Numerous patients implanted with Medtronic Defibrillators that have the defective Sprint Fidelis lead wires sought the assistance of an attorney to find out what their legal rights were, resulting in many individual lawsuits and some class-action lawsuits.
There are numerous ongoing investigations involving Medtronic and these defective leads. However, patients affected by these Medtronic defibrillators have grounds for cases based on three issues:
(1) Medtronic never should have put a defibrillator with Sprint Fidelis leads on the market
(2) Medtronic should have acted more quickly to recall the defective defibrillator
(3) Manufacturers of medical devices, such as the Medtronic lead, have a duty to make safe products under the legal theory of strict liability
The first issue involves the Food and Drug Administration (FDA). Medtronic did not test the Sprint Fidelis wires extensively on humans before placing the product onto the market for the public because the FDA did not require them to do so. The FDA stated that because Medtronic was simply modifying an existing model, such testing was not required. Should the FDA have required Medtronic to conduct such clinical trials, the problems with the lead wires, more than likely, would have been discovered.
Because these trials did not occur, the defective lead went undetected. The FDA’s failure to require extensive testing does not negate Medtronic’s responsibility to create a safe product. Had the company conducted their own research into the stability of the leads, they may have caught the flaw and corrected it before placing the lead on the market.
Medtronic waited before carrying out the recall of the defective defibrillators. The company knew that the leads were fracturing at higher-than-usual rate for months before taking action. Before implementing a recall, Medtronic first blamed physicians for the problems, claiming that they were not implanting the lead properly. By January 10, 2007, there were 599 reports of injury filed, 204 of them for “inappropriate shocks.” In February 2007, there were 152 injury reports, compared to the 27 in February 2006. After January 10, 2007, 1,030 more injuries were reported to the FDA, without any action taken. Dr. Robert Hauser of the Minneapolis Heart Institute states that he contacted Medtronic in early February 2007 about the problem and published a review of the injury cases in late March. The Heart Institute’s concern about the danger of these devices caused the institute to stop implanting the defibrillators in January. Others began to notice the delay as well. Iowa Senator Charles Grassley wrote in a letter to the FDA stating, “Medtronic was aware of the potential lead fractures several months before suspending sales of the Sprint Fidelis defibrillation leads. I am concerned that action may not have been taken in a timely fashion in this case as well.” Dr. William Maisel, who specializes in cardiac medical devices in Boston, told the New York Times that Medtronic's warning to doctors in March, which told doctors of some early fracture reports, is another example of medical device companies’ failure to react to a problem. “What is frustrating here is that this was another situation that was predictable,” Dr. Maisel told the paper. Although both the FDA and Medtronic were aware of the rising number of injuries, instead of taking action to correct the situation, Medtronic launched a million-dollar ad campaign titled “What’s Inside,” urging the public to inquire with their doctors as to whether they would be a good candidate for a Medtronic device or not.
There are more than 1,000 lawsuits filed against Medtronic for their faulty lead wire. Some of the cases are based on the legal premise of strict liability. This is a liability for which proof of a guilty mind in relation to one or more elements comprising the guilty act is not required. In other words, the court does not have to prove that Medtronic had a “guilty mind”—knew that their product was faulty—in order to prove that their lead wires were legally responsible for harming and killing others. To clarify further, anyone who is engaged in the stream of commerce of the lead wires (from Medtronic, the manufacturer, all the way down to the retailer that sold the hospital the defibrillator), may be responsible because the lead wires were defective and a person died. The court does not have to prove negligence but the injured patient has to prove that the product was defective. The theory goes on to reason that injuries from products may occur because the manufacturer failed to provide adequate instructions for use, and that they should be able to foresee that someone down the line will misuse the product and should make sure to design and manufacture a product so that injuries do not happen.
At this time, Medtronic has not yet settled any of the Sprint Fidelis cases. Many involved in medical malpractice and other areas of personal injury law predicted that the Medtronic lead wire cases would settle out of court, but court decisions have proved these predictions unfruitful. On May 18, 2009, a U.S. district court dismissed a lawsuit against Medtronic because the FDA had previously approved the Sprint Fidelis defibrillator lead wires connected with patient deaths. This approval occurred because the Sprint Fidelis lead wires were a modification of the previous, more dependable, Sprint Quattro model. Even though this case and others against Medtronic were dismissed, the principle of pre-emption is likely to be a legal controversy for some time, especially if the FDA approves other devices that later are alleged to be unsafe or defective.
Currently there are many law firms available to the public that devote their practices to representing clients injured by the Medtronic Sprint Fidelis lead wire.
- Medtronic Defibrillator. Retrieved December 24, 2009 from http://www.medtronicdefibrillator.com/
- Defibrillators (Implantable). Retrieved December 24, 2009 from http://www.medtronic.com/our-therapies/defibrillators/index.htm
- Medtronic Defibrillator: What to Do If You Have One. Retrieved December 24, 2009 from http://www.defibinfo.com/medtronic-defibrillator