Teva Lobbies Supreme Court Again to Rule on Failure-to-Update Claims
Teva is asking the U.S. Supreme Court to overturn a Pennsylvania state court ruling that would let individuals sue generics makers for failing to promptly update their labels in response to new safety concerns, a move some experts say directly contradicts federal statutes.
The Israeli drugmaker’s April 8 brief in Teva Pharmaceuticals v. Dorothy Bennett follows a decision by the Pennsylvania Supreme Court not to review the Philadelphia County court’s ruling that lawsuits claiming Teva took too long to change the label on generic Reglan (metoclopramide) to reflect warnings of tardive dyskinesia are not preempted by the FD&C Act.
The Pennsylvania court essentially opened generics makers to state lawsuits by people claiming they should have updated their labels, Teva claims, citing some 2,300 individual complaints nationwide that were consolidated in the Philadelphia case.
The first warnings of the movement disorder were added to branded Reglan in 2004, five years before the FDA mandated a boxed warning. Many of the plaintiffs who blamed Teva for their tardive dyskinesia did so in 2001 and 2002 — a period in which Teva could not alter its labeling without FDA say-so.
This is Teva’s third stab at getting the nation’s highest court to consider failure-to-warn arguments. At the end of March, the Supreme Court rejected generics subsidiary Pliva’s request to hear similar arguments in an Iowa Supreme Court decision leaving the drugmaker vulnerable to lawsuits under state law.
In January, SCOTUS turned down Teva’s request to review a California appeals court ruling that would also make generics makers liable for failing to update labels to reflect new risks.
Essentially, Teva sees these various lawsuits as attempts to circumvent federal law on generic labeling, says James Beck, an attorney with Reed Smith in Philadelphia who is familiar with the litigation. The only legal avenue that should be open to the claimants is to file a citizen petition with the FDA, he said.
With two strikes already against it, Beck doesn’t give Teva strong odds of getting the Supreme Court to review the Pennsylvania case — especially since the firm didn’t update its labeling after the FDA required boxed warnings in 2009, as required.
Read Teva’s brief at www.fdanews.com/04-14-15-Tevabrief.pdf. — Lena Freund