Northern California Record

Thursday, December 5, 2019

Fidelma Fitzpatrick appointed lead council of Plaintiffs' Executive Committee in Bayer cases

By Christopher Mobley | Feb 22, 2017

Medical malpractice 06

ALAMEDA COUNTY — Fidelma Fitzpatrick, a medical device attorney at Motely Rice, has been appointed lead counsel of the Plaintiffs' Executive Committee for the Essure litigation in California against Bayer Corp.

Fitzpatrick was appointed by Judge Winifred Y. Smith in Superior Court of California, County of Alameda.

As chair of the Plaintiffs' Executive Committee, Fitzpatrick will be responsible for coordinating the activities on behalf of all plaintiffs during pretrial hearings. She will lead a five-person executive committee, which includes Edward A. Wallace of Wexler Wallace LLP; M. Elizabeth Graham of Grant & Eisenhofer PA; Kim Dougherty of Janet, Jenner & Suggs LLC; and Erin Copeland of Fibich Leebron Copeland Briggs & Josephson. Graham and William A. Kershaw of of Kershaw, Cook & Talley will serve as the plaintiff's co-liaison counsel. Alycia A. Degan of Sidley Austin LLP was designated as the defendants' lead and liaison counsel. 

The committee will also conduct discovery and settlement negotiations, as well as delegate tasks to other counsel and deliver periodic status reports. 

The California cases against Bayer Corp. had previously been coordinated as a Judicial Council Coordinate Proceeding and assigned to Smith.

Hundreds of the plaintiffs who have made the claim against Essure are represented by the Motley Rice law firm, which Fitzpatrick is a member of. Fitzpatrick has already worked on many cases against Essure during her time at Motley Rice. She also represents clients in environmental matters, including personal injury and property damage, as well as those who have been victims of corporate malfeasance.

The litigation against Bayer Corp. comes from lawsuits involving Essure birth control. According to the FDA, more than 9,000 women across the U.S. have claimed that Essure has caused them permanent and serious injuries, including autoimmune diseases, perforated organs and severe pelvic pain. Other reported complications include fetal death and other severe side effects. 

Essure is a permanent form of birth control that involves the insertion of flexible coils through the cervix into the fallopian tubes. Although the FDA had approved Essure in the past and once thought that it was an appropriate option for permanent birth control, it now thinks that some women will be at risk for severe complications if they use the product. A post market surveillance study plan report was submitted to the FDA by Bayer on March 29, 2016, and a six-month report is due on March 3. According to the post market surveillance study schedule, the study will last six years, with the due date for the final report scheduled for Sept. 1, 2023.

In February 2016, the FDA announced that it would require the company to conduct a clinical study and implement a patient decision checklist to make sure potential users of Essure understand the potential risks that may be caused by implanting the device. In October, the FDA added a black box warning to Essure's labeling, which is the  highest warning level from the FDA, and states that a product can cause serious injuries and death. 

Want to get notified whenever we write about U.S. Food and Drug Administration (FDA) ?

Sign-up Next time we write about U.S. Food and Drug Administration (FDA), we'll email you a link to the story. You may edit your settings or unsubscribe at any time.

Organizations in this Story

U.S. Food and Drug Administration (FDA)