The condition, known as gynecomastia, is so severe that some of the boys have required mastectomies (removal of the breasts).
Risperdal, also known by its generic name risperidone, is an atypical antipsychotic that changes the effect of brain chemicals. The U.S. Food and Drug Administration (FDA) first approved Risperdal in 1993 as an adult schizophrenia treatment. In 2003, the FDA approved it as a treatment for bipolar disorder in adults. In 2006, it was approved to treat irritability in children with autism. And in 2007, it was expanded once again to treat schizophrenia and bipolar in kids.
However, according to a former Johnson & Johnson sales manager, the company didn’t wait to obtain FDA approval before promoting its use for children. At a recent Risperdal trial in Pennsylvania, the manager claimed that Johnson & Johnson trained salespeople to promote Risperdal to children’s doctors as early 2003. The company issued this directive despite lacking approval for any use in children at the time. In addition, it 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.
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. In August 2012, the companies reached an agreement with those states to settle the claims of misconduct for $181 million.
J&J also paid $2.2 billions dollars to settle federal charges of false marketing and paying kickbacks for promoting drugs for unapproved uses.
|Johnson & Johnson has also faced fines and court awards in other 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.|
|Shortly after the Arkansas settlement, it reached a $158 million settlement with Texas.|
|South Carolina officials won a $327 million award over claims that Johnson & Johnson sent marketing letters to doctors that overstated the safety of Risperdal.|
According to Bloomberg, the drug generated worldwide sales of $24.2 billion from 2003 to 2010. So it comes as little surprise that the company did not admit to wrongdoing in the multistate investigations. In fact, Johnson & Johnson continues to deny wrongdoing despite reaching settlements in several Risperdal personal injury lawsuits in recent months.
Status of Risperdal Lawsuits
Hundreds of Risperdal lawsuits have been filed on behalf of injured boys and young men in several states. Risperdal has already been the subject of several lawsuits over diabetes risks, prompting New Jersey to centralize Risperdal diabetes cases under mass tort procedures. State and federal courts may also centralize Risperdal gynecomastia cases as those claims continue to rise.
The Risperdal gynecomastia cases are currently at various stages of the litigation process. Trials have already begun in Risperdal gynecomastia cases, resulting in some noteworthy settlements. In September 2012, Johnson & Johnson settled one case for an undisclosed amount on the first day of trial in Pennsylvania state court. The following month, it settled five more cases in Philadelphia court.
More cases are expected, and potentially more settlements.
Meanwhile, state officials continue to scrutinize the marketing of Risperdal. In May 2013, the Kentucky attorney general announced a lawsuit alleging Johnson & Johnson concealed dangerous side effects of the drug, including diabetes, substantial weight gain, stroke and gynecomastia.
How We Can Help
Drugwatch is committed to helping people who have been injured by drugs like Risperdal. We provide helpful information about coping with the medical and financial burdens of drug injuries. In addition to the resources featured on Drugwatch.com, we also provide free information and support to individuals who have been injured by Risperdal.
If you or a loved one was injured by Risperdal, contact our Patient Advocates. They are available daily to answer your questions and offer other needed support. They can also suggest experienced Risperdal attorneys to explain the legal process and answer specific questions about any legal claim you may have.
Why Should You File A Risperdal Lawsuit?
According to researchers, Risperdal’s link to adolescent gynecomastia is higher than other antipsychotic drugs. Yet the recent complaint filed by the Kentucky attorney general alleges that “despite knowledge to the contrary,” J&J represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug.” It even directed salespeople to say that “Risperdal had a zero percent rate of diabetes in trials, contrary to its own study result.” These types of misrepresentations allegedly resulted in a wide range of injuries affecting populations from young boys to elderly dementia patients.
|People injured by Risperdal claim Johnson & Johnson and Janssen:|
|Illegally marketed Risperdal to children as a treatment for autism and other psychiatric disorders without FDA approval between 1993 and 2004.|
|Concealed the full extent of the drug’s health risks.|
|Misrepresented the benefits and risks for the drug in children.|
All too often, innocent consumers are left with severe physical and emotional injuries that take time and money to heal. Sometimes the injuries are permanent. Although state enforcement actions like the Kentucky attorney general’s recent lawsuit help hold drugmakers accountable for their actions, injured people like the boys who have been hurt by Risperdal often need to file their own lawsuits. Filing a pharmaceutical personal injury claim can help restore the injured to their previous quality of life or at least offer some improvement over their injured state.
Often such lawsuits are the only way to help pay for hospitalization expenses, pain medication, home health care, surgical costs, psychological counseling and other costs of coping with a potentially traumatic condition like gynecomastia during boyhood. Parents who lose time at work to help care for their sons’ injuries may also be eligible for compensation. In addition to obtaining needed compensation, people who sue also do so to bring attention to preventable Risperdal injuries.
Lawsuits may also provide an opportunity to award punitive damages against the drug’s maker and marketer. According to lawsuits, the company not only marketed the drug improperly and failed to warn about dangers, it also targeted doctors who treat troubled children. Such disturbing factors may lead some juries to find punitive damages appropriate in Risperdal cases. Actual results, however, vary by case.
People Who Filed Risperdal Lawsuits
Young men and the families of boys who have been injured by Risperdal have already filed lawsuits. People like Andrew Bentley of Houston are representative of some of the claimants who are holding Johnson & Johnson and Janssen accountable for their injuries.
The drug giants have defended themselves by claiming that their product contains adequate warnings. However, plaintiffs argue that the company did not properly disclose the health risks for a drug because it wasn’t even allowed to market to youth prior to 2006. That’s what happened to Andrew, who was 17 when his case went to trial. He was prescribed Risperdal to help treat problems associated with Asperger’s Syndrome. At the time, Risperdal was not approved for use in children.
Andrew developed breasts after taking Risperdal. The defendants claim that breast development is normal for boys going through puberty. But developing a condition that requires a boy to have a mastectomy is hardly normal.
|Other boys have also suffered, including:|
|Aron Banks was prescribed Risperdal at age 9. He suffered psychological trauma and later had his breasts surgically removed. Risperdal was not approved for childhood use at the time. Aaron filed a lawsuit at age 21 and argued that Johnson & Johnson marketed a defective drug and did not warn about the risks.|
|At least one boy in a group of Risperdal cases that settled in Philadelphia court last year had to have a double mastectomy because of his injuries.|
Disturbing stories about how the drug was marketed to troubled children in order to increase sales are still emerging. Meanwhile, victims continue to suffer physical injury and psychological trauma. If you or a loved one has suffered because of this drug, you may have legal options.
When a growing number of consumers claim that a drug causes serious injuries, the manufacturer sometimes issues a voluntary recall. But despite increasing complaints linking Risperdal to gynecomastia and other injuries, Johnson & Johnson has not issued a total recall of the drug. The company has only issued limited recalls of Risperdal through its Janssen unit, for reasons unrelated to gynecomastia and other permanent injuries.
In 2011, Janssen recalled several thousand bottles of Risperdal following consumer reports about a strange odor. The recall included a lot of about 16,000 bottles shipped between August 27, 2010, and February 15, 2011, as well as another lot of about 24,000 bottles shipped between November 2010 and January 1, 2011.
The offensive smell was believed to be caused by cross-contamination with the chemical preservative TBA (2,4,6 tribromoanisole). TBA was used to treat the wooden pallets used to ship the Risperdal. According to the FDA’s June 2011 notice about the recall, TBA is not toxic, but a small number of consumers experienced “temporary gastrointestinal symptoms.” At the time of the recall, patients were told that they could continue using Risperdal, but should return tablets to their pharmacists if they noticed a strange odor.
In September 2013, Janssen voluntarily recalled a lot of Risperdal Consta, a long-acting, injectable form of Risperdal that’s usually administered at clinics and doctors’ offices. After discovering mold during routine testing, Janssen recalled a lot shipped between January 14, 2013, and May 20, 2013 from wholesalers, distributors, healthcare providers and pharmacies. The company also issued a notice advising consumers to consult their doctors if they noticed irritation, infection or other problems at the injection site.
Johnson & Johnson saw these events as posing little risk to consumers. But for critics, the recalls raise serious concerns. Specifically, they worry that the manufacturer has not improved its oversight despite a number of manufacturing problems in recent years. Although the rise in Risperdal gynecomastia claims may not lead to an official recall, it will likely fuel growing concerns about the manufacturer’s commitment to consumer safety.