Unfortunately, when medical devices become defective, fail to work as expected or even begin inflicting harm on your body from the inside, it is not a simple matter of switching prescriptions. Your body will be under threat from the implanted medical device until you undergo yet another surgery to remove the device. The attorneys of Sullo & Sullo, LLP, are highly experienced Houston personal injury attorneys who will sit down with you and explain the legal aspects of your potential defective medical device lawsuit. We will fight aggressively on your behalf to ensure the harm you have suffered from a defective medical device is fairly compensated.
What Types of Medical Devices Are Potentially Hazardous?
The eleven most-implanted medical devices are cardio defibrillators, artificial hips, heart pacemakers, breast implants, spinal fusion hardware, IUD’s, metal screws, pins, plates and rods used in traumatic fracture repair, artificial knees, coronary stents, ear tubes and artificial eye lenses. Although it is clear that medical devices are meant to help those with limitations and improve their quality of life, in some instances proper care is not taken during the design or manufacture of these devices, placing innocent patients at risk.
In the past couple of decades a large number of defective medical equipment has been involved in litigation including hip implants, breast implants, pacemakers or heart valve regulators, spinal discs, artificial joints and mesh implants use in surgeries to correct prolapsed organs. While many of these medical devices have been recalled voluntarily by the manufacturer, others have been recalled as a result of FDA mandates. DePuy hip implants have recently come under fire as the metal-on-metal design can cause small cobalt and chromium slivers to enter the body.
Transvaginal mesh implants have also been found to potentially erode into surrounding organs, causing life-threatening health issues. Houston personal injury attorneys with significant experience in product liability and personal injury are necessary to protect your rights in the event of a defective medical device lawsuit. The attorneys of Sullo & Sullo have the integrity, experience and knowledge required to take on a large medical device corporation and will fight aggressively for their clients.
How Medical Devices Gain FDA Approval
Before a medical device can be marketed to the public it must first gain approval from a division of the FDA. This entity has the responsibility for testing and approving all medical devices to ensure their effectiveness and safety. Many medical devices slip through the FDA approval process under the 510(k) rule which is a pre-marketing submission sent to the FDA and is supposed to show that the device is safe and effective and is substantially equivalent to a device which is already on the market. Manufacturers of medical devices strive to have their device approved under the 510(k) as the rules are much less stringent. Premarket Approval by the FDA is a much more difficult process. The PMA application which requests approval to market a new medical device must contain sufficient valid scientific evidence proving with a reasonable assurance that the device is safe and effective for its intended use.
Medical Device Recalls
The FDA recalled forty-one medical devices in 2011, and to date have recalled ten medical devices thus far in 2012. A recall is taken when a specific obstacle with a device must be addressed and when this issue violates FDA law. Recalls are put into place when a device is found to be defective and/or when it is a clear risk to the health of the patients in whom the devices were used. A recall of an implanted device does not always dictate the product use must be discontinued, but in some cases only that it must be tested, tuned-up or mended. Should the FDA determine a medical device carries a risk of failure, patients are urged to discuss the risks of removing the device vs. the risk of leaving it in place with their physician. Manufacturers of defective medical devices will most often issue a recall voluntarily as a way of limiting their liability later on although the FDA has the legal right to recall a device should the company refuse.
The attorneys of Sullo & Sullo represent people, not case files, and will never overlook the human element of a lawsuit. We understand how a defective medical device can change your life forever as well as the lives of your loved ones. We will evaluate your case and determine what types of damages you are entitled to. Economic damages will compensate you for financial losses related to past and future medical expenses, loss of earnings or loss of employment or business opportunities.
Non-economic damages are intended to compensate victims for losses such as pain, suffering, emotional distress, loss of companionship, loss of enjoyment of life and inconvenience. Punitive damages are awarded to victims when the defendant clearly demonstrated intentional or reckless behavior or their actions were motivated by malice. Depending on the specifics of your case, you may be entitled to one or more of these damages. We at Sullo & Sullo want to help you during this difficult time. Our goal is not only to get you the financial settlement you deserve, but to offer compassion and help you put your life back on track after suffering under a defective medical device.
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