United States: Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary

We've been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that the learned intermediary doctrine ("LID"), which has been adopted in almost every state, was somehow incompatible with the Uniform Contribution Among Tortfeasors Act ("UCATA"), which has been adopted in over half of the states – although no other jurisdiction following both ever thought so. Fortunately, the Arizona Supreme Court granted review, which we hoped would lead to the 37th state high court adoption of the LID.

We weren't disappointed.

Today, the Arizona Supreme Court brought Arizona into the ranks of the vast majority of states that follow the learned intermediary doctrine:

Although the court of appeals has embraced the LID, this Court has not yet addressed the doctrine. In our view, the Third Restatement properly states the LID, and therefore we adopt § 6(d) as our expression of it. Adopting the doctrine places us with the majority of jurisdictions that have considered the matter.

Contrary to [plaintiff's] assertion, the LID does not create a blanket immunity for pharmaceutical manufacturers. . . . [I]f the manufacturer fails to provide adequate warnings to the learned intermediary . . ., a patient could sue and directly recover from a drug manufacturer based on its failure to properly warn the prescribing physician.

[Plaintiff] also asserts, and the court of appeals agreed, that the underlying rationale for the LID is no longer viable. But we find persuasive the reasoning of the Texas Supreme Court in rejecting this argument.

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. . . . 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.

Centocor [v. Hamilton], 372 S.W.3d [140,] 159 [(Tex. 2012)](citations omitted); see also Larkin [v. Pfizer, Inc.], 153 S.W.3d [758,] 763–64 [(Ky. 2004)].

Watts v. Medicis Pharmaceutical Corp., No. CV-15-0065-PR, slip op. at 6-8 (Ariz. Jan. 21, 2016) (lots of other citations omitted).

Predictably, the plaintiff in Watts first urged West Virginia's rejection of the LID in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), with her fallback position being the DTC advertising exception allowed in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1247, 1256 (N.J. 1999). The Arizona high court rejected both. Karl was "not . . . persuasive." Watts, slip op. at 8. "No other court has followed Karl, and several courts have criticized it. Even the West Virginia Supreme Court itself later relegated Karl to a 'but see' citation." Id. (citations omitted). The Perez exception was "adopted only in New Jersey," and was unnecessary, given the Third Restatement's exception for situations where "health-care providers will not be in a position to reduce the risks of harm." Id. at 8-9.

As for UCATA, the Arizona Supreme Court found no incompatibility:

Neither UCATA nor our case law undermines the LID. . . . UCATA's scheme is premised on notions of fault, which necessarily presuppose a breach of duty. Under the LID, however, a manufacturer satisfies its duty to warn the end user by adequately warning the learned intermediary, which duty, if satisfied, means that no actionable breach of a legal duty to the end user occurs. Because the LID and UCATA address two distinct subjects, they are not mutually exclusive. The LID identifies circumstances when a manufacturer has met its duty to warn and thus is not at fault. UCATA does not identify the scope of duties or when parties are at fault; instead, given a determination that multiple parties are at fault, it specifies how liability is apportioned among them.

Watts, slip op. at 10 (citations omitted). "A manufacturer that properly warns the learned intermediary fulfills its duty, a result that comports with UCATA because the drug manufacturer in that circumstance has not breached its duty and therefore is not at fault." Id. (citation omitted).

Finally, plaintiff claimed that the LID violated a provision of the Arizona constitution that tort compensation cannot be "abrogated" and "shall not be subject to any statutory limitation." Id. at 11 (quoting Ariz. Const. art. 18, §6). That was pretty weak, since the LID is not statutory. "Article 18, §6 does not preclude this Court from declaring, clarifying, or modifying the common law, and therefore the LID does not offend that clause." Watts, slip op. at 11. Nor did the LID "abrogate" anything. The LID allows suits "when the full medical information and warnings are not given to the medical provider" and "does not prevent the plaintiff from suing the prescribing medical provider." Id.

We're pleased that the latest threat to the LID has gone by the boards. That makes 37 state (and DC) high courts adopting the rule versus only Karl on the other side. Bexis, is particularly pleased, since he filed an amicus curiae brief in Watts. Bexis is now seven for seven in state supreme court cases involving either adoption or retention of the LID – with the aforementioned Centocor and Larkin decisions that Watts found so persuasive being two of those seven.

This post was first published on the Drug and Device Law Blog.

This article is presented for informational purposes only and is not intended to constitute legal advice.