Certain serious health conditions may require the use of complex medical devices. However, many patients have been injured by flaws in these products, which can consist of manufacturing defects, design defects, or errors in marketing a device. These claims often have arisen from products such as hip implants, transvaginal mesh and other contraceptive devices, and products designed to prevent heart attacks, such as stents and defibrillators. Injured patients can bring a product liability claim against a manufacturer or another party associated with a flawed medical device that caused their injuries.
An error in making a specific medical device can cause problems that are not otherwise present in the product line. Also, a medical device can be damaged en route to a consumer, which means that someone else in the chain of distribution may be responsible. Manufacturing defect claims are usually based on strict liability, which means that you need to prove only that there was a defect and that it caused your harm.
These types of cases can be more complex because they allege that the entire line of a product is inherently defective. Perhaps the manufacturer failed to account for a certain risk in its blueprint, or perhaps it failed to anticipate the device breaking down over time. In many situations, a plaintiff will need to show that there was a safer alternative design possible that would not have imposed a much greater cost.
Sometimes a manufacturer intentionally conceals a potential problem with a device, or it may be reluctant to recall a defective line of devices and lose the profits from them. Knowingly allowing consumers to buy and use a defective medical device can support a punitive damages award in addition to compensatory damages.
Medical devices may need to be used in a specific way to ensure the patient’s safety. If the manufacturer fails to provide appropriate warnings regarding the dangers of a device, or if it does not thoroughly instruct consumers on its safe use, it may be liable under a theory of failure to warn. Sometimes doctors, hospitals, and other health care providers also may be liable for recommending that a patient use a certain device without giving them proper instructions on how to use it.
Whom to Sue
Manufacturers, distributors, and suppliers tend to be the main defendants in these cases. You can sue any of these entities for releasing a defective device to the market. Since a substantial amount of money probably will be at stake, you should expect the case to be prolonged and hard-fought. You will need expert testimony to describe the defect in the device and how it caused your injuries. These sophisticated claims are often best handled with the assistance of an attorney.
Other parties in the pharmaceutical industry also may bear some of the fault. If the manufacturer used an outside laboratory to check the safety of a device, the laboratory may be sued if it failed to conduct tests properly. Also, sales representatives of the manufacturer may be independently liable if they glossed over certain risks of a device or recommended it to doctors for inappropriate uses.
Health care providers that were involved in recommending a device to patients may be sued under a medical malpractice theory. Doctors have responsibilities to inform their patients of potential risks and give them instructions on how to use a device. In some cases, hospitals and clinics also may bear some fault.