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Bayer accused of under-reporting contraceptive issues to FDA

Bloomberg July 10 | Updated on July 10, 2020 Published on July 10, 2020

Bayer AG failed to report thousands of complaints of injuries allegedly caused by its Essure contraception device to the US Food and Drug Administration (USFDA), 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 US in 2018, a year after pulling it from other markets.

The release of hundreds of documents at the request of Public Justice, a non-profit advocacy group, adds to Bayer’s legal entanglements, two weeks after the company announced a settlement to resolve US lawsuits over its flagship weedkiller Roundup and other products.

The litigation over the herbicide, which Bayer inherited when it acquired Monsanto, continues to hobble the stock, which fell as much as 1.6 per cent early Friday in Frankfurt. A plan to resolve future Roundup lawsuits for about $1.25 billion was temporarily suspended this week after a judge raised substantial questions about the proposal, which was part of a broader $11-billion settlement deal involving mostly current claims.

Bayer said on 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 2.7 lakh 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 Essure lawsuits in California are headed toward trial after the company failed earlier this year to get them dismissed.

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.

Alleged under-reporting of complaints includes: Conceptus didn’t report instances where Essure devices were removed due to pain, unless the determination was made that removal was medically necessary. Conceptus had a history of not reporting complaints as related to Essure if symptoms didn’t resolve after removal. Conceptus had a history of not investigating complaints that came directly from patients. Bayer decided not to report Conceptus-era legacy complaints that it identified as reportable under its own criteria. Bayer’s fight to keep the documents sealed underscores the lengths some corporations will go to ― including endangering public health ― in order to protect their bottom line, Public Justices 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.

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Published on July 10, 2020
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