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.
The court, relying on a wealth of precedent, also quickly dismissed plaintiff’s express warranty claim as expressly preempted because allowing the claim “would require persuading a jury that Essure was not safe and effective, a finding that would be contrary to the FDA’s approval.” Id. at *17.
That leaves the one dark spot in the decision—manufacturing defect. The court found the claim was not preempted because plaintiff alleged that defendants “deviated from the FDA manufacturing standards.” Id. at *11-12. What those specific manufacturing standards that were purportedly violated are does not appear to have been sufficiently pleaded, at least not in the portion of the complaint cited in the opinion. Instead, plaintiff gets away with “laundry-list”-type allegations of possible modes of device failure. Id. at *13-14 n.3. The court acknowledged that the complaint only included “general allegations for how specific alleged manufacturing defects may have violated FDCA specifications.” But it was apparently willing to overlook that deficiency because plaintiff’s allegations of potential defects adequately pleaded “concerns that the devices did not comply with manufacturing requirements.” Id. at *16. Unsupported ”concerns” should not meet the TwIqbal standard, but they did here and the claim survived.
Ortiz may not be a Coupe de Ville at the bottom of a Cracker Jack box, but we’ll take two out of three wins any day.