Reference no: EM131274375

Centocor, Inc. (Plaintiff-Appellant) v. Patricia Hamilton (Respondent)
Texas Court of Appeals, Thirteenth District 310 S.W.3d 476; 2010 WL 744212 (2010)
Patricia Hamilton, 47, began taking Remicade for her Crohn's disease in December 2001. Remicade is manufactured and marketing by Centocor, Inc. Crohn's disease is an inflammatory disease of the intestines. The following year, Hamilton developed drug-induced lupus. Lupus is a chronic autoimmune connective disease that can affect any part of the body

Hamilton sued Centocor, claiming that the company failed to warn doctors of the drug's risks. Hamilton had watched a company-provided videotape about Remicade treatment that did not list lupus-like syndrome as a potential side effect. Instead, the videotape indicated that Remicade changed patients' lives. Hamilton thought she would feel great after the Remicade treatments, like the patients who shared their stories in the videotape.

A Corpus Christi jury found that Centocor was liable for fraud. The jury awarded Hamilton $4,687,461.70 in actual and punitive damages. The jury awarded Thomas Hamilton, Patricia's spouse, $120,833.71 in actual and punitive damages.

On appeal, Centocor argued that the learned intermediary doctrine precludes the Hamiltons'recovery because, as a matter of law, Centocor's warnings to Patricia's physicians were adequate. Centocor argued that it had no duty to warn Patricia directly. In the decision excerpted here, the appellate court rejects Centocor's argument and recognizes an exception to the learned intermediary doctrine when a drug manufacturer engages in direct-to-consumer advertising that fraudulently touts the drug's efficacy while failing to warn of its risks

Justice Yáñez
The changes in the delivery of healthcare brought about by direct marketing and managed care demonstrate that the theoretical underpinnings of the "learned intermediary" doctrine do not apply when a drug manufacturer directly markets to its consumers, the patients.

First, although a doctor must still write a prescription for prescribed drugs, it is clear that many doctors are not spending the amount of time necessary to pass along warnings by pharmaceutical companies. The problem this creates is compounded by the fact that patients [now] make the ultimate decisions regarding the drugs they will take and will often ask for drugs by name.

Second, drug manufacturers who directly market their products to consumers are hard-pressed to argue that only a physician would understand the propensities and dangers involved and that they lack effective means to communicate directly with consumers. In fact, by directly marketing to consumers and providing warnings in those advertisements, drug manufacturers have completely undermined their own arguments.

Third, and similarly, it is illogical that requiring manufacturers to provide direct warnings to a consumer will undermine the patient-physician relationship when, by its very nature, consumer-directed advertising encroaches on that relationship by encouraging consumers to ask for advertised products by name.

In sum, the premises underlying the doctrine are unpersuasive when considered in light of direct marketing to patients. The situation presented is more similar to the recognized exceptions to the doctrine, where courts considering the issue have found it was unreasonable for a manufacturer to rely on an intermediary to convey a warning, given that direct advertising and changes in the provision of healthcare impact the doctor's role and promote more active involvement by the patient. Under these circumstances, we hold that when a pharmaceutical company directly markets to a patient, it must do so without fraudulently misrepresenting the risks associated with the product.

CRITICAL THINKING ABOUT THE LAW
Please refer to Case 6-3 and consider the following questions:

1. If you were charged with defending a pharmaceutical company, what would you advise the company to do to encourage a court in a future case to reject the learned intermediary doctrine?
Clue: Think about what you would ask both patients and doctors during the discovery process about the facts that led the doctor to prescribe a particular drug to a patient.

2. In rejecting the learned intermediary doctrine, which ethical norm is the court showing it prefers?
Clue: Figure out who benefits from the court's decision and how this group benefits.