(Bloomberg) -- A Bayer AG official warned the company of increased government scrutiny of injuries from its Essure contraceptive implant years before it was pulled from the market, according to recently unsealed court documents.
Four months after Bayer bought the maker of Essure for $1 billion in 2013, a senior manager of product surveillance, Michael Reddick, said in an email the company would see “a large increase in the number of (side-effect reports) filed” that “will certainly be noticed” by the U.S. Food and Drug Administration.
A surge in reports was coming because women were complaining of excessive bleeding and pelvic pain from the metal coils implanted into their fallopian tubes, and Bayer was changing the criteria that had been used by Essure developer Conceptus for alerting the FDA about patient injury claims, the unsealed documents show.
Complaints did increase, and in 2016, the FDA required a stricter warning label about Essure safety risks. Sales fell, and Bayer stopped selling the implant two years later. David Kessler, a former FDA commissioner and expert witness paid by women suing the company, said Bayer and Conceptus failed to properly report complaints and that regulators may have demanded stricter labeling as early as 2006 if they’d been aware of all the problems patients claimed.
The communications about Essure are part of about 38,000 individual lawsuits against the German company, which said earlier this month it set aside 1.25 billion euros ($1.47 billion), “primarily” to resolve Essure claims. A settlement announcement may come as early as Thursday, a person familiar with the matter said. Bayer declined to comment on the settlement.
The company opposed the release last month of thousands of pages of documents collected for the lawsuits, including internal records, employee depositions and reports by experts. None of the suits have gone to trial yet.
Kessler said Essure remained on the market without adequate safety warnings for a decade because of the unreported complaints.
“A medical device company has a responsibility, independent of what FDA directs it to do, to alert physicians and patients to risks that were unknown to or poorly understood by FDA but were known to the company,” Kessler said in a 2019 report filed with the court. He headed the FDA from 1990 to 1997, before Essure was approved by the agency in 2002.
Brittney Manchester, an FDA spokeswoman, didn’t immediately return a call Wednesday for comment about the unsealed Essure files.
Bayer disputes Kessler’s conclusions that the complaint-handling system was flawed and cited reports in the unsealed documents from physicians and experts who blame improper placement of the implant as the cause of complaints by women.
“The company stands behind the safety and efficacy of Essure, 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,” Daniel Childs, a Bayer spokesman, said in an email.
A Bayer-hired expert, Mary Brady, who worked on implanted medical-device safety at the FDA, said Conceptus and Bayer “had sufficient complaint-handling procedures at all times” and that the agency had reviewed them during regular audits.
While complaints increased after Bayer changed its policy in 2013, the company said that was largely due to “voluntary” reports from the public fueled by a patient-advocacy group called E-Sisters.
During that same period, the FDA required makers of rival contraceptive devices, such as Merck & Co.’s Nuvaring, to revise their warning labels. In 2014, Merck agreed to pay $100 million to settle thousands of women’s suits over the birth-control device, without admitting any wrongdoing.
Bayer points to studies over almost two decades supporting Essure’s safety profile and showing it is a safer option and more effective than traditional surgeries for permanent contraception.
Implanting Essure “had less risk associated with it” and “could be done under more minimal anesthesia” than tubal ligation, said Rebecca Allen, a Rhode Island obstetrician-gynecologist hired as an expert witness by Bayer.
Some patients complained it didn’t work or caused excessive bleeding, organ damage, migraines, vomiting and miscarriages. The suits against Conceptus and Bayer piled up. On Aug. 4, Bayer said settlement talks have “intensified and have made good progress in recent weeks.”
Last month, a California state court judge unsealed thousands of documents filed as part of the litigation, including some Conceptus and Bayer internal files, at the request of Public Justice, a nonprofit advocacy group backed by plaintiffs’ lawyers.
The unsealed files “brought to public light’’ the harm the device has done to scores of women, said Fidelma Fitzpatrick, the lead plaintiffs’ lawyer for thousands of Essure suits in California. “This case has highlighted the absolute necessity for complete transparency by corporations when people’s lives and health are at stake,’’ she said in an emailed statement.
Bloomberg News attempted to reach the people mentioned in the unsealed court filings, but they either declined to comment or didn’t respond to phone calls or emails.
Kessler criticized Conceptus for requiring a doctor to confirm an Essure-related injury before it was considered reportable. He said in the unsealed documents the practice violated FDA side-effect regulations and led to “underreporting” of the device’s problems.
Gregory Lichtwardt, Conceptus’s chief financial officer, said that when consumers called in Essure complaints, he sought to resolve them before they became lawsuits, the unsealed documents show.“To the extent the patient is threatening liability, by 2009, the company had agreed with its insurance carrier that it would make some sense for us, financially, to offer settlements directly to the patients prior to the claim actually moving into litigation,” Lichtwardt said in the May 2019 deposition.
Childs, the Bayer spokesman, said there was nothing unusual or improper “for a company to resolve a matter with a patient or consumer when it receives a complaint.”
The case is Essure Products Cases, JCCP No. 4887, Superior Court for Alameda County, California (Oakland).
(Updates with comment from plaintiffs’ lawyer.)
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