The Supreme Court of Alabama held that the manufacturer of a brand-name prescription drug may be held liable for misrepresentation under Alabama law to a person who has been injured by the equivalent generic drug as a result of his physician’s reliance on the brand-name manufacturer’s misrepresentations. The opinion reaffirmed an earlier decision which had been challenged on rehearing by Wyeth, Inc., and numerous amici (Products Liability Council, United States Chamber of Commerce, Business Council of Alabama, and others).
Cunningham Bounds (along with Center for Constitutional Litigation Counsel’s Chief Litigation Counsel Louis Bograd ) appeared asamicus curiae on behalf of the American Association for Justice in support of reaffirmance.
The Alabama Supreme Court began its analysis by noting that plaintiff Weeks' claim was for misrepresentation, not products liability: "This is not a claim that the drug ingested by Danny was defective; instead, it is a claim that Wyeth fraudulently misrepresented or suppressed information about the manner in which (i.e., the duration) the drug was to be taken." The Court then concluded that Weeks' claim satisfied all of the traditional elements of fraudulent misrepresentation under Alabama law.
The Court first determined that it was reasonably foreseeable that Weeks' physician would rely on Wyeth's representations in prescribing the generic equivalent:
the labeling for a generic drug is required by federal regulations to be the same as the labeling for the brand-name drug. Therefore, an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product. A brand-name manufacturer is well aware of the expiration of its patent and well aware that a generic version of the drug will be made when that patent expires. It is recognized that generic substitutions are allowed in all 50 states. A brand name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.
The Court next rejected Wyeth's argument that it could not be liable because it made no representations directly to the plaintiff:
Wyeth's argument completely ignores the nature of prescription medication. The Weekses cannot obtain Reglan or any other prescription medication directly from a prescription-drug manufacturer. The only way for a consumer to obtain a prescription medication is for a physician or other medical professional authorized to write prescriptions (i.e., a learned intermediary) to prescribe the medication to his or her patient. This Court has adopted the learned intermediary doctrine, which provides that a prescription-drug manufacturer fulfills its duty to warn users of the risk associated with its product by providing adequate warnings to the learned intermediaries who prescribe the drug and that, once that duty is fulfilled, the manufacturer owes no further duty to the ultimate consumer. When the warning to the prescribing health-care professional is inadequate, however, the manufacturer is directly liable to the patient for damage resulting from that failure.
Finally, the Alabama Supreme Court rejected the argument that Wyeth owed no duty to the user of a generic drug. Under Alabama law, the Court declared:
there is a duty not to make a false representation (1) to those to whom a defendant intends, for his own purposes, to reach and influence by the representation; (2) to those to whom the defendant has a public duty created by statute or pursuant to a statute; and (3) to those members of a group or class that the defendant has special reason to expect will be influenced by the representation.