$4.5 Billion in Drug Sales in One Year – The Question is: Was it Worth it?

Our government’s Food and Drug Administration (FDA) has some pretty important things to say.

For example: “Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. The FDA’s evidence-based system of drug approval and the OTC monograph system play essential roles in ensuring that drugs are both safe and effective.” (http://www.fda.gov/Drugs/…)

Unfortunately, it appears that Johnson & Johnson did not follow the rules when it came to marketing their drug Risperdal. Instead, evidence suggests that marketing began for different age groups and disorders long before they were approved.

In the Risperdal lawsuit, allegations have been made that Johnson & Johnson’s business unit, Janssen Pharmaceuticals, marketed Risperdal to doctors who treated children well before the FDA approved its use for that age group, maybe even as early as 2002. Since the FDA did not approve Risperdal as a treatment for irritability in 5- to 16-year olds with autistic disorder until 2006, and did not approve Risperdal as a treatment for bipolar I disorder in children and adolescent schizophrenia until 2007, these are serious allegations.

A powerful second-generation antipsychotic, Risperdal has been prescribed “off-label” for treatments ranging from attention deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression; however, there is an important caveat. While doctors may prescribe drugs for off-label treatments, pharmaceutical companies are not allowed to market a drug for its off-label treatments.

However, again, Johnson & Johnson’s Janssen Pharmaceuticals seems to have done just that, illegally marketing Risperdal’s off-label uses to promote sales.

The issue at stake does not just involve legality, though. It also involves human life and safety; it involves doing the right thing for patients; it involves, especially, doing the right thing for our families and for our children.

You see, when companies break rules, bad things tend to follow.

Case in point: Risperdal has been shown to lead to male breast growth in some patients and a panel of federal drug experts found the risks of Risperdal too high to justify its use in treating behavior disorders in children. That is why treating ADHD and other behavior disorders remains off-label for Risperdal despite the same drug’s use in children with schizophrenia and autism. The risk of Risperdal, these drug experts found, was too high to justify its use for treatments that could be accomplished with alternative medications.

This was a critical decision made to protect our children, and we believe that pharmaceutical companies should respect these decision on behalf of public health.

But hey… Johnson & Johnson made $4.5 billion in Risperdal sales in 2007.

The question is: Was it worth it?

At Baron & Budd we are proud to announce our participation in the lawsuit for victims of Risperdal and hope to help the patients and their families who suffered from this drug. If you or someone you know was harmed by Risperdal, please contact Baron & Budd to speak with an attorney at 866-520-2755 or contact us here.

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