Law

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases.  The case is Watts v. Medicis Pharmaceutical Corp., No. cv-15-0065-PR, 2016 WL 237777 (Ariz. Jan. 21, 1016), and the Arizona Supreme Court's unequivocal adoption of the doctrine allows us to check one more state off the list—the number stand at 37 states (plus D.C.) whose highest courts have adopted the LID.  (See our headcount here). 

Having now had the opportunity to take a deeper dive, we can say that the Watts opinion is a solid endorsement of the learned intermediary doctrine and an artful explanation of the doctrine's underpinnings.  But before we get there, we note that Bexis filed an amicus brief in support of adopting the doctrine.  On the other side, the lead author of an amicus brief for the trial lawyers was former Arizona Supreme Court Chief Justice Stanley G. Feldman.  Bexis versus the former Chief?  We like those odds.  We actually worked in Phoenix for a year following law school and became acquainted with Chief Justice Feldman while we clerked in the chambers next door.  This was in the mid-1990s, and while he was a polarizing figure even then because of his background as a plaintiffs' advocate, we came to know him as a brilliant and vigorous individual.  On the learned intermediary doctrine, however, we don't mind saying that the former Chief is wrong and that his successors (and Bexis) got it right.

So what about the Arizona Supreme Court's opinion?  In Watts, the plaintiff took prescription medicine for acne on two separate occasions, each time for 20 weeks, and she allegedly experienced drug-related lupus and hepatitis.  When she later sued the drug's manufacturer, she alleged that the manufacturer failed adequately to warn her of the consequences of the drug's long-term use.  Why did she claim that the manufacturer failed adequately to warn her, the patient, and not the prescribing physician?  We suspect it was because the drug's prescribing information included both lupus and hepatitis under its warnings and precautions.  However, the discount card that the plaintiff herself received from her physician was less specific, stating that "[t]he safety of using [Solodyn] longer than 12 weeks has not been studied and is not known."  Id. at *1.  The trial court granted the manufacturer's motion to dismiss, presumably under an application of the learned intermediary doctrine.

The Arizona Court of Appeals vacated the judgment in an opinion that can be characterized as nothing short of bizarre and that we have covered extensively (here, here, and here).  The Court of Appeals ruled that the learned intermediary doctrine conflicted with the Uniform Contribution Among Tortfeasors Act ("UCATA").  According to that court, the learned intermediary doctrine interferes with the application of comparative fault because it "preemptively limits a manufacturer's duty" and thus conflicts with UCATA's demand that "each defendant in a tort case is liable for his or her own respective share of fault."  Id. at *6.  Of course, the Court of Appeal's opinion completely confused duty and liability with the allocation of fault once liability is found, but we're getting ahead of ourselves. 

The Arizona Supreme Court granted review, vacated the Court of Appeals' opinion, and adopted the learned intermediary doctrine.  The Court was even so kind as to describe exactly what it was going to do at the very beginning of the opinion:

Under the learned intermediary doctrine ("LID"), a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the specialized class of persons who may prescribe or administer the product.  We hold today that the LID generally applies to a prescription drug manufacturer.  We further conclude that the LID is not displaced by the Uniform Contribution Among Tortfeasors Act.

Id. at *1.  As the Arizona Supreme Court reasoned,

The premise for the LID is that certain types of goods (such as prescription drugs) are complex and vary in effect, depending on the end user's unique circumstances, and therefore can be obtained only through a qualified intermediary like a prescribing physician, who can evaluate the patient's condition and weigh the risks and benefits. 

Id. at *3.  Thus, the Court held that the learned intermediary doctrine applies generally to prescription drug manufacturers, and it did not stop there. 

First, the Arizona Supreme Court adopted the learned intermediary doctrine as set forth in the Restatement (Third) of Torts: Product Liability § 6.  We routinely see courts applying the learned intermediary doctrine, but it is less common (though not unprecedented) to see reliance on the Third Restatement.  Here, the Arizona Supreme Court embraced it:  "In our view, the Third Restatement properly states the LID, and therefore we adopt § 6(d) as our expression of it."  2016 WL 237777, at *3.  The court even noted parenthetically that "[a]bsent Arizona law to the contrary, this court will usually apply the law of the Restatement."  Id.

Second, the Arizona Supreme Court rejected the idea that the learned intermediary doctrine creates "blanket immunity" for pharmaceutical manufacturers, reasoning that a patient can still have a claim "if the manufacturer fails to provide adequate warnings to the learned intermediary."  Id. at *4.  This states the obvious.  Warnings-based claims under the LID exist in most every jurisdiction and sometimes are the exclusive basis for liability in prescription drug and medical device cases. 

Third, the Court ruled that the learned intermediary doctrine was not in any way outdated.  The Court of Appeals had found that the rationale underlying the doctrine "was no longer viable," but the Supreme Court ruled that its rationale is as vital as could be.  Quoting the Texas Supreme Court, the Arizona court stated,

Because patients can obtain prescription drugs only through their prescribing physicians . . . 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.

Id. at *4.  When we said at the outset that the opinion was artful, we had this quote in mind.  Maybe "artful," is not the correct word, but we still think this quote captures the underpinnings of the doctrine very nicely in a nutshell.  Moreover, the Arizona Supreme Court expressly rejected the West Virginia Supreme Court's opinion in State ex rel. Johnson & Johnson Corp. v. Karl and correctly characterized that opinion—which found that the learned intermediary doctrine to be outdated—as an outlier.  Id. at *5. 

Fourth, the Court rejected a "direct-to-consumer" advertising exception to the learned intermediary doctrine.  We have always scratched our heads at the "DTC" exception, which exists only in New Jersey.  Even when prescription drug manufacturers advertise to consumers, the product is still available only by prescription, i.e., only from a learned intermediary.  In rejecting a DTC exception, the Arizona Supreme Court held that the learned intermediary doctrine provided sufficient protection to patients under its own terms.  Id. 

Fifth, the Arizona Supreme Court dismantled the Court of Appeals reliance on UCATA, and it did so on the basis that we describe above.  The LID defines the scope of a manufacturer's duty; UCATA governs the allocation of fault once liability is found.  As the Arizona Supreme Court put it,

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.

Id. at *6.  There you have it—apples and oranges. 

Sixth, and certainly not least, the Arizona Supreme Court rejected arguments based on the Arizona Constitution's anti-abrogation clause, which provides that "[t]he right of action to recover damages for injuries shall never be abrogated, and the amount recovered shall not be subject to any statutory limitation . . . ."  Ariz. Const. art. 18, § 6.  Several other states have comparable constitutional provisions, and plaintiffs' lawyers often roll them out in opposition to civil justice reform efforts.  The plaintiffs' lawyers rolled it out here (we are told that Justice Feldman likes the argument).  The Court, however, rolled it right back in, locked the door, and threw away the key.  It held unanimously that the anti-abrogation provision has no effect on the evolution of common-law claims, and the learned intermediary doctrine does not abrogate anything anyway: 

Moreover, the LID does not abrogate a right to recover damages, but instead provides a means for a manufacturer to fulfill its duty to warn the end user by properly warning the learned intermediary. . . .  It does not prevent a plaintiff from asserting an action against the manufacturer in appropriate circumstances, such as when the full medical information and warnings are not given to the medical provider.

Id. at *7.  In other words, plaintiffs can assert a failure-to-warn claim, just not the one they want.  Nothing about that offends the Arizona Constitution, which is welcome commentary on anti-abrogation provisions generally. 

The opinion is terrific, but the result is not a complete win for the drug manufacturer.  The Arizona Supreme Court declined to reinstate the trial court's order dismissing the case and remanded the matter for further proceedings consistent with its opinion.  Perhaps the trial court will dismiss the case again, or maybe the manufacturer will have to raise the adequacy of the warnings or warnings causation on a motion for summary judgment.  Either way, the manufacturer's duty to warn will run to the prescribing physician, and not the patient directly, and that is way it ought to be.