A class action investigation has emerged against Bayer HealthCare, the manufacturer of the birth control Essure. Essure is marketed as a permanent, non-surgical form of birth control. However, users of Essure have suffered serious complications such as bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage and ectopic pregnancy. The class action stems from the fact that these patients were allegedly not warned about these side effects.
Essure consists of two flexible coils made of metal and polyester. The coils are inserted through the vagina and uterus and are placed inside each fallopian tube. As tissue develops around the metal coils, pathways towards conception become blocked. Essure received premarket approval by the Food and Drug Administration in 2002. It soon became popular as the only permanent sterilization method outside of surgical tube ligation. Because of the demand for non-surgical permanent sterilization, Essure was expedited through the usual FDA approval process, a pivotal issue in the current investigation.
Since its approval in 2002, 4,500 reports of complications have been filed with the FDA relating to Essure. The plaintiffs are now challenging the market approval of the drug by the FDA. At the moment, the FDA approval of the drug is shielding Bayer from product liability due to federal preemption laws. Federal preemption laws stem from the Supremacy Clause, and state that if Congress drafts a law specifically stating that it preempts state regulation, then it will.
The federal law governing medical devices is called the Medical Device Amendments Act of 1976, and contains one of these preemption clauses. The plaintiffs here hoping to get around the preemption clause face an uphill battle. As the Supreme Court held in a 2008 case (Rigel v. Medtronic) that the preemption clause of the Medical Device Act prevents injured patients from filing lawsuits based on state law claims involving medical devices that received premarket approval from the FDA.
If the federal preemption clause is upheld here, the plaintiffs can still recover damages. This is if they can prove that the manufacturing company deviated from the specifications set forth when it applied for FDA approval. The plaintiffs are doing just that in this case by alleging that Bayer failed to report and actively concealed organ perforations resulting from Essure use, erroneously used non-conforming materials in the manufacture of Essure, and manufactured Essure at an unlicensed facility. Whether these alternative causes of action prevail remains to be seen.