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Johnson & Johnson is appealing a $327 million verdict by a South Carolina judge, who ordered the company to pay the damages for illegally promoting Risperdal and overstating the benefits of the atypical antipsychotic.
In 2011, South Carolina Circuit Court Judge Roger Couch order the company to pay $300 for every Risperdal sample box it gave away in the state and also charged the company $4,000 for every “Dear Doctor” letter it sent out, resulting in $327 million in damages.
Johnson & Johnson has appealed the award, arguing that the damages are unfair because it was never shown that anyone was harmed due to its actions. The South Carolina Supreme Court is expected to hear oral arguments on the appeal later this week, but a decision will not be returned for several months.
South Carolina was just one of several states which have pursued lawsuits over Risperdal illegal marketing. Arkansas, Louisiana and Texas also leveled fines of hundreds of millions of dollars against the company.
The company also agreed to pay the federal government $1 billion to settle off-label marketing claims. Off-label marketing occurs when a drug company promotes the use of its drug for purposes other than those approved by the FDA, and is illegal. Doctors can prescribe a drug for any purpose they see fit, but companies cannot promote them for unapproved uses.
The DOJ began investigating Johnson & Johnson’s marketing of Risperdal in 2004, looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes. In 2009, Omnicare reached a settlement with DOJ over kickback charges. The DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings. In January 2010, the DOJ filed a civil False Claims Act complaint against J&J.
Johnson & Johnson has also been accused of illegally promoting Risperdal for use among children prior to obtaining FDA approval for such use. While the manufacturer has challenged the South Carolina damage award, attempting to argue that no users were actually injured, the company does face a number of product liability lawsuits over male breast growth from Risperdal use by children.
In October, Johnson & Johnson reached a Risperdal settlement with the families of five boys who allegedly experienced unnatural male breast growth after taking Risperdal. However, Johnson & Johnson still faces about 100 product liability lawsuits over Risperdal breast growth side effects among boys. All of the complaints involves similar allegations that the drug maker failed to adequately research the medication or warn about the risk of breast growth among teen boys taking the antipsychotic.