In 2025, New York state and federal courts issued a series of consequential decisions shaping the litigation landscape for pharmaceutical, medical device, and other Food and Drug Administration (FDA)-regulated industries. Defense counsel must closely track these rulings, which continue to refine pleading standards, preemption, the learned intermediary doctrine, and class-action viability.
In this review, Harris Beach Murtha’s Medical and Life Sciences Industry Team Leader Kelly Jones Howell, and Appellate Practice Group Leader Brian Ginsberg, together with Anthony Ruzzi and Sean Ferrito, analyze notable decisions from the past year and assess their implications for pending and future litigation involving drugs, devices, dietary supplements, foods, cosmetics and other regulated products.
This article examines several significant developments, including:
We also highlight a newly enacted New York statute — the AVOID Act — that materially alters third-party practice in all civil litigation and warrants close attention in FDA-regulated product cases.
Pleading Pitfalls and Federal Preemption
Nelson Gallego, Administrator of the Estate of Jillian Rose Castro Figueroa v. Tandem Diabetes Care, Inc., No. 24-CV-146 (MKB), 776 F. Supp. 3d 119 (E.D.N.Y. Mar. 28, 2025)
Plaintiff’s administrator sued Tandem Diabetes Care, the manufacturer of a Class III insulin pump, asserting New York law claims for manufacturing defect, negligent design, failure to warn, breach of implied warranty, negligence, and wrongful death. Tandem moved to dismiss under Rule 12(b)(6), arguing that the claims were preempted by federal law and inadequately pleaded.
The decedent used Tandem’s X2 insulin pump, which integrates continuous glucose monitoring to adjust insulin delivery. Plaintiff alleged that the pump should have been manufactured with thicker materials to prevent breakage if dropped.
Judge Margo Brodie dismissed all claims. The court held that most causes of action were expressly preempted by § 360k of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), which bars state-law requirements different from, or in addition to, federal regulations. While acknowledging the narrow “parallel-claim” exception, Judge Brodie reiterated that plaintiffs in the Eastern District must identify a device-specific FDA violation and plead facts linking that violation to the alleged injury. See Crissi v. Johnson & Johnson Vision Care, Inc., No. 15-CV-4230, 2016 WL 4502038 (E.D.N.Y. Aug. 25, 2016).
Plaintiff’s manufacturing and design defect theories failed because the complaint did not allege deviation from the FDA-approved Premarket Approval (PMA) specifications. The court further emphasized that claims premised solely on alleged violations of Current Good Manufacturing Practices (cGMPs) generally are insufficient absent device-specific allegations.
Plaintiff’s negligence, failure-to-warn, and implied-warranty claims were likewise dismissed for failure to plead an actionable parallel violation of federal requirements. The wrongful-death claim fell with the underlying causes of action. Judge Brodie granted leave to replead only the negligent design and wrongful-death claims.
Defense Takeaways
Parallel claims remain exceptionally difficult to plead. The specificity required routinely collides with the MDA’s sweeping preemption framework and Supreme Court precedent. The decision also reinforces that generalized cGMP allegations will rarely suffice in the Eastern District of New York. Still, courts may permit amendment in narrow factual circumstances, underscoring the importance of early, aggressive motion practice.
Federal Preemption and the Learned Intermediary Doctrine
Feige Wieder v. Advanced Bionics, LLC, No. 24-CV-8495 (DEH)(GWG), 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025)
Parents of an infant plaintiff sued Advanced Bionics, a manufacturer of Class III cochlear implants, asserting claims for manufacturing and design defect, breach of warranty, fraud, failure to warn, negligence, loss of services, and violations of New York General Business Law §§ 349–350. Defendant moved to dismiss based on federal preemption.
Plaintiffs alleged that bodily fluids could breach a polymer seal, causing electrical shorting. After a voluntary recall of unused devices, the infant’s implant was initially deemed functional but later failed. Scar tissue prevented re-implantation, leaving the child with only partially functional hearing.
Magistrate Judge Gabriel Gorenstein granted the motion in part, concluding that many claims were expressly or impliedly preempted, or failed to plead viable parallel violations. Importantly, the court rejected plaintiffs’ attempt to rely on the recall as evidence of cGMP violations, holding that recall alone — without more — does not establish a breach of federal requirements.
The court dismissed the General Business Law and fraud claims because they were predicated on materials approved during the PMA process and thus preempted. Failure-to-warn claims were also barred. Judge Gorenstein rejected plaintiffs’ argument that New York law imposes a duty to warn the FDA, explaining that New York’s learned intermediary doctrine confines the duty to prescribing physicians — not regulators. See Banker v. Hoehn, 278 A.D.2d 720 (3d Dep’t 2000).
One negligence claim survived: the allegation that defendant’s employee tested the implant using proprietary software unavailable to the treating physicians. The court concluded New York law could recognize a duty under those circumstances.
Defense Takeaways
The learned intermediary doctrine remains a formidable shield in New York products cases, foreclosing attempts to recast alleged regulatory reporting obligations as state-law warning duties. Recalls alone do not establish defect or regulatory noncompliance, and General Business Law and fraud claims remain ill-suited to traditional product-liability theories. At the same time, defendants should expect courts to scrutinize operational conduct — such as testing procedures — under ordinary negligence principles.
Failure to Warn and Synergistic Products
Liana C. Silverstein v. CoolSculpting - Zeltiq Aesthetics, Inc., Index No. 152580/2018, 235 A.D.3d 604 (1st Dep’t 2025)
In a significant appellate victory co-drafted with national counsel and argued by Harris Beach Murtha’s Medical and Life Sciences Industry Team and Appellate Practice Group, the First Department addressed whether a device manufacturer may be liable for alleged risks posed by another product used in conjunction with its own.
Plaintiff suffered burns after applying ice packs following treatment with the CoolSculpting device, a Class II FDA-regulated product. She argued that Zeltiq had a duty to warn of synergistic dangers arising from the combined use of CoolSculpting and ice packs.
The court rejected the theory. Ice packs were not required, supplied, or recommended by Zeltiq, and therefore did not constitute a synergistic product. The court further held that Zeltiq’s duty to warn extended only to the prescribing physician, not the patient directly. Because placing ice on bare skin presents an obvious risk known to trained clinicians, and was, in fact, known by the treating physician in particular, any causal link between the manufacturer and plaintiff’s injury was severed. Summary judgment was awarded to the defense.
Defense Takeaways
Silverstein provides powerful precedent against efforts to expand manufacturer liability to products made or supplied by others. The decision also reinforces the continuing vitality of the learned intermediary doctrine and supports early resolution where prescribing physicians are aware of the relevant risks.
OTC Acne Products and Benzene Allegations
Kouyate v. Harvard Drug Grp., LLC, No. 1:24-cv-6223-GHW, 2025 WL 2773159 (S.D.N.Y. Sept. 26, 2025)
Plaintiff brought a putative consumer-fraud class action alleging undisclosed benzene in an Over-the-Counter (OTC) acne wash, relying on testing conducted by Valisure. Defendant moved to dismiss, arguing that FDA monographs governing benzoyl peroxide products preempted state-law labeling claims.
The court agreed. The monograph required disclosure of benzoyl peroxide concentration but imposed no obligation to warn about potential benzene formation from degradation. Because benzene was not a purposely added ingredient, the FDCA did not require disclosure.
The court also rejected plaintiff’s negligence-per-se theory, holding that trace degradation byproducts do not render a monograph-compliant product misbranded or adulterated. FDA guidance suggesting limits was non-binding and insufficient to sustain liability.
Defense Takeaways
Courts continue to apply robust preemption principles to OTC class actions. Notably, the “independent laboratory” cited here — Valisure — has been the subject of FDA criticism concerning its testing methodology for benzoyl-peroxide products. Defense counsel should rigorously challenge laboratory methodologies and motives, particularly where plaintiffs rely on advocacy-driven testing to bootstrap consumer claims.
The AVOID Act: New Constraints on Third-Party Practice
In late 2025, Governor Kathy Hochul signed the AVOID Act, amending CPLR § 1007 and dramatically tightening deadlines for impleader. Effective April 18, 2026 — and retroactive to pending cases — the statute requires:
- Contractual indemnity claims to be impleaded within 60 days of serving an answer;
- Other indemnity or contribution claims within 60 days of learning their factual basis;
- An absolute 12-month bar from a party’s answer absent court and plaintiff consent.
Subsequent third-party actions face cascading deadlines of 45, 30 and 20 days, respectively. Extensions are limited to 30 days by court order. Filing a Note of Issue forecloses further impleader entirely, subject to narrow employment-law carve-outs.
Defense Takeaways
The AVOID Act will accelerate risk-transfer analysis and likely prompt earlier — and more frequent — third-party filings. At the same time, it arms defendants with a potent procedural defense against untimely indemnity claims. Coverage litigation may increase, as post-resolution indemnity actions remain unaffected.
Conclusion
The 2025 decisions surveyed here underscore New York courts’ continued adherence to federal preemption principles, strict pleading requirements and the learned intermediary doctrine — while also signaling that traditional negligence theories remain viable in limited circumstances. Coupled with the procedural sea change brought by the AVOID Act, these developments demand early strategic assessment and aggressive defense positioning in all FDA-regulated product matters.
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