## Facts

- Elizabeth Ann Conte, treated for GERD, was prescribed metoclopramide and took only generic versions for nearly four years.
- Conte developed tardive dyskinesia, a serious and irreversible neurological condition, allegedly from long-term metoclopramide use.
- Wyeth manufactured the brand-name drug Reglan and authored the labeling and product information that generic makers were required to match under federal regulations.
- Conte alleged Wyeth’s warnings understated the risk of serious neurological effects from use beyond 12 weeks despite knowledge that physicians often prescribed longer courses.
- Conte claimed her physician relied on Wyeth’s product information in prescribing metoclopramide, even though the pharmacy dispensed a generic product.
- Conte sued Wyeth and three generic manufacturers (Pliva, Purepac, Teva) for negligence, negligent misrepresentation, and fraud/misrepresentation based on alleged warning and labeling deficiencies.
- The trial court granted summary judgment for all defendants, concluding (as to Wyeth) no duty to generic users and insufficient reliance, and (as to generics) lack of reliance and federal preemption.
- Conte appealed.

## Issues

1. Whether a brand-name manufacturer owes a common-law duty of care for negligent misrepresentation and related claims to a patient who ingested only the generic equivalent, when the prescriber allegedly relied on the brand-name manufacturer’s product information.
2. Whether there was a triable issue that Conte’s physician relied on Wyeth’s product information.
3. Whether Conte produced sufficient evidence of reliance on the generic manufacturers’ information to defeat summary judgment, and whether preemption needed to be reached.

## Decision

- The court reversed summary judgment for Wyeth on the misrepresentation-based claims.
- The court held Wyeth’s duty of due care in providing product warnings can extend to patients who used only generics when physicians foreseeably rely on Wyeth’s labeling and product information.
- The court found evidence created a material factual dispute regarding the physician’s reliance on Wyeth’s information, precluding summary judgment.
- The court affirmed summary judgment for the generic manufacturers because Conte failed to show her physician relied on any information supplied by them.
- Because lack of reliance disposed of the claims against generics, the court did not decide the asserted federal preemption defense.

## Legal Principles

- A drug manufacturer’s duty to use due care in communicating warnings and safety information may extend beyond consumers of its own product when the manufacturer’s information is intended to influence prescribers and reliance by prescribers is foreseeable.
- Misrepresentation-based claims may be analyzed as informational torts; product-identification limits associated with strict products liability do not necessarily control when liability is based on allegedly misleading warnings or statements.
- Foreseeability that physicians will rely on brand-name labeling, combined with regulatory requirements that generic labeling match the brand, can support a duty running to patients dispensed generic equivalents.
- Traditional tort limits—proof of reliance, causation, and foreseeability—function as constraints on the scope of liability.
- Reliance remains an essential element of negligent misrepresentation and intentional misrepresentation claims; absence of evidence of reliance warrants summary judgment.

## Conclusion

The court held that a brand-name manufacturer may be liable for misrepresentation-based claims by a patient who took only generic metoclopramide when the prescribing physician foreseeably relied on the brand-name labeling, reversed summary judgment for Wyeth due to a triable reliance dispute, and affirmed judgment for the generic manufacturers for lack of reliance evidence.


Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008)