CHAPTER § 9.03 The Learned-Intermediary Doctrine
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§ 9.03 The Learned-Intermediary Doctrine
[1] Overview
[a] The Doctrine Defined
Under the most common formulation of the learned-intermediary doctrine, a pharmaceutical manufacturer satisfies its duty to warn of the risks associated with use of its medication if it adequately warns the prescribing physician of these risks.111 This doctrine shifts the traditional product-liability rule requiring a manufacturer to warn the consumer of the risks associated with a product's use. A health care professional is in the best position to assess the risks and benefits associated with the use of a particular drug by a particular patient.112 Therefore, the manufacturer's duty runs only to the prescribing physician or other health care provider.113 Consequently, an adequate warning to a physician will bar potential liability against a manufacturer premised on a failure to warn.114 Under the learned-lntermediary doctrine, in order to establish liability for an inadequate warning, the plaintiff must prove: "(1) that the product warnings given by the drug manufacturer to health care providers are inadequate; and (2) that the inadequate warnings were a producing cause of and/or proximately caused [p]laintiffs' subsequent injuries."115
Practitioners should bear in mind that, although the learned-intermediary doctrine is often invoked by defendants as a liability shield, it is not a common-law affirmative defense. As the Texas Supreme Court explained, the doctrine merely "shifts the manufacturer's duty to warn the end user to the intermediary[;] it does not shift the plaintiff's basic burden of proof."116 As a result, in any case in which the defendant invokes the learned-intermediary doctrine, it remains the plaintiff's burden to prove that the warning given by the manufacturer to the doctor/intermediary was inadequate.117
[b] Widespread Acceptance of the Doctrine
Some form of the learned-intermediary doctrine has been recognized by or applied under the law of every state, as well as Puerto Rico and the District of Columbia,118 although several courts have recognized and applied various exceptions to the doctrine,119discussed below.120
The most prominent attack to the learned-intemediary doctrine came from the West Virginia Supreme Court of Appeals. In 2007, that court held that, in light of changes in drug advertising, pharmaceutical manufacturers should have a duty to warn the ultimate consumer, and not just the consumer's doctor.121 The West Virginia Legislature abrogated this decision in 2016 by expressly adopting the Learned-Intermediary Doctrine by statute.122 In codifing the learned-lnteredmiary doctrine, the West Virginia legislature did not provide any of the exceptions listed below.123 Therefore, West Virginia affords more expansive use of the doctrine compared to other states.
Since West Virginia's 2007 decision, a federal district court sitting in diversity in New Mexico declined to follow the learned-intemdiary doctrine.124 That court predicted that New Mexico law would not recognize the doctrine.125 Despite this decision, New Mexico state courts and federal courts applying New Mexico law continue to apply the doctrine.126
Considering the great weight of authority applying the learned-intermediary doctrine, courts are unlikely to completely abrogate the doctrine. Instead, opponents focus on challenging the doctrine's scope and expanding exceptions to the doctrine, as detailed below.
[2] Scope of the Learned-Intermediary Doctrine
Traditionally, the learned-intermediary doctrine has applied to failure-to-warn claims.127 Some courts have applied the doctrine only to such claims brought under a negligence theory,128 whereas most other courts recognize that the doctrine applies to all failure-to-warn claims brought under any theory of products liability.129 Moreover, later decisions have expanded the scope of the doctrine beyond traditional principles of strict liability or negligence to encompass claims based on a breach of the implied warranty of merchantability or fraud or both.130
For example, the Fourth Circuit, applying Virginia law, concluded that the learned-intermediary doctrine applied broadly to claims for breach of implied warranty and fraud arising out of injuries resulting from the use of a particular medical device.131 The court reaffirmed its understanding of the learned-intermediary doctrine to apply broadly to claims sounding in a failure to warn132 so long as the "intermediary" was independent of the manufacturer and thus in a position to exercise his or her own judgment when deciding the best course of medical treatment.133
Although the Eleventh Circuit concluded that it need not decide whether Alabama law would apply the learned-intermediary doctrine to fraud claims, it nevertheless recognized that in order to survive summary judgment, the plaintiff who attempts to bring a fraud claim based on a failure to warn of purported risks must establish with particularity any purported fraudulent statements, as well as specific statements on which the plaintiff purportedly relied.134 Thus, the court fended off a back-door attempt to circumvent the learned-intermediary doctrine.
In addition to broadening the scope of claims covered by the learned-intermediary doctrine, courts have also broadened the class of individuals who may qualify as learned intermediaries. Specifically, some courts have recognized that the principles of the doctrine may apply to protect pharmacists and pharmacies from liability, to the extent the failure-to-warn claim relates to prescription pharmaceuticals.135 Courts have also recognized that the doctrine may apply to any health care professional who is legally authorized to prescribe drugs, i.e., advanced-practice nurses who have been trained and have the authority to prescribe drugs.136
[3] Exceptions to the Learned-Intermediary Doctrine
Although the learned-intermediary doctrine applies or has been recognized in nearly all states, there are several recognized exceptions. The doctrine has historical common-law roots,137 and courts have shown a willingness to adopt limited exceptions to the rule to grapple with the substantial changes in the health care industry since its adoption.138 Specifically, "[c]ourts have carved out exceptions to the learned intermediary rule 'where there is a lack of communication between patients and their physicians or where patients essentially control the selection of the product.'"139
The Restatement (Third) of Torts describes a limited, blanket exception to the learned-intermediary doctrine: when a "manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings[,]" the manufacturer's duty to warn runs to the patient-consumer.140 This exception recognizes that abrogation of the traditional learned intermediary is "warranted for drugs that are dispensed or administered to patients without the personal intervention or evaluation of a health-care provider."141
The Supreme Court of Connecticut has grouped the recognized exceptions to the learned-intermediary doctrine as applying to six categories of pharmaceuticals or medical devices: "(1) vaccine inoculations; (2) oral contraceptives; (3) contraceptive devices; (4) drugs advertised directly to consumers; (5) overpromoted drugs; and (6) drugs withdrawn from the market."142
[a] Vaccine Inoculations
The first of these categories of exceptions, vaccine inoculations, is the most widely recognized and perhaps the least controversial.143 This is the exception expressly recognized in the comments to the Restatement (Third) of Torts: Products Liability.144
[b] Oral Contraceptives and Contraceptive Devices
Less recognized but nevertheless frequently litigated is an exception for oral contraceptives and contraceptive devices.145 There are several distinctions between contraceptives and other prescription products which courts have used to impose a duty on the manufacturer to warn the patient directly.146 First, patients exercise "heightened participation [ ] in decisions" to use contraceptives.147 Second, manufacturers can feasibly issue direct warnings to patients.148 Third, the existence of FDA regulations governing certain warnings to consumers of oral contraceptives supports warning consumers of all risks.149 Lastly, physicians participate very little in the process to prescribe these maintenance pharmaceuticals.150 Massachusetts was the first state to apply an exception for oral contraceptives, and several federal district courts have followed its lead.151 However, other courts have expressly rejected this exception,152 or have noted that it should only apply to oral contraceptives and not contraceptive devices.153
[c] Overpromoted Drugs
The exception for "overpromoted drugs" derives from an Illinois appellate court that found a manufacturer liable for failing to warn about the known risks of an off-label use of a pharmaceutical.154 The court found compelling evidence supporting the conclusion that the manufacturer had itself "promoted, encouraged and advertised the off-label use of [the pharmaceutical] by providing financial and technical assistance to a limited number of members of the medical community without attempting to communicate to these physicians and the medical community at large the dangers and risks attendant to this use."155 Although this decision has been characterized as an "exception" to the doctrine, it could also be understood as a case in which the manufacturer failed, in the first instance, to satisfy its burden under the learned-intermediary doctrine to warn physicians of non-obvious known risks. The doctrine is, of course, not an absolute bar to liability: a manufacturer must still warn the health care professional of the risks about which it knows or should reasonably know.156
[d] Direct-to-Consumer Marketing
Perhaps the most controversial of these exceptions is the apparently broad...
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