Holly Kelly Ennis
FDA Grants Bayer Another Variance Regarding Essure
It is hardly surprising given the history of the complicit relationship between Bayer and the FDA, that the FDA has acquiesed yet again to Bayer by allowing Bayer to reduce some of its responsibilities regarding the reporting of adverse events to the FDA as required by law. As part of its post market safety monitoring and reporting, Bayer is still required to submit adverse event reports that it receives regarding the Essure device to the FDA. In the current litigation concerning Essure, Bayer has demanded that all Plaintiffs produce their social media posts in an attempt to weed out plaintiffs, hoping to prove some Plaintiffs were aware of their Essure related injuries long before filing lawsuits. As the social media posts are being produced, Bayer has become aware of thousands of reportable events, requiring adverse event reports to the FDA. Because of the anticipated volume of the information (bought on by Bayer's own actions), Bayer applied for and the FDA, not surprisingly granted, Bayer's request for a variance from some of the medical device reporting requirments.
In an April 24, 2020 letter, the FDA approved Bayer's request for a deviation from traditional Medical Device Reporting requirments. This variance specifically applies to the MDR-reportable events that Bayer becomes aware of from social media between November 2016 and November 2020. The FDA has essentially given Bayer permission to roll up potentially thousands of adverse event reports about the Essure device into monthly spreadsheets. The agency granted this variance from April 24, 2020 through April 30, 2021, "because of the anticpated volume and nature of this information." The FDA continued stating, "it continues to require that Bayer submit Essure-associated reportable events, outside of the events specifically covered in this variance, in accordance with current Medical Device Reporting requirements."
Of course this begs the question: If there are so vastly many reportable events that Bayer seeks a variance on reporting requirements, why did it take Bayer so long to remove Essure from the market in the first place? Bayer is responsible for the "volume" of reportable events by not pulling Essure from the market sooner and by forcing Plaintiffs to produce years and years worth of social media; yet Bayer seeks a variance and a reprieve from reporting on the issues it created. Today is the annual shareholders meeting in Germany and the shareholders should tell Bayer loud and clear that this behaviour is simply unacceptable.
In the variance, the FDA states that Bayer must:
*Submit a spreadsheet on a monthly basis that "includes all reportable events" that it is made aware of during that time. The firm is to submit its spreadsheets to the FDA by the 10th of each month.
*Attach a MedWatch 3500A reporting form to monthly spreadsheets. The form must include the total number of events by type (ie, death, malfunction, serious injury) and a patient or device code. It also must specify patient demographics and name the source of the report.
*Create adverse event analysis reports that analyze spreadsheet information quarterly, as well as cumulatively. The reports should include a "comprehensive analysis" of information from the MedWatch form, as well as the number of devices that were returned to Bayer. The firm should also provide summaries of any investigations it conducted in relation to returned devices. Additionally, a final analysis report that analyzes all adverse event data found during the yearlong variance must be sent to the agency no later than July 29, 2021.
The FDA also noted it was updating the Problems Reported with Essure web page to include updated information on the MDRs the agency has received on Essure since its approval. This information can be accessed at https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure.