Defective Medical Devices
Millions of people rely on medical devices such as pacemakers, defibrillators, prosthetics and dialysis machines to live healthier and more effective lives. They put their lives in the hands of the companies that manufacture these devices, trusting that they have conducted the necessary tests and quality assurance to ensure that their products function properly. When manufacturers release defective products to the marketplace, they may be held responsible in a court of law.
The U.S. Food and Drug Administration (FDA) dictates the approval process for medical equipment, but it is ultimately the manufacturer’s responsibility to ensure the safety of its products. Flaws in design and manufacture sometimes lead to the production of defective medical devices. This, in turn, often leads to injury or death of the patients who use these devices.
Medical Device Companies Must Compensate Victims When Negligent
When a defect is discovered, it is the manufacturer’s responsibility to properly inform the FDA and the public about the flaw and any potential risks. After learning about a defective medical device, the FDA has two options: it can ask the manufacturer to voluntarily recall the item or it can mandate a full recall. Regardless of the FDA’s action, the manufacturer must take responsibility for the consequences of its product’s defect.
Failure on the part of a manufacturer to sufficiently inform the public in a timely manner about a defective medical device is an act of negligence. This disregard for public safety makes the manufacturer potentially liable for any illnesses, injuries or deaths that occur as a result of the defective device.
Examples of Defective Medical Devices
Defective medical devices affect thousands of people every year. Recently, two manufacturers of cardiac devices have been forced to issue recalls due to defects that could lead to serious injury or death.
Guidant Implantable Defibrillators and Pacemakers
In June 2005, Guidant voluntarily recalled its implantable defibrillators due to the risk the device could experience an internal short circuit. This defect could prevent the defibrillator from delivering the shock required to keep a patient’s heart rate normal.
Additionally, in July 2005 Guidant voluntarily recalled certain models of pacemakers after it was found they may contain a defective seal that could let in unwanted moisture. Moisture can damage electronic circuitry, causing a device to malfunction; in this case, the defect could have led to inconsistent stimulation of the heart, which could have caused serious heart problems or death.
Medtronic Defibrillator Leads and Pacemakers
In October 2007, Medtronic issued a recall of its Sprint Fidelis defibrillator leads, which connect the defibrillator to the heart. There are documented cases of the leads developing fractures, which can prevent the defibrillator from sending a lifesaving shock or prompt it to deliver painful, unnecessary shocks.
Additionally, in November 2005, Medtronic recalled certain Sigma Series pacemakers due to a faulty connection between the device’s main circuitry and its header. This defect could have caused the device to cease functioning.
Defective Product Lawsuits
Victims of defective medical devices need to be aware of any legal recourse they may have. The lawyers at Levin, Simes, Kaiser & Gornick have been successfully defending personal injury cases for decades. Contact them at (800) 901-4001 to learn about your legal rights and opportunities for compensation.
Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104
Ph: 1.800.901.4001
Fax: 415.981.1270
