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Post-PLIVA Plaintiff Loses Failure to Warn Claim

By Robyn Hagan Cain on April 18, 2013 | Last updated on March 21, 2019

According to the Supreme Court, brand name drug manufacturers can be sued for failure to warn, even though the federal government — through the Food and Drug Administration — gives approval to put drugs on the market. FDA approval is not a defense.

The Supreme Court reached the opposite concluding regarding generic drugs: Generic drug manufacturers cannot be sued on a failure to warn theory.

Those conflicting rulings have forced plaintiffs with claims against generic drug manufacturers to think outside the box to keep their cases alive. Unfortunately, as the Fifth Circuit Court of Appeals noted this week, those attempts are frequently unsuccessful.

Penny Morris sued PLIVA, TEVA, and Actavis -- all generic drug manufacturers -- for injuries related to using metoclopramide (brand-name Reglan). Her suit was stayed awaiting the Supreme Court's decision in PLIVA v. Mensing, the generic-drug-failure-to-warn case. Based on the Court's PLIVA decision, the district court dismissed Morris' complaint, finding that the complaint was preempted.

Morris appealed based on four theories, including an interesting attempt at circumventing PLIVA: She claimed that TEVA could be held liable for failure to warn because of its status as a reference listed drug (RLD) holder. Because TEVA's product was designated an RLD By the FDA, Morris argued that it was the equivalent of a brand-name manufacturer's metoclopramide.

The Fifth Circuit disagreed, writing:

As the district court noted, the Fourth Amended Complaint did not raise this claim, which Appellants mislabeled in 2010 as "newly discovered." The information was available in the 2003 "FDA Orange Book." Yet even if an amendment were allowed, we agree with the district court's analysis, in rejecting this claim, that it "assumes, without authority, that the FDA considered TEVA to be a brand name manufacturer with the requisite duty to unilaterally change its product's labeling simply because the FDA designated TEVA's metoclopramide as the RLD.

(The appellate court also noted that the metoclopramide that Morris ingested, a tablet, may be distinguishable from the oral solution for which TEVA was the RLD.)

Despite her creative argument, the Fifth Circuit affirmed dismissal.

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