A pacemaker is a medical device, first used in Sweden in the 1950s, for patients with heart problems. The device sends electrical impulses that help stabilize patients who have irregular heartbeats. Implanting a pacemaker is usually performed by a cardiologist or a surgeon.
Unfortunately, some pacemakers have flaws which can cause death, heart attacks, or heart failure due to the defect. Typically, the Food and Drug Administration issues alerts about pacemaker defects to hospitals, doctors, the makers of the devices, and distributors. There are three kinds of recalls:
- Class III. This is least serious. The device is recalled because of a legal defect even though the risk to patients is minimal.
- Class II. The device has been found defective and the risk to patients, including the risk to their life, is substantial.
- Class I. This recall classification is reserved for the most serious type of life-threating risk.
The basis for bringing a product liability claim for a failed pacemaker
When the FDA recalls a device, the manufacturers and distributors must stop making and selling the devices. The patient’s remedy when he/she learns of the recall, often by way of their cardiologist, is to contact experienced product liability lawyers who can hold the manufacturers and distributors liable for creating a defective product and causing injury to the patient. Sometimes the patient only learns of the defect when the pacemaker malfunctions, causing physical harm. A defective pacemaker even has the power to kill.
Two pacemaker brands that have been the subject of recalls and litigation are pacemakers made by Guidant Corporation and Medtronic. Medtronic was required to recall more than 60,000 pacemakers when it was discovered that a cleaning solvent shorted out the circuits in the Medtronic Kappa and Sigma pacemakers. Guidant recalled more than 170,000 pacemakers in 2005 due to product defects.
In product liability cases, it is not necessary to prove that the manufacturers were reckless or careless during the design or production phase. Instead, you just need to prove that the product was defective, and the defect caused your injuries, or the death of a loved one.