As insightful and modest as the Blog can be, we are not infallible. Every once in a while, two posts get written on the same decision, sometimes because we try to make sure a new post goes up every non-holiday weekday of the year. Because of the aforementioned modesty, however, we are hesitant to deprive our readers of our insights. So, we present two posts in one, the latter of which overlaps some with a prior post by a new Blog contributor. As different as the two underlying cases and decisions are, there are some common themes between them. For one, some types of litigation seem to last longer than you might expect with different plaintiffs trying the same thing over and over, regardless of success. For another, even legal principles that seem like bedrock can erode, so results can change. We start with the newer decision.
The More Things Change
Pelvic mesh litigation has been going on for more than a decade. The MDL in which Hinton v. Boston Sci. Corp., — F. Supp. 3d –, 2024 WL 328873 (D. Mass. Jan. 29, 2024), would have been pending if filed sooner was opened back in 2012. The pelvic mesh litigation was largely driven by regulatory actions related to pelvic organ prolapse devices, but most of the cases involve sling devices to treat stress urinary incontinence. Even after it was clear that the slings had favorable evidence on risk-benefit and would not be subject to the same “up-regulation” as the pelvic organ prolapse mesh devices, the sling cases continued, in part because doctors kept using their best judgment to implant slings in patients. In Hinton, the plaintiff’s sling was implanted in August 2019, after pretty much all the relevant FDA actions on pelvic mesh devices. She allegedly suffered pelvic pain, had an explant within two months of implant, and sued in the defendant manufacturer’s local federal court within another four years. As we have detailed many times (like here and here), the defendants have been doing better in these sorts of cases in the non-MDL courts, either on remand from an MDL or with direct filing post-MDL closure.
The Hinton plaintiff asserted the typical multiplicity of claims under Arkansas law. Defendant’s motion to dismiss targeted only the manufacturing defect and warnings claims, probably because experience showed the other claims could survive, at least until summary judgment. For manufacturing defect, Arkansas follows the same principle as many states in requiring that the plaintiff’s particular product “deviat[ed] from the norm,” which means that the released product was different than it was supposed to be per design and manufacturing specifications. We are not saying plaintiffs in medical device cases can never plead a legitimate manufacturing defect claim, but attempts to push through repackaged design claims are far more common. That was the case in Hinton and the court did not fall for it. Saying the product’s design creates a propensity to malfunction is, at best, a design defect allegation. Id. at *1.
Plaintiff also tried the old res ipsa loquitur argument that fails about as often. As the court noted, citing an Arkansas Supreme Court case that follows the general rule, “Strictly speaking . . . res ipsa loquitur has no application to strict liability.” Id. at n.1. It sure does not apply to complicated allegations about mesh degradation—as made up and plainly inapplicable in a two-month implant case as they are—and other alleged mechanisms for pain with an implanted sling because res ipsa only applies when jurors can assess it based on their “everyday experience.” Id. at *2. Plaintiff also did not plead how her pain could only have been from a manufacturing defect. Id. In other words, plaintiff was done in by simultaneously over pleading general theories and under pleading specific facts.
On the warranty claims, Arkansas requires pre-suit notice and, of course, plaintiff did not provide any. She tried to claim that the statutory pre-suit notice requirement applies to buyers, and she was a mere third-party beneficiary of a contract between the manufacturer and her physician. Not surprisingly, her complaint had claimed she was the purchaser of the product and in privity with the manufacturer, another requirement that plaintiffs typically fail in implanted medical device cases. Id. In any event, Arkansas federal courts had already rejected the same arguments in hernia mesh cases. Bringing the case away from Arkansas—perhaps expecting a more plaintiff-friendly venue—would not change the result. Id. at *3 (noting that the forum shopping plaintiff “cannot expect that new trails will be blazed”).
Of Puppets And Standing
On this Blog, we have been known to quote all sorts of fictional characters, usually in a strained attempt to be funny or witty. We have also tried to highlight when courts break from the typically staid language of written decisions to their own forays into humorous snark. (A tip: A judge’s joke is always funny in his or her presence. Pro tip: Laughing on the inside is typically insufficient to show an appreciation of the humor.) However, we cannot recall a court’s deadpan delivery (as we read it) of statements about a puppet as if was an actual sentient being. There are a few ironies in this discussion coming out of the Fifth Circuit’s decision in Children’s Health Defense v. FDA, No. 23-51067, 2024 WL 244938 (5th Cir. Jan. 23, 2024) (“CHD”), in the context of a ruling on standing. For one, the Fifth Circuit made a mockery of standing in a well-publicized decision from August 2023. For another, if we were to look for humor in a federal appellate decision, the Fifth Circuit might be the last place we look. In addition, the decision affirmed the dismissal of a case against FDA over orders related to pediatric authorizations for two COVID vaccines. Perhaps most importantly, the puppet being discussed is Elmo, decidedly the least funny of all Sesame Street characters. Not to get too controversial here, but Oscar the Grouch, Cookie Monster, Grover, and even Snuffleupagus run comedic circles around Elmo. (Note that we wrote this before Elmo became a mental health advocate of sorts; that does not change our view of the character’s comedic abilities.)
A year ago, we marveled that litigation over COVID vaccine policies was still on-going. CHD is more about non-existent policies than actual policies, but, over the course of two years, it meandered up to affirmance in the Fifth Circuit after dismissal in the Western District of Texas. The named plaintiff was an entity apparently created by parents in Texas to bring the lawsuit, which was joined by some individual Texas plaintiffs and later some from North Carolina. They sued FDA after the rejection of a May 2021 petition to FDA over what were then pretty limited pediatric vaccine authorizations. In terms of legal particulars, the suit was grounded in the Administrative Procedures Act and standing was based on the alleged risk that the plaintiffs’ minor children would be vaccinated without their consent or feel marginalized by big red bullies like Elmo for not getting vaccines. Under traditional standing principles articulated by the Supreme Court and the all the circuits, these plaintiffs had no real shot at standing. But, in these courts, with this defendant, and with this subject matter, perhaps the standing bar might be lower. Under other circumstances, the fact that the Fifth Circuit issued an unpublished per curiam decision affirming a dismissal while applying the typical personal jurisdiction standards would not merit a post. Here, we think it did, in part because AHM (a.k.a., Hippo) was not mentioned in CHD.
After the declaration of a public health emergency for what would become the COVID-19 pandemic, FDA issued emergency use authorizations for a Pfizer/BioNTech vaccine for people sixteen and up and for a Moderna vaccine for people eighteen and up. Some of the following dates are a bit fuzzy because of gaps in CHD, but this is the rough chronology of what followed in regards to the operative facts of CHD: 1) in May 2021, FDA expanded the Pfizer authorization to cover individuals twelve and up, 2) that month, the newly minted CHD petitioned FDA to undo the authorizations for the vaccines or at least the pediatric use portion of them, 3) FDA expanded the Pfizer authorization to cover individuals five and up, 4) FDA denied the petition, 5) CHD and some Texans sued in January 2022, and 6) in June 2022, FDA expanded both the Pfizer and Moderna authorizations to cover individuals six months and up. Nowhere in that chronology is the enactment of a federal, state, or local law authorizing the vaccination of any of plaintiffs’ minor children—whose ages are not specified in CHD—without parental consent. We have thus far omitted the key fact: On a date not specified in CHD, Sesame Workshop “released a YouTube video announcing that Elmo had gotten the COVID-19 vaccine.” 2024 WL 244938, *2.
This video was part of plaintiffs’ claim that their children had an injury in fact, the key to standing. Per the following footnote, it appears that the panel watched the video, although perhaps the plaintiffs did not.
Plaintiffs allege that Elmo sent the message that children will “get sick if [they] don’t take the COVID-19 vaccine.” In doing so, Plaintiffs rely on a video that suggests otherwise. See Sesame Street: Elmo Gets the COVID-19 Vaccine, Sesame Street, available at https://www.youtube.com/watch?v=bwimt9n2JEk. In the video, Elmo’s father states that: “I had a lot of questions about Elmo getting the COVID vaccine. Was it safe? Was it the right decision? I talked to our pediatrician so I could make the right choice. I learned that Elmo getting vaccinated is the best way to keep himself, our friends, neighbors and everyone else healthy and enjoying the things they love.” Id. Further, the video explains that “it’s okay to have questions about the COVID-19 vaccine for your kids. Get the latest facts by speaking with your pediatrician or healthcare provider.” Id.
Id. at n.3. We hope that the thoughts of the panel watching the video, with or without the transcript feature, and a clerk typing “Elmo’s father states” tickle you as much as they do us. More substantively, the idea that a video with puppets delivering a message that parents should talk to their children’s pediatricians in making a decision on vaccination helped create an injury in fact was laughable. “[T]hat a third party might harass their children for being unvaccinated, [or] that their children may be exposed to pro-vaccine messaging” were “hypothetical dangers  untethered to the law.” Id. at *4. Standing cannot be based on an alleged “psychological consequence produced by observation of conduct with which one disagrees.” Id. (internal citation and punctuation omitted). Without discussing anything in the In re: Social Media Adolescent Addiction/Personal Injury Products Liability Litigation MDL, we can say that taking offense at content on social media is part and parcel of social media and not a legitimate basis for standing.
Even if Elmo and pals created an injury in fact, it did not provide standing to sue FDA over its vaccine authorizations. Id. Recall that CHD’s petition to FDA, the denial of which spurred the suit, complained of authorizations that covered usage in people twelve and up. Thus, plaintiffs’ minor children implicated by the authorizations presumably no longer watched Elmo videos or at least did so with a healthy dose of tween/teen skepticism. Also, the Elmo video was apparently posted in June 2022 (per the internet, not the CHD decision). It certainly could not have been a basis for standing when the suit was filed five months earlier. The same disconnect was seen in plaintiffs’ other injury theory, which related to the possibility that their minor children might be vaccinated with their consent. This could not possibly meet the standards articulated in Clapper v. Amnesty Int’l USA, 568 U.S. 398 (2013), that injuries in fact could not be based on “allegations of possible future injury” unless it is shown that a concrete injury is “certainly impending.” Id. at *3. Here, at best, the plaintiffs alleged that “some hypothetical third party might, at some hypothetical point in the future and through some hypothetical means,  vaccinate their children against their wishes.” Id. at *3. Particularly given that the state law where these plaintiffs (and presumably their minor children) lived prohibited vaccination without parental consent, this was too speculative an injury to bestow standing.
Even setting aside suits like AHM, which may become more popular depending on what the Supreme Court does, ensuring the application of traditional, tight constitutional limits on standing matters to drug and device companies. For one thing, they do use social media and even something called “television” to provide information about their products. Someone who merely takes offense or claims to suffer “psychological consequence produced by observation of [the manufacturer’s information] with which one disagrees” should not have standing. For another, a deterioration of the injury in fact requirement for standing could open the door to expanded litigation over “fear” claims, claims based on alleged risk of future injury, and other product liability theories without a tangible current physical injury. It is nice to see the Fifth Circuit reiterate the traditional, pre-AHM standing standards. The Sesame Street stuff was just a bonus.