Lawsuits totaling more than 900 have been filed in California against Bayer Healthcare for serious side effects caused by their contraceptive device Essure. Until early this month Bayer has successfully kept the door locked against more than 40,000 complaints related to Essure but a ruling by a judge in California may have smashed down that door.
Judge Winifred Smith of the Superior Court in Alameda County granted a motion in the beginning of October to coordinate 55 cases filed against Bayer. At the same time, she sided with the plaintiffs against Bayer concerning pre-emption. Bayer contended that plaintiffs were not allowed to file suit under federal preemption law, but the California court did not agree.
In addition to the preemption ruling, Bayer's headaches are compounded by a bi-partisan piece of legislation known as HR 5403 or Ariel Graces Law named for the invitro death of the baby girl blamed on the failure of Essure as a contraceptive. The legislation would allow lawsuits against drug makers for harm caused by defective medical devices. The law emanates from Riegel vs. Medtronic, a U.S. Supreme Court ruling that protected manufacturers of certain medical devices from litigation.
Attorneys believe that the recent ruling will be instrumental in breaking down the door blocking thousands of cases, not only against Essure but many other defective medical devices present and future. Drug makers could no longer slip though that loop hole in the law. The hope of thousands of women rests in that decision which would make manufacturers accountable for their actions.
Some Disturbing History of Essure
Essure is a birth control device that was marketed by Bayer Healthcare as a safe and effective method of permanent birth control. It is a non-surgical method, consisting of two implants - one for each fallopian tube. Once in place the implants stimulate the growth of scar tissue which blocks the fallopian tube, preventing fertilization. Since Essure was released there have been complaints filed by thousands of women alleging serious complications including:
· Migration to outside the fallopian tube requiring hysterectomy
· Organ perforation
· Ectopic pregnancy
· Full term pregnancy
· Painful intercourse
· Heavy bleeding
· Back Pain
· Fatigue and depression
· Weight fluctuation
· Auto Immune Diseases
The clear majority of Essure complaints are from women, but there are also some by their spouses alleging loss of consortium.
In addition to the detrimental side effects claimed, the lawsuit also alleges that Bayer violated the FDA conditional premarket approval which was issued in 2002. The condition requiring Bayer to notify the FDA of over 16,000 reports of serious side effects was allegedly not followed. This failure to report invalidated the FDA approval of the product, making Essure adulterated, the lawsuit claims.
Filing an Essure Lawsuit Against Bayer
Typically, claims related to the detrimental side effects of Essure are filed individually as opposed to a class action. If you believe you have a claim against Bayer for severe side effects, due to the insertion of an Essure birth control device, it is imperative that you contact an attorney with experience concerning defective medical devices. You need a confident law firm who will stand firmly against a pharmaceutical giant. It is also important that you waste no time in filing as statutes of limitation apply and hesitating could cost you the opportunity to file. If you suffered adverse side effects caused by Essure you may be entitled to compensatory damages for medical bills, lost income, pain and suffering, loss of consortium and more.