Of the Legal Staff
While Pennsylvania has been unsuccessful so far in bringing state court claims that it was defrauded by off-label marketing by Janssen Pharmaceuticals of its antipsychotic drug Risperdal, the state will now share in a $181 million settlement with the company over similar claims.
The settlement proceeds will be shared by 37 states and was said by some of the states’ attorneys general to be the largest multistate settlement to be reached with a pharmaceutical company.
According to the settlement agreement Pennsylvania filed in Dauphin County Court of Common Pleas today, the state’s claims in Commonwealth v. Ortho-McNeil-Janssen Pharmaceuticals for more than $150 million in damages related to payments state Medicaid made to Janssen are expressly excluded from the general release in today’s settlement. That means the state, which just lost its battle in the Commonwealth Court to rejuvenate that case, could continue to appeal if desired.
While that lawsuit raised fraud and misrepresentation claims, the multistate settlement reached today raised claims under the Pennsylvania Unfair Trade Practices and Consumer Protection Law.
According to a statement from Pennsylvania Attorney General Linda Kelly, the states alleged that Janssen promoted Risperdal for off-label purposes to the geriatric and pediatric populations and specifically targeted nursing-home patients with Alzheimer’s disease, dementia, depression and anxiety. The states argued those uses were not FDA-approved nor shown to be safe or effective.
After a four-year investigation, Janssen has agreed to change how it promotes and markets its antipsychotic drugs, according to Kelly. Under the terms of the settlement, for the next five years Janssen must disclose the FDA-identified risks of its drugs in its promotional materials. It must present information about the drugs’ effectiveness in a balanced manner, Kelly said.
Additionally, personnel trained in science, not marketing, must develop the medical content or communications addressed to health care providers. Also, grants cannot be used to promote its atypical antipsychotic drugs. Janssen must also refrain from having policies that offer financial incentives to sales professionals that would reward off-label marketing, Kelly said.
Aside from Pennsylvania, the states involved in the settlement are Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming. The District of Columbia is also part of the settlement.
Drinker Biddle & Reath, which represents Janssen in the state court lawsuit, was also involved in today’s settlement, according to the settlement agreement.
The settlement is not an admission of guilt, nor is it a fine or penalty, the agreement notes.
"We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness," Janssen President Michael Yang said in a statement today.