Kentucky Attorney General Jack Conway announced the settlement of two pharmaceutical cases for total of $39.5 million. The settlements end the litigation of the Purdue Pharma case regarding OxyContin and the Johnson & Johnson case regarding Risperdal.
- The OxyContin case was settled on Dec. 22 for $24 million – more than 50 times what Kentucky was originally offered in 2007 to settle the case.
- The Risperdal case, a consumer protection lawsuit alleging that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers, was settled on Dec. 22 for $15.5 million.
“These companies engaged in reckless behavior that put our citizens at risk,” Attorney General Conway said. “Both companies knowingly and aggressively marketed drugs they knew to be harmful in order to drive profits. I am pleased we were able to recover damages for the Commonwealth and recover funds to help expand addiction treatment in Kentucky.”
Risperdal is a second-generation antipsychotic prescription drug approved by the FDA to treat schizophrenia and acute mania associated with bipolar disorder. The Kentucky Consumer Protection lawsuit alleged that the makers of Risperdal misled consumers about its dangers and marketed the drug for purposes other than those approved by the FDA. Risperdal is manufactured and distributed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
“Janssen and Johnson & Johnson put patients at risk when they marketed Risperdal without disclosing the drug’s known side effects,” Attorney General Conway said. “These side effects were even more harmful to children and elderly patients.”
Janssen marketed Risperdal to children before it was approved to do so in 2007 by the FDA. It failed to disclose to parents, physicians and patients that Risperdal may cause a hormonal imbalance, which could cause breast tissue development and infertility in both boys and girls. Janssen was aware of the risk and did not update the drug’s warning label because it felt awareness of the risks could cost the company up to $150 million per year.
Janssen also marketed Risperdal for a non-FDA approved use in treating dementia in non-schizophrenic elderly patients. It even created an elder care sales force, despite having its own study that showed Risperdal doubled the risk of death in the elderly. Risperdal’s label did not disclose this risk to the public until 2003, even though a Janssen-funded trial indicated the risk in 1997. In 2013, Janssen pleaded guilty to federal charges of misbranding the drug regarding the promotions to the elderly.
Marketed as an atypical anti-psychotic
Additionally, Janssen marketed Risperdal as an atypical anti-psychotic with low weight gain and diabetes risk. However, its internal studies indicated that after one year, patients on Risperdal had as much weight gain as its main competitor and a greater risk of diabetes.
“Going forward, we have tough terms in the settlement that will govern the way Risperdal can be marketed in the future here in Kentucky,” Attorney General Conway said. “It is my hope that the General Assembly will allocate the money to expand addiction treatment in Kentucky.”
In addition to the $15.5 million payment to settle the claims, Janssen is prohibited from promoting Risperdal for non-FDA approved uses or for populations in which it is not approved. Janssen will be required in Kentucky to clearly disclose risks associated with the drug. It will also not be allowed to promote the drug for a single symptom for which it is not approved, such as depression or anxiety, without reference to the underlying mental illnesses that Risperdal is approved by the FDA to treat.
In the settlement, Janssen does not admit wrongdoing. A copy of the settlement agreement is available here.
The settlement resolves allegations that Purdue Pharma illegally misrepresented and/or concealed the highly addictive nature of OxyContin and encouraged doctors who weren’t trained in pain management to overprescribe the opioid pain reliever to Kentucky patients.
The Food and Drug Administration (FDA) approved OxyContin in 1995. Following its release, Purdue immediately launched an aggressive national marketing campaign to promote the drug, which was led by sales representatives who falsely told doctors that OxyContin wasn’t addictive and was less likely to be abused than other opioid drugs.
Kentucky filed its lawsuit in 2007 to recover damages to the Commonwealth after Purdue pleaded guilty in U.S. District Court in the Western District of Virginia for misbranding OxyContin. In that case, three of its top executives also pleaded guilty to misdemeanor misbranding.
At the time, Kentucky was offered approximately $500,000 to settle its claims, which the Commonwealth refused. Now after eight years of hard-fought litigation, and while still facing significant legal issues in the case, Kentucky will receive $24 million. The agreement also extends injunctive relief that was set to expire in 2017. The court order directs the General Assembly to appropriate the funds to expand addiction treatment in Kentucky.
“Purdue Pharma created havoc in Kentucky, and I am glad it will be held accountable,” Attorney General Conway said. “Purdue lit a fire of addiction with OxyContin that spread across this state, and Kentucky is still reeling from its effects.”
In the settlement, Purdue does not admit wrongdoing. A copy of the settlement agreement is available here.
$500 million in settlements
ht years as Attorney General, Conway secured $500 million in consumer protection and Medicaid settlements. He increased Medicaid Fraud collections by 600 percent and investigated more elder abuse and neglect cases than any previous Kentucky Attorney General. He helped craft legislation that shut down half of the state’s pain clinics and worked to address the resurgence of heroin in Kentucky. He educated more than 45,000 parents, students and teachers about the dangers of prescription drug abuse through his “Keep Kentucky Kids” safe program. He secured Kentucky’s future tobacco payments by settling the Tobacco Master Settlement Agreement case. Attorney General Conway also led national efforts to investigate the practices of some for-profit colleges and shut down the website GIBill.com, which was a for-profit college lead generator masquerading as a government website. GIBill.com is now under the control of the U.S. Department of Veterans Affairs.
Attorney General Conway also created a Cybercrimes Unit that’s become a national model. The unit has a 100 percent conviction rate and has seized more than 1 million child pornographic images from the Internet.
“It’s been an honor to serve as Kentucky’s 49th Attorney General,” Attorney General Conway said. “I know that by working together, we’ve made Kentucky a safer place to live, work and raise a family.”