Out of California, on an issue of first impression, an appellate court in January held a name-brand prescription drug manufacturer's duty to use due care when providing product warnings extends to patients whose prescriptions are filled with the generic version of the drug. See Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 85 Cal. Rptr. 3d 299 (2009). Because the factors examined by the California court to determine whether a duty was owed are similar to the factors Pennsylvania courts consider, it is conceivable that such a ruling from a Pennsylvania court may be looming in the near future.  

Defendant Wyeth manufactures and markets Reglan, the name-brand form of metoclopramide, used to treat gastoesophageal reflux disease (GERD). Other defendants in the Conte case, Purepac Pharmaceutical Company, Teva Pharmaceutical USS, Inc. and Pliva, Inc., manufacture generic versions of the same drug. Conte admittedly took only the generic versions of this medication. After almost four years on the medication, she developed tardive dyskinesia, a debilitating and incurable neurological disorder.

Conte alleged her condition was due to her long-term consumption of the drug and that the warnings provided failed to adequately warn of the known dangers resulting from its long-term use. She claimed that the defendants knew or should have known of a widespread tendency among physicians to misprescribe metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drug's labeling substantially understates the risks of serious side effects from extended use. She brought claims against Wyeth for fraud, fraud by concealment and negligent misrepresentation, claims against the generic manufacturers for negligence, strict products liability, negligence per se, and breach of express and implied warranties and a claim against her doctor for medical negligence.

The trial court granted summary judgment in favor of all the manufacturers, as to Wyeth on two grounds: (1) Conte could not show that she or her physician relied upon warnings or product labeling disseminated by Wyeth; and (2) the name-brand manufacturer owed no duty to individuals who take only generic versions of the product. The appellate court reversed as to Wyeth, holding that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends to those patients whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug. The court further held that Conte showed there was a material factual dispute as to whether her doctor relied on Wyeth's product information, thus precluding summary judgment in favor of Wyeth.

The possible importance of this case in jurisdictions outside of California is that, in finding that Wyeth owed a duty to Conte, the California court looked at the same or very similar factors as most courts do to determine whether a duty of care exists in a novel situation: (1) the foreseeability of harm to the plaintiff; (2) the degree of certainty that the plaintiff suffered injury; (3) the closeness of the connection between the defendant's conduct and the plaintiff's injury; (4) the moral blame attached to the defendant's conduct; (5) the policy goal of preventing future harm; (6) the burden to the defendant and consequences to the community of imposing a duty of care; and (7) broader consequences including the availability, cost and prevalence of insurance for the risk involved.

The court found that, as a generic metoclopramide user, Conte was within the name-brand manufacturer's "range of apprehension" of those affected by its Reglan product warning and that it was foreseeable that physicians would rely upon Reglan's product information in issuing prescriptions that would be filled with generic metoclopramide. Although the court stated that, in the absence of overriding policy considerations, foreseeability of risk is of primary importance, it also found that the factors of the degree of certainty that the plaintiff suffered injury and the closeness of the connection between the defendant's conduct and the plaintiff's injury weighed in favor of finding that a duty existed. Further, the court found that any moral culpability the name-brand manufacturer might bear for any misrepresentation was not lessened by the user's ingestion of the generic drug and that, although the burden to the defendant and consequences to the community of imposing a duty of care could not be assessed, it was not determinative, absent evidence that imposing liability would chill innovation in the pharmaceutical industry, or that imposing a duty of care would give rise to uncontrolled or perpetual liability for name-brand drug manufacturers.

Pennsylvania state and federal courts consider very similar criteria when determining whether to impose a duty of care in a negligence case. See Althaus v. Cohen, 562 Pa. 547, 756 A.2d 1166 (2000)(determination of whether a duty exists involves weighing several discrete factors: (1) the relationship between the parties; (2) the social utility of the actors' conduct; (3) the nature of the risk imposed and foreseeability of the harm incurred; (4) the consequences of imposing a duty upon the actor; and (5) the over-all public interest in the proposed solution). See also Sovereign Bank v. BJ's Wholesale Club, Inc., 395 F. Supp. 2d 183 (M.D. Pa. 2005), quoting the Althaus factors. Although there was no relationship between Wyeth and Conte, it is conceivable that a Pennsylvania court could find that the other factors weigh in favor of imposing a duty of care on Wyeth, as the California court did. To counter such an argument, the message from California may be that name-brand manufacturers should marshal evidence that imposing such a duty on them would chill innovation and lead to uncontrolled, perpetual liability for them.