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Risperdal Lawsuit

Risperdal and Risperdal Consta, (Generic Named Risperidone) are prescription medications that are categorized as anti-psychotics. Risperdal is available in pill form, while Risperdal Consta is an injectable medication for patients who need longer term effects from the medication. Risperdal was first approved by the Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults. Risperdal was later approved for treatment of Bipolar ! disorder in children and adults, Irritable dementia in the elderly, and autism spectrum disorders in children and adolescents. Risperdal has also been marketed as an off-label treatment option for people with Attention Deficit Disorder (ADD).

Since its release, Risperdal has been associated with many serious side effects, including breast growth in boys and men, movement disorders, diabetes, and increased cardio-vascular risks. In 2006, the FDA required the makers of Risperdal to place a black box warning on the medication because of its association with serious side effects.

At this time, there are over 420 lawsuits that have been filed against the manufacturers of Risperdal for the serious side effects that the patients suffered. In addition, there have also been several serious criminal investigations and settlements regarding this medication conducted by various government entities.

Parties Involved In The Lawsuit

Risperdal and Risperdal Consta were developed and manufactured by Janssen Pharmaceuticals. Janssen is a subsidiary of the Johnson and Johnson Company. Risperidone, the generic version of this anti-psychotic medication is manufacture by Patriot Pharmaceuticals, another subsidiary of Johnson and Johnson.

Most lawsuits that involve breast growth (Gynecomastia) name Risperdal or Risperdal Consta as the main medications that caused harm. However, several new lawsuits have recently emerged that have also named the medication Invega, another anti-psychotic medication produced by Janssen Pharmaceuticals.

Timeline Of Important Facts

1993  

Risperdal was given approval for sales in the United States for the treatment of schizophrenia in adults and for short term treatment for adults with Bipolar I syndrome. Through aggressive marketing, Risperdal became the leading antipsychotic medication on the market.

2001  

The first new report was published by the Miami Herald about the dangerous side effects associated with Risperdal. Surprisingly, the Herald reported these side effects in children. The drug was being used to “calm” unruly foster children in the Miami area. At this time, the drug was not approved for this use.

2002  

Janssen Pharmaceuticals issues a letter to the Canadian Health Ministry stating that there were adverse side effects when using Risperdal in dementia patients. At that time, 37 deaths from stroke had been reported. Janssen Pharmaceuticals did not issue this letter to American doctors until 2003

2004  

Risperdal has over one million annual prescriptions being written and is increasing sales by promoting off label uses. This medication is now being actively used to treat ADD, Autism, and Alzheimer’s.

2005  

The Food and Drug Administration requires Janssen Pharmaceuticals to place a Black Box Warning on Risperdal. The FDA only requires this type of labeling for drugs with severe side effects. Despite the new warning, sales skyrocket to $2.1 billion.

2006  

Duke University releases a very important study about the dangers of Risperdal in children. The study shows that this medication causes gynecomastia in boys and young men and that young girls who take this medication are having very early onset of puberty and begin lactating. The study concludes that the dangers of using this medication far outweigh the benefits in children.

2007  

The FDA approves the use of Risperdal for treatment of schizophrenia only in teenagers. This approval is a surprise to many people in the medical community.

2008  

The first lawsuit filed against Janssen Pharmaceuticals and Johnson and Johnson for gynecomastia occurs. Six boys are named as Plaintiffs in the suit. Two of these siz boys had to undergo mastectomies to correct the condition.

2010  

A 21 year old man files a lawsuit against the drug manufacturers for physical and emotional trauma from Risperdal. This man had grown breasts after taking the medication between 1999 and 2004, a time when this medication was not approved for use in children. Johnson and Johnson settled this case on the first day of its trial in 2012.

2011  

Johnson and Johnson recall 2 and 3mg tablets of Risperdal because of a foul odor reported by consumers. No information to the cause of the contamination has been disclosed.

2012  

Johnson and Johnson has settled several cases filed against it for abnormal breast growth. As news of these lawsuits are made public, many more boys and men come forward with the same physical side effects as those in the lawsuits. Additional suits are filed.

2013  

Risperdal Consta was recalled after several viles tested positive for contamination. The drugs were found to have chemicals in them that are used to treat wooden pallets to keep them from decaying.

2013 -November

Johnson and Johnson agrees to pay the government $2.2 billion for illegally marketing Risperdal and encouraging off label uses for the medication.

2016  

Cases continue to emerge across the country from people who have been disfigured and emotionally injured by this dangerous medication. At this time, over 420 cases are active in the court system concerning Risperdal.

Side Effects Associated With Risperdal

Risperdal works by altering serotonin and dopamine levels in the brain. These crucial hormones also play a significant part in other bodily functions. Because these hormones are being altered, serious side effects have been associated with the use of this medication. These serious side effects include:

  • Gynecomastia – Abnormal breast growth in boys and young men. Some of these boys have also experienced lactation.
  • Early Onset Puberty – Girls that have taken this medication are entering into puberty at a very young age and begin to lactate.
  • Tardive Dyskinesia – Involuntary movements of the tongue, lips, face, torso, or arms. This condition can be treated but cannot be cured.
  • Type II Diabetes – The onset of Type II Diabetes has been shown in elderly patients who use this medication. A study conducted in 1999 shows that patients using Risperdal for more than one year are likely to develop Type II Diabetes
  • Cardio Vascular Events – Many elderly people have suffered stroke and stroke like events that were taking this medication.
  • Death – Several people have died from the side effects associate with Risperdal.
  • Floppy Iris Syndrome – New research has been released in Canada showing that people undergoing cataract surgery who have taken Risperdal are at greater risk for Floppy Iris Syndrome. This can potentially lead to blindness.