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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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If, like this blogger, you had small children in the early 2000s, subconsciously you may have read today’s title with a Scottish brogue.  That’s because it might recall a scene from Shrek where Mike Myers (Shrek) and Eddie Murphy (Donkey) are having a philosophical conversation about the many and varied attributes of ogres.  “Ogres are

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A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a permanent contraception implant, was among those products. The standard claim is that the Essure implant can cause women to suffer pelvic pain, blood clots, and various other injuries. A plaintiff lawyer at the conference recounted (from a certain point of view) the Essure development and medical stories, concluding that Essure would be a “slam dunk … if not for the fact that it is a PMA product.”

Aye, there’s the rub. Essure is, indeed, a medical device that went through, and passed, the FDA’s rigorous Pre-Market Approval process. PMA approval means that almost all product liability theories are preempted by federal law. If state law, including jury verdicts, would impose any requirement different from, or in addition to, the FDCA, then such state law must yield. Consequently, tort claims against PMA products are difficult to sustain. Still, difficult is not the same as impossible. Plaintiff lawyers have tried all sorts of clever ways to circumvent PMA preemption. But clever is not the same as correct. Good for courts that can tell the difference.

Such a court issued the opinion in Norman v. Bayer Corp., 2016 U.S. Dist. LEXIS 96993 (D. Conn. July 26, 2016). As is typical, the complaint in that case covered the product liability waterfront, with claims for strict liability, negligent failure to warn, negligent training, negligent manufacturing, negligent misrepresentation, negligence per se, and breach of warranty. As is typical, the complaint devoted most of its girth to the generic development and medical stories alluded to above. In the 29 pages of the Norman complaint, “only four short paragraphs” related to the plaintiff and her experience with the product.Continue Reading Federal Court Dismisses Essure Complaint