Defective Medical Devices and Medical Device Recalls

Defective Medical Devices

Consumers want to be able to trust that the medical devices they rely on are safe. Even though the Federal Food and Drug Administration (FDA) closely monitors medical devices, injuries caused by these products are common. When someone is injured by a defective or dangerous medical device, they can bring a lawsuit to recover compensation.

What is a Medical Device?

A medical device can be virtually any device used by physicians, nurses, hospitals, techs, or therapists to treat a disease or health condition. There have been many high-profile cases about defective medical devices in the news over the past few years.

Product Liability Law and Defective Medical Devices

There are three main types of lawsuits that victims of defective medical devices file. First, an injured person may assert that a device was improperly manufactured. A manufacturing defect can occur at any point in the stream of commerce up to where the patient received the medical device. For example, if the device was damaged in the hospital, it could still be deemed a manufacturing defect in court.

A second type of lawsuit involves products that were negligently designed and are unreasonably dangerous. These types of claims may result in punitive damages—a high damage award meant to punish the negligent offender.

Finally, if a product is marketed in a defective manner (for example the warning about a side-effect is inadequate or non-existent), the manufacturer can be held liable. This liability extends up to the hospital, sales rep or medical provider who put you in contact with the device.

The products below have made headlines because they have caused injuries to consumers who trusted that these products were safe.

Medtronic Insulin Infusion Sets

Medtronic announced a “worldwide recall” of their insulin infusion sets after determining that a component in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing.  This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia (low blood sugar) potentially resulting in unconsciousness, coma or even death. For more information, click here.

Cobalt Toxicity (Metal Hip Replacement Side Effects)

Numerous problems have surfaced regarding metal on metal hip replacements. Often, these defects result in patients needing unnecessary surgery just to remove the defective implants. Thousands of patients have suffered from cobalt toxicity and metallosis injuries as a result of defective implants. Although liability is generally borne by the manufacturer, in some instances the surgeon who performed the procedure is also liable. DePuy is a popular brand of hip implants that has had a high rate of failure, resulting in numerous lawsuits

Transvaginal Mesh

Transvaginal mesh is a treatment for pelvic prolapse and urinary incontinence. Mesh implants have been linked to a number of severe complications, such as “mesh erosion.” The pieces that break off can perforate nearby organs.

LASIK Eye Surgery

LASIK is an extremely common procedure used to treat vision problems. It is generally considered a safe and effective procedure. But things can go wrong. The equipment may be damaged, or the surgeon may have been negligent in diagnosing a patient’s candidacy for successful treatment or performing the procedure.

Intrauterine Devices (IUDs) and Contraceptive Devices

IUDs have been increasingly coming under scrutiny for their safety. The devices can be expelled, or dislocate, leading to dangerous unintended pregnancies. Hemorrhaging is another problem that has been identified.

DaVinci Robotic Surgery

Robots reduce the stress and fatigue experienced by surgeons in longer operations, but there have ben reports of injuries from system failure and surgeon error.

Guidant Defibrillators (Pacemakers)

The common device known as a pacemaker was the subject of a major recall in 2005. Not all models are affected by the recall. Some of the recalled products fail to notify the patient when the battery has failed or is running low.