If your son was prescribed medication with a 3.8% chance of causing him to grow large breasts, would you let him take it?
Canadian and American courts will have to grapple with this question as class action law suits have erupted over the use of the drug Risperdal.
Risperidone, sold under the name Risperdal is a antipsychotic drug used to assist those with mental health issues. The drug is typically prescribed to treat ADHD, schizophrenia, autism, bipolar disorder and dementia.
There is an ongoing class action lawsuit against the makers of Risperdal in Canada, Jannsen and it's parent company Johnson & Johnson. Anyone who has consumed Risperdal (not the generic equivalent) and suffered either gynecomastia or hyperprolactinemia is eligible to be a party to the class action law suit against the pharmaceutical companies.
Gynecomastia is a condition which causes males to develop large breasts, due to an increase in breast tissue. Risperdal causes hormone imbalances by increasing production of prolactin, which leads to increased tissue growth. A 2001 study conducted by the drug maker found that 3.8% of teenage boys given Risperdal developed breasts that were very likely caused by the drug.
In the United States, similar law suits have already resulted in settlement payouts of over one billion dollars. Similar lawsuits and large settlements have also taken place in Europe.
The lawsuits are premised on the idea that the drugs contained substantial risk to children without adequate warning of the risk.
It is alleged that Jannsen targeted their advertising at teenagers.
Every drug contains a trade-off; how beneficial is it to use, and how unlikely and significant are its side effects. The World Health Organization lists Risperdal as an essential medicine that every healthcare system must possess, indicating how important the drug is. The question is not if people should have taken the drug at all, but if they were given adequate warning of the drug's side effects to make an informed decision. The greater the risk, the greater the disclosure required. It is being argued that Jannsen failed to give adequate warning about the drug's risk.
Since Risperdal news has become a hot topic, controversy has further erupted over an alleged quid pro quo arrangement where Janssen pressured doctors into prescribing Risperdal in order to be eligible to earn high speaking fees from Janssen sponsored events.
One former Risperdal user who developed breasts as a result of the drug, Eddie Bible swears that had he known about the drug's risk, he would not have taken it. However, even with the shocking side effects, individuals are still very unlikely to suffer the side effects of the drug, and if the drug is uniquely valuable, then many individuals would have taken the drug in spite of the accompanying risks. Despite this, warning of the potential risk is required.
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