Trouble started for Johnson and Johnson (J&J) and its subsidiary, Janssen Pharmaceuticals, in 2012, when the company reached a settlement with the State of Texas for $158 million. Texas claimed that the company falsely advertised its medication, Risperdal, for uses not approved by the FDA. Not long after the Texas Risperdal settlement, J&J and Jansen reached another such settlement with 36 states and the District of Columbia for $181 million after being subjected to similar allegations of fraud.
Also in 2012, the first ever lawsuit against J&J for Risperdal side effects went to trial. The adolescent male plaintiff developed female breast tissue (a condition called gynecomastia) after taking the medication between 1999 and 2004 for a psychotic disorder. That plaintiff’s ingestion of the dangerous drug occurred before the medication was approved for use in children in 2006. Again, J&J settled out of court.
The following year, J&J and Janssen agreed to pay $2.2 billion to resolve both civil and criminal allegations related to its Risperdal marketing practices brought by the Justice Department. The Justice Department accused J&J and Janssen of targeting child psychiatrists to promote use of the drug in an off-label capacity before it was approved for use in children.
After the many billions of dollars required to resolve claims that it had mis-marketed its product, many states levied fines against the company for defrauding their Medicaid programs by promoting off-label uses.
J&J might have thought its Risperdal fraud allegations had been swept under the rug; however, in 2015 the company faced numerous additional lawsuits. In March, an Alabama man claimed that taking Risperdal in 2002 caused him to develop gynecomastia, a condition that causes men to develop female breasts. A jury awarded the man $2.5 million in damages, and that man’s bravery in taking on the pharmaceutical giant led to sufficient publicity to get the ball rolling for thousands of victims to come forward.
J&J subsequently settled its third gynecomastia lawsuit out of court only several hours after the trial began. The following gynecomastia lawsuits would not be so easy for J&J. A jury found J&J responsible for the plaintiff’s development of breasts in both cases and forced the company to pay a total of $2.25 million in damages.
This year has not started out any better for J&J. In January, the Supreme Court upheld a 2011 South Carolina verdict ordering J&J and Janssen to pay a $124 million penalty to the State of South Carolina. 2016 is lining up to be a pivotal year in Risperdal lawsuits with over 1,600 cases currently pending in Philadelphia state court. The discovery phase is underway and the first of these lawsuits is anticipated to begin in the spring.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.