District Court Rejects "Failure-To-Withdrawal" For Generic Drug Manufacturers
We discussed the First Circuit’s opinion in Bartlett v. Mutual Pharmaceutical in two previous posts (here and here). In a nutshell, in Bartlett, the First Circuit refused to find preemption under the Supreme Court’s opinion in Pliva v. Mensing for the plaintiff’s design defect claim against the generic drug manufacturer because the generic manufacturer could “…avoid defective warning lawsuits as well as design defect lawsuits by not making the drug...” in the first place.
Confronted with a similar issue, the District Court for the Eastern District of Kentucky in In Re Darvocet, Darvon, and Propoxyphene Products Liability Litigation MDL reviewed the Bartlett decision and found the First Circuit’s reasoning unconvincing…to say the least. In fact, the district court did not even really offer a review of Bartlett in its opinion at all--that's how unconvinced the Kentucky court found Bartlett.
The plaintiffs in the Darvocet MDL offered the recent Bartlett decision in response to a show cause order as to why claims against certain generic defendants should not be dismissed on Mensing preemption grounds. The district court quickly dismissed the Bartlett reasoning:
Having reviewed the Bartlett decision, the Court agrees with the Generic Defendants. In Bartlett, the First Circuit adopted the “failure-to-withdraw” argument previously rejected by this Court and others…This argument—which failed to persuade either the Supreme Court or the Eighth Circuit on remand in Mensing, and the Sixth Circuit in Smith v. Wyeth, Inc.—is no more availing now. Moreover, the First Circuit offered little explanation for accepting it, noting simply that the Mensing opinion had not specifically addressed design-defect claims.
Consequently, the Eastern District of Kentucky court dismissed the claims against the generic drug manufacturer defendants.
Although the district court made summary work of the Bartlett decision, the Eastern District of Kentucky's opinion raises similar points we raised in our second post. Namely, the “failure-to-withdraw from the market” argument was already rejected by the Supreme Court in Mensing—such rejection was in fact even mentioned by the First Circuit in Bartlett. Despite recognizing that the argument was already rejected in the context of a failure-to-warn claim, the First Circuit offered no explanation as to why the underlying rationale would not also lead to Mensing preemption for a design defect claim.
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