Learned Intermediary Doctrine
In a typical products liability case, a manufacturer owes a duty to warn the end user about the hazards inherent in their products. For manufacturers of prescription drugs and many medical devices, however, the duty to warn runs to the physician, not to the patient. Thus, these manufacturers have a duty to warn physicians of the risks associated with their products but need not warn the patient regarding those same risks. The primary rationale for this rule, called the “learned intermediary doctrine,” is that physicians, not their patients, are best positioned to understand the relevant benefits and risks associated with various prescription drugs and medical devices. Once a manufacturer has fulfilled its duty to warn the physician, the duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.
The question decided by the Supreme Court of California in its June 20, 2024 opinion was: “If a prescription drug or medical device manufacturer has breached its duty under the learned intermediary doctrine to provide an adequate warning (or any warning at all) to the physician, how must the plaintiff prove that the failure to warn caused his or her injury? Is the plaintiff required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product, or may the plaintiff instead establish causation by showing that the physician would have communicated the stronger risk warning to the plaintiff, either in their patient consent disclosures or otherwise, and a prudent person in the patient’s position would have declined the treatment after receiving the stronger risk warning?
The Supreme Court of California held: “A plaintiff is not required to show that a stronger warning would have altered the physician’s decision to prescribe the product to establish causation. Instead, a plaintiff may establish causation by
showing that the physician would have communicated the stronger warning to the patient and an objectively prudent
person in the patient’s position would have thereafter declined the treatment. The causation analysis, however, must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of a more adequate warning. In other words, where the evidence shows that the physician would have continued to recommend the treatment notwithstanding the stronger warning, the plaintiff must prove that an objectively prudent person in the patient’s position would have declined treatment despite the physician’s assessment that the benefits of the treatment for the patient would still outweigh any risks disclosed by a stronger warning. As in the informed consent context, the test is what an objectively prudent person in the patient’s position would have done in light of all the information presented and is not determined by the plaintiff’s subjective belief as to what he or she might have done with the benefit of hindsight.”
Source Himes v. Somatics, LLC, S273887.
If you or a loved one suffered injuries (or worse) as a result of the fauilure to provide adequate warning regarding a prescription drug or medical device in California or in another U.S. state, you should promptly seek the legal advice of a pharmaceutical or medical device claim lawyer in your state who may investigate your drug claim or medical device claim for you and represent you or your loved one in a claim against a pharmaceutical company or medical device manufacturer, if appropriate.
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