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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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On Monday, Bexis blogged about a very bad vaccination decision — bad in its reasoning and bad in its maleficent effect on vaccine policy in this country.  Over the past couple of years, we’ve written quite a few posts on vaccination cases. The law in this area has gotten a vigorous workout largely because of Covid-19, of course.  That particular vaccine became a subject of massive political debate for reasons that seem entirely stupid to us. 

Why stupid?  Let us count the ways.  First, the biggest vaccine haters are often supporters of the former President, whose administration did a lot to hasten development of the Covid vaccine.  Second, the distrust of the Covid vaccine is largely premised on ignorance and conspiracy mongering.  Third, the claims that Covid vaccine mandates undermine the Bill of Rights not only ignore logic, they ignore clear precedents involving other vaccines. 

Indeed, we think that observing the treatment of other vaccines, free of the fog of political warfare, might help clarify thinking on vaccine mandates.  Perhaps people can at least doff their tin foil hats temporarily.  

In Goe v. Zucker, 43 F.4th 19 (2d Cir. 2022), the Second Circuit reviewed a proposed class action challenging the scope of medical exemptions to New York’s mandatory school immunization requirements.  Prior to June 2019, New York allowed exemptions from the immunization requirements for both nonmedical and medical reasons. But after a big measles outbreak, New York repealed the nonmedical exemption (as we said in our vaccine post last week: yay) and clarified the medical exemption.  The plaintiffs filed a lawsuit, contending that the new vaccine regulations violated their fourteenth amendment due process rights, as well as section 504 of the Rehabilitation Act, 29 USC section 794.  The district court dismissed the complaint and the plaintiffs appealed to the Second Circuit.  

Continue Reading Second Circuit Upholds New York Measles Vaccine Mandate

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Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq.  That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere.  After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing.  The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.

Continue Reading Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

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The recent defense win in Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), demonstrates why many plaintiff-side counsel are well-advised to steer away from cases involving PMA medical devices.  Between federal preemption and TwIqbal, not one of the plaintiff’s “seventeen separately enumerated causes of action” escaped the defendant’s motion to dismiss.  Id. at *3.

Continue Reading Preemption and Pleading Send Plaintiff Packing

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It’s the start of cold and flu season, so why not talk about cough syrup.  Most cough medicines come in two versions – daytime and nighttime.  The nighttime version typically contains an antihistamine which are known to cause drowsiness.  Daytime versions often contain an expectorant (to thin and loosen mucus) and a cough suppressant.  A common cough suppressant is dextromethorphan hydrobromide (DXM).  That is the ingredient at issue in Goldstein v. Walmart, Inc., 2022 U.S. Dist LEXIS 196743 (S.D.N.Y. Oct. 28, 2022). 

Walmart sells its own brand of OTC cough medicine containing DXM and the label says “Non-Drowsy.”  Plaintiff alleges she relied on that statement in selecting the medicine and she became unexpectedly drowsy after taking it.  She filed a putative class action alleging breach of express warranty, breach of the Magnuson-Moss Warranty Act, and violations of various state consumer protection laws.  Defendants moved to dismiss all claims as preempted.

The federal regulations governing OTC medicines are found in monographs which are promulgated by the FDA and set the approved active ingredients for a class of drugs as well as any conditions under which they are considered safe and effective.  Id. at *7-8.  There is a monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic drugs.  It requires certain products in this class to carry a warning that the drug may cause drowsiness.  DXM is not one of them.  Id. at *8. 

The FDCA has an express preemption clause for OTC drugs – requirements that are “different from or in addition to” or “not otherwise identical with” the FDCA are preempted.  Product liability claims have an exception, but this is not a products case.  The opinion does a thorough walk through of the relevant case law.  Id. at *21-31.  Plaintiff tried to squeeze her claims through a small gap in the preemption window: “preemption does not preclude a state-law claim if the state requirement is outside the scope of the relevant federal requirements.”  Id. at *23.  Courts within the Southern District of New York have approached the scope question and reached slightly different conclusions. 

Continue Reading Southern District of New York Puts Non-Drowsy Labeling Claims To Bed

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Fraud via omission of facts is a popular plaintiff lawsuit theory, but many of those lawsuits themselves suffer from the omission of plausibility and specificity.  In Womack v. Evol Nutrition Assocs., 2022 U.S. Dist. LEXIS 145754 (N.D.N.Y. Aug. 16, 2022), the plaintiff filed a purported class action alleging that a manufacturer of energy drinks failed