Essure Problems 

October 6, 2016

The Honorable Paul Ryan

Speaker U.S. House of Representatives

Washington, DC 20515

The Honorable Nancy Pelosi

Minority Leader

U.S. House of Representatives

Washington, DC 20515

Re: Support H.R. 5403, the “Ariel Grace’s Law”

Dear Speaker Ryan and Leader Pelosi:

The American Association for Justice (AAJ), formerly the Association of Trial Lawyers of America (ATLA), is writing to express our strong support of H.R. 5403, the “Ariel Grace’s Law.” This much needed legislation addresses the Supreme Court’s 2008 decision in Riegel v. Medtronic1 by simply restoring Congressional intent and the ability of injured consumers to hold negligent medical device manufacturers accountable for product related deaths and injuries.

Consumers who are injured by medical devices often suffer permanent, debilitating injuries or even death. Yet, the Supreme Court decision in Riegel ignored Congressional intent and disregarded 30 years of experience under the 1976 Medical Device Amendments. Prior to Riegel, FDA regulations and state tort law worked together to protect consumers from dangerous devices. As a result, many dangerous devices were successfully removed from the market, increasing overall safety for all consumers. The Riegel decision, however, has since provided total immunity to device manufacturers who fail to adequately warn consumers about the safety risks of their devices.

Injured consumers of defective medical devices should not be prevented from holding negligent manufacturers accountable for their injuries. Under Riegel, patients and taxpayers are left footing the bill. This raises the cost of insurance and leaves the patient with no compensation for permanent losses caused by the device’s failure. In addition, for patients who can no longer work, immunity for the device industry places additional burdens on taxpayer supported programs such as Social Security Disability.

H.R 5403, “Ariel Grace’s Law” would fix the Supreme Court’s decision and restore the ability of injured consumers to hold negligent medical device manufacturers accountable when their products cause injury and death.

1 552 U.S. 312 (2008).

For these reasons we strongly support “Ariel Grace’s Law” and urge Congress to act

quickly to pass this important legislation.

Sincerely,

Linda Lipsen

Chief Executive Officer

American Association of Justice