Pharmaceutical & Life Sciences News

Bayer Accused of Underreporting Contraceptive Issues to FDA (2)

July 10, 2020, 7:13 AM

Bayer AG failed to report thousands of complaints of injuries allegedly caused by its Essure contraception device to the U.S. Food and Drug Administration, according to newly unsealed documents.

After acquiring original Essure maker Conceptus in 2013, the German conglomerate continued the California-based company’s practice of not reporting complaints to the FDA, according to an unsealed court filing by the lead attorney in the coordinated lawsuits by thousands of women in California.

“It was Bayer’s failures to comply with its reporting obligations that made it impossible for FDA to know that updates to Essure’s warnings were needed,” the attorney,...

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