We previously wrote about the First Circuit's decision in Bartlett v. Mutual Phamaceutical Co., Inc. which refused preemption for a design defect product liability claim against a generic drug manufacturer.  In our previous post on Bartlett, we discussed the apparent frustration on the part of the First Circuit with the Supreme Court's decision in Pliva v. Mensing.  For this reason, the First Circuit was unwilling to leave the injured plaintiff in Bartlett with no avenue of remedy for her injuries from a generic drug and decided against preemption for her design defect claims.

Taking a look at the Bartlett opinion again, the First Circuit did not even attempt to distinguish the difference between the impossibility of a generic drug manufacturer changing the drug's label under federal law with the impossiblity of the generic drug manufacturer changing the chemical composition of the drug under federal law.  Moreover, as the First Circuit recognizes: it is unclear "how [a manufacturer] could alter a one-molecule drug anyway."  The First Circuit acknowledged that Mutual's argument--that a generic drug manufacturer cannot alter the label of the drug or the composition of the drug under federal law--had "some force" but quickly rejected it. 

As we discussed previously (here and here), the Supreme Court's decision in Mensing found federal preemption for state law failure-to-warn claims against a generic drug manufacturer based largely on the "impossibility" of generic drug manufacturers' ability to comply with both state law and federal law. For the most part, a generic drug manufacturer cannot change the label on its drug; all label changes must proceed through the brand name manufacturer.  When a generic drug manufacturer is sued under state law for failing to adequately warn of certain harmful side effects on its drug's label, state law is in effect creating additional labeling standards above what is required by federal law.  On its face, this might not seem to be of much issue as it occurs in numerous areas where federal and state law overlap, but when you add the "impossibility" of complying with both state and federal law in the mix, here is where preemption comes in.  

The Supreme Court's "impossibility" analysis under Mensing is of importance because the First Circuit in Bartlett larglely ignores the reasoning of the Mensing decision.  If the First Circuit actually followed the Supreme Court's reasoning in Mensing, it most likely would have concluded that if the "impossibility" of changing a drug's label under federal law allowed for preemption of state law failure-to-warn claims then the "impossibility" of changing a drug's chemical composition under federal law would lead to a finding of preemption for state law design defect claims.  For this reason, the First Circuit's opinion that "the generic drug manufacturer need not make the drug in the first place to avoid design defect claims" rings hollow because the Supreme Court could have ruled the same for a generic drug manufacturer facing the impossibility of changing its drug's label in the context of a failure-to-warn claim.  In other words, faced with the impossibility of complying with state and federal---beit the drug's label or the drug's composition--the Supreme Court could have simply stated that "the generic drug manufacturer need not make the drug in the first place to avoid the impossibility of complying with both state and federal law."  The Supreme Court of course did not come to this decision.  

In fact, the First Circuit knew that the Supreme Court rejected similar arguments that the generic drug manufacturer need not make the drug at all:

Mutual argues with some force that the generic maker also cannot alter the composition of the drug and so PLIVA's policy of encouraging generics by preempting state tort claims should extend to design defect as well as claims based on inadequate warning.  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.

Thus, the First Circuit seemingly recognized that the Supreme Court's reasoning in Mensing would lead to preemption for design defect claims as well, but refused to accept such a conclusion.

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