Pharmaceutical Manufacturer Liability Law

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The means of marketing medications has changed. No longer do the manufacturers direct all their marketing efforts at physicians upon whom the patient relied for advice. For trial lawyers, the challenge is to recognize and adapt to such circumstances, and to press for changes in tort law to reflect the evolving marketplace.

Evolution of Pharmaceutical Manufacturer Liability Law: Challenging the “Learned Intermediary” Doctrine

By any measure, our country is in the process of dramatic change in the delivery of health care to its citizens. The traditional means through which we seek out, undergo, and pay for medical care are going through a metamorphosis nationally, the end result of which remains unclear. For trial lawyers, the challenge is to recognize and adapt to such circumstances, and to press for changes in tort law to reflect the evolving marketplace.

While HMO expansion has gathered most of the attention, the historical model under which prescription drugs went from manufacturer to patient, static for decades, has undergone great change as well. Under the historical model, the manufacturer researched and developed medication to address a particular condition or illness. Upon receiving federal approval to market the new drug in the U.S., the manufacturer directed its marketing and sales efforts solely at physicians. Patients had little if any direct access to information about the drugs, and relied upon the physician to make decisions about whether the patient was an appropriate candidate for the drug. Similarly, patients relied on their physician to instruct them in proper use of medication, and to instruct and warn them about side effects and possible complications.

It is against this backdrop that tort law developed imposing limits on liability against pharmaceutical manufacturers. Under general principles of product liability, manufacturers have a duty to warn of defects or dangers in the use of their products that are not open or obvious to the intended user. The underlying basis for this is the assumption that manufacturers have the opportunity to instruct anticipated users through manuals and warning literature provided with the product.

With pharmaceuticals, however, it was recognized that patients rely on their doctors to understand the significance of the risks involved and to assess relative advantages and disadvantages of particular drugs. Thus, special product liability protection for drug manufacturers developed. Known as the “learned intermediary” doctrine, it recognized the primacy of the doctor-patient relationship while denying pharmaceutical manufacturers blanket immunity from strict liability and design defect claims to which other manufacturers are subject. The manufacturer discharged its duty to warn the ultimate user by supplying the doctor with information about the drugs dangerous propensities.

The learned intermediary doctrine

Under the learned intermediary doctrine, the sole recourse for defects or injury from undisclosed risk was against the doctor or health care provider who prescribed the medication. The doctor could in turn blame the drug manufacturers for failing to provide sufficient information and warnings to the doctor. The learned intermediary doctrine has at least four premises: reluctance to undermine the doctor-patient relationship; absence of the need for the patient’s informed consent; inability of the drug manufacturers to communicate with and educate patients; and complexity of the product. See Perez, et al. v. Wyeth Laboratories, Inc., 1999 N.J. Lexis 1000 (August 9, 1999).

New and pervasive efforts by pharmaceutical manufacturers to market directly to consumers has weakened the premises that underlay the learned intermediary doctrine. Drug manufacturers now advertise drugs and medical products on the radio, television, and most recently the internet. These efforts have progressed to the point where we are treated to the spectacle of failed presidential candidates confessing sexual dysfunction to millions and urging us to “show courage” and talk to our physician about a prescribed medical cure. Advertisements for prescription drug products as diverse as treatments for hay fever (Claritin) and male pattern baldness (Minoxidil) are now standard fare.

With this direct marketing has come an erosion of the bases for the learned intermediary doctrine. The doctor-patient relationship of today is very different than that in existence even twenty years ago. The use of medications that are subject to advertising are usually elective in nature, so the decision to take a drug is not exclusively a medical one. Perez, 1999 N.J. Lexis 1000 p. 12. Managed care has given physicians less time to inform patients about risks and benefits of drugs, and the doctor’s dual allegiances to his HMO employer and his patient are evident. Certainly, with the billions the pharmaceutical industry is spending on direct marketing, it can no longer argue that it lacks the ability to communicate directly with potential patients. Similarly, the direct marketing campaign belies the longstanding premise that the subject of prescription drugs is too complex to explain to consumers. If it is so complex, the drug companies should not be using 30 second television spots to manipulate consumers into requesting particular medications by name.

The effect of direct marketing on the learned intermediary doctrine

A recent decision by the New Jersey Supreme Court recognized limitations on the learned intermediary doctrine. In Perez, et. al. v. Wyeth Laboratories, et al., plaintiffs sued the manufacturer that had marketed a prescription contraceptive patch through a massive direct advertising campaign, including advertising on television and in print in such magazines as Glamour, Mademoiselle, and Cosmopolitan. No warnings were included in the advertising, which instead emphasized convenience and simplicity. The plaintiffs claimed serious side effects that were not disclosed in the ads. Wyeth asserted the learned intermediary doctrine, arguing that the sole remedy was against the prescribing physicians for failing to obtain informed consent. The trial court agreed, dismissing the cases against the manufacturer. The appellate court agreed, indicating that if the warnings to the physician were considered adequate under New Jersey law, then there was no warning defect for failing to warn the users directly. The New Jersey Supreme Court disagreed, ruling that the learned intermediary doctrine was not a bar to the plaintiffs’ actions.

It is one thing not to inform a patient about the potential side effects of a product; it is another thing to misinform the patient by deliberately withholding potential side effects while marketing the product as an efficacious solution to a serious health problem.

1999 N.J. Lexis 1000, p. 13. The New Jersey court was clear in preserving the learned intermediary doctrine where the traditional model still applies. Had Wyeth simply supplied the prescribing physician with information about the product, and not advertised directly to the patients, there would have been no cause of action directly against Wyeth on an independent “failure to warn” basis.

The Third Restatement of Torts is likely to guide Maine’s response if and when this issue arises. The Third Restatement, section 6, does not address the learned intermediary doctrine directly. It states that a prescribed drug or device is not “reasonably safe” due to inadequate instructions or warnings if these do not set out foreseeable risks of harm in materials provided to the doctors or health care providers in a position to reduce the risk of harm consistent with the warnings. Comment b. to this section, specifically mentions the learned intermediary doctrine favorably, with the duty to inform resting solely on the prescribing physician. But the comment continues:

However, in certain limited therapeutic relationships the physician or other health-care provider has a much-diminished role as an evaluator or decision maker. In these instances it may be appropriate to impose on the manufacturer the duty to warn the patient directly.

This language, in conjunction with section 6(d)(2) (drug or device is not reasonably safe if 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”), will likely be the basis under which the learned intermediary doctrine is challenged in Maine.