A number of our previous blog posts (here, here, and here) discussed the Supreme Court’s decision in Pliva v. Mensing, which held that state failure-to-warn claims against generic drug manufacturers were preempted by the Federal Food, Drug, and Cosmetic Act, particularly the 1984 Hatch-Waxman Amendments.  Our most recent post on the topic was Metz v. Wyeth in which the Middle District of Florida applied Mensing and found preemption for a number of product liability claims for recovery but did not find preemption for claims of breach of implied warranties.  

Bartlett v. Mutual Pharmaceutical Co., Inc. is another recent application of Mensing--this time from the First Circuit Court of Appeals. In Bartlett, the First Circuit held that a state design defect claim against a generic drug manufacturer was not preempted under Mensing.  In Bartlett, the First Circuit refused to extend Mensing preemption to design defect claims declaring “that it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims.”  While the court's conclusion in itself is interesting in the context of pharmaceutical products liability, the court's reasoning is really what gives pause--namely, that the generic drug manufacturer did not have to manufacture and sell the drug in the first place.

Bartlett involved the generic drug sulindac, a Non-Steroidal Anti-Inflammatory Drug (“NSAID”).  Karen Bartlett was prescribed the brand name drug “Clinoril” for shoulder pain, but was given the generic sulindac by her pharmacist.  As a result of ingesting sulindac, manufactured by Mutual Pharmaceutical, Ms. Bartlett developed Stevens-Johnson Syndrome and toxic epidermal necrolysis.  This resulted in the deterioration of the 65% of the outer layer of her skin and near blindness.  Based on the extent and permanency of Ms. Bartlett’s injuries, the First Circuit concluded: “Bartlett's injuries were truly horrific.”  Bartlett brought a number of claims against the generic drug manufacturer, Mutual.  She received a substantial jury verdict which was appealed on a number of grounds.  In this post, we review the First Circuit’s handling on appeal of the design defect claim only. 

The court begins by noting that courts “traditionally have refused to review the reasonableness of the designs of prescription drugs.”  However, the court found that New Hampshire law permits such review—namely, liability can be found  for selling “any product in a defective condition unreasonably dangerous to the user or consumer when the product causes injury to the user or consumer.”  Mutual countered with Buckingham v. R.J. Reynolds Tobacco Co. which required not merely unreasonable dangerousness but proof that an alternative, safer design exists.  However, Mutual argued that the plaintiff's claim failed because there could not possibly be an alternative, safer design because sulindac could not be made in a different and safer form—“sulindac is a one-molecule drug; and the variations in suldinac as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.”  

The court first dismissed Mutual's interpretation of Buckingham in that an allegation of a safer alternative design was necessary for a design defect claim.  In turning to the issue of preemption, the First Circuit noted that Mensing only preempted failure-to-warn claims because generic manufacturers, unlike brand name manufacturers, cannot unilaterally change their label.  Under similar logic, Mutual argued “with some force” that a generic manufacturer cannot alter the chemical composition of its drug either and thus Mensing should preempt state design defect claims also.  The First Circuit remained unconvinced since Mutual could have refrained from selling the drug to begin with:

But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context….

And, not only has the Supreme Court not yet said it would extend [Mensing's] exception to design defect claims, but—while the generic maker has no choice as to label—the decision to make the drug and market it in New Hampshire is wholly its own. Thus, Bartlett having lost her warning claim by the mere chance of her drug store's selection of a generic, the Supreme Court might be less ready to deprive Bartlett of her remaining avenue of relief.

True, such arguments can be turned on their head.  To refuse preemption here is…in tension not with the holding but with part of [Mensing’s] rationale; [however,] a generic maker can avoid defective warning lawsuits as well as design defect lawsuits by not making the drug...

Thus, the First Circuit refused to extend Mensing preemption to design defect claims, leaving it “to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims.”  Moreover, “[g]iven the widespread use of generic drugs and the developing split in the lower courts, …this issue needs a decisive answer from the only court that can supply it,” obviously implying the Supreme Court.

The First Circuit's reasoning in Bartlett is rife with frustration at the Supreme Court’s decision in Mensing.  The court cannot bring itself to the conclusion that Mensing might have implied total immunity from products liability claims for generic drug manufacturers.  For this reason, Bartlett seems to be an ends-based decision--a way to provide an avenue of relief for the unfortunate injuries suffered by Karen Bartlett.  A decision leaving her with no remedy under the law was an unfair and unjust option that the court was not willing to take.  Moreover, in more than one instance throughout its opinion, the First Circuit wanted to make apparent its refusal to participate in eliminating the last avenue of remedy for Karen Bartlett, almost daring the Supreme Court to decide otherwise.  It remains to be seen if Mutual will take up the First Circuit’s "challenge."

The Boulder business lawyers  at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.