On June 20, the California Supreme Court issued its decision in Himes v. Somatics LLC.[1]
This 7-0 ruling has vast implications for manufacturers of medical products, namely manufacturers of prescription drugs and medical devices that reach patients through a learned intermediary, as well as for medical providers and the healthcare industry as a whole.
Responding to a certified question of state law from the U.S. Court of Appeals for the Ninth Circuit, the California Supreme Court held that, under California law, medical product manufacturers may be liable for alleged patient injuries if patients can show that their treating physicians — in the face of a stronger warning of the product’s potential adverse effects — would have decided against the treatment.
Alternatively, a patient may establish liability through evidence that the physician, even while still recommending the treatment, would have relayed a stronger warning to their patient and that an objectively prudent patient hearing such warnings would have refused treatment altogether.
The court’s newly articulated causation standard for medical product manufacturer liability redraws the boundaries between patient informed consent and the learned intermediary doctrine as a legal defense. As explained below, the court’s ruling may have resounding impacts on manufacturers and other key stakeholders in the healthcare industry in the years ahead.
Underlying Facts and Procedural History
In 2017, Michelle Himes and other patients filed a putative class action in the U.S. District Court for the Central District of California asserting state law diversity claims from injuries they allegedly suffered from electroconvulsive therapy, or ECT, that their physicians had prescribed them.[2] ECT is a medical procedure where a device sends electric currents into a patient’s brain to induce seizures that improve certain mental health conditions.[3]
The defendant, Somatics LCC, manufactures the ECT devices that allegedly caused their injuries, including brain injury, permanent retrograde amnesia, cognitive impairment and death.
But according to the plaintiffs, Somatics never conducted any clinical trials of its ECT device to evaluate its safety and efficiency.[4] In addition to their own alleged injuries, the plaintiffs further claimed that Somatics knew of, but failed to investigate, hundreds of patient reports of injury and death from ECT.[5]
And as the plaintiffs alleged, Somatics failed to report any adverse events to the U.S. Food and Drug Administration, never provided any warnings at all to physicians about the material risks of ECT and misbranded their ECT device to avoid FDA regulation.[6]
Somatics moved for summary judgment in 2021, asserting the learned intermediary doctrine as a complete defense against the plaintiffs’ claims of strict liability, negligence and loss of consortium.[7]
As a historical matter, under the learned intermediary doctrine, medical product makers could defeat liability for failure-to-warn claims if the manufacturer could show that it (1) advised a learned intermediary, i.e., the prescribing physician, of the material risks associated with the medical product, and (2) the intermediary still prescribed that product to the patient.
The principle behind the doctrine is that “patients often rely on their physician’s expertise and judgment in making medical treatment decisions” and providing informed consent, and not on warnings, if any, provided directly by the medical product manufacturer.[8]
Applying that doctrine, the district court initially assumed for purposes of the summary judgment motion that Somatics failed to provide any warnings of ECT’s risks to physicians.[9]
Still, the district court granted summary judgment for Somatics because it concluded that the plaintiffs could not demonstrate causation — i.e., that the nondisclosed risks associated with ECT would have altered their physicians’ choice to prescribe ECT — regardless of the potential inadequacy of Somatics’ disclosures, how physicians may relay stronger warnings to their patients or how patients may react to those stronger warnings.[10]
The plaintiffs appealed to the Ninth Circuit, arguing that the district court had applied an unduly demanding causation standard that turned solely on the physician’s choice to prescribe ECT while disregarding the physician’s warning practice and patients’ informed consent.[11]
The Ninth Circuit affirmed summary judgment for one plaintiff because his physician testified that even stronger risk warnings by Somatics would not have altered his decision to prescribe ECT or to even disclose additional risks to his patients.[12]
However, the Ninth Circuit revived Himes’ claims, citing factual evidence that, while Himes’ treating physician would still have recommended ECT to Himes, he also would have passed on a stronger warning had Somatics provided one.[13]
Thus, the operative question remained whether patients can overcome the learned intermediary defense by showing either they personally or a reasonable person in their shoes would have declined a particular medical product after hearing a hypothetical stronger warning from their physician.[14] Finding an absence of controlling state precedent on the issue of causation, the Ninth Circuit certified the case to the California Supreme Court.
The California Supreme Court’s Opinion in Himes v. Somatics
The Ninth Circuit certified the following question of state law to the California Supreme Court:
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?[15]
Underscoring the high stakes of the California Supreme Court’s decision, a wide array of industry stakeholders filed amicus briefs supporting the medical product manufacturer.
Writing for a unanimous court, Justice Joshua Groban responded to the Ninth Circuit’s question by rejecting the manufacturer’s argument that the learned intermediary doctrine operates as a complete defense to causation and liability unless the patient can prove that the treating physician would have refused to prescribe the product given the stronger warning.
Siding partly with the patients and partly with amici, the court held that causation for a medical product manufacturer’s failure to warn of adverse risks may be proven by evidence that either (1) “a stronger risk warning would have altered the physician’s decision to prescribe”; or (2) “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.”[16]
Although the court’s decision widens the door for medical product maker liability, the court did not hand the plaintiffs a full win.
For one, the court reinforced the continued viability of the learned intermediary doctrine by shutting down the patients’ contention that, if a manufacturer fails to properly warn physicians, then it bears the burden of warning the patients directly to avoid failure-to-warn liability.[17]
The court reasoned that direct manufacturer-to-patient warnings would undermine informed consent and the learned intermediary doctrine by removing physicians from the equation altogether.[18]
Second, according to the court, the patients incorrectly argued that causation can be met by patient testimony that they would have personally declined the treatment had they had received a stronger risk warning.
As the manufacturer argued, the patients’ proposed subjective rule for crediting retrospective patient testimony would upend the learned intermediary doctrine and put manufacturers in an impossible position of speculating how idiosyncratic patients may react to their physicians’ hypothetical risk disclosures.[19]
In their amicus briefs, industry stakeholders echoed these concerns, warning that a rule that turns on patients’ hindsight testimony would “operate as a virtually automatic bar to summary judgment” in medical failure-to-warn cases.[20]
The court, seeking to avoid the bias of hindsight while respecting patient decision making, struck a different balance altogether. Under its newly articulated causation test, patients “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.”[21]
Its new test therefore applies an objective test that still accounts for “personal characteristics … or circumstances unique to the patient.”[22]
Potential Implications of the Himes Decision
Stronger medical product risk disclosures may be necessary to defeat causation and liability in California and potentially nationwide.
Himes effectively adds a new pathway for plaintiffs to establish causation and liability against manufacturers. In a post-Himes world, manufacturers must now also defend against claims that their warnings were inadequate and that in the face of a counterfactual stronger warning by their physician, objectively prudent patients would have refused treatment.
Given this, Himes may contribute to an uptick in patient-initiated litigation against manufacturers and more failure-to-warn cases surviving motions to dismiss and summary judgment. To avoid this, manufacturers may respond to Himes by modifying their warnings to encompass all potential risks, so as to avoid heightened judicial scrutiny into how counterfactual stronger warnings by physicians may affect patient choices.
Although the Himes decision solely concerned the standard for causation in California courts, the size of California’s patient base means that medical product manufacturers nationwide may be incentivized to warn of all potential risks of treatment using their product.
While this may deter claims against manufacturers, amici also insisted that this outcome perversely incentivizes manufacturers to over-warn about all possible medical risks, no matter how remote, thereby obscuring the most salient risks to the detriment of physicians and patients alike.[23]
Himes may place medical product manufacturers at odds with physicians, hospitals, insurers and patients.
As a general matter, under the learned intermediary doctrine, a medical product manufacturer’s duty to warn runs primarily to physicians, and not to patients. Thus, in cases where the medical product warning is adequate, medical providers and malpractice insurance bear any liability since the learned intermediary defense establishes the medical provider prescribing the product as the intervening cause of the patients’ injuries.
Through the Medical Injury Compensation Reform Act, California law limits all noneconomic damages for meritorious claims against physicians and other medical providers — e.g., for pain and suffering, discomfort, loss of consortium, and death.[24]
After enacting MICRA in 1975 to constrain the ballooning cost of malpractice insurance for medical providers,[25] the California Legislature recently amended MICRA’s damages cap to up to $500,000 in 2023, with annual increases for an upper limit of $1 million by 2033.[26]
Crucially, MICRA “applies only to actions alleging injury suffered as a result of negligence in rendering the professional services that hospitals and others provide by virtue of being health care professionals.”[27]
By contrast, California law imposes no damages limit for meritorious injury claims against manufacturers. So, while the learned intermediary doctrine may have historically discouraged patients from bringing injury-related suits against medical product manufacturers, the Himes ruling may encourage more plaintiffs to assert, and prevail in, actions against manufacturers seeking monetary relief far above MICRA’s damages cap.
And in future failure-to-warn actions asserting comparative liability against both the physician and manufacturer, physicians — potentially seeking to shift liability away from themselves — may be inclined to testify that the manufacturer’s disclosures inadequately warned of risks, and that they would have reviewed and conveyed a stronger warning to patients had one been provided.
Thus, Himes raises important implications for the entire medical industry going forward.
For instance, to the extent Himes substantially raises legal costs for medical product manufacturers — including for makers of surgical machines, heart-lung machines, ventilators, incubators, dialysis machines and many others — amici warned that such ballooning costs may negatively affect the research, development and availability of medical breakthroughs to treat serious conditions, echoing the California Legislature’s concerns motivating MICRA nearly a half-century earlier.[28]
The state high court ruling leaves unanswered questions and potential defenses on the table under the Federal Food, Drug and Cosmetic Act.
One question that was not before the California Supreme Court is what role, if any, federal preemption may have on a plaintiff’s claims.
Specifically, the Federal Food, Drug and Cosmetic Act expressly preempts state law in regulating medical instrumentation, with few exceptions.[29] The FDCA provides:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.[30]
Whether Section 360k(a) intended to preempt causation in the context of state tort actions remains an open question. The U.S. Supreme Court has visited the issue twice, once for Section 510(k)-cleared devices, like the ECTs at issue in Himes, and again for higher-risk premarket-approval devices.
In Reigel v. Medtronic Inc. in 2008, the high court found that Section 360k(a) expressly preempts state law tort claims alleging negligence and strict liability for PMA-approved devices, if such claims are based on state requirements “different from, or in addition to,” federal requirements relating to safety and effectiveness.[31]
For 510(k)-cleared devices, however, the U.S. Supreme Court has taken a different approach, holding that state law claims were not preempted by Section 360k(a) because the 510(k) process does not impose requirements regarding the safety and effectiveness of the device.[32]
Since the 510(k) process merely establishes that the device is substantially equivalent to a predicate device, the U.S. Supreme Court ruled in Medtronic Inc. v. Lohr in 1996 that the federal government had not established requirements in the same manner that it does for premarket-approval devices.[33]
In addition to express preemption provided for in § 360k(a), there are also implied preemption theories that have applied in FDCA cases.[34]
Indeed, this case will be interesting to watch on remand to see whether and how Somatics raises preemption defenses moving forward, for example, by noting that the patient’s claims would have required the defendants to include warnings for their device that was “different from, or in addition to” the federal requirements relating to safety and effectiveness.[35]
The defense is made further complex because the ECTs at issue in Himes were initially required to proceed to market via the premarket-approval pathway, but were down-classified to Class 2 devices eligible for the 510(k) pathway, thus making the express preemption arguments under U.S. Supreme Court precedent murky, yet plausible.[36]
What’s Next
The case now returns to the Ninth Circuit to reconsider the district court’s grant of summary judgment with the California Supreme Court’s latest guidance on causation and potential liability.
The Ninth Circuit had previously found a genuine dispute of material fact about whether the Himes’ physician, in the face of a hypothetical stronger warning, would have passed the warning on to her, and so the Ninth Circuit will likely reverse the grant of summary judgment and remand to the district court to decide whether an “objectively prudent person in the plaintiff’s position” would have declined the treatment if given a stronger warning.
As the case progresses, it remains to be seen what evidence the plaintiffs will adduce and what additional defenses, such as those potentially available under the express preemption provision in the FDCA, that the manufacturer will assert.
What is clear, however, is that Himes has the potential to significantly change nationwide medical product warnings as well as the litigation landscape for medical product manufacturers, physicians, patients and other healthcare industry participants in the years ahead.
[1] No. S273887, 2024 WL 3059637 (Cal. June 20, 2024).
[2] Pls.’ Class Action Compl. ¶ 2, Riera v. Mecta Corp., 2021 WL 2024688 (C.D. Cal. May 14, 2021), ECF No. 1.
[3] While Plaintiffs’ briefs centered on allegedly harmful consequences of ECT, the American Psychiatric Association (“APA”) filed an amicus brief seeking to correct alleged misstatements by Himes regarding the efficacy of ECT, which it insisted effectively treats certain mental health conditions. APA Br. at 9; see Electroconvulsive Therapy (ECT), Mayo Clinic (Oct. 12, 2018).
[4] Riera, 2021 WL 2024688, at *1.
[5] Id.
[6] Id.
[7] Somatics Mot. for Summ. J., supra note 3, at 16-18, ECF No. 80.
[8] Himes, 2024 WL 3059637, at *8.
[9] Riera, 2021 WL 2024688, at *5.
[10] Id. at *5-6.
[11] Himes v. Somatics LLC, 29 F.4th 1125, 1126 (9th Cir. 2022).
[12] Id.
[13] Himes v. Somatics, LLC, 2022 WL 989469, at *2 (9th Cir. Apr. 1, 2022).
[14] Himes, 29 F.4th at 1126.
[15] Id. at 1127.
[16] Himes, 2024 WL 3059637, at *5.
[17] Id. at *6; see Opening Br. on the Merits, supra note 2, at 3.
[18] Himes, 2024 WL 3059637, at *6-7.
[19] See id. at *9-10; see also CMA, CDA, and CHA Br. at 34.
[20] PLAC Br. at 4-5, 23-24.
[21] Himes, 2024 WL 3059637, at *1 (emphasis added); see Opening Br. on the Merits, see supra note 2, at 46.
[22] Himes, 2024 WL 3059637, at *9.
[23] PLAC Br. at 10-11.
[24] See Cal. Civ. Code § 3333.2.
[25] See Lopez v. Ledesma, 12 Cal. 5th 848, 855–56 (2022).
[26] See Cal. Civ. Code § 3333.2(g).
[27] Flores v. Presbyterian Intercommunity Hosp., 63 Cal. 4th 75, 88 (2016).
[28] CLS Br. at 22-24; PLAC Br. at 5; CJAC Br. at 11.
[29] 21 U.S.C. § 360k(a).
[30] Id.
[31] See Reigel v. Medtronic, Inc., 552 U.S 312, 328–30 (2008).
[32] See Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996).
[33] See id., at 492-94.
[34] See e.g., Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341, 347–48 (2001).
[35] Defs.’ Answer to Pls.’ First Am. Compl., supra note 3, at 15, ECF No. 23.
[36] 21 C.F.R § 882.5940.
