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June 2012

Texas Supreme Court Rejects "Direct-to-Consumer Advertising Exception" to Learned Intermediary Doctrine

In Centocor, Inc. v. Hamilton,1 a unanimous Texas Supreme Court reaffirmed the "learned intermediary doctrine," whereby a prescription drug manufacturer generally has no duty to directly warn a patient who receives its drug about the medication's potential risks.  The manufacturer instead fulfills its duty under Texas law by providing adequate warnings about the drug's possible side effects to the prescribing physician, who then acts as a "learned intermediary" between the manufacturer and the patient in assessing the medication's potential risks and benefits.  The Hamilton Court refused to adopt a "direct-to-consumer advertising" or "mass marketing" exception to the learned intermediary rule, reversing the Texas intermediate court of appeals.  Hamilton brings Texas into line with the majority of States that have declined to permit a cause of action against a prescription drug maker where the manufacturer provides adequate warnings about a drug's risks to the prescribing doctor.

Hamilton involved the prescription drug Remicade, which is manufactured by Centocor and approved by the FDA for the treatment of Crohn's disease.  The FDA-approved labeling for Remicade warned that patients taking the drug could develop an auto-immune condition known as "lupus-like syndrome."  The plaintiff's physicians were aware of this risk, but chose to prescribe Remicade to treat the plaintiff's condition.  The plaintiff was then referred to a separate infusion clinic where the drug was administered intravenously.  While at the clinic and receiving the infusion, the plaintiff watched an informational video supplied by Centocor that allegedly over-emphasized Remicade's benefits and omitted a warning about lupus-like syndrome.  The plaintiff later developed the condition and sued Centocor over alleged misrepresentations in the video.  Centocor argued that it discharged its duty to warn under the learned intermediary doctrine by providing adequate warnings to the plaintiff's prescribing doctors, who then used their medical training and experience to determine whether the drug was an appropriate treatment.  But the trial court permitted the plaintiff's claims to proceed and the jury returned a multi-million dollar compensatory and punitive damages award.      

Centocor appealed the jury's verdict to Texas's Thirteenth Court of Appeals, which rejected Centocor's argument that the learned intermediary rule barred the plaintiff's claims.2 The court of appeals held that the rule does not bar liability where a manufacturer directly provides the plaintiff with information that purportedly over-emphasizes a drug's benefits and omits warnings about adverse side effects. 

The Texas Supreme Court granted review, reversed this portion of the court of appeals' decision, and rendered judgment for Centocor.  The Court confirmed that the learned intermediary doctrine applied, holding "that a prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly."3

Because patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary and because the 'learned intermediary' is best suited to weigh the patient's individual needs in conjunction with the risks and benefits of the prescription drug, we are in agreement with the overwhelming majority of other courts that have considered the learned intermediary doctrine and hold that, within the physician-patient relationship, the learned intermediary doctrine applies and generally limits the drug manufacturer's duty to warn to the prescribing physician.4

The court also clarified that the learned intermediary doctrine is a common-law rule rather than an affirmative defense.5  "While the learned intermediary doctrine shifts the manufacturer's duty to warn the end user to the intermediary, it does not shift the plaintiff's basic burden of proof" on the elements of a failure-to-warn claim.6  

The Hamilton court then reversed the lower court's adoption of a direct-to-consumer ("DTC") advertising exception.  Although the court acknowledged that there may be extreme cases where an exception is warranted,7 it concluded that Hamilton was not such a case.  The plaintiff had barely heard of Remicade before her doctors prescribed it and she did not watch the allegedly misleading video until she was already receiving an IV infusion of the drug.8  Furthermore, it found no need for such an exception generally:

[W]e believe that patients who seek prescription drugs based solely on DTC advertising will obtain them only when the prescribing physician has evaluated the potential risks and benefits for the particular patient.  To safeguard the public from harmful products and misleading advertising, both the federal government and Texas law regulate the design, marketing, and distribution of prescription drugs. . . .  Drug manufacturers that fail to comply with FDA regulations can face criminal fines and imprisonment as well as civil penalties. . . .  Although pharmaceutical companies have increased DTC advertising since courts first adopted the learned intermediary doctrine, the fundamental rationale for the doctrine remains the same: prescription drugs require a doctor's prescription and, therefore, doctors are best suited to communicate the risks and benefits of prescription medications for particular patients through their face-to-face interactions with those patients.9

The Hamilton court also recognized that a plaintiff could not avoid application of the learned intermediary rule by characterizing her claim as sounding in fraud rather than in product liability:

[T]he crux of the Hamilton's claim rests on Centocor's alleged failure to provide an adequate warning of the potential risks and side effects associated with Remicade.  We hold that when a patient alleges a fraud-by-omission claim against a prescription drug manufacturer for alleged omissions about a prescription drug's potential side effects, (1) the patient cannot plead around the basic requirements of a failure-to-warn claim, and (2) the learned intermediary doctrine applies.10

Finally, the Hamilton court found that any deficiency in Centocor's warning to the doctors was not a producing cause of the plaintiff's injuries:

[W]hen the prescribing physician is aware of the product's risks and decides to use it anyway, any inadequacy in the product's warning, as a matter of law, is not the producing cause of the patient's injuries. . . .  It is undisputed that all of [Plaintiff's] medical providers were aware that [Plaintiff] could potentially develop lupus-like syndrome as a side effect of Remicade.  [Plaintiff] presented no evidence that [the] prescribing physicians or [Plaintiff] would have acted differently if Centocor provided a different warning that included [additional information].11

Because the plaintiff failed to present this proof, the court reversed the court of appeals' decision and rendered judgment in Centocor's favor.

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1 Centocor, Inc. v. Hamilton, No. 10-0223 (Tex. June 8, 2012).
2 See Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App.–Corpus Christi 2010).
3 Slip op. at 28 (citations omitted).
4 Id. at 30.
5 Id. at 38-39.
6 Id. at 41.
7 See id. at 35.
8 Id. at 35-36. 
9 Id. at 37-38 (internal citations omitted).
10 Id. at 47-48 (footnote omitted). 
11 Id. at 49-50 (internal citations omitted). 

Drug & Medical Device


Drug & Medical Device