DOJ/FDA Brief in SCOTUS Generic Drug Preemption Case Hands Plaintiffs New Liability Theories


Cross-posted at WLF’s contributor page

During the last four years, the Food and Drug Administration has been a faithful ally of the plaintiffs’ bar, routinely opposing any suggestion that federal approval of a prescription drug preempts a state-law tort claim against the drug’s manufacturer.  That’s why it came as surprise to some when last week the United States filed an amicus curiae brief urging the Supreme Court to rule in Mutual Pharmaceutical Co. v. Bartlett that federal law preempts design-defect claims against the manufacturer of a generic drug.  The plaintiffs’ bar need not worry, however; the amicus brief set out a detailed roadmap that explained to plaintiffs how they can avoid preemption findings in all future cases.  The roadmap was wholly gratuitous; it raised issues not presented by Bartlett, and its only apparent purpose was to help lawyers filing tort suits to draft complaints that could withstand preemption claims.

Plaintiffs already have a clear path for suing brand-name drug companies; the Supreme Court held in 2009’s Wyeth v. Levine that failure-to-warn claims against brand-name companies were not preempted, even though the warning language on product labeling has in all cases been explicitly approved by FDA.  But tort suits against generic drug companies have been more difficult to maintain.  Over the objections of FDA and the Solicitor General, the Supreme Court held in 2011’s PLIVA, Inc. v. Mensing that failure-to-warn claims against generic drug companies are preempted by federal law, primarily because generic companies have no authority to make unilateral changes to their product labels even if they come to believe that stronger safety warnings are warranted.

In response, many enterprising plaintiffs’ lawyers began to focus on design-defect claims as a means of avoiding Mensing dismissal.  The pending Bartlett case will determine whether Mensing applies to design-defect claims and whether it requires a finding that such claims against generic drug manufacturers are similarly preempted.  The federal government gave the only intellectually honest answer to that question:  design-defect claims are preempted because they conflict with the federal drug approval process.  A drug manufacturer violates federal law if, in an effort to comply with a state-law determination that its drug is unreasonably dangerous and thus defectively designed, it alters the design of its drug.  The U.S. agreed with WLF’s amicus brief in Mutual Pharmaceutical, which argued that under Mensing, a tort claim is preempted if the only means by which the manufacturer can comply with both federal and state law is, as in Bartlett, to withdraw its FDA-approved drug from the market.

But the U.S. was not content to limit itself to addressing issues directly raised by Bartlett.  Instead, it went out of its way to propose a brand new cause of action that, in the federal government’s view, would survive preemption.  It noted that federal law deems a drug “misbranded” if it is “dangerous to health” when used as directed; and that FDA can determine a drug to be “dangerous to health” and thus “misbranded” even though it previously approved the drug for marketing.  It suggested that States might want to create a new “misbranding” tort and that if they did, such tort claims would not be preempted by federal law because such claims would “parallel” (i.e., not conflict with) federal law.  It would be enough, in the U.S.’s view, for the plaintiff to allege that “new evidence” that has emerged since the product was approved by FDA renders the drug unreasonably unsafe.  And, of course, an enterprising plaintiffs’ lawyer will never have difficulty discerning “new evidence” of health concern after examining the adverse health reports that all manufacturers must submit to FDA.

There is serious question whether this hypothesized “misbranding” cause of action could survive a Mensing preemption claim.  After all, the “dangerous to health” analysis would require examining the adequacy of warnings contained on the product label and, as Mensing found determinative, generic manufacturers have no right to alter FDA’s previously approved product labeling.  But FDA has an answer to that problem as well: the Government’s brief discloses that FDA is actively considering a new rule that would administratively overturn Mensing by granting generic manufacturers a short-term unilateral right to alter product labeling when new evidence suggests a need for stronger health warnings

Enough.  It is the job of Congress, not the executive branch, to write federal drug law and to determine when state tort law is preempted because it interferes with the accomplishment of Congress’s purposes.  It is particularly inappropriate for the Administration to be drawing roadmaps for plaintiffs’ lawyers to assist them in circumnavigating Supreme Court preemption decisions.

One thought on “DOJ/FDA Brief in SCOTUS Generic Drug Preemption Case Hands Plaintiffs New Liability Theories

  1. Pingback: Finger on the Pulse: From Our Blogroll and Beyond | The Legal Pulse

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