The Learned Intermediary Rule is good medicine and sound public policy, which protects companies that manufacture prescription medicines and devices. Unfortunately, however, the Learned Intermediary Rule is being eroded by several regulatory and marketing developments, which unnecessarily increase the legal exposure of companies. Companies should therefore be careful about how and where they promote their products and should let regulators and legislators know the benefits of maintaining the Learned Intermediary Rule.

Putting Information In The Right Hands
Under traditional product liability law, companies that manufacture prescription medicines generally don't have to provide warnings directly to consumers. Instead companies direct their warnings to physicians, who act as "learned intermediaries" by making informed decisions to provide medication to their patients, the ultimate consumers. Simply put, if the physician receives a warning about an adverse reaction, the company is not liable if the patient experiences the reaction. State courts in almost all 50 states have accepted this legal principle, reasoning that the person most knowledgeable about both the medicine and the patient should decide what will most benefit the patient.

These courts generally cite two factors to support the need for a learned intermediary: First, if patients were given the complete and often highly technical, statistical warnings about adverse events associated with medicines, they might unreasonably reject life-saving medications; physicians, however, can more rationally weigh the risks against the benefits. And second, while it would be almost impossible for companies to provide warnings directly to patient-consumers because there is no sure way to reach them, companies can satisfy their duty to warn physicians of risks associated with prescription medicines through package inserts and the Physicians Desk Reference. Indeed, physicians testify consistently in depositions and trials that good medical practice requires them to read the information available to them regarding medicines they prescribe and to decide what warnings to give patients.

Courts in numerous states apply the Learned Intermediary Rule to dispose of cases by granting judgment for pharmaceutical companies before trial in cases where there are adequate warnings. Over the years, however, courts have crafted exceptions to the Learned Intermediary Rule, and new technological marketing advances and legislation may create more exceptions.

The following four developments may threaten the Learned Intermediary Rule and physicians' relationships with individual patients: 1) Direct advertising to certain groups of consumers both in the United States and internationally; 2) The Internet, and medicine companies' home pages; 3) The Omnibus Budget Reconciliation Act of 1990 (OBRA), which places pharmacists as an intermediary between the physician and patient; and 4) New Food & Drug Administration (FDA) requirements and recommendations that companies write package inserts and brochures for patients.

Specific Marketing Campaigns Can Expand A Manufacturer's Duty To Warn
State and federal courts have long held that the Learned Intermediary Rule does not apply when prescription medicines such as immunizations are advertised and provided in a public setting where no doctor needs to be present. Thus, the manufacturers of polio and swine flu vaccinations may be liable for side effects unless they warn the consumer, and those providing such vaccinations routinely provide general warnings. Regulations enacted in the late 1980s eliminated the requirement that manufacturers of seven childhood vaccines provide warnings directly to consumers, but the principle survives -- that liability may attach whenever a medication is marketed directly to consumers.

Among the medications that may not be subject to the Learned Intermediary Rule because they are marketed directly to consumers are birth control pills and IUDs, which are advertised in magazines and promoted through pamphlets in doctors' waiting rooms. Indeed, not only is the pill marketed directly to the consumer, but the decision to take the pill is often made primarily by the young, healthy patient with little physician input or follow-up. Accordingly, some courts have held that manufacturers of birth control pills must warn patient-consumers, not just physicians, of risks associated with the pill.

Technology will likely expand this consumer-marketing liability because some marketing directed at physicians may end up reaching the consumer. For example, anyone with a computer and modem anywhere in the world can access a pharmaceutical company's home page, on which the company describes the many uses and benefits of its product. Additionally, the Internet provides a forum in which patients have greater access to articles about research and about new, unapproved medicines.

So how do we accommodate the Internet and medicine company home pages to protect the Learned Intermediary Rule? A first step is to apply the same thinking to home pages and information available on the Internet as to other, more traditional, advertising and labeling. For example, companies should include directions to consult a physician. Also, companies should be careful to include information about the medicine's status in all countries where it is available. Otherwise, patients (and doctors) may want to try medicines not approved by their countries' regulators.

The Internet And Patient-Consumer Advocacy
Similarly, the Internet increases the risk that a medication will be applied to a use other than those approved by the appropriate regulatory body or recommended by the company. In a nation of ever more informed consumers, the Internet could inadvertently promote such "off-label" use of prescription medicines. Anyone with an Internet home page can link that page to a pharmaceutical company's home page without the company's knowledge or consent and regardless of whether the linked site is about on-label or off-label use. A consumer can then ask a doctor specifically for the medicine.

Because of this, the FDA is attempting to create regulations regarding the use of the Internet. One of the FDA's main concerns about product information on the Internet is the ease with which users can jump from web site to web site -- specifically from a web site focused on an unapproved use of a medicine or device straight to the company's home page. This has raised many questions, including whether companies should be required to distinguish between promotion directed to health care professionals and patient-consumers on the Internet, and if so, how?

To help preserve the Learned Intermediary Rule despite wide Internet access, companies should be as circumspect on their home pages as they are in their print marketing and package labeling, the contents of which are often subject to regulation. Because it is much harder to monitor, much less control, information provided by sources other than the pharmaceutical companies on the Internet, it may be necessary to stress approved uses more in this forum than in other, more traditional media, as well as to recommend that a physician decide whether a particular medicine is appropriate.

OBRA and Pharmacist Liability
Pharmacists traditionally have had no duty to warn patients about a medication's risks -- that is the physician's job. Indeed, if pharmacists did have a duty to warn patients about medicines, then pharmacists would demand that companies warn them (and not just physicians) about all potential risks of prescription medicines. The Omnibus Budget Reconciliation Act of 1990 (OBRA) and similar foreign legislation may bring about that result.

OBRA requires pharmacists to discuss the following with Medicaid patients: 1) the name and description of the medicine; 2) the dosage form, dosage, route of administration, and duration of medicine therapy; 3) special directions and precautions for preparation, administration and use by the patient; 4) common severe side or adverse affects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; 5) techniques for self-monitoring medicine therapy; 6) proper storage; 7) prescription refill information; and 8) action to be taken in the event of a mis-dose.

OBRA also requires pharmacists to maintain patient profiles, which include disease history and a comprehensive list of current medications and medical devices. Most important for the future of the Learned Intermediary Rule, OBRA says pharmacists must counsel Medicaid patients concerning "matters which in the exercise of the pharmacist's professional judgment (consistent with state law respecting the provision of such information), the pharmacist deems significant." For example, pharmacists require a pharmacist to ask a doctor why a certain medicine was prescribed. If a physician prescribes a medicine for an off-label use, the pharmacist may even refuse to fill the prescription, thereby preventing treatment that a physician has decided will benefit the patient.

Does this mean pharmacists must warn about risks and side effects? It would not be surprising to see some courts interpret it that way. What is more, most states have enacted legislation requiring pharmacists to offer counseling to all patients, not just Medicaid patients. A few courts have already held that pharmacists may have a duty to warn about possible risks associated with prescription medicines.

In a Tennessee case, for example, a pharmacist argued he had no duty to warn of the interaction between two prescription medicines and asked the court to grant summary judgment in his favor before trial. But the court said a jury should decide whether, under the particular facts of that case, a reasonable pharmacist would have warned the patient. In other words, the court said a pharmacist does have a duty to provide reasonable warnings; the only question was whether it was unreasonable not to mention the particular risk in that case.

Similarly, in a New York case, the court found that summary judgment for the pharmacist was improper because the pharmacist knew the patient personally, knew he was an alcoholic, and knew (or should have known) that the medicines prescribed were contraindicated with the use of alcohol. The pharmacist in that case may have had a duty to warn the patient and to speak with the prescribing physician about whether the medications were appropriate.

The holdings in these cases remain exceptions to the rule, but perhaps not for long. A Michigan appeals court ruled in January 1996 that pharmacists have a legal duty to warn consumers about adverse medicine interactions when they start to use a computer system that checks for adverse interactions. Thus, OBRA and corresponding state laws may eviscerate the Learned Intermediary Rule by placing pharmacists as intermediaries between patients and physicians.

At the very least, OBRA and state law requirements will undoubtedly result in additional litigation against drugstores and pharmacists, as they are an additional "deep pocket" to whom plaintiffs' attorneys can turn. It is equally certain that pharmacists sued for failure to warn will demand that the pharmaceutical companies to pay their litigations costs. This will render the Learned Intermediary Rule meaningless, as a manufacturer who has discharged its duty to warn physicians may find itself defending a lawsuit against a pharmacist for alleged failure to warn. The increased cost involved in making the pharmaceutical manufacturer the virtual insurer of its products in this way will be passed along to consumers in the form of higher prescription medicine costs, or possibly by a decrease in money for research and development of new medicines.

New FDA Requirements and Recommendations
The FDA and regulatory bodies in other countries recently began requiring and strongly recommending that companies write package inserts for patients. This is a disturbing development because in order to make warnings accessible to and understandable by patients, companies may have to overwarn in a way that may jeopardizes patient care. One of the primary purposes of the Learned Intermediary Rule is to place knowledge about the indications, risks and benefits of a medicine in the hands of the person most knowledgeable about the overall patient-medicine picture, who can then make an intelligent choice about what will be beneficial for the patient. Most patients are incapable of fully understanding the often highly technical warnings about adverse events associated with medicines, or they just don't want to know.

These new guidelines create a Catch-22: If patients are given the same technical, accurate, FDA-approved warnings that are provided to physicians, they will have no way to evaluate them and may reject life-saving medications on the basis of a listed, but statistically very small, risk. However, if the warnings are simplified, there is a real risk of either exaggerating or downplaying the indications, contraindications and side effects of medicines. Simplified warnings also run the risk of being labeled as over-promotion, thus opening companies up to liability on that basis.

Global Solution
The Learned Intermediary Rule is good health care that must be preserved. Each patient is an individual who shares a different amount and nature of information with his or her doctor, and typically shares very little with his or her pharmacist. The erosion of the Learned Intermediary Rule greatly affects the physician-patient relationship by placing pharmacists in the place of physicians and requiring judgments and decisions from them that they are not trained to make. Making pharmacists second-guess physicians' decisions will also create friction and mistrust in the physician-patient relationship.

Pharmaceutical companies should work with pharmacist organizations to lobby for modification of the new OBRA and state law rules that imply pharmacists have a duty to warn patients. This battle will also be fought in the courts, as plaintiffs are likely to ask judges to expand on the duties listed in the statute.

Companies must also craft Internet submissions and communications carefully to avoid over-promotion and international misunderstandings that could lead to liability. At the same time, however, actively monitoring the Internet and suggesting that physicians be consulted about any new medicine or treatment, will help to control the flow of information about new medicines and hopefully strengthen the Learned Intermediary Rule by directing patients to their physicians, first and foremost, for individualized treatment decisions.

Despite the exceptions and technological advances creeping up on the law, the Learned Intermediary Rule continues to be affirmed as a general principle. The California Supreme Court recently (in August, 1996) strongly affirmed the Learned Intermediary Rule in a prescription medicine product liability case. The court emphasized that the duty of a medicine manufacturer is only to give adequate warning of "actually known or reasonably scientifically knowable" risks to physicians; there is no duty to ensure that any warning reaches the patient for whom the medicine is prescribed. The court also reaffirmed that there is no duty to warn of risks which are "readily known and apparent" to physicians, regardless of warnings given by companies. Thus, the manufacturer is allowed to rely on the learned intermediary's expertise.

In these days of "tell-the-consumer-everything" regulatory and legislative groups must make sure that physicians can continue to practice their best professional judgment not only in selecting a therapy for a patient but in deciding what to tell the patient about the therapy as well.