It is not often discussed, but did you know that dangerous, unregulated, and counterfeit medical products, including prescription and over-the-counter drugs, are a major cause for concern around the world? So much so that both the United States Federal Drug Administration and INTERPOL have investigative units specifically dedicated to combating these dangerous products. Counterfeit medications and untested and unregulated medical products can cause extreme pain and suffering or even death in some patients. Accordingly, it is important to recognize the signs of injury from dangerous medical products and learn how to protect yourself from being a victim or test subject of such.
Medical Implant Devices
Non-organic medical implant devices, such as artificial joints, pace makers, and surgical meshes, are among the most dangerous medical products. However, according to the FDA, even medical devices that are classified as posing a significant risk of illness or injury can be approved if they have some kind of therapeutic purpose. It is much simpler to get a medical device approved for use than actual pharmaceuticals, and the amount of testing required is minimal in comparison to traditional drug trials. Further, most surgeons do not have specialized training when it comes to implanting these devices, and it is often the product's sales representative who shows the doctor how to use and implant the device before and during surgery. The famous “transvaginal mesh” cases are an example of these types of products. In those cases, patients were implanted with a medical surgical mesh, which is device implanted to support certain organs in the place of weakening tendons. However, implantation of these relatively untested mesh devices by attaching them to the vaginal area caused thousands of women to experience mesh erosion, pain, rejection of the implant, infection, bleeding, organ perforation, and urinary problems, which resulted in additional surgeries and permanent physical and nerve damage. What was supposed to be a simple means of providing support to weakening organs turned into a lifetime of pain for certain patients simply because the products were not rigorously tested prior to implant. They became the proverbial guinea pigs for a device that was not ready to be on the market.
Injuries Caused by Dangerous Medical Products
The type and placement of a medical implant device will often determine the injuries and side effects you can experience from such, but the following injuries are most commonly associated with dangerous medical implant devices:
- Nerve, bone, and tissue trauma to the area of implant;
- Organ perforation;
- Loose product fragments;
- Bodily fluid leaks, and
- Abnormal bone and tissue growth around the device.
If you know you had a medical device implanted and are experiencing pain, discoloration, or swelling in or near the area, you should consult a doctor about the risks posed by the device. Even if you have been using the device injury free for years, there is no telling when your body will decide to reject or attack the non-organic material. Further, bones, tissues, and muscles may slowly begin to grow over and integrate with the product, which can lead to complex future treatments and surgeries.
The “Chain” of Products Liability
Although medical products can be relatively unregulated, the FDA does at least require all of those parties involved with making, marketing, or utilizing the product to register it with the FDA. These parties include:
- Commercial distributors;
- Developers; and
- Accessory and component manufacturers.
If a product is registered, your attorney will be able to trace its origin, which may help in determining how and why you were injured by the product. For example, perhaps there was a manufacturing defect or the product was not sterilized or labeled properly such that it was used for the wrong purpose. Or maybe there was not an issue with the product, but after reading the labeling requirements it appears that it was miss-installed by the doctor, which is a potential medical malpractice as opposed to products liability action.
Florida Products Liability Law
If you have been injured by a dangerous medical device or product, your legal cause of action generally lies in theory called “products liability,” but this does not mean that you don't have a case against the doctor or company that assisted with the installation of the device. Under Florida law, a products liability action is defined as a lawsuit “based upon a theory of strict liability, negligence, breach of warranty, nuisance, or similar theories for damages caused by the malfunction, construction, design, formulation, installation, preparation, or assembly of a product.” The only catch is that the injuries you received from the product must be greater than those you would have suffered without its use. For example, if you have a heart condition that, without a pace maker, would likely cause death, even if implantation of the pace maker results in pain and discomfort, you would likely not have an action in products liability because the benefits of implanting the life-saving device outweighed its potential defects.
Contact a Clearwater Products Liability Attorney Today
There is nothing more discouraging than when what was meant to treat or cure a medical condition actually causes greater pain and loss. Few patients understand the weak regulations involving dangerous medical products and may make a decision regarding such without understanding the risks involved. If you have been injured by a medical product, you are entitled to the compensation you deserve to assist you in living life to its fullest. The attorneys at the Dolman Law Group Accident Injury Lawyers, PA have the experience you need to fight the medical corporations that are turning a fast profit at the expense of your health and well-being. Most corporations will make millions of dollars by rolling out an untested medical product before side effects and symptoms begin to develop in patients. They even anticipate this being the case. Don't let them get away with it! Call our Clearwater office today at 727-451-6900 for a free, no-risk consultation about your rights after a failed medical implant.