From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 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, foods, 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 2024 pertaining to:
• Medical Devices – Daubert Challenge to Expert Opinions
• Biologics - Causation Under Frye and PREP Act Extension
• Food Class Actions – PFAS, Plausibility and Deference to Primary Jurisdiction of FDA
• Dietary Supplements- Express Preemption of Labeling Claims
• OTC Drugs - Preemption Via Monograph
Medical Device Fracture Daubert Challenge- Krom v. Smith & Nephew, Inc., No. 1:21-cv-01050 (AMN/DJS), 2024 WL 3378031 (N.D.N.Y. July 11, 2024) (appeal dismissed)
Plaintiff, a hip implant patient, alleged four products liability claims under New York law sounding in negligence, strict products liability, breach of express warranty and breach of implied warranty. Each claim relied on the same basic allegations, that defendant manufacturer's allegedly defective femoral stem implant product fractured and caused plaintiff injury. Defendant moved for Federal Rules of Civil Procedure (FRCP) Rule 56 summary judgment, premised upon a Daubert challenge to the testimony of plaintiff's two disclosed experts. Plaintiff’s expert engineer was not qualified by experience, knowledge, skill, training or education to offer any opinions regarding the medical device at issue, as the expert had not attended medical school, had no medical training or background, never designed or prepared warnings for a femoral stem component or any other medical device and never worked for a medical device company, for the Food and Drug Administration (FDA) or for any other agency that regulates medical devices. Even if the expert could be qualified to offer opinions, the Court found the methods underlying her industry standards and warning defect opinions were unreliable. To the extent her methodology was even described, it consisted primarily of speculation based on her personal and non-medical device experience. Plaintiff’s second expert did not provide a report and an attorney-drafted summary of what the expert would testify about was insufficient under FRCP Rule 26. Neither expert posited that there was either a design or manufacturing defect, which plaintiff conceded during the pendency of the summary judgement motion.
Since the cause of plaintiff's femoral stem fracture following revision surgery was beyond the knowledge of a layperson, expert testimony was required. Even assuming plaintiff could posit admissible expert witness opinion evidence, which she could not, summary judgment was warranted. Because defendant provided warnings describing that the femoral stem could fracture and because the implanting surgeon was aware that the femoral stem could fracture, plaintiff’s warning-based strict liability and negligence claims failed due to lack of causation. (citing Tomaselli v. New York & Presbyterian Hospital, 728 F. App'x 41 (2d Cir. 2018) (summary order). Also, the implanting surgeon was an informed intermediary and was sufficiently warned of the risk of fracture. (citing Fane v. Zimmer, Inc., 927 F.2d 124, 129 (2d Cir. 1991).
Insofar as the warranty claims were concerned, the Court noted that prior to his surgery, plaintiff had no contact with defendant manufacturer, received no information from defendant, and was unaware of any warranty by defendant. Plaintiff did not address the continued viability of the breach of warranty claims given this factual record and the Court deemed the breach of warranty claims abandoned.
Medical Devices - Potential implication for future cases:
Causation is a matter within the unique purview of expert witness opinion evidence. Even a medical device fracture requires proof of defect in design, manufacture or warning through expert opinion. A known risk of fracture may trigger the learned intermediary defense.
Expert Opinion of Biologic Causation Under Frye - Wholey v. Amgen Inc., 232 A.D.3d 565 (1st Dept. 2024)
Plaintiffs alleged that Wholey’s use of Enbrel, an FDA-approved biologic product, to address rheumatoid arthritis, caused her to develop squamous cell carcinoma of the tongue (SCCT). Defendants moved to exclude the opinions by plaintiffs' general causation experts, and for summary judgment dismissing the complaint. The trial court excluded plaintiffs' causation experts from testifying, and found plaintiffs failed to sustain the burden of establishing that the experts' theory of causation was generally accepted in the relevant scientific community, under the Frye rule (see Frye v United States, 293 F. 1013 (D.C. Cir. 1923)).
Plaintiffs' experts acknowledged there were no clinical studies or medical literature to support their causation theory. Plaintiffs' experts also failed to establish that their reliance upon an individual case occurrence, as well as FDA warnings and adverse case reports related to the use of Enbrel, was an accepted methodology of determining a causal connection between plaintiff's SCCT and her use of Enbrel. The First Department has held that "observational studies or case reports are not generally accepted in the scientific community on questions of causation" (citing Heckstall v Pinkus, 19 A.D.3d 203, 205 (1st Dept 2005)).
Plaintiffs could cite no New York cases that support their "steppingstone methodology" argument, and to the extent they relied on a federal case to advance that argument (In re Neurontin Mktg., Sales Practices, & Prods. Liab. Litig., 612 F. Supp. 2d 116 (D. Mass 2009)), the Special Master persuasively distinguished the case, noting that the class of drugs analyzed there was understood to share the same mechanism of action. Here, by contrast, plaintiffs' experts did not rebut the statements of Defendant’s experts that Enbrel had a unique mechanism of action compared with other similar drugs. In any event, the Appellate Division observed, federal expert admissibility standards under Daubert v Merrill Dow Pharms., Inc., 509 U.S. 579 (1993) are less stringent than New York's Frye rule. As there was no other evidence in the record to create a factual issue as to whether Wholey's use of Enbrel caused her SCCT, dismissal of the complaint was affirmed.
Biologics - Potential implication for future cases:
New York state strictly applies the Frye “general acceptance” rule to medical product causation, which is considered a more stringent standard than Daubert, and requires that experts posit an accepted methodology of determining causal connection between use of the product and the disease alleged.
PFAS in Food Packaging Class Action- Winans v. Ornua Foods North America Inc., 731 F. Supp. 3d 422 (E.D.N.Y. 2024)
In this putative class action relating to the alleged presence of per- and polyfluoralkyl substances (“PFAS”) in Kerrygold Salted and Unsalted Butter Sticks labeled as “PURE IRISH BUTTER”, defendant Ornua Foods North America Inc. moved to dismiss under FRCP Rules 12(b)(1) and 12(b)(6) the claims for deceptive business acts or practices in violation of New York General Business Law § 349; false advertising in violation of GBL § 350; selling of adulterated or misbranded food in violation of the New York State Agriculture & Markets Law § 199-a; negligence per se; and unjust enrichment. In response to a New York state law banning PFAS in food packaging, Ornua had issued a recall of its Kerrygold Butter products because the packaging contained PFAS.
The federal district court found plaintiff had Article III standing to bring her claims. Although some courts have required testing to prove that the PFAS allegations were plausible (actual presence of PFAS in product), here there was a recall, and thus no need to prove the presence of PFAS. It was also plausible to plead that the PFAS could migrate from the packaging to the butter itself. However, plaintiff lacked standing to seek injunctive relief individually and on behalf of a class. The public injunction claim was dismissed.
Ornua’s motion to dismiss was denied in reference to the GBL §§ 349 and 350, AML § 199-a, unjust enrichment and negligence per se claims. These claims survived, as the misrepresentations were plausibly pled. Ornua urged the Court to read the phase “pure Irish butter” as meaning “butter purely from Ireland,” rather than “pure butter from Ireland.” Assuming the butter contained PFAS, the Court concluded that a reasonable consumer could be misled by the “pure Irish butter” label and it was plausible that a reasonable consumer reading the label would conclude that the adjective “pure” modifies the noun “butter.” The word “pure” is a common product label, and other courts have concluded that a reasonable consumer viewing the product would interpret the terms to mean that the product is free of other substances.
“All Natural” Foods Multidistrict Litigation Claims - Bustamante v. Kind, LLC, 100 F.4th 419 (2d Cir. 2024)
In this multidistrict litigation, plaintiffs-appellants asserted that the phrase “All Natural” that appeared on the labels of KIND food products was deceptive and misleading. Plaintiffs sought damages on behalf of themselves and three classes, based on common law fraud, as well as consumer protection and false advertising laws in New York, California and Florida.
After the parties completed discovery, KIND moved for summary judgment, to preclude plaintiffs’ experts from offering testimony in opposition to its motion for summary judgment, and to decertify the classes. The District Court excluded the expert reports, finding that the consumer perceptions surveys upon which the expert theories were based were biased, leading, and methodologically flawed. These failures, and expert opinions which challenged ingredients as “typically” sourced or not “natural” provided no useful information about how a reasonable consumer understands “All Natural.” Plaintiffs’ purported evidence failed to present any cohesive definition of what a reasonable consumer would expect from products labeled “All Natural.”
The Second Circuit affirmed the District Court’s grant of summary judgment and preclusion of the opinions of plaintiffs’ experts. Notably, while the “evidence” to which plaintiffs pointed may have sufficed to overcome a motion to dismiss, or to support a motion for class certification, it failed to raise a triable issue of fact at summary judgment. Because plaintiffs failed to produce admissible evidence demonstrating what a reasonable consumer acting reasonably, would expect of KIND products bearing the “All Natural” label, summary judgment was proper.
Deference to Primary Jurisdiction of FDA - White et al. v. Beech-Nut Nutrition Co., No. 23-220-cv, 2024 WL 194699 (2d Cir. January 18, 2024)
Plaintiffs, parents of babies allegedly exposed to dangerous levels of lead, arsenic, cadmium and mercury in baby food, appealed from the Northern District of New York’s order dismissing their claims without prejudice in deference to FDA under the primary jurisdiction doctrine. Beech-Nut had filed a motion to dismiss, or alternatively sought to stay the 70 count putative class action, arguing that FDA had primary jurisdiction over plaintiffs’ claims. In deferring under the primary jurisdiction doctrine, the district court reasoned that FDA was working on its initiative, “Closer to Zero: Action Plan for Baby Foods” where, by April 2024, FDA planned to finalize action levels for lead and propose action levels for arsenic, with cadmium and mercury consideration.
However, circumstances changed and FDA no longer expected to finalize lead action levels in April 2024, and it revised its expected timeline for issuing draft guidance on proposed action levels for arsenic and cadmium. [In fact, FDA did not issue its guidance for industry on the action levels for lead in processed food intended for babies and young children until January 6, 2025.] Thus, on balance, the Second Circuit concluded that the potential costs resulting from these indefinite delays outweighed any possible benefits that could be obtained from deferring to the agency. In doing so, the Court found it unnecessary to apply the so-called Ellis factors. Ellis v. Trib. Television Co., 443 F.3d 71, 82-83 (2d Cir. 2006) ((1) whether the question at issue is within the conventional experience of judges or whether it involves technical or policy considerations within the agency’s particular field of expertise; (2) whether the question at issue is particularly within the agency’s discretion; (3) whether there exists a substantial danger of inconsistent rulings; and (4) whether a prior application to the agency has been made). For these reasons, the Court vacated the judgment of the district court and remanded the case for further proceedings.
Foods - Potential implication for future cases:
While New York federal courts continue to scrutinize purported class actions involving food products which might contain PFAS to ensure the claims are plausibly pled, and they often require testing to prove PFAS presence, the testing requirement may be unnecessary if the presence is not in dispute, such as evidenced by a recall. In other instances, FDA may have the initial right and burden to promulgate standards for foods, but where FDA fails to act as promised, deference will not be afforded.
Dietary Supplement Labeling Express Preemption- Jackson-Mau v. Walgreen Co., 115 F.4th 121 (2d Cir. 2024)
In a putative class action against a glucosamine-based dietary supplement manufacturer and retailer, asserting three causes of action under New York law -- deceptive business practices in violation of GBL § 349, breach of contract and unjust enrichment -- consumer alleged that the dietary supplement she purchased was mislabeled because it contained a different formulation of glucosamine than the one displayed on the front of the label and disclosed on the label's Supplement Facts panel. The complaint alleged the product's label, which displayed the name “Glucosamine Sulfate” and identified the dietary ingredient as “Glucosamine Sulfate Potassium Chloride,” misled her into believing that the product contained single-crystal glucosamine when it in fact contained blended glucosamine.
Defendants moved for summary judgment on the ground that the state law mislabeling claims were wholly preempted by the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., which establishes national standards for the labeling of dietary supplements. The district court granted summary judgment for defendants on federal preemption grounds. On appeal, the Second Circuit affirmed.
A dietary supplement manufacturer must declare the names of the dietary ingredients that are present in the supplement in the Supplement Facts panel, usually found on the side of a product's label. See 21 C.F.R. § 101.36(b), (e). Dietary ingredients for which FDA has not established a Reference Daily Intake or Daily Reference Value must be declared by their “common or usual name[s],” determined by testing the ingredient with a validated method of identification. Id. § 101.36(b)(3)(i). Thus, in the absence of an established Reference Daily Intake or Daily Reference Value, glucosamine must be declared by its common or usual name. Reliable and appropriate methods of identification may be found in compendia, such as the official United States Pharmacopoeia. The Second Circuit agreed that defendants had shown that the product's glucosamine-based dietary ingredient passed compendial identity tests.
Plaintiff’s mislabeling theory as to the Supplement Facts panel was expressly foreclosed by 21 U.S.C. § 343-1(a) (4), which preempts “any [state] requirement for nutrition labeling of food that is not identical to the [common or usual name] requirement of section 343(q).” Id. Because FDA has not established Reference Daily Intakes or Daily Reference Values for glucosamine-based dietary ingredients, see 21 C.F.R. § 101.9(c), the product was properly branded under section 343(q) as determined by a reliable and appropriate method of identification. Plaintiff’s state law claims as to the Supplement Facts panel would thus impose under state law a labeling requirement for blended and single-crystal glucosamine that is “not identical to” the “common or usual name” requirement imposed by 21 U.S.C. § 343(q) and implemented by 21 C.F.R. §§ 101.36(b) (3), 101.9(g)(2). This is exactly what the FDCA does not permit, affording express preemption under FDCA.
OTC Drug Preemption of Ineffective Claims - In re: Oral Phenylephrine Marketing and Sales Practices Litigation, No. 23-md-3089-BMC, 2024 WL 4606818 (E.D.N.Y. October 29, 2024) (appeal filed 12/20/2024)
Plaintiffs brought nearly 100 cases, consolidated in a multidistrict litigation, against defendant retailers and manufacturers of over the counter (“OTC”) cough and cold medicines containing the drug phenylephrine (“PE”). Plaintiffs, purchasers of these medicines, alleged that defendants knew that PE was ineffective as a nasal and sinus decongestant but produced, marketed and sold products containing PE to consumers anyway. The parties agreed that plaintiffs would file a “streamlined” complaint, and defendants would move to dismiss it, to test claims and defenses common across the consolidated cases. The complaint asserted various claims under New York state law, as well as a civil Racketeer Influenced and Corrupt Organizations Act (“RICO”) claim. Defendants contended that the state claims were preempted by the federal Food, Drug, and Cosmetic Act (the “FDCA”), that plaintiffs lacked standing to assert the RICO claim, and that the RICO claim was precluded by the FDCA.
FDA approved PE as a “safe and effective” nasal decongestant since 1985. In 2007, three individuals petitioned FDA to increase the allowed maximum dose of PE because a meta-analysis of existing studies indicated that, at the current dosage level, PE was likely no better than a placebo. FDA’s Nonprescription Drug Advisory Committee (“NDAC”) reviewed the petition but, finding further study was needed, did not recommend that FDA declassify PE as “safe and effective” or change any regulations governing the labeling and dosage of PE products. A group of manufacturers associated with one another, including through the Phenylephrine Task Group of the Consumer Healthcare Products Association, banded together to defend the effectiveness of PE. Plaintiffs alleged that the task group provided deliberately misleading submissions to the NDAC on multiple occasions and disseminated similarly misleading information to the public in the form of press releases, studies and surveys, and that was a violation of RICO.
The district court dismissed plaintiffs’ claims as preempted. The existing PE monograph and the general monograph did not suggest that manufacturers have a freestanding duty to update their indications in response to new scientific information. Indeed, the Court found it unclear if manufacturers could even do so without misbranding the product: if they updated the “Uses” section to indicate that PE is not an effective nasal decongestant, they would be using alternative language describing exactly the opposite of those indications for use established in the applicable OTC drug monograph. Here, the Court reasoned that by promulgating the monograph regulation as one means of OTC drug approval, FDA determined that it is neither false nor misleading to represent that PE is an effective decongestant. Manufacturers, of course, are obligated to respond to newly acquired scientific information if, for example, the drug is found to be dangerous to health. But manufacturers are not obligated to update their indications simply because the drug may be ineffective.
In addition to their state law claims, plaintiffs allege that the RICO defendants violated RICO by engaging in numerous acts of mail and wire fraud in furtherance of a scheme to defraud the public and mislead FDA into believing that PE is an effective decongestant. Defendants moved to dismiss plaintiffs’ civil RICO claim for lack of statutory standing and preclusion by the FDCA. Applying the “direct purchaser” rule, a standing doctrine that bars downstream indirect purchasers from bringing an antitrust claim to plaintiffs’ civil RICO claim, the Court dismissed plaintiffs’ claim for lack of standing.
By excepting state product liability law from express preemption in the FDCA’s OTC drug provisions (21 U.S.C. § 379r), Congress allowed states to layer additional state protections atop federal ones, but only when those protections relate to safety; whether a drug is effective remains within the exclusive purview of FDA. This division reflects a balance between twin aims of the FDCA: safety and uniformity.
Preemption under OTC Monographs - Collaza v. Johnson & Johnson Consumer, Inc., No. 23-cv-06030 (ALC), 2024 WL 3965933 (S.D.N.Y. August 27, 2024) (appeal filed on 9/27/2024)
Plaintiff brought a purported class action complaint alleging Tylenol Extra Strength Rapid Release Gelcaps purchased did not work faster than cheaper Tylenol alternatives. FDA published a tentative final monograph on acetaminophen in 1988 which set the “conditions under which a category of OTC drugs or specific OTC drugs [including acetaminophen] are generally recognized as safe and effective and not misbranded.” 21 C.F.R. § 330.10(a)(7)(i). FDA had also published two non-binding guidance documents on acetaminophen dissolution rates. Defendant argued that the 1988 monograph’s requirements for “immediate release” labeling on OTC drugs like acetaminophen preempted plaintiff’s New York state common law claims of violation of New York General Business Law § 349 and § 350, unjust enrichment and declaratory relief. Other courts in New York, Massachusetts and California previously came to the same conclusion that similar allegations as to “rapid release” acetaminophen products were preempted by the FDCA’s regulation of “immediate release” tablets. Plaintiff suggested that “immediate” and “rapid” are not synonymous. However, the “immediate release” and “rapid release” terms both referred to the products’ dissolution rate and were sufficiently similar such that they were covered by the FDA regulations.
Even though FDA did not use the exact words “rapid release” in its regulations, this does not mean that FDA does not regulate the subject matter of OTC acetaminophen dissolution standards. FDA published regulations and guidance addressing when an OTC acetaminophen product can be considered “immediate release,” “rapidly dissolving” and “very rapidly dissolving.” Plaintiff’s claims were thus preempted.
OTC Drugs and Dietary Supplements - Potential implication for future cases:
Medical products that generally do not require FDA’s pre-approval, such as dietary supplements, are nonetheless subject to standards set out by the Food, Drug, and Cosmetic Act which can provide preemption of labeling claims. Monographs which describe the conditions under which OTC drugs are generally recognized as safe and effective can provide a preemption basis.
Vaccines- 12th Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
Effective January 1, 2025, the Secretary of the Department of Health and Human Services has amended its Declaration under the PREP Act to provide liability immunity to certain individuals and entities against any claims arising out of the manufacture, distribution, administration or use of medical countermeasures, including COVID-19 vaccines, through December 31, 2029. The Secretary has determined there is a credible risk that COVID-19 may in the future constitute an emergency and has amended the Declaration to prepare for and mitigate that future risk, by extending the time period of federal liability immunity.
