Pharmaceutical companies anticipate that the next several months will provide needed clarity and consistency regarding the pre-emption landscape for manufacturers of generic pharmaceutical products, with the Supreme Court scheduled to hear oral argument on March 19 in Mutual Pharmaceutical Co. Inc. v. Bartlett.

Bartlett is an appeal from the 1st Circuit’s upholding of a $23 million award to plaintiff Karen Bartlett, on the basis that claims that a generic manufacturer defectively designed a drug are not pre-empted by the Hatch-Waxman Act. The 1st Circuit distinguished design defect claims from claims that a generic manufacturer failed to adequately warn of a drug’s risks, the latter of which were held to be pre-empted by the Supreme Court in its 2011 Pliva, Inc. v. Mensing decision due to the federal requirement that the label on generic products mirror that of its name-brand counterparts. Design defect claims are distinguishable, according to the 1st Circuit, due to a generic manufacturer’s discretion to stop manufacturing a drug which is determined to be defective or unreasonably dangerous under state law. The court reached this conclusion despite its own acknowledgement that generic drugmakers have no more control over or ability to change a drug’s design than they do to change a drug’s label—the cornerstone conclusion of the Mensing ruling.

Considered an outlier among post-Mensing rulings, Bartlett found unexpected support in the District Court for the Southern District of Ohio on Jan. 25, when Judge James L. Graham denied the motion for judgment on the pleadings of defendants Sandoz, Inc. and Eon Labs, Inc. in Arters, et al. v. Sandoz, Inc., et al., a case emanating from the plaintiff’s claim that taking the generic arrhythmia drug amiodarone caused him to suffer permanent blindness. The court noted the 1st Circuit’s analysis in Bartlett, as well as the myriad federal decisions post-Mensing that have concluded that design defect claims are pre-empted under the same analysis articulated by the Mensing court. Distinguishing the primary post-Mensing decision in its own 6th Circuit, Smith v. Wyeth, the court reflected that Smith considered exclusively failure-to-warn claims and did not analyze the pre-emption of design defect claims.

The Arters court ultimately held that the plaintiff’s design defect claim rested on an alleged duty distinguishable from that duty to provide treating physicians with adequate warnings about a drug’s risks. Rather, the court held, the plaintiff advanced a claim that the generic manufacturer had a duty to refrain from selling a product that is unreasonably dangerous under Ohio law. This is a duty that may be satisfied in accordance with federal law as “the federal law neither compels nor grants generic drug manufacturers a substantive right to sell their product in contravention of Ohio law,” according to the court.

The Arters order was issued just three days after the Solicitor General weighed in with an amicus curiae brief to the Supreme Court in Bartlett, in which the government provided limited support to Mutual Pharmaceutical’s argument that a generic manufacturer’s duty to design a safe product is so closely interconnected to its duty to provide adequate warnings of its risks that federal pre-emption of one must necessarily mean pre-emption of the other under Mensing. The government advanced just one limitation to a broad pre-emption rule, arguing that design defect claims would not be pre-empted if the plaintiff comes forward with “new and scientifically significant” evidence of a drug’s list that the drug is rendered misbranded under federal law.

The impending argument and decision in Bartlett should bring some clarity to this complicated issue, potentially setting up an escalating conflict among the federal courts as to the potential liability of brand-name manufacturers, as the primary designer and labeler of pharmaceuticals, when the proof shows the plaintiff exclusively ingested the generic counterpart.