Patient May Not Sue Name-Brand Manufacturers Over Generic Reglan, Eleventh Circuit Rules – Guarino v. Wyeth et al.

By July 3, 2013 July 10th, 2019 Reglan

Last week, I wrote as a pharmaceutical liability lawyer about a generic Reglan injury lawsuit at the U.S. Supreme Court, which closed another legal avenue of recovery against drug manufacturers. Close on the heels of that decision comes Guarino v. Wyeth et al., an Eleventh U.S. Circuit Court of Appeals decision affirming dismissal of a generic Reglan lawsuit for several reasons. Plaintiff Andrea Guarino of Florida took generic Reglan for more than 12 weeks and developed tardive dyskinesia, an incurable nervous disorder that causes uncontrollable movements. Like many other plaintiffs who developed the disorder, Guarino sued the brand-name manufacturers of Reglan (metoclopramide) as well as the manufacturer of the generic equivalent that she actually took. The Florida district court dismissed her lawsuit, finding some claims preempted and the name-brand claims barred by Florida law.
Guarino was prescribed metoclopramide from May to August of 2007, which was more than the 12 weeks advised by the FDA. It is undisputed that she only took the generic drug. At the time, there was a warning on the label about tardive dyskinesia, but it was not a black box warning. She filed her lawsuit before the U.S. Supreme Court decided in PLIVA v. Mensing that generic drug manufacturers cannot be held liable on failure to warn claims because they are not permitted to unilaterally change their labels. On that basis, the district court dismissed Guarino’s claim against Teva. It then granted summary judgment to the brand-name manufacturers she had sued, ruling that Florida law does not permit her to recover damages from companies whose products she had never used. Guarino appealed both decisions.
On appeal, Guarino contended that her claims against Teva were not preempted because she was trying to hold Teva liable for failing to adequately communicate a 2004 label change to doctors, not for failure to warn. The Eleventh disagreed. The Mensing court found it would be impossible for generic manufacturers to comply with federal law, which requires their labels to be exactly the same as the name-brand equivalent drugs’, and “state law” as created by state courts’ decisions. Calling the claim “failure to communicate” doesn’t change its nature, the Eleventh said, and it is preempted. On the brand manufacturers, Guarino argued that they could be held liable because they controlled the label she was claiming was inadequate. But the Eleventh ruled that no Florida court has ever accepted this “novel theory of liability,” and federal courts may not make new state law without support. It suggested that redress of this situation lies with federal or state legislatures.
As a defective drug attorney, I would welcome action on this issue from the state legislatures or from Congress. As the Supreme Court and the Eleventh, no doubt among many others, observed, the current legal situation leaves patients hurt by generic drugs with zero recourse in most situations. Unless the manufacturer broke an FDA rule, introduced manufacturing defects or designed the drug defectively, there’s no way for defective drug lawyers like me to recover fair damages, no matter how serious the injuries are. Courts in Alabama and California have found liability for name-brand manufacturers, but as the Eleventh observed, this is the exception. Considering what’s at stake for plaintiffs like Guarino, who is permanently disabled, I believe our country should do better.


If you were injured by a drug you thought was going to help you, you should talk to Carey, Danis & Lowe about your legal rights and your options. To learn more, call us today at 1-877-678-3400 or send us a message online.
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