Supreme Court Could Hear Case from Generic Reglan Manufacturer

The U.S. Supreme Court could soon weigh in on the issue of federal preemption in generic drug cases, now that a petition for certiorari was filed with the high court on November 10, 2014, by Pliva, Inc.

The Iowa Supreme Court recently ruled that Pliva, Inc., could be held liable for injuries from a drug’s insufficient warning labels. Pliva, Inc., has petitioned in hopes of having the Iowa decision overturned.

Pliva Inc., makes the generic heartburn medication, Metoclopramide, commercially known as Reglan. Like several defendants in similar cases this year, Pliva Inc., argues that federal law should preempt such state tort law claims against manufacturers.

Whether generic drug manufacturers can be held liable for failing to adequately and timely update their labels is an issue that has played out across several courts over the past year. Generics manufacturers are expected to update their labels to match their branded counterparts on a regular basis.

A split across appellate courts

There is currently a split across federal and state appellate courts regarding the preemption. Plaintiff Theresa Huck originally filed the Iowa Supreme Court case, claiming she developed the neurological disorder tardive dyskinesia after taking generic metoclopramide, sold under the brand name Reglan. But Huck is not the only plaintiff to have filed suit against a generic drug manufacturer for experiencing tardive dyskinesia due to taking generic Reglan.

Just two days after Pliva, Inc., filed its petition for writ of certiori, a New Jersey appellate court affirmed the 2013 decision of its trial court, a judgment in favor of plaintiffs who were injured by the gastric reflux drug, Reglan. The Superior Court of New Jersey’s Appellate Division determined that the plaintiffs, who suffered tardive dyskinesia after taking generic Reglan, could proceed against the manufacturers of Reglan. The New Jersey court’s finding - that state law failure-to-warn claims are not preempted by federal law - may be persuasive law if the Supreme Court grants certiori to Theresa Huck’s case.

The “Generic Defendants,” as the New Jersey appellate court referred to them, had a duty under federal law to adopt the changes to the brand-name warning labels on the drugs. In affirming the trial court’s reasoning, the appellate court said,

[I]f labels belonging to generic manufacturers of tablets did not match the brand-name manufacturers of tablets, then there are [at] least some changes to their labels that federal law would allow, or even require, these defendants to make, and state tort law in this situation does not conflict with federal law. Consequently, . . . to the extent that generic manufacturers of metoclopramide tablets failed to update the labels to be the same as the brand-name label, they are excluded from preemption.

Meanwhile in Iowa, Huck originally brought her generic drug case in a state trial court, where a decision was granted in favor of Pliva, Inc. However, in June 2014, Iowa Supreme Court justices partly reversed the decision in favor of Pliva, Inc., after Huck’s appeal. The Supreme Court of Iowa reasoned the U.S. Supreme Court’s Mensing ruling does not necessarily preempt all state tort law claims against generic drug manufacturers.

“If the court takes the case up, the results would be helpful in clarifying the scope of federal preemption of claims against generics,” Alan Klein, of Duane Morris LLP, has said. Updates on the case, titled Pliva Inc. v. Theresa Huck, can be found through the U.S. Supreme Court’s website by searching case number 14-544.