A recent decision by the California Supreme Court underscores why courts should be hesitant to grant class certification in cases in which the learned intermediary doctrine applies.  

In Himes v. Somatics, LLC, 2024 WL 3059637 (Cal. June 20, 2024), the Court considered the appropriate causation standard to be applied to failure-to-warn claims involving prescription drugs or medical devices.  In such cases, the learned intermediary doctrine instructs that manufacturers owe a duty to warn physicians, but not the physicians’ patients, about certain risks accompanying the use of their prescription drugs and many medical devices.  For purposes of establishing causation in these cases, the Court held that a plaintiff need not show that a stronger risk warning provided to the physician would have altered the physician’s decision to prescribe the product in the first place.  Instead, under California law, a plaintiff may establish causation by showing that the physician would have communicated the stronger risk warning to the patient, and that an objectively prudent person in the patient’s position would have declined the treatment after receiving that stronger risk warning (notwithstanding that the patient’s physician still would have recommended the treatment).

Though Himes was not a class action, the Court’s discussion of the causation standard highlights several individualized questions of causation that may defeat certification in class actions in which the learned intermediary doctrine applies.  As the Court explained, whether causation exists may depend on factors like the following, which may differ on an individual-by-individual or case-by-case basis:

  1. what the physician would have communicated to the patient regarding the treatment and the allegedly undisclosed risks;
  2. whether the physician, after weighing and assessing the risks and benefits, would have still recommended the treatment even if the manufacturer had provided an adequate warning of the alleged risks; and
  3. whether a patient would have declined the treatment despite the physician’s assessment.  On this question, the Court observed that the answer might in turn depend on factors such as:
    1. whether the treatment was novel or was instead an established method for addressing the patient’s condition;
    2. the availability and utility of alternative treatments and the degree to which they have previously been tried in an effort to address the patient’s condition;
    3. the severity of the patient’s condition;
    4. the likelihood that the treatment would have resulted in more than marginal benefits to the patient; and
    5. other personal characteristics of the patient or circumstances unique to the patient.

Class certification discovery and arguments designed around these inherently patient- and physician- specific issues could prove valuable for defending against class certification.

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Photo of Alyssa McGraw Alyssa McGraw

Alyssa Vallar is an associate in the firm’s Washington, DC office and a member of the Litigation and Investigations Practice Group. Prior to joining the firm, Alyssa clerked for the Hon. Gerald Bard Tjoflat on the U.S. Court of Appeals for the Eleventh…

Alyssa Vallar is an associate in the firm’s Washington, DC office and a member of the Litigation and Investigations Practice Group. Prior to joining the firm, Alyssa clerked for the Hon. Gerald Bard Tjoflat on the U.S. Court of Appeals for the Eleventh Circuit.

Photo of Andrew Soukup Andrew Soukup

Andrew Soukup has a wide-ranging complex litigation practice representing highly regulated businesses in class actions and other high-stakes disputes. He has built a successful record of defending clients from consumer protection claims asserted in class-action lawsuits and other multistate proceedings, many of which…

Andrew Soukup has a wide-ranging complex litigation practice representing highly regulated businesses in class actions and other high-stakes disputes. He has built a successful record of defending clients from consumer protection claims asserted in class-action lawsuits and other multistate proceedings, many of which were defeated through dispositive pre-trial motions.
Andrew is co-chair of the firm’s Class Action Litigation practice group.

Andrew has helped his clients achieve successful outcomes at all stages of litigation, including through trial and appeal. He has helped his clients prevail in litigation against putative class representatives, government agencies, and commercial entities. Representative victories include:

  • Delivered wins in multiple nationwide class actions on behalf of large financial companies related to fees, disclosures, and other banking practices, including the successful defense of numerous lenders accused of violating the Paycheck Protection Program’s implementing laws, which contributed to Covington’s recent recognition as a “Class Action Group Of The Year.”
  • Successfully defending several of the nation’s leading financial institutions in a wide variety of litigation and arbitration proceedings involving alleged violations of RICO, FCRA, TILA, TCPA, FCBA, ECOA, EFTA, FACTA, and state consumer protection and unfair and deceptive acts or practices statutes, as well as claims involving breach of contract, fraud, unjust enrichment, and other torts.
  • Successfully defended several of the nation’s leading companies and brands from claims that they deceptively marketed their products, including claims brought under state consumer protection and unfair deceptive acts or practices statutes.
  • Obtained favorable outcomes for numerous clients in commercial disputes raising contract, fraud, and other business tort claims.

Because many of Andrew’s clients are subject to extensive federal regulation and oversight, Andrew has significant experience successfully invoking federal preemption to defeat litigation.

Andrew also advises clients on their arbitration agreements. He has successfully helped numerous clients avoid multi-district class-action litigation by successfully enforcing the institutions’ arbitration agreements.

Clients praise Andrew for his personal attention to their matters, his responsiveness, and his creative strategies. Based on his “big wins in his class action practice,” Law360 named Mr. Soukup a “Class Action Rising Star.

Prior to practicing law, Andrew worked as a journalist.