Fulbright Briefing
Julie Alleen Hardin and Darren P. Lindamood
June 18, 2012
Introduction
The learned intermediary doctrine remains alive and well in Texas. In an important decision for the pharmaceutical industry, the Texas Supreme Court rejected the latest attempt to create a direct-to-consumer advertising exception to the doctrine that has guided the industry's duty to warn for decades.
First recognized over 50 years ago,1 the learned intermediary doctrine permits a manufacturer to satisfy its duty to warn end users of the risks associated with a product by providing an adequate warning to an intermediary, for example a healthcare provider, who then assumes the duty to convey the necessary warnings to the patient.2 Courts nationwide have applied the doctrine to pharmaceutical products, reasoning that "the entire system of drug distribution in America is set up so as to place the responsibility of distribution and use upon professional people."3 Patients acquire their prescription through a doctor, who is in the best position to evaluate a medication's warnings, ascertain patient risks, and know the propensities of a given drug.4 The doctor stands between the drug and the patient, and thus the manufacturer need not warn the patient directly.5
With the proliferation of direct-to-consumer ("DTC") marketing, the learned intermediary doctrine came under attack in 1999.6 In Perez v. Wyeth Laboratories, the plaintiffs argued that Wyeth, the maker of Norplant, should not be granted a dismissal based on the learned intermediary doctrine given the company's extensive DTC advertising.7 Wyeth advertised Norplant on TV and in women's magazines — pieces the plaintiffs asserted were aimed at women, not their physicians — but allegedly failed to warn of Norplant's side effects.8 Although the FDA did not cite Wyeth for these ads, the New Jersey Supreme Court reversed Wyeth's dismissal, holding that the learned intermediary doctrine does not apply to the direct marketing of drugs to consumers.9 The court reasoned that "when mass marketing of prescription drugs seeks to influence a patient's choice of a drug, a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product."10 If instead, Wyeth had chosen not to advertise directly to patients, no independent duty to warn patients would have existed.11
In crafting the parameters for the DTC exception, the court recognized a rebuttable presumption that a pharmaceutical company satisfies its duty to warn consumers if it complies with "FDA advertising, warning and labeling requirements."12 The court did not elucidate fully the evidence necessary to overcome the presumption.13 But the court did state that the jury may be charged with deciding whether the absence of information or presence of misinformation violated FDA requirements, and whether such violations were a substantial factor in causing the plaintiffs' harm.14
After Perez, no longer can a pharmaceutical manufacturer that engages in DTC advertising expect a New Jersey court to look only to the adequacy of the warnings provided healthcare providers, without regard to the alleged duty owed to and marketing aimed at patients.15 As predicted, the decision in Perez encouraged more challenges to the learned intermediary doctrine. Since the opinion was issued, however, no court to consider the DTC advertising exception has followed New Jersey's lead — not until the Corpus Christi Court of Appeals issued its opinion in Centocor.16
Centocor v. Hamilton
When Ms. Hamilton developed complications after taking the prescription drug Remicade for her Crohn's disease, she sued the manufacturer, Centocor, for failing to warn her that Remicade had the risk of causing a lupus-like syndrome.17 The Remicade package insert included a precaution for "the development of a lupus-like syndrome,"18 but Ms. Hamilton asserted that Centocor was obligated to warn her directly. Relying on an informational video she watched at the clinic when she received her first infusion, Ms. Hamilton urged that Centocor misled her and downplayed the risks because "lupus-like syndrome" was not identified as a possible side effect in the Centocor video.19 The trial court rejected Centocor's argument that, based on the learned intermediary doctrine, it owed no duty to warn Ms. Hamilton directly.20
The jury found Centocor liable for fraud, negligent misbranding, negligent marketing to Plaintiff's doctors, misrepresentation to Plaintiff's doctors, and negligent undertaking.21 When Centocor appealed, the Corpus Christi Court of Appeals affirmed the judgment, explaining that "the theoretical underpinnings of the 'learned intermediary' doctrine do not apply when a drug manufacturer directly markets to its consumers."22 Following Perez, the court created an exception to the learned intermediary doctrine for manufacturers who engage in DTC advertising.23
The Texas Supreme Court granted Centocor's petition for review, reversed the court of appeals, and rendered judgment for Centocor on all of plaintiff's claims. Embracing its first opportunity to apply the learned intermediary doctrine in the pharmaceutical context, the unanimous Texas Supreme Court held 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."24 The court rejected Ms. Hamilton's urging to adopt a DTC advertising exception, holding that the learned intermediary doctrine applied to all of her claims.25 In reaching its conclusions, the court recognized that the underlying rationale for the learned intermediary doctrine remains just as viable today as it has for decades.26
Applying the doctrine to the evidence presented, the court explained that Ms. Hamilton failed to meet her burden of proof at trial.27 While she may have offered sufficient evidence that the Remicade warning was inadequate, she presented no evidence that her physicians' decision to prescribe Remicade was due to the allegedly inadequate warning, or that her physicians would have acted differently had a different warning been provided.28 The court considered testimony that the prescribing physician would have considered additional information not included in the package insert insufficient to establish that such information would have changed the physician's prescribing decision.29 Having failed to satisfy her burden of proving that Remicade's allegedly inadequate warning was the producing cause of her injuries, the court entered a take nothing judgment for the plaintiff.30
While the Texas Supreme Court's opinion should be heralded as the right result, a detailed parsing of the language chosen leads to a word of caution. In describing its conclusions, the court was consistently careful to base its holding on the "facts of this case" and "on this record."31 In distinguishing Perez, the court emphasized that the Remicade instructional video was shown after the infusion process had begun and was "not the type of misleading DTC advertizing that concerned the Perez court."32 Instead of making direct claims to consumers regarding the product's efficacy, the video was more akin to an "educational tool" that was "available to help patients feel more relaxed about the infusion process, by explaining some of the benefits and side effects of the treatment process."33 The court reached its holding "without deciding whether Texas law should recognize a DTC advertising exception when a prescription drug manufacturer distributes intentionally misleading information directlyto patients or prospective patients."34
Plaintiffs could seize on this language to argue that the court left open the possibility that a different record could and should support the creation of a DTC exception to the learned intermediary doctrine. But in most jurisdictions, the learned intermediary doctrine remains the standard by which failure to warn claims will be judged.
[1] See generally Sterling Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966); Marcus v. Specific Pharms., 77 N.Y.S.2d 508, 509 (N.Y. Sup. Ct. 1948).
[2] Centocor, Inc. v. Hamilton, No. 10-0223, slip op. at 22 (Tex. June 8, 2012),available at http://www.supreme.courts.state.tx.us/historical/2012/jun/100223.pdf.
[3] Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex. Civ. App.—Corpus Christi 1973, writ ref'd n.r.e.).
[12] Id. at 1259.
[13] The court indicated that "for all practical purposes, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of [failure to warn] claims." Id.
[16] Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App.—Corpus Christi 2010) vacated, No. 10-0223, 2012 WL 2052783 (Tex. June 8, 2012); see also, e.g., In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 812 (N.D. Ohio 2004) ("[N]o other state has followed New Jersey's lead."); In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 812 (E.D. Tex. 2002) ("New Jersey law is in direct conflict with the law of every other jurisdiction in the United States."). But see Murthy v. Abbott Labs., Civ. Action No. 4:11–cv–105, 2012 WL 734149, at *8 (S.D. Tex. Mar. 6, 2012) ("Given the underlying justifications for the learned intermediary doctrine, the Court believes that the Texas Supreme Court will likely agree with the Court of Appeals' reasoning in Centocor, Inc."); Rimbert v. Eli Lilly & Co., 577 F. Supp. 2d 1174, 1222 (D. N.M. 2008) ("The Court believes that the Supreme Court of New Mexico, given the opportunity in 2008, would not adopt the learned-intermediary doctrine, because of the erosion of the justifications for adoption of the doctrine, given the changing dynamics between doctors and patients, patients' self-diagnosis, and DTC advertising by drug manufacturers."); State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 910 (W. Va. 2007) ("In rejecting the application of the learned intermediary doctrine to drugs that had been the subject of direct-to-consumer advertising, the Supreme Court of New Jersey opined, and we agree, that such advertising obviates each of the premises upon which the doctrine rests.").
[24] Centocor, Inc., No. 10-0223, slip op. at 28. The court noted that Texas Civil Practices & Remedies Code § 82.007 did not apply because the statute became effective after the suit was filed. See id. at 33 n.19. This statute creates a rebuttable presumption that compliance with FDA-approved guidelines shields the "healthcare provider, manufacturer, distributor, and prescriber" from liability for "allegations involving failure to provide adequate warnings or information." Id. (quoting Tex. Civ. Prac. & Rem. Code § 82.007).
[26] Id. at 29 (citing Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974) ("Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a 'learned intermediary' between manufacturer and consumer.")).
Julie Alleen Hardin
Darren P. Lindamood
