Risperdal Gynecomastia Litigation
Gynecomastia is a condition in which young boys develop large breasts that can require surgery to correct. Users of Risperdal claim they experienced humiliation and psychological trauma due to breast growth resulting from the antipsychotic drug. Many of them were prescribed the drug as young boys even though the U.S. Food and Drug Administration (FDA) had not yet approved the drug for use in children.
Now, they are filing lawsuits against the drug’s maker Johnson & Johnson. Their reasons include:
- Severe physical and emotional injuries
- Hospitalization and coping expenses
- Compensation for lost employment time
- Restoring and improving quality of life
- Bringing attention to preventable injuries
- Punitive damages against drug’s maker and marketer
About 2,100 Risperdal cases have been filed in the Philadelphia County Court of Common Pleas and its Complex Litigation Center alone, according to court statistics. The cases generally allege Risperdal use caused boys and young men to develop gynecomastia.
Risperdal was also the subject of several lawsuits over diabetes risks, prompting New Jersey to centralize Risperdal diabetes cases under mass tort procedures.
$70 Million Risperdal Verdict
In July 2016, a Philadelphia jury awarded $70 million to a Tennessee teen who blamed Risperdal for causing him to develop female-size breasts. The award is the largest in Philadelphia litigation over the same drug and side effect, according to a Bloomberg report.
The teen’s lawyers told jurors he started taking Risperdal at age 5 to treat a psychiatric disorder. He never received a warning about breast development, they said. The lawyers further argued Johnson & Johnson hid the results of a study from doctors which showed Risperdal caused abnormal breast development in boys so that the doctors would keep writing prescriptions.
The jury found Johnson & Johnson failed to adequately warn the teen and his family that Risperdal could cause him to develop breasts and awarded him damages for emotional distress.
The ruling marks the fifth time the drugmaker has been found by Philadelphia juries to have failed to properly warn users and doctors about the risk of gynecomastia. It was being appealed to the Superior Court.
The record-setting award is almost 30 times larger than the former highest Risperdal-side-effect verdict award: $2.5 million given to Austin Pledger.
In February 2015, Austin Pledger became the first victim to win a Risperdal jury trial. Pledger, who is an Alabama resident, was prescribed Risperdal in 2002. He sued the drug’s maker after he developed size 46 DD breasts, claiming the company did not disclose or properly warn of such side effects before Pledger was prescribed Risperdal. The court found Johnson & Johnson failed to warn the drug could cause breast development and awarded Pledger $2.5 million.
The following month, a jury in a different trial also found Johnson & Johnson illegally marketed the drug. However, the jury could not find proof the drug caused breast growth in the plaintiff, Billy Cirba, so no damages were awarded. Cirba filed a lawsuit against Johnson & Johnson in March 2013 that alleged he grew large breasts following years of Risperdal use. According to the suit, Cirba began taking Risperdal in 2002 at age 6. At the time, the drug was only approved by the FDA for use in adults.
Timothy Stange of Wisconsin filed the third Risperdal trial to be heard by a jury. The trial, which began Oct. 15, 2015, was the first jury trial in which the plaintiff began taking Risperdal after the FDA expanded its use. The jury awarded Stange $500,000. He took Risperdal from 2006 to 2009.
A jury in the fourth trial awarded Nicholas Murray $1.75 million. Murray developed breasts after taking Risperdal for five years as an adolescent. He continued taking the drug after the FDA expanded the drug’s approval for use in children. The jury concluded Johnson & Johnson failed to adequately warn of the risks for breast growth.
Johnson & Johnson has settled several Risperdal personal injury lawsuits both before and during trials. However, the company did not admit wrongdoing under the agreements and continues to deny liability for Risperdal injuries.
Although Pledger received the first jury verdict, Aron Banks actually had the first Risperdal personal injury lawsuit to go to trial. In September 2012, Johnson & Johnson agreed to settle the case on the first day of trial in a Philadelphia court.
Banks claimed the drug caused him to develop breasts large enough to require surgery to remove them. He was prescribed Risperdal in 2000 when he was 9 years old — before the drug was approved for use by children — and continued taking it until 2004. Banks says he also suffered psychological trauma, rapid weight gain and injury to his endocrine system.
Other Risperdal Settlements
In the month following the Banks settlement, Johnson & Johnson settled five more cases in Philadelphia court. The settlement amounts for each case were kept confidential.
In November 2013, Johnson & Johnson backed out of settlements with 77 plaintiffs before the agreements were finalized. The plaintiffs had argued that the company had created marketing materials and published articles understating the risks of developing breast tissue.
Status of Risperdal Gynecomastia Lawsuits
After the $70 million Risperdal verdict award, Johnson & Johnson settled what would have been the sixth case to go to trial over Risperdal side-effect allegations. The settlement was followed by two victories for the company: a judge dismissed one case and the court ruled in the drugmakers’ favor in the other.
In 2015, Johnson & Johnson still faced about 1,500 cases in Philadelphia over claims that Risperdal caused boys to grow female breasts. As of March 2017, at least three cases had trial dates in state court.
J&J Pays Billions to Settle Marketing Scandal
Former U.S. Attorney General Eric Holder accused Johnson & Johnson of putting “some of the most vulnerable members of our society” at risk of serious injury while it pursued greater profits. Specifically, the company used illegal, aggressive marketing to get doctors to prescribe Risperdal to the elderly and children for unapproved uses, according to the U.S. Department of Justice.
In November 2013, Johnson & Johnson agreed to pay more than $2.2 billion to settle a decade-long investigation into illegal promotion of Risperdal between 1999 and 2005. The resolution is one of the largest health-care fraud settlements in U.S. history, the Justice Department said. It includes criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
Illegally Marketing Risperdal to Children
At the heart of the investigation were claims that Johnson & Johnson used aggressive marketing to get doctors to prescribe Risperdal to children. State and federal attorneys general also claimed the company specifically disregarded FDA warnings not to promote the antipsychotic for childhood use.
In particular, they alleged that Johnson & Johnson promoted Risperdal for pediatric use as early as 1994, despite not receiving FDA-approval for any Risperdal childhood use until 2006. By 2000, more than one-fifth of Risperdal was going to children and adolescents.
At a Risperdal trial in Pennsylvania, a sales manager claimed that Johnson & Johnson trained salespeople to promote Risperdal to children’s doctors as early 2003. In fact, that year the company had a “back to school” marketing campaign for Risperdal, and a manager allegedly discussed including “lollipops and small toys” in sample packages.
In addition, the company is accused of paying doctors to speak favorably of the drug, sponsoring golf outings and offering other incentives encouraging physicians to prescribe Risperdal to children and adolescents.
In 2015, a Philadelphia jury ruled against J&J in a suit filed by the family of an autistic 20-year-old Alabama man who developed breasts after taking Risperdal. The jury, which awarded $2.5 million to the family, heard testimony from former FDA Commissioner David Kessler. He testified that the drug maker didn’t do enough to warn everyone about the gynecomastia risk. Kessler said the drug maker knew Risperdal could cause breast development in boys as early as 2001 but information about that wasn’t added to the drug labeling until 2006.
Promoting Risperdal to Elderly with Dementia
The government investigations revealed that Johnson & Johnson used a variety of tactics to get doctors to prescribe Risperdal.
These tactics included:
- Offering sales representatives incentives to promote unapproved uses to doctors
- Paying kickbacks to the largest nursing home pharmacy in the U.S.
- Offering doctors trips and “lucrative consulting agreements” to prescribe Risperdal to more patients
Johnson & Johnson cut a deal with Omnicare, a company that provided pharmaceutical services in nursing homes. Johnson & Johnson agreed to share profits with Omnicare if Omnicare doctors would prescribe Risperdal.
Despite knowing the FDA had not approved Risperdal for the elderly, Johnson & Johnson created a sales force of 136 people to market it to that demographic. The company called its team ElderCare. The FDA objected and pointed to “an excess number of deaths” among the seniors who took the drug.
In 2005, the FDA issued a black box warning, the agency’s strongest warning, alerting the public that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The box also warns the drug is not approved for use in patients with dementia-related psychosis.
Allegations of illegal marketing activities between 1993 and 2004 eventually landed Johnson & Johnson and Janssen in hot water with consumer protection regulators in 36 states and the District of Columbia. The company and its pharmaceutical unit reached a $181 million consumer fraud settlement with those states in August 2012.
The company did not admit to wrongdoing in any multistate investigations. In fact, Johnson & Johnson continues to deny wrongdoing.
Johnson & Johnson has faced separate fines and court awards in multiple states:
- A Louisiana jury ordered it to pay $257.7 million to the state for defrauding the state Medicaid program and misleading regulators and the public about the drug’s health risks.
- Arkansas fined the company $1.2 billion for improper marketing.
- Johnson & Johnson reached a $158 million settlement with Texas.
- Kentucky’s attorney general announced a $15.5 million settlement with Johnson & Johnson in 2015.
- Johnson & Johnson agreed to a $5.9 million settlement with Montana.
- South Carolina officials won a $327 million award over claims that Johnson & Johnson sent marketing letters to doctors that overstated the safety of Risperdal.
In May 2012, the Kentucky attorney general announced a lawsuit alleging Johnson & Johnson concealed dangerous side effects of Risperdal, including diabetes, substantial weight gain, stroke and gynecomastia. According to researchers, the link of Risperdal to adolescent gynecomastia is higher than other antipsychotic drugs.
The complaint filed by the Kentucky attorney general alleged that “despite knowledge to the contrary,” Johnson & Johnson represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug.”
The company even directed salespeople to say that “Risperdal had a zero percent rate of diabetes in trials, contrary to its own study result,” according to the complaint. These types of misrepresentations allegedly resulted in a wide range of injuries affecting populations from young boys to elderly dementia patients. Johnson & Johnson settled the suit in 2015 for $15.5 million.
In 2008, the attorney general’s office in Montana filed a lawsuit against Janssen Ortho LLC and Janssen Pharmaceuticals Inc. over its illegal, unfair and deceptive marketing of Risperdal. Janssen agreed to settle the lawsuit for $5.9 million in 2014. “Janssen actively deceived Montana physicians and consumers when it promoted Risperdal as safe and effective for a variety of conditions, when in fact, Janssen was aware of dangers associated with its drug that it hid from the public,” the office said in a press release.
South Carolina filed a complaint against Johnson & Johnson in April 2007 over false marketing claims related to Risperdal. A trial court found the drugmaker’s Janssen unit had improperly marketed Risperdal and concealed its risks. The court ordered the company to pay $327 million. South Carolina’s Supreme Court later dropped the penalty to $136 million.
The attorney general of Texas brought a lawsuit against Johnson & Johnson accusing the company of improperly marketing Risperdal to state residents on the Medicaid health program for the poor, including children. Johnson & Johnson offered to settle with the attorney general on the sixth day of the trial. The company agreed to pay $158 million.
Emily Miller is an award-winning journalist who has held writing and editorial positions with numerous print and online publications around the U.S. She draws on her background as both a patient and a journalist to help readers understand complex health topics. Her most recent experience is in writing about litigation involving medicines that cause life-altering side effects.
- U.S. Department of Justice. (2013, November 4). Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations. Retrieved from https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations
- Stanton, T. (2016, January 11). Time for J&J to pay up in $124M Risperdal case as SCOTUS deflects final appeal. Retrieved from http://www.fiercepharma.com/pharma/time-for-j-j-to-pay-up-124m-risperdal-case-as-scotus-deflects-final-appeal
- Kristof, N. (2015, September 17). When Crime Pays: J&J’s Drug Risperdal. Retrieved from https://www.nytimes.com/2015/09/17/opinion/nicholas-kristof-when-crime-pays-jjs-drug-risperdal.html?_r=0
- Fisk, M.C. (2017, March 9). The Lawsuits Keep Coming for Johnson & Johnson. Retrieved from https://www.bloomberg.com/news/articles/2017-03-09/the-lawsuits-keep-coming-for-johnson-johnson
- Feeley, J. (2016, July 1). J&J Hit With $70 Million Risperdal Verdict Over Male Breasts. Retrieved from https://www.bloomberg.com/news/articles/2016-07-01/j-j-faces-record-70-million-verdict-over-male-breasts
- Malfitano, N. (2016, December 22). Sixth Risperdal case heard in Philly dismissed by judge. Retrieved from http://pennrecord.com/stories/511060908-sixth-risperdal-case-heard-in-philly-dismissed-by-judge
- Reuters. (2015, February 26). South Carolina court orders Johnson & Johnson to pay $136 million in Risperdal case. Retrieved from http://www.reuters.com/article/us-johnson-johnson-risperdal-lawsuit-idUSKBN0LU0YM20150226
- Fair, M. (2016, November 2). J&J Settlement Ends Latest Pa. Risperdal Case Before Trial. Retrieved from https://www.law360.com/articles/858749/j-j-settlement-ends-latest-pa-risperdal-case-before-trial
- Thomas, K. (2012, August 30). Johnson & Johnson Unit Settles State Cases Over Risperdal. Retrieved from http://www.nytimes.com/2012/08/31/business/johnson-johnson-unit-settles-state-cases-over-risperdal.html
- Kentucky.gov. (2015, December 23). AG Conway Announces Two Pharmaceutical Settlements Totaling $39.5 Million. Retrieved from http://kentucky.gov/Pages/Activity-stream.aspx?n=AttorneyGeneralJackConway&prId=6
Did you or a loved one suffer from gynecomastia (breast growth) after taking Risperdal?