PA Superior Court Reverses Risperdal Defense Verdict as Court Strikes Janssen Pharmaceuticals Only Favorable Jury Verdict

“Johnson & Johnson Hit With Another Trial Verdict Reversal”

By Mark York (November 17, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS) The Superior Court of Pennsylvania reversed the single defense verdict reached in favor of Janssen Pharmaceuticals, the manufacturer of anti-psychotic drug Risperdal. The reversal and order for a new trial stemmed from a 2015 trial that resulted in the one Risperdal defense verdict to date. The case is part of the mass tort docket for Risperdal cases in the Philadelphia County Court of Common Pleas, (see RISPERDAL Case No 296 PHILADELPHIA COURT OF COMMON PLEAS BRIEFCASE), where more than 6,000 Risperdal cases are pending.

The 22-page unanimous Superior Court decision by Judge Jack Panella, reversed the Janssen defense win in the Risperdal trial where plaintiff William Cirba filed suit against Janssen Pharmaceuticals and lost, as well the subsequent denial of Mr. Cirba’s request for a retrial based on “erroneous evidentiary rulings.”

The ruling ordered a new trial and will now be limited to the issues of causation and damages.

LAYPERSON AT TRIAL IS NOT AN EXPERT

The Superior Court stated the trial court made a reversible error at trial, by allowing physician’s assistant Michelle Baker’s testimony to be weighed on the same level as that of a medical expert. Ms. Baker was involved in the treatment of Mr. Cirba from 2005 to 2013, as a physician’s assistant.

During the Cirba trial, a videotaped deposition from Baker was played in which she stated an opinion that Cirba’s gynecomastia (the development of breast tissue) was the result of “extreme weight gain” rather than negative side effects from Risperdal. Cirba had been prescribed the drug to treat oppositional defiant disorder.

Cirba’s counsel objected that it was improper that Baker’s layperson testimony was considered equal to that of an expert, since she was not designated or qualified prior to trial – while the defense believed Baker’s deposition did not cross over into expert testimony and “constituted permissible lay opinion testimony, as it was rationally based on her perception of plaintiff during treatment.” Which the Superior Court has obviously disagreed with.

The jury returned a verdict in favor of Janssen in March 2015, although the jury at that time believed Janssen failed to properly warn Cirba’s physicians of gynecomastia risks associated with Risperdal, it stopped short of finding Janssen negligent in directly causing Cirba’s gynecomastia.

The Superior Court sided with the plaintiff in believing admitting Baker’s testimony was an attempt to enter the realm of expert knowledge.

Defendants’ experts opined that weight gain rather than Risperdal ingestion caused plaintiff to appear to have gynecomastia. Baker’s testimony, in which she opined that plaintiff’s weight gain, rather than his Risperdal usage, caused him to appear to have gynecomastia, was causation testimony offered by a witness who personally treated the plaintiff” Panella said.

Panella added Baker’s opinion was “offered without the proper vetting and safeguards surrounding expert testimony.”

“Further, this opinion was introduced into evidence due to the trial court’s improper application of the law, which is clearly an abuse of discretion. Therefore, we find that the trial court abused its discretion in denying plaintiff’s request for a new trial, limited to the issues of causation and damages,” the panel stated, in reversing the judgment and remanding the case for further proceedings.

SAME PANEL STRIKES RISPERDAL SOL CLAIMS

In a separate 18-page ruling also issued Nov. 13, the exact same three-judge panel upheld the trial court’s striking down of arguments that the statute of limitations in two Risperdal cases, featuring plaintiffs Jonathan Saksek and Joshua Winter, should have been tolled until 2013.

Saksek and Winter were prescribed Risperdal in 1997 and 1998, allegedly began developing gynecomastia in 1998 and 2002, respectively, but didn’t file suit until 2014. Both plaintiffs brought suit after seeing television advertising connected to Risperdal litigation in 2013.

The defense agreed with the trial court that the statute of limitations mandated the grant of summary judgment, but contended if the discovery rule applied, it would have only tolled the statute of limitations until October 2006, when Risperdal’s prescribing label was changed to include a warning about gynecomastia.

In January 2015, Judge Arnold New granted a defense motion for summary judgment and ruled an applicable statute of limitations applied to both Saksek and Winter’s cases, feeling that they should have known of Risperdal’s gynecomastia-related injury risks by June 30, 2009.

Both plaintiffs appealed, and the appeals were consolidated, but the higher court agreed with the trial court.

“Plaintiffs were aware of their injuries when they began experiencing unexplained weight gain – and breast growth – after starting Risperdal treatment in 1998 and 2002. However, from 1998 and 2002 until 2013, when plaintiffs were notified of the commercial claiming a link between gynecomastia and Risperdal, they did nothing to uncover the cause of their unexplained breast growth and weight gain. Plaintiff cannot hope to establish that they acted with reasonable diligence, when they admit that they failed to act at all,” Panella stated.

Their breasts were there, and had been there, for years. And then, in October 2006, the label on Risperdal changed, expressly linking usage of the drug to gynecomastia. Their breasts were clearly not temporary by 2006. Accordingly, by that date, ‘reasonable minds would not differ in finding that’ plaintiffs knew, or should have known, of their injuries and the cause of those injuries by this point,” Panella added.

RULING AFFECTS OTHER CASES

Kline commented on the Superior Court’s statute of limitations ruling, indicating it could be far-reaching beyond merely the instant cases.

“We believe [this] harsh ruling, which may bar the claims of thousands of claimants who could not possibly have known of their gynecomastia injury and its cause, is legally and factually wrong. We plan to appeal further, seeking to reopen the courthouse doors to them,” Kline said.

Janssen’s stated:  “We are pleased the Superior Court affirmed Judge New’s ruling on the application of statute of limitations.

MASS TORT DOCKET GROWING

More than 6,400 Risperdal lawsuits – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over Xarelto  (See Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation PA State Court) and asbestos, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s. In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.

Appeal Docket: Superior Court of Pennsylvania case 2451 EDA 2015 & 576 EDA 2015

Trial Docket: Philadelphia County Court of Common Pleas case 130301803, 140200183 & 140301170

 

 

 

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XARELTO in Philadelphia Court: Will The BMSQ “California Plavix” SCOTUS Ruling Affect Out of State Plaintiffs?

XARELTO in Philadelphia Court of Common Pleas: Will The “California Plavix” Supreme Court Ruling Affect Out of State Plaintiffs?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

Bayer, which has a headquarters in Pennsylvania, recently used a June 2017 U.S. Supreme Court decision on out of state plaintiffs and court jurisdictions to dismiss dozens of lawsuits from a Missouri federal court in the “Essure” birth control litigation. It remains to be seen if Bayer will use the same strategy in other jurisdictions, like Philadelphia, where the Xarelto blood thinner cases are piling up, see XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase.

Thousands of out-of-state plaintiffs flocked to Philadelphia recently to file lawsuits over prescription drugs, but a recent U.S. Supreme Court decision might deter that practice in the future, see  June 19, 2017 Bristol-Myers v. Superior Court of California (Plavix Jurisdiction).

The many claimants who have brought their lawsuits in Philadelphia will have to see if pharmaceutical companies like Bayer, Johnson & Johnson and others who are facing many thousands of other claims from out-of-state plaintiffs, will rely on the June 19th U.S. Supreme Court ruling that states an out-of-state plaintiff couldn’t file suit in California, due to a lack of jurisdiction.

The Supreme Court justices ruled 8-1 in favor of Bristol Myers-Squibb after the company argued plaintiffs living outside California who alleged injury from BMS’s blood thinner Plavix, should not be able to sue the company in that state.

The Supreme Court ruled that, essentially the “all inclusive view of personal jurisdiction by non-resident plaintiffs has come to an end.” Plavix was not designed or made in California, and the company is headquartered in New York. The ruling may simply force thousands of pending cases across the country to be refiled in other venues, as plaintiff firms are not likely to simply withdraw the cases as massive losses, without having their day in one court or another.

A non-residents plaintiff can file suit in the Philadelphia County Court of Common Pleas, if the defendant is either incorporated in Pennsylvania, or has a principal place of business in Pennsylvania, which limits the legal options for Bayer, based on their corporate headquarters in the state.

Two of the biggest mass tort programs in the Philadelphia Complex Litigation Center docket are the Risperdal litigation, which is produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and allegedly causes males to develop breasts, Janssen has been hit with several large multi-million dollar verdicts in Risperdal trials. The other is Xarelto, a blood-thinner made by Bayer and Johnson & Johnson that allegedly causes uncontrolled bleeding events, and the makers failed to warn of the dangers. The Xarelto MDL 2592 in US district Court ED Louisiana . see Xarelto MDL 2592 Mass Tort Nexus Briefcase, where close to twenty thousand additional Xarelto cases are pending.

Bayer will be having a much harder time using the BMS Plavix decision to dismiss non-resident plaintiffs from the Philadelphia courtroom, given it’s headquarters in Pittsburgh, Pennsylvania.

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Johnson & Johnson’s Risperdal Behind Massive Spike in Mass Tort Litigation

Risperdal-V2-headerBy Anjelica Cappellino. This article is reprinted from The Expert Institute.

There has been a huge spike in mass tort litigation due to the Johnson & Johnson medication, Risperdal, an anti-psychotic drug used to treat schizophrenia and other psychiatric disorders. Risperdal has been the center of litigation for years due to allegations that the drug causes breast tissue growth in young men, a condition called gynecomastia. This past year, however, Risperdal has accounted for over a third of all mass tort lawsuits pending in the Philadelphia Complex Litigation Center. Mostly comprised of individual suits rather than class actions, the verdicts may differ greatly, depending upon the evidence presented in each case. Due to the scientific and medical nature of the drug’s effects, experts in the field may strongly impact the verdict.

Risperdal’s Litigation History and Current Lawsuits

Risperdal has received a significant amount of attention dating back to 1994, when the drug first went on the market and Johnson & Johnson was accused of illegal marketing activities. In one of the largest health care fraud settlements in United States history, Johnson & Johnson was forced to pay more than $2 billion in penalties and settlements to state and government entities as a result of lawsuits relating to Risperdal and two other drugs, as well as civil and criminal complaints about their use. The Department of Justice stated Risperdal and two other Johnson & Johnson drugs were promoted for dementia patients, when Risperdal was approved only to treat schizophrenia. The Food and Drug Administration did not approve this use as safe and effective.

Deceptive marking actions are not the only claims against Risperdal.  The largest cause of action against the drug is that it causes men to develop gynecomastia. This breast development can have devastating and long-term effects on young men. At least 13,000 product liability claims involving Risperdal have been filed in courts around the United States, alleging that Johnson & Johnson was aware that the medication could cause gynecomastia, but concealed that information to the public.

Most of the current litigation is pending in the Los Angeles Superior Court and the Philadelphia Court of Common Pleas in Pennsylvania, where a small group of cases went to trial as part of a bellwether trial process. In February 2015, in one of the first cases to go to trial, a Pennsylvania jury awarded $2.5 million in damages to a 20-year old male plaintiff who had been using Risperdal since he was eight years old. A month later at the second trial, the plaintiff was not awarded any damages after a jury concluded that there was insufficient evidence that Risperdal caused his breast growth. However, the jury did find that the company provided inadequate safety warnings. In November of that same year, a separate jury in the same court awarded $1.75 million to another Risperdal user who developed breasts after taking the drug since age five. In July 2016, the largest award in Philadelphia Risperdal litigation was reached. A jury awarded a Tennessee teenager $70 million in damages after finding that Johnson & Johnson officials failed to warn the young man and his family that the drug could cause him to grow breasts. Most recently, in January 2017, Johnson & Johnson entered into a pre-trial settlement days before another Philadelphia trial, a case which would have been the seventh trial about Risperdal’s link to gynecomastia.

With more than 2,000 cases pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas, and another 300 cases pending in Los Angeles Superior Court, litigation is far from over. The total number of mass tort cases pending in Philadelphia’s Complex Litigation Center at the beginning of 2017 has risen to its highest level in more than five years. Risperdal accounts for the second largest percentage of cases, making up more than 31 percent of Philadelphia’s mass tort docket. In 2016, there were 550 pending Risperdal cases, a 40 percent increase from the previous year.

How Have the Experts Weighed in?

Since the inception of the first lawsuit, expert witnesses were vital to the outcome of the case. David Kessler, a pediatrician and former Food and Drug Administration Commissioner, has been a vocal expert witness in the Risperdal litigation. Since 2012, Kessler has offered his expert services to plaintiffs as both a pediatrician and failure-to-warn expert, writing detailed reports about Johnson & Johnson’s promotion of Risperdal for non-approved uses in children. In 2015, Kessler testified in a Philadelphia trial that Johnson & Johnson knew as early as 2001 that Risperdal could cause gynecomastia in boys, five years before the company adding a warning about such a side effect on its label. The crux of most Risperdal cases is whether the company adequately warned the plaintiff of the drug’s side effects. Therefore, expert testimony like Kessler’s is indispensable in establishing that Risperdal did not contain adequate warnings of its possible side effects.

As plaintiffs often begin taking Risperdal in their youth, pediatricians have served as vital expert witnesses in explaining the effects of the drug on young males. Pediatric neurologists and endocrinologists have testified to explain how the drug affects the hormone levels and nervous system. Specifically, the drug stimulates the pituitary gland and elevates levels of prolactin, a hormone that is related to female breast development and lactation in nursing mothers.

In addition to Risperdal’s long-term effects on young men, the causal link between Risperdal and gynecomastia must also be established. As David Kessler previously testified in January 2015, he concludes that there is a connection. Kessler has pointed to a clinical trial, funded by Johnson & Johnson, that showed 3.8% of young males using Risperdal developed breasts. Kessler testified that the medication “probably or very likely” triggered the condition. Because gynecomastia is caused by elevated amounts of prolactin, experts have testified that if children’s levels of prolactin are monitored while on the medication, the development of gynecomastia can be more easily recognized, opposed to incorrectly attributing the side effects to weight gain.

In light of the growing mass tort litigation, the Philadelphia Court of Common Pleas is scheduled to convene a meeting on March 9, 2017 concerning its centralized docket of Risperdal claims. Although several plaintiffs have reached confidential settlements prior to trial thus far, there are thousands of cases that are still pending and there are no signs that litigation will slow down in 2017.

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Janssen Settles Latest Risperdal Case Before Trial in Philadelphia

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

Janssen Pharmaceuticals Inc. settled the lawsuit of a New York boy who took the antipsychotic drug Risperdal and grew female breasts, just before the case was to go on trial in  Philadelphia County Court of Common Pleas, according to Law360.

The case is Zachary Sabol et al. v. Janssen Pharmaceuticals Inc. et al., case number 130402100, and the settlement amount was not disclosed. It would have been the seventh trial in Philadelphia’s mass tort program, where 2,300 cases are pending against the drug maker.

The plaintiff and his family filed suit against Janssen in 2013 charging that he developed gynecomastia, or the abnormal growth of female breast tissue, after being treated with Risperdal for nearly a decade.

The FDA approved Riserdal in 2006 for treating autism in adolescents. When Sabol began taking the drug, however, it was only approved for use in adults and indicated that gynecomastia was a rare side effect that occurred in fewer than one in 1,000 patients. Warning labels were later updated to show there was a 2.3 percent rate of gynecomastia in adolescents taking the drug.

The litigation has continued for three years 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.

Recent Headlines in Risperdal:

Infographic: The Disgraceful History of Risperdal

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

Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

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

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

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

Dr. Mark P. Solomon, a plastic surgeon in Bala Cynwyd, PA.
Expert witness Dr. Mark P. Solomon, a plastic surgeon in Bala Cynwyd, PA.

On the 11th day of a trial on whether Risperdal caused a young man to grow female breasts, a Philadelphia judge who is new to the mass torts litigation, rejected the expert testimony of a physician who has testified in nearly all the Risperal cases, and dismissed the case.

The ruling was shocking, in light of the $70 million verdict returned on July 8, 2016, by a jury also in the Philadelphia County Court of Common Pleas that the antipsychotic drug caused a Tennessee boy to grow female breasts. That case was heard before Judge Paula Patrick.  The verdict followed other plaintiff successes, totaling $4.75 million, that plaintiffs have recovered so far in earlier Risperdal cases.

The expert — Dr. Mark P. Solomon — has testified for the plaintiffs since a $2.5 million verdict was returned in Feb. 2014, in favor of the plaintiff, Austin Pledger, who took Risperdal for autism and developed enlarged breasts, or gynecomastia, from taking the drug.

“Legally insufficient”

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

In the latest case, Moroni  v. Janssen Pharmaceuticals Inc., case number 130501076, state judge Sean Kennedy ruled, “At the conclusion of my research and my staff’s research, it is my opinion that under Texas law, Dr. Solomon’s testimony is legally insufficient to prove causation in this case, and as such, I am granting defendant’s motion for compulsory nonsuit.”

According to the motion for nonsuit filed by Janssen, Dr. Solomon based his opinion solely on reviewing a photo of the plaintiff. Dr. Soloman practices in, among other things, male breast reduction.

“The court’s ruling was totally unexpected in a case which had more than sufficient expert support under the governing law,” said plaintiff attorney Jason Itkin of Arnold & Itkin LLP said in a statement. “We are confident that the erroneous ruling will be reversed, and our client, Tommy Moroni, will be heard by a jury on another day.”

Moroni’s case was the sixth to go to trial in Philadelphia’s Risperdal mass tort program, which consists of about 2,000 cases.

Plaintiff Tommy Moroni started taking the powerful antipsychotic as a 7-year-old boy living in Wichita Falls, Texas, in 2004 to treat ADHD, obsessive-compulsive disorder, anxiety, depression and suicidal ideation. He took the drug for four years, but then a doctor diagnosed him with gynecomastia in Nov. 2010.

The litigation has continued for three years 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.

 

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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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