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From Products Liability Law Daily, June 17, 2013

Failure to Warn, Failure to Incorporate Brand Name Drug Label Change Dismissed by 8th Circuit; Non-Warning Design Defect, Breach of Implied Warranty Claims Against Generic Drug Maker Reversed and Remanded

By Sarah E. Baumann, J.D.

A patient could not proceed with her products liability action against the brand name manufacturer of a gastrointestinal drug because she had consumed only the generic version of the drug, and, therefore, the brand name manufacturers did not owe her a duty of care under the applicable state law, the U.S. Court of Appeals for the Eighth Circuit ruled (Bell v Pfizer, Inc., June 14, 2013, Riley, W). Also, the patient could not proceed with (1) failure to incorporate label change claims against the generic manufacturer because they were vitiated by the learned intermediary doctrine, or (2) failure to warn claims because they were preempted by federal law. However, the court of appeals determined that the patient’s claims for non-warning design defect and breach of implied warranty merited analysis by the trial court to determine whether they stated a claim under Arkansas law.

Background. The patient, Shirley Bell, was prescribed Reglan® in 2008 to treat abdominal pain and epigastric problems. Throughout the year, she took the generic version of the drug, metoclopramide. In 2009, the FDA required manufacturers of metoclopramide to include a black box warning, the FDA’s most serious warning, about the risk of tardive dyskinesia (a movement disorder) from prolonged use of the drug. In 2010, the patient filed a products liability action against the brand name manufacturers of Reglan (Wyeth, LLC and its parent, Pfizer, Inc.; Schwarz Pharma, Inc.; and Alaven Pharmaceutical, LLC) and the generic manufacturer of metoclopramide (Pliva, Inc.), alleging that she developed tardive dyskinesia as a result of her usage of the drug. Specifically, she alleged negligence, strict liability, breach of warranties, misrepresentation, suppression of evidence, fraud, and gross negligence.

A federal district court in Arkansas granted the brand name manufacturers’ motion for summary judgment. Later the same year, the U.S. Supreme Court issued its decision in Pliva, Inc. v Mensing (131 S.Ct. 2567 (2011)), in which it held that a patient’s state law tort claims against generic manufacturers based on their failure to provide adequate warning labels for metoclopramide were preempted by federal law. In 2012, the district court dismissed Bell’s remaining claims against Pliva as failure to warn claims barred by Mensing. Bell appealed both the grant of summary judgment and the dismissal of claims.

Brand name manufacturers. The Eight Circuit upheld the trial court’s grant of summary judgment as to the brand name manufacturers. Arkansas law requires a consumer to demonstrate that a product manufactured or distributed by a particular defendant caused her injuries (Ark. Code. Ann. sec. 16-116-102(5)). Because Bell never used Reglan, but instead used its generic form, metoclopramide, she did not state a claim and could not hold the brand name drug makers liable under Arkansas law, the court ruled. Furthermore, the court held that the duty of care a manufacturer owes to its users about a product’s risks does not extend to the manufacturer’s competitors.

Failure to incorporate label changes. Generic drugs must carry the same labeling as that approved for the brand name drugs to which they are equivalent. Bell argued that Pliva was liable for failing to update the warning label on its generic drug in 2004 when the Reglan label was updated reflecting that the drug should not be taken for more than 12 weeks. However, the Eight Circuit determined that the argument was made moot by the learned intermediary doctrine, which holds that manufacturers are responsible for notifying physicians of product risks, since physicians are in the best position to explain risks to consumers. Because Bell’s physician actually prescribed Reglan—and not generic metoclopramide manufactured by Pliva—he was aware of the drug’s risks and still chose to prescribe it to Bell.

The patient admitted that in prescribing Reglan, her physician relied on information published in the brand name manufacturers’ “package inserts and/or the Physicians’ Desk Reference.” Thus, the causal link between the patient’s injury and the generic drug maker’s admitted failure to incorporate the 2004 label change, if any, was broken because the patient’s prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated to him. Also, because the patient’s physician prescribed Reglan and relied on its labeling, there was nothing to indicate that Pliva’s failure to update its warning affected Bell’s physician’s prescribing decision or Bell’s injury in any way. Without a causal link between Pliva’s failure to incorporate the 2004 labeling change and Bell’s injury, the federal district court’s dismissal of that claim was not error, regardless of whether Mensing preempted the claim, the Eighth Circuit determined.

Remaining claims. Mensing held that state law claims against generic manufacturers of metoclopramide based on failure to provide adequate warning labels were preempted by federal law, since generic manufacturers could not satisfy state law duties to change labels without violating their federal duty to keep the label the same, unless the brand manufacturer’s label changed or the FDA instructed the generic manufacturer to change the label. The district court dismissed all of Bell’s claims against Pliva as failure to warn claims that were barred by Mensing. However, the Eight Circuit determined that the claims for non-warning design defect and breach of implied warranty could conceivably be viable under Arkansas law if based on something other than failure to warn.

Based on its analysis, the Eight Circuit affirmed the district court’s grant of summary judgment to the brand manufacturers. It dismissed the claims against Pliva regarding its failure to incorporate the 2004 label change and Bell’s failure to warn claims. However, it reversed the district court’s dismissal of the non-warning design defect and breach of implied warranty claims against Pliva and remanded them for further analysis.

The case number is 12-1674.

Attorneys: William B. Curtis (Curtis Law Group), Terrence J. Donahue, Jr. (McGlynn & Glission), and George Robert Wise, Jr. (Brad Hendricks Law Firm) for Shirley J. Bell; Henninger S. Bullock (Mayer & Brown), Lyn Peoples Pruitt (Mitchell & Williams), and Kannon K. Shanmugam (Williams & Connolly) for Pfizer, Inc.; Andrew Calica (Mayer & Brown) for Schwarz Pharma, Inc.; and Matthew V. Brammer (Ulmer & Berne) and Emmett B. Chiles (Quattlebaum & Grooms) for Pliva USA.

Companies: Pfizer, Inc.; Wyeth, LLC; Schwarz Pharma, Inc.; Alaven Pharmaceutical, LLC; Pliva USA

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

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