A South Carolina judge has upheld a $327 million civil penalty against health giant Johnson & Johnson, which in March was found guilty by a jury of overstating the safety and effectiveness of Risperdal, its former blockbuster antipsychotic drug. This is the biggest verdict in the country over the marketing of Risperdal. The pill for schizophrenia and bipolar disorder once brought J&J more than $3.4 billion in annual sales.
As we have previously reported, Johnson & Johnson has been involved for years in litigation over alleged kickbacks, promotion for unapproved uses and other efforts to boost Risperdal over competing drugs. Dozens of pending state and federal cases allege illegal marketing practices for Risperdal, including one case set for trial this month. Texas is seeking more than $1 billion in that case.
Interestingly, Texas joined a whistleblower’s lawsuit over alleged kickbacks paid more than a decade ago to several doctors who were officials in the state’s mental health department. It’s alleged that the payments were made to give Risperdal preference over other antipsychotic drugs. One former official is accused of accepting honoraria from J&J to fly around the country urging doctor colleagues in other states’ Medicaid and mental health programs to use Risperdal over other drugs.
In the South Carolina case, Circuit Court Judge Roger Couch denied Johnson & Johnson’s motions asking either for a new trial or to overturn or amend the verdict. Johnson & Johnson says it will appeal this ruling. On March 22, a jury in the Spartanburg Court of Common Pleas found that Johnson & Johnson and subsidiary Janssen Pharmaceutica Inc., which makes Risperdal, violated state law by giving doctors deceptive information about the drug’s risks and effectiveness. During the trial, there was compelling evidence in the form of internal e-mails from J&J employees and officials that the marketing staff was promoting the drug as being better than what the science actually showed.
Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar, plus many more common but less-serious side effects.
On June 3, 2011, in the South Carolina case, Judge Couch ordered J&J to pay civil penalties amounting to $327.1 million. That’s the total of fines of $4,000 for each of more than 43,000 letters touting Risperdal that Johnson & Johnson distributed to doctors, plus $300 each for 509,000 free samples given to doctors that contained detailed package inserts describing the medication’s effects and safety.
Risperdal marketing and promotion is also the subject of a number of criminal and civil federal investigations. States including Alaska, Arkansas, Louisiana, Massachusetts, Mississippi, Montana, New Mexico, Pennsylvania, Texas and Utah have pending cases against J&J. Those cases seek reimbursement of Medicaid payments for Risperdal, compensation for treating patients who suffered adverse reactions, penalties for violations of state consumer fraud statutes, damages for “overpayments,” or other fines or penalties.
Attorneys General of about 40 states, “have indicated a potential interest in pursuing similar litigation against” Johnson & Johnson. I understand they have obtained agreements to stay running of the statute of limitations while they pursue a “coordinated civil investigation” regarding potential consumer fraud actions in connection with the marketing of Risperdal.
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