In most cases, when a defective product is sold, consumers retain the legal right to pursue a personal injury lawsuit in order to seek compensation from the manufacturing company.

For potential plaintiffs of Essure lawsuits, this may no longer be a legal option, since a legal rule known as preemption has prevented patients injured by this birth control device from filing lawsuits against the medical device’s manufacturer, Bayer Pharmaceuticals.

However, one woman has filed a complaint in Philadelphia court, challenging the federal application of preemption to all Essure lawsuits including hers. She claims the preemption doctrine should not apply to the Essure medical device. Should this particular plaintiff’s case end in a favorable outcome, this would make way for other Essure victims to file their own personal injury lawsuits in order to receive compensation for their alleged injuries.

What is Essure?

Essure is a non-hormonal birth control product that is currently manufactured by Bayer. During a non-surgical implantation procedure, two Essure coils that are composed of polyester and metal are inserted into a patient through their vagina and uterus, where they are then placed inside each of the fallopian tubes. Over the course of a few months, scar tissue will form around the coils, preventing conception and pregnancy.

While many women have found success with this form of non-hormonal birth control, more than 4,500 other consumers have filed adverse events reports with the FDA, claiming Essure complications and personal injuries. Some serious complications linked with Essure use include: bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy.

Background on Essure Federal Preemption

Federal preemption is a legal doctrine that stems from the U.S. Constitution’s Supremacy Clause, which states federal laws trumps inconsistent state regulations and laws. However, in order for a federal statute to supersede a state law, the U.S. Congress must draft a law that specifically states the federal statute preempts the specific state regulation in question.

In 1979, the federal government established the Medical Device Amendments Act; this document contains a preemption clause to state medical device regulations. It is important to note that this preemption provision does not expressly prohibit medical device lawsuits based on state tort claims, such as claims of negligence and breach of warranty.

In 2008, the Supreme Court ruled in the case known as  Riegel v. Medtronic that the preemption provision found in the Medical Device Amendment Act prevents injured victims from seeking compensation based on medical device state law claims, especially for devices that received FDA premarket approval. This decision is now a current problem for women allegedly harmed by Essure, as they cannot file Essure lawsuits against Bayer.

According to a New York Times editorial piece criticizing the court’s decision in Riegel v. Medtronic, the newspaper noted:

“When it passed the 1976 law, Congress almost certainly had no intention of removing the right to sue. Senator Edward Kennedy, the Senate sponsor of the law, and Representative Henry Waxman, who sat on the House panel that approved it, have both said that Congress had no intention of granting the manufacturers immunity from lawsuits over injuries caused by their devices.”

Despite criticism by The New York Times and other news sources, the federal preemption law against Essure and other medical devices stands. Essure victims cannot seek compensation from Bayer unless a federal judge rules that Essure’s premarket approval by the FDA should be invalidated.