Products Liability Law Daily Wrap Up, TOP STORY—WARNINGS ISSUES—8th Cir.: Summary judgment to Teva upheld based on learned intermediary doctrine in contraceptive implant case, (Feb 9, 2021)

By Joshua Frumkin, Esq.

Absent state-level guidance, the court determined that the Nebraska Supreme Court likely would follow the majority trend and apply the learned intermediary doctrine to contraceptive devices.

In a case arising from an implantable contraceptive device that broke after implantation, the U.S. Court of Appeals for the Eighth Circuit upheld the federal district court in Nebraska's grant of summary judgment to the product’s manufacturer, Teva Pharmaceuticals USA, Inc. The appellate panel determined that under Nebraska law, Teva was obligated to warn only medical professionals-not patients directly-about the potential risks of its device. However, because the Nebraska Supreme Court has not yet decided whether to apply the learned intermediary doctrine to contraceptives, one judge dissented and recommended certifying the question to the state high court for adjudication (Ideus v. Teva Pharmaceuticals USA, Inc., February 8, 2021, Stras, D.).

Teva Pharmaceuticals USA, Inc. and Teva Women's Health, Inc. (collectively, Teva) manufacture and sell an implantable contraceptive device named ParaGuard T 380A Intrauterine Copper Contraceptive (ParaGuard). Teva provides two inserts with warnings and instructions for the product, one for physicians and one for patients. At some point, the patient consented to implantation of the contraceptive device, but when she later tried to have it removed, her physician discovered that it had broken apart. Removing the contraceptive required surgery. The patient sued Teva in federal district court for breach of its duty to warn. The district court granted summary judgment to Teva based on the learned intermediary doctrine [see Products Liability Law Daily’s March 5, 2019 analysis]. The patient appealed.

Learned intermediary doctrine. The appellate panel upheld the district court's ruling based on its anticipation that the Nebraska Supreme Court would rule similarly. The state high court adopted the Restatement (Third) of Torts’ provision on the learned intermediary doctrine in Freeman v. Hoffman-La Rouche, Inc. This section of the Restatement provides that manufacturers of prescription drugs and medical devices are protected from liability for failing to warn a patient if they adequately inform the patient's health care provider, unless "special facts require a direct warning to the consumer." Nebraska has yet to explore whether implantable contraceptives require such a direct warning. When, as here, a federal court is tasked with applying state law in an area in which the state's highest court has yet to rule, the federal court must attempt to predict what the state's supreme court would decide.

The parties agreed that Nebraska law applied to this case, that Teva provided adequate warning to the patient's physician, and that the sole issue on appeal was whether Teva also had an obligation to warn the patient. The patient argued that Nebraska would recognize the exception to the learned intermediary doctrine, following decisions from Massachusetts and Michigan. However, the court distinguished the Michigan cases as "less than clear" on the issue, and noted that at least 15 states and several federal courts have rejected the exception on the ground that contraceptives are not meaningfully different from other medical devices. The court further found that Nebraska indicated it would follow the majority rule in its opinion adopting the Restatement provision. Finally, the court distinguished its earlier decision in Hill v. Searle Laboratories, a Division of Searle Pharmaceuticals, Inc., in which it had refused to apply the learned intermediary doctrine to IUDs: Hill was decided over 30 years ago under Arkansas law, and the Arkansas Supreme Court had not embraced the doctrine beforehand. For those reasons, the Eighth Circuit affirmed the district court's grant of summary judgment to Teva.

In a footnote, the majority opinion noted that neither party requested that the issue be certified to the Nebraska Supreme Court. The Eighth Circuit hadn't done so in Hill, and it had even less guidance from the state in deciding Hill.

Dissent. Judge Jane Kelly, writing in dissent, argued that the Eighth Circuit lacked adequate guidance from Nebraska courts on this subject and that the court should have certified the question to the Nebraska Supreme Court before deciding the appeal. The judge specifically argued that the Freeman decision concerned the application of the learned intermediary doctrine to acne medications, not contraceptives. Further, the dissent pointed out that the adopted provision of the Restatement has a specific carve-out for direct-to-consumer warnings. Moreover, the Freeman decision cited to a New Jersey decision which utilized that exception, and the patient here asked specifically for that exception to be applied to this case. The dissent asserted that the question of whether the prescribing of contraceptives was different from that of other drugs or medical devices was a state-level public policy decision that should not be decided by a circuit court. Finding that certification would neither deprive the court of jurisdiction nor force the parties to state court, the dissent stated that the question should be certified to the Nebraska Supreme Court before the Eighth Circuit rules on the matter.

The case is No. 19-1361.

Attorneys: Vincent J. Moccio (Bennerotte & Associates, P.A.) for Stephanie Ideus. Frederick M. Erny (Ulmer & Berne LLP) for Teva Pharmaceuticals USA, Inc. and Teva Women's Health, Inc.

Companies: Teva Pharmaceuticals USA, Inc.; Teva Women's Health, Inc.; Teva Branded Pharmaceuticals Products R&D, Inc.

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