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The Medical Device Safety Act of 2009 will have a major impact on the health and safety of millions of Americans. This is a vital piece of legislation, and its passage is necessary to protect American citizens from defective medical devices such as pacemakers, defibrillator cables, catheters, and infusion pump.

These devices are widely used in people of all ages, and recalls are disturbingly common. Many Americans have suffered and died because of problems with medical devices, but under current law, manufacturers cannot be held legally responsibility when they sell defective devices that cause personal injuries and wrongful deaths. Manufacturers immunity in 1976 in the Medical Device Amendments. MDA says that states cannot impose their own requirements on medical devices if the states’ requirements are more stringent than federal requirements. So, when the Food and Drug Administration, a federal agency, grants Pre-market approval for a medical device, the manufacturer has protection from legal liability for any damage that the device may ever do.

Making the FDA the final authority on matters of health, life, and death is a danger to everyone. The agency’s record on ensuring the safety of foods and drugs is abysmal. It has repeatedly approved deadly prescription drugs, and it has consistently allowed contaminated drugs and foods to injure and kill Americans.

The FDA has been equally incompetent in its reviews of medical devices. A recent report from the Government Accountability Office found that the FDA‘s review and approval process is inadequate to assure patient safety, and scientists within the agency have agreed with the GAO‘s findings.

Further, the FDA has never fulfilled its responsibility to test the safety of 27 “legacy” devices, which are medical devices that were approved for use before the enactment of MDA in 1976.

Despite the FDA‘s deadly record of incompetence, the Supreme Court dealt patients who receive defective medical devices a huge blow in 2008 when it ruled in favor of a medical device maker in Riedel v. Medtronic. In that case, a patient sued Medtronic, Inc., the manufacturer of a balloon catheter that burst and caused him to suffer emergency coronary bypass surgery.

Medtronic argued that the Food, Drug, and Cosmetic Act preempts state-law damage suits brought by patients who have suffered personal injuries from medical devices that the FDA has approved. The court agreed with Medtronic and dismissed the case, leaving consumers with no legal recourse against manufacturers of medical devices that cause personal injuries and wrongful deaths.

The Supreme Court‘s ruling was viciously anti-consumer, and it was also a complete contrast to a more recent decision in a strikingly similar case. In Wyeth vs. Levine, the Supreme Court ruled in favor of a woman who lost her arm because of the incorrect administration of a prescription drug. So, the court has granted immunity to makers of medical devices, while drug makers are held responsible for personal injuries and wrongful deaths caused by their products, and that is a contradiction that defies all logic.

Recognizing the injustice of shielding medical device manufacturers from responsibility for their products, Congressmen Henry Waxman (D-CA), chair of the House Committee on Energy and Commerce, and Frank Pallone (D-NJ), chair of the Health Subcommittee, have introduced The Medical Device Safety Act of 2009. In the Senate, Edward Kennedy (D-MA) and Patrick Leahy (D-VT) have introduced a companion bill.

Many consumer groups have urged passage of this new bill. The prestigious New England Journal Of Medicine and the Des Moines Register have written strong editorials urging legislators to act in the best interests of the American people by holding manufacturers of medical devices responsible for the products that they sell.

The ability of injured consumers to bring lawsuits against the companies that have inflicted personal injuries and death is vital in holding manufacturers responsible for their products. Drug manufacturers and every other type of business face that responsibility. Manufacturers of medical devices, which are literally devices of life and death, must stand up to the same scrutiny. All Americans can play an important role in getting this necessary legislation passed by contacting their senators and their representatives in Congress and asking them in very strong terms to work in the best interests of the citizens who elected them by passing The Medical Device Safety Act of 2009.

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Richard Alexander