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A pacemaker is a medical device that delivers electrical impulses to the heart to stabilize heart rhythms. Irregular heartbeat affects millions of Americans, but in most cases, the defect causes no serious problems. For some though, an irregular heart rhythm can be life-threatening.
Pacemakers were introduced in the 1950s, when Medtronic, Inc. developed the first external unit to resolve the irregular heart rhythm problem. Shortly after in 1958, the first internal pacemaker was surgically added to a patient in Sweden in an experimental procedure.
Since then, pacemakers have become a commonly used option for preventing heart attacks. Yet, not all pacemakers are created equal; some have serious design flaws which can harm, rather than help patients.
When a pacemaker is found to have defects, the United States Food and Drug Administration (FDA) issues alerts to physicians, hospitals, manufacturers, and distributors. When the defects are found to violate FDA law, the organization will issue a recall. There are three kinds of recalls.
A Class III recall occurs because of a legal violation, but the unit has been found to hold little risk to patients. In a Class II recall, risks to patients with the defective medical device are considerable, including a possibility of a life-threatening condition. Class I recalls are the most serious, with a strong chance of the patient developing a life-threatening condition.
An FDA recall means that the defective medical devices in stock must be returned to the manufacturer for destruction. Pacemakers already implanted in patients remain. This creates the potential for serious health problems for some of these patients. Even those who do not experience a complication from the device have to deal with the worry and anxiety about the possibility that one day, they may.
When a patient receives notification of a recall, the FDA is stating that the device could malfunction at any time. A malfunction of a defective pacemaker is serious, resulting in needless pain and possibly loss of life. In many cases, the treating physician has moved, retired, or is simply unwilling to revisit the patient. If this happens, patients are advised to contact a knowledgeable Philadelphia medical product liability lawyer immediately.
Even in the absence of a recall, a defective pacemaker may malfunction. Malfunctions are typically how the FDA is alerted to such problems in the first place. In recent years, pacemakers manufactured by Guidant Corporation and Medtronic, Inc. have been found to have serious design defects. In just one recall, a cleaning solvent was found to have shorted out the circuits of a pacemaker manufactured by Medtronic, Inc. The company was forced to recall more than 60,000 units.
Regardless of whether a pacemaker manufacturer intended harm or not, strict liability laws hold them responsible for problems caused by their defective medical devices. Because product liability laws differ in each state, patients with such problems living in the Philadelphia area should consult with an attorney who knows the law in both Pennsylvania and New Jersey. Moreover, the time allowed for filing a claim is limited, so patients should not hesitate to seek legal counsel for questions pertaining to a product recall.
The Philadelphia medical product liability lawyers at Brookman, Rosenberg, Brown & Sandler help patients adversely affected by defective medical devices such as recalled pacemakers. If you or someone you love has been harmed by a faulty pacemaker, please arrange a consultation now via our simple, online form or by calling 800-369-0899 or 215-569-4000. From our Center City Philadelphia office, we assist clients throughout the Delaware Valley including those in Pennsylvania and New Jersey.