High Court Won’t Hear Risperdal Speech Case

The U.S. Supreme Court rejected 1/11 a petition filed by Ortho-McNeil-Janssen asking it to review a South Carolina Supreme Court decision that imposed a $124 million civil penalty against Janssen for a “Dear Doctor” letter it sent involving the label for its Risperdal (risperidone) anti-psychotic drug. The South Carolina attorney general filed suit against the company claiming that it violated the state’s unfair trade practices act because of the letter and because of the FDA-approved Risperdal label that the state said did not contain adequate warnings about side effects.,

Washington Legal Foundation (WLF) and Pharmaceutical Research and Manufacturers of America (PhRMA) had filed amicus briefs urging the court to hear the case. WLF argued that Janssen consistently asserted before all South Carolina courts that the statements in its Dear Doctor letter were truthful and the state never demonstrated that anyone was misled or harmed by the speech. It said that the South Carolina Supreme Court held that the decision did not violate the company’s First Amendment rights because it found that the company’s actions were unfair or deceptive and thus unlawful under state law.

According to WLF, there is significant public interest in encouraging an open exchange of information about the side effects of antipsychotic drugs. “The decision below, by imposing a huge judgment against a drug manufacturer based on speech not containing a knowing or reckless falsehood, is likely to have a chilling effect on such speech,” it cautioned. It said that high court review was warranted to determine whether government speech regulation of this sort is consistent with the First Amendment.

In its brief, PhRMA said that under the state’s theory, it did not matter whether the drug was harmful or miraculous. And the jury was instructed that it did not need to find that the company’s speech was actually false or that the company had any intent to deceive. The trade group said the state suit “punishes protected speech in violation of the First Amendment, runs headlong into FDA’s exclusive marketing authority over labeling and marketing of pharmaceutical products, and imposes an unconstitutionally excessive fine.” It also cautioned that without Supreme Court review, the decision “will encourage 50 roving state regulators to upend the important aspects of the federal scheme for enforcing the Federal Food, Drug, and Cosmetic Act. Litigation was proliferating before the decision; now it could redouble.”