The Corpus Christi Court of Appeals recently held that the learned intermediary doctrine does not apply to a drug manufacturer that advertises its products to consumers.  In doing so, the court affirmed the plaintiff’s multi-million dollar judgment against the drug manufacturer.

The court’s opinion is rather lengthy and traces the origins of the learned intermediary doctrine in Texas.  Basically, the court found:

  • that the drug manufacturer has a duty to warn consumers about known dangers concerning its product;
  • the learned intermediary doctrine provides an alternate means of fulfilling this duty;
  • other court have recognized exceptions to the doctrine; and
  • the Restatement contemplates situations where the doctrine would not apply.

These factors, coupled with the drastic change by which drugs are marketed, led to this holding:

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 unreasonable to 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 its product.

This opinion raises a number of questions.  One question is why the court considered the doctor’s role and responsibility diminished, as opposed to increased, in light of direct marketing of drugs to consumers.  The court relied in part on the fact that doctors spend less time with patients as a result of managed care to justify its holding.  Second, what is the impact of telling manufacturers that publishing some of the side effects, as opposed all conceivable side effects, constitutes fraud supporting punitive damages?   Are drug manufacturers better off publishing no side effects and leaving that information to doctors?  Is the public better off?  The court noted that the advertisement counseled consumers to consult with their healthcare provider, visit the website for more information, and stated that the advertisement should not be used as a substitute for talking to your doctor.

The court’s opinion in Centocor, Inc. v. Hamilton can be found at this link.