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.
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.