Calling it a "landmark settlement," one state attorney general from among 35 other s pitted against New Jersey-based pharmaceutical giant Johnson & Johnson (J&J) lauds the recent settlement between J&J and the U.S. Food and Drug Administration (FDA), which also includes the three dozen plaintiff states.
The complex and protracted product liability litigation leading up to the settlement began to take shape following a probe of the drug maker in 2004 that centered upon alleged deceptive advertising and unlawful off-label marketing and sales of the antipsychotic medications Risperdal and Invega. The consumer protection settlement has been termed the largest multistate drug settlement of its kind ever.
As to just how big that is, media reports indicate that J&J is on the hook for $181 million to resolve the civil claims against it and its Janssen unit. New Jersey is among the states that will receive a portion of the damage award.
Risperdal was approved for use in the United States in 1993, but only for the treatment of psychotic disorders such as schizophrenia. That limitation cut materially into its sales potential, which led to Janssen soon promoting the drug for unapproved uses such as dementia, Alzheimer's disease, bipolar conditions and mood and anxiety disorders, including depression.
Although that marketing and advertising expansion greatly fueled the sales of J&J's antipsychotics, it was clearly illegal and unethical, say health regulators.
J&J states that it will abide fully by the settlement terms and no longer promote the drugs for any off-label use. As is typical with such agreements, the company did not admit to any wrongdoing.
If you or a family member has been injured as a result of a dangerous or defective Johnson & Johnson product, please contact Breslin & Breslin for a free consultation.
Source: Bloomberg, "J&J will pay $181 million to settle Risperdal ad claims," David Voreacos and Margaret Cronin Fisk," Aug. 30, 2012