On July 15, a federal appeals court reinstated design defect and breach of implied warranty claims against the makers of generic Reglan, commonly used to treat nausea and vomiting.
In its opinion, the 8th Circuit U.S. Court of Appeals explained that, despite the U.S. Supreme Court’s recent decision in Mutual Pharmaceutical Inc. v. Bartlett, where the non-warning (of serious risks and side effects) claims were brought under New Hampshire law, the claims in this case were brought in Arkansas, which applies a different law when determining preemption as to whether drug manufacturers are exempt from tort claims regarding the U.S. Food and Drug Administration (FDA).
Joyce Fullington brought her lawsuit in the U.S. District Court for the Eastern District of Arkansas, alleging that her ingestion of generic Reglan caused her to contract tardive dyskinesia, a serious, in most cases permanent, adverse side effect, for which there is no cure.
Fullington sued Pfizer, Wyeth, Schwarz, PLIVA, Teva Phramaceuticals USA Inc., Alaven and Mutual Phramaceutical Company Inc., but the brand-name defendants filed a motion for summary judgment, which states that based on the facts, there is no genuine issue of material fact upon which they could be found liable. This is just legal jargon which means that there is nothing in the lawsuit that the defendants could be found liable of, so they must therefore be relieved of any legal liability.
Fullington admitted that she never took the brand-name version of the drug, but that the brand name defendants (Wyeth, Pfizer, Schwarrz, and Alaven) are still liable for her injuries because they did not adequately warn of the risks associated with metoclopramide, or Reglan. However, the District Court granted the brand-name defendants’ motion for summary judgment, because under Arkansas law, a brand-name drug manufacturer may not be held liable for injuries arising from the use of a generic equivalent.
In addition to dismissing the claims against the brand-name defendants, the District Court also dismissed the claims against the generic defendants (PLIVA, Teva, and Mutual). It stated in its opinion that pursuant to PLIVA Inc. v. Mensing, these claims are now federally preempted. InMensing, the U.S. Supreme Court ruled that the Food, Drug, and Cosmetic Act’s prohibition on changes to generic drug labels preempts any failure-to-warn claims brought against generic drug manufacturers.
This means that if a brand-name drug manufacturer does not put warning labels on its products, the generic-brand drug manufacturers for that same product cannot be held liable, since they must adhere to the same warning labels as their brand-name counterparts. And according to Arkansas law, Fullington cannot sue the brand-name manufacturers since she never took the brand-name version of Reglan. Therefore, she developed tardive dyskinesia as a result of taking this drug, yet nobody may be held accountable, since the District Court found all of Fullington’s claims are premised on “failure-to-warn allegations”.
Fullington obtained leave so that she could amend her complaint, but did not amend the misrepresentation or implied warranty claims, so the District Court dismissed them as they had done previously. The other claims which she did amend, the District Court found to be premised on the same inadequate warnings allegations, in addition to finding that Fullington’s design defect allegations remained too conclusory to meet federal pleading standards.
Fullington appealed the District Court’s grant of summary judgment to the brand-name defendants, as well as the dismissal of her claims against the generic defendants, but the appellate court affirmed the grant of summary judgment to the brand name defendants.
Their reasoning was that, “Fullington’s claims against the Brand Defendants are all ‘product liability actions,’ so they are only viable if she is able to make a product identification. Because Fullington stipulated that she never used Reglan manufactured or distributed by any of the Brand Defendants, she ‘cannot hold them liable under Arkansas law.’”
To succeed on a design defect claim under Arkansas law, Fullington must establish that the product was in a defective condition, the defective condition rendered the product unreasonably dangerous, and the defect proximately caused the complained-of-injury.
The court concluded by reversing the dismissal of Fullington’s non-warning breach of implied warranty claims and remanded them for further consideration as to whether they adequately stated viable claims under Arkansas law, and if so, whether the Generic Defendants could nonetheless establish preemption. They relied on another Arkansas case, Bell, where there was an exception to preempted failure-to-warn claims, leaving Fullington’s non-warning design defect and breach of implied warranty claims to be determined in court.
The appellate court added, “we disagree with the district court’s conclusion that Fullington’s design defect allegations were too conclusory to survive a motion to dismiss because her complaint includes ‘sufficient factual matter, accepted as true, to state a claim for relief that is plausible on its face.’ Furthermore, to the extent the district court found Fullington’s claims insufficient because she failed to submit ‘factual allegations that PLIVA or Mutual, as opposed to the brand-name manufacturers, actually designed metoclopramide,’ such an allegation is unnecessary under Arkansas law.”
“In contrast to New Hampshire’s risk-utility approach, Arkansas state courts focus on consumer expectations in determining whether a product is unreasonably dangerous. Consequently, it is not immediately clear whether Arkansas, unlike New Hampshire, offers generic manufacturers an opportunity, consistent with federal obligations, to somehow alter an otherwise unreasonably dangerous drug. Therefore, we reverse the dismissal of Fullington’s design defect allegations and remand to the district court for further consideration in light of Bartlett.”
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