A pharmacist called her to inquire, but allegedly provided her no further warning about potential health risks. Klasch withdrew her statement regarding the allergy, stating that she had taken the same medication before without incident. The pharmacist filled the prescription.
A few days later, Klasch developed an upset stomach and then skin rashes and burns. Her symptoms worsened, and she went into a coma before passing away.
Klasch’s estate sued Walgreen and her physician for wrongful death. The lower court granted Walgreen’s motion for summary judgment based on the learned intermediary defense, and plaintiff appealed to the Nevada Supreme Court. (Nevada has no intermediate court of appeal.) The physician settled with the estate before the appeal.
Background of the Learned Intermediary Doctrine
The learned intermediary defense originated in negligence cases brought against drug manufacturers. Under this doctrine, the manufacturer is not liable for breach of a “duty to warn” consumers of drug risks, if it provides sufficient information on those risks to the treating physician. This is because the physician becomes the “intermediary” between the drug manufacturer and the consumer, absolving it of direct responsibility to warn the consumer/patient. The rationale is that the physician is in a much better position to convey drug risk information to patients.
Most states have adopted some form of learned intermediary rule, and it remains the majority rule. About half have extended the learned intermediary doctrine to pharmacists as well, despite the fact that pharmacists are technically “intermediaries” between physicians and patients.
Adopts a Limited Form of the Rule
In Klasch, the trial court found the learned intermediary defense precluded a suit against Walgreen. It then dismissed the claims against the pharmacy in their entirety. On appeal, in a case of first impression in Nevada, its Supreme Court agreed with the lower court’s theoryof the learned intermediary defense.
The court held the doctrine is available to defend against duty of care claims in Nevada, including relative to pharmacies. It agreed that the theory that the physician, and not the pharmacist, is in the best position to understand the patient’s condition and prescribe the right medication makes sense. The court said the pharmacist should not be in the position of having to second-guess the physician’s prescription.
Even so, the Nevada court reversed the lower court’s summary judgment decision, holding the particular facts of the case did not seem to fit the defense. It said in the Klasch case, the pharmacist had knowledge about “a customer specific risk,” the sulfa allergy, which meant the learned intermediary defense did not “foreclose [the] pharmacist's potential for liability.”
The court articulated the duties that arise when a pharmacist possesses knowledge of patient specific risks: “[T]he pharmacist has a duty to warn the customer or to notify the prescribing doctor of the customer-specific risk.” Since it appeared Walgreen took neither of those steps, the court reversed summary judgment and remanded the case to the district court for further proceedings consistent with its opinion.
Does the Court’s Holding Undermine the Learned Intermediary Defense?
The Klasch decision has left some wondering if the NevadaSupreme Court’s adoption of the learned intermediary defense has any teeth. The concern is the ultimate holding undermines the real-world applicability of the defense.
“Here, Walgreen at least tried,” notes Beatrice O’Donnell, Philadelphia, cochair of the ABA Section of Litigation’s Mass Torts Litigation Committee. “The pharmacy didn’t just bury its head in the sand; it called the patient and discussed the allergy. It’s a lot more than pharmacies do in some circumstances,” she adds.
Although she can understand the Klasch court’s logic, the result is “frustrating” for Walgreen and other pharmacies who are trying to figure out what factual scenario might warrant the learned intermediary defense. O’Donnell suggests shifting accountability for patient care from physician to pharmacist simply due to a piece of information the pharmacy has is the first footfall on a slippery slope.
Pharmacies today are more sophisticated in terms of the patient knowledge they have available through electronic recordkeeping, points out O’Donnell. That knowledge should not make pharmacies responsible for patient care.
“I don’t want to give Walgreen the responsibility for my healthcare—that should remain on the shoulders of the physician,” she opines. That is why she believes the learned intermediary defense is vital in pharmaceutical duty of care cases. “The logic behind the learned intermediary defense is that the physician is in a better position and more qualified than a pharmacist to understand the big picture of the patient’s medical care,” she says.
She notes that just as electronic drug information is becoming available to the pharmacies, more detailed electronic medical information is available to physicians as well. As such, the physicians remain in the best position to monitor their patients’ health.
Learned Intermediary Doctrine Alive and Well
“The Klasch decision emphasizes that the learned intermediary defense still has its place in negligence cases where the pharmacist had no knowledge suggesting that it would be prudent to question a physicians’ direction,” says Julie Lefkowitz, Hackensack, NJ, chair of the Institutional Providers Subcommittee of the Section of Litigation’s Health Law Litigation Committee. Lefkowitz believes the Klasch decision is more about interpreting difficult facts than undermining the learned intermediary defense.
While Lefkowitz notes the resulting liability to pharmacies may seem a harsh, it is important to realize that this decision does not impose a duty on pharmacies to get an in depth “medical history” from each patient. Rather, it just shows pharmacies cannot ignore their preexisting knowledge of a patient’s specific risk.
Klasch “does not impose a duty to pharmacies to warn of the general manufacturer drug warnings that are not patient specific; that is still the physician’s duty," Lefkowitz adds. “Where the pharmacist has knowledge to suggest it would be prudent to question the physician’s direction,” she concludes, “then he or she probably needs to take that step and ask some additional questions, typically of the [prescribing] doctor.”
Teresa Rider Bult is an associate editor for Litigation News.