An Arkansas judge imposed a $1.1 billion fine on Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, after a jury found the companies liable for deceptive trade practices and false claims. The state of Arkansas sued the companies, alleging that they presented false and misleading information to doctors and patients about the antipsychotic drug Risperdal. The state attorney general’s office accused the companies of downplaying, hiding, or omitting mention of the risk of certain side effects in off-label uses of the drug. This is one of several verdicts against Janssen and Johnson & Johnson in suits brought by state governments, and more lawsuits are pending in other states.
This case is important to advocates for victims of pharmacy and medication errors because doctors and pharmacists rely on accurate information to perform their professional duties. Incorrect or misleading information endangers patients’ health, and even their lives, particularly when such information may have been deliberately put forth by a drug’s manufacturer.
Risperdal first entered the market in 1994 as a “second-generation” antipsychotic. Johnson & Johnson has earned billions of dollars from sales of the drug, which became available in generic form under the name Risperidone in 2004. The U.S. Food and Drug Administration (FDA) first approved Risperdal for the treatment of schizophrenia in adults. It later approved the drug for use in schizophrenia patients ages 13 to 17, and for bipolar disorder. The drug is sometimes used “off-label” for anxiety disorders and other mental health conditions.
The controversy in the Arkansas lawsuit began in 2003, when Janssen sent a letter to over 6,000 doctors in the state regarding use of Risperdal in elderly dementia patients. The letter allegedly minimized or concealed information regarding the elevated risk of stroke and diabetes for elderly dementia patients using the drug.
The state of Arkansas sued Johnson & Johnson and Janssen in 2007 for violations of state deceptive trade practice laws. It asked the judge to impose the statutory fine of $5,000 for each prescription issued under the marketing campaign, estimating the total number of prescriptions to be more than 250,000.
The judge penalized the companies for almost 239,000 prescriptions that violated the state’s False Claims Act, and for 4,600 letters to doctors violating the Deceptive Trade Practices Act. He imposed fines of $5,000 and $2,500, respectively, for these violations, totalling $1.1 billion.
At least eleven other states have sued Johnson & Johnson over Risperdal marketing, and the company is reportedly negotiating a settlement of potential federal claims with the U.S. Attorney General. Maryland has not filed a lawsuit yet. The Arkansas judgment is the largest one faced by the company so far. A South Carolina verdict for $327 million withstood a judge’s review in December 2011. The company settled a claim by the state of Texas for $158 million, with no admission of fault, in January. Observers quoted in Bloomberg BusinessWeek have suggested that Arkansas may accept a smaller settlement amount.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs prescribed or administered incorrectly. Contact us today online or at (800) 654-1949 to see if you may recover damages.
More Blog Posts:
Drug Manufacturer Recalls Vaccine Due to Expired Ingredients, Pharmacy Error Injury Lawyer, April 6, 2012
Risperdal Recalled by Manufacturer Due to Drug Contamination, Pharmacy Error Injury Lawyer, July 29, 2011
FDA Warns of Confusion between Risperdal and Requip, Leading to Medication Error, Pharmacy Error Injury Lawyer, June 27, 2011
Photo credit: ‘20110420-RD-LSC-0308 – Flickr – USDAgov’ by U.S. Department of Agriculture (20110420-RD-LSC-0308) [CC-BY-2.0], via Wikimedia Commons