Johnson & Johnson CEO, Alex Gorsky, Ordered to Attend Deposition As Risperdal Trials Restart

J&J faces two new trials related to its antipsychotic drug Risperdal for the first time since late 2019. A court ordered testimony from CEO Alex Gorsky in one. 

By Dave Schatz

New Brunswick, NJ - Alex Gorsky, Johnson & Johnson's chairman and chief executive was ordered to provide a deposition regarding the antipsychotic drug Risperdal in a case scheduled for trial October 4.  

Risperdal is J&J's brand name for the powerful antipsychotic medicine risperidone, which allegedly causes gynecomastiaa condition of overdevelopment or enlargement of the breast tissue in men or boys.

The plaintiffs in the case, Somerville et al v. Janssen Pharmaceuticals, Inc. et al argued that Gorsky's role in the marketing and sale of the antipsychotic medication was significant enough that he "should be compelled to provide testimony regarding his unique knowledge," according to court papers. (Frederick Somerville, 28, a Missouri resident, sued J&J in 2017 when this suit began.)

Gorsky, 61, who announced recently that he'll step down from two positions he's held for nine-years, effective January 3, has not been deposed in Risperdal litigation since 2013. He'll become J&J's executive chairman next year.

The New Brunswick-based giant is currently facing new Risperdal trials for the first time since October 2019.

While a Missouri Circuit Court in the City of St. Louis recently entered a “Commission to Issue a Subpoena Outside the State of Missouri” to the Court of Common Pleas of Bucks County State of Pennsylvania and to Middlesex County Superior Court of the State of New Jersey, Gorsky asked the Pennsylvania court to quash the subpoena. 

“In an attempt to circumvent Pennsylvania law and subvert the rulings of four judges on the Court of Common Pleas, Plaintiff's counsel has obtained an order from a Missouri court for the deposition of Mr. Gorsky by way of commission to this Court,” reads court papers. 

“These efforts pursue no objective other than to unreasonably annoy, burden, and harass Mr. Gorsky and Defendants, which is prohibited by the Pennsylvania discovery rules. Accordingly, this Court should grant the Joint Petition, quash the subpoena, and issue a protective order to prevent yet another deposition of Mr. Gorsky.”

Plaintiffs have until September 13 to submit arguments against the motion to quash Gorsky's testimony, according to a court document. A decision is expected thereafter.

Aside from the trial in St. Louis, in which Gorsky is being forced to testify, another Risperdal trial is scheduled to begin in Philadelphia on September 13. That trial is for plaintiff Michael Herman. It originally went to trial in January of 2019, but resulted in a mistrial. The jury will decide both compensatory and punitive damages.  

The Risperdal case in St. Louis will not only mark the first to go to trial in that arena, but a jury will also consider both compensatory and punitive damages, as well. 

J&J disclosed in an annual regulatory filing that it was facing 11,900 Risperdal claims, as of the “fiscal year ended December 29, 2019,” citing what became that year’s largest plaintiff’s verdict in the nation, in favor of Nicholas Murray.

The vast majority of Risperdal cases have been tried in Philadelphia resulting in compensatory awards as high as $76 million. The first punitive damages case, tried in 2019, resulted in an $8 billion verdict, which the judge later reduced to a figure equaling 10 times the initial compensatory award. 

Jason Itkin, an attorney with  Arnold & Itkin and his associates are handling more than 700 Risperdal claims for plaintiffs in Missouri. 

“There’s obviously a lot of questions that we’d like Gorsky to answer," said Itkin of the potential deposition.

The chief executive's testimony would mark his first live deposition in any Risperdal case and take place during the trial's first week, said Itkin. 

A pretrial conference is scheduled for September 2 and 3, according to court documents.

While the St. Louis court agreed with Gorsky and his attorneys that it lacked the authority to issue Gorsky a subpoena outside of Missouri to sit for a deposition, it found that it had the authority to sign commissions to the appropriate New Jersey and Pennsylvania courts to issue the out of state subpoenas to insure Gorsky's attendance.  

"Therefore, it is ordered and decreed that Plaintiff's Motion to Compel the Deposition of Alex Gorsky ... is hereby granted," read court papers.  

The testimony "could lead to discoverable information regarding Defendants’ alleged illegal marketing of Risperdal in use by children and attempt to cover-up their illegal activities once they became a matter of public record as a result of litigation,” read court papers.

Itkin said J&J does anything it can to "get off the hook," citing a limited number of delay tactics or appeals. There's only a limited amount of time J&J's army of lawyers could tie things up through the legal process, he added.

Gorsky's Role Marketing Risperdal 

When Gorsky joined J&J's Janssen Pharmaceuticals division as a sales representative in 1988, he didn't anticipate the striking volume of costly Risperdal litigation years later.

A decade later he was promoted to sales manager and Vice President of marketing for the unit. Then 13 months later he became Vice President of sales and marketing.

“And one of your responsibilities was for the CNS Division [Central Nervous System], correct?” Gorsky was asked in a 2012 deposition of his tenure as vice president of Janssen. “Yes it was,” responded Gorsky, also stating that “part of that responsibility was the drug Risperdal.”

 “… I believe I became president of Janssen [United States] in late 2001,” stated Gorsky, according to court papers.

But Gorsky left the position around February 2003. At some point that year, he took on responsibilities at J&J in Europe, according to court papers.

In 2004, Gorsky left J&J to work for Novartis. He was appointed Head of Pharma North America and Chief Executive Officer of Novartis Pharmaceuticals Corporation in the fall of 2005, according to a biography. But after about a four-year stint there, he returned to J&J in 2008.

In 2009 he was Worldwide Chairman of J&J’s Surgical Care Group and became J&J’s Chief Executive Officer in April, 2012. In December 2012 he was promoted to Chairman and CEO of J&J.

While Gorsky in 1997 was Vice President of Janssen’s CNS Division, which conducted Risperdal marketing, sales of the drug increased from $500 million to $800 million nationwide.

“The sales of Risperdal expanded during that time from $500 million,” said Gorsky in court papers, affirming that Risperdal was “part of [his] responsibility.”

In early 2001, Gorsky sent an email to employees at both Janssen United States and Janssen Belgium; the subject line read: “Competitive Activity, ” according to court papers. The email described prolactin levels as a “weak spot” that needed “defending."

“While we cannot respond to each and every competitive jab … We should expect that we will be challenged on a number of fronts due to our market position … Therefore we need to be proactive in expanding on our strengths (efficacy long and short term, agitation, weight gain, etc.) and defending our weak spots (prolactin, QTc, EPS),” stated the email, which Gorsky confirmed was read back to him correctly in a deposition.

Asked whether he identified prolactin as one of Risperdal’s weak spots, Gorsky said that he “Identified it as one of our weak spots relative to our competitors and our positioning in the marketplace at the time,” according to court papers.

Gorsky’s leadership role in the marketing of Risperdal has been questioned, perhaps more than any of J&J’s many liability claims against its drugs, consumer products, and medical devices. Key to the Risperdal litigation is evidence that J&J manipulated data and orchestrated an article set for publication in 2003 in the Journal of Clinical Psychiatry. J&J denied an association between Risperdal and gynecomastia. In 2013, litigation revealed that a data set showing the statistically significant relationship between Risperdal and gynecomastia was intentionally withheld from the authors of that article.

Bad News For J&J In Key Case

While no Risperdal-gynecomastia trials in the ongoing mass tort program in Pennsylvania State Court of Common Pleas were expected to be heard until at least February of this year amid the pandemic, J&J last year received unwanted news from the state's highest court.

"The Petition for Allowance of Appeal is Denied," said an order issued by the Supreme Court of Pennsylvania, thus rejecting Janssen’s final effort at the close of 2019 to overturn the $76 million judgement in favor of plaintiffs Andrew Yount and his mother, Billie Ann, of Tennessee in the Yount v. Janssen case.

During a four-year period J&J exhausted its appellate remedies. But the case will eventually go to trial for the second time (since 2016) to settle the issue of punitive damages.  

The high court effectively upheld and affirmed the 2016 Yount verdict, where a jury found that J&J was negligent and failed to adequately warn of the risk of gynecomastia associated with Risperdal.

The Yount case was the fifth Risperdal case tried in the mass tort program in Philadelphia; there are over 7,200 others waiting, amid COVID-19 delays. Itkin and his team are representing most of the claimants there.

“There will be no Civil trials until after January 1, 2021,” confirmed Stanley Thompson, Director of the Complex Litigation Center in the First Judicial District of Pennsylvania, last year. “Mass Tort Team Leader Judge Arnold L. New has not yet approved scheduling of trials for these programs in 2021," he had said.

J&J disclosed in an annual regulatory filing that it was facing 11,900 Risperdal claims, as of the “fiscal year ended December 29, 2019,” citing what became the year’s largest plaintiff’s verdict in the nation, in favor of Nicholas Murray.

“Product liability lawsuits continue to be filed … [J&J] has successfully defended a number of these cases but there have been verdicts against the [J&J], including a recent verdict in October 2019 of $8 billion in punitive damages … which was subsequently reduced [on January 17] … to $6.8 million by the trial judge,” said the filing, referring to the Murray case.

Itkin cited a decline in J&J’s transparency, accountability, and corporate governance, saying its attitudes toward patient and consumer safety have slipped.

“Johnson & Johnson didn’t start out as a company that was like this,” he said. And he thinks of the drugmaker as “a repeat offender that "knowingly chose to hurt children in order to increase their profits."

J&J “is a company that shows no remorse and no empathy for the victims," he said. "We look forward to being able to try more cases in the court of law and expose what they've done."

In the filing, J&J was citing the Murray v. Janssen case, which was the first and only Risperdal case yet to reach a verdict for punitive damages, determined under law in the plaintiff’s home state of Maryland. The $6.8 million figure is 10 times the $680,000 compensatory award granted in the initial Murray trial, prior to punitive damages being allowed. (It was reduced from $1,750,000 to $680,000 in March of 2016.)

Yount, now in his early 20's, claimed the antipsychotic medication that Janssen manufactured and marketed caused “Personal Injury to himself,” according to court papers. He suffered “Gynecomastia” and “Weight Gain” from taking “Risperdal and/or Risperdal Consta.”

Yount was initially prescribed Risperdal, off-label, in August 2003, when he was 4-1/2. Prescribing off-label occurs when a drug is prescribed by a medical professional for use beyond those contained in the drug’s Federal Drug Administration approved uses.

“This includes prescribing a drug for a condition not indicated on the label, treating the indicated condition at a different dose … than specified in the label, or treating a different patient population,” read court papers.

FDA in 1993 approved the use of Risperdal to treat schizophrenia and bipolar mania for adults only, but in late 2006 it was finally approved for children to treat the irritability associated with autism. While federally approved to treat schizophrenia and bipolar disorder, doctors also prescribe the drug for unapproved uses such as treating attention deficit/hyperactivity disorder, anxiety, sleep difficulties, and depression.

Thirteen claims were  asserted against Janssen in the Yount case: Negligence, Negligence Design Defect, Fraud, Strict Product Liability, Failure to Warn, Strict Product Liability, Design Defect, Breach of Express Warranty, Breach of Implied Warranty, Violation of Pennsylvania Unfair Trade Practices and Consumer Protection Law, Unfair and Deceptive Trade Practices, Conspiracy, Punitive Damages, Medical Expenses Incurred by Parent, and Loss of Consortium.

“In January 2004 … after Plaintiff began taking Risperdal, A.Y.’s [Andrew Yount’s] mother went to Doctor Eker and expressed concern that his breasts were enlarging,” read court papers. 

After being diagnosed with ADHD and oppositional defiant disorder, Yount was on and off Risperdal for years. He also tried a dozen different meds. For example, one of his doctors believed his development of female breasts at the age of five was a rare occurrence, but when she believed his gynecomastia had reduced, she put him back on Risperdal.

The first Risperdal-gynecomastia case to go to trial in the mass tort program resulted in a $2.5 million award for plaintiff Austin Pledger and his family in early 2015, but the case was settled for an undisclosed amount, before going to trial the second time to decide possible punitive damages. The settlement amount is sealed. 

The case was the first to go to trial following a 2.2 billion settlement J&J reached with the Justice Department in 2013 for improperly marketing Risperdal to children, older adults and those with developmental disabilities. A jury found J&J was “negligent by failing to provide an adequate warning” to the prescribing doctor, according to court papers, which noted that the defendants’ negligent failure to provide an adequate warning was a cause of Pledger’s gynecomastia

Punitives No Longer Barred

Previously, Risperdal trials went forward on compensatory damages only. Punitive damages were barred altogether in New Jersey, which prohibits punitive damages in product liability lawsuits that involve FDA approved medications.

But in a 2014 order citing the “New Jersey Product Liability Act,” Judge New ruled that New Jersey law applied to punitive damages. The fact that Janssen has a substantial place of business in Titusville, New Jersey, was a factor in his decision.

“No one can get punitive damages for bodily injury anywhere in the United States no matter where they live or where they were injured,” Stephen A. Sheller of Sheller PC, one of Yount’s attorneys had said, adding that Judge New issued J&J “a get out of jail free card on punitive damages.” 

But Sheller, who in 2018 wrote “Big Pharma Big Greed: The inside story of one lawyer’s battle to stem the flood of dangerous medicines and protect public health,” along with Sidney D. Kirkpatrick and Chris Mondics, fighting and appealing the denial of punitive damages for plaintiffs. Three years ago the Pennsylvania Superior Court, one of Pennsylvania's two intermediate appellate courts, decided that Risperdal cases are eligible for punitive damages. 

First pegged at $70 million in July 2016, a month later the verdict “was molded to add Delay Damages of $6,661,024, for a total verdict of $76,661,027,” noted court papers. 

Tennessee law was applied and the court is likely to rule that the law of Yount’s domicile (home state) will be the controlling law in the second trial as well. That’s partly because in the punitive damages phase of the Murray case, the plaintiff’s domicile of Maryland was the controlling law.

“The idea behind punitive damages is that as a society we want to deter bad, dare I say, evil conduct and hurting kids is as bad as it gets,” said Itkin, noting the health care giant’s sheer size. “To make sure they don’t do this again, whether it be to kids or the elderly, is to hold them accountable in the court of law." 

Still, Janssen argued in the Yount case that only the FDA, not state law, had authority to change the labeling to reflect a warning for off-label use: “Because Risperdal was not approved for pediatric use – it was an 'off-label' use and only the FDA had the authority to warn about off-label uses,” read court papers. 

But the intermediate court cited a changes being effected (CBE) exception, only if the manufacturer had newly acquired information about the drug or showed a causal association between the drug and an effect that warranted a new or stronger warning, and said: “Newly acquired information is data, analysis, or other information not previously submitted to the [FDA that] reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA,” read court papers.

When Yount began Risperdal in 2003, he had difficulty sitting still and exhibited aggressive behavior such as biting and hitting people, according to court papers. He also broke windows, stripped the paint off of a door, and broke a chicken’s back.

Risperdal Consta sales across the nation decreased nearly 7 percent in the first nine months of the year, from $237 million to $220 million, compared to last year, while total pharmaceutical sales increased 5.2 percent, according to J&J’s third-quarter results, reported October 13. (For the quarter, sales of the med were down 11 percent from $79 million to $70 million, year-over-year.)

Ahead of the awaited punitive damages trial, Yount’s attorneys commented: "This jury verdict affirmance and rejection of J&J's preemption arguments dovetails with the appellate rulings against J&J relating to the drug Risperdal, where similar verdicts have been upheld, and punitive damages have been reinstated," said a statement from Kline & Specter attorneys Chip Becker and Thomas Kline and Arnold & Itkin. "All paving the way for continued progress and additional jury verdicts against a company whose misconduct toward children has been exposed in the courts of this Commonwealth."

Asked to comment on the Yount case, Janssen said in a statement that it was considering its legal options. 

“Risperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions.”

J&J in October 2019 criticized the verdict in the second Murray case, calling the award "excessive," "unfounded," and “grossly disproportionate with the initial compensatory award."

The jurors in four out of seven Risperdal cases have awarded about $75 million worth of damages against Janssen, though two were thrown out midtrial due to lack of evidence.”

Most have been filed in state courts in California, Missouri, and Pennsylvania, with some pending actions elsewhere in the United States and Canada, according to J&J. 






Comments

Dave Schatz said…
Please feel free to republish this report with byline: Dave Schatz.

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