On April 3, 2002, Gary Dietz consulted with his family physician, Dr. Zuppa because he was suffering from anxiety, depression, insomnia, and stress. He denied any suicidal ideation. Dr. Zuppa prescribed Paxil. Eight days after filling the prescription, Dietz committed suicide by jumping in front of a train. Six years later, the manufacturer of Paxil issued stronger warnings of an increased risk of suicide among children and adolescents.
Dietz's estate filed suit against the manufacturer of Paxil, SmithKline Beecham Corporation (SBC), for products liability. SBC defended on the grounds of the learned intermediary defense and its motion for summary judgment was granted. This appeal to the 11th Circuit Court of Appeals ensued.
The learned intermediary defense only fails if the manufacturer fails to warn the physician appropriately.
As a general rule, in a products liability case premised on a failure to warn, the plaintiff must show that the manufacturer had a duty to warn, that the duty was breached by the manufacturer, and that harm was caused to the plaintiff by the manufacturer's breach of its duty. However, in this case, Georgia law allows the learned intermediary defense, which allows the manufacturer to meet its duty to warn by warning the physician who will be prescribing the medication. The learned intermediary defense only fails if the manufacturer fails to warn the physician appropriately. If the physician has knowledge of the warning and prescribes the drug anyway, the causal connection that leads back to the manufacturer is broken. In this case, the court noted that Dr. Zuppa expressly testified that he still agreed with his decision, and would have prescribed Paxil for Dietz even if he had been aware of the warning that was issued in 2008. The court of appeals affirmed the dismissal.
The learned intermediary defense is great for drug manufacturers, but it may leave physicians all alone in litigation. While it may be difficult, it is of paramount importance that physicians keep up with the myriad warnings that are issued by manufacturers, especially the black box warnings issued by the Food and Drug Administration. The final decision on whether the patient should take a drug should be the patient's. The physician must inform the patient of any significant risks that pertain to the medication and let the patient, if competent, make the decision.
Although the doctrine of informed consent is generally considered in the context of invasive procedures, it should be considered whenever there is a material risk associated with a treatment that may occur in the absence of negligence. This is just such a case. The risk of suicide may be heightened with some antidepressants, but it is not possible to predict with any certainty which patients may be affected. It is simply known that the risk may be greater for some patients. If the patient is warned of the risk but agrees to proceed with the treatment, he or she may be deemed to have assumed the risk.
Patients who fall into the class for whom the risk is increased should be warned of the risk, and the warnings should be carefully documented, to the extent possible. There is always a question regarding the risks for which warnings should be given. The test is whether the risk is material. Generally speaking, a risk is material if it is one of which the reasonable patient would want to be informed, or of which the reasonable practitioner would normally inform the patient. If the warning was given, but the warning was not documented, it often becomes a question of whose credibility is greater: the physician who claims that the risk was disclosed or the family who claims that the deceased would not have taken the drug had he been fully aware of the risk. The sympathies of the jury often gravitate toward believing the bereaved.
Good communication is often the best risk management tool. If there are risks associated with the treatment, they should be disclosed to the patient or family, and let the patient and family decide on the advisability of the treatment. Dietz v. SmithKline Beecham Corp., No. 09-0167 (11th Cir. March 5, 2010)
John C. West, J.D., M.H.A., is a senior health-care consultant with Global Loss Prevention, Inc., a Chartis company. This column constitutes general advice not legal advice. Readers should consult with counsel for legal concerns. For questions or comments contact john.west2@chartisinsurance.com.