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Why is Johnson & Johnson being sued for its Risperdal branded drugs?
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Risperdal Lawsuit Overview
The Risperdal lawsuit relates to various lawsuits filed by men and boys (or their families) against Johnson & Johnson along with some of its affiliates alleging that the use of their drug caused the enlargement of male breasts.
The purpose why doctors prescribed Risperdal to men and boys was to treat mental illnesses such as schizophrenia, bipolar disorder, or irritability due to autism.
In technical terms, the enlargement of breasts in men is called gynecomastia.
The brand names that have been particularly referred to in various lawsuits are:
- Risperdal Consta
The various Johnson & Johnson entities named in various lawsuits are:
- Janssen Pharmaceuticals Inc.
- Johnson & Johnson
- Patriot Pharmaceuticals Inc.
- Janssen Research and Development
Since there have been thousands of injuries and negative consequences suffered by patients using Risperdal, a “black box warning” was placed on the drug.
A black box warning on its labels is one of the strictest warnings that the FDA can place on a particular drug.
What Is Risperdal
Risperdal is an antipsychotic drug prescribed by doctors in an attempt to restore the brain’s normal chemical functions.
It was in 1993 that the FDA (Federal Drug Administration) approved the administration of Risperdal to adults to treat illnesses such as schizophrenia, acute mania, and mixed episodes associated with Bipolar I Disorder.
In 2006 and 2007, the FDA further approved the use of Risperdal to treat bipolar disorder in juveniles, schizophrenia in children, and to treat certain behavioral symptoms caused by autism in children.
Risperdal Side Effects: Gynecomastia
Many Risperidone lawsuits, lawsuits for adults, and children allege that the use of the J&J drugs in question leads to the production of prolactin hormones stimulating the development of breasts in men and male children.
In women, the hormone can lead to spontaneous milk production and in men the growth of male breast tissue.
According to various studies, the side effects of these drugs may lead to not only negative physical impacts on the person but also emotional consequences as well such as poor social functioning, poor mental health and poor self-esteem.
A study published in the Journal of Clinical Psychopharmacology reported that Risperidone increased a man’s prolactin levels leading to hormonal imbalances that cause gynecomastia.
Here is a list of common side effects reported by the use of Risperdal, Risperidone and other related drugs:
- Restless muscles (eyes, tongue, jaw, neck)
- Uncontrolled shaking
- Weight gain
- White patches
- Sores in mouth and on lips
Doctors are still prescribing Risperdal as it remains approved by the FDA.
Johnson & Johnson Product Liability Disclosure
Johnson & Johnson states in its 2018 annual report that it is exposed to various product liability lawsuits involving the same and some of its subsidiaries involving various products.
Particularly, they state that “the most significant of these cases include: (…) 13,400 [cases] with respect to RISPERDAL”.
In this regard, J&J indicates that the “claimants in these cases seek compensatory and, where available, punitive damages”.
Johnson & Johnson also indicates that it believes that it has a substantial defense in these cases and has made the necessary accruals for product liability claims and lawsuits in compliance with applicable accounting rules.
There are lawsuits in many states filed against J&J.
What’s notable is that there is particularly a high volume of legal actions and lawsuits filed in Philadelphia before the Philadelphia Common Court of Pleas.
Risperdal Lawsuit Jury Awards
Considering there were approximately 13,400 Risperdal side effect lawsuits around the United States, it is not feasible to list the various settlement amounts claimants may have received or the number of cases that J&J and its subsidiaries were able to successfully defend against.
Here is a sample of different Risperdal lawsuit settlement amounts that can provide you with an overall portrait of the lawsuits:
- According to Bloomberg, in July 2016, a jury in Philadelphia ordered Janssen, a J&J subsidiary, to pay an award of $70 million to Andrew Yount who developed breasts when using the Risperdal drug
- According to the People.com, in February 2015, a jury in Alabama awarded $2.5 million to Austin Pledger for having developed 46 DD size breasts
- According to NYup.com, in September 2017, a New York jury awarded Shaquil Byrd the sum of $1 million for having developed gynecomastia when taking the J&J drug
Risperdal Lawsuit Settlements
In addition to the various awards granted by the court or jury, the company Johnson & Johnson has also settled various cases out of court.
In the personal injury lawsuit settlements, typically the settlement amounts remain confidential and the defendant does not admit to any wrongdoing or liability of any kind.
For example, in September 2012, the lawsuit filed by Aron Banks against J&J was settled on the first day of trial.
On May 27, 2017, Johnson And Johnson settled a case with a boy in California who had taken the antipsychotic drug Risperdal.
Over the course of the years, J&J and its affiliates have been able to settle many pending personal injury lawsuits against them.
US Department of Justice Investigations
The US Department of Justice had filed various criminal and civil investigations against Johnson & Johnson relating to the prescription drugs Risperdal, Invega, and Natrecor.
Particularly, they were looking at “promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider”.
According to the November 4, 2013 press release, Eric Holder, the Attorney General, stated that “the conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust”.
In the end, J&J agreed to pay more than $2.2 billion to resolve all the investigations launched against it and its subsidiaries.
In essence, the marketing of Risperdal to doctors was considered to be for “off-label” usage.
In other words, off-label usage means that the drug was not approved by the FDA for the specific purpose the doctors were prescribing them to their patients.
Risperdal And Risperdone Lawsuit Takeaways
So what should you know about Risperdal Lawsuits?
Let’s look at a summary of our findings.
Risperdal Lawsuit (Gynecomastia lawsuit)
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