Product Liability Update

The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices.  A learned intermediary is a medical expert, such as a prescribing physician, who can weigh the risks and benefits of a medication and make informed prescription decisions based on knowledge of a particular patient.  The rationale for this defense is that prescribing physicians have the education, training, and experience to weigh the risks and benefits of a medication for a patient and make informed prescription decisions. Based upon the learned intermediary’s position between the manufacturer and the consumer, coupled with his or her medical expertise in being able to gauge the product’s appropriateness for a particular patient, many courts have held that a manufacturer cannot be held liable if a prescribing physician was independently aware of the link between the product and the alleged defect.

The Nevada Supreme Court first implicitly recognized the learned intermediary doctrine as a viable defense in 1994 in Allison v. Merck.  Although the Allison Court did not explicitly adopt the learned intermediary doctrine, it acknowledged the existence of the defense while rejecting its application in the mass immunization context.  Outside the mass immunization context, the Nevada Supreme Court has never rejected the learned intermediary doctrine.  Instead, more recently, in Klasch v. Walgreen Company the Nevada Supreme Court expressly adopted the learned intermediary doctrine in the pharmacist/customer context after finding the underlying public policy concerns were “sound.”  When analyzing the issue, the Nevada Supreme Court made clear that the physician is responsible for knowing the patient’s specific situation and conveying relevant information:

Traditionally, the learned-intermediary doctrine has been used to insulate drug manufacturers from liability in products-liability lawsuits. Under the learned-intermediary doctrine, a drug manufacturer is immune from liability to a patient taking the manufacturer’s drug so long as the manufacturer has provided the patient’s doctor with all relevant safety information for that drug. It is then up to the patient’s doctor–who has the benefit of knowing the patient’s specific situation–to convey to the patient any information that the doctor deems relevant.

The Nevada Supreme Court reaffirmed this position in Kerns v. Hope when it stated that “[i]t is up to the doctor who has knowledge of the patient’s particular situation to convey any relevant safety information to that patient.” While such pronouncements indicate that the Nevada Supreme Court agrees with the underlying rationale of the learned intermediary doctrine, some Nevada state courts nevertheless still refuse to extend Klasch beyond the pharmacist/customer context.

Nevada federal courts decisions, by contrast, have recently applied the learned intermediary defense in numerous product liability cases.  For example, summary judgment was granted in Moses v. Danek Medical, Inc. after the court found the learned intermediary doctrine applied because of the doctor’s independent knowledge of the risks and the FDA status of the medical device at issue. Another federal court held in Kwasniewski v. Sanofi-Aventis U.S., LLC that “the duty to warn about potential side effects of a drug rests solely with the prescribing physician” and this rule “seeks to prevent less-informed intermediaries from second-guessing the decision of a treating physician who has superior, more comprehensive knowledge as to the patient’s specific medical situation and the risk-benefit balance of prescribing a particular drug.”

Based upon these cases, pharmaceutical companies and medical device manufacturers can assert the learned intermediary doctrine as a valid defense in Nevada.