State law claims for failure to warn and misbranding brought by two consumers of metoclopramide against the manufacturers of the generic drugs they used were not preempted, the Georgia Court of Appeals said in reversing in part a trial court’s decision to dismiss the claims. However, dismissal of the patients’ claims for the generic maker’s alleged failure to update the drugs’ labels was affirmed, as was the dismissal of claims brought against the manufacturers of the name brand drug. The court also upheld the trial court’s refusal to dismiss claims brought against two companies that had authored patient education materials distributed with the drugs (PLIVA, Inc. v. Dement, November 20, 2015, Phipps, H.).

Background. Two consumers developed tardive dyskinesia, a neurological condition, after taking generic versions of the prescription drug Reglan™ (metoclopramide) for several months. Each filed suit against PLIVA, Inc., Generics Bidco I, LLC, and Teva Pharmaceuticals USA, Inc., which manufactured the generic medication that they used. They also brought suit against Alaven Pharmaceutical, LLC, Wyeth LLC, Wyeth Pharmaceuticals, Inc., and Schwarz Pharma, Inc., which were the manufacturers of the name brand version. Finally, they also brought claims against Wolters Kluwer Health, Inc., and Gold Standard, Inc., which authored patient education materials related to the drug. The patients alleged claims in connection with allegedly inadequate warnings based on negligence, misrepresentation, and breach of warranty.

The generic manufacturers moved to dismiss, asserting that all of the claims against them were preempted. The trial court dismissed claims based on a failure to warn arising under Georgia law, failure to withdraw or suspend sales, and failure to communicate warning label change information to the healthcare community, but denied dismissal for claims for failure to update the labels. The trial court also granted the brand name manufacturers’ motion to dismiss, finding that they could not be held liable because the patients had not used their products. The court declined to dismiss the claims against authors of the patient education materials because the companies had not shown that the patients could not possibly introduce evidence entitling them to the relief they sought. The generic drug makers, the patients, and the authors filed appeals, which were consolidated before the appellate court.

Preemption. The trial court erred when it dismissed the patients’ state law failure to warn claims against the generic drug manufacturers. In PLIVA v. Mensing, the U.S. Supreme Court did not unequivocally find that claims against generic drug companies were preempted. The Mensing court determined that impossibility preemption applied to claims involving a generic maker’s failure to unilaterally alter its labeling to comply with state law warning duties, but did not grant blanket immunity against all state warning claims. The patients brought claims against the generic manufacturers other than those involving the federal “sameness” requirement, including that these companies violated their duty to warn of dangers from their products of which they knew (or had constructive knowledge) and that this failure to warn may constitute a defect for strict liability purposes. Because the impossibility preemption was not implicated in these claims, preemption does not apply. Further, the patients’ claims that the generic drug manufacturers failed to suspend or withdraw sales of a “misbranded” drug should not have been dismissed. They alleged that the drugs were misbranded because did the labels failed to include information that had been required by a 2004 update, and that the Georgia law prohibiting the sale of misbranded drugs paralleled federal law to that extent. As a result, it was not impossible for the generic drug makers to comply with both federal and state law regarding these claims.

Finally, the claims for failure to communicate warning label change information to the healthcare community properly were found to have been preempted.

Failure to update. The patients’ complaints sufficiently alleged claims based on the generic manufacturers’ alleged failure to update their labels to include a 2004 warning that the drugs should not be taken for more than 12 weeks. Although PLIVA conceded that it was required to update its packaging in 2004 to include the warning but failed to do so, it argued that the failure to update claim was an impermissible attempt to enforce the federal “sameness” requirement because this duty is not enforceable by private litigation. However, the patients did not seek to enforce the sameness requirement but to recover damages under state law; further, it was not impossible for the generic makers to comply with both federal and state law because they could have done so by updating their labeling in 2004 to conform to the label that had been approved and mandated by the FDA.

Name brand manufacturers. The appellate court affirmed the dismissal of the claims against the name brand drug manufacturers. The patients claimed that the name brand drug manufacturers were strictly liable because they controlled the design and labeling of the generics; alternatively, they asserted that common law claims were available and that public policy supported these claims. However, a plaintiff pursuing strict liability or negligence claims under Georgia law must prove that the defendant manufactured or distributed the product that caused her injury or that she was exposed to the defendant’s product. The court noted that the overwhelming majority of courts have held that a brand name manufacturer cannot be held liable for injuries caused by the ingestion of a generic drug. The companies owed no duty of care to consumers who never used their drugs, and the claims against them properly had been dismissed.

Patient education materials authors. The claims against the companies that authored the patient education materials will go forward. The companies asserted that they did not owe the patients a legal duty, the First Amendment to the U.S. Constitution barred the patients’ claims, and that there was no privity with the patients. The patients’ complaints had alleged that the companies authored patient education materials that included information about the drug at issue that were provided to patients by pharmacists, typically when the prescriptions were picked up. They also alleged that the companies undertook to provide accurate drug information in these materials and had knowledge that consumers using the drug would rely on that information, and that the patients had read and relied upon that information and were injured by the companies’ wrongful conduct. This was sufficient to deny the authors’ motions to dismiss and for judgment on the pleadings.

The case Nos. are A15A1157, A15A1158, A15A1159, A15A1160, A15A1161, A15A1162, A15A1163, A15A1164, A15A1165, A15A1349, and A15A1404.

Attorneys: James Lynn Hollis (Balch & Bingham LLP) and Linda E. Maichl (Ulmer & Berne LLP) for PLIVA, Inc. Robert Cape Buck (The Buck Law Firm) for Angela Wallace Dement. Stephen Mann Brooks (Nelson Mullins Riley & Scarborough LLP) for Wyeth LLC and Alaven Pharmaceutical, LLC. Caroline Johnson Tanner (Holland & Knight LLP) for Gold Standard, Inc. Stephen L. Cotter (Swift, Currie, McGhee & Hiers, LLP) for Wolters Kluwer Health, Inc. Michael J. Goldman (Hawkins Parnell Thackston & Young LLP) for Teva Pharmaceuticals USA, Inc.

Companies: PLIVA, Inc., Gold Standard, Inc.; Wolters Kluwer Health, Inc.; Teva Pharmaceuticals USA, Inc.; Alaven Pharmaceutical, LLC; Wyeth LLC, Generics Bidco I, LLC