WASHINGTON (Legal Newsline) - The Washington Legal Foundation recently filed a friend-of-the-court brief to support the overturning of a $124 million South Carolina Supreme Court decision regarding the information drug manufacturers share with doctors about the potential side effects of drugs.
The case, Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. South Carolina, questions whether civil penalties of $124 million should be imposed against Janssen under the South Carolina Unfair Trade Practices Act and is before the U.S. Supreme Court. The penalties were based on a letter sent to doctors in 2003 and on the drug information provided with each prescription of Risperdal.
South Carolina contends that the letter and documentation did not include adequate warnings about potential side effects of Risperdal, an antipsychotic drug manufactured by Janssen.
“We look upon it as a serious infringement on First Amendment rights,” said Richard Samp, chief counsel at WLF.
“A drug company sent a letter to doctors expressing its views about the efficacy of its FDA-approved drug and some plaintiffs lawyers representing the state of South Carolina disagreed with the views expressed by Janssen, and as a result of that there’s been a ($124 million) liability verdict entered.
"We don’t think that that’s the proper way to encourage discussion of important medical issues.”
The issue of the case rests on whether or not the Dear Doctor Letter can be considered fraudulent. In its 2015 opinion, the South Carolina Supreme Court wrote, “The unfair trade practices judgment against Appellant is supported by federal law, including the federal 'tendency to deceive' standard.”
In its brief, the Washington Legal Foundation said that fraud had not been adequately proven. The brief stated, “Throughout this litigation, Janssen has asserted that the statements contained in the Dear Doctor Letter and its label were truthful, and it introduced substantial evidence of truthfulness at trial.”
Samp said, “In order to prove fraud you have to show that the speaker did not believe what he was saying and intended to deceive.” The WLF contends that Janssen had no such intention.
“We think that a very important First Amendment principal is at stake,” Samp said. “When you’re talking about matters of public importance, and this clearly is, you may not sanction people for their speech without some evidence that they were speaking intentionally falsely.”
The case also involves the difference between free speech for private people and free speech for organizations.
“The Supreme Court has always differentiated when it comes to first amendment rights between what is known as commercial speech, usually advertising, and other types of non-commerical speech,” Samp said.
“While commercial speech is entitled to a number of protections, it has less.”
The information was sent by Janssen to doctors.
“Doctors don’t buy the product,” Samp said. “Doctors write prescriptions for a patient who then buys the product from a pharmacy. Whether this should be commercial speech at all is a major unresolved issue.”