Help Pass The Medical Safety Device Act

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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Chamber of Commerce: Business As Usual at a Theater Near You

In what seems to be an endless bombardment of spin campaigns, the chamber of commerce has now cracked into the movie business, by releasing a trailer to be shown in Washington, D.C. area theatres. Titled’ “The Faces of Lawsuit Abuse,” The Chamber has once again launched an attack against the world’s best legal system in an attempt to shield their exclusive members from lawsuits.

By shamelessly exaggerating isolated issues of what some would call questionable legal practices, the chamber is attempting to invalidate the entire civil legal system of the United States. Although they insist that their goal is to protect everyday citizens from greedy trial attorneys, the truth is that this campaign is just a new phase of their longstanding credo that negligent corporations should never be held accountable. Period.

The consequences of the chamber reaching their goal would be disastrous. Throughout American history, the legal system has combated against the corporate structure and won the right to protect its citizens from the profit driven manufacturers of today’s modern society. From the food we eat, to the toys our children play with, all products sold to consumers today would not be nearly as safe as they are if it were not for the modern legal system. If the Chamber had its way, parents would have never been able to sue when a defective crib killed their child, veterans of Vietnam would not have been compensated for their exposure to deadly toxic agents, and citizens would have never been properly warned of the dangers of tobacco.

The irony of it all is, that while the Chamber doesn’t want everyday Americans to use the legal system, they are actually one of the biggest lawsuit-filers in Washington. Except in their case, Chamber sues on behalf of Wall Street banks, oil companies, and lead paint manufacturers.

Let the government know how you feel about this immoral attack on the best legal system in the world. Write to your local and state representatives and let them know that you do not want the Chamber of Commerce walking on our constitution in order to protect the wallets of its contributors.

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Legal Side Effects or Legal Remedy?

In May’s issue, Kate Wilcox stated that a recent U.S. Supreme Court’s decision left drug companies “wide open for lawsuits” because it allowed juries to hold negligent drug companies accountable for harm they cause. The principles expressed by the Supreme Court in the Wyeth decision require federal regulations to improve transparency and public participation in the FDA regulatory process. Also, the decision recognized the state civil justice system provides an additional protection against billion dollar pharmeceutical companies when government regulations fail, and therefore agencies must limit their attempt to preempt state law, except in cases when Congress has explicitly stated its intent to do so. The decision upholds laws that are much needed, especially in light of the long standing practice of pharmaceutical companies to sponsor and pay for the, “research,” of the drugs they make. This practice allows the companies to market the drug’s positive effects while concealing the dangerous side effects that harm patients. The Court’s decision upholds important constitutional rights afforded to all citizens in this country and should be welcomed by a journal that promotes scientific study.

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