The Learned Intermediary Doctrine Must Die
The Learned Intermediary Doctrine, adopted by the Washington Supreme Court in 1978, creates a special immunity from liability applicable only to pharmaceutical companies that manufacture and market drugs and medical devices prescribed by physicians for use by patient consumers. The Doctrine is outdated, unnecessary, and simply wrong in the modern world, where drug companies aggressively advertise, market, and deliver drugs directly to consumers over the Internet. Our Supreme Court should kill this anachronistic Doctrine in the next case to raise the issue.
The Learned Intermediary Doctrine Is Obsolete
By way of background the Learned Intermediary Doctrine provides that a drug manufacturer satisfies the duty to warn in a product liability case if the manufacturer gives adequate warnings to the physician who prescribes the drug or device. Terhune v. A. H. Robins Co., 90 Wn.2d 9, 577 P.2d 975 (1978) (involving Dalkon Shield IUD; relying on Restatement (Second) of Torts, § 402A, comment k (1965)). Terhune and the Learned Intermediary Doctrine, which predate the Washington Product Liability Act (“WPLA”), RCW Chapter 7.72, effectively insulate drug manufacturers in Washington from liability for defective drugs based an often-ambiguous or innocuous warning, leaving the patient’s physician facing what should be the manufacturer’s liability. Our courts have never updated the Doctrine to accommodate modern reality.
In 2007, based on developments in prescription medicine and direct-to-consumer (“DTC”) advertising by drug manufacturers, the West Virginia Supreme Court rejected the Learned Intermediary Doctrine in a comprehensive, well-reasoned opinion, State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899 (2007). This article summarizes the bases for that decision and urges practitioners to seize the next opportunity to challenge and kill the Doctrine in Washington.
The Learned Intermediary Doctrine, Originating When “Doctor Knew Best,” Has Been Eroded By Modern Medicine And Advertising
Generally, a manufacturer has the duty to warn consumers about the risks of its products. The Learned Intermediary Doctrine is an exception to that general rule, excusing manufacturers from warning patients when they properly warn the prescribing physician or healthcare provider of the product’s dangers. Under this exception, the manufacturer’s duty to warn extends only to the prescribing provider, who acts as a learned intermediary between the manufacturer and the ultimate consumer, thus assuming responsibility for advising patients of the drug’s risks.
The Learned Intermediary Doctrine allows drug companies to be protected from liability by burying an elusive, deceptive, and inadequate warning in fine print in the drug’s package insert. It reflects an anachronistic and excessively paternalistic model of the physician-patient relationship, fails to take into account changes in the delivery of health care services, and ignores how managed care has constrained physician autonomy so that prescribing decisions may no longer reflect an informed medical judgment. See Lars Noah, Symposium: The Products Liability Restatement: Was It a Success?: This Is Your Products Liability Restatement on Drugs, 74 Brooklyn L. Rev. 839, 894 (Spring 2009) (summarizing criticisms).
Pharmaceutical companies should not be insulated from liability for advertising when such advertising influences the legally recognized fiduciary relationship of patient-physician through subversive, but real, manipulation of both parties to that relationship. Given that drug promotion weakens the patient-physician relationship and makes it difficult for a physician to function as a true “learned intermediary,” courts should eliminate the [Learned Intermediary Doctrine] and impose joint liability on the part of the pharmaceutical manufacturer and the physician in [Direct-To-Consumer] advertising cases.
Heather Harrell, Direct-To-Consumer Advertising of Prescription Pharmaceuticals, The Learned Intermediary Doctrine, And Fiduciary Duties, 8 Ind. L. Rev. 69, 92-93 (2010/2011) (footnote omitted). See also, e.g., Ashley Porter, Comment: Old Habits Die Hard: Reforming the Learned Intermediary Doctrine in the Era of Direct-To-Consumer Advertising, 43 McGeorge L.Rev. 433, 448-54 (2012); Robert J. Friedman, General Issue: Featured Contributors: Take Two Of These And Sue Me In The Morning: Efficacy Of The Learned Intermediary Doctrine In Prescription Drug Failure To Warn Cases, 22 St. Thomas L. Rev. 278, 287 (Winter 2010).
According to comprehensive research by the West Virginia Supreme Court in rejecting the Doctrine, 21 states (including Washington) have adopted the Learned Intermediary Doctrine by case law (3 of which also enacted statutes), and one state has adopted the Doctrine only by statute. Karl, 647 S.E.2d at 904, nn.6-7. In six other states, the highest courts have either referred to the Doctrine “favorably in dicta, or have adopted it in a context other than prescription drugs”. Id. at 904 n.8 (citing e.g., Terhune). The basic rationale for the rule is that:
[M]edical professionals, and only medical professionals, have the requisite knowledge, training, and judgment to properly match particular drugs with distinctive benefits and dangers to particular patients with distinctive constitutions and medical conditions, and to properly monitor the results thereafter. If manufacturers fulfill their obligations to provide full and fair information to healthcare professionals, those professionals should be able to make intelligent, reasonably safe, and effective treatment decisions. In turn, a prescribing doctor is obliged under the law of torts to inform the patient of a drug’s benefits and risks (as well as the benefits and risks of no treatment and alternative treatments), and to monitor how the drug affects the patient.
David G. Owen, Article: Dangers in Prescription Drugs: Filling a Private Law Gap in the Healthcare Debate, 42 Conn.L.Rev. 733, 760-61 (Feb. 2010) (footnotes omitted; proposing abolition of Learned Intermediary Doctrine).
In Washington, in 1988, ten years after the Washington Supreme Court’s decision in Terhune, our Legislature adopted the WPLA, RCW Chapter 7.72. The WPLA is silent on the Learned Intermediary Doctrine, though RCW 7.72.030(1)(b) and (c) require warnings in certain circumstances, including to “product users”.1
After another 10 years, in 1998, the American Law Institute issued the Restatement (Third) of Torts—Product Liability, with a “tepid endorsement”2 of the Doctrine in Section 6(d). This section requires manufacturers to warn not only prescribing providers, but also “other health care providers” and even patients in some circumstances.3 The Restatement (Third) incorporates exceptions developed in the caselaw, including a general exception when the manufacturer knows or should know that a physician will not be in a position to provide an adequate informed warning. Comment e to § 6 discusses circumstances when direct warnings to patients may be justified under subsection 6(d)(2)). Karl, at 911-12.
In drafting pattern jury instructions under the WPLA, the Washington Supreme Court Committee on Jury Instructions commented that Washington law is not clear as to whether the standard in a prescription drug-warnings case is negligence or strict liability.4 The Committee recommends that if the trial court applies strict liability, it should instruct the jury using the language of the WPLA. WPI 110.03, “Manufacturer’s Duty to Provide Warnings or Instructions With Product,” Comment (Jan. 2012).
The Washington Supreme Court has not revisited the Learned Intermediary Doctrine in the 34 years since Terhune was decided in 1978. While continuing to cite and apply Terhune and the Learned Intermediary Doctrine, no court in Washington has examined the continued viability of the Doctrine since, or together with, the WPLA (1988), the Restatement (Third) (1998), modern prescription practices, or direct-to-consumer advertising. See Luttrell v. Novartis Pharms. Corp., 2012 U.S. Dist. LEXIS 142816, at *42-47 (E.D. Wash. Oct. 1, 2012); Laisure-Radke v Par Pharmaceutical, Inc., 426 F.Supp.2d 1163 (W.D. Wash. 2006); Estate of LaMontagne v. Bristol-Myers Squibb, 127 Wn. App. 335, 111 P.3d 857 (2005); Young v. Key Pharms., Inc., 130 Wn.2d 160, 922 P.2d 59 (1996) (4-4 plurality affirmed Court of Appeals decision holding Restatement (Second) § 402A comment k applies to prescription drugs); Washington State Physicians Ins. Exch. v. Fisons Corp., 122 Wn.2d 299, 313, 858 P. 2d 1054 (1993). See also Ruiz-Guzman v. Amvac Chemical Corp., 141 Wn.2d 493, 7 P.3d 795 (2000) (pesticides; incorporating comment k into the WPLA); Rogers v. Miles Laboratories, Inc., 116 Wn.2d 195, 802 P.2d 1346 (1991) (en banc) (blood products).
The West Virginia Supreme Court Abrogated The Learned Intermediary Doctrine
In 2007, the West Virginia Supreme Court, in Karl, a case of first impression, became the first jurisdiction to reject the Learned Intermediary Doctrine altogether (though the New Jersey Supreme Court in Perez v. Wyeth Labs, Inc., 161 N.J. 1, 734 A.2d 1245 (1999), was the first to create an exception for DTC advertising of prescription drugs in a failure-to-warn case).5 The Karl Court’s opinion, written by then-Chief Justice Robin Jean Davis in a 3-2 vote, is well-written, thoroughly documented, and makes common sense from a historical and current point of view. The supporting data and articles cited by the court create an impressive argument for abrogating the Doctrine wherever it exists, a position which other courts, prescribing physicians, their insurers and trade associations should join.
Tracing the history of the Learned Intermediary Doctrine back to 1925, Karl notes the significant changes in the drug industry that followed the adoption of the Learned Intermediary Doctrine—that is, DTC advertising, with its impact on the physician-patient relationship, and the Internet as a common method of dispensing and obtaining prescription drug information. The Learned Intermediary Doctrine was developed at a time when pharmaceutical manufacturers did not advertise to patients, but directed all sales efforts to physicians through literature and “detail men” who touted the benefits of the drugs and downplayed their side effects. “In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks.” Karl, 647 S.E.2d at 908 (quoting Perez, 734 A.2d at 1246-47.
But all that has changed: “Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines.” Id.
Karl outlines the arguments against DTC advertising in terms of its impact on the physician-patient relationship. Physicians are increasingly asked and pressured by their patients to prescribe drugs the patient has seen advertised, such as the diet drug combination fen-phen, which was widely prescribed despite scant hard, scientific evidence of its effectiveness or potential side effects. Physicians feel attacked for prescribing too often and too readily to inappropriate patients, and they blame pushy patients, who are prodded by DTC advertisements and in turn pressure doctors to come up with quick treatments. Physicians complain it is “impossible to compete with pharmaceutical companies’ massive advertising budgets, and resign themselves to the fact that if consumers make enough noise, they will eventually relent to patient pressure.” Karl, at 909 (quoting Tamar V. Terzian, Note, Direct-to-Consumer Prescription Drug Advertising, 25 Am.J.L. & Med. 149, 158 (1999); Ozlem A. Bordes, The Learned Intermediary Doctrine and Direct-to-Consumer Advertising: Should the Pharmaceutical Manufacturer Be Shielded from Liability?, 81 U. Det. Mercy L. Rev. 267, 280-81 (Spring 2004)).
Critics of DTC advertisements also argue: the ads distort doctor-patient relationships and may increase prescription drug use; because ads are designed to sell products, they are inadequate sources of information and poor substitutes for medical advice; the ads do not discuss other medications or alternative treatments, including no treatment; and, the ads cannot diagnose an ailment. The physician must then re-educate misinformed patients. Studies of DTC advertising confirm that it generates an increased patient demand for drugs and causes physicians to spend more time reviewing the benefits and risks of a specific brand and explaining restrictions when patients request a brand outside the plan’s drug formulary. DTC ads create unreasonable or inappropriate patient expectations for product effectiveness and lead patients to request inappropriate products. Karl, at 909.
Informed consent requires a patient-based decision instead of the paternalistic approach of the 1970s, so that the decision to take a drug is no longer simply a matter for medical judgment. Drug manufacturers (who spent $ 1.3 billion on advertising in 1998) no longer lack effective means to communicate directly with patients. Advertising campaigns can pay billions of dollars in dividends to drug manufacturers. The fact that manufacturers are advertising their drugs and devices to consumers suggests that consumers are active participants in their health care decisions, invalidating the concept that it is the doctor, not the patient, who decides whether a drug or device should be used. Karl, at 910 (quoting Perez, at 1255-56).
Requiring drug manufacturers to provide direct warnings to a consumer will not undermine the patient-physician relationship. Consumer-directed advertising already encroaches on that relationship by encouraging consumers to ask for advertised products by name.
[C]onsumer-directed advertising rebuts the notion that prescription drugs and devices and their potential adverse effects are too complex to be effectively communicated to lay consumers. Because the FDA requires that prescription drug and device advertising carry warnings, the consumer may reasonably presume that the advertiser guarantees the adequacy of its warnings. Thus, the common law duty to warn the ultimate consumer should apply.
Karl, at 910-11 (quoting Perez, at 1255-56). As the court summarized in Perez, “When all of its premises are absent, as when direct warnings to consumers are mandatory,” the Learned Intermediary Doctrine, “itself an exception to the manufacturer’s traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law.” Perez, at 1256.
Many jurisdictions have addressed the shortcomings of the Learned Intermediary Doctrine by developing various exceptions: (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. Karl, at 911 (quoting Vitanza v. Upjohn Co., 257 Conn. 365, 778 A.2d 829, 846-47 (2001) (internal citations omitted). As noted, the Restatement (Third) incorporates these exceptions. The American Law Institute also recommended that courts consider imposing tort liability on drug manufacturers failing to provide direct warnings to consumers in two areas: (1) when government regulatory agencies have mandated that patients be informed of risks attendant to the use of a drug, such as the FDA requirement that birth control pills be sold to patients accompanied by a patient package insert; and (2) when manufacturers advertise a prescription drug in the mass media and regulations require information about the risks. Karl, at 913 n.16 (quotingRestatement (Third), §-6, cmt. e). Adequate warnings to the healthcare provider in these situations should not insulate the manufacturer from tort liability.See Laisure-Radke v. PAR Pharmaceutical, Inc., 426 F. Supp. 2d 1163, 1172 (W.D. Wash. 2006) (because FDA regulations provide only minimum requirements, compliance does not necessarily establish warnings were adequate; citing Wash. State Physicians Ins. Exchange & Assoc. v. Fisons Corp.,122 Wn.2d 299, 328-29, 858 P.2d 1054 (1993)). See also Stevens v. Novartis Pharms. Corp., 358 Mont. 474, 247 P.3d 244, 259 (2010) (“[t]he realities of modern medicine increasingly conflict with the learned intermediary doctrine’s underlying premises.”)
The majority in Karl concluded that, given the plethora of exceptions to the Learned Intermediary Doctrine, there was no benefit in adopting it. The court stated this is particularly so when West Virginia’s law of comparative contribution among joint tortfeasors is adequate to address liability issues among physicians and drug companies when patients sue for injuries related to prescription drugs. If drug manufacturers can provide warnings to consumers under the numerous exceptions, then they can provide adequate warnings to consumers in general. Because drug manufacturers reap billions in profits from sales of prescription drugs and products, and know their harms, while consumers bear the significant health risks of using those drugs, manufacturers should provide appropriate warnings to the ultimate product users. Public policy supports a rule requiring manufacturers to warn the ultimate user.
The benefit in warning the consumer directly is far outweighed by the costs. It is not as though the manufacturer must incur costs to discover the risks as they are already known. It is only a matter of adding the consumer to the list of who to warn. …
…[C]onsumers need more protection. As a response to the changing times, courts have diminished the manufacturer’s shield of the learned intermediary doctrine. They have imposed a duty to warn the consumer in addition to the physician. In doing so, the goal of product liability to protect the ultimate user from harm, is more attainable.
Karl, at 913-14 (citations omitted).
For all the reasons in Karl, it is time for Washington courts to kill the Learned Intermediary Doctrine.
1. RCW 7.70.030(1)(b) and (c) provide:
(b) A product is not reasonably safe because adequate warnings or instructions were not provided with the product, if, at the time of manufacture, the likelihood that the product would cause the claimant’s harm or similar harms, and the seriousness of those harms, rendered the warnings or instructions of the manufacturer inadequate and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.
(c) A product is not reasonably safe because adequate warnings or instructions were not provided after the product was manufactured where a manufacturer learned or where a reasonably prudent manufacturer should have learned about a danger connected with the product after it was manufactured. In such a case, the manufacturer is under a duty to act with regard to issuing warnings or instructions concerning the danger in the manner that a reasonably prudent manufacturer would act in the same or similar circumstances. This duty is satisfied if the manufacturer exercises reasonable care to inform product users.
See also WPI 110.03.
2. Perez v. Wyeth Labs. Inc., 161 N.J. 1, 734 A.2d 1245, 1253 (1999) (quotation omitted).
3. Section § 6, ¶(d) provides:
A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) Prescribing and other health care-providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings, or
(2) The patient when the 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.
4. Discussing 4-4 split on this issue in Young v. Key Pharms., Inc., 130 Wn.2d 160, 175-78, 922 P.2d 59 (1996).
5. Apart from West Virginia in Karl and New Jersey in Perez, “no other state has adopted a categorical carve-out to the learned intermediary doctrine for direct-to-consumer advertising.” Porter, McGeorge L.Rev. at 451.
Ron Perey, WSAJ EAGLE member, is a personal injury and medical malpractice trial lawyer, and founder of Perey Law Group in Seattle. He was WSAJ Trial Lawyer of the Year in 2011.
Carla Tachau Lawrence, WSAJ member, is a Seattle lawyer doing research and writing, of counsel to the Perey Law Group.