A South Carolina judge ordered Johnson & Johnson to pay $327 million in penance for mismarketing its antipsychotic drug Risperdal. The civil judgment against J&J's Ortho-McNeil-Janssen Pharmaceuticals subsidiary stems from two things: a letter to physicians promoting Risperdal as safer than and superior to rival drugs and sample boxes with deceptive labels, the judge's ruling states.
In a 17-page ruling, Judge Roger Couch chastised the company's management for allowing "the profit-at-all-costs mentality to cloud" their approach to marketing the drug. The letter to doctors, which eventually drew a warning from FDA for false and misleading claims, was a "clever effort" to "manipulate the message" about Risperdal, Couch ruled (as quoted by Bloomberg).
Couch ordered Janssen to pay $174.2 million in penalties for the letters. That amounts to $4,000 for each of the 7,142 letters sent to South Carolina doctors. Every letter was considered to be a single violation of the state's consumer-protection laws. The remainder of the judgment--$152.8 million--was based on a fine of $300 for each of the 509,499 suspect sample boxes distributed, Reuters reports.
The company says it's planning to appeal the ruling. "We don't believe that the dissemination of an FDA-approved package insert constitutes a violation of the South Carolina Trade Practices Act," a Janssen spokeswoman told Bloomberg. "We do not believe the ruling can be upheld on appeal."
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