Canada: Be Careful What You Wish For: A Canadian Perspective on Direct-to-Consumer Advertising And The ‘Learned Intermediary’ Rule

By Barry Leon, Esq., and Cynthia Tape, Esq.*

Published in Andrews Litigation Reporter: Drug Recall, June 2004.

"Our medical-legal jurisprudence is based on images of health care that no longer exist." So begins the judgment of the New Jersey Supreme Court in Perez v. Wyeth Laboratories Inc., the one court in the United States to hold that the manufacturer of a prescription drug may not rely on the "learned-intermediary" rule if it engages in direct-to-consumer advertising of that product.¹

While no other U.S. court appears to have followed New Jersey’s decision, significant changes in the marketing of prescription drugs and consumer participation in health care decision-making suggest that a re-evaluation of the learned-intermediary rule in Canada may lie ahead.

Under Canadian law, the general rule is that the manufacturer of a product has a duty to warn the ultimate consumer of any material risks associated with the product’s use. In the case of certain types of products, however, an exemption is granted where a "learned intermediary" inevitably intervenes between the manufacturer and the ultimate consumer. In that situation, "a manufacturer may satisfy its informational duty to the consumer by providing a warning to what the American courts have, in recent years, termed a ‘learned intermediary.’"²

Thus, a prescription drug manufacturer can discharge its duty to warn by informing the prescribing physician (the classic learned intermediary) of the material risks. The rationale for the learned-intermediary rule was explained by the Court of Appeal for Ontario in Buchan v. Ortho Pharmaceutical (Canada) Ltd.:

[P]rescription drugs are more likely to be complex medicines, esoteric in formula and varied in effect and, by definition, are available only by prescription. The prescribing physician is in a position to take into account the propensities of the drug and susceptibilities of his patient. He has a duty of informing himself of the benefits and potential dangers of any medications he prescribes, and of exercising his independent judgment as a medical expert based on his knowledge of the patient and the product. In taking the drug, the patient is expected to, and it can be presumed does, place primary reliance on his doctor’s judgment.³

In keeping with this rationale, the learned-intermediary rule has been applied in the context of prescription drugs and medical devices but not to intermediaries in other contexts.⁴ The defense may not, however, apply to all prescription drug products.

Buchan involved the adequacy of the warnings given by Ortho Pharmaceutical to consumers and physicians about certain risks associated with an oral contraceptive product. In considering the learned-intermediary rule, the Court of Appeal noted that most jurisdictions in the United States recognized the rule without exception. However, a number of state courts had established an exception in the case of oral contraceptives because those courts considered that type of drug to have "vastly different" characteristics:

The oral contraceptive thus stands apart from other prescription drugs in light of the heightened participation of patients in decisions relating to the use of "the pill"; the substantial risks affiliated with the product’s use; the feasibility of direct warnings by the manufacturer to the user; the limited participation of the physician (annual prescriptions); and the possibility that oral communications between physicians and consumers may be insufficient or too scanty standing alone fully to apprise consumers of the product’s dangers at the time the initial selection of a contraceptive method is made as well as at subsequent points when alternative methods may be considered.⁵

The Court of Appeal ultimately decided Buchan on the basis that the warning given by Ortho to physicians was inadequate. While it was thus unnecessary to decide whether the manufacturer of an oral contraceptive was under a common-law duty to warn consumers directly, the judge referred to a 1970 advisory report on the safety and efficacy of oral contraceptives and then commented in obiter as follows:

As the advisory committee pointed out, "in prescribing [oral contraceptives], the doctor is usually acting neither to treat nor to prevent a disease. He is prescribing for socioeconomic reasons." Furthermore, unlike the selection of an appropriate drug for the treatment of illness or injury where patient involvement is typically minimal or non-existent, consumer demand for oral contraceptives prompts their use more often than doctors’ advice. The decision to use the pill is one in which consumers are actively involved; more frequently than not, they have made the decision before visiting a doctor to obtain a prescription.

For these reasons, … I am of the view that oral contraceptives bear characteristics distinguishing them from most therapeutic, diagnostic and curative prescription drugs. The rationale underlying the learnedintermediary rule, in my opinion, does not hold up in the case of oral contraceptives.⁶

The reasons expressed by the Court of Appeal in Buchan for acknowledging an exception to the learned-intermediary rule in the case of oral contraceptives might arguably apply to other drugs as well, now more than ever.

The "doctor knows best" paradigm is waning as consumers take a more active interest in health products and health care decision-making. At the same time, pharmaceutical companies are seeking to have more direct marketing contact with potential customers. "Lifestyle" drugs to treat "lifestyle disorders" are reportedly a growth industry.⁷

In this changing health care environment, courts may begin to apply the commentary in Buchan more widely. This has already happened in one case in the United States — Perez, referred to above — as a result of direct-to-consumer advertising.

In Perez, the New Jersey Supreme Court held that a manufacturer that engages in DTC advertising is not entitled to rely on the learned-intermediary rule.⁸ The court reviewed the following pillars on which the learnedintermediary doctrine is based and held that none of them applies in today’s health care environment:

• Reluctance to undermine the doctor-patient relationship;

• No need for informed consent in an era of "doctor knows best";

• Inability of a drug manufacturer to communicate with patients; and

• Complexity of the subject matter.

As a result, the Perez court concluded as follows:

The question in this case, broadly stated, is whether our law should follow these changes in the marketplace or reflect the images of the past. We believe that when mass marketing of prescription drugs seeks to influence a patient’s choice of a drug, a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of the duty to provide proper warnings of the dangers or side effects of the product. ⁹

In the United States, direct-to-consumer advertising of prescription products was tightly controlled by the Food and Drug Administration until the late 1990s. Before then, advertising of prescription products (including prescription drugs and medical devices) was permitted under the Food, Drug and Cosmetic Act, but there was a statutory requirement that advertising include information about the product’s potential side effects, contraindications and overall effectiveness.¹⁰

While it was feasible to include this information in print media advertising, compliance was practically impossible for broadcast media. The situation changed in the late 1990s when the statutory requirements were relaxed for broadcast advertising.¹¹ As a result, ads for prescription drugs are now commonly seen on U.S. television and are freely transmitted into Canada as well.

In Canada, however, there is a broad prohibition against DTC advertising. Canada’s Food and Drugs Act prohibits the advertising of "any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A."¹² Schedule A is a comprehensive list of diseases and abnormal states, including arthritis, cancer, depression, diabetes, epilepsy, heart disease, hyper/hypotension, kidney disease, liver disease, obesity and tumors.

In addition, the regulations of the Food and Drugs Act do not allow prescription drugs to be advertised to the general public, except for representations as to the "brand name, proper name, common name, price and quantity of the drug."¹³ As a result, the advertising of prescription drugs directly to consumers is constrained.

In recent years, however, Health Canada has been considering whether restrictions on such advertising should be eased, as they have in the United States. In 1999, for instance, the Health Products and Food Branch sought input from stakeholders on the objectives, considerations and policy options relating to DTC advertising of prescription drugs in Canada.¹⁴ And studies are being carried out on the impact of DTC advertising on consumers, physicians and the health care system in Canada.¹⁵

If the restrictions are relaxed, the consequences of such a change for drug manufacturers may be significant. Direct-to-consumer advertising may be good medicine for pharmaceutical companies’ bottom lines, but Perez may signal that an unexpected and unwelcome side effect could be in store.

1. Perez v. Wyeth Labs. Inc., 734 A.2d 1245 at 1246 (N.J. 1999).

2. Hollis v. Dow Corning Corp., [1995] 4 S.C.R. 634 at 658.

3. Buchan v. Ortho Pharm. (Canada) Ltd. (1986), 54 O.R. (2d) 92 at 103 (C.A.). See also Hollis, supra note 2 at 658, citing Reyes v. Wyeth Labs., 498 F.2d 1264 at 1276 (5th Cir. 1974).

4. See, for example, Bow Valley Husky (Bermuda) Ltd. v. Saint John Shipbuilding Ltd., [1997] 3 S.C.R. 1210 (builder of an oil rig is not a learned intermediary), and Guimond Estate v. Fiberglas Canada Inc., (1999), 207 N.B.R. (2d) 355 (Q.B.), aff’d 221 N.B.R. (2d) 119 (C.A.) (manufacturer could not rely on warnings given to a retailer to satisfy its duty to warn consumers about the health risks of styrene).

5. Buchan, supra note 3 at 104.

6. Buchan, supra note 3 at 122.

7. "The disease-specific characteristics and psychosocial factors associated with lifestyle disorders make them perfectly suited for direct-to-consumer advertising." The Lifestyle Drugs Outlook to 2007: Challenges and opportunities in a high-profile growth market, Reuters Business Insight, New Strategic Management Report, excerpt at www.reutersbusinessinsight.com/content/rbhc0069m.pdf.

8. The drug at issue was Norplant, a contraceptive surgically implanted under the skin of a patient.

9. Perez, supra note 1 at 1247. The court did not leave pharmaceutical companies completely exposed, however. It held that a manufacturer that has complied with regulatory requirements for drug advertising, labeling and warnings is entitled to a rebuttable presumption that the duty to warn has been appropriately discharged.

10. Food, Drug, and Cosmetic Act, 21 U.S.C. § 352(n); 21 C.F.R. pt. 202.1.

11. See U.S. Department of Health & Human Services, Food and Drug Administration, Guidance for Industry: Consumer-Directed Broadcast Advertisements (August 1999), available at www.fda.gov/cder/ handbook/.

12. Food and Drugs Act, R.S.C. 1985, c. F-27, s. 3(1).

13. Food and Drug Regulations, C.R.C. c. 870, s. C.01.044.

14. See, for example, Discussion Document: Direct-to-Consumer Advertising of Prescription Drugs (Apr. 6, 1999), available at www.hc-sc.gc.ca/hpfb-dgpsa/oria-bari/99-04-14_3_e.html.

15. See, for example, B. Mintzes et al., An Assessment of the Health System Impacts of Direct-to-Consumer Advertising of Prescription Medicines (DTCA), available on the Web site of the Centre for Health Services and Policy Research at the University of British Columbia; the executive summary is available at www.chspr.ubc.ca/ hpru/pdf/dtca-v1-execsum.pdf. See also B. Mintzes et al., How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA," 169(5) C.M.A.J. 405 (Sept. 2, 2003).s