Medical devices save and improve the lives of countless patients. In some cases, however, defective medical devices cause injury to the very people they are intended to help. Victims of defective medical device injuries can incur significant expenses, and often wonder what legal options they have.
The defective medical device lawyers of Hale & Monico are committed to holding manufacturers liable when the devices they make harm patients. We investigate our clients’ injuries and demand the compensation and justice they deserve.
Common Examples Of Defective Medical Devices
Extensive research and testing go into the development of medical devices and equipment. Although these tools are regulated by the Food and Drug Administration (FDA), mistakes are made that allow defective products onto the market. Some of the notable devices that have harmed patients are:
- Silicone breast implants
- Hip implants and artificial joints
- Artificial disks
- Vaginal mesh implants
- IVC filters
- Insulin pumps
- Heart stents
- Intrauterine devices and implantable contraceptives
These are just some of the devices that have been found to be defective. Many of these products are ultimately recalled, but not before causing harm to numerous patients.
What Causes Defects?
The medical device industry is big business, and there are significant profits to be had by driving its products to the market. In the rush to develop these devices, corners are sometimes cut and important details are overlooked. Most defects can be attributed to at least one of the following reasons:
Improper or insufficient testing. Although testing is required for the FDA to approve a medical device, not all tests are appropriate for gauging the effect of the device on humans. Medical procedures are complicated, and the tools and equipment that are used can impact the body in more than one way. In some cases, the tests themselves are appropriate, but there are not enough tests performed. The FDA often relies on test results provided by device manufacturers, and those results may not be reliable.
Defective designs. Some products, especially those implanted, are not designed in a way that makes them compatible with the human body. An example of this is the IVC filter. These devices are designed to prevent blood clots from reaching the lungs. But the IVC filter has been known to fracture, and its pieces can then migrate to other parts of the body and cause injury. Even though the device is constructed according to technical specifications, its design can pose a danger.
Defective manufacturing. A device can be designed in a way that safely accomplishes its intended purpose. But that doesn’t mean the particular device used on you was safely made. Like any other product, medical devices are not always built properly. They may be constructed with poor quality materials, or there could be a problem on the assembly line.
Will A Medical Device Recall Help Me?
A manufacturer will recall a medical device when it is found to be defective or pose a threat to human life or health. However, a recall does not always mean that a patient will be told to stop using a product. In other words, a recall should not necessarily be equated with removal of a product from the market. The manufacturer may take steps to correct the problem by adjusting or otherwise fixing the device.
The situation is similar with respect to devices that are implanted. In the event an implant is recalled, that doesn’t mean it will be removed from the patient. The manufacturer will typically notify physicians about the problem. At that point, the doctor will discuss the issue with the patient and advise as to the risk of removing it versus leaving it in place.
Medical device companies typically recall products on their own, but the FDA has the power to compel them to do so. Regardless, the effect the device will have on a patient’s health will vary. A product that is not taken off the market, or removed from the body, can continue to pose health risks. Whether the product in question has been recalled or not, you should contact a knowledgeable defective medical device attorney.
Taking Legal Action Over A Defective Medical Device
Personal injury cases involving defective medical devices are more properly understood as product liability cases. Although the subject matter is primarily the patient’s injury, the nature of the product has to be investigated. As opposed to medical malpractice cases, where a physician’s negligence is at issue, product liability cases require proof that a defect caused injury or death to the victim.
Recovering compensation usually means proving at least one of the following:
- Design or manufacturing flaws. As mentioned above, these are either problems with the way a product is designed or how a specific product is made.
- Failure to warn. The manufacturer may be held liable if it does not warn doctors or patients of known risks posed by its products.
- Failure to recall. If the manufacturer did not take prompt action in recalling a product, or didn’t recall it at all, it could be held liable.
Chicago Lawyers Helping Those Injured by a Defective Medical Device
Hale & Monico understands the complexities of product liability law. But we know that building a successful case requires much more. Medical device companies have significant sums of money invested in their products, and they – and their lawyers – vigorously defend those interests.
Proving liability means thoroughly investigating the facts surrounding the defect and gathering sufficient evidence to prove negligence. It also means relying on experts who understand the technical aspects of these products and can testify in court about why they are defective.
In order to win your case, you need a comprehensive legal strategy that justifies your claims and anticipates the defendant’s counterarguments. We go all in to make the strongest case, for the most compensation, possible.
Let Hale & Monico go to work for you. Give us a call today to schedule your consultation.