Parallel Violation Claims

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Today we bring you another generally favorable Essure preemption decision.  Plaintiff brought three causes of action against the manufacturer and the court dismissed two of them.  So, in the immortal words of Jim Steinman as belted out by Marvin Lee Aday, we shouldn’t be sad because two out of three ain’t bad.  And one of the two is actually quite good.  So, we certainly aren’t crying icicles like Meat Loaf.  More like when we went looking for a ruby in a mountain of rocks, we came up with a sapphire instead.   

We’ve written about Essure cases over the years, like here and here.  And in many ways Ortiz v. Bayer Corp., 2022 U.S. Dist. LEXIS 226472 (E.D.N.Y. Dec. 13, 2022), is not much different.  Plaintiff alleged injuries from a permanent contraceptive device and brought claims for failure to train, manufacturing defect, and breach of express warranty.  The types of claims that sometimes skirt around the twin guards of PMA preemption—Riegel express preemption and Buckman implied preemption.  The court dismissed the training and warranty claims but ruled plaintiff did enough at the pleadings stage to keep her manufacturing defect claim.

The failure to train warning took a double hit as both expressly and impliedly preempted.  First, to the extent plaintiff demanded training beyond what the FDA requires, they were asking the state to impose an obligation on defendants that was “different from or in addition to” federal requirements and therefore was expressly preempted.  Id. at *10.  That left plaintiff’s argument that they were pursuing a “parallel” claim that defendants breached a purported duty to train under New York law.  But the court ruled that a general negligent undertaking claim under state law falls short of any “clearly articulated state law duty or cause of action to parallel the federal training requirements.”  Id. at *11.  That’s a useful aspect of the preemption argument that negligent undertaking claims are too broad to be genuinely equivalent to a specific FDA physician training obligation. 

Continue Reading Two Out of Three Ain’t Bad

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Product liability litigation over Class III medical devices is an interesting creature.  Absent something unusual, cases and litigations should not get past motions to dismiss.  That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976.  We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption.  (We do not really think the plaintiff lawyers think that, although they sure argue it enough.)  But the usual is more common than the unusual by definition.  When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo.  When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations.  An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman.  We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology.  Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse.  The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.

Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist.  After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA.  (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name.  In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.”  These are usually signs that at least one claim will survive summary judgment.)  A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.

Continue Reading Fallacious FDA Reporting Claim Finally Falls

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Bexis has just submitted revisions and updates to Chapter 4 of his treatise, Drug and Medical Device Product Liability Deskbook.  Chapter 4 is “The Federal Framework,” and one of the topics it covers is the use of claimed FDCA violations as the basis for state-law claims, including, most prominently, negligence per se.  Bexis addresses in depth a number of non-FDCA-based common-law defenses to negligence per se: (1) consistency with legislative intent; (2) the force-of-law requirement; (3) prohibition on creation of novel tort duties; (4) inapplicability of licensing statutes; (5) requirement of a specific standard; and (6) causation issues.  That means Bexis has been reading a lot (hundreds) of recent non-FDCA negligence per se cases, involving everything from traffic accidents to firearms to data breaches.

Continue Reading On Pleading Negligence Per Se

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As we write this, our firm’s “return to office” date is less than two weeks away.  We will be delighted to see, hug, and collaborate in person with colleagues we’ve missed for two long years (computer visages notwithstanding), though we confess to panic at the prospect of “real clothes.” And shoes.  It’s all a bit

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Some product liability cases are so bad they won’t fly even in California.  Gall v. Smith & Nephew, Inc., ___ Cal. Rptr.3d ___, 2021 WL 5027197 (Cal. App. Oct. 29, 2021), is one of those.  Plaintiff alleged that the defendant inadequately warned about the alleged risks of a hip implant, or alternatively that the

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There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease

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This blog is no stranger to the In re Smith & Nephew Birmingham HIP Resurfacing (BBR) HIP Implant Products Liability Litigation, MDL 2775, pending in the District of Maryland.  Nor have we hidden our disregard for several of its decisions, going back to its preemption ruling on defendant’s motion to dismiss which made our

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The plaintiff in Vesoulis v. Reshape Lifesciences, 2021 WL 1909725 (E.D. Louisiana May 12, 2021), was a dentist. So if he was complaining about pain and suffering, we’d step back and take notice. (Think of the Steve Martin song from the Little Shop of Horrors musical film.) The plaintiff certainly did have something