The child was only two years old when doctors surgically implanted a defibrillator into her chest. This medical device was intended to compensate for a life-long heart defect that Avery has inherited. Unfortunately, the defibrillator was only effective for about a year when Avery began to experience a frightening side effect: repeated and painful shocks to her heart.
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The problem was revealed to be the defibrillator’s lead, which had fractured and was causing electrical shocks to be delivered directly to the girl’s heart. The child’s lead was only one of many produced by the company that have proven to be defective. The model was recalled in 2007. The company has not revealed the precise defect that makes these leads dangerous.
- Car Accident
- Bicycle Accident
- Wrongful Death
- Dog Bite Accident
- Slip & Fall Accident
- Motorcycle Accident
- Pedestrian Accident
- Medical Malpractice
- Professional Negligence
- Premises Liability Accident
- Construction Site Accident
- Commercial Trucking Accident
Because people are understandably wary of the medical products, they chose to have the child’s defibrillator lead replaced with one from a different company. This is where their legal complications began. Because they were not using a typical replacement lead, the company has refused to cover the costs of the child’s second surgery – even though their defective product created the need for this procedure in the first place.
While seeking fair compensation, the family has encountered a relatively new legal doctrine that could end their hopes of justice – and those of many other injured people. This doctrine is called preemption.
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What Preemption Means for Victims
According to the preemption doctrine, a company’s responsibility for the safety of its products ends as soon as the products are approved by the Food and Drug Administration. According to this argument, the FDA assumes responsibility for public safety by declaring a product safe for use. If this product later turns out to be defect, and causes harm to innocent consumers, their cases should be filed against the FDA and not the products’ manufacturers.
The problem with this proposal is that numerous examples of FDA errors can easily be found. In fact, the Agency has been repeatedly criticized for not evaluating certain kinds of products thoroughly enough, and being too easily manipulated by the companies it is meant to monitor. It is not hard to see why a policy that allows corporations to legally hide behind the FDA while influencing its decisions could ultimately be very harmful to consumers.
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