California court: Wyeth accountable for harms caused by generic metoclopramide

On November 7, the First District Court of Appeal in San Francisco, California, overturned a previous ruling in the case of Conte v Wyeth and ruled that Wyeth, the manufacturer of Reglan (metoclopramide), should be held responsible for harm caused to Elizabeth Conte, who developed tardive dyskinesia after taking generic metoclopramide for nearly 4 years. The court upheld the previous ruling in favor of Purepac, Pliva, and Teva, manufacturers of generic metoclopramide.

On November 7, the First District Court of Appeal in San Francisco, California, overturned a previous ruling in the case of Conte v Wyeth and ruled that Wyeth, the manufacturer of Reglan (metoclopramide), should be held responsible for harm caused to Elizabeth Conte, who developed tardive dyskinesia after taking generic metoclopramide for nearly 4 years. The court upheld the previous ruling in favor of Purepac, Pliva, and Teva, manufacturers of generic metoclopramide.

The original ruling in favor of Wyeth was based partly on the tenet that, as a name-brand manufacturer, Wyeth does not owe duty to use due care to patients who take generic versions of its brand-name medications. The appeals court stated, however, that “Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent.”

Conte took generic metoclopramide for gastroesophageal reflux disease (GERD) from August 2000 to April 2004; she was never administered Reglan. She asserted that she was overexposed to metoclopramide, which is only approved for 12 weeks of use, because of the manufacturers’ “dissemination of false, misleading and/or incomplete warnings about the drug’s side effects.”

Conte asserted that her physician relied on Wyeth’s prescribing information for Reglan when he prescribed metoclopramide; the court suggested that this evidence is “equivocal” but supports a “reasonable inference” that the physician did rely on the prescribing information for Reglan, adding that because generic drugs must be biologically equivalent to their name-brand versions, it is “eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth’s representations about Reglan.”

The court stated that it was “unpersuaded by Wyeth’s assertion that imposing liability would undermine the goal of preventing future harm because it would chill innovation in the pharmaceutical industry,” noting that no evidence had been provided to support such a claim.

The judgment in favor of Purepac, Pliva, and Teva was upheld because, as the appeals court stated, there was no evidence that Conte’s physician relied on the prescribing information from any of these manufacturers.

For a more detailed analysis of this court case, please see the articleConte v Wyeth.