Drug and medical device makers generally need to warn only physicians, not patients, of certain risks of the products, but the Supreme Court today holds in Himes v. Somatics, LLC that injured patients are not out of equation when it comes to determining whether an inadequate warning caused damage. The plaintiff need not establish that a proper warning would have changed the physician’s prescription advice, the court says, but only 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.”
Answering a question posed by the Ninth Circuit, the court’s unanimous opinion by Justice Joshua Groban states, “We cannot wholly discount the essential role of patient choice in medical treatment decisions.” But it does add a defense-friendly caveat: “where the evidence shows that the physician would have continued to recommend the treatment notwithstanding the stronger warning, 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.” And the court reaffirms the “learned intermediary doctrine” that “the ‘absence of an adequate warning about a prescription drug [or medical device] to a physician’ does not ‘result in a duty to provide a warning to the patient.’ ”
The Ninth Circuit wanted California law clarified for an appeal in a case with a claim that, as the federal panel summarized, a manufacturer’s “misbranding and failure to warn about certain risks of its electroconvulsive therapy (‘ECT’) device caused” injuries. The district court had granted a defense summary judgment after finding a lack of evidence that a stronger warning would have affected the prescription decision of the plaintiffs’ physicians.
[August 14 update: The Ninth Circuit yesterday filed a three-page memorandum that concludes, “In light of th[e] [Supreme Court’s] response, we vacate the district court’s summary judgment for Somatics as to Himes’ claims, and remand for the district court to reassess whether summary judgment is warranted as to those claims under the causation analysis formulated by the Supreme Court of California.”]