The Learned Intermediary Doctrine: Uniformity at Last?

In the States

Cases nationwide are expanding the application of the doctrine to proximate cause as well. In the context of “warning causation,” the learned intermediary doctrine provides a key additional defense to companies by hinging their liability on the prescribing decision of the plaintiff's doctor.

West Virginia's Legislative Action

In June 2007, the West Virginia Supreme Court of Appeals issued an opinion rejecting the learned intermediary doctrine, holding that the duty to warn consumers applied equally to manufacturers of prescription medicines as to manufacturers of other products. State ex rel. Johnson & Johnson Corp. v. Karl, 220 W. Va. 463, 478 (2007). The majority of the court determined that, with the proliferation of direct-to-consumer (DTC) advertising, patients now take an active role in their health care decisions. As a result, the court believed that manufacturers could explain the risks and benefits of medicines directly to patients, “obviat[ing] each of the premises upon which the [learned intermediary] doctrine rests.” Id. at 474-75. The court did not, however, limit its holding to products that had been advertised to consumers. Id. at 478.

By contrast, other states to consider a DTC advertising exception to the learned intermediary doctrine have either rejected it ( see Centocor Inc. v. Hamilton, 372 S.W.3d 140, 163-64 (Tex. 2012)) or limited it to situations in which the medication was advertised to consumers and where the particular plaintiffs at issue were affected by that advertising (see Perez v. Wyeth Labs., Inc., 734 A.2d 1245, 1257, 1260 (N.J. 1999)).

A number of West Virginia federal courts attempted to narrow Karl's scope. See, e.g., Roney v. Gencorp, 654 F. Supp. 2d 501, 505 (S.D. W. Va. 2009) (explaining that “[t]he reasoning [of Karl ] is not applicable to a scenario outside the prescription pharmaceutical context and the risk of direct-to-consumer advertising”); Tyree v. Boston Sci. Corp., 56 F. Supp. 3d 826, 832 (S.D.W. Va. 2014) (applying the learned intermediary doctrine and distinguishing Karl on the basis that the defendant did not directly advertise to consumers and the product was a medical device requiring implantation by a physician rather than a consumed prescription drug). Nevertheless, Karl was still considered broadly applicable throughout the state. See, e.g., Muzichuck v. Forest Labs., Inc., 2014 WL 3530367 (N.D. W. Va. July 15, 2014). Courts even refused to apply the learned intermediary doctrine from other states under choice-of-law theories, holding that it was contrary to West Virginia public policy. See Vitatoe v. Mylan Pharms., Inc., 696 F. Supp. 2d 599, 610 (N.D. W. Va. 2010).

In response, the West Virginia legislature took action to abrogate Karl . A 2011 bill seeking to codify the learned intermediary doctrine passed, but only after being amended to mandate the application of the law of the place of injury on duty-to-warn issues. In other words, the learned intermediary doctrine would apply to the claims of non-West Virginia residents, but not to plaintiffs from West Virginia itself. See W. Va. Code. ' 55-8-16. A broader bill failed in 2015 at the House Judiciary Committee. See S.B. 377, 2015(RS) (W. Va. 2015).

On Jan. 13 of this year, however, Senators Gregory L. Boso (R) and Ed Gaunch (R) introduced Senate Bill 15, the purpose of which was “to adopt and codify the learned intermediary doctrine as a defense to a civil action against a manufacturer or seller of a prescription drug based upon inadequate warnings or instructions.” The bill was passed by both houses of the West Virginia Legislature, with modifications, in February, and signed into law by Governor Earl Tomblin on February 25. It is now codified at ' 55-7-30 of the Code of West Virginia, titled, “Adequate pharmaceutical warnings; limiting civil liability for manufacturers or sellers who provide warning to a learned intermediary.”

The new law provides in subpart (a): “A manufacturer or seller of a prescription drug or medical device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves, among other elements, that: (1) The manufacturer ' acted unreasonably in failing to provide reasonable instructions or warnings regarding foreseeable risks of harm to prescribing or other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; and (2) Failure to provide reasonable instructions or warnings was a proximate cause of harm.” It also explicitly emphasizes in subpart (b) that, for the purposes of the learned intermediary rule, no distinction exists between failure to warn claims for prescription medicines and medical devices.

Arizona Judicially Adopts the Doctrine

Before 2015, Arizona appellate courts had long implemented the learned intermediary doctrine without disagreement from the Arizona Supreme Court. See, e.g., Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993), review denied (Ariz. Nov. 1, 1994); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978), review denied (Ariz. May 2, 1978). It came as a surprise, therefore, when the Arizona Appellate Division held last January in Watts v. Medicis Pharmaceutical Corp. that the doctrine was both inconsistent with the Uniform Contribution Among Tortfeasors Act (UCATA) and outdated in light of DTC advertising. 342 P.3d 847, 854-56 (Ariz. App. 2015).

In Watts, the plaintiff took two 20-week courses of a prescription medicine for acne, after which she developed allegedly drug-induced lupus and hepatitis. Watts v. Medicis Pharm. Corp., 2016 WL 237777, at *1 (Ariz. Jan. 21, 2016). Even though those risks were listed in the full prescribing insert, the plaintiff only received information that the safety of using the medicine for longer than 12 weeks was unknown. Id . The Plaintiff filed a lawsuit alleging, inter alia , that the manufacturer failed to adequately warn her of the consequences of the medicine's long-term use. Id. at *2.

Overturning the superior court's grant of dismissal, the Appellate Division found that the plaintiff's claim could proceed on the basis that she personally had not been adequately warned. Otherwise, the Appellate Division noted, the pharmaceutical manufacturer would be “shielded from liability,” contravening UCATA's requirement that parties in the chain of distribution have fault proportionally apportioned to them. Watts, 342 P.3d at 855.

The Arizona Supreme Court reversed the Appellate Division's ruling a year later, conclusively reinstating the learned intermediary doctrine in Arizona. The court explained the principles and policies underlying the rule, emphasizing that the prescribing physician “is best suited to weigh the patient's individual needs in conjunction with the risks and benefits of the prescription [medicine].” Watts, 2016 WL 237777, at *4 (quoting Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 159 (Tex. 2012)). In so holding, the court expressly rejected the reasoning provided by the West Virginia Supreme Court, noting that it does “not find Karl persuasive.” Id. at *5. Accordingly, it refused to adopt a DTC advertising exception and noted that the rule “sufficiently protects consumers” by providing a cause of action for failure to adequately warn the prescribing physician. Id . Moreover, the court disagreed that the learned intermediary doctrine conflicts with UCATA because the latter focuses on “fault,” which presupposes a breach of duty. The learned intermediary doctrine, by contrast, defines conditions under which no breach occurs. Id. at *6.

Learned Intermediary and Proof of Causation

In addition to defining the duty of drug and device manufacturers, the learned intermediary doctrine also provides a framework for assessing proximate cause that underscores the critical role of the prescribing physician. Several recent decisions highlight the central role of the doctrine.

The failure to establish warning causation through testimony from a learned intermediary led to the recent dismissal of 31 cases from a New Jersey multicounty litigation. See In re Accutane Litigation, No. 271, slip op. at 36 (N.J. Super. Law Div. Jan. 29, 2016). The parties agreed that the learned intermediary doctrine applied to issues of warning causation, but disagreed on the standard: The defense argued that if the prescribing physician would still have recommended or prescribed the medication even given a different warning, the claim could not stand. The plaintiffs argued that a stronger warning would have caused their physicians to conduct a different risk/benefit discussion with them, causing them in their capacities as informed patients to refuse their prescriptions. Id. at 4-5.

Rejecting the plaintiffs' argument, the court recognized a consideration not normally discussed in court opinions: that due to human nature, “the patient is likely to testify that she/he would never have taken the medication had they known then, what they know now.” Id. at 7. The court determined that in each case the plaintiff was a “'willing patient' who only thought differently about taking the medicine after acquiring new information through the litigation process,” and that the physicians would have made the same prescribing decision with a stronger warning. Id. at 9. Because of the learned intermediary doctrine, the court refused to allow the plaintiffs the benefit of “hindsight” and granted summary judgment. Id. at 9, 36. This decision, which applied the laws of New Jersey, Kansas, Louisiana, California and Texas, was consistent with two prior New Jersey appellate rulings applying the laws of Florida and California. See Gaghan v. Hoffmann-La Roche Inc., 2014 N.J. Super. Unpub. LEXIS 1895 (N.J. App. Div. Aug. 4, 2014); Sager v. Hoffmann-La Roche Inc., 2012 N.J. Super. Unpub. LEXIS 1885 (N.J. App. Div. Aug. 7, 2012).

Although the distinction between the doctor's prescribing decision and the ultimate choice of the plaintiff to refuse a medication is not presented as squarely in other recent cases, they nonetheless reaffirm that warning causation hinges on prescribing decision. In In re Avandia Marketing, Sales Practices & Product Liability Litigation, 2016 WL 574074 (3d Cir. Feb. 12, 2016), the U.S. Court of Appeals for the Third Circuit reaffirmed that in order to prove a failure-to-warn claim, “a plaintiff must establish proximate cause by showing that had the manufacturer issued a proper warning to the plaintiff's prescribing physician, the physician would not have prescribed the drug to the plaintiff and the injury would have been avoided.” Id. at *3. The court cited precedent in Pennsylvania law demonstrating that a physician has a duty to make an independent medical judgment and to understand a drug's characteristics. Where the physician testified clearly that he would have prescribed the medication in question for the plaintiff again based on his current knowledge of the risks of the medication, summary judgment was warranted. See id. at *4.

Finally, a Mississippi court reached the same conclusion in Estes v. Lanx, Inc., 2015 WL 9462964, at *3 (N.D. Miss. Dec. 23, 2015). In Estes , the plaintiff filed a lawsuit after two pedicle screws fractured within five months of his spinal fusion surgery. Id. at *1. The Plaintiff alleged, inter alia, that the manufacturer not only failed to warn about the medical risks associated with the procedure, but also that it had breached a duty to inform the hospital and the attending physician that the spinal fixation system had not been properly cleared. Id. at *3. The court granted summary judgment because the treating physician testified that he was aware of the risks of device failure and that he still used the product. Moreover, the court found that the plaintiff “failed to put forth evidence that the treating physician would not have used this product had he known of the alleged lack of FDA clearance for the device or components of the product.” Id.

A More Uniform Landscape

The adoption of the learned intermediary doctrine by the two former “holdout” states produces a new level of nationwide consistency that recognizes the critical role of the physician in making prescribing decisions. Moreover, recent warning causation decisions provide clarity on the evidence required to establish the proximate cause element. In light of the practical difficulties that often preclude manufacturers from communicating the full range of risks associated with a medicine to lay consumers, these developments appropriately limit manufacturer liability while preserving the physician/patient relationship from outside interference.

Emily Ullman and Annie Wang are litigation associates in the DC office of Covington & Burling LLP. They can be reached at [email protected] and [email protected].