Lawsuits against generic drug manufacturers not necessarily barred by federal law, federal court rules

by Jay Pate

Shirley J. Bell was prescribed the brand name drug Reglan to treat her abdominal pain and epigastric problems. Bell’s pharmacist substituted generic metoclopramide manufactured by Pliva for the brand name Reglan prescribed by Bell’s physician. Bell continued to take metoclopramide as directed through December 2008.

Bell alleges she developed the neurological movement disorder tardive dyskinesia as a result of “long-term ingestion” of metoclopramide. In 2009, the FDA required manufacturers of metoclopramide to change their label to include a black box warning about the risk of tardive dyskinesia from prolonged treatment. Bell faults Pliva for not adequately informing her and her physician before 2009 of the known risks associated with long-term metoclopramide use. In 2010, Bell filed a product liability action against Pliva and others.

Meanwhile, in an unrelated lawsuit (that happened to involved the same generic drug), Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011), the United States Supreme Court held that it was impossible for Pliva and other generic manufacturers of metoclopramide “to comply with both their state-law duty to change the label and their federal law duty to keep the label the same” as the label approved for the brand name drug. As such, the Supreme Court held that federal law preempts all “state tort-law claims based on certain drug manufacturers’ alleged failure to provide adequate warning labels for generic metoclopramide.” In so holding, the Supreme Court rejected lowers courts that previously held a generic manufacturer could satisfy their state law duties without violating federal law by (1) proposing a label change to the FDA that it could impose, (2) suggesting the FDA send a warning letter, or (3) by suspending sales of the product.

In light of the decision in Mensing, the district court in Bell’s case granted her permission to amend her lawsuit against Pliva. Bell’s amended complaint again asserted claims for negligence; strict liability; breach of warranties; misrepresentation, suppression of evidence, and fraud; and gross negligence. Finding that Bell’s newly-styled allegations remained, in essence, failure-to-warn claims that are barred by Mensing, the district court dismissed Bell’s claims with prejudice.

Bell appealed and the Eighth Circuit has, in part, reversed the dismissal. Bell v. Pfizer, No: 12-1674 (8th Cir. 2013). Although the court of appeals agreed with the district court that “the vast majority of Bell’s allegations in her amended complaint set forth preempted failure to warn claims,” it held that it was “unable to conclude, at this point, that Bell’s design defect and breach of implied warranty claims, other than those based on an inadequate warning or labeling, are in essence, failure-to-warn claims that are barred by Mensing.”

The Eight Circuit noted that the plaintiff in Mensing did not dispute that her various causes of action were ultimately failure to warn claims “at the core.” In contrast, Bell claims she has asserted design defect and breach of implied warranty claims that do not depend on any failure to warn. Because the issue was raised by a motion to dismiss, the court accepted Bell’s allegations in her complaint as true and construed them in her favor. Thus, the Eighth Circuit reversed the district court’s dismissal of Bell’s non-warning design defect and breach of implied warranty claims and remanded for further consideration of those claims by the district court.

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