The U.S. Supreme Court recently issued its opinion in Mutual Pharmaceutical Co. Inc. v. Bartlett. Bartlett involved a claim by a woman who contracted Stevens-Johnson syndrome, a bizarre and rare reaction to an alleged wide variety of drugs (including over-the-counter drugs) that causes necrosis of the skin, following consumption of a generic anti-inflammatory drug. The primary holding of Bartlett continues the Supreme Court’s recent trend of immunizing generic drug manufacturers from liability based upon FDA requirements that the generic be substantially equivalent in design to the “innovator” or branded version of the drug, and that it contain the same labeling as approved for the branded version.
While Bartlett is expressly limited to the generic drug context, it presents a tantalizing glimpse of the Court’s potential receptiveness to similar arguments regarding supposed feasible safer alternative design in the context of branded pharmaceuticals. The Court noted that redesign of the generic drug was not possible for two reasons, the first being requirements that the generic be equivalent to the branded drug, but the second, and more interesting to branded manufacturers, being that an alteration to the chemical composition of the drug results in an entirely different drug that would require new FDA approval. Slip Op. at 10-11.
We have long argued that any drug design defect claim should be barred as a matter of law, because any “alternative design” of a drug is an entirely different drug from the one approved by the FDA. Any opinion that a drug is “defectively designed” is simply an opinion that the FDA should never have approved the drug.
Modification of a drug’s chemical formulation results in a different drug, not an “alternatively designed” drug, with potentially different pharmacological effects, and which would be subject to an individualized FDA approval process and clinical testing. Any argument that this is the better “alternative design” presupposes that the FDA would have approved such a formulation, which is almost always pure conjecture if the alternative drug is not presently marketed. No expert can honestly opine that approval would have been granted without engaging in pure, unfounded speculation. The FDA is solely vested with authority to approve or disapprove the drug application. Drug approval is a years-long give-and-take process between the manufacturer and the FDA, based upon the subjective analysis of the FDA, which cannot be replicated by plaintiffs’ experts in a courtroom. Indeed, the truckloads of data (including the phases of clinical testing) necessary to be developed for drug approval could never be replicated by plaintiffs’ experts and have never been developed by them.
Drug designs aredifferent from other product designs. The Restatement (Third) of Torts: Products Liability § 6(c) recognizes the logical disconnect in applying the common law rule regarding a “safer alternative design” in the drug product case. Under the Restatement (Third) § 6(c), plaintiffs may establish defectiveness by showing that safer alternative drugs were available on the market, which reasonable health care providers would have prescribed in place of a defendant’s drug for all classes of patients.
But proposing a different drug formulation is proposing a different drug, not proposing an “alternative design” for an existing drug, and there are pharmacological as well as regulatory reasons why plaintiffs should not have the same unfettered ability to propose “alternative designs” for drug products as they would for other types of product. In jurisdictions that require plaintiffs to prove a “feasible safer alternative design,” the feasibility of a proposed alternative design must require plaintiffs to prove that such a formulation could be marketed and sold in the U.S. (i.e., that it would receive FDA approval). To take such matters outside of the realm of pure speculation, this means, practically, that only already-marketed alternatives should be considered in assessing whether the drug at issue is defectively designed. See, e.g., Williams v. Ciba-Geigy Corp., 686 F. Supp. 573, 578 (W.D. La. 1988), aff’d 864 F.2d 789 (5th Cir. 1988); Ortho Pharm. Corp. v. Heath, 722 P.2d 410, 416 (Colo. 1986).
Still, this leaves the question of second-guessing the FDA’s approval of the drug in question. While the Supreme Court has not yet been receptive to the preemption of claims against innovator pharmaceutical defendants in the same manner in which it has barred claims against pre-market approved medical devices, any “design defect” claim in the context of an extensively regulated, thoroughly-reviewed product like a prescription drug necessarily comes down to an argument that the FDA erred in approving the drug in question, which should be a preempted claim. See Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir 1990) (the courts are not empowered to “usurp” the power of the FDA); see also Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4 (2001).
We look forward to seeing whether any defendants seize upon the Bartlett opinion’s recognition that an “alternative design” of a branded drug results in a different drug entirely. If you have made such arguments, please feel free to contact us (especially if you can brag about your results).