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Objective Standard of Causation Applies in Medical Product Liability Cases—S.C.
Plaintiffs Must Show if Adequate Advisement Had Been Given by Drug-Maker, Doctor Would Have Relayed Stronger Warning, Reasonable Patient Would Have Declined Treatment—Groban
By a MetNews Staff Writer
A plaintiff suing a medical device or prescription drug manufacturer for product liability may establish causation between the injury and a failure to warn, under the learned intermediary doctrine, by showing that a stronger risk admonition would have been communicated by the physician to the patient and an objectively reasonable person would then have declined the treatment, the California Supreme Court held yesterday.
The question arose by way of a certified question from the Ninth U.S. Circuit Court of Appeals which asked the high court to resolve the following question:
“Under California law, in a claim against a manufacturer of a medical product for a failure to warn of a risk, 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 establish causation by showing that the physician would have communicated the stronger risk warnings 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?”
Justice Joshua P. Groban wrote the opinion for the unanimous court, declaring:
“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 notwithstanding the physician’s continued recommendation of the treatment.”
Product Liability Action
Plaintiff Michelle Himes sued Somatics, LLC in federal court for negligence, strict liability, and loss of consortium, alleging that the company failed to provide an adequate warning regarding certain risks associated with undergoing electroconvulsive therapy (“ECT”).
An ECT device treats severe psychiatric disturbances by inducing a major motor seizure through the application of brief, intense electrical currents to the patient’s head. Dr. Raymond Fidaleo determined that ECT was an appropriate next-step for Himes after her depression continued to decline despite having been prescribed at least nine different antipsychotics and antidepressants.
Himes contends that she was only warned that ECT could cause short-term memory loss and that Somatics failed to disclose to her physician that its ECT device could cause “permanent brain damage, severe permanent retrograde and anterograde amnesia, and acute and/or chronic organic brain syndrome,” the injuries she alleges she suffered. She asserts that the failure to warn caused her injuries.
District Court Judge R. Gary Klausner of the Central District of California granted summary judgment in favor of Somatics, finding that causation had not been shown.
Specifically, he found that the non-disclosed risks must be “sufficiently high” such that it would had “changed the treating physician’s decision to prescribe the product” and that no evidence was presented that a more detailed warning would have changed Fidaleo’s mind.
Learned Intermediary Doctrine
Groban noted that a “duty to warn” in a medical product liability case runs to the doctor and not the patient under the learned intermediary doctrine. According to the doctrine, pharmaceutical companies and medical device manufacturers have a duty to warn physicians, rather than the patients, of any non-negligible risks associated with the products as the doctors are best positioned to understand the risks and benefits of the course of treatment.
Once the manufacturer has fulfilled its duty to warn the physician, the duty then falls on the health-care provider to provide the appropriate information so that the patient can make an informed choice as to whether to proceed with the recommended care.
Groban said:
“[T]he manufacturer fulfills its general duty of care owed to the patient by providing an adequate warning to the patient’s physician. If the manufacturer fails to provide an adequate warning to the patient’s physician, then the patient may sue asserting negligence for breach of its general duty of care or asserting strict liability for marketing a product that has been rendered defective due to the inadequate warning.”
Failure to Warn
Groban remarked that the question presented by the Ninth Circuit requires the court to analyze “how Himes may be able to prove that, but for Somatics’s failure to warn her physician, Himes would not have been injured.”
Somatics argues that a plaintiff must show that the treating physician would have changed his prescribing decision had the additional warnings been provided, an impossible task for Himes as Fidaleo testified at a deposition that additional warnings would not have changed his mind.
He said:
“In Somatics’s view, the patient’s own decision as to whether to accept the recommended treatment is irrelevant, meaning that if the patient’s physician testifies that he or she would not have changed his or her prescribing decision, then there can be no liability. Somatics believes its view of causation best aligns with the learned intermediary doctrine given the doctrine’s recognition that patients generally rely on their physicians’ medical expertise when deciding on a particular course of treatment.”
Informed Consent Analysis
Finding decisions relating to informed consent to be applicable to the analysis, he opined:
“Implicit in our informed consent rule is the recognition that patients will sometimes opt out of the medical treatments their physicians recommend, as is their right…. If Somatics were correct that the physician’s prescribing decision is all that matters, and the patient’s own decision as to whether to undergo the treatment after having learned of the risks is irrelevant, then there would be no need for the informed consent rule.”
The jurist continued:
“Like our informed consent jurisprudence, the learned intermediary doctrine affirms patient autonomy in medical treatment decisions….[B]y ensuring that physicians will assist patients in understanding manufacturer warnings relating to material risks and in balancing those risks against the benefits of treatment, the doctrine enables patients to make intelligent treatment decisions.”
Physician Recommendation
Groban explained that the analysis will begin by looking at whether the stronger warnings would have changed the doctor’s recommendation:
“The causation analysis should therefore begin by determining what…the patient’s physician would have communicated to the patient regarding the relative risks and benefits of the prescription drug or medical device in response to a stronger warning, and should then turn to whether an objectively prudent person in the patient’s position would have declined the treatment even where the evidence shows that the physician’s treatment recommendation would have been unchanged by the stronger warning. In other words, 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.”
He acknowledged that the court’s role is limited to “providing guidance” on the general principles of California law, but he noted, “for the purpose of providing guidance,” that many of the issues raised by Somatics will be relevant to the causation analysis, saying:
“[R]elevant factors that should be considered in determining whether an objectively prudent patient would have declined physician-recommended treatment include, but are not necessarily limited to, whether the physician weighed and assessed the risks and benefits of the treatment and, after discussing those risks and benefits with the patient, continued to recommend the treatment….”
Objective Analysis
Rejecting Himes’ assertion that a subjective standard of causation should apply, as it does in other consumer failure-to-warn contexts, he said:
“[W]hereas consumer products are generally used for personal convenience or pleasure, prescription drugs and medical devices are often necessary to ensure the health of the patient….A subjective standard that relies on the plaintiff’s postinjury assessment regarding how he or she would have reacted to the warning in isolation would not only be prone to hindsight bias, it would also fail to take into account the context in which the risks of prescription drugs and medical devices are discussed with patients as well as patients’ general reliance on the treatment recommendations of their physicians.”
The case is Himes v. Somatics, LLC, 2024 S.O.S. 1921.
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