Medication and medical device makers will have a more difficult time defending against lawsuits brought by people claiming they were harmed by medical treatments, allegedly because the companies failed to warn strenuously enough about risks that could be posed by using their products.
On June 20, the California Supreme Court weighed in on a closely-watched fight over the scope of the so-called "learned intermediary doctrine" and its impact on lawsuits filed against drug and medical device makers under California law.
In a ruling welcomed by plaintiffs' lawyers, the state high court ruled unanimously that manufacturers cannot escape so-called failure to warn personal injury lawsuits by showing the companies communicated a warning about the risks of using their products to doctors, and patients followed their doctors' recommendation to move ahead with the treatment.
Bijan Esfandiari
| Wisner Baum
Rather, the court said the lawsuit can continue against the manufacturers if plaintiffs show "an objectively prudent person" would have declined treatment if doctors had communicated a stronger warning, even if their doctors ultimately recommended going ahead with the treatment.
The decision arose from a case in which a woman, identified as Michelle Himes, sued Somatics LLC, a company that makes devices used in so-called electroshock therapy, known formally as electroconvulsive therapy (ECT).
According to court documents, Himes' physicians recommended she undergo treatment with Somatics' ECT devices to treat severe depression. According to court documents, doctors had previously attempted to treat the disorder with "at least nine different antipsychotics and antidepressants" medications. She was also reportedly hospitalized on several occasions.
According to court documents, Himes underwent 26 different ECT treatments, which allegedly resulted in "permanent brain damage," as well as amnesia and dementia.
Himes filed suit in 2017, in part, accusing Somatics of failing to warn of the severe side effects from the ECT devices. While she acknowledged Somatics had warned that using its products could result in short-term memory loss, Himes claimed the warning fell short of full disclosure of serious risks.
She asserted that alleged failure to warn caused her more significant injuries after using the ECT devices.
In federal court, Somatics initially won the case, as a judge determined Somatics should prevail under the "learned intermediary doctrine," a legal principle that generally absolves drug and medical device makers of a responsibility to warn patients directly of the risks from using their products. Rather, the doctrine makes it sufficient under the law for such manufacturers to warn doctors and other medical professionals of the risks, who then can use those warnings to determine if the potential benefits to patients may outweigh the risks of administering medical treatments.
Patients can then rely on the recommendations of their doctors - the "learned intermediaries" - when deciding whether or not to undergo the procedures. This generally shields medical device and medication makers from many kinds of failure to warn lawsuits, if they can show that "stronger warnings would not have altered the physician's decision" to recommend moving ahead with the treatment.
That legal standard is used in many jurisdictions throughout the U.S., and the doctrine can be deployed in California courts, as well.
According to court documents, Himes' doctor testified that "'he still would have recommended ECT even if he had been informed of' the risk of permanent brain damage and memory loss."
Himes and her lawyers appealed that decision to the U.S. Ninth Circuit Court of Appeals, where judges agreed that no additional warning from Somatics would have persuaded Himes' doctor to change his recommendation against moving ahead with ECT, after all other treatments had failed.
However, the Ninth Circuit said it could not answer under California law if Himes should be allowed to proceed under the "objectively prudent person" standard instead. That court then referred the matter to the California Supreme Court, which is considered to be the final arbiter on such questions of California state law.
And the state high court said the plaintiffs should be allowed to press their failure to warn claims, despite the recommendations of Himes' doctor concerning her treatment.
The court did not determine that Somatics should be held liable for allegedly failing to warn. But it likely gave new life to her legal claims, and those of many other potential defendants seeking to sue medical manufacturers for injuries allegedly caused by their products, even when treatments using those products have been prescribed by their doctors.
The decision was authored by Justice Joshua Groban. The court's six other justices concurred in the decision, with no dissents.
The companies cannot necessarily use the learned intermediary doctrine to escape failure to warn suits, in part, because courts should not "allow health care professionals to substitute their judgment for that of their patients," the California Supreme Court said, citing a 2014 decision from their counterparts on the Iowa State Supreme Court.
"... Under the learned intermediary doctrine, the physician’s judgment and advice remains central to the causation analysis, but the ultimate decision of whether to go forward with the treatment resides with the patient," Groban said.
So, while the doctor may not change their recommendation based on a stronger warning, the patient still might, if a stronger warning were communicated, the justices found.
“A plaintiff is not required to show that a stronger warning would have altered the physician’s decision to prescribe the product to establish causation," Groban wrote.
"A plaintiff may instead establish causation by showing 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 notwithstanding the physician’s continued recommendation of the treatment.”
The ruling was hailed by the plaintiffs' lawyers, from the firm of Wisner Baum, of Los Angeles.
“As a result of the California Supreme Court’s Himes decision, moving forward, pharmaceutical and device manufacturers who fail to warn of risks associated with their products can no longer avoid liability by misusing the learned intermediary doctrine," said attorney Bijan Esfandiari, senior partner at Wisner Baum. He argued the case before the Supreme Court.
"Today’s decision ...is not only a victory for consumers injured by defective pharmaceuticals and medical devices but is a victory for anyone who champions patient autonomy.”
Somatics was represented by attorney Jonathan M. Freiman and others with the firms of Wiggin and Dana, of New Haven, Connecticut, and Poole Shaffery & Koegle, of Valencia.
Somatics' attorneys did not immediately reply to a request for comment on the ruling.