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We’ve pointed out several times recently (and will be pointing out in an ACI presentation today) that cases against over the counter (OTC) drugs are on the uptick. Why?  Here’s our theory: there are lots of OTC consumers, hence lots of potential plaintiffs, and there are no pesky learned intermediaries, which means that plaintiffs can

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Bischoff v. Albertsons Co., 2023 U.S. Dist. LEXIS109367 (SDNY June 26, 2023), is another favorable preemption ruling in the current spate of class action strike suits attacking “rapid release” over-the-counter (OTC) products, here acetaminophen, that were marketed in conformity with FDA regulations.  

The plaintiff claimed that she purchased a generic form of “rapid release”

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By the time of a Fourth Amended Complaint, a plaintiff is bound to get things right, right?  Wrong.  In Greenwood v. Arthrex, Inc. et al., 2023 WL 3570436,(W.D.N.Y. May 19, 2023), the plaintiff claimed that a medical device burned her during surgery.  She filed one, two, three, four, and, ultimately, five complaints under New

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We know the real quote attributable to Bill Gates is “content is king,”  But as communications continue to become shorter and more compressed, context can get lost in the shuffle; and context as much as content, drives our knowledge and interactions.  So, when the court in Henry v. Nissin Foods (U.S.A.) Co., opined that

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Second chances, sure.  Two bites at the apple, we see it all the time.  Three strikes before you are out, fairly common.  But a fourth amended complaint to cure basic pleading deficiencies?  That seems overly generous by any standards.  Well, almost any standards because that is what plaintiff got in Greenwood v. Arthrex, Inc.

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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