New Risperdal Mass Tort Trial Underway Against J&J in Philadelphia

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

The sixth trial against Johnson & Johnson’s Janssen subsidiary concerning its Risperdal anti-psychotic drug is underway in the Philadelphia Court of Common Pleas.

Plaintiff Tommy Moroni of Sargent, Nebraska alleges that he was first prescribed Risperdal in Dec. 2004 to treat his oppositional defiant disorder, anxiety and depression. He took the drug for four years after a doctor diagnosed him with gynecomastia in Nov. 2010. Moroni  v. Janssen Pharmaceuticals Inc., case number 130501076, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

2,000 lawsuits filed

Plaintiff attorney Jason Itkin or Arnold & Itkin in Philadelphia argued that Risperdal causes spikes in the prolactin hormone, causing  gynecomastia, or the development of female breast tissue.

The litigation has continued for three years, with 2,000 plaintiff cases filed in Philadelphia. Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July.  Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Among the evidence against J&J are:

  • Video testimony from former FDA Commissioner David Kessler that J&J manipulated the data shown to the agency to obscure that it causes gynecomastia.
  • The FDA approved Risperdal only for treating schizophrenia in adults. The warning label said that gynecomastia was a rare side effect.
  • The FDA declined to approve the drug for children in 1997, but in Oct. 2006 approved it to treat symptoms of autism in adolescents.
  • Internal emails show company officials saying the drug was worse than its competitors in terms of prolactin elevation.

Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted Risperdal to older adults, children and people with developmental disabilities, according to the Justice Department.

Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.

 

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Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

The parties in a case charging that a boy who took Risperdal, causing him to grow female breasts, settled for an undisclosed amount with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Meanwhile, appeals continue over when the statute of limitations begins to run for victims of the Risperdal side effects.

  • A total of 2,085 Risperdal products liability cases are pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas.
  • Another 300 cases are pending in the Superior Court of Los Angeles.

J&J Suppressed Science

In the Philadelphia case that settled, the plaintiff started taking Risperdal at age six for Asperger’s syndrome. N.F. v. Janssen Pharmaceuticals, Case No. 13500998. It would have been the sixth case to go to trial over evidence that Janssen hid a scientific link between the antipsychotic drug and male breast growth, or gynecomastia.

Jason Itkin of Arnold & Itkin in Houston, TX.
Plaintiff attorney Jason Itkin of Arnold & Itkin in Houston, TX.

Risperdal was approved by the U.S. Food and Drug Administration in 2002 to treat schizophrenia, but was not cleared for use in children until 2006.

Evidence that the company lied  about the scientific link and hid it from the Food and Drug Administration led to a $70 million jury verdict against Janssen on July 1. The case is Andrew Yount v. Janssen Pharmaceuticals Inc. et al., case number 1304002094, in the Court of Common Pleas of Philadelphia County, Pennsylvania. 

The jury in the Yount case found that J&J intentionally falsified, concealed, or destroyed material evidence,” states a press release from Arnold & Itkin.

“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,” the press release states.

Janssen knew about a key safety analysis since 2002, but failed to give it to the FDA, as they should have, when looking to get Risperdal approved for children, according to New Brunswick Today.

In 2013 the Department of Justice penalized Johnson & Johnson for more than $2.2 billion to resolve criminal and civil investigations allegations include off-label marketing and kickbacks to doctors and pharmacists relating to Risperdal.

Appeal over Statute of Limitations

A appeals panel of the Pennsylvania Superior Court may decide in three cases whether plaintiffs should have been reasonably aware that Risperdal caused breast enlargement as of June 30, 2009, starting the statute of limitations.

In January 2015 Judge Arnold L. New, the Coordinating Judge of the Complex Litigation Center, ruled that plaintiffs had two years to file a claim starting from the 2009 date. In Re: Risperdal Litigation, case numbers 576 EDA 2015, 590 EDA 2015 and 2451 EDA 2015, in the Superior Court of the State of Pennsylvania.

Judge New said the potential connection between Risperdal and gynecomastia had been revealed in several medical journals and media reports, and added to the drug’s warning label.

In oral arguments in September, plaintiff attorneys argued to the appeals court that the trial judge had improperly attempted to set a global accrual date for Risperdal claims that didn’t conform to the individual experiences of the two men whose cases served as a springboard for the ruling.

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More Risperdal Cases Set for Trial in Philadelphia

Derek T. Braslow
Derek T. Braslow

Eight cases involving the antipsychotic drug Risperdal are set for trial against Janssen Pharmaceuticals in the Philadelphia Court of Common Pleas, with the company settling cases even as it denies that the drug causes disfiguring gynecomastia in boys.

Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has caused gynecomastia, or the development of female breast tissue, according to leading plaintiff’s lawyer Derek T. Braslow of Pogust, Braslow & Millrood in Conshohocken, PA. This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

Read these updates:

Risperdal Docket in Philadelphia Court of Common Pleas

Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

New Judge Knocks Out Plaintiff’s Expert, Abruptly Dismisses Risperdal Case

$70 million Verdict against Janssen Pharma in Risperdal Breast-Growth Case

The litigation has been continuing for three years, with 2,000 plaintiff cases filed in Philadelphia and the next trial set for January.  Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July.  Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Fined $2.2 Billion

Janssen, a subsidiary of Johnson & Johnson, never got approval to market the drug for minors. Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted the  drug to older adults, children and people with developmental disabilities, according to the Justice Department.

Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.

Former commissioner of the U.S. Food & Drug Administration (FDA) David Kessler testified in 2015 that the company hid information about the gynecomastia risk as early as 6 years before it changed the drug’s label to include the injury, which is characterized by abnormal breast tissue growth in adolescent boys and young men. He also told the jury that Janssen failed to inform physicians of the gynecomastia risk associated with the drug.

Scientific research supports claims that Risperdal may cause gynecomastia in boys. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology indicated that risperidone, which is the generic of Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”

Braslow said that J&J has been settling Risperdal cases, but the amounts are not disclosed. The highest settlements are for boys who undergo double mastectomy.  He advised plaintiff lawyers to focus on cases involving prescriptions written from 2000 to 2006.

Risperdal has carried a black-box warning by the FDA since September 2006 to warn about the increased risk of death in elderly patients with dementia-related psychosis. In addition to the increased risk of death in the elderly, Risperdal has added warnings associated with Tardive Dyskinesia, which is the development of abnormal facial, shoulder and limb movements that a patient cannot control.

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Philly Judge Adds $6.66 Million Delay Interest to $70M Risperdal Verdict

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

Philadelphia Court of Common Pleas Judge Paula Patrick ordered Janssen Pharmaceuticals to pay an additional $6.66 million in delay damages to plaintiff Andrew Yount and his family after they recovered a $70 million jury verdict last month.

The damages were calculated at 4.25% annually starting April 16, 2014, when the complaint was served, and increasing to 4.5% from April 16, 2016, to July 1, 2016, the date of the verdict.

The case is Andrew Yount, et. al., vs. Janssen Pharmaceuticals, Inc. et. al., Case No. 130402094.

Yount began taking Risperdal in 2003 to treat psychiatric problems. When the drug caused him to develop gynecomastia, or the abnormal growth of breast tissue, he filed suit in April 2013.

During the trial, plaintiff attorney Jason Itkin of Arnold & Itkin LLP in Houston argued that Jannsen knew at the time that Risperdal was associated with spikes of the prolactin hormone, which causes the gynecomastia.

It was the fifth Risperdal lawsuit tried in Philadelphia, and by far the largest verdict so far. Earlier verdicts ranged from $500,000 to $2.2 million. The jury also found that Janssen “intentionally falsified, destroyed or concealed records.”

Gynecomastia

Lawyers for the plaintiff demonstrated that Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson, attempted to downplay the risks of the drug causing gynecomastia, a condition in which boys develop female breast tissue. While the drug was initially approved for a small market, those suffering from bipolar and schizophrenia-related disorders, Janssen reportedly worked to expand doctors’ recommendations of the drug to include treatments for dementia, behavioral problems, and autism. At the time the plaintiff began taking the drug the Food and Drug Administration (FDA) had only approved it for adult use.

Follow our continuing coverage:

Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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Emerging and Ongoing Mass Tort Litigation Update

MTN

You can’t miss this!
 

Mass Tort Nexus has added the hottest emerging litigation to its September Course: RoundUp Litigation. This could be the biggest mass tort since asbestos.

In addition to the hands-on practical knowledge all course attendees receive, we are privileged to have an all-star panel of attorney speakers discussing current, emerging and ongoing Mass Tort litigations.

Best of all, this program will be interactive.  There will be ample Q&A after each presentation.

Whether you have dabbled in Mass Torts or are new to the practice area, the “Four Day Mass Tort Success Course” will help you avoid common mistakes, while giving you a road map to success in Mass Torts.  We teach you a step by step process to make sure you understand the methods and metrics of this practice area.

Please join us  Sept 23rd  – Sept 26th for the “Four Days to Mass Tort Success Course” in Fort Lauderdale.  Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com for more information.

RoundUp Cancer Emerging Litigation 
 
timothy-litzenburg-200x300

Timothy Litzenberg will be addressing the emerging RoundUp Cancer litigation. Timothy filed one of the original complaints in district court on behalf of a client who developed cancer after exposure to RoundUp. He is also one of the attorneys supporting the Plaintiffs’ motion to consolidate and transfer (i.e., to form an MDL) currently before the Judicial Panel on Multidistrict Litigation.

In district court, Monsanto failed to derail the RoundUp litigation. Monsanto, as well as Plaintiffs attorneys including Tim have now separately moved to support the formation of an MDL. This emerging Toxic Tort may involve more plaintiffs than any in history. Do not miss out on the chance to get information on this litigation in its early
stages. 
IVC Filter Product Liability Litigation

John Dalimonte now serves on the Steering Committee of the Cook Medical IVC filter litigation and the Bard IVC filter Litigation. He will be speaking about  the Cook and Bard IVC litigations, as well as other ongoing and emerging IVC Filter Litigation, which involve more IVC manufacturers. John has served in leadership positions on a number of MDLs and was Co-Lead Counsel in the Vioxx product liability litigation.

The IVC filter litigation may be one of the largest mass product liability litigation’s of all time, with respect to the number of plaintiffs and payouts. This litigation puts the “complex” in complex litigation and the opportunity to interact with one of the leading attorneys in this case is invaluable.
Proton Pump Inhibitor Product Liability Litigation

Bryan Aylstock will present the emerging Proton Pump Inhibitor litigation. Bryan is currently serving as one of three coordinating Co-Lead Counsel members charged with overseeing five separate Multi-District Litigations (MDLs), involving the use of TVM products. Additionally, Bryan has served in leadership positions in the Zoloft product liability litigation, the Avandia product liability litigation, as well as other MDLs.

Bryan is an outstanding lawyer and arguably one of the best business minds in Mass Torts. The opportunity to get in on the ground floor of an emerging litigation with guidance from a tested Mass Tort gladiator is worth the trip to Fort Lauderdale.

 Risperdal Product Liability Litigation

Derek Braslow will be speaking about the Risperdal product liability litigation. Derek now serves as Liaison Counsel in the Risperdal litigation and has served in many Court-appointed leadership positions in other pharmaceutical litigations. He has been in leadership positions on many MDLs, including Co-Liaison Counsel Zimmer Durom Hip Cup, as well as leadership positions in the Levaquin product liability litigation and the Paxil suicide litigation.

The Risperdal litigation is not a typical Mass Tort litigation. Derek’s insights on the Risperdal case will give knowledge and information that will be useful far beyond this single litigation.
 
Talcum Powder Product Liability Litigation
 
James Onder will be speaking on the subject of the Talcum Powder litigation. He is one of the lead attorneys in the City of Saint Louis consolidation, which has already produced multiple Jury verdicts exceeding fifty million dollars each.
James, and other members of his firm, have served as co-lead counsel and in various leadership positions on many MDLs. The opportunity to hear James speak about a difficult litigation, that he and his co-counsel firms managed to achieve massive jury awards in will be  an opportunity you won’t want  to miss.  
 
Xarelto Litigation
&
Stryker Hip Litigation “Life After the MDL”
 

Joseph Osborne will be speaking on the Stryker Hip Litigation, as well as other Hip Implant litigation. Long after other firms stopped accepting or seeking clients for the metal on metal hip implant litigations, Joseph continued to accept clients who were, and continue to be, injured by these defective products.He served in leadership positons on the Stryker Nexgen Knee MDL, the Biomet M2 Hip MDL, the Stryker Hip MDL, the American Medical System TVM MDL, as well as many other multidistrict litigations.

Joe also serves on the Science Committee in the Xarelto MDL and will be providing information about this litigation.
 
Taxotere, Onglyza and Fluoroquinolones
 
Ryan Thompson will round out the panel speaking and answering questions about three litigations every firm should be considering.  Not yet forty years old, Ryan has already achieved a record of achievements, that most lawyers would consider a stellar lifetime career. He served as Co-Lead Counsel on the Incretin Memetics Litigation, as well as in leadership positions on many MDLs. Ryan is often involved in emerging litigations in a major way. His grasp of the science involved in pharmaceutical and medical device litigation and his willingness to take risks have resulted in his incredible rise in the world of Mass Tort litigation.
One of Ryan’s early victories involved taking on a major credit reporting agency and collecting 28 Million dollars, in a litigation other firms had overlooked. Ryan brings a unique perspective to mass torts. It is a privilege to hear Ryan speak and even more of a privilege to get to know him.

Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com for information and to book your seat for the September Course.

 

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$70 million Verdict against Janssen Pharma in Risperdal Breast-Growth Case

risperdal-infographicA jury in Philadelphia ruled on July 8 that the antipsychotic drug Risperdal caused a Tennessee boy to grow breasts and imposed a $70 million verdict on its manufacturer, Janssen Pharmaceuticals.

Lawyers for the boy argued that scientists for the company were well aware of the risks and sought to downplay them. The company disputed that allegation during the Common Pleas Court trial and said that physicians were fully informed of potential side effects.

It was the fifth Risperdal lawsuit tried in Philadelphia, and by far the largest verdict so far. Earlier verdicts ranged from $500,000 to $2.2 million. the jury also found that Janssen “intentionally falsified, destroyed or concealed records.” That finding is necesdsary for plaintiffs to recover more than the $750,000 damages cap that Tennessee law imposes on noneconomic damages.

The products liability action, Case C.P. Philadelphia No. 130402094, was heard before Judge Paula Patrick.

Gynecomastia

Plaintiffs Counsel was Jason Itkin, Arnold & Itkin in Houston. Defense Counsel was David Abernethy, Drinker Biddle & Reath in Philadelphia. A spokeswoman for Janssen said the verdict went against the evidence, and the company will seek an appeal.

Lawyers for the plaintiff demonstrated that Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson, attempted to downplay the risks of the drug causing gynecomastia, a condition in which boys develop female breast tissue. While the drug was initially approved for a small market, those suffering from bipolar and schizophrenia related disorders, Janssen reportedly worked to expand doctors’ recommendations of the drug to include treatments for dementia, behavioral problems, and autism. At the time the plaintiff began taking the drug the Food and Drug Administration (FDA) had only approved it for adult use.

Follow our continuing coverage:

Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

risperdal-infographicKentucky Attorney General Jack Conway announced the settlement of two pharmaceutical cases for total of $39.5 million. The settlements end the litigation of the Purdue Pharma case regarding OxyContin and the Johnson & Johnson case regarding Risperdal.

  • The OxyContin case was settled on Dec. 22 for $24 million – more than 50 times what Kentucky was originally offered in 2007 to settle the case.
  • The Risperdal case, a consumer protection lawsuit alleging that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers, was settled on Dec. 22 for $15.5 million.

“These companies engaged in reckless behavior that put our citizens at risk,” Attorney General Conway said. “Both companies knowingly and aggressively marketed drugs they knew to be harmful in order to drive profits. I am pleased we were able to recover damages for the Commonwealth and recover funds to help expand addiction treatment in Kentucky.”

Risperdal Settlement

Risperdal is a second-generation antipsychotic prescription drug approved by the FDA to treat schizophrenia and acute mania associated with bipolar disorder. The Kentucky Consumer Protection lawsuit alleged that the makers of Risperdal misled consumers about its dangers and marketed the drug for purposes other than those approved by the FDA. Risperdal is manufactured and distributed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

“Janssen and Johnson & Johnson put patients at risk when they marketed Risperdal without disclosing the drug’s known side effects,” Attorney General Conway said. “These side effects were even more harmful to children and elderly patients.”

Janssen marketed Risperdal to children before it was approved to do so in 2007 by the FDA. It failed to disclose to parents, physicians and patients that Risperdal may cause a hormonal imbalance, which could cause breast tissue development and infertility in both boys and girls. Janssen was aware of the risk and did not update the drug’s warning label because it felt awareness of the risks could cost the company up to $150 million per year.

Janssen also marketed Risperdal for a non-FDA approved use in treating dementia in non-schizophrenic elderly patients. It even created an elder care sales force, despite having its own study that showed Risperdal doubled the risk of death in the elderly. Risperdal’s label did not disclose this risk to the public until 2003, even though a Janssen-funded trial indicated the risk in 1997. In 2013, Janssen pleaded guilty to federal charges of misbranding the drug regarding the promotions to the elderly.

Marketed as an atypical anti-psychotic

Additionally, Janssen marketed Risperdal as an atypical anti-psychotic with low weight gain and diabetes risk. However, its internal studies indicated that after one year, patients on Risperdal had as much weight gain as its main competitor and a greater risk of diabetes.

“Going forward, we have tough terms in the settlement that will govern the way Risperdal can be marketed in the future here in Kentucky,” Attorney General Conway said. “It is my hope that the General Assembly will allocate the money to expand addiction treatment in Kentucky.”

In addition to the $15.5 million payment to settle the claims, Janssen is prohibited from promoting Risperdal for non-FDA approved uses or for populations in which it is not approved. Janssen will be required in Kentucky to clearly disclose risks associated with the drug. It will also not be allowed to promote the drug for a single symptom for which it is not approved, such as depression or anxiety, without reference to the underlying mental illnesses that Risperdal is approved by the FDA to treat.

In the settlement, Janssen does not admit wrongdoing. A copy of the settlement agreement is available here.

OxyContin Settlement

The settlement resolves allegations that Purdue Pharma illegally misrepresented and/or concealed the highly addictive nature of OxyContin and encouraged doctors who weren’t trained in pain management to overprescribe the opioid pain reliever to Kentucky patients.

The Food and Drug Administration (FDA) approved OxyContin in 1995. Following its release, Purdue immediately launched an aggressive national marketing campaign to promote the drug, which was led by sales representatives who falsely told doctors that OxyContin wasn’t addictive and was less likely to be abused than other opioid drugs.

Kentucky filed its lawsuit in 2007 to recover damages to the Commonwealth after Purdue pleaded guilty in U.S. District Court in the Western District of Virginia for misbranding OxyContin. In that case, three of its top executives also pleaded guilty to misdemeanor misbranding.

At the time, Kentucky was offered approximately $500,000 to settle its claims, which the Commonwealth refused. Now after eight years of hard-fought litigation, and while still facing significant legal issues in the case, Kentucky will receive $24 million. The agreement also extends injunctive relief that was set to expire in 2017. The court order directs the General Assembly to appropriate the funds to expand addiction treatment in Kentucky.

“Purdue Pharma created havoc in Kentucky, and I am glad it will be held accountable,” Attorney General Conway said. “Purdue lit a fire of addiction with OxyContin that spread across this state, and Kentucky is still reeling from its effects.”

In the settlement, Purdue does not admit wrongdoing. A copy of the settlement agreement is available here.

$500 million in settlements

ht years as Attorney General, Conway secured $500 million in consumer protection and Medicaid settlements. He increased Medicaid Fraud collections by 600 percent and investigated more elder abuse and neglect cases than any previous Kentucky Attorney General. He helped craft legislation that shut down half of the state’s pain clinics and worked to address the resurgence of heroin in Kentucky. He educated more than 45,000 parents, students and teachers about the dangers of prescription drug abuse through his “Keep Kentucky Kids” safe program. He secured Kentucky’s future tobacco payments by settling the Tobacco Master Settlement Agreement case. Attorney General Conway also led national efforts to investigate the practices of some for-profit colleges and shut down the website GIBill.com, which was a for-profit college lead generator masquerading as a government website. GIBill.com is now under the control of the U.S. Department of Veterans Affairs.

Attorney General Conway also created a Cybercrimes Unit that’s become a national model. The unit has a 100 percent conviction rate and has seized more than 1 million child pornographic images from the Internet.

“It’s been an honor to serve as Kentucky’s 49th Attorney General,” Attorney General Conway said. “I know that by working together, we’ve made Kentucky a safer place to live, work and raise a family.”

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Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

risperdal-infographicPHILADELPHIA – If the results of the first trials are any indication, Janssen Pharmaceuticals might find itself with a hefty price tag connected to more than 1,600 Risperdal cases currently pending in Philadelphia, even without the prospect of paying punitive damages – though an appeal might change that.

Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has found itself the subject of lawsuits from male plaintiffs nationwide who were prescribed the drug and claimed to have suffered from gynecomastia, the development of female breast tissue.

This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

Statistics recently issued by the Philadelphia County Court of Common Pleas Complex Litigation Center and its director Stanley Thompson stated a total of 1,606 Risperdal cases had been filed in the court system as of the end of November.

That figure will not be final either. The court will attract more cases in the future, as 95 were filed in November.

Three of the four trials that have concluded have resulted in victories for plaintiffs. Two have exceeded $1 million, and the other victory went for $500,000 – a total of $4.75 million to plaintiffs.

This is despite the fact that punitive damages have been disallowed in the cases, though plaintiffs attorneys have appealed that decision.

Speaking recently on behalf of fellow plaintiff liaison counsel Thomas Kline of Kline & Specter and Stephen A. Sheller of Sheller P.C., Christopher Gomez, also of Sheller P.C. expressed optimism that the ban would be lifted in the future.

“We are confident that at some point punitive damages will be reinstated,” Gomez said.

In February, the first of these cases to make its way through the CLC reached its conclusion. Alabama man Austin Pledger, who was prescribed Risperdal in 2002 as a teenager for treatment of mood swings related to his autism, developed size 46 DD breasts, allegedly as a result of taking the drug.

In 2002, Risperdal had not yet received Food and Drug Administration (FDA) approval for prescription to adolescents, but it would later receive such designation in 2006 – along with a causation warning that the drug may lead to gynecomastia in some male users.

Pledger asserted Janssen did not disclose the side effect to his doctors before he was prescribed Risperdal. A Philadelphia jury awarded Pledger $2.5 million in February, and post-trial motions are currently pending in the case.

However, Philadelphia County Court of Common Pleas Judge Arnold New ruled in June of last year that punitive damages were not applicable in cases involving Risperdal. In a post-trial motion in the Pledger case, New reiterated his stance in October of this year that punitive damages would not apply.

Though Janssen (a Johnson & Johnson subsidiary) is a Pennsylvania corporation, New stated the marketing and development for Risperdal, along with all relevant Food and Drug Administration correspondence regarding it, was addressed to Janssen’s principal business location in New Jersey – and was therefore bound by that state’s Product Liability Act.

Per that legislation, cases involving pharmaceutical manufacturers are only subject to punitive damages if it could be proven that the manufacturer knowingly concealed information about their product from the FDA.
In the case of William Cirba, the second plaintiff whose Risperdal case has reached the Philadelphia County Court of Common Pleas, Janssen emerged with a victory.

Cirba, 19, was prescribed Risperdal when he was six years old for the treatment of oppositional defiant disorder in 2002, and asserted he also grew breasts as a result of taking the drug.

Cirba added Janssen was aware of the presence of gynecomastia among a percentage of Risperdal users prior to 2006, but allegedly concealed the information from Cirba’s physicians.

In response, Janssen argued it provided sufficient caution of the risks associated with Risperdal to Cirba’s prescribing doctors and his gynecomastia wasn’t diagnosed until 2014, the year after he filed his lawsuit against Janssen.

In the end, the jury in Cirba’s case concluded his medical condition could not be connected to adverse side effects from Risperdal, though it further determined the company was negligent in warning of the risks of the drug.

A third trial, involving Maryland plaintiff Nicholas Murray, was recently decided in Murray’s favor for $1.75 million. Murray was prescribed Risperdal at the age of nine in 2003, for off-label treatment of symptoms associated with his Asperger’s Syndrome.

Like Pledger and Cirba, Murray also allegedly contracted gynecomastia as a result. The $1.75 million jury verdict represents damages for “disfigurement and mental anguish.” Post-trial motions in Murray’s case are also currently pending.

Stange v. Janssen Pharmaceuticals reconvened this month and resulted in a $500,000 jury verdict for the plaintiff, Timothy Stange.

Similar to the Cirba case, the jury found Janssen was negligent in failing to provide a warning about the drug. However, in this particular suit and unlike the Cirba case, the jury did conclude that same negligence directly caused Stange’s injuries. Stange is from Wisconsin.

“There have been three cases tried to jury verdicts. In each case the jury has found that Janssen failed to warn about the risk of gynecomastia in children and adolescents,” Gomez said before the Stange verdict.

“In two of the cases, there have been multimillion-dollar jury verdicts. We expect this trend to continue.”
When asked if counsel had any settlement talks with Janssen to this point, Gomez stated they had not and intended to continue to proceed with trials in each Risperdal case.

“There are no settlement talks at this time. We are prepared to continue to go and try the cases with Janssen/Johnson & Johnson,” Gomez said.

Gomez said Janssen’s Pennsylvania corporate base made Philadelphia an ideal venue for the cases to be heard.

Gomez explained 12 Risperdal cases are currently in discovery and heading to trial in 2016.

Defense liaison counsel in the Risperdal litigation – Kenneth Murphy of Drinker, Biddle & Reath and Stephen Imbriglia of Gibbons P.C., both of Philadelphia – offered no comment.

In an email statement, Janssen spokesperson Robyn Reed Frenze said the company “will continue to defend this litigation and will try cases where appropriate” regardless of where they were filed, and agreed with New’s decision to apply New Jersey law to these cases on the subject of punitive damages.

Frenze further commented, “Risperdal (risperidone) has helped and is still helping millions of patients with debilitating mental illnesses and neurodevelopmental conditions as part of a comprehensive treatment plan.”

An October Securities & Exchange Commission filing showed Janssen has created a reserve fund regarding pending product liability litigation.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

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