Bayer Must Face Essure Reporting Claim

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By Julie A. Steinberg

Aug. 31 — Bayer Healthcare must face some claims by an Idaho couple alleging the wife became pregnant about a year after receiving an Essure permanent contraceptive device ( Richardson v. Bayer Healthcare Pharm., Inc. , 2016 BL 282974, D. Idaho, No. 15-00443, 8/30/16 ).

Most of Susan and Brian Richardson’s claims were barred by federal medical device law, the U.S. District Court for the District of Idaho said Aug. 30.

But the court allowed claims that Bayer Healthcare Pharmaceuticals Inc., whose parent company is Bayer AG, and related companies failed to report certain adverse events to the Food and Drug Administration.

The Essure device was conditionally approved under the FDA’s premarket approval process. Therefore only independent state-law claims based on the violation of a federal requirement could survive.

Idaho law provides the basis for such a claim, the court said.

The court followed the reasoning of Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013). There, the U.S. Court of Appeals for the Ninth Circuit allowed claims that a device maker violated an independent duty under Arizona law when it failed to adhere to federal device reporting regulations.

Idaho law similarly provides an independent remedy: A medical device maker’s duty to warn should be construed to include reports to the FDA, the court said.

Although the Richardsons failed to allege they wouldn’t have used Essure had the information been disclosed to the FDA, a jury must determine how disclosure would have affected the adequacy of the warning to the plaintiffs, it said.

Aherin Rice & Anegon represented the plaintiffs.

Elam & Burke, P.A. represented Bayer.

To contact the reporter on this story: Julie A. Steinberg in Washington at jsteinberg@bna.com

To contact the editors responsible for this story: Steven Patrick at spatrick@bna.com and Nicholas Datlowe at ndatlowe@bna.com

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