In the US, thousands of claims are consolidated in a Pennsylvania State court, the Philadelphia Court of Common Pleas, where at least four Risperdal trials have already been held. In three of these jury trials, plaintiffs who claim to have developed gynecomastia after being prescribed Risperdal have won over $75 million in compensation. To date, Johnson & Johnson has only been able to successfully defend itself in one case.
At the same time, Janssen and its parent company have settled a number of other Risperdal cases. In fact, the first gynecomastia claim ever filed reached settlement during the first day of trial in 2012. The second Risperdal trial also ended in a settlement agreement, after one week of trial proceedings. And the next year, a case involving 77 different plaintiffs was settled.
More recently, Janssen and Johnson & Johnson have continued to settle Risperdal claims, entering into two undisclosed agreements at the end of 2016.
Original Warning Label Listed Gynecomastia As “Rare”
When Risperdal was first approved as a treatment for schizophrenia in 1993, medical researchers had already discovered that other antipsychotic drugs could increase the levels of prolactin, a hormone key in milk production, in male patients. Thus it wasn’t a surprise that Risperdal’s original warning label listed gynecomastia as a rare side effect, one occurring in 0.001% patients or fewer. Just as it was well-known that antipsychotics could increase prolactin, it was also well-known that increases in prolactin could lead to an enlargement of breast tissue in boys and men.
But as Risperdal’s warning label reassured doctors and patients, gynecomastia was an exceedingly-rare side effect of taking the drug, not a common occurrence. This is the crux of the case against Janssen. In their lawsuits, patients say Janssen had good reason to believe that gynecomastia was fairly-common in Risperdal patients, but concealed that fact from the public.
Company-Funded Study Finds High Risk
In contrast to the statements made by Janssen Pharmaceuticals, doctors and researchers have told a very different story. Risperdal, studies find, appears to cause gynecomastia far more often than Johnson & Johnson has been willing to admit. In fact, one of Janssen’s own studies found evidence that up to 5.5% of boys who took Risperdal would develop gynecomastia, a far-higher rate than the 1-in-10,000 risk listed on the drug’s warning label. And when was that study conducted? As David Kessler, former-Commissioner for the Food & Drug Administration testified at one of the first Risperdal trials, the study was finished in 2001. Yet Risperdal’s label continued to inform doctors that gynecomastia was “rare” in Risperdal patients for another five years.
Today, the product labeling guide suggests that gynecomastia occurs in about 2.3% of young men taking Risperdal, though past and more-recent research provides evidence of an even greater increase. A recent study published in the Journal of Child and Adolescent Psychopharmacology, for example, found that Risperdal patients between 15 and 25 years of age were more than five times as likely to develop gynecomastia as boys and men who didn’t take the drug.
Did Janssen Withhold Evidence From FDA, Patients?
Another paper that has come to the fore in Risperdal litigation was conducted in 2003, according to Medpage Today. Funded by Janssen Pharmaceuticals, the study was explicitly designed to monitor prolactin levels in boys taking Risperdal. While prolactin levels in children appeared to increase over the first two months of treatment, the hormone had stabilized by five months.
But the researchers also found evidence of SHAP, “side effects hypothetically attributable to prolactin.” Gynecomastia was at the top of the list. And even more telling, the study’s raw test data illustrated a direct correlation between elevated levels of prolactin and the incidence of gynecomastia. In hindsight, the connection between Risperdal and breast enlargement seems clear. In 2003, however, things were different.
When the study was finally published, its primary result, the correlation between prolactin and gynecomastia, was left out. Instead, the researchers wrote that “there was no direct correlation between elevated prolactin and SHAP,” even though the actual data from the paper said otherwise. These data tables, as testimony from a Risperdal trial would reveal, were never submitted to the Food & Drug Administration. And the label remained unchanged, at least where gynecomastia was concerned, for another three years.
States File Suit Over Off-Label Marketing
State and federal investigators, however, had keyed into a potential problem by 2004 and it would eventually lead to the first wave of lawsuits filed over Risperdal. As various government-led investigations revealed, Johnson & Johnson had begun to market Risperdal for unapproved uses.
At least, that was the accusation leveled against the company in civil lawsuits filed by Attorneys General from no fewer than 36 States. Beginning around 2004, State after State accused Johnson & Johnson in open court of peddling Risperdal for indications that had never been approved by the Food & Drug Administration, from dementia in elderly patients to all manner of neurocognitive disorders in children, including kids with autism spectrum disorders.
The drug didn’t receive FDA approval as a treatment for kids until 2007, but long before that, government prosecutors claimed, Johnson & Johnson had opened Risperdal up to new patient populations. In many cases, the lawsuits alleged, the international corporation had even designed illegal kickback schemes to get doctors to prescribe more and more pills and injections off-label, defrauding the government of millions in Medicaid funds.
DOJ Says Janssen Marketed Risperdal Illegally
Eventually, the case against Johnson & Johnson was so large that federal authorities got involved. In 2013, the US Department of Justice filed its own lawsuit against the company. As federal prosecutors told the story, Janssen Pharmaceuticals had begun marketing Risperdal off-label as early as 2002, well before medical researchers could determine the risks and benefits of these unapproved uses.
Janssen Pleads Guilty To Off-Label Promotion
The most astonishing part of this lengthy saga? Janssen Pharmaceuticals pled guilty, admitted to promoting Risperdal for symptoms of psychosis and other behavioral disturbances in elderly patients who did not have schizophrenia. As we’ve already mentioned, the drug was only approved to treat schizophrenia in 2002.
Janssen’s guilty plea is surprising because most major pharmaceutical corporations never admit liability, even when the allegations are coming from the federal government. Unlike Janssen, most companies enter settlement agreements, but continue to deny any and all wrongdoing. That’s how the cases filed by Attorney Generals ended. Janssen and Johnson & Johnson were fined hundreds of millions of dollars, but never admitted responsibility.
Learn More About Filing A Lawsuit
Nearly 20,000 boys and young men have filed Risperdal lawsuits in federal and state courts. Janssen Pharmaceuticals has already fielded dozens of lawsuits from government prosecutors, paying out millions of dollars in fines. And in the first few years of the growing Risperdal litigation, the company has been ordered to pay patients with gynecomastia over $75 million, to say nothing of over 80 undisclosed settlement agreements. Our experienced product liability attorneys believe the case against Johnson & Johnson and its subsidiary is remarkably strong. To learn more about case eligibility, contact our lawyers today to receive a free legal consultation.