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The state of Kentucky has reached a $39.5 million settlement with the makers of OxyContin and Risperdal, resolving claims that the safety of the drugs were misrepresented to the state’s residents.
The settlement agreement requires Johnson & Johnson to pay $15.5 million over failing to warn about the potential side effects of Risperdal, and Purdue Pharma LP must pay $24 million over similar claims involving the painkiller OxyContin.
The state has pursued the lawsuits for nine years, saying that the companies aggressively marketed the drugs in Kentucky without adequate risk warnings.
Kentucky’s claims against Johnson & Johnson indicate that the company illegally marketed Risperdal for pediatric use before it received approval by the FDA to market the drug for use with children. The lawsuit claimed that the company failed to warn that it could cause infertility and hormonal imbalances in children, defrauding the state’s Medicaid program.
For young boys, Risperdal has been linked to an increased risk of a medical condition known as gynecomastia, which causes abnormal breast growth among males. Johnson & Johnson also faces a number of Risperdal lawsuits from individual plaintiffs who say they were not warned of the male breast growth side effects.
Johnson & Johnson has been quietly dealing with breast growth litigation over Risperdal for years, but the number of cases has continued to grow as more families and young adults learn that there may be a link between problems suffered following a diagnosis of gynecomastia and Risperdal use as a child.
The company has been ordered to pay a number of multimillion dollar verdicts in Risperdal gynecomastia claims that have gone to trial. The first Risperdal case to go to trial in Philadelphia involved a similar complaint filed by Austin Pledger and his family, ending in a $2.5 million jury award in February 2015.
In March, a second Risperdal bellwether trial ended in a defense verdict in favor of the drug maker. In a claim brought by William Cirba, that jury found that insufficient evidence was presented to establish that the teen’s abnormal breast growth was actually caused by use of Risperdal.
A third trial in November resulted in a $1.75 million award to Nicholas Murray, a 21-year-old autistic man from Maryland. All three cases were held in the Philadelphia Court of Common Pleas.
The state accused Purdue Pharma of downplaying the addictive side effects of OxyContin, a powerful opioid, to the state’s residents, resulting in Medicaid fraud. The lawsuit claimed the company knowingly misrepresented OxyContin addiction side effects to doctors and patients.
This was the last state case pending against Purdue Pharma, which settled claims in 49 other states in 2007.