Healthy Skepticism Library item: 14294
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Sandlin S.
State Sues Maker of Risperdal
Albuquerque Journal 2008 Sep 12
http://www.abqjournal.com/news/state/12112857240newsstate09-12-08.htm
Full text: Risperdal is a wildly successful antipsychotic drug that has made millions for the Johnson and Johnson subsidiary that developed and marketed it.
But the New Mexico Attorney General’s Office contends that the manufacturer, Janssen, a division of Ortho-McNeil-Janssen Pharmaceutical Inc., hid the dangers of the product and marketed it to populations for which it was never intended – particularly the elderly and children.
The state claims the company’s alleged promotion of the drug for nonmedically necessary uses cost New Mexico taxpayers millions of dollars out of the Medicaid program to reimburse patients who were prescribed Risperdal. And it also claims a host of state laws were broken in the process, including the Unfair Practices Act.
Janssen spokeswoman Kara Russell said the company is committed to the highest ethical standards and responsible behavior. She said Janssen routinely informs and discloses all appropriate information about its drugs, including Risperdal, to the medical community, governments and agencies.
The company promotes its drugs only for uses approved by the U.S. Food and Drug Administration, she said. For Risperdal, those are bipolar mania, schizophrenia and the irritability associated with autistic disorder.
“We only promote our products for the indications for which they are approved,” Russell said.
According to the lawsuit:
Janssen got FDA approval to market Risperdal oral tablets for the treatment of schizophrenia in 1993 and for variations to treat bipolar disorder in 2003. But the drug has shown a propensity for its users to gain weight, have movement disorders and other health problems, including diabetes.
Since its launch, the maker has “engaged in widespread fraudulent statements and conduct, and pervasive false and misleading marketing, advertising and promotion.” The maker failed to warn and misled physicians, consumers and the state regarding its adverse effects.
The maker actively marketed the drug for uses in several populations where its safety had not been established, such as people with sleep disorders, elderly patients with dementia and patients with depressive or mood disorders.
The alleged scheme was carried out by directly soliciting physicians to prescribe it by giving false information to them and to pharmacists, including the development of deceptive and misleading medical literature and funding of questionable scientific literature.
One marketing plan used company-funded events at which doctors selected, trained and approved by Janssen would falsely oversell Risperdal’s safety and effectiveness, according to the complaint.
The strategy worked, making more than two-thirds of all dollars spent on Risperdal going for nonmedically necessary uses and making the drug the mostly widely used antipsychotic of its type in the world, with sales skyrocketing to $3.5 billion in 2005.
The lawsuit was filed for the Attorney General’s Office in the 1st Judicial District Court in Santa Fe by a Houston civil litigation firm, Bailey Perrin Bailey, which specializes in lawsuits over the new generation of antipsychotic drugs known as atypical antipsychotics. The firm represents other states in lawsuits over Risperdal, including one filed in Pennsylvania state court in February.
The lawsuit is the second time in two years the state has sued a drugmaker raising questions about state obligations under federal Medicaid law, as Janssen attorney Douglas Schneebeck of the Modrall law firm noted in removing the lawsuit to federal court.
