Defective Medical Devices


Medical products and devices save hundreds of thousands of lives every day, but they also pose serious risk to patients. Technological advances have made medical devices extremely sophisticated, but have put patients at risk for new injuries. The U.S. Food and Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man… or intended to affect the structure or any function of the body of man… and which does not achieve any of its primary intended purposes through chemical action within or on the body of man…and which is not dependant on being metabolized for the achievement of any of its primary intended purposes.” In basic terms, a medical device is a device or a part of a device that intended to diagnosis or treat illness. Medical devices do not include prescription drugs.

Commonly used medical devices include pacemakers, hearing aids, stents, syringes, hip replacements, knee implants, pain pumps, external defibrillators, contacts, cochlear implants and breast implants. The FDA divides medical devices into three categories—Class I, Class II and Class III—depending on the risk the device poses to the public. Class I medical devices pose a minimal risk to the patients. Almost half of all medical devices are included in Class I and include non-invasive devices, such as bandages, slings, and hand-held surgical instruments. Class II devices pose a greater risk to the public and General Controls are not sufficient to adequately protect the consumer. Therefore, Class II devices are subject to Special Controls, which include special labeling requirements and performance standards. Class II devices can include surgical drapes, X-Ray systems, wheelchairs and walkers. Class III devices pose the highest risk to patients, as these devices are typically life-sustaining devices. These devices are subject to the most stringent standards. These high-risk, life-sustaining devices include heart valves, defibrillators, breast implants and pacemakers.

Medical device manufacturers are expected to produce products that function properly and effectively. When they breach this expectation the patient has the right to recover for any injuries that resulted from use. If you or a loved one has been injured by a defective medical device you are entitled to recover for any medical expenses, lost and future wages, pain and suffering and scarring or disfigurement caused by the defective device, in addition to punitive damages. Call the Miami injury attorneys at Friedland | Carmona to assist you in obtaining the money you deserve!

Friedland | Carmona currently represents a number of clients involved in various Miami products liability cases. With over twenty years of combined experience in handling these types of cases, the Fort Lauderdale personal injury attorneys at Friedland | Carmona can assist you and your family members in obtaining to the recovery you deserve. Jonathan Friedland has tried product liability cases in both State and Federal Court and has an outstanding track record of success. Recently, a Miami Federal jury awarded a Friedland | Carmona client over $200,000 for a defective prosthetic device. Plaintiff alleged that his partial left knee prosthetic device broke apart inside his knee, requiring the removal of the device and a total knee replacement, just eighteen months after the device was implanted rather than the normal eight to ten years later! This case also became the standard for similar product defect cases across the United States.

Call the Miami product defect lawyers at Friedland | Carmona at 305-661-2008 or fill out the contact information to your left to receive your FREE consultation. You will receive advice and a thorough review of your product liability claims and options. Many victims never get the settlement they deserve because they are unsure if they have a claim. Don’t hesitate—Contact the Kendall accident lawyers at Friedland | Carmona today! Let our family take care of your family!