The Medical Device Safety Act will restore the rights of injured consumers to hold negligent medical device manufacturers accountable when their products cause injury and death.
A February 2008 Supreme Court decision, Riegel v. Medtronic, ignored Congressional intent and disregarded 30 years of experience under the 1976 Medical Device Amendments (MDA), during which FDA regulation and state tort law worked together to protect consumers from dangerous devices. The Riegel decision gives total immunity to device manufacturers that fail to adequately warn consumers about device risks. When patients with devastating injuries are unable to hold the negligent manufacturer accountable, the patient and the taxpayers are left footing the bill.
For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed to the taxpayers. And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability. All this cost shifting does nothing to help the injured patient, drains public funds, and does not encourage the manufacturer of the faulty device to fix the problem.
The Medical Device Safety Act of 2008 will fix the Supreme Court's flawed Riegel decision. The bill does two things:
It restores Congressional intent by explicitly stating that actions for damages under state law are preserved. It makes the amendment retroactive to the date of enactment of the Medical Devices Amendment of 1976. The bill doesn't change the federal preemption of state law; it simply removes the presumption of total immunity and no accountability that the federal courts gave to manufacturers and the FDA decision-makers. The Court took the decision-making process out of the hands of Congress and of the court system and put it completely in the hands of FDA bureaucrats. State legislators and attorneys general are joining the cause of rolling back the situation to before the Supreme Court's decision and restoring the status quo in effect for decades.
- U.S. House of Representatives
- U.S. Senate
I urge Congress to swiftly pass the Medical Device Safety Act of 2009. In 2008, the Supreme Court overturned decades of established law when it ruled in Riegel v. Medtronic, Inc. that a person harmed by a faulty medical device cannot sue to hold the manufacturer accountable. The Court misinterpreted existing federal law, finding that Congress intended to leave patients harmed by FDA-approved medical devices no options for redress in the courts. History has shown us that allowing patients to hold manufacturers accountable through such lawsuits helps to keep medical devices safe, and the Supreme Court's misunderstanding of Congressional intent must be reversed.
Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to meet this standard. The Medical Device Safety Act will allow lawsuits by injured patients to go forward. The decision whether to allow patients to sue manufacturers of medical devices should be made by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.
I hope the Medical Device Safety Act will have your support.
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