Medical Device Makers Must Review Approach After California Case

A recent ruling from the California Supreme Court has significant implications for pharmaceutical and medical device manufacturers defending against failure-to-warn claims in California.

The decision answered a question posed by the US Court of Appeals for the Ninth Circuit: What evidence is necessary to demonstrate that an alleged failure to warn caused a plaintiff’s injury in a prescription pharmaceutical or medical device products liability case?

Specifically, the Ninth Circuit asked, must a plaintiff show that a stronger warning would have altered the physician’s prescribing decision, or that a physician would have communicated the stronger warning to the patient and that a reasonable patient in plaintiffs’ position would have declined treatment? On June 20, the state’s highest court declared the latter to be the case under the facts in Himes v. Somatics.

The court’s adoption of the objective “reasonably prudent person” standard from medical malpractice informed consent jurisprudence could prompt novel arguments on warnings causation. Manufacturers need to know that law and understand how the reasonable person standard will operate under the facts of their case.

Although the standard is an objective one, as the court discussed in its opinion, the “reasonable person” standard may account for certain personal characteristics or other unique circumstances of an individual plaintiff.

In deciding whether a “reasonably prudent person” would have rejected treatment if their physician provided new or different information during the informed consent process, a jury might be permitted to consider, for example, relevant aspects of a patients’ prior medical history, physical or emotional characteristics, or pattern or practice of being conservative or taking risks.

Other relevant factors could include whether the treatment was novel or an established therapy, the availability and utility of alternative treatments, the severity of the patient’s condition, and the likelihood that the treatment would benefit the patient.

These individual characteristics traditionally haven’t been a focus of pharmaceutical and medical device failure-to-warn cases. Manufacturers need to rethink their traditional approaches and ensure these issues are explored in detail in discovery, discussed with experts, and accounted for at trial.

The ruling was also an important reaffirmation of the learned intermediary doctrine amid an evolving doctor-patient relationship. Rapid advances in technology have democratized medical information, shifting the balance of power toward patients and altering the historically paternalistic relationship. This shift has caused some to question the viability of legal doctrines developed with that traditional notion in mind.

The California Supreme Court embraced the shift toward greater patient autonomy, recognizing “the essential role of patient choice in medical treatment decisions” and that “it is ‘reserved to the patient alone’ to weigh the disclosed risks against the patient’s own ‘fears and hopes’ in deciding whether to undergo the recommended treatment.”

However, far from gutting the learned intermediary doctrine, the court set a high bar for plaintiffs to meet to successfully prove a failure to warn claim involving a prescription pharmaceutical or medical device.

It affirmed that the learned intermediary doctrine—that a pharmaceutical or medical device manufacturer’s duty to warn runs to physicians, not patients directly—isn’t an affirmative defense or an exception to a manufacturer’s usual duty to warn, a mistake commonly made by courts and litigators. Instead, the doctrine defines the element of duty—part of the plaintiff’s burden of proof.

The court rejected the plaintiff’s attempt to set a subjective standard for causation, ruling that causation can’t be established through patients’ own self-serving, hindsight testimony that they would have declined treatment had they been given stronger warnings.

The court reaffirmed the essential role of the physician’s testimony, ruling that the causation analysis must begin with what, if anything, the physician would have communicated about the risks of the product. Proof of whether and how any new risk information would have affected the physicians informed consent process and prescribing decision will still be central to each case.

Even if a prescribing physician testifies that they would have passed on new risk information, a plaintiff must still prove that an “objectively prudent person” would have rejected their doctor’s advice and refused treatment.

These rulings assure that the learned intermediary doctrine will remain a robust and lasting counter to product liability failure-to-warn claims in California.

The case is Himes v. Somatics, LLC, 2024 BL 210497, Cal., S273887, 6/20/24.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Mark Sentenac is partner, Anneke Shepard is counsel, and Sneha Banerjee is an associate in King & Spalding’s product liability and mass torts practice group.

Sabrina Murugesu, a summer associate at the firm, contributed to this article.

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