In a previous post, MassTortDefense began analysis of the 5th Circuit’s decision in Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), in which the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. The Court emphasized that the prescriber testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the proposed warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it, but it would not have changed his prescription decision. What about the heeding presumption?
Appellant also contended that, regardless of Dr. Sonn’s testimony, Texas law created a presumption supporting a causal link between Wyeth’s inadequate warning and her husband’s death. The Court rejected that broad argument: Texas law creates no such presumption. In general, when a manufacturer fails to give adequate warnings or instructions, a rebuttable presumption arises that the product user would have read and heeded such warnings or instructions (the “read and heed” presumption). This presumption’s effect is to shift the burden of producing evidence to the party against whom it operates. But, significantly, the Court found that neither Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries. In fact, Texas has explicitly rejected the Restatement (Second) of Torts § 402A, Comment j’s “read-and-heed” presumption for policy reasons, and because it has been superseded by the Third Restatement § 2. See Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 336–37 (Tex. 1998). 2008 WL 1821379 *6. [Indeed the comment 1 to Section 2 calls the prior language “unfortunate.”]
Further, the Fifth Circuit doubted that the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. The read-and heed presumption has been justified because it excuses plaintiff from the necessity of making self-serving assertions that he would have followed adequate instructions, simply to put the issue of causation in sufficient dispute to avoid summary judgment or directed verdict, and it assists plaintiffs in cases where the person injured has died and evidence of what he would have done is unavailable for that reason. In the learned-intermediary context, however, it is the prescribing physician, not plaintiff, who has to testify about his or her decision to prescribe. 2008 WL 1821379 *7.
Moreover, MassTortDefense would point out that applying the read and heed presumption to prescription product contexts confuses two very different warnings: unavoidable risk warnings, and preventable risk warnings. The latter describe risks that can be avoided by the consumer by using a product in certain manner. The former, however, associated with prescription products, can only be avoided if the consumer chooses not to use the product at all. Thus, the question becomes whether the potential benefit of the prescription product outweighs a potential risk. The choice is not between a safe, or less safe use, or unsafe use, of the product, but whether to use the product at all. With prescription products, the FDA has determined that for indicated populations, the risks do not outweigh the benefits. A good albeit older discussion of why the heeding presumption doesn’t make sense in this context is found in Thomas v. Hoffman-LaRoche, 949 F.2d 806, 812-14 (5th Cir. 1992).
Further, even if the presumption applied, it arguably would not have changed the result here. It is a rebuttable presumption, and Dr. Sonn remained firm in stating that even if Ackermann’s proposed “black box” warning had been given to him, he would have considered it — but it would not have changed his decision to prescribe Effexor. For all these reasons, the Fifth Circuit concluded that the district court properly granted summary judgment to Wyeth on appellant’s failure-to-warn and strict-liability claims because she failed to show that an inadequate warning was a producing cause of her husband’s death.