Legislation has been introduced in the Senate and House of Representatives which would restore the ability of consumers to hold manufacturers of medical devices accountable through product liability lawsuits for injuries caused by defective products like heart defibrillators, artificial valves, artificial knees and hips. To show your support for this bill, it is important to act now and contact your legislators.

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The Medical Device Safety Act of 2009 was introduced in the U.S. House and U.S. Senate to reverse a decision by the U.S. Supreme Court last year in Riegel v. Medtronic, which held that product liability lawsuits challenging the safety or effectiveness of medical devices are pre-empted by federal law if they are approved by the FDA.

Corporations which manufacture defective medical devices and dangerous drugs have been arguing for years that they should be insulated from liability for injuries caused by their products so long as the FDA approved the products. However, in reality, the FDA is not equipped to be the last line of defense for product safety, and their regulations should be viewed as the floor, not the ceiling.

Ultimately, responsibility for the safety of medical devices and prescription drugs should fall to the manufacturer, and a consumer should be entitled to compensation when a corporation fails to ensure that their product is safe and effective.

Earlier this month, in the case of Wyeth v. Levine, the U.S. Supreme Court came down on the side of the consumer, finding that makers of pharmaceutical drugs are not insulated from liability for faulty warning labels, regardless of whether the FDA approved the label.

However, the Riegel decision is continuing to present substantial hurdles for individuals injured by defective medical devices, such as the Medtronic Sprint Fidelis defibrillator lead that was recalled in 2007.

Although Medtronic was aware that the small wires they were selling to connect cardiac defibrillators to the heart were prone to fracture or break, they continued to allow the products to be implanted for months.

In January 2009, U.S. District Judge Richard H. Kyle in Minneapolis cited the Riegel decision as the basis of his dismissal of over 1,400 Medtronic lawsuits that had been filed on behalf of patients who were injured by the defective Medtronic defibrillator leads.

The legislation introduced by Sentator Edward Kennedy (MA-D), Rep. Frank Pallone (NJ-D) and House Energy and Commerce Chairman Henry Waxman (CA-D) could restore these lawsuits and protect other consumers injured by medical devices, by ensuring that they are able to hold the manufacturer responsible for a negligent design that results in a dangerous and defective medical device.


To preserve your right to pursue a product liability lawsuit for injuries caused by a bad medical device, it is important that you contact your Senators and Representative to make sure they understand the importance of supporting the Medical Device Safety Act.

The civil justice system and state court juries are an important safeguard to hold companies accountable for decisions which put profits ahead of consumer safety. Let your voice be heard.

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