DRI Publishes Christopher Hurst’s Review of 2023 Product Liability Case Law from within the First Circuit

Federal law impliedly preempts state law claim that drug manufacturer should have warned of animal studies and possible link to birth defects.

In re: Zofran (Ondanestron) Prods. Liab. Litig., 57 F.4th 327 (1st Cir. 2023)

The First Circuit Court of Appeals affirmed the district court's grant of summary judgment for a drug manufacturer where the MDL plaintiffs claimed that the manufacturer should have warned prescribing doctors and pregnant women of a possible link to birth defects. 

The district court held that the claim was preempted because federal law prohibited plaintiffs' proposed drug label changes and the First Circuit affirmed. The women took the drug off-label to treat pregnancy - related nausea and vomiting.

Applying recent Supreme Court precedent, Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019), the First Circuit held that the plaintiffs' proposed warning, that "animal studies showed harm to the fetus when Zofran was ingested during pregnancy," was preempted because compliance with both plaintiffs' proposed drug label changes and with federal law was impossible, and that the manufacturer had satisfied the necessary elements of its preemption affirmative defense as a matter of law.

The First Circuit rejected plaintiffs' argument that the manufacturer could have invoked the FDA's Changes Being Effected ("CBE") procedure, which allows manufacturers unilaterally to amend an FDA-approved label and to seek after-the-fact approval for the change from the FDA. The CBE procedure is one of four pathways for the drug manufacturer, citizens, or the FDA itself to make changes to a drug's label. 

Manufacturers may use the CBE procedure "to reflect newly acquired information."  The plaintiffs argued that three Japanese animal studies, which the manufacturer did not originally submit to the FDA as part of the new drug approval process, were sufficient "newly acquired information." The First Circuit held that the three animal studies were not "newly acquired" as a matter of law because the studies were not meaningfully different than other studies which the manufacturer submitted as part of the drug approval process. The three animal studies did not meet the definition of "newly acquired information," which is information that "reveal[s] risks of a different type or greater severity or frequency than previously included in submissions to FDA."  

The First Circuit found unpersuasive the opinion of plaintiffs’ regulatory expert, a former FDA official, that the Japanese animal studies constituted newly acquired information. The court noted that the expert's opinion is "likely inadmissible" because the question of whether the studies constitute newly acquired information is a question of law and expert testimony on questions of law "is rarely admissible." Thus, the court concluded that there was insufficient evidence of newly acquired information to justify invoking the CBE procedure.

The First Circuit further held that even if the non-disclosed animal studies constituted "newly acquired information" based on which the manufacture could have invoked the CBE procedure, the FDA would have rejected plaintiffs' proposed change. Applying Albrecht, the First Circuit found that there was "clear evidence" that the FDA would have rejected the proposed changes because in 2021, after the three Japanese animal studies had been disclosed to the FDA, the FDA approved a revised label on the drug that stated that animal data revealed "no significant effect . . . on the maternal animals or the development of the offspring." 

The court reasoned that "when the FDA formally approves a label stating one thing with full and obvious notice of the directly contrary position, one can read the approval as rejecting the contrary position." Therefore, there was clear evidence that the FDA would have rejected plaintiffs' proposed warning, and the district court properly awarded summary judgment.

Personal Jurisdiction: "relatedness" prong not satisfied where forum resident plaintiff eats contaminated food out of state but does not become ill from food poisoning until returning home to forum the next day; the relatedness doctrine still has teeth following the U.S. Supreme Court's 2021 Ford Decision

Capello v. Restaurant Depot, LLC, 21-cv-356-SE, 2023 WL 2588110 (D.N.H. Mar. 21, 2023) (appeal pending before First Circuit)

The plaintiff, a New Hampshire resident, purchased and ate a salad from a restaurant in New Jersey. The restaurant prepared the salad using romaine that was distributed by the defendant California corporation.  The plaintiff became ill the next day after he returned home to New Hampshire.  The defendant distributes romaine products to major New England distributor and grocery stores with knowledge that its products will then be sold in New Hampshire.

The district court dismissed the plaintiff's complaint for lack of personal jurisdiction because the plaintiff could not meet his burden under the relatedness prong of the specific personal jurisdiction analysis. 

The district court rejected the plaintiff's argument that he could establish relatedness under the "more relaxed" standard of Ford Motor Co. v. Montana Eighth Judicial Dist. Court, 141 S. Ct. 1017, 1022 (2021). In Ford, the court held that the relatedness doctrine was satisfied because the plaintiffs were forum residents who were injured in the forum, and the defendant served a market for the vehicles in the forum, even though the defendant did not sell the plaintiff's particular vehicles in the forum.  

The plaintiff tried unsuccessfully to frame his jurisdictional facts within the framework of Ford, arguing that because of incubation periods, his injury actually occurred in-forum, like the Ford plaintiffs, not in New Jersey where he consumed the salad. 

The court rejected that argument, reasoning that "a jurisdictional rule driven by the length of an incubation period would be difficult to employ. It could result in a court concluding that a food-poisoning injury occurred in a state a plaintiff passed through only briefly as he traveled from the location of ingestion to his final destination. 

A court could do so only after it received and considered evidence regarding the bacteria's precise incubation period in a particular plaintiff." The court further reasoned that the plaintiff had offered "no legal justification for pinning the injury at the moment of the onset of symptoms rather than at the moment of consumption." An appeal of the decision remains pending before the First Circuit and will be argued December 6, 2023.

Toxic torts: summary judgment granted under admiralty law in asbestos case

McIsaac v. Air & Liquid Sys. Corp., 19010282-NMG, 2023 WL 4409516 (D. Mass. July 7, 2023)

Plaintiff alleged that her decedent was exposed to asbestos during his Navy service. The district court granted summary judgment for the defendant pump manufacturer for lack of sufficient product identification under admiralty law. 

The plaintiff's decedent died before being deposed, and the plaintiff's product identification evidence consisted of records demonstrating that the defendant's pumps were present on two ships that the plaintiff's decedent worked on, and the testimony of one of the decedent's former co-workers. 

The co-worker testified that he worked with the plaintiff's decedent on one or both ships, but that he could not recall the brand name or manufacturer of the pumps that they worked on together. 

Applying maritime law, the district court ruled that the plaintiff had failed to proffer sufficient facts to show that the decedent had a "high enough level of exposure" to the defendant's products to show that they were a substantial factor in causing his mesothelioma; the mere fact that the defendant's products were present somewhere at the place of work was not enough.

PFAS: denial of motion to dismiss failure to warn and strict products liability claims against paper mill suppliers

Higgins v. Huhtamaki, Inc., 1:21-cv-00369-JCN, 2023 WL 6516538 (D. Me. Oct. 5, 2023)

The Maine plaintiffs alleged that their groundwater wells were contaminated with PFAS by a paper mill operator and three chemical companies that supplied chemicals to the paper mill. The supplier defendants' motion to dismiss was denied. The district court ruled that the plaintiffs had sufficiently alleged that the supplier defendants had a duty to warn the paper mill of the risks associated with PFAS, and that their injury was proximately caused by the failure to warn. 

The district court rejected the supplier defendants’ argument that the learned intermediary/sophisticated user doctrine barred plaintiffs' failure to warn claim because the plaintiffs could plead in the alternative that both the paper mill and the suppliers had a duty to warn and knew or should have known of the dangers of releasing residuals containing PFAS.  

The district court also rejected the defendants' argument that disposal of a product is not an intended use, noting that the defendants had cited no Maine case applying the intended use element, and that Maine law only required that "a plaintiff might reasonably have been expected to use, consume, or be affected by the product, which would cove foreseeable uses rather than limiting liability only to those uses that the manufacturer intended."

December 31, 2023