This article discusses various types of drug reactions that can occur in a person and when a physician can be held responsible for reactions to both prescribed and over-the-counter-drugs.
It often times comes up in medical-legal forums that a person has suffered some sort of drug reaction. The nature of the reaction can be very relevant from a legal standpoint. The cause of an adverse drug reaction may be that a pharmacist mis-prescribed a drug or a doctor failed to note a drug allergy, which was listed in the medical record, and then prescribe that very drug.
A drug allergy reaction, is caused by some genetic “coding” in the person whereby exposure to the chemical(s) in a particular drug causes a rejection reaction that was previously undocumented in their medical records. The body protects itself from foreign material which can be harmful. If a foreign material is able to somehow make its way into the circulatory system (the blood) it will travel through the system’s circulation where it will quickly be noted by the Immune System as foreign. Once that happens, the system, through various chemical and cellular reactions, destroys, or kills, that material. A system with the genetic defect described above will “over” react. These reactant chemicals (mediators) can cause inflammation and swelling which can be very harmful and even life threatening in some cases (such as if the reaction is in the throat or lungs). This differs from an adverse drug reaction, which is when the drug itself is toxic to the system in its own right. It can cause the exact same clinical picture as a drug allergy, but is caused by different conditions.
We often associate drug reactions to prescription drugs. This is a misconception. A client can have an adverse reaction to an over-the-counter (“OTC”) drug. There are two different situations where this can lead to a lawsuit.
The first occurs when the drug has a dosage error or impurity. That is, you can take the correct drug but an incorrect amount, or the correct drug which also contained something else within it and suffer adverse reactions as a result. Often this situation lends itself to litigation against the pharmaceutical manufacturer as a product-liability styled lawsuit.
It can also be the case that a physician recommended the OTC drug to the patient when they should not have. In such cases the physician can be held liable for wrong doing if the drug was not prescribed properly for the patient’s condition. The mere fact that the drug is OTC doesn’t mean that the physician has obtained some sort of safe harbor for recommending it. For example, a physician who prescribes Advil to a patient whose record shows a history of allergy or adverse reaction to Advil, is just as guilty of medical malpractice as if a prescription drug was prescribed. It is simply not the case that for a physician to be liable for prescription errors the drug has to be a prescription drug. A physician can “prescribe” an OTC drug to a patient just as a physician can prescribe a non-OTC drug. The fact that a drug is labeled or characterized a given way has no bearing whatsoever on the actions of a physician instructing a patient to use that drug.
Continuing with the example of Advil a physician may orally instruct the patient to take it for arthritis. This instructing is just as much a prescription as writing for a scheduled prescription on a piece of paper. The act of the physician recommending and instructing the use of a given drug (treatment) for a given condition (arthritis) is the same. Advil has various dangers attached to its use, such as stomach ulcers and kidney damage. It may be that a given patient should not be instructed to take Advil, or that certain monitoring must be performed while taking it. Failure to address those issues could lead to very serious medical consequences. Again, these are issues that are in the control of the doctor and not the maker of the drug. It is arguably more dangerous to prescribe a patient an OTC drug many times. The reason for this is the ease with which the patient can obtain the drug. Ordinarily, a doctor can control the times a patient must come in for some sort of monitoring by simply allowing the prescription to expire. This protects the doctor and the patient from some over sights. Obviously, with OTC drugs this back up is lacking. In general, the legal boundaries defining medical malpractice from product liability is referred to as the Learned Intermediary Theory in Illinois upon which there exists significant case law.
It must also be noted that OTC drugs can be, and often are, as toxic and dangerous as prescription drugs. It is not a medically accurate position to assume, or otherwise treat, OTC drugs as some sort of unimportant junior partner to prescription drugs. For the most part, drugs get classified as OTC when the FDA approves it because of widespread use with consideration of the safety profile of the drug. For instance, drugs like aspirin, non-narcotic pain relievers, cold remedies, and the like, are so commonly used that to require the population of the United States to visit a doctor for a prescription to obtain such drugs would be extremely burdensome and expensive. Accordingly, the drugs that are OTC generally only contain low doses of active drug ingredient.
In the setting of medical malpractice litigation it must be understood, by both parties, that the legal point being disputed in drug reaction cases is not whether the patient has suffered an allergic reaction versus an adverse reaction, (because this often can’t be determined), but rather whether the applicable standard of care required the doctor to abstain from giving the drug to begin with. If the standard of care didn’t call for the drug to be given then it is irrelevant which reaction occurred. The fact is, that had the drug not be given there would have been no drug induced reaction at all.