APA is vowing to wage a forceful effort to fight a class-action lawsuit alleging that it illegally conspired with Novartis Pharmaceutical Corporation and its Ciba-Geigy division to boost profits for the company’s stimulant drug Ritalin (methylphenidate).

The suit was filed in a state court in Brownsville, Tex., by attorneys for three individuals who bought Ritalin that had been prescribed for their children’s attention-deficit/hyperactivity disorder (ADHD).

The suit was quickly shifted to the U.S. District Court for the Southern District of Texas based on the diversity of citizenship of the plaintiffs, who are residents of Texas, and the three defendants.

The suit charges that APA and the drug manufacturer engaged in a concerted campaign to promote the diagnosis of ADHD and the efficacy of Ritalin in treating the disorder. It alleges as well that APA received financial gain from Ciba-Geigy (which in 1996 merged with Sandoz to form Novartis) for taking part in this public relations initiative.

Also named as a defendant is the citizens organization Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD), an organization of parents that the plaintiffs allege receives funding from Novartis.

The plaintiffs—Maria Elena Hernandez, Miguel Hernandez, and Heather Butler—are suing as individuals and on behalf of everyone in the U.S. who purchased Ritalin to treat their children’s ADHD in the four years preceding the filing of this suit. If the court sanctions the class-action aspect of the suit, it could encompass millions of plaintiffs whose children have taken Ritalin after an ADHD diagnosis.

The plaintiffs claim that APA colluded with Ciba-Geigy, which began manufacturing Ritalin in 1955, "to create, develop, promote, and confirm the diagnoses of Attention Deficit Disorder [ADD] and [ADHD] in a highly successful effort to increase the market for its product Ritalin."

They charge that as a result of the alleged conspiracy, APA developed and included the ADD diagnosis in the third edition of its Diagnostic and Statistical Manual (DSM-III), which was published in 1980. They maintain that a similar process led to the inclusion of ADHD as a diagnosis in DSM-III-R, which was released in 1987.

The plaintiffs insist that when symptoms or behaviors are given a diagnosis in DSM, they take on heightened significance in the form of "an official-seeming medical imprimatur." In the case of ADD and ADHD, they claim that the behaviors labeled as a psychopathology "may, in fact, be normal," but once such a diagnosis is created, it "generates vast numbers of new prescriptions" and leads to increased insurance coverage and substantial attention from the public.

In addition to alleging a conspiracy between APA and the drug maker, the plaintiffs charge that Ciba/Novartis boosted Ritalin sales by "actively promoting and supporting the concept that a significant percentage of children suffer from a ‘disease’ which required narcotic treatment/therapy," that this medication was the "drug of choice" in treating ADD and ADHD, and that the company bankrolled organizations such as CHADD so members would legitimize the diagnoses and the need to use Ritalin to treat them.

They further charge that APA, the drug manfacturer, and CHADD committed fraud by providing misleading, inadequate, or incorrect information about the use and efficacy of Ritalin to physicians, the public, and school personnel.

The case is currently in the discovery phase during which each party may be asked to identify and turn over to the other party’s attorneys all documents—whether written or electronic—that those lawyers believe may be relevant to the case. The documents that the plaintiffs’ attorneys have requested from APA are all those that reflect communications about Ciba/Novartis, the ADD and ADHD diagnoses, and Ritalin and other psychostimulant treatments for the disorders from 1975 to the present.

In condemning the suit as "groundless," APA Medical Director Steven Mirin, M.D., emphasized that DSM-IV and the preceding editions of the diagnostic manual were "developed through an open process involving more than 1,000 nationally and internationally known researchers and clinicians drawn from a wide range of mental and general health fields." He pointed out as well that the DSM criteria "are accepted and used by mental health and medical professionals worldwide" and are "fully consistent" with the World Health Organization’s International Classification of Diseases.

"The allegations. . .are an opportunistic attack on the scientific process that underlies this effort," Mirin stated.

In a written response to the suit, Novartis states that the charges are all without merit and vows to "defend the suit vigorously."

The company maintains that ADHD is an extremely well-studied disorder and that reports of its symptoms and treatment have appeared in the country’s leading medical journals. It points out that "Ritalin has been used safely and effectively in the treatment of millions of ADHD patients for over 40 years and is the most studied drug prescribed for the disorder, with over 170 studies completed in more than 6,000 school-aged children."

The plaintiffs’ attorneys are asking the court to order the refund of all money paid by everyone in the class to purchase Ritalin in the last four years, treble damages as a result of the fraud allegations, monetary damages, and an order barring any of the defendants "from failing to provide all known information concerning the lack of long-term efficacy of Ritalin . . .to purchasers, doctors, educators, and the general public."