Last of Ritalin-Based Lawsuits Against APA Comes to a Close

And then there were none. The plaintiffs in the fifth of five Ritalin-related lawsuits against APA and Novartis Pharmaceutical have withdrawn their class-action suit.

The last of the suits to come to an early end was the one filed in federal court in New Jersey, and it was withdrawn by the plaintiffs on February 5. Similar suits in California, Florida, Texas, and Puerto Rico have already been dismissed by judges or withdrawn by the plaintiffs before they got to trial (Psychiatric News, June 15, 2001; August 17, 2001; September 21, 2001).

All five of the suits alleged that APA and Novartis engaged in an illegal conspiracy to boost the sales of Novartis’s Ritalin brand of methylphenidate and thus improve the company’s bottom line. The suits charged that to achieve these increased profits for Novartis, APA and the drug company conspired to define the diagnosis of attention deficit disorder (ADD), and later attention-deficit/hyperactivity disorder (ADHD), which have appeared in the last several editions of APA’s Diagnostic and Statistical Manual of Mental Disorders (DSM), in an unnecessarily broad manner. The suits then allege that APA and Novartis touted the efficacy of Ritalin as a treatment for the disorder.

Ritalin, which came on the market in 1955, was developed by Swiss drug maker Ciba-Geigy. That company merged with Sandoz Pharmaceuticals in 1997, and the new company took the name Novartis. For decades Ritalin was the only brand of methylphenidate available, though with its patent protection now expired, generic versions of the drug are being manufactured by other companies.

There is a substantial body of scientific data gathered over several decades showing that methylphenidate is an effective treatment for children with ADD or ADHD.

The New Jersey lawsuit, along with the other four, was filed by a parent who had purchased Ritalin after a physician had prescribed it to treat a child diagnosed with ADD or 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 that had been prescribed for their children. If certified as a class action, all of the plaintiffs in the class would have been eligible to receive an award for damages if courts had found APA and Novartis guilty of the charges.

The five suits also named as a defendant the advocacy group Children and Adults With Attention Deficit/Hyperactivity Disorder (CHADD). They contended that CHADD received money from Novartis and then conspired with the company to promote the use of Ritalin for children who showed signs of hyperactive behavior.

Last October the judge in the New Jersey suit, Charles Walsh of the Superior Court of New Jersey in Bergen County, ruled that the plaintiffs’ claim was insufficiently specific. He gave them 90 days to provide additional material to bolster their charges. The plaintiffs did not follow through on the judge’s order, and once the deadline had passed decided to withdraw their complaint.

On learning of the New Jersey plaintiffs’ decision to withdraw their suit, APA President Richard Harding, M.D., told Psychiatric News, “It is very gratifying to see our judicial system work. Once the facts were brought into the open, there was no doubt about what the eventual outcome of these cases would be.”

What is a shame, Harding stressed, “is the enormous waste of resources” that defending itself against these charges cost APA. “While the whole episode was a tremendous waste of time, money, and resources for all the parties, we made it clear from the beginning that APA would do whatever was necessary to defend the scientific basis of diagnostic nomenclature, our profession’s freedom to choose appropriate treatments for the patients we serve, and vigorously take on those who oppose these principles in the court and in the court of public opinion.

“The medical profession never stands taller than when it refuses to allow a court to modify or ban a proven medical intervention for a proven medical disorder,” he said.

Dorothy Watson, general counsel for Novartis, stated that the failure of all five suits “sends a strong message that the decision of how to treat ADHD is between the parent, patient, and physician and has no place in the courts.”

While the withdrawal of the charges appears to signal the end of the New Jersey lawsuit, the fact that the plaintiffs exercised a voluntary withdrawal means that they can renew it at some point. To ensure that does not happen, APA may ask the judge to ignore the voluntary dismissal and rule on the merits of the case. If the judge dismisses the case with prejudice, it would preclude its being brought again.

All of the suits were filed by lawyers who had had considerable success filing nationwide class-action suits against huge corporations, particularly those in the tobacco industry. They, along with some antipsychiatry activists, apparently hoped that these five suits would spawn dozens of others across the United States in a crusade against both organized psychiatry and the pharmaceutical industry. ▪