Johnson & Johnson (JNJ) has announced settlement in five lawsuits over plaintiffs claims that its antipsychotic drug Risperdal caused increased breast-tissue growth in boys.
There are more than 400 lawsuits in which the plaintiffs allege that J&J and its Janssen unit caused personal injuries from the use of Risperdal. More than 100 involve claims that the drug caused young boys to grow breasts.
The U.S. Food and Drug Administration approved Risperdal for psychotic disorders including schizophrenia in 1993.
Global sales of Risperdal peaked at $4.5 billion in 2007 and declined to $527 million in 2010 after the patent expired.
According to plaintiffs claims, J&J hid the fact that Risperdal could increase hormone levels that caused breast development in males and trained salespeople to downplay the information to doctors.
U.S. Dept of Justice Investigation
The U.S. DOJ has been investigating Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses. J&J officials reached an agreement with the U.S. DOJ to pay as much as $2.2 billion to resolve the investigation of its drugs sales, including Risperdal.
The company agreed to pay $181 million to resolve claims by 36 states that it improperly marketed and advertised Risperdal and Invega, another antipsychotic.
In April, an Arkansas court ordered the drugmaker to pay $1.2 billion in fines over Risperdal marketing. J&J decided to end a trial in Texas over the drug’s sales with a $158 million settlement. This case included claims that the company marketed the drug for children while lacking approval by FDA regulators for such use.
In June 2011, a South Carolina court ordered J&J to pay $327 million in penalties for deceptively marketing the antipsychotic drug. J&J recently lost an appeal in Louisiana to dismiss an award of almost $258 million that a jury ordered it to pay over Risperdal marketing.
The Risperdal cases include A.B., a minor v. Janssen Pharmaceuticals, 00649, Philadelphia Court of Common Pleas, January Term 2010.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.