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This article was published on Philly.com. The other thing to note is that the plaiontiffs are also sued Elsevier, a medical publisher which publishes The Pink Sheet, for publishing articles about the drug that “fraudulently convey false and misleading information concerning the safety and efficacy of Risperdal” and “conceal the risks of serious adverse events.”

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Lawsuits filed over drug side effects

By Stacey Burling

A Philadelphia law firm today said it filed 10 lawsuits on behalf of boys and young men who developed serious side effects – including the growth of breasts – while taking the antipsychotic medications Risperdal and Invega.

The suits were filed in Philadelphia Court of Common Pleas. Lawyer Stephen Sheller said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. His firm also has 10 cases involving boys who took Risperdal and another medication pending in New Jersey.

The drugs in the Philadelphia cases are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson. All of the companies, which are named in the suits, are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania, Sheller said.

Only one of the plaintiffs, a young man who took Risperdal in his teens, is from Philadelphia. He could not be reached for comment. The suit says he experienced rapid weight gain and developed breasts that will require surgical removal. The side effects caused him to suffer “mental anguish” and “embarrassment,” the suit said.

Sheller said some of his already-troubled clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain. “I would say 38D, some of them,” Sheller said. “No boy wants to have a B cup, certainly not a D.”

Janssen declined to comment. “We have not received details of the cases and are therefore unable to comment at this time,” spokeswoman Kara Russell said.

The suits also named Excerpta Medica Inc., of Bridgewater, N.J., and its parent, Elsevier Science Publishing Co. Inc., of New York. Sheller said the companies were involved in publishing ghostwritten studies they should have known were misleading or exaggerated. An Elsevier spokesman said the company had not had time to evaluate the suits.

Risperdal and Invega are antipsychotic drugs with similar chemical structures and side effects, Sheller said. In children and adolescents, Risperdal is FDA-approved for treatment of schizophrenia, bipolar mania, and symptoms of autism, said Kenneth Smith, an Alexandria, Va., lawyer who is working with Sheller on the cases. The drug is prescribed off-label to about 70 percent of the patients of all ages who take it, he said. Most of the patients in the Philadelphia cases were taking the drug off-label for problems such as attention deficit disorder, Tourette syndrome, and disruptive behavior.

Most of the suits, which accuse the drug company of negligence and fraud, involve patients who took Risperdal. One patient took Risperdal and Invega, Sheller said. The suits allege that Janssen did not adequately warn doctors and patients about the drugs’ dangers and actively promoted off-label uses of Risperdal. Sheller said the company had insisted that court documents in the New Jersey cases be sealed “for the improper purpose of preventing the public from learning about the true risks of adverse effects associated with Risperdal.”

Prescribing information for Risperdal on Janssen’s Web site mentions on page 11 that breast growth or gynecomastia is a potential side effect for drugs that elevate levels of the hormone prolactin, as Risperdal does. On page 33, it says that 2.3 percent of 1,885 children and adolescents in clinical trials reported this side effect. Smith said that data were added to the prescribing information in 2006.

Sheller said he believed the numbers were much higher. Other drugs can improve children’s behavior with fewer side effects, he said.

Rao Gogineni, head of child and adolescent psychiatry at Cooper University Hospital, said he had long been aware that Risperdal and other antipsychotic medicines could cause breast enlargement in children.

“We monitor it carefully, and we catch it early and stop it,” he said. He said his practice tested blood prolactin levels every few months. Gogineni, who has about 500 patients in his practice, said he had seen two or three children with breast growth in the last two years.

Read original article here:  http://www.philly.com/philly/business/homepage/20100107_Lawsuits_filed_over_drug_side_effects.html

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