On The Docket
David B. Brushwood, BSPharm, JD
The OTC regulatory classification presumes that users of OTC medications will read and heed the information in the product labeling. Medications that are capable of being labeled for safe and effective use without medical supervision are classified as “OTC” rather than as “Rx Only.” A case from North Carolina describes a discouraging situation in which a patient died following her use of an OTC epinephrine inhaler, despite warnings in the labeling that cautioned against her use of the product.
The patient’s longtime boyfriend went to a pharmacy “to seek a product to aid decedent with relief from her shortness of breath.” The boyfriend asked the pharmacist on duty whether the epinephrine inhaler was “good for breathing.” The pharmacist responded, “Exactly.” The boyfriend did not discuss any of the patient’s underlying health issues with the pharmacist.
The boyfriend returned to the patient’s home and gave the inhaler to the patient. After self-administering one puff of the medication, the patient experienced cardiopulmonary arrest. She was transported to a hospital where she died.
The product packaging contained the statement, “Do not use unless a doctor said you have asthma.” The packaging also said, “Ask a doctor before use if you have heart disease or high blood pressure.”
The patient had not been diagnosed with asthma. The patient had been diagnosed with congestive heart failure, CKD, and hypercholesterolemia. She had hypertension, and she had an implanted pacemaker.
The boyfriend did not read the information on the product packaging at the time of purchase. There was no evidence that the patient read the labeling information prior to her use of the product.
The patient’s estate sued the product’s manufacturer for negligence by selling a product that was alleged to be “dangerous and an essentially useless product.”
The manufacturer moved for dismissal of the case based on the contributory negligence of the patient. The trial court granted the manufacturer’s motion to dismiss, and the patient’s estate appealed.
Rationale
The appellate court explained that, in determining the adequacy of a product warning, North Carolina law requires consideration of whether a consumer knew or should have known, through the exercise of reasonable and diligent care, of a product’s warnings and instructions.
The court explained that the warnings on the inhaler packaging “clearly informed and warned potential users not to use the product unless they had been diagnosed with asthma, and it also instructed users with heart disease or high blood pressure to consult with a doctor.”
The court concluded that both the patient and the boyfriend “either knew, or with the exercise of reasonable and diligent care, should have known of these warnings.” The patient’s contributory negligence barred the claim against the product manufacturer as a matter of law. The dismissal of the lawsuit was affirmed.
Takeaways
The OTC category of drugs provides relatively easy access to certain medications without requiring a visit to a prescriber. The allegations in this case stated that “the general public’s perception is that over-the-counter medications are inherently risk-free.” This was a terribly costly misperception. There are no risk-free medications. The proper choice of medications, and the proper use of chosen medications, can reduce the risks of their use, but risks cannot be eliminated.
Patients who opt for self-medication are responsible for managing the risks of medication use. They have a responsibility to read the information that accompanies a medication. They have a responsibility to follow warnings that are relevant to them.
In an attempt to explain how these responsibilities were met, the allegations in this case stated that the selection of the inhaler was “made with a pharmacist’s assistance and was preceded by an online search.” This was a purposeful product acquisition.
Unfortunately, the patient’s boyfriend and the pharmacist did not engage in the sort of rich discussion that could have prevented the patient’s death. ■