Poll v. Stryker Sustainability Solutions, Inc., 2014 U.S. Dist. LEXIS 6309 (D. Az. Jan. 17, 2014), is a pretty good preemption decision but, more important, another decision holding that courts may take judicial notice of documents on the FDA website as part of a motion to dismiss. The case involved a hip resurfacing system,
One of the benefits of blogging is that, after a while, dedicated readers start helping us out. Usually, we’re in a position simply to pass what we receive along to the rest of our audience, but sometimes the heads-ups we receive are actually beneficial to our own litigation. Either way, keep those opinions and orders coming.
That’s what happened last Wednesday. We received two interesting cases from two different sources. The first case was a nice preemption win, Wells v. Allergan, Inc., C.A. No. 6:12-3509-TMC, slip op. (D.S.C. Jan. 13, 2014), sent to us by prevailing counsel, Rich Dukes, of Turner Padget. We, of course, turned around and shipped Wells off to Westlaw, and by the time you read this, it should be available at 2014 WL 117773.
Wells involves a device, injectable gel dermal fillers, that before reading the decision, we confess we’d never heard of. We still don’t know much about them, but their critical attribute, from a preemption standpoint, is that they were pre-market approved by the FDA. Ring that bell, and we defense lawyers start salivating.
With good reason.
In Wells, PMA preemption resulted in outright dismissal for failure to state a claim. The court summed up the scope of FDA activity in a PMA pithily: “During that process, the FDA evaluates everything about the device, from labeling to safety.” Wells, slip op. at 3. There’s a nice discussion of Buckman preemption, too, id. at 3-4, but nothing so quotable.
Anyway, the plaintiff in Wells fell back, as PMA plaintiffs are wont to do, on “parallel” claims. No dice. Plaintiff didn’t plead anything more than “barebones, conclusory allegations.” Slip op. at 5. The complaint did not “identify the federal requirement applicable to the device,” “explain how that violation . . . caused the plaintiff’s injury,” or “identify specific device defects.” Id. at 4-5. Thus, Wells earned a place on our TwIqbal cheat sheet as well.Continue Reading New Stuff From Our Readers
By now, we were supposed to be on a tropical beach, reading a Booker prize short-lister and twirling a tiny tangerine-colored umbrella in a sneaky-evil drink. But somehow we won a few extra days in the Philly ice-box. Thanks, last minute (and mysterious) “aircraft maintenance.” Thanks cruel fate. Like Edith in Downton Abbey, mayhaps
Today we bring you a third case in one week regarding prosthetic hip implants. Here and here we reported on courts correctly ruling that plaintiffs had not adequately pleaded product liability claims involving their hip prostheses and/or that federal law expressly preempted claims involving devices approved through the FDA’s rigorous Premarket Approval (“PMA”) process. We
Yesterday we blogged about Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS (E.D.N.Y. July 15, 2013) – a hip implant case that was dismissed because the court found the complaint woefully deficient. Keeping with the same subject matter, today we have another hip implant case, from a neighboring court, with another insufficient complaint, plus a positive preemption ruling. Sort of a variation on a theme.
In Simon v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 170413 (S.D.N.Y. Dec. 3, 2013), plaintiff also alleged that she was injured by implantation of the R3 Acetabular System. It’s important to the preemption discussion to know a little bit more about the device. The R3 System includes a liner component made of cross-linked polyethylene (non-metal). Id. at *6. The R3 System, with its non-metal liner, received §510(k) approval (“substantial equivalence”) from the FDA. Id. Defendant also manufacturers the Birmingham Hip Resurfacing (“BHR”) System — a separate PMA-approved device. The BHR System was designed to be used with a metal liner. As part of the BHR System, the metal liner also received PMA approval. Id. at *7. Plaintiff’s surgeon opted to implant the R3 System with the metal liner from the BHR System. Id. at *2.
Plaintiff alleged three causes of action: negligence, strict liability design defect, and breach of implied warranty. The court dismissed all three for roughly the same reasons. If the crux of plaintiff’s allegations are that her injury was caused by the R3 System as a whole – her complaint fails to state a claim. If she is alleging injury from the metal liner component alone – her claims are preempted.Continue Reading Hip Implant Litigation Part II – TwIqbal Plus Preemption
Today’s case comes with a lesson: don’t be easily discouraged from filing your TwIqbal motion. Consider it carefully, even if your case is part of a mass tort with a challenging background, including product recalls and FDA investigations. In fact, under those circumstances, it may be more important to scrutinize the plaintiff’s allegations. A filing
With Thanksgiving over, we move from the relatives to Relators. Not that those two topics are always so different. In some ways, they can be similar. Relatives sometimes complain. Relators always complain. Relatives can be loud. Relators blow big loud whistles. Relators hope to get a big chunk of change from their False Claims Act
Here’s a preemption case that we’ll likely have an opportunity continue to follow. A magistrate in North Carolina federal court recently issued a report recommending dismissal, on the basis of preemption, of product liability claims concerning the product Gelfoam. Bradley v. Baxter Healthcare Corp., 2013 U.S. Dist. LEXIS 158935 (W.D.N.C. Oct. 18, 2013). Gelfoam
Before there was reality television, there was a show about nothing. In one memorable episode of that show, the characters become enamored with purportedly non-fat frozen yogurt from a shop in which one character has invested.
When the characters notice that they have gained weight after regularly
consuming the frozen yogurt, the character who has invested takes some of the frozen yogurt to be tested for the presence of fat. After madcap hijinks ensue, the yogurt is determined to contain fat and the Mayor of New York, who also favored the frozen yogurt and believes he has developed high cholesterol, vows to clamp down on false advertising. That was “Seinfeld” and the investor, Kramer, lost his money as millions laughed.
In Burke v. Weight Watchers Int’l, Inc., No. 2:12-06742 (WJM), 2013 U.S. Dist. LEXIS 149249 (D.N.J. Oct. 17, 2013), the plaintiff used to like defendant’s diet ice cream bars—at least some of them—until she learned that each one might have 28 to 50 more calories than was listed on the package. So, she sued as a putative class representative for all consumers of all of defendant’s diet ice cream ban under the New Jersey Consumer Fraud Act, express warranty, implied warranty, and unjust enrichment. She will get at least one more chance to plead non-preempted claims, perhaps by shifting her focus to allegations based on how diet ice cream bars taste compared to real ice cream. The Häagen Dazs dulce split Dazzler surely trounces the defendant’s Dark Chocolate Dulcé de Leché Ice Cream Bar (one of the ones plaintiff sued over but did not buy)–no matter how many hundreds of additional calories the former actually has, it is worth it for those not vulnerable to a diabetic coma.
Continue Reading Do We All Scream For Diet Ice Cream?