The learned intermediary doctrine applied to protect a drug manufacturer from liability for a woman’s “catastrophic stroke” where the physician was aware of the risk of blood clots from the medication and prescribed it anyway, according to a federal appellate court. ABA Litigation Section leaders disagree as to whether the doctrine is beneficial.
A “Tragic Case”
In Hubbard v. Bayer Healthcare Pharmaceuticals Inc., a woman suffered a major stroke while taking an oral contraceptive in what the court referred to as a “tragic case.” A known risk of that drug is an increase in the risk of blood clots which cause strokes. The woman took the drug as prescribed by her physician for close to one year before her stroke and had taken a similar drug for ten years before that. Due to the stroke, the woman suffered paralysis and “severely impaired” cognitive function.
At the time the woman was prescribed the drug, the label warned of a risk of venous thromboembolism (VTE) and referenced studies on associated VTE risk. However, following a Food and Drug Administration (FDA) review of “… studies regarding the risk of blood clots in women taking drospireone-containing birth control pills,” the manufacturer revised its “… warning label to include, among other information, the possibility of up to a three-fold relative increase in blood clot risk.” After the stroke, the woman and her husband sued the company under various products liability theories, alleging that the manufacturer had failed to disclose known risks associated with the drug.
Physician Testimony Leads to Summary Judgment
The woman’s prescribing physician testified at deposition that he knew of the heightened risk of VTE from the drug before he wrote her last prescription. The doctor also testified that he would have prescribed the drug even if he had known of the updated risks which the plaintiffs claimed were not disclosed. The trial court granted the manufacturer’s summary judgment motion, reasoning that the plaintiffs could not prove the company’s inadequate warning caused the woman’s injury, and that the prescribing physician’ testimony established “that no different warning would have changed the prescribing decision and avoided the injury.”
The U.S. Court of Appeals for the Eleventh Circuit upheld the summary judgment ruling and explained that the learned intermediary doctrine “imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose.” A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question.
The Eleventh Circuit held that under the doctrine, the drug company did not have a duty to warn the woman about product risks; its sole duty was to warn her prescribing physician. Since the woman’s prescribing physician knew about the associated risks with the drug and would have prescribed it even if he knew about the additional risks, the woman was unable to meet her burden. The court noted that “… in cases where a learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided, courts typically conclude that the causal link is broken and the plaintiff cannot recover.” Although causation is typically a fact issue for the jury, under Georgia law, when proximate cause evidence is “plain and undisputed,” summary judgment is appropriate. The court applied that rationale here.
Is the Doctrine Beneficial?
Litigation Section leaders disagree as to whether the learned intermediary doctrine is beneficial. “The learned intermediary doctrine is an exception to the rule that manufacturers must provide direct warnings of product risks to consumers. In the initial decisions, courts created the doctrine as a means to avoid the argument that there was no privity of contract between patients and drug manufacturers,” notes Janet G. Abaray, Cincinnati, OH, Section member. “By creating the construct of the ‘learned intermediary,’ the courts were able to protect plaintiffs in cases where manufacturers gave inadequate warnings to physicians who prescribed drugs to the patients. Over the decades, the concept developed into a defense against claims by patients who claimed injury due to prescription drugs,” she continues. “The flaw with an over-application of the doctrine is it assumes patients have no input into decisions about their own medical care. That is not an accurate view of the doctor-patient relationship in the modern era, nor does it accurately reflect the ability of drug companies to communicate directly to patients,” concludes Abaray.
Another Section leader believes that the doctrine serves its purpose. “The learned intermediary doctrine does a good job of allocating risk to all parties involved (e.g., manufacturer, physician, patient, pharmacy, etc.). The FDA-approval process is complicated and thorough, so as long as the manufacturer is not hiding any known risks it should be able to rely on the safe harbor created by the approval of the label. Likewise, the manufacturer should also be able to rely on the prescribing physician’s experience, knowledge, and understanding of the known risks,” explains Tonya G. Newman, Chicago, IL, cochair of the Section’s Products Liability Litigation Committee.
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