In February 2008, the Supreme Court of the United States 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 court’s recent decision in Riegel v. Medtronic gave total immunity to device manufacturers who fail to adequately warn consumers about device risks. The court, failing to understand that FDA approval does not mean a device is entirely safe, sided with the corporate world over the rights of its citizens, preventing the public from suing when a medical device fails and causes serious harm.
When patients with devastating injuries are unable to hold the negligent manufacturer accountable, the patient and the taxpayers are left footing the bill. For a patient with private health insurance, the health insurance would most likely cover the additional surgery. However, true to the nature of the beast, the price of that patients coverage will most likely increase, leaving that patient stranded to find a way to pay for their increasingly unaffordable health insurance, with no compensation for the physical limitations caused by the device’s failure.
For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed to, that’s right, you, 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.
So what can be done? Write to your state and federal representatives and let them know you support the Medical Device Safety Act of 2008. What will it do? The bill simply does two things:
1) It restores Congressional intent by explicitly stating that actions for damages under state law are preserved.
2) It makes the amendment retroactive to the date of enactment of the Medical Devices Amendment of 1976.
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. An American who thinks people should have some access to the courts – any access at all – should be for the act, because right now, in these situations, there is no access, and that’s not the American way.
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