McNair v. Johnson & Johnson, 818 S.E.2d 852

Background

Mrs. McNair ingested a generic levofloxacin manufactured by Dr. Reddy’s; Janssen (brand Levaquin® inventor) drafted the brand label later copied verbatim by generics under federal law.
The McNairs sued Janssen for failure to warn and negligent misrepresentation, arguing Janssen controlled the warnings and knew of the risk of ARDS.
Federal law (Hatch-Waxman / FDA rules) requires generic labels to match brand labels and generally precludes generics from unilaterally changing warnings.
Janssen moved for summary judgment arguing West Virginia products-liability law requires the defendant to have manufactured or sold the injuring product; the district court granted judgment for Janssen.
The Fourth Circuit certified whether West Virginia law permits failure-to-warn and negligent-misrepresentation claims against a brand manufacturer when the injured plaintiff took a generic.
The West Virginia Supreme Court answered: no — plaintiffs cannot sue the brand manufacturer for failure to warn or negligent misrepresentation arising from ingestion of a generic drug the brand did not manufacture or sell.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Can a consumer who ingested a generic drug sue the brand manufacturer for failure to warn?	McNair: Janssen drafted the warnings and knew generics must copy them, so Janssen owes a duty and can be liable.	Janssen: Products-liability duty attaches only to manufacturer/seller of the product that caused injury; Janssen neither made nor sold the generic.	No — West Virginia law requires the defendant to have manufactured or sold the injuring product; brand not liable for generic ingestion.
Can negligent misrepresentation be asserted against brand for labels used on generics?	McNair: Brand’s statements foreseeably caused reliance and harm because generics must replicate brand labels.	Janssen: No duty to users of another manufacturer’s product; foreseeability alone is insufficient to create duty.	No — negligent-misrepresentation claim fails because no duty exists absent manufacture/sale of the injuring product.
Is the warning label itself the "product" for purposes of products liability?	McNair: The label is the actionable instrumentality; holding brand liable targets the entity that authored the label.	Janssen: The label evidences a defect in the drug, but the injuring product was the generic drug, not the label itself.	No — West Virginia treats inadequate warnings as a type of product defect, but the product is the drug; liability remains tied to manufacturer/seller of that drug.
Should courts depart from common-law rules because Mensing creates an "unfortunate" gap (generics immune; brand potentially liable only to brand users)?	McNair: Courts should adapt tort law to avoid leaving generic-users without remedy; some jurisdictions have recognized duties.	Janssen: Policy, statutory law, and precedent support limiting liability; remedy belongs to Congress or FDA, not courts.	No — Court declines to expand tort liability; policy, precedent, and recent state statutes favor restricting liability to manufacturer/seller.

Key Cases Cited

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (federal law preempts state failure-to-warn claims against generic manufacturers because generics must match brand labels)
Wyeth v. Levine, 555 U.S. 555 (2009) (brand manufacturers may be liable under state law for failure to warn because they can unilaterally change labels)
Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (discusses preemption in the drug-labeling context and limits on state-law claims)
Morningstar v. Black & Decker Mfg. Co., 162 W. Va. 857 (1979) (West Virginia recognizes use-defectiveness from inadequate warnings and the product-liability framework)
Ilosky v. Michelin Tire Corp., 172 W. Va. 435 (1983) (describes duty-to-warn standards and tests for product unsafefulness)
Aikens v. Debow, 208 W. Va. 486 (2000) (duty is a question of law involving foreseeability and policy considerations)