Inside the Learned Intermediary Doctrine
By Chris A. Johnson, Alicia J. Donahue, and Paula Sarti – July 29, 2013
Generally, product manufacturers have a duty to warn consumers directly of all material, foreseeable risks associated with the use of their product. Restatement (Third) of Torts: Prods. Liab. § 2(c) (1998). However, many courts have recognized an exception in situations in which the product is recommended or prescribed to the consumer by a learned third party, such as a physician. That exception is called the learned intermediary doctrine. Restatement (Third) of Torts: Prods. Liab. § 6 cmt. d (1998).
The doctrine is important to drug manufacturers because it allows them to discharge their duty to warn consumers about their products by informing the learned intermediary, commonly the prescribing physician, of all material risks associated with their use. Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996). The prescribing physician is ultimately responsible for directly informing the patient about the potential benefits and risks of using the medication. Restatement (Third) of Torts: Prods. Liab. § 6 cmt. b (1998) Thus, prescription drug manufacturers’ duty to warn consumers flows through the patients’ prescribing physicians, not directly to consumers.
For prescription drug manufacturers, the rationale behind the doctrine is based largely on the fact that prescription drugs’ actions are complex and the prescribing physician is the one best able to determine the drug’s potential benefits and risks for a particular patient. Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 191 (Tex. 2004) (stating that the doctrine is based on the idea “that it is better for the patient for the warning to come from his or her physician”); Restatement (Third) of Torts: Prods. Liab. § 6(d)(1) cmt. b (1998) (“The rationale supporting this ‘learned intermediary’ rule is 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.”).
Because prescription drugs are complex products whose effects can vary from consumer to consumer, patients can obtain them only through a prescribing physician. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154 (Tex. 2012), reh’g denied (Aug. 17, 2012). It is thus “reasonable for the manufacturer” of the prescription drug “to rely on the health-care provider to pass on its warnings” because “the learned intermediary understands the propensities and dangers involved in the use of a given drug, and as the prescriber, he stands between this drug and the ultimate consumer.” Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App. 2000).
There are many policy reasons for adopting, and firmly applying, the learned intermediary doctrine in the context of prescription drugs, including (1) prescribing physicians are “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”; (2) manufacturers lack the means to provide warnings directly to patients; and (3) direct warnings to patients would interfere with the doctor-patient relationship. Larkin v. Pfizer, Inc., 153 S.W.3d 758, 763 (Ky. 2004).
Although this doctrine has been officially adopted by the state supreme court or legislature in only 22 states, the doctrine has been applied in 48 states (including federal courts predicting state law), Puerto Rico, and the District of Colombia. State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 903–5 (W. Va. 2007); In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 806–9 (E.D. Tex. 2002). Some courts, however, have recognized limited exceptions to the doctrine as applied to certain prescribed products, including mass immunization vaccines, contraceptive drugs and devices, and, more recently, products that have been featured in direct-to-consumer (DTC) advertising. Davis v. Wyeth Labs., Inc., 399 F.2d 121, 131 (9th Cir. 1968); MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 138–39 (1985); Perez v. Wyeth Labs. Inc., 734 A.2d 1245, 1254–58 (N.J. 1999).
While the exceptions for mass immunization vaccines and contractive drugs and devices are based on the lack of or limited involvement by physicians, the rationale for the DTC advertising exception is that patients’ active participation in their own health care negates their reliance on a learned intermediary. Davis, 399 F.2d at 131; MacDonald, 394 Mass. at 136–38; Perez, 734 A.2d at 1256.
The DTC advertising exception was created in 1999 by the New Jersey Supreme Court in Perez. Specifically, the court held that prescription drug manufacturers marketing their products directly to consumers could not use the learned intermediary doctrine to shield themselves if their advertising failed to provide adequate warnings and information about the side effects of the product.
The Perez court found that DTC advertisements (1) encroach on the doctor-patient relationship because the patient may come into the doctor’s office asking about a particular drug and (2) rebut the notion that prescription drugs or devices are too complex to warn the patient adequately about all risks in the abstract. At the same time, the court also held that a manufacturer’s adherence to the Food and Drug Administration’s (FDA’s) approved warning label and packaging requirement created a rebuttable presumption of adequacy.
Given the tremendous increase in DTC advertisements for prescription medications over the past few decades, some initially feared that this exception raised the potential that the learned intermediary doctrine would ultimately be obliterated. U.S. Ad Spend Falls Nine Percent in 2009, Nielsen Wire, Feb. 24, 2010 (the amount of money spent on DTC advertising for prescription drugs rose from $1.3 billion in 1998 to $4.5 billion in 2009). As a result, a popular debate continues on whether more DTC advertisements with truthful, non-misleading statements about prescription medications benefit society. At issue in this debate is the conflict between a paternalistic view of consumers and the value placed on access to truthful information.
However, although such advertisements can be seen routinely on television and other media, the learned intermediary doctrine is still alive and well. William A. Dreier, Liability for Drug Advertising, Warnings, and Frauds, 58 Rutgers L. Rev. 615, 646 (2006) (since Perez, there has been no New Jersey court decision applying the DTC exception to hold a drug manufacturer liable). Other jurisdictions have overwhelmingly rejected application of the exception. At least six jurisdictions addressing the issue have rejected the Perez rationale and refused to adopt a DTC advertising exception.
For example, after carefully considering the reasoning underlying the Perez ruling, the Texas Supreme Court in Centocor overturned its lower court adoption of a DTC exception, succinctly stating:
Although pharmaceutical companies have increased DTC advertising since courts first adopted the learned intermediary doctrine, the fundamental rationale for the doctrine remains the same: prescription drugs require a doctor’s prescription and, therefore, doctors are best suited to communicate the risks and benefits of prescription medications for particular patients through their face-to-face interactions with those patients.
Centocor, Inc., 372 S.W.3d 140, 162 & n.21.
In fact, in the 14 years since Perez, only one state’s highest court has been persuaded by its rationale. State ex rel. Johnson & Johnson Corp., 647 S.E.2d at 913–14 (rejecting application of the learned intermediary doctrine altogether based in part on the reasoning of Perez). Thus, even with the DTC exception and the increase in DTC advertising of prescription drugs, the learned intermediary doctrine remains a strong and important defense for drug manufacturers in failure-to-warn cases. The exception that could have potentially swallowed the rule is severely limited by the presumption of adequacy for following FDA-mandated label and packaging requirements and has not gained much traction.
Keywords: litigation, products liability, learned intermediary doctrine; direct-to-consumer advertising, prescription drug manufacturer