Ortho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson, was just ordered to pay over $327 million in penalties over how it marketed <"http://www.yourlawyer.com/topics/overview/risperdal">Risperdal, allegedly using deception in its claims that the controversial antipsychotic is a safer, better version than what the competition offers. Risperdal (Generic: Risperidone) is a newer atypical antipsychotic drug prescribed to help people combat Schizophrenia and Bi-Polar Disorder.
We just reported that drug giant, Johnson & Johnson earmarked an unknown sum of money to resolve its Risperdal woes with the federal governmentâ€”a separate action; federal prosecutors are seeking about $1 billion in connection to allegations of illegal marketing of the antipsychotic medication.
According to Judge Roger Couch of Spartanburg, South Carolina, Ortho-McNeil-Janssen violated South Carolinaâ€™s consumer protection laws on an ongoing, routine basis by writing to doctors in 2003 promoting Risperdal as better than its competitorâ€™s drugs; the letters also contained what was described as deceptive information in Risperdalâ€™s warning label, wrote Bloomberg News. Judge Couchâ€™s 17-page ruling also stated that executives at Ortho-McNeil-Janssen, quoted Bloomberg News, â€œallowed the profit-at-all-costs mentality to cloudâ€ their judgment concerning how the drug was marketed and labeled.
Ortho-McNeil-Janssen disagrees, saying they will appeal the order, and arguing it fully disclosed health risks associated with Risperdal and appropriately conducted the drugâ€™s marketing. â€œWe donâ€™t believe that the dissemination of an FDA- approved package insert constitutes a violation of the South Carolina Trade Practices Act,â€ said Kara Russell, a Janssen spokeswoman, quoted Bloomberg News. â€œWe do not believe the ruling can be upheld on appeal,â€ Russell added in her emailed statement.
Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.
South Carolinaâ€™s case concerned claims made by Johnson & Johnson and Ortho-McNeil-Janssen in its 2003 correspondence sent to some 700,000 United States Physicians, said Bloomberg News. The U.S. Food and Drug Administration (FDA) responded with a warning letter that stated that Johnson & Johnson made false and misleading claims that played down the possibly fatal outcomes related to diabetes and that also exaggerated Risperdalâ€™s benefits versus its competition.
Defective Risperdal labeling involved at least 772,000 prescriptions in South Carolina alone from 1994 to 2007; was involved in 183,144 sales calls made to physicians by the drug makerâ€™s representative; and appeared on 496,545 distributed sample boxes, according to the stateâ€™s lawyers, said Bloomberg News. Judge Couch said that he found the Risperdal letter that was distributed to South Carolina physicians to be a â€œclever effortâ€ to â€œmanipulate the messageâ€ about Risperdal, quoted Bloomberg News.
Judge Couch found that penalties were in order for about 7,180 of the letters and 36,372 cases in which Risperdal representative used the document to market the drug in person, said Bloomberg News, citing court records. Penalties were based on the rate of about $4,000 per violation of South Carolinaâ€™s consumer-protection laws, according to Judge Couchâ€™s ruling. The judge also said that 509,499 sample boxes of Risperdal distributed in North Carolina contained deceptive labeling that called for penalties; North Carolina was awarded $152.8 million in penalties, at a rate of $300 per violation.