LOS ANGELES, June 20, 2024 — Wisner Baum attorneys prevailed before the California Supreme Court on Thursday in a landmark ruling that clarifies a gap in the law that the pharmaceutical industry has exploited for decades.
On June 20, 2024, the court rejected a device manufacturer’s argument that only a physician’s decision to prescribe is relevant to legal (proximate) causation and that patient autonomy should be disregarded. The Supreme Court’s ruling confirms that patient autonomy remains sacrosanct and must be considered in pharmaceutical product liability failure to warn cases.
Specifically, the defendant, Somatics LLC, a manufacturer of an electroshock therapy (ECT) device, which did not dispute in the lower court that its electroshock therapy (ECT) device can cause brain damage and permanent memory loss; did not dispute it failed to warn doctors of the risk of brain damage and permanent memory loss; and did not dispute that plaintiff, Michelle Himes, sustained brain injury, nonetheless argued it should be immune from liability because the plaintiff’s doctor testified he would have prescribed treatment with ECT even if the manufacturer had warned him of the risk of brain damage.
The Supreme Court of California’s decision can be found here.
Relying upon the “learned intermediary doctrine,” which provides that manufacturers have a duty to warn physicians of risks associated with their drugs and devices, but not patients directly, Somatics argued that, to establish liability against it, Himes was required to show a stronger warning would have altered the physician’s decision to prescribe the product. The Supreme Court unanimously rejected this argument and instead held that “the patient’s role in deciding his or her own course of treatment does
not disappear in the context of the learned intermediary doctrine” and that “the learned intermediary doctrine does not allow health care professionals to substitute their judgment for that of their patients.” See Order at 15.
The Supreme Court concluded:
“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. A plaintiff may instead 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 notwithstanding the physician’s continued recommendation of the treatment.” See Order at 29.
Pharmaceutical and device manufacturers have used the learned intermediary defense for decades and have successfully convinced some courts to dismiss meritorious claims brought by injured patients by arguing the doctor would have prescribed the medication or medical procedure and the autonomy of patients was irrelevant. The Supreme Court’s decision in Himes eliminates this illogical defense.
Wisner Baum, LLP senior partner, Bijan Esfandiari, argued the Himes case before the California Supreme Court and stated: “As a result of the California Supreme Court’s Himes decision, moving forward, pharmaceutical and device manufacturers who fail to warn of risks associated with their products can no longer avoid liability by misusing the learned intermediary doctrine. Today’s decision in Himes is not only a victory for consumers injured by defective pharmaceuticals and medical devices but is a victory for anyone who champions patient autonomy.”
Related links:
Plaintiff-Petitioner, Michelle Himes, Opening Brief on the Merits:
https://supreme.courts.ca.gov/sites/default/files/supremecourt/default/documents/14-270-s273887-app-michelle-himes-opening-brief-merits-071522.pdf
Plaintiff-Petitioner, Michelle Himes, Reply Brief:
https://supreme.courts.ca.gov/sites/default/files/supremecourt/default/documents/17-450-s273887-app-himes-reply-brief-merits-102022.pdf
Plaintiff-Petitioner, Michelle Himes, Consolidated Answer to All Filed Amicus Curiae Briefs:
https://supreme.courts.ca.gov/sites/default/files/supremecourt/default/documents/25-760-s273887-app-resp-ac-brief-122822.pdf
Oral Argument:
https://jcc.granicus.com/player/clip/4594?meta_id=117736
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