I’m David Holub, an attorney focusing on personal injury law in northwest Indiana.
Welcome to Personal Injury Primer, where we break down the law into simple terms, provide legal tips, and discuss personal injury law topics.
Today’s question comes from a caller who said, “I was reading the FDA warning on the medication my doctor prescribed for me. It lists several contraindications for taking this medicine, and I fall into one of the categories of people who should not take the medicine. Should I stop taking the medicine?”
Interesting question. I had to remind the caller that we are lawyers and not medical doctors. After that reminder, we figured out why she was really calling a lawyer.
We get calls like this often. We’ve grown accustomed to the fact that the callers really do not want medical advice. They understand we cannot give and do not give medical advice.
The real question the caller meant to ask was, “would they have a legal case if the medication harmed them?”
If a person falls within a described contraindication, it typically means that under no circumstances should they take the medication. If you do not readily understand the term “contraindicate,” don’t feel bad. It is highly confusing.
Think this way: if your car uses gasoline, the hose that puts gasoline in your tank is the product that is “indicated” for your vehicle. The hose that pumps diesel fuel would be “contraindicated” for your car.
Some drugs come with an “absolute contraindication”, meaning never giving it under any circumstance to a patient already taking a listed medication or who has a listed condition. Why? Because it is known to seriously harm or kill the patient.
Another category you will see listed in FDA medication warnings is the “precaution.” This generally means that an adverse reaction is predictable if a patient is already taking certain drugs or has specific conditions. Still, the patient’s physician can weigh the pros and cons of the medicine and give it if they believe that the pros outweigh the cons in consultation with the patient.
Beyond the situations we have described, there is “off-label” use of a drug. This means that the manufacturer does not identify the drug as being beneficial to treat a specific condition, but the doctor thinks it might help anyway, so she prescribes it to the patient.
A classic “off-label” use was involved in the diet drug scandal 15 years ago involving the giving of fen-phen to patients. Doctors discovered that using two drugs together, each designed for different uses, suppressed patients’ appetites. No one ever tested what would happen to patients if the two drugs were taken together. What happened was the drug combination severely damaged the heart valves of many patients.
Doctors can be held liable for harm caused by the “off-label” use of drugs. But, usually, manufacturers cannot. But, if manufacturers experience a massive increase in sales due to off-label use, they too can be liable in many situations.
If a doctor gives a contraindicated drug to a patient, they often can be held liable. If informed consent was given, meaning the patient was told and signed off on taking the medication knowing it could harm them, liability may be hard to establish. Of course, by listing a contraindication, the manufacturer typically is shielded from liability if the warning was clear and adequate.
I hope you found this information helpful. If you are a victim of someone’s carelessness, substandard medical care, a product defect, work injury, or another personal injury, please call (219) 736-9700 with your questions. You can also learn more about us by visiting our website at DavidHolubLaw.com – while there, make sure you request a copy of our book “Fighting for Truth.”