The latest case pitting the maker of the antipsychotic drug Risperdal against parents whose son had a double mastectomy is ready for a Philadelphia courtroom.
Johnson & Johnson’s Janssen Pharmaceuticals will defend itself against claims that Risperdal caused the boy to grow breasts that later had to be removed surgically — and will take on a former high-ranking FDA administrator in the process.
Plaintiff’s lawyers in the Philadelphia Court of Common Pleas say doctors prescribed Risperdal “off label” to the boy at age 8, causing him to develop breasts that could only be repaired mastectomy. Off-label refers to a use not approved by the Food and Drug Administration (FDA). The practice is legal, but drug companies are not allowed to market their products for unapproved uses.
The parents claim J&J and its Janssen Pharmaceuticals unit illegally marketed the medication to be prescribed for in children and did not warn that young men and boys could grow breasts – a condition called gynecomastia, according to court documents. They claim s doctors would not have prescribed the drug if they had known the risks.
Janssen’s lawyers say labeling for the drug provided sufficient warning because “it lists the possibility of elevated levels of the hormone that can cause gynecomastia,” FiercePharma reported.This is not the first case of its kind brought against the New Jersey-based drug company. Hundreds more lawsuits await trial.
Risperdal also causes other known side effects, including diabetes, heart problems and movement disorders.
J&J Lawyers Attempt to Discredit Former FDA Official
The case also features a showdown between Johnson & Johnson and former former FDA Chief David Kessler. J&J attorneys last week accused Kessler of becoming a “hired gun” for consumers suing drug makers and “cutting and pasting” facts from other cases into his conclusion in the current case. Kessler has testified J&J did not adequately warn the public about Risperdal’s side effects, Bloomberg reported.
“Each case is complex and there is an enormous amount of details associated with them,” Kessler said. “To say I’ve testified each and every time the same way would be incorrect.”
According to Kessler, Janssen knew Risperdal could cause breast development in boys as early as 2001 but didn’t include any information about it in the drug labeling until 2006. The company also aggressively encouraged doctors to prescribe the drug for off-label uses, Kessler added.
In another unrelated trial against Eli Lilly & Co. and Takeda Pharmaceutical Co., Kessler testified that the pharmaceutical companies knew their blockbuster diabetes drug Actos caused bladder cancer. The jury awarded $9 billion to the plaintiff in that case.
Risperdal Made Billions for J&J, Brought Lawsuits
Although Risperdal went off patent in 2007, J&J generated about $24 billion worldwide off drug sales from 2003 to 2010. The medication also brought in its share of legal woes because of off-label marketing practices.
J&J settled lawsuits brought against it by 37 states and the District of Columbia for close to $340 million. Later it paid $2.2 billion to settle a federal whistleblower lawsuit.
It lost another $1.2 billion in a trial in Arkansas, but the verdict was later overturned over a statute issue. Similarly, the company overturned another $257 million verdict in Louisiana after it convinced the court that it had not violated state law.
J&J still faces about 1,000 Risperdal gynecomastia lawsuits in Philadelphia state court, and experts expect more to follow.