SAN FRANCISCO (Legal Newsline) - A California appeals court upheld the dismissal of lawsuits against Wyeth and other pharmaceuticals companies over a heart drug that was once criticized by Ted Kennedy and is supposed to be used only as a last resort because of its dangerous side effects.
California patients who were prescribed amiodarone, sold under the brand name Cordarone, between 2005 and 2017 claimed doctors were misled into using it as a first-line treatment and companies failed to warn them about the dangerous side effects. The patients also said they wouldn’t have taken it if they had received a “Medication Guide” as required by the Food and Drug Administration.
A trial court dismissed the claims as preempted by federal law and California’s First Appellate District Court, Division Two, upheld the dismissal in a November 3 decision. Any claims the warnings were inadequate run up against the learned intermediary doctrine, the appeals court ruled, under which drug companies have a duty to warn physicians, not patients, and the drug was sold with an FDA-approved warning label. Even if the companies violated FDA rules by failing to distribute patient medication guides, the court said, only the government can enforce that rule.
Amiodarone was first imported into the U.S. for off-label use to treat life-threatening ventricular fibrillation and tachycardia that didn’t respond to other therapies. The Food and Drug Administration approved it for use in the U.S. in 1985, but only on a “special needs” basis.
In 1989 the FDA warned Wyeth against claiming “an early decision for Codarone can improve the odds” in its off-label marketing. Then-Sen. Ted Kennedy later issued a press release condemning the promotion as “putting patients at risk.” Multiple other drug companies later sold generic amiodarone.
The plaintiffs argued the learned intermediary rule was an affirmative defense that required the drug companies to prove they provided adequate warnings to physicians. They relied on two cited two unpublished orders by federal courts remanding cases to state court in California with notes suggesting the learned intermediary doctrine was an affirmative defense, but without any analysis.
The appeals court said it wasn’t aware of any California decision supporting the idea, however, and held the burden was on the plaintiffs to prove the warnings to physicians were inadequate.
As an alternative argument, the plaintiffs said the drug companies misled the doctors and thus had a duty to warn patients directly. But the allegations of misleading marketing dated from years before the plaintiffs claimed injury, the court concluded.
Since 11 years had passed between when Wyeth was accused of misrepresentation and when patients were supposedly harmed, the court ruled, “as a matter of law plaintiffs have not alleged facts to show that Wyeth’s promotion is a proximate cause of their injuries.”
The court also rejected claims Wyeth funded third-party research that misrepresented the safety of the drug, saying the fact it provided some grants to researchers didn’t rise to the level of supporting the idea it controlled the content of the articles.