A California state appellate court recently ruled that a name-brand pharmaceutical manufacturer’s common-law duty of care in formulating product warnings extends to patients whose doctors foreseeably rely on such product information when prescribing a medication, even if the prescription is ultimately filled with a generic equivalent.  Conte v. Wyeth, Inc., No. A116707, A117353 (Cal. App. Ct. 1st  Dist. Nov. 7, 2008).

The plaintiff, Elizabeth Conte, was prescribed Reglan in its generic or name-brand form to treat her gastroesophageal reflux disease.  She took the generic form of the drug for approximately four years, allegedly developing a serious and irreversible neurological condition as a result of the continuous use of the drug.  She then filed a lawsuit against the manufacturer of the generic and Wyeth, the manufacturer of the name-brand Reglan, alleging that the drug label warnings failed to adequately inform patients of the known dangers of long-term use of Reglan or its generic equivalents.

The trial court dismissed the suit against Wyeth.  The trial court found that Ms. Conte’s claim against Wyeth failed because (1) Ms. Conte could not prove that she or her doctor relied on Wyeth’s warnings or product labels when prescribing the drug and (2) a name-brand pharmaceutical manufacturer’s common-law duty does not extend to patients who take generic versions of their drug.  The trial court further held that (1) the common-law state tort claims against generic pharmaceutical manufacturers were preempted by federal law under the Food, Drug and Cosmetic Act and (2) Conte did not rely on Wyeth’s warnings or product labels.|

The appellate court reversed the trial court’s decision with respect to Wyeth.  The court distinguished a failure to warn case in strict products liability from a negligence case.   In doing so, the court  stated that, although Conte’s claim could not sustain a strict liability case because Wyeth did not manufacture or sell the drug that caused Conte’s injury, Wyeth could nevertheless be held liable for common law fraud and negligent misrepresentation claims.  The court stated that Wyeth had a common law duty to use due care in formulating and disseminating product information that it knows or should know will be used by physicians when prescribing Reglan or its generic equivalents.

For a copy of the decision, please click here.