The Learned Intermediary Rule and Direct-to-Consumer Advertising

By Zachary Shapiro

In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has no corresponding duty to directly warn the patient.

This rule has been justified by the belief that the prescribing physicians is “in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.” Larkin v. Pfizer, Inc. 153 S.W.3d 758, 763-764 (Ky. 2004). Furthermore, historically, pharmaceutical manufacturers lacked effective means to communicate directly to patients. Courts did not want to extend liability when pharmaceutical companies were complying with FDA regulations regarding proper warnings to consumers. Finally, there was a belief that any direct warning would interfere with the doctor-patient relationship. 

However, the rise of direct-to-consumer advertising (DTC going forward) for pharmaceuticals has dramatically changed the landscape. While the Restatement (Third) leaves this issue to “developing case law” (Comment e to §6d) the rise of DTC advertising undermines several of the arguments in favor of the LIR. Pharmaceutical companies currently spend millions to advertise their products, making it unreasonable to argue that they do not have effective means to communicate to patients. Furthermore, DTC advertising is already changing the traditional doctor-patient relationship. Patients influenced by DTC often come to their physician asking for a particular medication, rather than asking the doctor for their unbiased medical opinion. Most dangerously, DTC can make patients feel that they are familiar with a drug, which can make them far less “savvy” consumers when it comes to their own health. If patients feel like they know everything about a pharmaceutical due to DTC, they may be less likely to question their doctor, or inquire about rare side effects. Providing patients with promotional information, which is only part of the drug’s profile, can actually make them less informed.

DTC Ads for pharmaceuticals are regulated under 21 C.F.R. §202.1. These regulations already require that ads contain a “true statement of information in brief summary relating to side effects, contraindications . . . . and effectiveness” as well as a “fair balance between information relating to side effects and contraindications,” meaning companies must include proper warnings in their ads. § 202.1(e)(1).

Currently, all but two states (N.J. and W.Va.) maintain the LIR without a DTC exception, while several states (such as Texas) have expressly rejected any DTC exception. A DTC exception would mean that direct marketing of drugs to consumers generates a corresponding duty requiring manufacturers to warn of defects in those products. This exception would ensure that if a company engages in DTC marketing of their pharmaceutical, then they could no longer use the LIR as a shield from liability for failure to warn claims related to that product.

To be clear, I am not advocating removing the LIR. However, a DTC exception would allow “patients deprived of reliable medical information to establish that the misinformation was a substantial factor contributing to their use of a defective pharmaceutical product.” Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1263 (N.J. 1999). Such an exception would help ensure that any company that utilizes DTC advertising is careful to make sure that their ads contain strong and clear warnings.

Therefore, rather than automatically shielding manufacturers from failure to warn claims under the Learned Intermediary Rule, I believe that an exception is justified when the company engages in DTC advertising.

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