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Defective Medical Device Victims Right to Sue

The United States Supreme Court’s interpretation of the 1976 exemption clause in its decision in Riegel vs. Medtronic has set a dangerous precedent. The court’s conclusion in the case was that a medical device (in this case, a Medtronic catheter) manufacturer was shielded from liability because the Medical Device Act’s pre-exemption clause “bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.” In other words, the court decided that if a product has received FDA premarket approval, consumers harmed by said product are prohibited from litigation.

A new bill proposed in the House of Representatives – HR 5403, or Ariel Grace’s Law – would allow citizens who have been harmed by defective medical devices, even those that received FDA premarket approval, access to the court system. See the story at for more information.

Legislation Inspired by Dangerous Sterilization Coil


HR 5403 was inspired by Essure’s permanent sterilization coil, which has complications ranging from organ perforation to ectopic pregnancy to excessive bleeding and pain and more. While thousands of women in the country have claimed that they have suffered harm as a direct result of their use of the coil, Essure is protected from liability thanks to the FDA premarket approval process and the Supreme Court’s decision. Those behind the legislation state that Essure’s protection violates states’ sovereignty, which guarantees citizens’ access to courts. Further, the immunity is also viewed as a barrier to the reevaluation and improvement of medical devices that may be dangerous, and takes away any incentive for medical device manufacturers to eliminate hazards.

Has a Defective Medical Device Caused You Harm?

For most victims of defective medical devices, litigation is still an option – the right to sue remains for victims of all medical devices that did not receive FDA premarket approval. For those who are victims premarket approval devices, like the Essure permanent sterilization coil, seeking reparation for harm may be more difficult, if not impossible. Whether or not HR 5403 will pass through congress and be signed into law is unknown; if it does not, victims may have a very difficult time receiving any compensation for their losses.

Our Defective Medical Device Attorneys Can Help

At the law firm of Cohen, Placitella & Roth, P.C., our competent Philadelphia medical device litigation attorneys fully support Ariel Grace’s Law, and believe that all defective medical device victims should be able to have their day in court. If a dangerous defective medical device, drug, or other product has caused you harm, our team wants to represent you.

If you have questions about your right to sue, the amount of damages you may be able to collect, and how to begin the process, start by calling our law firm today. You can also request a free case consultation by filling out our online form. Our attorneys will work hard on your behalf to uphold your rights!


Contact us for your consultation (215) 567-3500