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From Products Liability Law Daily, July 16, 2013

Claims against generic drug manufacturers remanded in part to determine design defect viability under state law

By Anthony H. Nguyen, J.D.

An appellate court affirmed in part, reversed in part, and remanded to the district court for further consideration design defect claims in a product liability suit alleging that consuming a prescription drug and its generic equivalent resulted in the development of tardive dyskinesia (Fullington v Pfizer, Inc., July 15, 2013, Gruender, R). Although the appellate court affirmed the lower court’s decision that state law had not created exceptions for labeling, warning and design defect claims against the brand-name drug manufacturers, it was questionable whether the state law presented an alternate means for generic drug manufacturers to alter their products.

Background. Joyce Fullington (Fullington) filed a product liability suit against various manufacturers of the prescription drug Reglan® and its generic equivalent, metoclopramide, alleging that the drug caused her to develop tardive dyskinesia. In her suit, Fullington asserted causes of action under Arkansas law for negligence, strict liability, breach of the implied warranties of merchantability and fitness for a particular purpose, misrepresentation, suppression of evidence, and fraud.

Under 21 U.S.C. sec. 355(j)(2)(A) manufacturers of generic drugs are required, as a condition to selling their products, to establish that their product is “chemically equivalent” and “bioequivalent” to the reference listed drug replicated. Although Fullington’s physician wrote her a prescription for Reglan, her pharmacist filled her prescription with the generic metoclopramide. In Arkansas, pharmacists are permitted to substitute generic drugs when filling a prescription for a brand name drug.

The district court ruled that all of Fullington’s claims were either not viable under Arkansas law or were preempted by federal law regarding drug product labeling pursuant to the U.S. Supreme Court’s decision in Pliva v Mensing (131 S.Ct. 2567 (2011)). The district court also ruled, in the alternative, that to the extent Fullington pled product liability claims other than failure to warn, namely manufacturing or design defect claims, her allegations failed to meet federal pleading standards.

Preemption generally. The U.S. Supreme Court in Mensing upheld the FDA’s interpretation of its regulations as requiring that “the warning labels of a brand-name drug and its generic copy must always be the same—thus, generic drug manufacturers have an ongoing federal duty of ‘sameness.’” Accordingly, a generic drug manufacturer could not unilaterally strengthen the warnings on its product’s labeling. This “impossibility” preemption existed when a party could not independently do under federal law what state law required of it. Therefore, claims seeking to impose liability based on a manufacturer’s failure to strengthen or modify a generic drug’s labeling are preempted by federal drug regulations.

As a result, under the regulatory scheme, certain design defect claims are preempted as well. The Supreme Court ruled recently in Mutual Pharmaceutical Co. v Bartlett (No. 12-142, June 24, 2013) that because a generic drug manufacturer could not unilaterally redesign its product’s labeling or design, a design defect claim imposing liability for a failure to undertake one of these two courses of action also was preempted.

Brand-name manufacturers. Upon review, the Eighth Circuit noted that Fullington had stipulated that she only ingested metoclopramide; at no point did she ingest Reglan or any other product manufactured or distributed by one of the brand-name manufacturers. Fullington argued that Arkansas law did not require product identification because her claims were based on negligence, misrepresentation, suppression of evidence, or fraud. The appellate court disagreed, noting that no exceptions existed under the Arkansas Product Liability Act; product identification was necessary for all product liability actions. Thus, the court held that the district court did not err in granting the brand-name manufacturers’ motion for summary judgment.

Failure to warn. Generally, a manufacturer’s inadequate warning is not a proximate cause of an injury so long as the prescribing physician had independent knowledge of the risk that the inadequate warning should have communicated. Fullington admitted that “her prescribing doctor relied upon information published in the package inserts and the Physicians’ Desk Reference…or otherwise disseminated by the Reference Listed Drug Company.” As a result, Arkansas’s learned intermediary doctrine applied and the appellate court affirmed the dismissal of Fullington’s claims against the generic manufacturers.

Breach of implied warranty. Although the Eighth Circuit affirmed the lower court’s dismissal of failure to warn claims, it held that the district court had erred in categorizing Fullington’s non-warning design defect and breach of implied warranty claims as failure-to-warn claims. The appellate court reversed the dismissal of Fullington’s non-warning breach of implied warranty claims and remanded for further consideration as to whether Fullington’s breach of implied warranty claims were viable under state law.

Design defect. The appellate court also disagreed with the district court’s conclusion that Fullington’s claims in the alternative, specifically design defect allegations, did not satisfy federal pleading standards because the claims were too conclusory. The appellate court noted that Fullington’s claims included sufficient factual matter to state a claim for relief that was plausible on its face. In remanding to the lower court for determination, the Eighth Circuit noted, though, that the Supreme Court’s decision in Bartlett presented an obstacle to Fullington’s design defect claim. It was not immediately clear to the court that Arkansas law offered generic drug manufacturers an opportunity, consistent with federal law, to somehow alter an otherwise unreasonably dangerous drug, because Arkansas law focused on consumer expectations rather than the risk-utility approach in the Bartlett decision.

The case number is 12-2945.

Attorneys: William B. Curtis (Curtis Law Group) for Joyce Fullington. Lyn People Pruit (Mitchell & Williams) for Pfizer, Inc, and Wyeth, LLC. Henninger S. Bullock (Mayer & Brown) for Schwarz Pharma, Inc., and Alaven Pharmaceutial, LLC. Matthew V. Brammer (Ulmber & Berne) for Pliva, Inc. Geoffrey M. Coan (Hinshaw & Culbertson) for Mutual Pharmaceutical Company, Inc.

Companies: Pfizer, Inc; Wyeth, LLC; Schwarz Pharma, Inc.; Alaven Pharmaceutial, LLC; Pliva, Inc.; Mutual Pharmaceutical Company, Inc.

MainStory: TopStory WarningsNews PreemptionNews DrugsNews ArkansasNews IowaNews MinnesotaNews MissouriNews NebraskaNews NorthDakotaNews SouthDakotaNews

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