The California appellate court holding, which has sparked considerable controversy and disdain within the legal and pharmaceutical industries and in courts throughout the country, was issued in November of 2008. Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008). Conte involved the use of metoclopramide, a drug which had been sold by Wyeth as Reglan before going off patent and becoming subject to manufacture in generic forms. A user of one of these generic medications alleged that as a result of prolonged use of the drug, she developed tardive dyskinesia, a debilitating and incurable neurological disorder. She filed suit, not against the manufacturer of the generic drug or the doctor who prescribed it, but against the deep-pocketed manufacturer of the name-brand form of the drug.
The Conte court broke new ground with its holding:
We hold that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent. The risk of harm is foreseeable to Wyeth.
As such, even though it was undisputed that the plaintiff had not consumed a product manufactured by Wyeth — indeed, it was a product of its competitor — and undisputed that Wyeth did not provide labels for or sell the product at issue, Wyeth essentially was held liable for the alleged negligence of another. This California court opinion has, however, been universally rejected by courts throughout the country, all of which apparently recognize the dangers of extending liability to one company for the actions of another.
Most recently, nearly identical issues were addressed in a federal district court in Florida. Levine v. Wyeth, Inc., — F. Supp. 2d —, No. 8:09-CV-854-T-33AEP, 2010 WL 456773 (M.D. Fla. Feb. 10, 2010). The Levine plaintiff, just as the Conte plaintiff had before him, conceded that he never ingested Reglan or any other product made by the defendant, but claimed instead that he developed tardive dyskinesia as a result of use of the generic form of the drug. Relying on the Conte opinion, he alleged theories of negligent misrepresentation, fraud, negligence, strict liability, and breach of warranty.
The plaintiff claimed that doctors, pharmacists, and patients, in prescribing or being prescribed prescription drugs, rely on information provided by companies like Wyeth. The defendant, in turn, simply argued that it could not be held liable under any of the plaintiff’s causes of action as a matter of law because the plaintiff never used its product.
The Florida court sided with Wyeth, granting its motion for summary judgment as to all causes of action:
The holding in Conte is not binding on this Court, and runs counter to the overwhelming majority of case law, including that of Florida. The Court cannot impose a duty of care on Defendants here where the generic manufacturers are responsible for the contents of their label, and where the Defendants lacked direct control as to the contents of that label.