It has been 23 years since New Jersey adopted a direct-to-consumer advertising exception to the learned intermediary rule. And, as of last week it remains the only state to have done so. Every state has adopted some version of the learned intermediary rule. So, it is saying something that in almost a quarter of a century, no other state has found that DTC marketing by pharmaceutical companies negates the rule. The Washington Supreme Court’s unanimous decision in Dearinger v. Eli Lilly and Company, — P.3d –, 2022 WL 1788992 (Wash. Jun. 2, 2022), tells us why.
Plaintiff suffered a stroke after taking the prescription drug Cialis. Id. at *1. He sued the manufacturer in federal court and the manufacturer moved to dismiss on the ground that it provided adequate warnings to plaintiff’s physician. Id. Because plaintiff argued in response that there is an exception to the learned intermediary rule for drug manufacturers who advertise their products directly to consumers, the federal court certified that question to the Washington Supreme Court.
Washington adopted the learned intermediary rule as part of its common law in 1978 and has not recognized an exception ever since. Id. at *2. Three years later, Washington adopted the Washington Product Liability Act (WPLA). So, the first question the court was asked to consider was whether the WPLA impliedly repealed the learned intermediary rule. It would have to be implied because the learned intermediary rule is not addressed one way or the other in the WPLA. However, “[t]o abrogate the common law, there must be clear evidence of the legislature’s intent to deviate from the common law.” Id. at *3. In fact, the WPLA itself provides that “[t]he previous existing applicable law of this state on product liability is modified only to the extent set forth in this chapter.” Id. (citing RCW 7.72.020(1)). The learned intermediary rule is “existing applicable law.”
Amicus supporting plaintiff cited four provisions of the WPLA they allege modified the learned intermediary rule. For all four, amicus focused on the fact that the WPLA required warnings but overlooked that the WPLA does not address to whom the warnings had to be given. The first provision makes “harm caused by warnings or marketing” a products liability claim. But nowhere does it say the warnings have to be directed to a consumer. Id. The second provision says a product is not reasonably safe if adequate warnings could have been provided but were not. Again, nothing about the warnings needing to go to the consumer. Third, the WPLA provides that in deciding whether a product is not reasonably safe, the fact finder can apply the consumer expectations test. The plaintiff’s argument therefore was that consumer expectations opened the door to a DTC exception because DTC advertising influences consumer expectations. Id. The court rejected this argument on two grounds – (1) plaintiff can also prove his case using a risk-utility test and (2) the WPLA is again silent on who the manufacturer must warn. The court could only infer the provision required a direct consumer warning and that is not “clear evidence” of legislative intent. Id. The last provision cited by plaintiff’s side was one that allows the fact finder to consider evidence of compliance with regulations. Plaintiff argued this conflicted with the learned intermediary rule because the FDA requires warnings to consumers when manufacturers market drugs to consumers. The FDA also requires warnings to physicians. So, this provision is not contrary to the learned intermediary rule. Rather, the fact finder can consider FDA regulations in deciding whether the manufacturer’s warnings to the physician were adequate.
After finding the learned intermediary rule was not in conflict with the WPLA, the court considered plaintiff’s policy arguments for creating a DTC exception. For that, the court started with the primary policy underlying the rule – “that a physician is in the best place to understand both the drug and the patient’s medical history.” Id. at *4. A physician has a legal obligation to exercise his independent medical judgment in prescribing a medication and a patient must rely on that judgment to obtain a prescription medication. It is a special relationship grounded in the physician’s expertise. The court rejected plaintiff’s argument that changes in the doctor/patient relationship and increased DTC advertising have eroded the policy justification for the learned intermediary rule.
Plaintiff had no evidence to support a claim that physicians do not exercise independent judgment in prescribing medications. His only argument was that DTC advertising makes patients more active participants in their own healthcare. But that does not mean that a doctor “abdicates [his] duty to exercise independent judgment.” Id. at *5. In fact, he is legally not allowed to. Doctors are charged with discussing the risks and benefits of treatment and obtaining informed consent from their patients. If a doctor neglects this duty, there is no need to modify the learned intermediary rule. The proper cause of action in that case is not against the drug manufacturer but against the doctor for malpractice. Id. at *6.
Nor did plaintiff present any evidence to support that patients do not rely on physicians’ judgement to obtain prescription drugs. Even if plaintiff relied on DTC advertising, the physician is still the primary reliance source because the physician is the gatekeeper. A patient cannot get access to prescription drugs, legally, without a doctor. Id.
Finally, plaintiff failed to refute that doctors are in a superior position to communicate warnings to their patients. Prescription drugs and their warnings and complex. Doctors have specialized training to understand the warning complexities. Perhaps more importantly, doctors can personally tailor warnings to their patients in a way the manufacturer cannot. DTC advertising is one-size fits all. The manufacturer does not know any individual’s medical history and therefore cannot adequately warn any specific individual the way a doctor can.
Therefore, the presence of DTC advertising does not undo any of the policy reasons underlying the learned intermediary rule. All DTC advertising for prescription drugs can do is let an individual know a drug exists and what it treats. Whether that individual ultimately takes the drug is entirely dependent on whether his physician, exercising his independent medical judgment, recommends the drug and whether the patient, relying on his physician, chooses to take it. As long as the manufacturer provides warnings to the learned intermediary to allow that decision-making process to occur based on adequate information, the manufacturer has discharged his duty. DTC does not change the equation.