It has taken nearly three years, but the last of the five lawsuits against APA and others over the use of the drug Ritalin as a treatment for attention-deficit/hyperactivity disorder (ADHD) has quietly expired in a California courtroom.
On January 31 the U.S. Court of Appeals for the 9th Circuit upheld a U.S. district court judge’s dismissal of a conspiracy suit against APA and CHADD, an advocacy group that works on behalf of children with ADHD and their families. The suit also named Novartis Pharmaceuticals, maker of Ritalin, but the appeals court’s dismissal ruling did not include the drug company.
The California suit, along with similar ones filed in Florida, Texas, New Jersey, and Puerto Rico, alleged that the three organizations illegally conspired for years to promote and boost the sales of Novartis’s Ritalin brand of methylphenidate. (The drug was developed and marketed by Ciba-Geigy Pharmaceuticals beginning in 1955. In 1997 Ciba-Geigy merged with another Swiss drug maker, Sandoz, to form Novartis.)
All five suits were filed by parents who had purchased Ritalin after a physician prescribed it to treat a child diagnosed with ADHD. In each case the plaintiffs alleged that their suit was a class action and should thus include as additional plaintiffs all the parents in that state who had bought Ritalin after it had been prescribed for their children.
One by one the suits were dismissed by judges or withdrawn by the plaintiffs themselves after they learned of dismissals in other states.
"These lawsuits were attempts to deny the existence of ADHD, a disorder that affects millions of children," stated APA President Paul Appelbaum, M.D., in a press release following the ruling. He said that APA is "delighted" that the federal appeals court "confirmed that this litigation was utterly without merit."
The California suit alleged that in exchange for financial contributions from Novartis, APA "fraudulently and falsely" published ADHD criteria that it knew to be scientifically unreliable in its widely used Diagnostic and Statistical Manual of Mental Disorders(Psychiatric News, August 5, 2002; September 21, 2001; August 17, 2001). It charged that APA and Novartis had conspired to develop a definition of ADHD in the diagnostic manual that was unnecessarily broad and then tout the effectiveness of Ritalin as an important treatment for the disorder.
Child psychiatrist and APA Trustee-at-Large David Fassler, M.D., described the California judge’s ruling as "good news for APA and for the patients we treat." He told Psychiatric News that while APA "knew the allegations were without merit, the decision is certainly a welcome vindication. It’s also an endorsement of the scientific process used in the development of DSM-IV. We hope the outcome will discourage future suits of this nature."
In upholding the district court’s dismissal of the suit, the appeals court agreed that for APA and CHADD, the actions the plaintiff alleges are protected by a California free-speech statute known as the Strategic Lawsuit Against Public Participation—or SLAPP—law. It was enacted, the ruling pointed out, "to allow early dismissal of meritless First-Amendment cases aimed at chilling expression through costly, time-consuming litigation."
The appeals court did not, however, uphold the dismissal of the entire suit against Novartis. It noted that some of the allegations pertaining to Novartis that the lower court had dismissed because they did not meet the standards of the Federal Rules of Civil Procedures for pleading fraud were not actually based on fraud and, therefore, should not have been dismissed for failing to meet the heightened pleading requirements for fraud. As a result, the appeals court was not willing to uphold the dismissal of all charges against Novartis.
The appeals court also upheld the lower court’s ruling that dismissed the charges against all three defendants on the grounds that the plaintiff failed to provide any statements that could lend support to the circumstances of the fraud charges she was alleging against APA and the other defendants.
The appeals court ordered the plaintiff—Deborah Vess on behalf of her son, Todd Vess—to pay APA’s and CHADD’s costs related to filing the appeal. It ordered that Novartis’s costs were to be split between it and the plaintiff.
[Todd D.Vess, a minor; Deborah Vess, his guardian v. Ciba-Geigy, Novartis Pharmaceuticals, CHADD, American Psychiatric Association, No. 01-55834, D.C. No. CV-00-01839-RMB] ▪