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Drugs & Medical Devices

Risperdal & Gynecomastia – Tricking Teenage Boys Into Transgendered Lives

— March 1, 2014

The past decade has seen a rise in lawsuits surrounding gender and sex identity issues. For example, in 2012, the news followed Jenna Talackova, a transgendered beauty queen, as she battled Donald Trump to gain eligibility to compete in the Miss Universe pageant. In 2013, a Colorado court made a historical ruling when it decided that a male-to-female transgender student could not be barred from using the girls’ bathroom at school. In recent years, lawsuits have also been filed as to whether states should be obligated to fund hormone treatment for transgendered prisoners.

Some believe that, if an individual is born a male, but identifies as a female, that individual should not be forced to remain in a male’s body. No one should be forced to be something that he or she is not.

Of course, not everyone agrees that sex-change procedures should be permitted. Plenty of people tend to believe that we should all remain in the biological bodies into which we are born. No matter where you stand on the issue, at the very least, we can all certainly agree that no one should be forced to go through a sex change process against his or her will.

The great majority of males on our planet are, of course, not transgendered, and would therefore never consciously choose to transform themselves into females. In fact, most men would choose to lose a leg, an arm, his hearing, and just about anything else, before his masculinity. While there are, indeed, a minority of transgendered men in today’s world fighting for the right to transform themselves into women, there are now men out there having to fight for just the opposite. Thanks to the companies that have developed and promoted the so-called antipsychotic medications called ‘Risperdal’ and ‘Invega’, there are now men fighting to reclaim their masculinity.

We now know that Risperdal and/or Invega can, and did, cause many of its male users to grow breasts. Not only have adult men been put through this nightmare, but boys have as well—some of them as young as 3 years old. The companies that share responsibility for the development, manufacture, and promotion of these drugs include (1) Ortho-McNeil-Janssen Pharmaceuticals, Inc. (Hereinafter “Janssen”); (2) Johnson & Johnson; (3) Johnson & Johnson Pharmaceutical Research & Development, L.L.C; (4) Excerpta Medica Inc.; and (5) Elsevier Inc.

Originally, Risperdal was developed to treat symptoms related only to schizophrenia. However, in order to increase sales and profits, Janssen and the other above named companies promoted Risperdal and/or Invega for a variety of unapproved uses including autism, Attention-Deficit/Hyperactivity Disorder (ADHD), Obsessive-Compulsive Disorder (OCD), Oppositional-Defiant Disorder (ODD), Conduct Disorder (CD), Disruptive Behavior Disorder (DBD), Tourette’s syndrome, Post-Traumatic Stress Disorder (PTSD), and pervasive development disorders (PDD). Tragically, these off-label promotions came at the expense of the safety, health, and well-being of the public at large.

Many individuals who have suffered injuries and damages arising out of the use of Risperdal and/or Invega have filed lawsuits against Janssen and the other aforementioned companies for side effects caused by those drugs.

Among the side effects that the plaintiffs have had to endure include gynecomastia (which is abnormal development of breasts in males) and galactorrhea (which is lactation). The plaintiffs have suffered significant bodily and mental injury, pain and suffering, mental anguish, disfigurement, embarrassment, and inconvenience. In addition, many of the male plaintiffs have incurred past and future medical expenses because they need to undergo a mastectomy (surgery) to remove the breasts.

Had the defendant companies followed the law, the Plaintiffs’ extreme pain and suffering would not have occurred. Risperdal and Invega lawsuits allege that the companies listed above violated the Federal Food, Drug, and Cosmetic Act (the “FDCA”).  Sections 502(a) and 201(n) of the FDCA” (21 U.S.C. §§ 352(a) and 321(n)) require pharmaceutical companies to fully and accurately disclose all side effects related to a drug, including gynecomastia and other adverse effects that can be caused by Risperdal and/or Invega. In violation of the FDCA, the defendant companies did not adequately warn users of Risperdal or Invega of the risks of side effects like gynecomastia.

Furthermore, Sections 502(a) and 201(n) of the FDCA (21 U.S.C. §§ 352(a) and 321(n)) prohibit pharmaceutical companies from minimizing the risks or disseminating misleading information about a drug’s safety or efficacy. However, in violation of the FDCA once again, the defendant companies failed to disclose the true rick of the horrifying side effects associated with Risperdal and/or Invega. Instead, they promoted the drugs as being among the safest on the market. As a result, physicians prescribed the drugs to children, unaware of the serious risks of doing so.

The medical world has already acknowledged the seriousness of permitting a biological male to take a drug or hormone that will make him grow breasts. There are a number of steps that a transgendered individual must take before most medical authorities will approve him to begin the sex change process. First, the person must live for a period of a year or more in the new sex. See 1 Rights of Prisoners § 4:36 (4th ed.) quoting Gender Dysphoria (Betty Steiner ed. 1985). Only then will the person be administered hormones natural to the new sex. Id. For example, male to female transsexuals will be administered female hormones that will cause them to grow breasts.

Remember: In the above situation, we are talking about individuals who want to grow breasts. Inducing breast growth is so serious, that even biologically-born males who want to grow breasts are required to demonstrate their commitment for a year before they will be allowed to do so.  However, the victims of Risperdal and/or Invega, who had no desire to grow breasts whatsoever, had no such choice, warning, or safety measures in place before the unwanted transformations were forced upon them after ingesting the drug.

The males who took the drugs (at their doctors’ recommendations) now find themselves living in the same horrifying state that transgendered individuals find themselves— forced to live in a biological body that does not match the gender with which he identifies. An individual who is born a biological male, and who identifies as a male, should not be forced, against his will, to grow breasts.

Our law firm is currently accepting cases on behalf of men and boys who took the drug Risperdal or Invega and developed gynecomastia or other side effects as a result.

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