RxGuest Commentary

by Neha Casturi, a 2013 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.

A federal district court in California is addressing an important issue of first impression:  whether the “learned intermediary” doctrine applies in a consumer class setting. In Saavedra v. Eli Lilly & Co., the plaintiffs alleged that the warning labels on a popular anti-depression, anti-anxiety drug, Cymbalta, were inadequate. The June 13th ruling discussed the viability of the learned intermediary defense in consumer class actions, and also focused the parties on whether the court could certify the class under federal procedural rules.

The allegedly defective Cymbalta label warned consumers that in clinical trials, adverse effects upon “abrupt or tapered” discontinuation were possible. Additionally, the label warned that other Cymbalta-like drugs had the tendency to produce adverse effects upon discontinuation. The Saavedra plaintiffs allege that those warnings did not adequately inform consumers or healthcare providers of the “frequency, severity, and/or duration” of withdrawal symptoms. Plaintiffs have brought their suit under the consumer protection laws of four different states and seek certification of a class action.

Eli Lilly sought summary judgment, and Judge Wilson of the Central District of California instructed the parties to limit their motions to whether the learned intermediary doctrine applied. This doctrine holds, as the Saavedra court related, that a “drug manufacturer cannot be liable for failing to warn the ultimate consumer of potential side-effects of prescription medication, so long as adequate warnings are given to the prescribing physician.”

Case law from the four states under whose laws the plaintiffs sued recognize the learned intermediary defense in suits alleging a drug manufacturer’s failure to warn. No precedents exist, however, on the doctrine’s application in state consumer class actions. Judge Wilson surveyed rulings on that issue from various jurisdictions, finding near unanimity that the doctrine applied in consumer class actions. Thus, he adopted a consistent view in Saavedra and permitted the plaintiffs “additional discovery to demonstrate whether the warnings provided in this case were ‘adequate.’”

Next, the court considered the issue of class certification. It noted that “even if this Court, or a fact-finder, concludes that the warnings were inadequate [which negates defendant’s learned intermediary defense], Plaintiffs would still be required to prove that ‘the inadequacy or absence of the warning caused the plaintiff’s injury.’” Saavedra sought certification of her class under Federal Rule of Civil Procedure 23(b)(3), which requires that “questions of law or fact common to class members [must] predominate over any questions affecting only individual class members.”

Judge Wilson’s opinion clearly intimates that plaintiffs face a difficult task proving predominance in this case because circumstances surrounding each class member’s injury are undoubtedly different and would need individual evaluation to determine whether the warnings, in fact, caused the injury. Furthermore, injuries suffered by class members would vary in nature and degree. Several courts in other jurisdictions have held that the commonality prong was not met in similar lawsuits. Most notably, another federal district court in California, which denied certification in a prescription drug injury case, did so because “individual questions of fact regarding causation nevertheless subvert any benefits to be gained through a class action proceeding.”

Rather than rule at this point on class certification, Judge Wilson requested the parties to brief the predominance requirements and concerns.

The court’s acceptance of the learned intermediary doctrine as a defense in consumer class actions is important and commendable. Plaintiffs seemingly sought to exploit a loophole in the case law of California, Massachusetts, Missouri, and New York by filing the suit as a consumer protection action, instead of a tort law-based failure to warn claim. Judge Wilson’s ruling closes that loophole. From a broader legal policy perspective, because warning labels are not easily understood by lay individuals, physicians must have a responsibility to inform patients of the risks of a drug. Decisions allowing judges or juries to bypass the physician-intermediary’s role and hold manufacturers directly liable for that intermediary’s failure to warn undermine the doctrine’s protective purpose.

Even though Judge Wilson did not rule on certification, the predominance concerns he raises are also significant. Before prescribing Cymbalta, healthcare providers necessarily took numerous variables into account; variables that differ greatly from individual to individual. Thus, the injuries, and circumstances surrounding the injuries will be vastly different for each class member. The presence of these variables undermines the predominance requirement of Rule 23(b)(3). In Smilow v. Southwestern Bell Mobile Systems, Inc., the Fifth Circuit noted that “common issues predominate where individual factual determinations can be accomplished using computer records, clerical assistance, and objective criteria.” Essentially, the task of making these individual determinations would have to be mechanical in order to satisfy predominance. In a case like Saavedra, it is doubtful whether the individual determinations can be made mechanically.