Tuesday, 05 28, 2013
Shelley Catharine Johnson
Deputy Communications Director
Kentucky Attorney General Jack Conway and his Office of Consumer Protection today announced a lawsuit against Johnson & Johnson, Inc. and subsidiaries (J&J) for violating the Kentucky Consumer Protection Act by unfair, false, misleading, or deceptive labeling and promotion of its antipsychotic drug Risperdal.
The lawsuit, filed in Jefferson County Circuit Court, alleges that J&J hid the risks of Risperdal from Kentucky patients and doctors. Risperdal is part of a class of “second-generation” or “atypical” antipsychotic drugs. It was initially approved by the FDA for the treatment of schizophrenia, a condition affecting less than 1% of the population, and promoted by J&J more widely for other indications.
The Attorney General’s lawsuit alleges that J&J knew, yet concealed from consumers, that Risperdal carried an increased risk of dangerous side effects including clinically significant weight gain, diabetes, hyperglycemia (high blood sugar), hyperprolactinemia (high blood levels of prolactin) and gynocomastia (male breast development), and cerebrovascular adverse events including stroke and increased risk of death in the elderly with dementia. For example, in 1999 J&J had a clinical study that showed Risperdal was linked to increased incidence of diabetes and significant weight gain, but the results of that study were only made public a decade later through litigation over the drug, the suit alleges.
“The filing of today’s Complaint sends a clear message to pharmaceutical drug companies that they will not endanger the lives and health of the citizens of the Commonwealth,” General Conway said. “We will not stand idly by as a drug company profits from endangering the very people it is supposed to help.”
The lawsuit also alleges that, despite knowledge to the contrary, J&J represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug, including low weight gain. Furthermore, J&J allegedly instructed its sales force to communicate that Risperdal had a zero percent rate of diabetes in trials, contrary to its own study result. The suit also alleges that despite J&J’s knowledge to the contrary, the label for Risperdal did not warn consumers of the increased risk of cerebrovascular events such as stroke in the elderly with dementia until 2003, and did not warn consumers of the risk of hyperprolactinemia, which is higher than any other antipsychotic drug on the market, until 2007.
General Conway’s lawsuit seeks injunctive relief and civil penalties of up to $2,000 per violation and up to $10,000 per violation directed at consumers over age 60. The injunctive relief sought would seek to prevent J&J from future promotion or marketing of its drugs within the Commonwealth in an unfair, false, misleading or deceptive way.
Several other state Attorneys General have filed similar litigation against J&J over Risperdal.