Last week, the New Jersey Appellate Division added more uncertainty and unpredictability in generic pharmaceutical litigation when it allowed some failure to warn claims to proceed against generic providers of metoclopramide, a/k/a Reglan in the case of In re: Reglan Litigation. Most of plaintiffs’ claims were dismissed, but the Court allowed a claim based on an alleged failure to update the generic label to match brand-name labels. The generic manufacturers argued that they had in fact matched the brand name labels, but the Court found issues of fact existed that needed to be sorted out by a jury. The Court did not, however, identify what any of those issues of fact were.
Courts across the country continue to struggle with how to treat state law tort claims against generic drug manufacturers. The central issue is whether to allow state law tort actions to proceed, or to hold that such claims are preempted by Congress’s decision to facilitate a market for generics. In 2009 in Wyeth v. Levine, the U.S. Supreme Court held that state law failure-to-warn claims were not pre-empted because the brand manufacturers could have unilaterally strengthened their warnings.
In its 2011 decision in Pliva v. Mensing the United States Supreme Court recognized that it was creating a legal structure that treated similar plaintiffs differently: individuals injured by brand name pharmaceuticals could pursue tort claims but individuals experiencing the same injury from the same cause from generic pharmaceuticals could not. In 2013, two diametrically opposed rulings were issued by the U.S. Court of Appeals. In Morris v. Pliva, the Fifth Circuit held that a failure-to-update warnings claim was pre-empted under Mensing; the Sixth Circuit held the opposite in Fulgenzi v. Pliva. The split between these two lines of reasoning has cascaded through federal and state courts across the country, making this a particularly difficult and perilous area for the parties and their lawyers.
In 2013, the Supreme Court again rejected tort liability pursuant to the pre-emption doctrine in Mutual Pharmaceutical v. Bartlett. Lower courts have struggled to reconcile these decisions, no doubt in part due to concerns that seriously injured people could be denied any legal remedy based on the fortuitous circumstance of being given a generic drug at the pharmacy rather than the brand-name version.
Businesses and individuals need clear and consistent guidance about what the law is and how it will be enforced.
Whether the Supreme Court feels a need to clarify its holdings will soon be revealed. Multiple Petitions for Certiorari are pending in the U.S. Supreme Court that could resolve the split between Morris and Fulgenzi. Meanwhile, the Supreme Court’s call for Congress to explicitly resolve this “difficult pre-emption question” goes unanswered, leaving businesses, injured plaintiffs and the lawyers in a state of uncertainty.