With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme Court

By Kurt R. Karst –      

Back in August, we posted on a Petition for Writ of Certiorari filed by Mutual Pharmaceutical Company, Inc. (“Mutual”) appealing a May 2, 2012 decision from the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical Co. concerning design-defect, generic drug preemption, and the non-steroidal anti-inflammatory drug Sulindac Tablets, which Mutual markets under an ANDA FDA approved in 1991 (ANDA No. 072051).  The First Circuit, in affirming a decision from the U.S. District Court for the District of New Hampshire (Bartlett v. Mutual Pharm. Co., 760 F. Supp. 2d 220 (D.N.H. 2011) – see here), concluded that state law design-defect claims against generic drug manufacturers are not preempted by the Hatch-Waxman Amendments to the FDC Act, and that to avoid state tort law liability a company could simply stop making its generic drug products.  Obviously, that decision did not sit well with Mutual, and the appeal to the U.S. Supreme Court followed (Docket No. 12-142), with the following question presented to the Court:

Whether the First Circuit erred when it created a circuit split and held—in clear conflict with this Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)—that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

Over the past couple of months, interested parties have chimed in with amicus briefs asking the Supreme Court to take up the case.  The Generic Pharmaceutical Association says in its amicus brief that the First Circuit’s decision “reopens avenues of liability” that the Supreme Court closed in Mensing, and that Bartlett “is logically and legally indistinguishable from Mensing.”  Several generic drug manufacturers express similar concerns in their amicus brief, and the particular concern that “the state-by-state approach to labeling rejected in Mensing not be revived under a new name.”  In Mensing, the Supreme Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are unable to comply with both federal and state duties to warn. 

Respondent, Karen L. Bartlett, who, of course, has her own take on the question posed to the Supreme Court – i.e., “Whether this Court should grant certiorari to review the First Circuit’s conclusion that federal law does not preempt respondent’s strict products liability claim seeking compensation for severe injuries resulting from use of a generic pain medication manufactured by petitioner, where the First Circuit’s decision does not conflict with any decision of this Court or of any other court of appeals” – says in her Opposition Brief that Supreme Court review is not warranted here.  Respondent argues, among other things, that Mutual “erroneously attempts to depict the [First Circuit’s] decision as having blatantly departed” from Mensing, and that First Circuit’s decision does not create a circuit split with decisions in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (here) and Mensing v. Wyeth, 658 F.3d 867 (8th Cir. 2011) (here).  Moreover, says Respondent, “[c]ases such as this one, in which an injured patient obtains a damages judgment against a drug manufacturer based on a products liability theory other than failure to warn, are exceedingly rare” and don’t recur with sufficient frequency to warrant Supreme Court review.  In fact, according to Respondent, this case is “fundamentally different” from Mensing, beause, in contrast to Mensing, “nothing in New Hampshire law requires petitioner to change sulindac’s design, and nothing in federal law prohibits petitioner from declining to sell the drug.”

Mutual, which filed its Reply Brief on November 13th, immediately jumps on several claims made by Respondent.  Right off the bat, Mutual says that the First Circuit recognized that its decision created a “split in the lower courts” an practically begged the Supreme Court to take up the case to provide “a decisive answer.”  Mutual points out that both the Sixth and Eighth Circuits rejected stop-selling arguments, and that just before respondent filed its Opposition Brief, the Fifth Circuit rejected the same theory for a second time in Demahy v. Schwarz Pharma, Inc., Case No. 11-31073, 2012 WL 5261492 (Oct. 25, 2012) (here).  (The first time having been in Demahy v. Actavis, Inc., 650 F.3d 1045 (5th Cir. 2011) (here)).  Indeed, says Mutual,

this case demonstrates in spades that there is no plausible basis for distinguishing design-defect claims from failure-to-warn claims for purposes of the stop-selling theory.  Consistent with comment k, the instructions in this case make clear that the jury’s verdict hinged on precisely what Mensing barred: a finding that petitioner’s FDA-mandated warnings were inadequate.  More broadly, the First Circuit conceded that Hatch-Waxman’s sameness mandate applies equally to design-defect and failure-to-warn claims, and that the stop-selling theory could be deployed equally against both claims.  Given the record and those concessions, the stop-selling theory can be right only if Mensing is wrong—which is why the First Circuit effectively challenged this Court to reconsider that decision. [(Internal citations omitted; emphasis in original)]

Delving more deeply into the Fifth, Sixth, and Eighth Circuit decisions, Mutual argues that failure-to-warn and design-defect claims are really two sides of the same coin and are materially indistinguishable:

Respondent nonetheless seeks to reconcile these decisions by asserting that failure-to-warn claims are based on a duty to change product warnings (conduct federal law bars), whereas design-defect claims are based on a duty to stop selling the product (conduct federal law permits).  That is just wordplay.  Saying that failure-to-warn liability is imposed because a manufacturer failed to change the warning is just the flipside of saying that liability is imposed because the manufacturer sold a product with a defective warning.  The manufacturer’s duty is “to adequately and safely label [its] products” for sale, Mensing, 131 S. Ct. at 2577, so it has two options: Change the label or stop selling it.

That is just like respondent’s design-defect claim, which asserted petitioner sold a product with a defective design.  State law offered the same two options: Change the design or stop selling it. And because Hatch-Waxman equally precludes labeling and design changes, state law in both cases seeks equally to impose liability for selling products that manufacturers cannot lawfully “fix.”  [(Internal citation omitted; emphasis in original)]

Because of this interplay, “Mensing’s rejection of the stop-selling theory thus cannot be limited to failure-to-warn claims,” according to Mutual, and the Supreme Court’s logic must extend to every claim, “because every products case begins with a sale,” and “[w]ithout one, there is no basis to sue—and no need for a preemption defense.”

The Supreme Court is scheduled to consider Mutual’s Petition at a November 30, 2012 conference.