J&J Ordered to Pay $327 Million Penalty in False-Claim Suit - - BioPharm International


J&J Ordered to Pay $327 Million Penalty in False-Claim Suit

BioPharm Bulletin

A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a “Dear Doctor” letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.

The South Carolina court ordered J&J to pay $327 million in fines. According to an article in Bloomberg, Circuit Court Judge Roger Couch assessed a $300 penalty per sample box of the drug that was distributed and a $4000 penalty for the publication of the “Dear Doctor” letter, for a total penalty of more than $327 million. A much larger penalty could have been assessed if the fines had been levied on a per-prescription basis.

J&J plans to appeal the ruling. According to Bloomberg, the South Carolina case is one of about 10 such suits brought by states over misleading marketing of Risperdal. J&J succeeded in getting the charges dismissed in a similar suit in Pennsylvania and won an appeal after being fined in West Virginia, after which the state dropped its case.

blog comments powered by Disqus



GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate
July 29, 2014
Bristol-Myers Squibb and Ono Pharmaceutical Collaborate on Immunotherapies
July 28, 2014
FDA Accepts First Biosimilar Filing
July 24, 2014
Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
Author Guidelines
Source: BioPharm Bulletin,
Click here