From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices, dietary supplements, cosmetics and other FDA-regulated products, it is often helpful to step back and review holdings that have affected the industry and may shape the years ahead.

In this article, senior partner Judi Abbott Curry reviews, analyzes and shares potential implications for future life science cases, based on several key judicial holdings in New York in 2023 pertaining to:

• Pharmaceuticals – General causation and amended Rule 702
• Medical Devices – Class II and Class III preemption
• Class Actions – Plausibility, puffery and primary jurisdiction

Pharmaceuticals

Prescription Pharmaceuticals – General Causation of Autism
Daniels-Feasel v. Forest Pharms., Inc., 2023 U.S. App. LEXIS 19448, 2023 WL 4837521 (2d Cir. July 28, 2023)

Plaintiffs, a group of mothers who alleged they ingested Lexapro during pregnancy, brought product liability claims under state law regarding the effects of Lexapro, a prescription antidepressant medication in the therapeutic class of selective serotonin reuptake inhibitors (SSRIs), claiming their minor children developed autism spectrum disorder (ASD) because of their mothers' prenatal use of the drug. Plaintiffs appealed from a decision granting summary judgment for Defendant, after excluding from evidence the testimony of Plaintiffs' expert witnesses regarding the alleged causal relationship between Lexapro and ASD. To reach their causation conclusions, Plaintiffs’ experts synthesized literature examining prenatal SSRI use and ASD, (ostensibly) using a weight of the evidence methodology and applying the standard Bradford-Hill criteria. However, one expert categorically disregarded meta-analyses, and another expert “cherry-picked” only favorable studies to support his causal conclusion, did not rigorously explain the weight he attached to each Bradford-Hill factor and failed to consider the contrary evidence. The expert’s failure to explain whether each Bradford-Hill factor weighed in favor of general causation significantly hindered the replication and validation of the expert analysis. Several other experts offered opinions on biological possibility but not general causation, but biological plausibility alone is not enough to overcome Plaintiffs' general causation hurdle. Without expert testimony, Plaintiffs could not prove general causation, and summary judgment for Defendants was affirmed by the Second Circuit.

OTC Drugs – Expert Preclusion Under Amended Rule 702 of ASD/ADHD
In Re: Acetaminophen – ASD-ADHD Products Liability Litigation, 1:22-md-03043-DLC (S.D.N.Y. December 18, 2023)

In a multidistrict products liability litigation (MDL) alleging that the Defendants (manufacturer of Tylenol and retailers of store-branded acetaminophen products) violated their state law duties to warn consumers of the risk that children may develop autism ASD and/or ADHD as a result of in utero exposure to acetaminophen, Defendants’ motions to preclude the testimony of Plaintiffs’ general causation experts were granted, leaving Plaintiffs with no admissible evidence to demonstrate that prenatal exposure to acetaminophen causes either ASD or ADHD in offspring. Plaintiffs’ experts reviewed the body of scientific literature regarding in utero exposure to acetaminophen and its possible impact on neurodevelopment. However, they did not use that literature to render discrete opinions regarding that exposure and the risk of ASD and the risk of ADHD. Instead, they applied a “transdiagnostic” analysis that swept into their analyses (and conclusions) ASD, ADHD and other neurodevelopmental disorders. They failed to show this methodology is generally accepted by the scientific community. Such analyses, the court found, did not enlighten, but rather obfuscated, the weakness of the evidence on which these experts purported to rely and the contradictions in the research evaluated. The court applied the recently amended Rule 702 which now requires not only that an expert use “reliable principles and methods,” but also that “the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.” Assessing Plaintiffs’ experts’ opinions through the lens of the new Rule 702, Bradford-Hill criteria and the Daubert gate-keeping factors, the court determined there is no generally accepted scientific conclusion that in utero exposure to acetaminophen causes either ASD or ADHD and Defendants’ motions to exclude Plaintiffs’ experts’ general causation and biological plausibility opinions were granted.

PREP ACT - Liability Protections Continue Through 2024

While the U.S. Department of Health and Human Services has ended the COVID-19 public health emergency, PREP Act (Public Readiness and Emergency Preparedness Act, 42 U.S.C. 247d-6d) liability protections are still in place. HHS amended its PREP Act Declaration to extend liability protections for certain COVID-19 countermeasure activities beyond the May 11, 2023, end of the public health emergency. The PREP Act contains language which expressly preempts any state or local laws that are in conflict with HHS declarations, so that negligence, product liability and malpractice lawsuits or claims caused by, arising out of, relating to, or resulting from the manufacture, testing, development, distribution, administration, and use of a countermeasure, such as COVID vaccines, aimed at responding to the COVID-19 pandemic, are precluded. The 11th Amendment to the Declaration under the PREP Act for COVID-19 Medical Countermeasures extends PREP Act liability immunity through December 31, 2024, to all COVID-19 medical countermeasure activities provided through a federal agreement; for the manufacture, testing, development, distribution, administration and use of covered countermeasures, including vaccines and drugs licensed, cleared or approved by FDA to treat the coronavirus, and to health care providers including pharmacists, pharmacy interns and pharmacy technicians who administer COVID-19 and seasonal flu vaccines and COVID-19 tests, regardless of a federal agreement or emergency declaration.

Pharmaceuticals - Potential Implication for Future Cases:

In one of the first decisions to apply Amended Rule 702 to expert preclusion, New York’s Southern District noted the requirement that the expert’s opinion reflect a reliable application of principles and methods, along with the traditional Daubert gate-keeping factors and the generally accepted Bradford-Hill criteria, to assess general causation expert opinion evidence. Moreover, the Second Circuit confirms that a weight of the evidence methodology is not permission to cherry-pick the science that favors a Plaintiff’s case.

Medical Devices

Ortiz v. Bayer Corp., 2022 U.S. Dist. LEXIS 226472, 2022 WL 17817726 (E.D.N.Y. December 13, 2022) (Magistrate Report and Recommendation)

In a product liability litigation involving Class III pre-market approval (PMA) medical device Essure, a permanent female contraception which consists of two "micro-inserts" placed in a woman's fallopian tubes by a doctor, Defendants filed an F.R.C.P. 12(b)(6) motion to dismiss the amended complaint. The Count alleging “failure to train” was expressly preempted as it required Defendants to provide training or seek assurances from physicians regarding training that were greater than those required by the FDA, and it was impliedly preempted as there was no clearly articulated New York state law duty or cause of action to parallel the federal training requirements. The Count alleging Breach of Warranties through the use of journal articles, advertising media, and sales representatives to promote, encourage, and urge the use and purpose of the Essure device was expressly preempted by the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. The claims of manufacturing defect alleging that there were manufacturing defects in Plaintiff’s particular Essure device that caused the device to migrate, break, fracture, or deteriorate, and the claims that Defendants deviated from the FDA-approved design were not preempted. Claims which point to potential flaws with the device that, if proven, may show the device failed to comply with the design specifications for the device are not expressly or impliedly preempted.

Desch v. Merz N. Am., Inc., 2023 U.S. Dist. LEXIS 57618, 2023 WL 2734671 (E.D.N.Y. March 31, 2023)

Plaintiff was treated with Defendant’s Class II medical device, the Ulthera System, which uses ultrasound to provide a non-invasive alternative to face lifts. Plaintiff alleged that Defendants marketed their device for use on the entire face, despite receiving a denial of FDA clearance for that purpose. In determining whether the FDA's heightened de novo review process for certain types of Class II devices triggers the same express preemption that applies to Class III devices that receive PMA, the district court found Plaintiff's claims were not expressly preempted because the FDA's special controls document on which Defendants relied did not impose any specific requirements on the Ulthera System. However the court dismissed Plaintiff's strict liability, negligence and breach of implied warranty claims regarding an alleged manufacturing defect because Plaintiff's allegations were conclusory and failed to allege a specific product unit was defective as a result of some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction, instead alleging a failure to comply with federal current good manufacturing practice (CGMP's) requirements. The court also dismissed Plaintiff's claims to the extent they were based on Defendants' alleged off-label marketing promoting the use of the Ulthera System for the "full face." Even though the FDA declined to clear Defendants' marketing of the Ulthera System for this particular use, as the Supreme Court in Buckman explained, the FDA, rather than private plaintiffs, is responsible for deciding whether to enforce prohibitions related to off-label promotion. See Buckman v. Co. v. Plaintiffs’ Legal Committee 531 U.S. 341, 349-50 (2001). Plaintiff's failure to warn claims survived to the extent they were based on Defendants' alleged failure to warn the medical community at large, and withhold from the FDA, information about adverse events.

Medical Devices- Potential Implication for Future Cases:

Once again, New York courts recognize that “failure to train” is not a cognizable cause of action under New York medical device product liability law, and in fact such claims may be preempted under statutory laws. Likewise, off-label marketing and promotion claims may be preempted under Buckman. Complaints of manufacturing defect which fail to allege a specific product unit was defective as a result of some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction are insufficient to state a claim under New York law.

Class Actions

Class Actions – Primary Jurisdiction for Tainted Baby Food
In Re Beech-Nut Nutrition Food Co. Baby Food Litigation, 651 F. Supp. 3d 629 (N.D.N.Y. 2023), appeal filed by Thomas v. Beech-Nut Nutrition Co. (2d Cir. February 22, 2023)

A 70-count consolidated amended class action complaint alleging breach of warranties, fraud, negligent misrepresentations, and unlawful business practices related to baby food products which plaintiffs alleged contained certain toxic heavy metals, was prompted by the government’s release of a report titled “Baby Foods are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury.” In direct response to the report, the FDA informed the public that testing showed children were not at an immediate health risk from exposure to toxic elements in foods. FDA announced an action plan with measures FDA will take over time to reduce the presence of arsenic, lead, cadmium, and mercury, which can naturally appear in baby food due to environmental factors. Although Defendant recalled certain rice cereal products, Plaintiffs alleged Beech-Nut’s recall was incomplete and it continued to sell baby food products, in addition to its rice cereal products, containing dangerous levels of toxic heavy metals. In its F.R.C.P. 12(b)(1) and (6) motion for dismissal of the complaint, or, alternatively, for a stay in deference to the United States Food and Drug Administration’s primary jurisdiction, Defendant argued FDA, not the court through this class action, properly had jurisdiction over the regulation of heavy metals in baby food. The court agreed that dismissal on this ground was proper under the primary jurisdiction doctrine, weighing the Second Circuit’s so-called Ellis factors. Even though the parties had not made any previous application to the FDA on the issues before the court, and applying the primary jurisdiction doctrine would necessarily delay Plaintiffs’ case, resolution of Plaintiffs’ claims depended upon technical and policy considerations within the FDA’s field of expertise, food safety standards within the FDA’s authority and discretion, and there was a substantial danger of inconsistent rulings if individual courts made determinations regarding heavy metals. See Ellis v. Tribune Television Co., 443 F.3d 71, 82-83 (2d Cir. 2006).

Class Actions - Dietary Supplement Labeling
Baines v. Nature's Bounty (NY) Inc., 2023 U.S. App. LEXIS 32630, 2023 WL 8538175 (2d Cir. December 11, 2023)

On appeal, Second Circuit found it was too early in the litigation to determine if Plaintiffs’ claims were preempted because federal law requires the product to bear the name “fish oil,” as technical and scientific information was needed (typically not submitted in a pre-answer motion to dismiss). However, reasonable consumers would not be misled by labeling of the fish oil product as fish oil, where Plaintiffs alleged that Defendants’ product is no longer fish oil because it had undergone a transformation at a molecular level. It was not plausible that consumers who purchased Defendants’ product were actually thinking about the molecular form of their fish oil-derived omega-3s at all. Plaintiffs did not plausibly allege that the clarifying information on the back label contradicted the representations on the front label. Taking into account the entirety of Defendants’ labeling, to the extent the front label left any ambiguity about the contents of the product, the back label provided sufficient clarification. But see Rodriquez v. Target Corp., 2022 U.S. Dist. LEXIS 233767, 2022 WL 18027615 (S.D.N.Y. December 30, 2022) (amended complaint plausibly and sufficiently alleged that the label, which called the product "100% Wild Alaskan 1000 mg Fish Oil," but which Plaintiffs asserted was not natural fish oil, was literally untrue.)

Class Actions – Puffery on Pain Reliever Labels
Rodriguez v. Walmart Inc., 2023 U.S. Dist. LEXIS 53253, 2023 WL 2664134 (S.D.N.Y. March 28, 2023)

In a purported class action, consumers of lidocaine patches and creams claimed violation of New York General Business Law §§ 349 and 350, alleging Defendant falsely represented the packaging of the products in that they deliver a "maximum strength" dose of lidocaine and with respect to the patches, function as a "stay-put flexible patch" that "lasts up to 12 hours." It was plausible that a reasonable consumer would understand "maximum strength" to mean the patch product contained the maximum amount of lidocaine available on the market for that type of product. Plaintiffs plausibly alleged other products on the market delivered a higher dose than Defendant's products. Defendant asserted that "stay-put flexible patch" is non-actionable puffery and that "lasts up to 12 hours" is not materially misleading or a guarantee, but the question of whether "stay-put flexible patch" is non-actionable (objective) puffery could not be resolved at the motion to dismiss stage. Because it is plausible that a reasonable consumer would be misled by Defendant's labels and omissions relating to the "stay-put flexible patch" and "up to 12 hours" labels, Plaintiffs' GBL claims survived. See MacNaughton v. Young Living Essential Oils, LC, 67 F.4th 89, 97 (2d Cir. 2023) (“Once the statement is identified as both provable as false and plausible, a defendant can only prevail on the puffery defense after a fact-intensive inquiry on how a reasonable buyer would react. That inquiry cannot be resolved at the pleadings stage.”)

Class Actions – PFAS in Cosmetics
Onaka v. Shiseido Ams. Corp., 2023 U.S. Dist. LEXIS 53220, 2023 WL 2663877 (S.D.N.Y. Mar. 28, 2023)

In a claim involving per- and polyfluoroalkyl substances (PFAS) where Plaintiffs’ purported class action complaint alleged bareMinerals’ various cosmetic products contained so-called forever chemicals, the district court found the complaint was too vague to plausibly allege a connection between the claimed injury and the Plaintiffs, specifically if Plaintiffs had even purchased any PFAS-containing products. Plaintiffs alleged they sustained an economic injury by purchasing products labeled “clean” and “natural,” but which allegedly contained PFAS, and attempted to rely only upon their own testing and reports of PFAS in the industry to show the cosmetics they purchased contained PFAS. In dismissing the case based on lack of standing, the federal district court held that the complaint did not allege Plaintiffs tested any of their own purchases for PFAS. And as such, Plaintiffs’ claims were too speculative to confer standing. See also Brown v. Coty, Inc., 2023 U.S. Dist. LEXIS 54316, 2023 WL 2691581 (S.D.N.Y. March 29, 2023) (vague and speculative allegations that mascara cosmetic contained PFAS did not support plaintiff’s New York’s General Business Law, fraud, constructive fraud and unjust enrichment claims).

Class Actions – Sunscreen Label Clarifying Language
Richardson v. Edgewell Pers. Care, LLC, 2023 U.S. App. LEXIS 28725, 2023 WL 7130940 (2d Cir. October 30, 2023)

In a putative class action, Plaintiff alleged that Defendant Edgewell Personal Care, LLC engaged in false advertising and deceptive behavior by labeling its sunscreen products as “Reef Friendly” on the front label and “No Oxybenzone or Octinoxate” or “Hawaii Compliant: No Oxybenzone or Octinoxate” on the back label, even though the products contained other reef-harming ingredients. In its de novo review of the district court’s grant of a motion to dismiss under Rule 12(b)(6), the Second Circuit reversed and found the “Reef Friendly” front label could plausibly mislead a reasonable consumer into thinking the products contained no reef-harming ingredients and the back-label disclaimer was incomplete because it made no mention of the four other reef-harming ingredients found in the products. Taking the “Reef Friendly” and “No Oxybenzone or Octinoxate” or “Hawaii Compliant: No Oxybenzone or Octinoxate” labels together, a reasonable consumer could conclude that the only substances known to harm reefs were those listed in the back-label disclaimer. Such a disclaimer cannot be seen as “clarifying language” that may defeat a claim of deception. Plaintiff was not expected to look beyond misleading representations on the front label to discover the truth from the ingredient list that the product contains reef-harming ingredients.

Class Actions – Potential Implication for Future Cases:

The Second Circuit now finds that if a statement is identified as both provably false and plausible, a Defendant can only prevail on the puffery defense after a fact-intensive inquiry on how a reasonable buyer would react and such inquiries cannot be resolved at the pleadings stage. New York federal courts scrutinize purported class actions involving FDA-regulated products which might contain PFAS to ensure the claims are plausibly pled, and do not hesitate to dismiss complaints at the outset where they lack plausibility on their face. Courts should take into account the entirety of a product’s labeling, and to the extent the front label leaves any ambiguity about the contents of the product, the back label can provide sufficient clarification. However, Plaintiffs are not expected to look beyond misleading representations on the front label to discover the truth from the ingredient list on the back of the product.

The developments of 2022 indicate that it is critical to remain informed about changes in the law in order to develop the strongest product liability defense of pharmaceuticals and medical devices. We know it takes an enormous investment to develop innovative pharmaceuticals and medical devices to improve life experiences.