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New California Opinion: Drug Manufacturers May Owe a Broader Duty of Care

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Publications
9 DEC 2008

New California Opinion: Drug Manufacturers May Owe a Broader Duty of Care
ARTICLE PRODUCT LIABILITY AND TOXIC TORTS ALERT

by Shirli Weiss, Christopher Young and Julie Hussey

In California, a drug manufacturer’s common law duty to use due care in formulating product warnings may now extend to patients whose doctors foreseeably rely on the product information in prescribing the drug, whether the prescription is filled by the name-brand drug or a generic equivalent. In November 2008, the California Court of Appeal issued its decision in Conte v. Wyeth, 2008 WL 4823066 (Cal.App. 1 Dist.) Based on this decision, the fact that a name-brand drug manufacturer did not sell or manufacture the generic version of the drug that a plaintiff exclusively ingested may not relieve the name-brand manufacturer of its general duty to use due care in disseminating product information regarding the medication which may foreseeably be relied upon in prescribing the generic equivalent. In California, a generic prescription drug user cannot prevail on a strict product liability claim against the manufacturer of the name-brand form of the drug, if the manufacturer did not manufacture or sell the generic drug that allegedly caused the user's injury. However, actions based on a common law duty of care are viewed differently than strict liability actions. The general rule is that all persons have a duty to use ordinary care to prevent others from being foreseeably injured as the result of their conduct. Based on this longstanding general rule, in Conte v. Wyeth, the First Appellate District Court of California found that a drug manufacturer may owe a duty of care to both name-brand and generic equivalent medication users when disseminating product information which will be relied upon in

http://www.dlapiper.com/duty_of_care_ca_opinion/

12/9/2008

DLA Piper | Publications | New California Opinion: Drug Manufacturers May Owe a Bro... Page 2 of 3

prescribing medication To treat her gastroesophageal reflux disease, plaintiff Elizabeth Conte’s physician prescribed a generic drug--a version of Reglan, a drug manufactured and marketed by Wyeth. There is no dispute that, in her long-term consumption, Conte only took the generic version of the drug, which was not manufactured or sold by Wyeth. Conte developed a serious and irreversible neurological condition which she alleges was due to her long-term consumption of the generic. She also alleges that the warnings provided by both the name-brand and generic manufacturers of the drug failed to adequately warn of known dangers resulting from its long-term use. Conte sued Wyeth, the name-brand manufacturer and three generic manufacturers asserting claims for fraud, fraud by concealment and negligent misrepresentation. The Court of Appeal for the First Appellate District of California considered whether, in disseminating product warnings, a name-brand drug manufacturer owes a duty of care to patients who take a generic version of the drug pursuant to a prescription written in reliance on the name-brand maker’s information. Whether a drug manufacturer has a duty to users of generic versions of its products produced by other manufacturers is an issue of first impression in California. The Court of Appeal reversed the decision of the Superior Court of San Francisco County granting summary judgment in favor of Wyeth and held that the common law duty to use due care owed by a name-brand drug manufacturer when providing product warnings extends not only to consumers of its product, but also to those whose doctors foreseeably rely on the name-brand manufacturer’s product information when prescribing a medication, even if the prescription is filled with a generic version of the prescribed drug. The court also held that the plaintiff had shown there is a material factual dispute as to whether her doctor relied on Wyeth’s product information. Conte’s claims against Wyeth were premised factually on alleged misrepresentations in Wyeth’s labeling of Reglan and in the monograph on Reglan provided in the Physician’s Desk Reference. The court found that there was a factual dispute regarding reliance/causation: had Conte’s doctor relied on the product warnings when he prescribed the generic drug to Conte? Therefore, summary judgment on that ground was improper. The court affirmed summary judgment in favor of the three generic manufacturers on the grounds that Conte was unable to show a material fact existed as to whether her physician relied on any information supplied by the generic drug manufacturers. The court discussed fault-based theories versus strict product liability theories. The Plaintiff could not prevail on a strict product liability theory because Wyeth did not manufacture or sell the product that allegedly caused her injury. However, in view of the fact that she was pursuing causes of action based on Wyeth’s alleged failure to use due care in warnings about the name-brand product, the court rejected Wyeth’s reliance on strict product liability cases and the rule that a plaintiff must show that the defendant made or sold the allegedly defective product. The court then reviewed the common law on foreseeability in negligence actions and noted the general rule that all persons have a duty to use ordinary care to prevent others from being injured by their conduct. Because generic and name brands are required to be biological equivalents and because pharmacists are authorized to fill prescriptions for namebrand drugs with generic drugs, the court held it is foreseeable that a prescription for the name brand might be filled with a generic or that a doctor may rely on the name brand’s product information in prescribing a generic. The court disagreed with Wyeth’s assertion that imposing liability would undermine the goal of preventing future harm because it would chill innovation in the pharmaceutical industry or that it would subject Wyeth to permanent and uncontrolled liability. The court did not reach preemption arguments raised by the generic drug manufacturers.

http://www.dlapiper.com/duty_of_care_ca_opinion/

12/9/2008

DLA Piper | Publications | New California Opinion: Drug Manufacturers May Owe a Bro... Page 3 of 3

A complete copy of the opinion may be read here. [http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF] In summary, under this California case, when disseminating information about a product, a drug manufacturer may owe a duty not only to users of the drug that it manufactures, but also to the users of the generic equivalent of the drug where the user’s physician relies upon information disseminated by the drug manufacturer.

http://www.dlapiper.com/duty_of_care_ca_opinion/

12/9/2008


				
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