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, Fidelma Fitzpatrick, said in the filing.
Essure was marketed as a safe alternative to surgical techniques such as tying the fallopian tubes, but the FDA put restrictions on the device amid mounting complaints that it caused bleeding, pain and organ damage for users. Bayer stopped selling the implant in the U.S. in 2018.
The lawsuits in California are headed toward trial after the company failed earlier this year to get them dismissed.
Bayer said Thursday it continues to "stand behind Essure's safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 270,000 women over the past two decades."
The documents now being made public in the litigation "do not affect Essure's safety profile," which the company continues to monitor while working with the FDA, Bayer said in a statement.
The release of hundreds of documents in the Essure litigation at the request of Public Justice, a nonprofit advocacy group, comes just after Bayer's announcement two weeks ago of a $12.1 billion settlement to resolve U.S. lawsuits over its flagship weedkiller Roundup and other products in an effort to move on from the legal woes that have hobbled the stock for almost two years.
Conceptus had a backlog of open complaints as early as 2003 and which continued after Bayer started selling the product, according to the filings. In 2008, an internal audit by an independent consulting firm warned that the very large backlog of unresolved complaints could be a violation of FDA requirements, according to the unsealed documents.
"The company's unsuccessful fight to keep them sealed underscores the lengths some corporations will go to _ including endangering public health _ in order to protect their bottom line," Public Justice's staff attorney Stevie Glaberson said on the group's website. "It also highlights why the fight to limit secrecy in cases like this one is a critical part of holding companies accountable."
Bayer said in its statement that the FDA has repeatedly inspected its complaint-handling and reporting practices and "has never issued a warning letter."
(With assistance by Jef Feeley and Robert Burnson)
