Products Liability Law Daily Wrap Up, WARNINGS ISSUES—Drugs—D.N.J.: Pet owners' class action against Zoetis over Librela arthritis drug dismissed, (Oct 21, 2025)

By Wendy Biddle, J.D.

The consumers failed to adequately plead consumer fraud, product liability, and warranty claims related to a canine monoclonal =antibody treatment.

A federal district court in New Jersey, in an unpublished opinion, dismissed a putative class action lawsuit brought by eight pet owners against pharmaceutical manufacturer Zoetis, Inc. over allegations that the company misrepresented the safety of Librela, a monoclonal antibody treatment for osteoarthritis pain in dogs. The third amended complaint alleged that Zoetis failed to adequately warn veterinarians and pet owners about severe adverse events associated with Librela, including neurological injuries, musculoskeletal problems, hepatic and pancreatic damage, and death (Hartney v. Zoetis, Inc., No. 24-9698 (SDW) (AME) (D.N.J. Oct. 15, 2025) (unpublished decision)).

Background. According to the complaint, Librela is a long-acting monoclonal antibody known as bedinvetmab, administered through monthly injections to manage canine osteoarthritis. The drug works by blocking nerve growth factor, a protein associated with pain transmission. Approved in the European Union in November 2020 and in the United States in May 2023, Librela has since generated more than 10,000 adverse event reports to the FDA, according to the consumers' allegations.

Each of the eight named plaintiffs detailed similar experiences: they consented to Librela injections based on representations that the drug was safe, their dogs subsequently developed serious health problems, and they incurred veterinary expenses and emotional distress. The consumers contended that adequate warnings would have prevented their consent and altered veterinarians' prescribing decisions.

The complaint asserted twelve causes of action, including violations of consumer protection statutes from New Jersey, California, Illinois, Missouri, Texas, and Virginia, as well as claims under the New Jersey Products Liability Act, breach of express and implied warranties, negligence, fraud, negligent misrepresentation, and unjust enrichment.

Consumer protection claims. The consumers alleged violations of consumer protection statutes from New Jersey, California, Illinois, Missouri, Texas and Virginia. The court found that the complaint failed to identify any specific affirmative misrepresentation that any plaintiff actually saw or relied upon. The court noted that while these state statutes differ in detail, all generally require plaintiffs to allege unlawful or deceptive conduct, actual reliance or causation, and some form of ascertainable loss. The consumers' generic assertion that they believed Librela was safe was deemed too conclusory to satisfy these requirements. Additionally, the complaint failed to quantify the difference between the value promised and the value received.

The court acknowledged that the New Jersey Supreme Court has explained that claims alleging inadequate warnings must typically be brought under the New Jersey Products Liability Act (NJPLA) rather than consumer fraud statutes, unless plaintiffs plead affirmative misrepresentations distinct from failure-to-warn theories. However, the court permitted the consumers to reassert consumer protection claims in the alternative, provided they satisfy each state's pleading requirements.

NJPLA claim. For the NJPLA claim, which included both failure-to-warn and design defect theories, the court applied the learned-intermediary doctrine. Under this doctrine, a drug manufacturer satisfies its duty to warn by providing adequate warnings to prescribing professionals, who then convey risks to patients' owners. The court found the complaint deficient because it did not allege that veterinarians relied on any specific Zoetis materials, nor did it identify any advertisement the consumers actually saw.

The court further noted that the NJPLA provides a rebuttable presumption that FDA-approved warnings are adequate. To overcome this presumption, plaintiffs must allege deliberate concealment or nondisclosure of post-approval risk information. While the complaint referenced a January 2025 label change, it alleged no facts showing Zoetis withheld newly discovered risks.

On the design defect theory, the court found potential preemption issues, because once the FDA approves a drug, federal law prohibits unilateral changes to its formulation. The consumers alleged that Librela was defectively designed because safer alternatives existed. However, it would require speculation that the FDA would have approved a different formulation, and that the consumer would have used it.

Even absent preemption, the court noted that the consumers failed to identify any feasible alternative design or allege that Librela's risks outweigh its benefits, both necessary elements under the NJPLA. The court therefore dismissed the NJPLA claim.

Warranty claims. The warranty claims were dismissed for lack of specificity. The court explained that express warranty claims require identification of who made specific statements, their content, when they were made, and that they formed part of the bargain. Many jurisdictions also require pre-suit notice of breach and privity of contract, neither of which the consumers adequately pleaded. The court also dismissed the implied warranties claims. The complaint failed to allege that Librela was unfit for its ordinary use or for a particular purpose.

Negligence, unjust enrichment claims. The negligence claim was dismissed as subsumed by the NJPLA, which the New Jersey Supreme Court has held provides the exclusive remedy for harm caused by defective products. The unjust enrichment claim failed because the consumers pleaded no facts beyond those underlying their other theories and they failed to allege why legal remedies would be inadequate.

Motion to strike class allegations. Despite dismissing all claims, the court denied Zoetis's motion to strike the class allegations, finding it premature to rule on class certification at the pleading stage. The court noted that discovery would be essential to determining whether common issues predominate over individual questions of causation, reliance, and variations in state law.

The court granted the consumers leave to amend and file a fourth amended complaint addressing the deficiencies identified in the court's opinion.

The case is No. 24-9698 (SDW) (AME).

Judge: Wigenton, S.

Attorneys: Justin R. Parafinczuk (Parafinczuk Wolf, PA) for Cathy Hartney. Erin L. Leffler (Shook Hardy & Bacon LLP) for Zoetis, Inc.

Companies: Zoetis, Inc.

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