NEW BRUNSWICK, NJ–A 17-year-old from Tennessee who took Johnson & Johnson’s antipsychotic drug Risperdal suffered a severe enough injury to be awarded $70 million in compensatory damages by a Philadelphia jury on July 1.
The Hub City-based pharma giant now owes the teenager, Andrew Yount, and his family, 28 times more than it was ordered to pay in February 2015, after a similar verdict awarded $2.2 million to Austin Pledger, a young Alabama man who took Risperdal to treat his autism.
Both cases dealt with claims that J&J did not provide adequate warnings to patients and doctors over certain risks associated with Risperdal and the link to a condition known as gynecomastia, or the growth of female breast tissue in boys.
While the Pledger verdict represents the first of four losses for J&J from a group of five similar cases including the recent $70 million award in which jurors delivered a unanimous decision, the compensatory damages in the initial three cases only yielded $500,000 to $2.2 million per case.
A fifth case ended in a split jury, with some jurors saying they did not hear enough evidence to pinpoint Risperdal as the cause of a boy’s gynecomastia. Still, they agreed J&J should have warned the public that its blockbuster drug could lead to female breast tissue growth in males.
Yount, 17, reportedly began a course of Risperdal when he was five to treat a psychiatric disorder, and his lawyers explained to the jury that warnings about developing possible breast tissue were nowhere to be found.
But Yount’s legal team says the Pharma is also guilty of concealing records, as well as major misconduct.
“The jury in the Yount case found that J&J intentionally falsified, concealed, or destroyed material evidence,” reads a press release from Arnold & Itkin.
That finding enabled Yount to recover more than $750,000 which is Tennessee’s cap on noneconomic damages, according to the state’s law.
And the verdict did not include punitive damages, which are barred in the Garden State for drugs approved by the US Food & Drug Administration (FDA).
Though on appeal, a ruling says that New Jersey state law, which does not permit a claim for punitives, is applicable to all the cases against J&J subsidiary Janssen pharmaceuticals filed in Pennsylvania, where Janssen has places of business.
“In the Risperdal cases where we’ve gotten verdicts, none of them included compensation for punitive damages, and we say that question should have gone to the jury,” said Steve Sheller, one of Yount's lawyers.
Sheller said that if punitives were allowed in the Pledger case, the sum of all damages (combined) would have increased by at least four to five times.
While his legal team will be facing-off again with lawyers who represent J&J in about ten upcoming Risperdal-gynecomastia cases in Philadelphia starting on July 25, a Risperdal-gynecomastia case in the Superior Court of Los Angeles that began on July 18, allowed punitives, noted Sheller. And as many as 300 similar cases are awaiting trial in California.
“This verdict will help thousands of children, boys, and their families be made aware of the dangers of Risperdal. To put it mildly it’s about time that someone put J&J to task,” said Sheller.
He recalls settling an earlier group of Risperdal-gynecomastia cases with J&J for several clients about two years ago. However, with respect to J&J's current stance regarding the litigation, he feels the company is “going to go-for-broke.”
Three years ago, J&J agreed to pay a $2.2 billion health-fraud penalty to resolve criminal and civil probes associated with illegally promoting Risperdal for unapproved and off-label uses. The pill was finally approved for use by children in late 2006.
“During trial, evidence that became known in the case as 'Tab 4,' was publicly revealed for the first time. Tab 4 includes scientific data showing a link between Risperdal and gynecomastia. The lawyers made a case that J&J intentionally kept Tab 4 secret- withholding it from the FDA and keeping it out of published scientific studies,” reads a press release from Arnold & Itkin, a law firm that partners with Sheller.
New Brunswick Today reported that Janssen knew about a key safety analysis since 2002, but failed to give it to the FDA, as the company should have, when working to get Risperdal approved for children.
J&J concealed information that “never got out” to the FDA, physicians, or the public, said Sheller.
Jason Itkin, the lead attorney in the Yount case, told the Legal Intelligencer that J&J staked their claim on a "reanalysis" that they tried to use as an answer to a document the plaintiffs argued showed a significant link between Risperdal and gynecomastia that was never turned over to the FDA.
"As part of that reanalysis, what came to light in our trial was something known as Tab Four that confirmed the link between Risperdal and gynecomastia, but was again never turned over to the FDA. We think that was the reason the jury found they didn't turn over the information,” Itkin told the Legal Intelligencer.
"J&J came up with this reanalysis," said Sheller, explaining that the pharmaceutical giant added a reanalysis 12-years after the fact.
This is pure misconduct and concealment on their part, he said, adding that the company lied to the jury, saying it was an independent study done by Janssen, which is not true, noted Sheller.
Itkin also told the Intelligencer that a videotaped testimony of a longtime Janssen employee, from a prior Risperdal case, was not used in the Yount case because the legal team didn’t feel it was even necessary.
That person, Ivo Caers, a Janssen employee for 37-years, introduced himself to a jury (in the case most like the Yount case: William Cerba v. Janssen), as a “Compound Development Team Leader,” working on Risperdal for 18-years, according to a court transcript, which seems to corroborate with the contention that J&J withheld information.
Moreover, Caers was asked by Attorney Tom Kline, if Janssen ever brought the research that showed the association to the FDA.
“No, not as such, no” said Caers according to a transcript of the 2015 case.
Asked by lead attorney Tom Kline, why not? The biochemist responded: “Analysis that you eventually, after the input of the clinicians and in this case also the endocrinologists, make clinical sense and have clinical value, those are things that you bring forward at the appropriate moment,” according to a court transcript.
“But all the different exploratory findings, you don’t share,” said Caers.
J&J needed to support its claim that Risperdal was safe for use by kids and so it omitted important tables which demonstrated that the adverse event gynecomastia would occur in nearly all children taking the drug according to Sheller.
But J&J tried to convince the FDA the association was not important, and now hopes the reanalysis it recently introduced in court could help it win future Risperdal cases.
“The FDA was lead to believe even [if there's an] abnormal prolactin [level] you don’t have to monitor for it, ‘because it doesn’t mean anything,’" Sheller told NBT last year, referring to the tables which he says show the association between Risperdal and breast tissue growth.
J&J has roughly 126,500 employees who work at more than 250 operating companies and subsidiaries. The company reported an increase in sales for its pharmaceutical segment in both the U.S. and abroad on July 19.
On J&J's second-quarter call with investors, CEO Alex Gorsky said J&J's worldwide pharmaceutical sales were $8.7 billion, an increase of 9.7 percent.
U.S. sales were up 13.2 percent while sales outside the U.S. increased by nearly 5 percent, “driven by both strong sales of new products as well as core growth products,” added Gorsky.
“Delivering a fair return to shareholders is the final line of our credo, which clearly defines our first responsibility is to the doctors, nurses and patients, the mothers and fathers, and all others who use our products,” noted Gorsky earlier on the call.
Since 1943, the company's famous credo has stated J&J's primary commitment is to the people served by its products and services.
"Our Credo is more than just a moral compass. We believe it’s a recipe for business success," reads the J&J website.
“With our credo as our foundation, our aspiration is that by caring for the world one person at a time, we can help billions of people. Now that’s an important source of inspiration for our scientists and our business people,” Gorsky told shareholders a couple years ago at their annual meeting.
However, Yount’s attorneys feel the company has lost its way.
"[J&J has] targeted the most vulnerable among us — children with disabilities — and they sold a drug that that they knew would cause kids to become disfigured. When their conduct was exposed, [the company] went through great lengths to cover its tracks,” stated Itkin.
Itkin described how facing a juggernaut like J&J in court is not easy, especially given an injury involving disfigurement to a teengager.
“[It was] a challenge to simply say what the family had been through, and to make sure the jury still understood the significance of the harm that was done to this kid. It's trying to show the disfigurement without making it seem like you're playing to the jury's sympathies,” he told the Legal Intelligencer.
“In all these cases, Janssen and J&J bring forth a very large amount of legal resources. There's a lot of briefing, and you have to be prepared for everything. The sheer volume is a challenge.”
Terry Yount, the father of the teenager from Tennessee said, "We are glad that Andrew's suffering now stands for something. We hope this verdict gives hope to the thousands of other boys who were disfigured by Risperdal that they will get justice too."
"We're proud that a family from a little town in Tennessee was able to stand up against one of the world's largest pharmaceutical companies and hold them accountable for the harm they have caused our son," said Yount.
J&J will look to appeal the decision.
“We believe this verdict is not justified by the evidence, and that the award is clearly excessive and far out of line with any factual assessment of actual damages,” said a J&J spokeswoman, in a statement.