The road less traveled: West Virginia's rejection of the learned intermediary doctrine in the age of direct-to-consumer advertising.

• Author: Fogt, Kyle T.

1. INTRODUCTION II. BACKGROUND A. The Long and Storied History of the Development of the Learned Intermediary Doctrine and Its Exceptions 1. Origins of the Learned Intermediary Doctrine 2. The Current State of the Learned Intermediary Doctrine 3. Adapting to New Products and Problems: The Creation of Exceptions to the Learned Intermediary Rule B. Choosing the Road Less Traveled: Perez and Karl 1. The Perez Court's Adoption of a Direct-to-Consumer Advertising Exception 2. The Scholarly Response to Perez and the Direct-to-Consumer Advertising Exception 3. The Judicial Response to Perez and the Direct-to-Consumer Advertising Exception in New Jersey 4. Impact of Perez and the Direct-to-Consumer Advertising Exception Outside: of New Jersey 5. The Effect of Perez on the Viability of the Learned Intermediary Doctrine 6. The Karl Court's Rejection of the Learned Intermediary Doctrine III. ANALYSIS A. Analyzing Karl Through a Post-Perez Lens B. Potential Implications of Karl 1. The Assault on the Learned Intermediary Doctrine 2. Another Court Weighs in on the Learned Intermediary Doctrine 3. Will the Learned Intermediary Doctrine Survive This Assault? C. West Virginia Has Taken Us All for a Ride IV. RECOMMENDATION V. CONCLUSION I. INTRODUCTION

   Robert Frost gave us that indelible ideal of two roads diverging in the wood, and urged us to take the road less traveled. Countless schoolchildren and hopeless romantics still read the poem with that tone reserved for sharing life's wisdom as they promote the virtue of taking that road less traveled. The thought is revered, but can the road really remain less traveled if others heed the cacophony of voices promoting this road to the world?

   In the world of products liability, few state courts have heeded Frost's advice, instead growing resigned to taking the jurisprudential road that the majority of courts have followed before them. This is especially true in the area of prescription drugs and devices. Nearly every state has applied the learned intermediary doctrine to shield pharmaceutical manufacturers from liability for failure to warn consumers when the manufacturer provided adequate warning to the prescribing physician. (1)

   However, every now and then a court comes along and decides to take the road less traveled by questioning the conventional wisdom of this well-accepted legal doctrine. The New Jersey Supreme Court took the road less traveled and rejected the learned intermediary doctrine in cases in which the patient was the subject of direct-to-consumer (DTC) advertising by the pharmaceutical company. (2) Thus, the court restored the general rule, requiring the drug manufacturer to provide adequate warning to the consumer-patient. (3) Practitioners and professors alike sounded an alarm over this departure, and numerous commentators sought to predict whether others would follow New Jersey down this path. (4) Yet, no court followed New Jersey in the eight years after Perez. Then, in 2007, the Supreme Court of Appeals of West Virginia picked up where New Jersey left off and declined to adopt the learned intermediary doctrine. (5)

   This Note examines whether this rejection of the learned intermediary doctrine is simply another pursuit of Frost's indelible image, or rather, a sign of an impending shift in our medical-legal jurisprudence as the viability of this doctrine is again questioned. In Part ILA, this Note provides a concise background on the development of the learned intermediary doctrine and its exceptions in addition to giving the current state of the law. Part 11.13 discusses the New Jersey Supreme Court case and the response by commentators and courts in New Jersey and other states. Part III analyzes the West Virginia high court's decision and the court's reasons for declining to adopt the learned intermediary doctrine while looking at the implications for the learned intermediary doctrine and drug manufacturers. Part IV seeks to provide a workable solution for drug manufacturers and consumers alike.

2. BACKGROUND

   1. The Long and Storied History of the Development of the Learned Intermediary Doctrine and Its Exceptions

      1. Origins of the Learned Intermediary Doctrine

         The learned intermediary doctrine eliminates the need for a prescription drug manufacturer to warn the ultimate consumer of a drug's risks if the manufacturer has provided adequate warning to the prescribing physician. (6) The doctrine has a long and storied history with deep-rooted common law origins. Courts have traced its origin back to 1925 when a court (7) made the "first intimations that the manufacturer's duty to the ultimate consumer would be limited in the case of prescription drugs." (8) In 1948, a New York Superior Court concluded that the manufacturer of a prescription drug satisfied its duty to warn by providing warnings to the prescribing physician. (9) In 1967, the Eighth Circuit coined the pharmaceutical manufacturers' limited duty to warn as the "learned intermediary" doctrine. (10) The court wrote just one paragraph discussing this learned intermediary doctrine, yet commentators note that the court set a "commanding precedent." (11) Since its inception, the learned intermediary doctrine has been "a crucial defense" for prescription drug manufacturers. (12)

         In order to understand how this liability shield works, one must understand the general rules of liability for "failure to warn" in products liability. A product may be defective because of inadequate warnings or instructions. (13) In states that follow section 402A of the Second Restatement of Torts, a manufacturer is held strictly liable for physical harm resulting from a product that is "in a defective condition unreasonably dangerous to the user." (14) However, proper warnings may "prevent a product from being unreasonably dangerous." (15)

         Generally, a manufacturer has a duty to warn the ultimate user of any known dangers associated with its products. (16) However, the Second Restatement carved out an important exception to this general rule for manufacturers of prescription products. (17) This exception, commonly referred to as the learned intermediary doctrine, does not require the manufacturer to warn the ultimate consumer directly if it has provided adequate warning to the prescribing physician. (18) The doctrine is based on the principle that prescribing physicians are in the best position to evaluate the patient's needs to assess the risks and benefits of different treatment options. (19) Another court has explained that the manufacturer is not required to warn the patient because the patient cannot access prescription drugs and medical devices without the intervention of the learned intermediary, i.e., the doctor. (20) Thus, the health care provider is in a better position to warn the patient than the manufacturer. (21)

         The Restatement Third of Torts, which governs products liability, retained what the drafters considered "the traditional rule" for duty to warn in the prescription drug and device context by explicitly adopting the learned intermediary doctrine. (22) The comments to this section explain "that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy." (23) The health care professional then has a duty to provide the appropriate information to allow the patient to make an informed choice. (24)

      2. The Current State of the Learned Intermediary Doctrine

         Courts dispute how many states have adopted the learned intermediary doctrine. (25) Some surveys include those states in which a lower state court has adopted the doctrine or in which a federal court applying state law has concluded that the state high court would adopt the doctrine if given the opportunity. (26) The most inclusive survey concluded that 48 states, the District of Columbia, and Puerto Rico have applied or recognized the learned intermediary doctrine. (27) The Supreme Court of Connecticut relied on similar data and claimed to join the "overwhelming majority" of jurisdictions by adopting the learned intermediary doctrine. (28) On the other hand, the Supreme Court of Appeals of West Virginia, in considering only those states where the highest state court or the state legislature had adopted the doctrine, found that only 22 states had expressly adopted the learned intermediary doctrine. (29) The Supreme Court of Appeals of West Virginia concluded that while a majority of state high courts have adopted the doctrine, it is not "the overwhelming majority that has often been suggested by courts and commentators." (30) While there is no consensus on how many jurisdictions have adopted the learned intermediary doctrine, since only one court (31) has rejected it outright thus far, the doctrine seems to remain the majority view.

      3. Adapting to New Products and Problems: The Creation of Exceptions to the Learned Intermediary Rule

         One commentator noted that "[a]lmost as soon as the Eighth Circuit Court of Appeals first articulated the learned intermediary doctrine in 1966, courts began limiting its effect by exempting claims arising from specific medical products." (32) According to the Supreme Court of Appeals of West Virginia, "[m]any jurisdictions have addressed the shortcomings of the learned intermediary doctrine by developing various exceptions," (33) including exceptions for vaccine inoculations, (34) oral contraceptives, (35) contraceptive devices, (36) over-promoted drugs, (37) and drugs withdrawn from the market. (38) One commentator concluded that "the central theme, consistent among all of the cases fording an exception to the learned intermediate doctrine, is that the physician-patient relationship is not the same as in typical treatment scenarios." (39) When this premise, upon which the learned intermediary doctrine is built, is not present, a court may require the drug manufacturer to...