Search results for: avandia

Lord knows, there are a lot of meritless MDLs.  Bexis’ and Michelle’s Bone Screw litigation, prompted by a televised CYA freak-out by then-FDA Commissioner David Kessler over an off-label use that had become the medical standard of care, was one, and it gave us Buckman.  Several MDLs against modern anticoagulants, such as Xarelto, are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.  Currently, the Taxotere MDL – based on the dubious proposition that the plaintiffs cared more about hair loss than most effectively treating their breast cancer – and Zostavax – where not a single plaintiff can prove causation – come to mind.  Our colleagues defending other MDLS can also be excused for believing that their own litigation should be added to this list.

But for sheer factual baselessness, it would be hard to top the still-ongoing Avandia MDL, which somehow has managed to persist since 2007.  The Avandia litigation is infamously based on a purported increased risk that, over a decade ago, the FDA scientifically determined did not exist.  Briefly, a study erroneously found an increased risk of cardiovascular events with Avandia that led to both a boxed warning and additional studies.  The additional studies debunked that supposed increased risk and the FDA removed the boxed warning:Continue Reading Avandia Litigation – Is This Finally the End?

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) …

We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins.  And the cat.  (We mostly resisted the all-day live feed of the breed judging.)   Since the Best in Show lineup didn’t include a Standard Poodle, our “breed of the heart” (a cute Bulldog named Annabelle beat Ricky, the stunning black Standard Poodle, in the Nonsporting Group), and being nothing if not bandwagon jumpers, we were rooting for “Rumor” a gorgeous German Shepherd who was the top winning show dog of 2015 by many, many points.  And she showed beautifully.  But she was defeated by “C.J.,” a German Shorthaired Pointer. While we don’t count ourselves as sporting breed fanciers, C.J. is a cool dog.  And, most interestingly (maybe not, but it gives us a hook to transition to our case in a minute), C. J.’s grandmother, Carlee, was Best in Show in 2005. Carlee was known for her flawless “free stack” – instead of needing her handler to place her feet in the right positions and stretch out her neck – “stack” her – for the judge’s examination, she did it all by herself in the most striking of fashions.   Westminster trivia:  like the Adamses and the Bushes, Westminster can count one example of a father siring his eventual successor:  Robert, the English Springer Spaniel, was Best in Show in 1993.  His daughter, Samantha, “took the Garden” seven years later.  The ostensible point of dog shows is to reward the best specimens of each breed so they will pass their genes to future generations, so it is neat when a judge’s good decision is affirmed.

And so it was recently in the Third Circuit.  In In re Avandia Marketing, Sales Practices and Products Liability Litigation (Linda and John Schatz, appellants), — Fed. Appx, –, 2016 WL 574074 (3d Cir. Feb. 12, 2016) (applying Pennsylvania law), the panel considered Judge Cynthia Rufe’s grant of summary judgment to the defendant manufacturer in a case in the Avandia MDL. The plaintiff, who had taken Avandia, sustained bone fractures in two accidents and alleged that the manufacturer had failed to adequately warn of the risk of such fractures.  The manufacturer had informed doctors of this risk and, shortly thereafter, updated its warnings to include this information.  While it was not clear whether the plaintiff had already stopped taking the drug at this time, it was undisputed that she resumed taking it for a short time after the “bone fractures” warning was added to the label.Continue Reading Solid Affirmances: Avandia Summary Judgment, and Westminster

We have written before about the virtues of Lone Pine orders, which require plaintiffs to produce elementary evidence supporting their claims, usually some prima face evidence of exposure, injury, and causation. These orders provide an excellent tool to eliminate the cases filed in any mass tort by people just hoping to cash in without having…

Egad — yet another post on removal!
We’ll try to keep it mercifully brief.
In In re Avandia Marketing, Sales Practices and Prods. Liab. Litig., [That caption about covers the waterfront, doesn’t it?] MDL No. 1871, 2009 U.S. Dist. LEXIS 51558 (E.D. Pa. June 18, 2009), GlaxoSmithKline removed two “Avandia supposedly increases the risk of…

We have no personal knowledge of the litigation concerning GLP-1 receptor agonist medications and the Blog has not posted on it yet, but we do know something about litigation over widely used prescription medications.  Over the decades, there have been many drugs or classes of drugs that became “blockbusters” because they were widely prescribed to…

In Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008), the court, applying California law, correctly “decline[d plaintiff’s] invitation to create a new exception” to that state’s privity requirement “that would permit [plaintiff’s] action to proceed.”  Id. at 1023-24.  “[A] federal court sitting in diversity is not free to create new exceptions” to state law limiting liability.  Id. at 1024 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).  D&Z held, as we’ve discussed many times:

A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

423 U.S. at 4.  And the Supreme Court has kept on saying this.  Erie principles prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules.”  Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988).  “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

But when updating the learned intermediary section of his treatise, Bexis came across a peculiar MDL holding, that because a defendant supposedly “cite[d] no cases” for the proposition “that the learned intermediary doctrine should apply to Plaintiffs’ . . . consumer protection claims” under the laws of California, Maryland, Illinois, and Florida, then “the learned intermediary doctrine should not apply” to claims brought by plaintiffs in any of these states.  In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023).  The decision did not cite any precedent from any of these states (not even a trial court decision) affirmatively creating any exception to the learned intermediary rule for consumer fraud claims.  Id.Continue Reading Debunking Another Stunningly Wrong MDL Expansion of Liability

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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