Doing No Harm: Drug Side Effects in the Age of Litigation

6 mins read

The core message of the Hippocratic Oath is to do no harm to the patient. However, even in the time of Hippocrates there were medical practices that could be seen as doing some degree of harm to heal. That also holds true in the world of medicine today, especially in the realm of pharmaceuticals. While pharmaceutical companies have become more innovative, the very same drugs that can save people’s lives often come with serious side effects.

For example, the atypical antipsychotic Risperdal has been crucial in providing relief to individuals with schizophrenia and bipolar depression, as well as those with autism related irritability. Risperdal has also shown some promise in the treatment of ADHD. Yet, Risperdal also causes several serious side effects, and some of the Risperdal side effects have been the focus of several lawsuits.

In fact, in a case that was resolved in early 2015, a young man won a suit against Johnson & Johnson, the makers of Risperdal, after he developed gynecomastia (enlarged breasts) from taking the drug as a child. The suit alleged that the drug manufacturer never warned that gynecomastia could be a possible side effect, despite the fact that one of the studies conducted by Johnson & Johnson showed increased prolactin levels, which is a factor in developing gynecomastia.

This gynecomastia case was the first of its kind in this country, but there are several more in the works. There are also cases pending for other side effects including the increased risk of diabetes and increased risk of death in elderly patients.

So what is the pharmaceutical company’s responsibility when it comes to reporting possible side effects? Should the company plan and test for all possibilities, or only report the obvious results from the usually battery of tests?

That is actually a difficult call to make.

In the case of the gynecomastia, Johnson & Johnson did find evidence of increased prolactin levels during its testing; and, if you look up Risperdal side effects on, it lists hyperprolactinemia as a common side effect that occurs in up to 10 percent of people who take the drug. Right beneath the hyperprolactinemia entry, there is also an entry showing gynecomastia as an uncommon side effect in up to one percent of those who take the drug.

However, that information is listed fairly far into a densely-pack wall of information that many patients, and even doctors, might not read in full.

Additionally, although the information is there as of this writing, was that information available in 2006 when the young man in the gynecomastia lawsuit was first prescribed the drug?

Perhaps the best course of action is for pharmaceutical company representatives to provide both the pros and cons of the drugs when presenting them to doctors. That way, doctors know up front what the biggest risks are and they can properly educate their patients. If both the doctor and patient determine that the possible side effects outweigh the possible benefits, then they have the option to choose a different drug.

It would also be helpful for the most common and most serious side effects to be listed up front, in large, bold lettering, on all the patient information materials. Or, at the very least, require patients to talk with their pharmacists about the possible side effects and drug interactions before they fill the prescription.

While this might cause some patients to reconsider using the drug, and could adversely affect drug sales, it also has the effect of giving patients the option to “choose their poison.” Because while some patients may balk at taking a drug that causes gynecomastia or diabetes, others might feel that the relief the drug provides is well worth the risk.

The fact is that most drugs have some side effects. If doctors, and by extension the companies that provide those doctors with the tools they need to properly treat patients, wish to do no harm then the best way to achieve that is with clear and concise patient information and education.

Author Bio

Layla Davis from USA wrote this article and submitted to Pharma Mirror to get published.


All of the information provided in this article is of authors, does not necessarily represent the official views or policies of the Pharma Mirror Magazine. This article may contain one or more advertised links. You are also invited to write for Pharma Mirror Magazine.


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