COA narrows claims against Bayer in Essure birth control defect case

A panel of the Indiana Court of Appeals narrowed the claims of women who sued pharmaceutical giant Bayer claiming alleged defects in the permanent birth control device Essure. The ruling Wednesday came after the Indiana Supreme Court remanded the case for the appeals court to address the viability of plaintiffs’ claims.

In Bayer Corporation, et al. v. Rene Leach, et al., 19A-CT-625, Rene Leach and more than 30 other women sued Bayer Corporation and other entities involved in manufacturing Essure. The women claimed they experienced injuries following the implantation of the device.

The women alleged that Bayer violated Indiana’s Product Liability Act and other state and federal laws by covering up adverse information and by misleading federal regulators, the public and the plaintiffs. They also claimed that Bayer failed to meet certain regulatory obligations, including failing to timely and properly update warnings and labels, failing to report and respond to adverse events, failing to report negative clinical studies, and failing to perform post-market studies and surveillance.

Previously, Bayer was denied its motion for judgment on the pleadings after it argued that the women failed to adequately plead their claims and that their claims were preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.

The trial court certified its interlocutory order at Bayer’s request and the COA affirmed, holding that the women’s manufacturing defect claim was sufficiently pleaded and not preempted by federal law. The COA concluded that it didn’t need to address the other factual allegations and legal theories, however, because it had identified a claim upon which relief could be granted.

But the Indiana Supreme Court in a per curiam order remanded to the appellate court to consider the viability of each of the plaintiffs’ claims, finding it had failed to do so.

Thus, in a Wednesday decision, the COA affirmed in part, reversed in part, and remanded to the Marion Superior County after taking a look at each of the nine claims. It ultimately reversed the denial of Bayer’s 12(C) motion, first finding the pharmaceutical company was entitled to judgment on the pleadings on all tort claims premised on the failure to strengthen label warnings because federal law did not require it to do so.

“As the Seventh Circuit explained: ‘Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.’ … We conclude that federal law expressly preempts a manufacturing-defect claim based on failing to proactively strengthen warnings on the Essure label,” Judge L. Mark Bailey wrote for the unanimous appellate panel.

The panel additionally found that Bayer is also entitled to judgment on the pleadings on all tort claims that do not involve a defect recognized by the IPLA.

“Further, as to the claim that Bayer is liable for a failure to warn, because the IPLA contemplates a defect only where labeling or packaging is inadequate — and because the Women have not alleged that Bayer deviated from the FDA-approved labeling or packaging — Bayer is entitled to judgment on the pleadings on that claim,” the appellate court wrote.

However, the appellate court affirmed in all other respects when it concluded that Bayer had otherwise not demonstrated it was entitled to judgment on the pleadings.