Risperdal: When Drug Manufacturers Profits Outweigh Patient Risk

There is a saying that the “treatment is sometimes worse than the disease.” A good example of this is the drug Risperdal.

In 1993, the Food and Drug Administration (FDA) approved Risperdal for the treatment of adult schizophrenia. In 2006 and 2007, the FDA extended the permitted use of Risperdal to the treatment of schizophrenia in children, bipolar disorder in adults and children, and behavioral disorders for autistic children. Risperdal is the second most prescribed antipsychotic in the U.S., with annual sales exceeding $4.5 billion. It is estimated that Janssen Pharmaceuticals (Janssen), the manufacturer of Risperdal, has profited about $40 billion from the sale of the drug. Unfortunately, in its quest for profits, Janssen has failed to provide full disclosure of the horrible potential side effects of Risperdal. These side effects include:

  • breast development in boys
  • lactation in girls
  • diabetes and death in the elderly

Needless to say, the emotional side effects of young boys who develop breasts is severe, not to mention the trauma associated with reconstructive surgery to remove the permanent damage. According to Bloomberg, Janssen acted in a “calculated manner with intent to maximize profit with no regard to risk” when marketing Risperdal.

In 2010, the first civil suit regarding Risperdal was filed by a 21 year-old man who developed breasts. The man took Risperdal for a FDA unapproved use, yet Janssen marketed use for 5 years. He suffered physical damage and emotional trauma. In 2012, the case was settled by J & J on the first day of trial for an undisclosed amount.

In that same year, J & J was accused of improper marketing practices and fined $1.2 billion by an Arkansas federal court of Medicaid fraud and deceptive practices of marketing. It’s believed that J&J could see the writing on the wall, and settled lawsuits with 36 states and the District of Columbia for improperly marketing Risperdal toward the treatment of children. These cases resulted in combined settlements of more than $666 million.

In addition to state improper marketing lawsuits, civil suits are on the rise. Of the 420 civil lawsuits filed so far, 100 of these lawsuits are for breast development in boys, as a result of J & J’s failure to adequately warn of Risperdal’s risks.

In 2013, Janssen entered into a settlement with U.S. prosecutors for $2.2 billion. This is the government’s third largest whistle-blower suit with a pharmaceutical company, and includes $1.6 billion in civil payments. Under the plea agreement, Janssen will pay a $334 million fine and forfeit $66 million. Janssen ultimately accepted accountability for the actions in the guilty plea but denied liability or wrongdoing in the civil settlement associated with the suit.

The deadline for filing lawsuits for the side effects of Risperal based upon the applicable statutes of limitations will soon be approaching. If you or someone you know has suffered from the effects of Gynecomastia after taking Risperdal, you should contact Jacoby & Meyers who can put you in contact with an attorney who is experienced in litigating Risperdal cases.

Gregory Posch, student intern Jacoby & Meyers, LLC.