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion permit a generic manufacturer to include truthful warnings about the risks of a drug on its labeling when such truthful warnings do not appear on the labeling of the branded drug?”
Not much later, we saw the same point raised by a plaintiff-side lawyer in this story in 360:
“I think this decision has huge implications for the preemption doctrine,” Lou Bograd of the Center for Constitutional Litigation PC said.
“If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products,” he said.
Needless to say, we don’t think that’s true. Moreover, if plaintiffs try for what amounts to an Amarin-based Hail Mary pass, it may even create a jurisdictional advantage for our side.Continue Reading Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass
A major basis for our criticism of the FDA’s still pending generic drug labeling proposal, and why we prefer industry’s EAR (“Expedited Agency Review”) system better, is that the FDA’s proposal would create festival-seating style label changes, with each competing generic producer (and any still-extant branded reference listed drug (“RLD”)), on its own in deciding
It was big news that there will be a six hour return of The X-Files, a show that dazzled us from 1993 to 2002. The “myth-arc” episodes about an alien invasion, black oil, and the disappearance of Special Agent Mulder’s sister were overwrought and confusing, but the standalone entries were television at its creepy best. The bullpen of X-Files writers was stellar, including, among others, Darin Morgan and Vince Gilligan. You probably have heard of Gilligan, since he later went on to helm a program now carved on the medium’s Mt. Rushmore, Breaking Bad. (Gilligan’s current show, Better Call Saul, is also quite good. And the ‘hero’ is a lawyer!) Morgan is less well-known, but he penned some of the most admired X-Files episodes, which married humor to mystery in ways not matched since. If you want to treat yourself to three hours of splendid viewing, fire up Netflix and take in these four all-time great X-Files episodes, the first two by Morgan and the latter two by Gilligan:
Continue Reading Illinois Appellate Court Misapplication of Bartlett Preemption: The Monster Case of the Week
A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common.
The first deals with a recent Supreme Court decision that doesn’t even have anything to do (directly) with the FDA. In Perez v. Mortgage Bankers Ass’n, No. 13-1041, slip op. (U.S. March 9 2015), the Court overturned a D.C. Circuit gloss on the Administrative Procedures Act that purported to require administrative agencies generally (which is where the FDA comes in) to go through notice and comment rulemaking whenever they flip-flop on what is a mere “interpretive” rule. The Court shot that down, giving a significant win to the government. Slip op. at 9 (“In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules − whether or not they are consistent with earlier interpretations.”).
In the short term, that means that the FDA can change its interpretive rules – those that, like Guidance Documents, do not purport to have force of law – essentially when and how it likes (not exactly, but close enough for non-government work).Continue Reading Can The FDA Do That?
In a Federal Register Notice (link here) the FDA formally announced today that it’s revisiting its pending proposal to kill generic preemption. The comment period has been reopened and will extend until April 27, 2015. In addition, there will be a webcast “public meeting” on the proposal on March 27, 2015. Details as
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
We normally prefer to trumpet birthday wishes rather than deathday anniversaries. But the guillotining of King Louis XVI was such a huge moment in Western history, not just French history, that we cannot let the event of January 21, 1793, go unremarked. It is only a series of tiny conceptual steps to go from the French Revolution to nationalism, to total war, to the Napoleonic Code, to the metric system, and then to a weird overestimation of the films of Jerry Lewis.
Today is also National Hug Day in the United States. Surely, Louis and Marie Antoinette could have used a hug as they rode toward the Place de la Revolution, which is now called the Place de la Concorde. (In the Star Trek universe, the President of the United Federation of Planets is officed in the Place de la Concorde. What other legal blog supplies that sort of crucial context?) If we were discussing an especially lousy case today, we might say that we could use a hug, too. But that turns out not to be necessary, because we are today reporting on a perfectly sensible case that rejected the Conte infamy. It comes from the land of magnolias and Faulkner, of Robert Johnson and the International Ballet Competition, of Blind Melon and Viking Ranges. It comes from Mississippi.
The case is Truddle v. Wyeth,LLC, 2015 U.S. Dist. Lexis 4563 (N.D. Miss. Jan. 12, 2015). Being long-time blues lovers, we cannot resist mentioning that the Truddle case resided in the Delta Division of N.D. Mississippi. None of the courts in our burg has a title nearly so colorful. (We could see Philly courts conducting proceedings in a Schuylkill Division, Hoagie Division, Mummers Division, and, in honor of the Sixers basketball team, Tankers Division.) Truddle was a pro se case and, as with so many of the cases we discuss, it arose from very sad circumstances. A young man suffering from gastritis and related conditions was prescribed Reglan/metoclopramide. He subsequently committed suicide. That is not the typical injury alleged in Reglan/metoclopramide cases. His relatives sued both the manufacturers of brand name Reglan as well as the manufacturers of generic metoclopramide. Earlier in the proceedings, the court had dismissed the claims against the generic manufacturers based on Mensing preemption. Then the brand name manufacturers moved for summary judgment on the ground that there was no evidence that the decedent had ever taken brand name Reglan. Thus we have the ‘one-two punch’ we have written about several times before, including here and here and here, among others. The Truddle court followed the analysis of almost every other court in deciding that a brand name manufacturer cannot be held liable for injuries suffered by someone who never ingested the brand name product. Put another way, the Truddle court rejected the Conte craziness that came out of California and that has been rejected by every right-thinking court (though, sadly, incoherently, maddeningly, it has been embraced by Mississippi’s neighbor to the immediate east).Continue Reading One Mississippi, Two Mississippi: Dismissal of Claims against Brand Name Reglan and Generic Metoclopramide Manufacturers
It’s been a little slow over the holidays so we’ll go back to something that happened last year. On December 16, 2014 – almost three whole weeks ago – the Solicitor General filed his brief responding the Supreme Court’s request for the government’s views in the case called Teva Pharmaceuticals USA, Inc., v. Superior Court Of California, Orange County, No. 13-956. Here’s a link to the case’s SCOTUSBlog page. The prior published opinion in this case, Teva Pharmaceuticals USA, Inc. v. Superior Court, 158 Cal. Rptr.3d 150 (Cal. App. 2013) (which we’ll call “Pikerie” because that’s the plaintiff’s name), involved preemption in the generic drug context. Here’s our description of Pikerie from the blog’s generic preemption scorecard:
Overruling of demurrer affirmed. A duty to update claim is not preempted. It is not impossible to update warnings that the FDA has ordered changed, it is required. Following Fulgenzi. A “Dear Doctor” letter claim is not preempted, to the extent that the communication followed FDA-approved updates in the labeling.
Long-time readers might recall that the last time the SG’s office was invited to weigh on the FDCA and preemption of product liability litigation, in the Stengel case, it produced a ridiculously cramped version of PMA preemption that sought to emasculate Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and would have allowed virtually every claim to escape preemption. We reported on that here. Equally bizarrely, after explicitly stating that “every” court of appeals since Riegel had (in his view) gotten Riegel wrong, the SG in Stengel nonetheless recommended that certiorari be denied – hardly the a position taken by a litigant confident that the Court would agree with its position.
Then we have the FDA trying to amend the FDCA administratively to eliminate generic drug preemption altogether, which we have discussed on
several occasions.
Thus, we know that this administration is at least as hostile to FDCA-related preemption as the prior administration was supportive. Given that “duty to update” cases are really lousy cases for plaintiffs for a host of reasons unrelated to preemption (that’s why they’ve never been brought before), we’d have to think long and hard before doing something that would give this same crew a chance to take shots as preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). But the generic industry seems to have concluded it’s worth it, and their lawyers aren’t dumb.Continue Reading SG’s Reign of Error Continues