Johnson & Johnson now faces an estimated 20,000 Risperdal lawsuits, in which men from across the country blame Risperdal for causing gynecomastia, a swelling of breast tissue.

  • Thousands of patients have stepped forward
  • Jury awards to date over $75 million
  • Dozens of cases settled out of court

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With nearly 20,000 lawsuits filed, Johnson & Johnson can no longer hide behind undisclosed settlement amounts.

Laurence Banville
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Marching to court by the thousands, families across the country have filed suit against Janssen Pharmaceuticals over the company’s antipsychotic medication Risperdal, a drug plaintiffs say can cause male breast enlargement.

Risperdal Claims Say Janssen Hid Gynecomastia Link

Considered one of the globe’s most “essential medicines” by the World Health Organization, Risperdal has been FDA approved to treat schizophrenia since 1993. More recent years saw the drug’s indication extended to treat acute episodes of mania in patients with Bipolar 1 Disorder, as well as irritability in patients with autism spectrum disorders.

But its risks, including gynecomastia, a swelling of breast tissue in males, have many critics saying Risperdal does more harm than good.

Pills Spilling Out Of Bottle

What Is Risperdal?

Risperdal is manufactured by Janssen Pharmaceuticals, a subsidiary of multinational pharmaceutical conglomerate Johnson & Johnson. Janssen also manufactures an injectable version of the drug, known as Risperdal Consta, a long-acting formulation intended to last 2 weeks at a time. A generic version of the drug’s active ingredient, risperidone, is produced by Patriot Pharmaceuticals, a company based in the Philippines.

Risperdal’s approval was only expanded to treat young patients in 2007. On August 22, 2007, the FDA announced that the antipsychotic could be safely used to treat:

  • schizophrenia in patients between the ages of 13 and 17
  • episodes of acute mania or mixed episodes in patients with Bipolar 1 Disorder between the ages of 10 and 17
  • irritability associated with autism spectrum disorders in patients between the ages of 5 and 16

But state prosecutors say Janssen was promoting Risperdal for use in children long before receiving FDA approval. Even more troubling are allegations that the company has been actively concealing Risperdal’s damaging effects on young bodies.

Janssen Hid Risperdal’s Link To Gynecomastia, Kentucky Attorney General Says

On May 28, 2013, Kentucky’s then-Attorney General Jack Conway filed a lawsuit against Johnson & Johnson and Janssen Pharmaceuticals, claiming that the companies “knew, yet concealed from consumers, that Risperdal carried an increased risk of dangerous side effects including:

  • clinically significant weight gain,
  • diabetes,
  • hyperglycemia (high blood sugar),
  • hyperprolactinemia (high blood levels of prolactin) and
  • gynecomastia (male breast development)

After more than two years of litigation, Janssen agreed to settle the case for more than $15 million. But the company wasn’t required to accept guilt, and families around the nation say their pursuit of justice is just beginning.

Thousands File Lawsuits – & Janssen Is Settling

Thousands of Risperdal lawsuits have already been filed by families and young men who say the antipsychotic drug caused them to develop enlarged breasts. Gynecomastia, the condition in question, isn’t usually dangerous to a patient’s physical health, but its damaging effect on psychological and social wellbeing is thoroughly documented in the medical literature.

In their lawsuits, former patients say Janssen Pharmaceuticals presented Risperdal as a far-safer drug than other antipsychotics, with fewer side effects, despite knowledge to the contrary. Janssen claims it adequately warned of the risks, but families aren’t buying that, since many young men began developing their symptoms before the drug was even approved to treat children.

Legal experts believe numerous other families may be able to file their own lawsuits. While no Risperdal lawsuit is guaranteed to win, recent case developments suggest that Johnson & Johnson is motivated to settle cases involving gynecomastia. Even more promising?

Settlements & Verdicts

Aaron Banks, who says he began taking Risperdal at the age of 9, filed his own lawsuit in 2012. Banks claimed that the drug caused his breasts to grow so large that he needed a mastectomy. On the first day of trial, Johnson & Johnson settled Banks’ case for an undisclosed amount. The second Risperdal case to go to trial was settled 1 week into court proceedings.

By January 2014, more than 70 other plaintiffs had entered settlement agreements with Janssen over their own gynecomastia claims, although reports suggest that the company backed out before finalizing the agreements.

Trial Juries Hold Janssen Liable

Some cases, however, have gone to trial. Austin Pledger’s case was the first to see a verdict. Pledger, born with autism, claimed he was 8 when he began taking the drug. Eventually, his breasts grew to size 46DD and ultimately forced him to undergo a mastectomy. In February 2015, a Philadelphia jury awarded the now 20-year-old $2.5 million in damages, in a judgment that was later upheld by a Pennsylvania appeals court.

The same year, at least three other Risperdal lawsuits went to trial, with gynecomastia patients winning a combined $75 million in compensation.

Meanwhile, Johnson & Johnson continues to reach settlement agreements in Risperdal cases. Near the end of 2016, the company settled two lawsuits, both of which were only days before the start of trial proceedings. Unfortunately, the amounts of these settlements have not been disclosed. These more-recent developments have led to an explosion in Risperdal litigation. As of October 2017, an estimated 20,000 gynecomastia lawsuits have been filed against Janssen and Johnson & Johnson in American and Canadian courts.

Justice Department: Janssen Promoted Risperdal “Off-Label”

Janssen Pharmaceuticals has been accused of marketing Risperdal far beyond its approved indications, an explicit violation of federal law. In fact, the company has been mired in legal battles over the drug for years, hit first by a lawsuit filed by 36 state governments and then a second complaint started by the US Department of Justice.

In the Justice Department’s lawsuit, filed November 4, 2013, government prosecutors accused Janssen of marketing Risperdal for unapproved uses. The company’s deceit began as early as March 2002, when sales representatives started promoting the drug as an effective treatment for elderly patients with dementia, not schizophrenia, the only disorder for which Risperdal was approved at the time. Beyond “urging prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion” in older patients without schizophrenia, Janssen even set up a system of kickbacks to compensate doctors who prescribed Risperdal off-label.

Manufacturer Pled Guilty To Marketing Drug Illegally

Even more surprising than the government’s allegations? Janssen pled guilty, admitted its wrongdoing and agreed to pay $400 million in fines and asset forfeitures. Securing a guilty plea from pharmaceutical manufacturers is almost unheard of, even when federal prosecutors are leading the charge. Most companies settle these types of cases, agreeing to pay hefty fines in exchange for the right to deny all responsibility.

But the most shocking element of this story is that Risperdal was hit with a black box warning that reads “elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death” in 2005. The warning, mandated by the FDA, came only 2 years after Janssen actively marketed the drug for use in elderly patients with dementia. Whether or not Janssen has blood on its hands is an open question, one that must be asked.

36 States Have Filed Suit

Numerous states have filed suit against Janssen, too, accusing the company of concealing Risperdal’s dangerous side effects from the public and health professionals. In no less than 36 states, government prosecutors have leveled damning criminal charges against the Johnson & Johnson subsidiary:

  • In 2004, state prosecutors in Louisiana accused Janssen of mailing doctors a promotional letter that downplayed Risperdal’s risks and promoted its use for unapproved indications. The case concluded in 2010, with a jury fining Janssen $258 million, but the award was overturned in 2014 by the Louisiana Supreme Court.
  • South Carolina’s Attorney General’s Office filed suit against Janssen in 2007 for hiding the side effects of Risperdal and claiming the drug was safer than other treatments without enough medical evidence to back it up. After 4 years of furious litigation, a state judge ordered Janssen and Johnson & Johnson to pay $327 million. In 2015, the South Carolina Supreme Court chipped away at the fine, but it remains a hefty $136 million.
  • In Texas, Janssen was fined $158 million for “making false or misleading statements about the safety, cost, and effectiveness of the expensive anti-psychotic medication Risperdal, and improperly influencing officials and doctors to push the drug.” The company, though, wasn’t required to admit wrongdoing in the case, which ended in 2012.
  • In 2012, Arkansas accused Janssen of Medicaid fraud, saying the company had deceived doctors into prescribing Risperdal for unapproved uses while concealing the drug’s risks. A judge ordered the company to pay a staggering $1.2 billion, one of the largest fines ever imposed in a state-filed case of pharmaceutical fraud. Johnson & Johnson appealed the case, which made its way to Arkansas’ Supreme Court, who reversed the judgment in 2014. The state’s highest court said that “the state attorney general erred by suing under a law that applied to health care facilities, not drug companies,” according to the New York Times.

Most recently, Janssen settled a case filed by the state of Kentucky, which accused the company of marketing Risperdal for use in children before the FDA approved that indication in 2007. Beyond promoting the drug off-label, Kentucky’s prosecutors said Janssen had hidden evidence that Risperdal can cause hormonal imbalances and even infertility in younger patients. The settlement agreement, hammered out on December 22, 2015, requires Janssen to pay $15.5 million.

How Does Risperdal Work?

Risperdal is essentially a sedative, a tranquilizer, although researchers still aren’t sure how Risperdal works exactly. Like other so-called atypical antipsychotics, a category of drugs that includes Seroquel and Zyprexa, scientists think Risperdal blocks brain receptors that react to dopamine, an important neurotransmitter active in the body’s reward system and largely responsible for feelings of pleasure.

Dopamine also regulates motor control to a certain extent, which is probably why most atypical antipsychotics have been found to cause movement disorders in some patients. Compared to other antipsychotics, Risperdal actually presents less risk of movement-related side effects. But the drug’s effect on a hormone called prolactin is what researchers believe may be causing breast development in young male patients.

Gynecomastia: Science Behind The Link To The Antipsychotic

Reports of gynecomastia developing in young boys first surfaced in 1999. Children in foster care are often given antipsychotics, including Risperdal, as a “restraint” drug. Beyond the questionable ethics of that choice, young boys in Florida’s foster care system began complaining of breast sensitivity and enlargement.

The same year, a study published in the Journal of Clinical Psychopharmacology suggested a link between Risperdal’s active ingredient risperidone and increased levels of prolactin, a hormone known to cause gynecomastia. An Italian physician published a case report in the journal Pharmacopsychiatry‘s 1999 edition, describing a young male patient who developed gynecomastia after being put on Risperdal.

More concrete results came in 2005. That year, Dutch researchers stated unequivocally that Risperdal “significantly raises plasma prolactin levels in patients, but clozapine, olanzapine, and quetiapine [other antipsychotics] do not.” Their study was published in the American Journal of Psychiatry.

A 2014 review of Canadian health insurance claims suggested that Risperdal could increase the risk of gynecomastia by up to 69% in older men, Medscape Multispecialty reports. While he couldn’t ascribe statistical significance to the result, lead author Mahyar Etminan said his study even showed a “trend” that Risperdal could cause gynecomastia more frequently than other popular antipsychotics.

Latest Risperdal Updates

Laurence Banville - Risperdal Lawyer
Many are coming to understand the dangers posed by the drug Risperdal. Here you will find the latest news about the drug and subsequent lawsuits that are being filed.

October 10, 2017 – Plaintiff Awarded $1 Million Verdict In Risperdal Lawsuit

A jury in the U.S. District Court for the Northern District of New York issued a verdict on September 29, in favor of the plaintiff in a Risperdal lawsuit. Risperdal manufacturers Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were ordered to pay $1 million to a man who began taking the medication at the age of 9 for treatment of psychosis and developed gynecomastia as a side effect. Surgery was performed to remove his excess breast tissue but he still suffers from depression and embarrassment from the condition. The suit claimed that the manufacturers did not adequately warn the medical community or consumers of the risk of young boys developing gynecomastia when using Risperdal.

September 20, 2017 – Judge Upholds Verdict Of $2.5 Million For Risperdal Plaintiff

The first Risperdal lawsuit to occur resulted in a $2.5 million verdict for the plaintiff, who is now 22-years-old. The plaintiff suffers from the side effect of gynecomastia after having taken Risperdal to treat symptoms of Autism starting at the age of 8. In 2002, when he was first prescribed the drug off-label, it had not yet been approved for children or adolescents. However, his doctor testified that he was unaware of the possible side effect of male breast growth. A spokesperson for Janssen, a Johnson & Johnson subsidiary and manufacturer of the drug, expressed disappointment in the verdict and the company appealed it seeking a new trial. A Philadelphia judge denied their motion though, upholding the original verdict of $2.5 million.

August 28, 2017 – Plaintiffs In Philadelphia Lawsuits Concerned With SCOTUS Ruling

On June 19 of this year, the Supreme Court ruled in favor of pharmaceutical company Bristol Myers-Squibb who argued that plaintiffs who live outside of California and alleged injury from the company’s anticoagulant Plavix shouldn’t be allowed to sue them in that state. Earlier this year thousands of people filed lawsuits against Johnson & Johnson over prescription drugs including Risperdal in Philadelphia court. In Philadelphia County Court of Common Pleas, non-residents can sue if the defendant has a principal place of business in Pennsylvania or is incorporated in Pennsylvania. Plaintiffs in Philadelphia are concerned that companies could use the Supreme Court ruling where 94% of new lawsuits are filed by out of state plaintiffs. Close to 4,000 new lawsuits were filed from the beginning of 2017 to the end of May 2017 with a lot of those new suits being filed over Risperdal.

July 19, 2017 – Philadelphia Court Has Over 5,000 Risperdal Gynecomastia Lawsuits Pending

In the first half of 2017, the number of cases filed against Johnson & Johnson over the gynecomastia side effects of Risperdal has more than doubled and continues to increase. In the Philadelphia Court of Common Pleas, there were roughly 2,000 cases at the beginning of the year and there are now over 5,800 cases pending. These lawsuits have been pending for years and continuing to increase in number as more families discover the possibility of the anti-psychotic drug causing the devastating side effects. There have been some large cases which resulted in verdicts favorable to the plaintiffs and additional bellwether cases are expected to go to trial in Philadelphia.

June 20, 2017 – New Risperdal Lawsuit Filed Over The Use Of Drugs In Foster Care Children

Child advocates have filed a lawsuit in Missouri which alleges that children in foster care were prescribed Risperdal and other psychotropic medications inappropriately. According to the suit, medications like Risperdal are used often as “chemical straight-jackets” in children in foster care who have behavioral issues. The suit argues that children are at great risk due to the fact that their young brains and bodies are still developing. In many cases, these medications being used have not been cleared by the U.S. FDA for use in treating children with these behavioral issues, such as Risperdal which is not approved for use in children under 5. The child advocates that filed this suit hope to see the state implement systemic changes to stop the over-prescribing of these medications.

May 8, 2017 – Risperdal Lawsuit Filed By Mississippi Man

On April 3 a Mississippi man filed a Risperdal lawsuit against Janssen Pharmaceuticals in the San Francisco County Superior Court. The suit alleges that Janssen was fraudulent, negligent, failed to warn consumers, as well as other allegations. His complaint alleges that as a result of taking Risperdal he suffered several physical injuries including rapid weight gain and hyperprolactinemia. He seeks compensation for damages, disgorgement, medical expenses, restitution, legal fees, and punitive damages.

April 28, 2017 – An End To The Seventh Risperdal Trial

The 7th Risperdal trial that began this month has been thrown out mid-trial by the Philadelphia judge on Monday, April 17th. The Defendant, Janssen Pharmaceutical, argued that the plaintiff had failed to present enough evidence to support his claims that the drug manufacturer has failed to warn consumers of the risk of developing gynecomastia when taking the drug and the judge agreed. A mass tort currently exists in the Philadelphia court system and while the plaintiff did face a loss in this case, there are hundreds more like it awaiting trial.

March 2, 2017 – Risperdal Lawsuits Moving Forward In Court

Lawsuits which allege that the antipsychotic medication Risperdal caused gynecomastia and other side effects in young men have been consolidated into a mass tort program in the Philadelphia Court of Common Pleas. The mass tort is moving forward, according to a notice posted on the Court’s website, which states that the litigation is scheduled to convene on March 9th for a meeting. There are over 1, 000 lawsuits filed regarding Risperdal across the United States, with a lot of the suits located in Pennsylvania. The latest case to come to an end in PA was one of six lawsuits to have concluded since February of 2015. This recent suit came to end last July and awarded $70 million to a teen who began taking Risperdal at age 5 and developed gynecomastia.

February 6, 2017 – Philadelphia Risperdal Mass Tort Growing Rapidly

The litigation over the drug Reglan remains the largest single mass tort program in Philadelphia, but the mass tort for Risperdal has grown rapidly with 550 cases being added in the past year. Attorneys leading the litigation have stated that several thousand more lawsuits are expected to be filed. One attorney believes the reason for the increase in filing is due to a decision from Janssen, the defendant, and maker of Risperdal, to end a tolling agreement. Another reason contributing to the large number of cases in the tort program is that on average cases are taking longer to dispose of, according to court statistics. Kline, one of the attorneys involved in the litigation has stated that he will advocate for some administrative changes if the number of cases continues to increase.

January 10, 2017 – J&J Settles Another Risperdal Case Before Trial

The day before what would have been the seventh Philadelphia Risperdal case was set to begin, Johnson & Johnson agreed to settle with the plaintiff. The case alleged that the antipsychotic drug caused a young New York boy to develop gynecomastia or the growth of female breasts. There are nine more Risperdal cases scheduled to go to trial in Philadelphia, with over 2,000 more claims centralized in a mass tort program. Pennsylvania’s Superior Court is expected to issue rulings very soon on appeals which will impact the future Risperdal cases.

December 7, 2016 – What Will Happen After The Latest Risperdal Settlement?

Several Risperdal cases have already been settled awarding large sums to plaintiffs in the past couple of years. Most recently J&J, the manufacturer of Risperdal, settled a case in October. The settlement was confidential, so other plaintiffs can only speculate as to what the reasons were that the company decided to settle the case. J & J continues to deny any wrongdoing and has indicated that they are planning to continue to go to trial for the next case. Meanwhile, according to the U.S. Securities Exchange Commission,  the company faces over 15,400 Risperdal lawsuits all claiming the company downplayed the risk of developing gynecomastia.

November 2, 2016 – Risperdal Lawsuit Settled Before Trial Starts

A Risperdal lawsuit set to begin trial on Monday over claims that the antipsychotic caused the male plaintiff to develop female breasts, was settled before heading to court. The case would have been the sixth case from the Philadelphia mass tort program. The plaintiff’s attorney stated that the case was settled as a “one-off” and that no global settlement talks were taking place. He also said that jury selection for the next case is expected to begin in early December. A Janssen spokesperson confirmed that the case was settled but also noted the terms are confidential.

October 13, 2016 – J & J Allegedly Hid Risperdal Clinical Trial Data

According to Consumer Advocacy News, Janssen and J & J, the manufacturers of Risperdal, completed clinical studies regarding the risk of developing gynecomastia while taking the drug which indicated that  too many young boys developed the condition for Risperdal to receive FDA approval. In order to achieve results that would gain FDA approval, the company excluded all boys over the age of 10 from the data by reasoning that they would already have heightened levels of prolactin in their bodies due to puberty which could cause gynecomastia, although that is extremely unlikely. Additionally, the company added girls to the study. The number of trial participants that developed gynecomastia was 22 yet after diluting the data, only 5 were reported.

September 22, 2016 – Filmmakers To Create New Series Centered Around J&J’s Marketing Of Risperdal

Laura Ricciardi and Moira Demos, the filmmakers behind the popular “Making a Murderer” series have announced their new project will be to adapt the Huffington Post article “America’s Most Admired Lawbreaker” to television. The topic of the article is Johnson & Johnson’s aggressive marketing to children and the elderly of their antipsychotic drug, Risperdal, which had life-altering side effects. J&J allegedly knew of the potential to cause such horrible side effects and chose to market it to that demographic without warning anyway. The pharmaceutical giant has already paid out billions of dollars in settlements while other lawsuits regarding the drug continue to be filed.

August 12, 2016- Young Man Suffers Consequences Of Prescribed Risperdal For Behavioral Problems

A 26-year-old Missouri man is suffering the consequences of Risperdal that was prescribed to him as a child. He states that he was given the drug because he was considered to be a handful but was never diagnosed with a particular disorder.  Now, he suffers from sore breasts that leak occasionally. The breast discharge leaves him isolated and he does not go out much. Risperdal has been known to be prescribed off-label to children as young as five-years-old for very minor behavior related issues.

July 6, 2016- Teenager Awarded $70 Million In Gynecomastia Trial

On July 1st, 2016 a teenager who developed female-like breasts while using Risperdal, was awarded $70 million after filing a lawsuit against the makers of the drug. A Pennsylvania jury ordered Johnson & Johnson to pay the amount. According to court records, this verdict is the largest award so far for a gynecomastia lawsuit in the Risperdal mass tort program that is underway in the Philadelphia Court of Common Pleas.

June 2, 2016- Risperdal Punitive Damages Claims Under Consideration

The state Superior Court has been asked by a Philadelphia judge to affirm a $500,000 verdict that was awarded to a man who suffered adverse effects from using Risperdal last year. This case is the first instance of a state appeals court to address the issue of whether punitive damages claims should be allowed in the Risperdal trials.

May 11, 2016- Philadelphia Jury Awards $2.5 Million To Risperdal Plaintiff

A Philadelphia jury reportedly awarded $2.5 million to a young man who developed gynecomastia while he was using the drug Risperdal. The young man started using the drug from the time he was 8 years old, to treat possible autism and he ended up developing size 46DD breasts. The young man is now 21 years old. The jury decided that Johnson and Johnson was negligent in not correctly warning users that the drug could cause this type of condition.

April 26, 2016- Texas Man Alleges Risperdal Caused The Development Of Gynecomastia

A Texas man filed a lawsuit against the makers of the drug Risperdal, Ortho-McNeil-Janssen Pharmaceuticals, stating that the drug led him to develop male breast tissue. The male breast tissue he developed is medically known as gynecomastia. The man was prescribed Risperdal when he was 7-years-old for the treatment of his ADHD. Risperdal has never been approved for the treatment of ADHD, neither was it approved for use in children by the FDA.

March 29, 2016- Risperdal Lawsuit In Kentucky Awarded $15.5 Million

A Risperdal lawsuit filed by the Attorney General for the State of Kentucky has been awarded $15.5 million. The lawsuit alleged that the manufacturers of the drug were not upfront about the dangers linked to the drug to consumers, especially the elderly. The result of this lack of full disclosure was unnecessary and excessive costs to Medicare and Medicaid in the state, in instances where the drug was marketed and used for the treatment of dementia in non-schizophrenic elderly patients.

March 2, 2016- Can Risperdal Lawsuits Be Filed Beyond Statute Of Limitations?

There are growing concerns over whether or not individuals who were prescribed Risperdal in the 90s can now file lawsuits since finding out about the drug’s side effects due to the statute of limitations. Statutes can be reduced or extended under certain circumstances and this depends on whether or not the cause of action involved a personal injury, libel, or other claim. With Risperdal lawsuits, there have been some instances when courts had to reconsider time limits, especially if the individual had a mental illness and did not know what caused an injury like Risperdal gynecomastia. In such a situation the statute of limitations might be suspended until the it is discovered that the injury was caused by the defendant’s conduct.

February 10, 2016- Johnson & Johnson Risperdal Penalty Appeal Rejected By U.S. Justices

Recently, the U.S. Supreme Court dismissed hearing a Johnson & Johnson subsidiary appeal of a $124 million penalty. The penalty was imposed by a South Carolina ruling where a jury found the makers of the drug to have incorrectly marketed the anti-psychotic drug and did not properly disclose its side-effects. The courts penalty of $124 million remains intact.

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