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.
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