FDA To Ask Medical Device Makers to Prove Safety
In a step long awaited by medical injury lawyers, the U.S. Food and Drug Administration (FDA) has announced it will ask makers of external defibrillators, pacemakers, and other medical devices to prove the safety and effectiveness of their products.
These devices, among others, were allowed into the market with very little testing in 1976, before the medical device law was passed. After the law was enacted, the FDA was supposed to determine which of the older devices needed retesting before the agency could give approval for new versions. The agency, however, failed to do so and, for years since, has continued to approve such devices without requiring rigorous safety testing. The agency recently began a review of two of its older device categories and will be sending notices to the makers of at least 25 other device types, asking them to submit product safety information to the agency within 120 days.
The device categories include several high risk devices like external defibrillators, pacemaker parts, and others that have been in the news for various medical injury lawsuits. With this, the theory that the FDA has stringent monitoring processes and should, therefore, be the sole arbiter of a device's safety, has been debunked.
Meanwhile, patients across the country who have been implanted with Medtronic's Sprint Fidelis Defibrillator leads, just one example of the FDA's failure to monitor the safety of devices, are living in anxiety that their devices could malfunction, leading to severe injuries. For these patients, every day that goes by could mean further deterioration of the lead that connects the defibrillator to the heart, and even more anxiety. The extraction process is high risk and not recommended; these patients are caught between a rock and a hard place. They cannot undergo surgery because it is risky, and they cannot sue the company because of the Riegel vs. Medtronic Supreme Court ruling, in which the court held that a device maker could not be sued for injuries caused by an FDA-approved medical device.
The FDA and Defective Medical Devices
For those of use who have never fallen for the theory that the FDA's "stringent" review processes can be relied on, and that device makers, therefore, deserve immunity from lawsuits relating to agency-approved devices, this move by the FDA is a welcome first step. However, thousands of patients who have been injured by the use of these minimally tested devices continue their wait to seek justice for their injuries.
The medical injury attorneys at Arnold & Itkin LLP have extensive experience representing victims of injuries. If you have been injured by the use of a defective medical device, contact a medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.
Although the company says it has not received reports of death or serious injuries connected to the use of the catheters, the FDA has classified the recall a Class I. Generally, such a recall is issued when there is “a reasonable probability” that the use of a product can result in serious injuries or death. 3,000 catheters, .jpg)
It seeks to nullify the Supreme Court's ruling in Riegel v. Medtronic. In that case, the Supreme Court ruled that patients could not file 
Boston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations:.jpg)
On February 17th, a judge in Wisconsin dismissed a lawsuit filed by a 63-year-old man who needed surgery to remove a Medtronic device after the company warned that the batteries may suffer from a sudden depletion of power causing it to malfunction. Earlier this year, a judge in Minnesota dismissed hundreds of 
In January, Judge Kyle dismissed all Sprint Fidelis injury lawsuits citing a Supreme Court opinion that establishes the preemption of federal regulations over state law. Now, attorneys for the plaintiffs intend to cite potential .gif)
