Court finds Wyeth liable for generic’s harm

The court ruled that brand name pharma companies can be held liable in proceedings brought against manufacturers of generic versions of their drug.

If the ruling stands pioneer manufacturers could be struck by a double blow when a drug comes off patent, with an increased chance of being sued adding to the harm to profits caused by generic competition.

Wyeth is accused of producing warning labels that understated the dangers of using Reglan over a prolonged period of time. Although the patient did not take Wyeth’s Reglan, the fact that the physician could have “foreseeably​” relied upon its warning labels makes it liable under the court ruling.

The court ruling states that brand name manufacturer’s duty of care: “extends not only to consumers of its own product, but also to those 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​.”

Elizabeth Conte brought the case after she developed tardive dyskinesia, which was allegedly caused by taking generic versions of Wyeth’s Reglan (metoclopramide) for nearly four years.

Proceedings were brought against the generic manufacturers Teva Pharmaceuticals, Pliva and Purepac Pharmaceuticals and also Wyeth, the pioneer developer of the drug.

A court had previously ruled that Wyeth could not be held to account for harm caused by a product it had not manufactured but this was overturned on appeal in a 3-to-0 decision.

Conte’s actions against Wyeth were based on alleged misrepresentations in Wyeth’s labeling of Reglan and in a monograph it provided for the Physician’s Desk Reference (PDR).

Dr Elsen, who prescribed the generic versions of Reglan to Conte, testified that he “probably” read Wyeth’s monograph in the PDR during his residency training.

He also said that he generally refers to the PDR when considering prescribing Reglan and that he believed the information it contained was accurate.

The appeals court ruled that a defendant who writes and distributes “information about a product manufactured and sold by another may be liable for negligent misrepresentation​.”

Californian common law is used to support the ruling, which cites a case in 1969 against a magazine publisher. The appeals court uses this case to claim that its ruling is “not marking out new territory​”.

However, the ruling serves to highlight the aspect of Californian common law to potential claimants and lawyers, which could lead to similar cases being brought in the future.

The full court ruling can be found here​.