SCRUTINY OF ESSURE® INCREASES AS WOMEN COME FORWARD CLAIMING PERMANENT INJURIES
MT. PLEASANT, SC – (Jan. 14, 2016) – Motley Rice LLC, one of the nation’s largest plaintiffs’ firms, has filed two suits for California women against Bayer, Corp., Bayer Healthcare LLC, Bayer Essure, Inc., (formerly known as Conceptus, Inc.), Bayer Healthcare Pharmaceuticals, Inc., and Bayer AG for personal injuries and 10 alleged counts, including fraudulent concealment and negligent misrepresentation of the permanent birth control device Essure®.
Filed in the Superior Court for the State of California County of Santa Clara for Deanna Alonzo of Fillmore, Calif. and Desirea Harvey of Orangevale, Calif., the suits allege that Essure has permanently injured and altered the quality of life of these two young mothers and has left both with no other option than to have a hysterectomy to deal with the complications related to Essure.
Essure is a permanent birth control procedure that is a type of tubal sterilization that does not require an incision. During the procedure, a metal spring-like device wound with synthetic fibers is implanted in the fallopian tubes. The metal portion of the device consists of a stainless steel inner coil and an expanding nickel titanium outer coil. The fibers are designed to encourage surrounding tissue to adhere to the device, ultimately creating a barrier of tissue to block sperm from reaching the eggs.
Essure was approved by the FDA in 2002, and as of May 2015, there were more than 5,000 reports from both doctors and women to the FDA claiming Essure caused serious side effects, including 11 deaths. Five of those deaths were fetal deaths that occurred in women who became pregnant despite undergoing the Essure procedure.
Deanna Alonzo, 38-years-old, was implanted with Essure in 2013. Since the implant, she has suffered from debilitating symptoms that include migraines lasting for two to three days, severe pelvic pain, and chronic lower back pain. She is also suffering from a severe allergic reaction to the nickel in the device.
“I was told that Essure was a better option than undergoing a regular tubal ligation as a means of permanent contraception. Now, I wish I had never been convinced to go through with the Essure procedure. Unfortunately, I have realized I am not alone. I worry that thousands of other women who were implanted with Essure may suffer daily as I do,” said Deanna. “From financial stress, anxiety and migraines to the debilitating pain in my legs and lower back, I am devastated because I am often not able to enjoy activities with my family that I used to love. I believe Essure is the cause.”
Desirea Harvey, 33-years-old, was implanted with Essure in 2011. She alleges that the device has left her with such unbearable pain that she is no longer able to work and care for her three children.
“What these women and the reported thousands of others have alleged they experienced from Essure is truly tragic,” said Motley Rice medical device lawyer Fidelma Fitzpatrick (DC, MA, NY, RI). “Action, I believe unfortunately comes too late and only after thousands are left suffering. It is completely unacceptable that these women are suffering. I believe that Bayer should have to account for its actions and inactions in a court of law and be forced to tell the public the truth about its product.”
In September 2015, the FDA held a public meeting of its Obstetrics and Gynecology Devices panel to discuss the risks and benefits of Essure, hearing from medical experts and women. The FDA is expected to release its decision on the next step for Essure devices at the end of February 2016.
Motley Rice medical device attorneys Fidelma Fitzpatrick, Carmen Scott, Breanne Cope and Hayleigh Stewart Santra represent Ms. Alonzo and Ms. Harvey, along with attorney Erin Copeland of Fibich, Leebron, Copeland, Briggs & Josephson. The cases are Deanna Alonzo vs. Bayer, Corp., et al, Case No. 116CV290019 and Desirea Harvey vs. Bayer, Corp., et al Case No. 116CV290017.
Motley Rice attorneys have experience litigating medical device cases, particularly those created just for women, including holding leadership roles in these types of cases, such as transvaginal mesh, and understand the complex legal and scientific aspects of medical device litigation. They work to uncover aggressive product development and marketing practices that may have caused patients harm. Motley Rice lawyers have also represented women who have suffered from harmful medical drugs, including various types of birth control cases such as, Yaz®, Yasmin®, NuvaRing® and Mirena® IUD. Motley Rice attorneys handle all aspects of discovery and trial in medical device lawsuits, including product identification, medical causation, compliance with FDA regulations, adequacy of warnings, allegations of product defects, and coordination of witnesses and experts.
Learn more about Essure lawsuits.