|January 29, 2016, 08:00:00AM. By Heidi Turner|
The lawsuit was initially filed in 2007 by the state of South Carolina, which alleged that Janssen deceptively marketed Risperdal by hiding risks on labels that were attached to sample packs and by sending letters to doctors that claimed Risperdal was safer than other antipsychotic drugs. A South Carolina state judge found Janssen liable and ordered $327 million in civil penalties, which a higher court later reduced to $136 million. That award was later reduced by another $12 million.
“By 1997, Janssen also had information that Risperdal posed a serious risk of stroke, cardiac arrest, and sudden death in the elderly,” Justice Kittredge wrote for the Supreme Court of South Carolina in its decision (7/8/15). “Despite this clinical information, it was several years before Janssen updated the Risperdal label to accurately reflect the frequency and severity of the risk of hyperprolactinemia, weight gain and diabetes, or stroke, cardiac arrest, and sudden death in the elderly.”
Those judges further found that Janssen had information suggesting patients taking Risperdal were at an increased risk of developing diabetes mellitus and only shared results of a favorable study to the FDA, rather than sharing results of all studies. The Supreme Court of South Carolina also found that Janssen sent a Dear Doctor Letter that stated Risperdal was associated with a lower risk of diabetes than some other atypical antipsychotic medications.
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The judges were not impressed. “To put it mildly, the November 2003 DDL [Dear Doctor Letter] contained false information,” Justice Kittredge wrote in the decision. Although the Supreme Court of South Carolina reduced the award, it did so based on the statute of limitations, finding that the statute of limitations regarding the warning label was limited to a three-year period. As a result, the award was decreased from $327 million to $136 million.
Although Janssen still appealed the decision to the US Supreme Court, the US Supreme Court has rejected the motion to appeal and will not hear Janssen’s arguments.
Janssen has defended its drug saying it is safe and effective to use.
The lawsuit is Ortho-McNeil-Janssen Pharmaceuticals Inc v. South Carolina, U.S. Supreme Court, No. 15-600.