It appears that Janssen Pharmaceuticals and other defendants behind the manufacture and marketing of the antipsychotic drug Risperdal (risperidone) owe the state of South Carolina $124 million. The U.S. Supreme Court on Jan. 11 refused to review Janssen's appeal of a $124 million civil penalty that the state imposed for not disclosing the drug's risks, notably the risk of the enlargement of male breasts, a condition known as gynecomastia.
A South Carolina trial court awarded the state $327,073,700 in 2011, which the state's highest court reduced. The penalty was related to violations of the South Carolina Unfair Trade Practices Act, which the state ratified in 1993.
Risperdal lawsuits are still being filed by men, boys and the parents of the boys alleging, among other things, that the defendants exposed patients to an unreasonable risk that the corporations failed to disclose to patients and to health care professionals. More than 1,600 Risperdal lawsuits have been filed so far in Philadelphia, where a state court created a mass tort docket for handling uniform pretrial proceedings across all of the cases.
The Risperdal attorneys at Reich & Binstock are representing male victims who developed female-like breasts allegedly due to their use of the drug. Many of these patients required surgery to correct the damage. Patients who believe that they thusly have been harmed by Risperdal, no matter their state of residency, may contact Houston-based Reich & Binstock for a free consultation. Click this link or call toll-free 1-866-LAW-2400.
Settlements are attainable, and juries have awarded damages in these cases.
Plaintiffs in those Risperdal lawsuits that are centered on gynecomastia generally assert a connection between the use of the drug and increases in the user's levels of a hormone known as prolactin, which plays a role in breast growth and milk production.
The state of South Carolina presented damning testimony concerning this chemical connection during the trial there. One of the state's witnesses was Dr. Magali Haas, a Janssen medical research physician.
Dr. Haas came clean. The South Carolina Supreme Court ruling that reduced the civil penalty to about $124 million summarized the doctor's testimony this way: Haas "admitted that Risperdal is associated with elevated prolactin levels, which are more of a concern for developing adolescents than for fully formed adults, and that scientists do not know if the reproductive dysfunction linked with Risperdal is reversible," according to the state high court's opinion. "During the relevant time period, Risperdal was not approved by the FDA for use in patients under the age of eighteen; however, Dr. Haas testified that 'much of Risperdal's market in the U.S.' was attributable to prescription sales for patients under the age of eighteen and that Janssen spent millions of dollars for medical marketing activities involving the unapproved use of Risperdal in children and adolescents. Moreover, Dr. Haas acknowledged that despite Janssen's awareness of the heightened reproductive risks Risperdal posed to children and adolescents, no warnings or information about those concerns appeared on the Risperdal label because the FDA had not approved Risperdal for use in patients under the age of eighteen."
The South Carolina verdict is peanuts compared to a blow that the U.S. Justice Department delivered more than two years ago. In November 2013, Janssen's parent corporation, Johnson & Johnson, agreed to pay more than $2.2 billion in criminal and civil penalties to resolve numerous claims. One of those claims was that Janssen marketed Risperdal to children for several years prior to the U.S. Food and Drug Administration's approval of the drug for use by children.