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Medical Device and Safety Act

Federal regulatory agencies have become increasingly lax in their enforcement of rules and regulation that have been enacted to protect consumers. Many agencies have relied upon self regulation and enforcement which is essentially no regulation. The recent meltdown in the United States financial sector is some evidence that companies and individuals cannot be left to self-regulate.

It’s a sad fact that federal regulatory agencies have become to closely aligned to the industries they are supposed to regulate for the public’s well-being.

One of the most important regulatory agencies, the U.S. Food and Drug Administration (FDA), has become particularly lax in ensuring the health and safety of those who take medication and rely on properly functioning medical devices.

In an attempt to provide additional oversight in this critical area a small group of Senators introduced the Medical Device Safety Act of 2008.

The proposed legislation would allow victims of faulty medical devices to sue for injuries in state courts even if the medical device had been approved for use by the FDA. Such legislation, would not be needed if the FDA would perform its traditional regulatory role.

The United States Supreme Court recently ruled 8-1 that a federal law, the Medical Device Amendments of 1976, preempts state laws that provide for stricter standards for medical devices than does the federal statute. The Supreme Court Opinion stated that tort laws disrupted the “federal scheme” and that the FDA is the sole determining body to approve medical devices. This essentially makes it impossible to sue the company that manufactured the defective product.

The Courts Ruling subjects patients to possible death or debilitating conditions resulting from faulty medical devices approved by the FDA, while denying them the recourse of seeking compensation for damages in state courts. The Courts use of the word “scheme” correctly describes how the system works in the real world. In the current system a drug or medical device manufacturer develops a drug or device that if approved by the FDA may make the company billions of dollars and the executives millions of dollars in bonuses. The company seeking approval submits its studies for the drug or device to the FDA and the FDA reviews the material. Obviously, the drug or device company’s desire is to get an approval with as little research and restriction as possible. Upon approval by the FDA the drug or device company is essentially shielded from any harm caused by its product. As we have previously noted in other articles the FDA is understaffed and under funded. This results in the FDA having to rely upon the information given to them by the parties seeking approval.

The medicine/device industry vigorously opposes the legislation precisely because it has been able to duck behind the FDA shield to deflect claims by patients harmed by medical devices that didn’t live up to the government’s seal of approval.

Public advocacy groups have chronicled an increasing list of patients seriously injured by faulty medical devices over the last decade. Among the devices: Trident prosthetic hips, Prodisc spinal implants, Medtronic and Guidant defibrillators, St. Jude’s Silzone-coated heart valves and Sulzer’s hip and knee implants.

We believe the bill would ensure safer products by allowing personal injury lawyers to file lawsuits against manufacturers at the state level. Even officials at the FDA have questioned the agency’s ability to monitor and ensure the safety of medical devices.

Enactment of the Medical Device Safety Act of 2008 would be a good first step toward correcting the lax enforcement that leads to serious injuries and deaths for patients who put their trust in the miracles of modern medicine. Obviously, you cannot protect the public when you do not have the funding or the staff to regulate and at the same time you remove the threat of being held accountable in Court.