Jim McEldrew and our Philadelphia lawyers represent victims of Essure problems nationwide.
In March 2016, a federal judge in the Eastern District of Pennsylvania ruled that our clients’ lawsuits can proceed to discovery under PA law despite Bayer’s claims of express and implied preemption. The Philadelphia Inquirer reported that our cases are being “closely watched nationally” because they are “the farthest along in the litigation process.”
If you have suffered severe complications and injuries as a result of the implantation of the Essure birth control device, please call our office at (800) 590-4116 to speak to an attorney.
Essure Problems and Side Effects
Essure consists of two metal coils inserted into a woman’s fallopian tubes via a disposable delivery system. Complaints about the devices indicate that they may migrate from their intended location to perforate organs, break into pieces or otherwise disappear. Women with the medical device have had to have a hysterectomy. Despite the intended function of the device, women have also complained of unintended pregnancies, babies with birth defects and fetal deaths.
Women using Essure have complained of severe pelvic and abdominal pain, bleeding, rashes, hair loss, fever, night sweats, limb numbness, weight gain, fainting problems and vision problems. Women who are allergic to nickel may suffer an allergic reaction to the inserts as the product is made out of materials that contain a nickel-titanium alloy.
The History of Essure and the Lawsuits against Bayer
Essure was initially designed and manufactured by Conceptus, Inc. It received conditional premarket approval from the FDA on November 4, 2002. As a Class III medical device, the FDA applied its most rigorous premarket approval process which requires review of all studies and investigations of the safety and effectiveness of the device.
Bayer purchased Conceptus in 2013 for approximately $1.1 billion in cash. According to Bayer, 750,000 women worldwide have chosen to have their doctors implant Essure.
The Lawsuits and Federal Preemption
We are co-counsel in lawsuits against Bayer. The first one was filed in Philadelphia in 2014 and additional lawsuits were subsequently filed.
In the first major objection to the case from Bayer, they argued that express or implied federal preemption prohibits the cases from proceeding. The doctrine attempts to ensure that the court system in each state does not apply different requirements to a medical device than that is imposed by the U.S. Food and Drug Administration through the premarket approval process. In a ruling by U.S. District Court Judge Padova, the court held that the lawsuit could proceed to discovery on a few issues that were not barred by the preemption doctrine.
Latest News (2016)
Essure suit allowed to proceed in Philly, Philadelphia Inquirer – March 24, 2016
A federal judge in the Eastern District of PA held that five women can go ahead with their lawsuit against Bayer Healthcare. A commentator said the case is being closely watched nationally because it is the farthest along in the litigation process.
Dozens of women file suit over Essure health risks – NBC 5 (St. Louis), March 18, 2016
Attorneys filed a lawsuit in St. Louis on behalf of 32 women alleging that it didn’t warn people of the serious health problems linked to the medical device.
FDA decision on Essure birth control draws fire – Cincinnati.com, March 1, 2016
A local Cincinnati group pledged to continue fighting to remove the device from the market despite the FDA decision, after six months of deliberation, to add a black box warning to the packaging and order new clinical trials.
FDA mandates new warnings, new data for Essure contractive device – CNN, March 1, 2016.
The FDA required the addition of a black box warning to the label and a patient decision checklist signed by the patient and doctor before it is implanted.
Conn. Lawsuit Joins Thousands of Complaints About Birth Control Device – Connecticut Law Tribune, February 23, 2016
A Connecticut woman filed a lawsuit against Bayer following a hysterectomy in order to remove the Essure device.
Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement, Regulatory Focus – February 17, 2016
Representative Mike Fitzpatrick claimed the number of fetal deaths related to Essure were greater than what has been reported to the Food and Drug Administration.
Four Essure plaintiffs dismiss cases after preemption ruling, Reuters – February 8, 2016
Plaintiffs in four cases filed in the U.S. District Court for the Northern District of California filed notices to voluntarily dismiss their cases after the court granted a motion to dismiss by Bayer in the case of one of the plaintiffs.
Prior News (2013-2015)
Essure sterilization method under fire – CNN, September 27, 2015
A report in the New England Journal of Medicine accused the authors of a study funded by Bayer and published in the Journal of Minimally Invasive Gynecology of “fuzzy math”.
FDA to take another look at Essure contraceptive device after health complaints – NPR, July 14, 2015
The FDA scheduled a public advisory meeting of the Obsterics and Gynecology Devices Panel in order to review data concerning Essure and hear public comments from women, physicians and industry experts.
Long-Term Data on Complications Adds to Criticism of Essure Contraceptive Implant – New York Times, May 3, 2015
A long term study of Essure that ended monitoring of patients in 2007 only recently published its results in The Journal of Minimally Invasive Gynecology.
Erin Brockovich calls for end to Bayer’s Essure – BBC, June 24, 2014
Erin Brockovich, portrayed by Julia Roberts in the movie about PG&E’s use of hexavalent chromium, is questioning the use of Essure as a form of permanent birth control, claiming that the product has injured thousands of women.
First Lawsuit filed against FDA-approved Essure permanent birth control, Bayer HealthCare, ABC 15 Arizona, July 16, 2014
The first lawsuit because of alleged complications from the permanent birth control device Essure was filed in Philadelphia civil court in 2014.
FDA rule means Essure patients with complications can’t sue – ABC 2 (Baltimore), November 8, 2013
An attorney describes how the doctrine of federal preemption limits lawsuits against makers of medical devices approved by the U.S. Food and Drug Administration.