Arkansas Attorney General Dustin McDaniel announced Tuesday that he has been joined by his colleagues in 35 states and 65 members of the Arkansas General Assembly in asking the state Supreme Court to uphold a $1.2 billion judgment against a pharmaceutical company for defrauding the state Medicaid system about the safety risks of Risperdal, an antipsychotic drug.
“In an unprecedented, bipartisan showing, the attorneys general and state legislators, in separate requests, asked the Court today for permission to submit amicus curiae briefs,” also known as friend-of-the-court briefs, McDaniel’s office announced in conjunction with the filing of his brief.
A news release notes that the AARP, the group Public Citizen and former U.S. Food & Drug Administration Commissioner Donald Kennedy also submitted amicus briefs to the court.
The announcement follows the April 9 filing of friend-ofthe-court briefs by three national groups and the Arkansas Chamber of Commerce in support of drug manufacturer Ortho-McNeil-Janssen Pharmaceuticals’ appeal of the April 2012 judgment.
The judgment against Ortho-McNeil, a subsidiary of Johnson & Johnson, followed a Pulaski County Circuit Court jury’s findings that the company hid or downplayed potentially dangerous side effects on the drug’s label and in letters to Arkansas doctors.
The pharmaceutical company filed its appeal in December, and supporting briefs from the Washington Legal Foundation, the Product Liability Advisory Council Inc., Pharmaceutical Research & Manufacturers of America and the state chamber were filed in April.
McDaniel maintains that the jury verdict was consistent with Arkansas law, and the $1.2 billion in penalties assessed by Circuit Judge Tim Fox were proper, “based on the company’s serial violations of state law.”
“The company lied to our medical providers and putprofits ahead of people,” Mc-Daniel said Tuesday. “As state Attorney General, it is my responsibility to prevent actions like those, which defrauded our Medicaid program and jeopardized the health of our elderly and our children.”
His announcement continued, “My colleagues across the country realize the significance of this case to state attorneys general who are also responsible for protecting the citizens of their state, and that is why they are taking the rare step of seeking to be heard on an issue in the Arkansas Supreme Court. This extraordinary coalition of AG’s, lawmakers and consumer advocacy groups has come together to support the important policy behind this case. To deter this type of fraudulent, harmful behavior, states must have the ability to pursue penalties against the wrongdoers.”
In April, the Washington Legal Foundation said in anews release that when the FDA has approved the label for a prescription drug, “states have no business second-guessing labeling decisions.”
The foundation argued that Arkansas’ Medicaid Fraud False Claims Act, which the jury found the drug-maker violated, didn’t apply in this case.
“The statute does not authorize Arkansas to seek massive fines from a pharmaceutical company simply because it believes that the company should have affixed stronger safety warnings to a prescription drug,” the group said in April.
McDaniel’s brief and the supporting briefs contend that the penalty clearly falls within the range prescribed by state statute. “In fact,” the attorney general’s news release states, the judge “assessed penalties, per violation, on the lower end of that range. The large fine is the result of the serial violations … over the course of a number of years.”
At trial, McDaniel said, “the state argued successfully that the defendants on multiple occasions deceived Arkansas medical providers about risks of weight gain and diabetes, as well as strokes among elderly patients.”
Northwest Arkansas, Pages 14 on 06/24/2013