A California federal judge has been urged by attorneys for 59 women suing Bayer over claims concerning faulty Essure sterilization devices, be sent back to state court, arguing the lawsuit brings only state law claims. The plaintiffs allege that Essure caused perforated uteruses among other severe problems.
The plaintiffs allege that the sterilization device that is a method to prevent pregnancy, may cause perforation of the uterus, device movement or breakage, chronic pain and ectopic pregnancy. An ectopic pregnancy occurs if an embryo implants somewhere other than the uterus, such as in one of the fallopian tubes.
How Essure Works
Essure is made up of small coils – stainless steel, wound with polyethylene terephthalate polyester fibers, and placed in a larger nickel-titanium coil. It is a non-surgical procedure, and is inserted in the fallopian tubes by way of a catheter through the vagina. The coils induce scar tissue which forms and blocks the tubes, stopping sperm from reaching the eggs, thereby preventing pregnancy. This process may take three months, during which time, an additional form of birth control should be used.
The U.S. Food and Drug Administration (FDA) approved Essure for the market in the United States in 2002. The risks did not emerge until after the FDA approval, but the current lawsuit maintains that Bayer Corporation neglected its duty to give a timely warning to health care providers and the FDA.
Plaintiffs involved in the lawsuit claim that if Bayer had notified government regulators as soon as it became aware of the health risks and of quality control problems in its manufacturing process, the women would not have been harmed by the Essure device.
In October 2016, the FDA added a black box warning to Essure packaging to alert women of the potential injuries that may be experienced. The warning says that the “implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, causing persistent pain and requiring surgical removal.”
National law firm Parker Waichman has extensive and successful experience in product liability litigation, including Essure. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.
Question Surrounding the Case’s Location
Originally filed in Contra Costa County Superior Court in February, the case was removed to federal court one month later. The complaint maintains violations of California negligence, strict products liability, warranty, and fraud statutes. However, Bayer argued the case was correctly removed because it implicates the Federal Food, Drug and Cosmetic Act and the Medical Device Regulation Act, as well as federal negligence laws, sparking federal interest jurisdiction.
At the beginning of the recent hearing, U.S. District Judge William Alsup said he would remand the case, saying, “It should never have been brought here.” But as the hearing continued and each side presented contrasting U.S. Supreme Court precedent, the judge became less certain about how to rule. At some point, the judge suggested the parties ask for attorneys’ fees so they could appeal to the Ninth Circuit, saying, “This whole thing is going to turn on federal regulations anyway.”
“At trial, the plaintiff here will say negligence, and of course that’s a state law claim, so all day long that part will get remanded. But the plaintiffs are also saying they would like to point to violations of federal standards to how negligence per se,” he said. “So many people can dance on the head of a pin. … I don’t have an ax to grind with either of you. I just wish the law was clearer.”
It was noted that the judge could rely on the U.S. Supreme Court’s 2005 Grable & Sons Metal Products decision, which found a suit that brought only state law claims but turned on an interpretation of federal tax law should be considered in U.S. district court because federal issues “lie over some state-law claims.”
It was argued by the plaintiffs’ representation that Grabble self-identified as the exception, not the rule and said that more recent ruling did not affect the high court’s 1986 Merrel Dow Pharmaceuticals decision, another drug warning case, which the plaintiff’s attorneys said was more on point. That case showed that Congress’ intent with the FDCA was not to create a federal private cause of action, and even the subsequent Grable decision made mention of a congressionally approved balance of federal and state judicial responsibilities.
Legal Advice and Information Concerning Essure
If you or someone you know has been injured by a medical device, such as Essure, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).