## Facts

- Metoclopramide is the generic equivalent of the brand-name drug Reglan.
- Federal law requires generic-drug labeling to be the same as the corresponding brand-name labeling.
- Danny Weeks was prescribed and ingested only generic metoclopramide for an extended period and alleged he developed tardive dyskinesia and related injuries.
- Weeks alleged brand-name manufacturers knew long-term use posed a substantially higher risk of severe neurological side effects than their labeling disclosed.
- Weeks and his wife sued brand-name manufacturers, asserting Alabama tort claims including fraudulent misrepresentation, fraudulent suppression, negligent misrepresentation, and misrepresentation-based failure-to-warn theories.
- Weeks conceded the brand-name defendants did not manufacture or sell the pills he ingested.
- The federal district court certified to the Alabama Supreme Court whether Alabama law permits misrepresentation-based liability against a brand-name manufacturer when the plaintiff consumed only a generic made by another company.

## Issues

1. Whether, under Alabama law, a brand-name drug manufacturer may owe a duty supporting fraud or misrepresentation claims to a plaintiff injured by ingesting only the generic equivalent made by another manufacturer.
2. Whether the absence of product identity (the defendant did not make or sell the ingested product) categorically bars misrepresentation-based failure-to-warn claims.
3. Whether foreseeability of prescribing-physician reliance on brand-name labeling, given the federal “same labeling” requirement, can support duty and proximate causation.

## Decision

- The Alabama Supreme Court answered the certified question “Yes.”
- A brand-name manufacturer may be subject to fraudulent misrepresentation, fraudulent suppression, negligent misrepresentation, and related misrepresentation-based failure-to-warn theories even when the plaintiff ingested only the generic equivalent.
- The Court emphasized the ruling concerns misrepresentation-based theories tied to warnings and labeling, not strict products-liability claims for a defective product.
- The Court grounded duty in the brand-name manufacturer’s role as originator of labeling that generic manufacturers must copy and in the foreseeability that physicians will rely on that information when prescribing generics.
- The matter returned to federal court for further proceedings without dismissal solely on the ground that the defendants did not manufacture the product ingested.

## Legal Principles

- In misrepresentation-based warning cases, duty may arise from a manufacturer’s superior knowledge and its obligation to communicate risk information, not from having made the specific unit of product ingested.
- Because generic labeling must match brand-name labeling, it is reasonably foreseeable that prescribing physicians will rely on brand-name warnings and representations when prescribing the generic equivalent.
- Alabama law does not impose a categorical bar to liability in misrepresentation claims merely because the defendant did not manufacture or sell the injurious product, where alleged misstatements or omissions foreseeably induce third-party reliance that proximately causes injury.
- The learned intermediary doctrine supports focusing on whether the prescribing physician relied on the challenged labeling and warnings.
- Plaintiffs must still prove the traditional elements of the asserted torts (including reliance and causation); the decision addresses only whether a duty and potential liability can exist on these facts.

## Conclusion

The Alabama Supreme Court held that brand-name drug manufacturers can face misrepresentation-based claims for allegedly inadequate warnings and labeling by plaintiffs injured from ingesting only the generic equivalent, where it is foreseeable that a prescribing physician would rely on the brand-name labeling that generic manufacturers are required to duplicate.


Wyeth, Inc. v. Weeks, 159 So. 3d 649 (Ala. 2014)