Thursday, February 13, 2014

The Post Mensing fight continue

AAJ continue to advocate on how best to limit the effects of Mensing on plaintiffs who have already been injured by generic drugs.

A different case: Brinkley v. Pliva, Inc.

One such case is Brinkley v. Pliva, Inc., currently pending in the U.S. Court of Appeals for the Eighth Circuit. The Brinkley case is similar to Mensing in that the injured patients took the drug metoclopramide (the generic form of the drug Reglan) and developed tardive dyskinesia, a severe and often irreversible neurological disorder.

Brinkley's lawyers, Benjamin A. Bertram and J. Scott Bertram of Betram & Graf in Kansas City, Missouri; David M. Peterson and Nicholas S. Clevenger of Peterson & Associates in Kansas City, Missouri; Thomas J. Preuss of Wagstaff & Cartmell in Kansas City, Missouri; Daniel J. McGlynn and Terrence J. Donahue, Jr., of McGlynn, Glisson, Moulton in Baton Rouge, Louisiana; and Bill Curtis hired CCL to work on the appeal. CCL's Senior Litigation Counsel Louis Bograd, who argued on behalf of Gladys Mensing before the Supreme Court, is handling the appeal for Ms. Brinkley.

Brinkley differs from Mensing in that the plaintiff used generic metoclopramide after July 2004, when the FDA approved a new warning against long-term use for the Reglan label. Pliva, the manufacturer of the generic metoclopramide Ms. Brinkley took, never added this new warning to its labeling, but it could have. Once the change to the Reglan label had been approved, federal regulations permitted Pliva to add the same warning to its label without prior agency action.

Bograd says that, because federal law would have permitted this label change, Pliva may be held accountable and a state-law claim for failure to warn is not preempted by federal law.

The Sixth Circuit and many lower courts agree that claims like Brinkley's are not preempted, but the Fifth Circuit has rejected this argument. Brinkley provides an opportunity for the Eighth Circuit to weigh in on this issue.

The bottom line is that all drug manufacturers should have a duty to warn patients of the risks of using their products. Accountability matters, and this case may prove pivotal in advancing this cause for patients injured or killed by dangerous generic drugs before the FDA's new proposed rule can take effect.