No, we have not been drinking. Yes, we know the title of the post is jumbled. That is because the concepts of the learned intermediary doctrine, consumer protection, and class certification do not normally fit together so well. (See how we were being creative? If the format allowed it, we would channel e.e. cummings in the title with more than just irregular capitalization.) The court in Saavedra v. Eli Lilly & Co., No. 2:12-cv-09366-SVW-MAN, slip op. (C.D. Cal. June 13, 2003), dealt with them all together in a recent order. To further complicate things, the purported class included residents of California, Massachusetts, Missouri and New York and involved claims asserted under six different consumer protection acts from those states. The plaintiffs claimed that the label for defendant’s prescription antidepressant misrepresented the facts about the risk of physical and psychological adverse events when withdrawing from the medication, so the court did a smart thing and asked the parties to brief the issue of whether the learned intermediary doctrine applied to the consumer protection claims being asserted.  

Because the law of four states was at issue and the court took seriously its responsibility of deciding state law while sitting in diversity, what followed was clear endorsement that the learned intermediary doctrine applies to consumer protection claims for prescription drugs. The only case the court had before it from a state court in one of the four states at issue was an unpublished decision in Linnen v. A.H. Robins Co., 2000 WL 89379 (Mass. Super. Dec. 14, 1999), a case well known to us. Even that case, which involved classic prescription drug product liability claims over the death of a young woman, found that the learned intermediary doctrine applied to Massachusetts consumer protection claims. The federal case the court considered, applying the laws of various states, presented a rare clean sweep: every case that took a position held that the learned intermediary doctrine applies to consumer protection claims for prescription drugs or prescription medical devices. The reasoning was put best by the court in that old standby, In re Norplant,“[i]f the doctrine would be avoided by casting what is essentially a failure to warn claim under a different cause of action such as violation of the [state law consumer protection act] or a claim for misrepresentation, then the doctrine would be rendered meaningless.” 955 F. Supp. 700, 709 (E.D. Tex. 1997). We do not see any indication that the Saavedra plaintiffs claimed non-economic injuries to go with their alleged economic injuries, but their claims sounded like run-of-the-mill failure to warn claims. They even based their allegations solely on the content of the package insert, rather than contending that advertising made false claims touting the product’s benefits or minimizing its risks. So, the court held that the learned intermediary doctrine would apply to their claims. Clearly, this is the correct result.

This is where things got somewhat topsy-turvy. To start, despite twenty-one prior references to the “learned intermediary doctrine” and a section heading entitled “Application of the Doctrine to this Case,” the court miscast the doctrine as a defense on which defendant bore the burden of proving “that it adequately warned prescribing physicians of the effects of [the drug’s] withdrawal.” Slip. op. at 6. Then it seemingly reversed itself in saying “Plaintiffs are entitled to additional discovery necessary to demonstrate whether the warnings provided in this case were ‘adequate.’” Id. Huh?

Then the court discussed the impact of the application of the learned intermediary doctrine on class certification, noting that plaintiff ultimately will need to prove causation under both basic failure to warn law and consumer protection law. Causation, of course, is a highly fact-specific inquiry and the court invited further briefing on class certification. The hurdles standing in the way of class certification in cases involving the use of prescription medical products—as opposed to maybe the charges for them and statements about them—are well known, so the result here may be the same with or without the learned intermediary doctrine applied. However, it would have been nice if the court had correctly stated the“individualized assessments” to be reached on proximate cause for failure to warn, which the court said “will necessarily be different” for each plaintiff and proposed class member. Id. at 7.

The first in the non-exclusive list of three causation questions was phrased as “if the individual plaintiff had known about the severity, duration, and extent of Cymbalta withdrawal, would she or he have taken the medication?” Id. No, that is not the first proximate cause question for a prescription drug warning claim, however cast. It probably is not a question at all unless, at a minimum, the prescriber testifies that a different warning in the label would have changed how the risks were relayed to the particular patient by the doctor. Even then, since this is a case about economic injuries rather than physical or psychological injuries, the issue is not whether the individual plaintiffs would have taken the drug, it is whether they would have bought it. (We are pretty sure that the “consumer” in “consumer protection” does not refer to one who ingests a product. Car manufacturers that get sued under consumer protection law might like that definition, though.) Anyway, the decision that the learned intermediary doctrine applies means that the focus for adequacy of warnings and on proximate causation is on information provided to prescribing physicians and the decision-making of the individual prescribing physicians. Anything else would render the decision to apply the doctrine meaningless. We have heard that before, like three pages before.