Drug giant, Johnson & Johnson, has lost an Arkansas Risperdal lawsuit. Risperdal is an anti-psychotic that has been linked to adverse health reactions.
Janssen Pharmaceuticals Inc., a Johnson & Johnson subsidiary, was accused of minimizing and hiding risks linked with Risperdal, said a jury in the billion-dollar lawsuit, according to Bloomberg Businessweek. The plaintiff’s attorney is seeking fines of upwards of $1.2 billion for some 250,000 million Risperdal prescriptions in Arkansas’ Medicaid program that were paid over the course of 3 ½ years said Businessweek. Penalty decision will take place in a separate hearing, today, before Circuit Judge Tim Fox, who also presided over the trial.
It took the 12-person jury three hours to return its findings after hearing 10 days of testimony. The economics of the case were not provided to the panel, said Businessweek, which noted that both Janssen and Johnson & Johnson face dozens of similar Risperdal lawsuits in federal court and in other state courts.
As we’ve previously explained, antipsychotics are approved for serious psychiatric conditions; however, the drugs can be used at physician discretion and are being used for a range of disorders. Some of these other uses have seen recent approval by the U.S. Food and Drug Administration (FDA); many have not.
Jansen argued that it broke no laws and noted that Risperdal’s package insert was approved the FDA, said Businessweek. “
Janssen firmly believes it did not violate the Arkansas Medicaid Fraud False Claims Act or the Arkansas consumer fraud statute. Among other concerns, we believe the dissemination of an FDA-approved package insert did not constitute a violation of any Arkansas law. It is our position that an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules,” said Janssen in a statement last night.
Plaintiffs allege that Janssen lied to physicians saying that Risperdal does not lead to weight gain, diabetes, and other adverse health effects, specifically in senior patients. Meanwhile, the FDA directed Janssen to write to doctors correcting an prior letter that said Risperdal did not increase risks for developing diabetes, said Businessweek.
Texas also sued over Risperdal, reaching a $158 million settlement with Janssen, which admitted no fault, noted Businessweek.
We’ve long written about the links between antipsychotic medications and a number of adverse reactions, including reactions linked to Risperdal and a lack of proof of efficacy and associations with some serious side effects.
Atypical antipsychotics have been the focus of thousands of lawsuits; the drug class is also the single, largest spotlight for lawsuits filed under the federal False Claims Act. Every key drug company selling atypical antipsychotics have either settled lawsuits in the hundreds of millions of dollars or are the subject of probes concerning the massaging of results or use of questionable marketing.