Indiana Supreme Court remands Bayer birth control defect case to COA

The Indiana Court of Appeals will need to go back and consider the viability of each claim brought by more than 30 women who sued a medical company over one of its birth control products, the Indiana Supreme Court ordered on Friday.

Rene Leach and more than 30 other women sued Bayer Corporation and other entities involved in manufacturing Essure, a permanent birth control device, after they claimed to experience injury after the device was implanted.

Specifically, the women alleged after the implantation of the device, they experienced menorrhagia, extreme fatigue, abdominal pain, back pain, joint pain, and various skin rashes. They also asserted Bayer violated federal manufacturing requirements and that they are users and consumers under the Indiana Product Liability Act. Bayer ultimately stopped distributing the device in 2018.

In their suit against the pharmaceutical giant, the women alleged that Bayer violated both 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.

Additionally, they 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.

Bayer filed a motion for judgment on the pleadings, arguing 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. However, the trial court summarily denied Bayer’s motion and the Indiana Court of Appeals affirmed in December 2019.

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

“Here, like in most complex litigation, the plaintiffs allege several sets of operative facts, amounting to several discrete claims. The Court of Appeals addressed the legal viability of only one of those claims: defective manufacturing. The Court of Appeals did not analyze the remaining ones, reasoning that any viable claim preserves the entire complaint. But that is not correct,” justices wrote in a Friday per curiam order

“In a complaint with multiple claims, the viability of a single claim does not immunize a separate, deficient claim from judgment on the pleadings. When analyzing pleadings for Rule 12(C) purposes, Indiana courts are required to address the viability of each claim presented, disposing of only unviable ones.

“Here, the Court of Appeals failed to address the viability of each claim presented in the pleadings,” the high court wrote. “We remand to the Court of Appeals to consider the viability of each of the plaintiffs’ claims.”

The case is Bayer Corporation, et al. v. Rene Leach, et al., 20S-CT-354.

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