In order to safeguard patients from medical device recalls, manufacturers are responsible for testing the safety of their products—but many fall short. The approval process used by the U.S. Food and Drug Administration (FDA) to guarantee that medical advancements are available for the public in the form of safe and effective medical devices, has been said to be a flawed process with multiple loopholes. In many cases, exemptions granted by a shortcut process known as 510(k), allows for dangerous medical devices to be marketed with no safety studies being performed in humans.
The lack of oversight and tendency for the medical device industry to rush products to market without ensuring safety, has led to an increasing number of medical device injuries which continues to rise every year. Correspondingly, the number of medical device recalls has also risen but often, many patients are injured or even die as a result of a faulty or defective medical device or device failure.
A number of medical device injuries have resulted in notable recalls including:
- Infusion pumps
- Joint replacement devices
- Surgical mesh
- Surgical implants
- Automated devices
- Robotic or power surgical equipment
Not all injuries are caused by recalled devices or cause a device to be recalled. Devices may be recalled by the FDA due to:
- Defects or failure to perform as intended
- Injuries or harm caused by device
Devices may also be voluntarily recalled or simply withdrawn from the market and discontinued to no longer be sold by the company. A voluntary recall does not necessarily mean that a person has been harmed or that harm was probable, it may be something much less serious such as a packaging issue. When the FDA requires a recall however, it generally indicates that increased health risk was likely or had already occurred.
Complications of Notable Recalled Medical Devices
As federal regulators move to tighten oversight of recalled medical devices, one ubiquitous and troubling device—automated infusion pumps that intravenously deliver drugs (like pain meds, insulin and cancer treatments)—still plagues the industry. A common, and potentially deadly error is dispensing an inaccurate dose of medicine, e.g., instead of two units of a drug, an infusion pump has been known to dispense 22 units or conversely, fails to dispense enough.
Pulling a medical device recall product off the market so that it is no longer available, though costly, may be fairly simple. With some medical devices, however, it may become much more complicated when it has been implanted in patients. Implanted medical devices are sometimes left in place depending on risk to the patient. The patient and physician must work together to determine the level of risk of leaving the device in place, vs the risk of removal and replacement.
One case, faulty Medtronic’s heart defibrillator cable was a medical device recall implanted in 150,000 people in the U.S. and a quarter-million worldwide from 2004-2007 before it was recalled due to five deaths that occurred. Patients subsequently faced tough decisions whether to undergo risky and costly surgery to replace the recalled medical device or risk the cable cracking and seriously injuring them. A number of patients died during extractions of the devices, while others faced added risk from a device known to be faulty.
In less acutely dangerous cases, a device may be thought or known to increase the risk for long-term illness such as the link between textured breast implants and a type of cancer known as “breast implant associated anaplastic large cell lymphoma” (BIA-ALCL). Patients must consider the cost and trouble of removing and replacing an implant when compared to what may be a low risk for cancer. The company responsible for developing the implant may be unwilling to assist with costs without legal action.
Medical Device Recall Lawsuits
In many cases, patients or loved ones of those who have been harmed by a medical device which has been recalled are forced to pursue legal action in order to receive compensation for their injuries or losses. This is unfortunately true even when a medical device has clearly been shown to be defective and responsible for harm.
Filing a medical device lawsuit may help to provide compensation for medical costs, lost wages, pain and suffering and other damages. Seeger Weiss’ highly experienced medical device attorneys understand what it takes to pursue tort litigation of this nature.
Contact us today if you have been victimized by a medical device recall or call us at (888) 608-6433 for a free consultation.