Corporate Counsel Daily, Summary judgment affirmed in Cialis stroke victim’s suit against Eli Lilly and Company, (Mar 25, 2026)

By Chelsea N. Simms, Esq.

Because the evidentiary record foreclosed any showing that different warnings would have altered prescribing decisions and avoided harm, Eli Lilly & Company was not liable for the victim’s injury.

The Ninth Circuit affirmed summary judgment for Eli Lilly and Company, concluding that a man who suffered a paralytic stroke hours after taking the prescription drug Cialis failed to establish proximate causation under Washington products liability law. Reasoning that liability turned on whether prescribing physicians would have changed their treatment in response to an adequate warning, the court found that undisputed deposition testimony established that the urologist who prescribed Cialis would not have altered his decision, and the primary care physician’s testimony could not support causation because he did not prescribe the dosage at issue and, in any event, fell outside the scope of the manufacturer’s duty to warn. And, because these defects were dispositive, the alleged procedural errors were harmless and did not affect the outcome (Dearinger v. Eli Lilly and Company, No. 24-682 (9th Cir. Mar. 20, 2026)).

Eli Lilly & Company manufactures and sells Cialis, a prescription drug used to treat erectile dysfunction, enlarged prostate symptoms, and pulmonary arterial hypertension. Plaintiff, prescribed Cialis for erectile dysfunction, suffered an intracerebral hemorrhage (ICH)—a type of stroke—within hours of taking the drug.

Following his stroke, he and his wife filed suit in the U.S. District Court for the Western District of Washington asserting product liability claims under the Washington Products Liability Act, alleging that Eli Lilly failed to provide adequate warnings regarding the risk of intracerebral hemorrhage associated with Cialis. After being denied counsel, the Plaintiffs proceeded pro se and the court ultimately granted summary judgment in Eli Lilly’s favor, concluding that the Plaintiffs failed to establish proximate causation (see Products Liability Law Daily’s Feb. 8, 2024, analysis). The Plaintiffs moved for reconsideration, which the district court denied in part based on the sham affidavit rule.

On appeal, the Plaintiffs challenged the denial of counsel, the grant of summary judgment, the application of the sham affidavit rule, and the district court’s failure to advise them to amend their complaint to add additional defendants. The Ninth Circuit affirmed the judgment in all respects.

Appointment of Counsel. The Ninth Circuit found that, assuming the district court had abused its discretion in denying the Plaintiffs’ motions for appointment of counsel, any such error was harmless. Even if counsel had been appointed, the outcome would not have changed because summary judgment properly turned on undisputed testimony establishing the absence of proximate causation. As a result, the alleged denial of counsel did not affect the substantive merits of the claims or the correctness of the judgment.

Proximate Causation. The court’s affirmance centered on the Plaintiffs’ failure to establish proximate causation under the Washington Products Liability Act (WPLA), which requires proof of both cause in fact and legal causation, and in the prescription drug context, that inquiry is governed by the learned intermediary doctrine. Under that doctrine, a manufacturer satisfies its duty to warn by adequately informing the prescribing physician of the drug’s risks, because the physician is uniquely positioned to weigh those risks and communicate them to the patient.

To establish proximate cause in a failure-to-warn or defective labeling claim, the Plaintiffs were required—and failed—to show that an adequate warning would have altered the prescribing physician’s conduct in a way that would have avoided the harm. Agreeing with the district court that the Plaintiffs failed to meet this burden as to any relevant prescriber, the Ninth Circuit affirmed summary judgment on the issue.

Dr. Bardin. The court concluded that deposition testimony of Dr. Bardin—the urologist who initially prescribed Cialis to the Plaintiff—was fatal to proximate causation. Dr. Bardin testified unequivocally that even if the warning label had included the additional risk information the Plaintiffs contended was required, he would not have changed his prescribing decision. Because it was undisputed that Dr. Bardin would not have treated the product differently in response to an alternative warning, the Plaintiffs could not establish that any inadequacy in Eli Lilly’s warnings was a “but for” cause of the intracerebral hemorrhage.

Dr. Horst. The Plaintiffs unsuccessfully attempted to rely on the deposition testimony of Dr. Horst, the primary care physician who stated that he would not have prescribed Cialis to someone with the Plaintiff’s family history of intracerebral hemorrhage if he had been warned of that risk. The court rejected this theory for two independent reasons.

First, the factual record established that Dr. Horst only prescribed a daily 5 mg dose of Cialis and that the Plaintiff testified he stopped taking those pills shortly after they were prescribed in March 2017—well before the January 2018 hemorrhage. Dr. Horst never prescribed the 20 mg dosage that the Plaintiff had taken prior to his injury. As a result, even accepting Dr. Horst’s testimony, there was no causal connection between his prescribing conduct and the injury at issue.

Second, the court declined to extend the manufacturer’s duty to warn beyond prescribing physicians to include treating physicians. Although the Washington Supreme Court had not directly addressed this issue, the Ninth Circuit opined that it would not expand the learned intermediary doctrine in that manner. The court found persuasive an unpublished Washington Court of Appeals decision declining to impose a duty to warn treating physicians, emphasizing the Washington Supreme Court’s focus on the “unique” role of prescribing physicians. On that basis, the court concluded that Dr. Horst’s testimony could not establish proximate cause for prescriptions written by Dr. Bardin.

Sham Affidavit Rule. The Ninth Circuit found that, even if the district court may have erred in applying the sham affidavit rule to deny the Plaintiffs’ motion for reconsideration, any such error was harmless. Even crediting Dearinger’s later sworn statement asserting that Dr. Horst was the “actual prescriber” of the Cialis at issue, the Plaintiffs still failed to establish proximate causation for the reasons already identified. The court emphasized that summary judgment remained warranted on the merits regardless of how the affidavit was treated.

Omission of Obvious Defendants. Finally, the court rejected the argument that the district court erred by failing to advise the pro se Plaintiffs to amend their complaint to add claims against the physicians. The Ninth Circuit reasoned that the physicians were not “obvious” omitted defendants because the complaint did not allege wrongdoing by them, even when construed liberally. Absent allegations suggesting liability, the district court had no obligation to prompt amendment.

The case is No. 24-682.

Judge: Per Curiam.

Attorneys: Brian Christopher Nadler (Fennemore Craig, PC) for David Jay Dearinger. Cole Carter (Kirkland & Ellis, LLP) for Eli Lilly and Co.

Companies: Eli Lilly and Co.

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