Nearly a dozen documents outlining Bayer's dealings with the U.S. Food and Drug Administration in litigation over discontinued birth control device Essure will no longer be confidential.

In a tentative ruling, Alameda County Superior Court Judge Winifred Smith partially lifted a blanket protective order covering most of the roughly 70 million pages of discovery documents in the case. If the order holds, 16 court documents and part of a deposition will be available to the public. Plaintiffs counsel allege that Essure's previous parent company, Conceptus, intentionally hid records revealing the negative side effects of the product.

"Where the subject matter of a protective order concerns health or safety matters, the court will also consider the public interest in access to the information," Smith wrote. "Matters of public safety are of public interest because judicial proceedings may bring issues to light that deserve legislative or regulatory attention."

As of December 2018, the FDA received 32,773 medical device reports related to Essure, a permanent implant inserted into the fallopian tubes. Side effects have included hair and tooth loss, chronic bleeding, miscarriages, and death of both Essure recipients and their infants. Bayer took the product off the market in July 2018.

The unsealed documents include reports prepared after FDA inspections and annual reports submitted to the agency, as well as internal documents outlining the company's standard operating procedures around product return, complaint handling and reporting.

Many of the documents are more than a decade old. FDA confidentiality on trade secrets and commercial and financial information expires after 10 years.

"If a [Freedom of Information Act] request would result in an unredacted public document, then the protective order will permit public disclosure of an unredacted document," Smith wrote. "Additionally, the 10-year limit on confidentiality designations for trade secrets and commercial or financial information is consistent with California and federal case law on protective orders generally."

Winifred Smith Alameda County Superior Court Judge. Photo: Hillary Jones-Mixon

Bayer counsel Chris Cotton, of Shook Hardy & Bacon in Kansas City, Missouri, took issue specifically with removing the confidentiality designation on the internal documents from Conceptus prior to Bayer's purchase of the company in 2013. That includes Corrective and Preventive Action documents and Standard Operating Procedure (SOP) reports.

"SOPs by definition speak to how the company operates," Cotton said in a motion hearing Wednesday, asking for an order without prejudice to revisit this issue. "That has value even when we talk about older documents."

Plaintiffs attorney Lori Andrus, of Andrus Anderson in San Francisco, argued that Bayer had been unable to show good cause for maintaining the secrecy of the documents.

Smith said she would take the lawyers' guidance under advisory. "I'm not sure you can foreclose a party for raising an issue with the court," she said. "But the tentative order was pretty clear."

In an interview after the hearing, Andrus said the ruling is significant, because Bayer had now been treating proceedings like they're in private arbitration, even though they're in a public court, she said.

"Justice will be done in public, putting a limit on how corporate America thinks it can operate in secret without accountability," she said.