Medical Products Liability Cases Can Happen to Anyone

It is a sad reality that some medical devices that physicians and surgeons place inside people do not function in the fashion for which they were intended. This does not even begin to question the actions or inactions of the surgeon or physician who placed the medical device. Often enough a medical product does not work as well as intended if it is not properly installed in the patient.


Perhaps you suffered a trauma or had a medical condition that required a medical device to remedy. Instead, you are now worse off after undergoing a painful surgery. At that point, you must first deal with any emergency or acute medical issues. You should also discuss with an attorney your right to seek compensation from the medical device manufacturer. Medical devices are governed by products liability laws, which are often related to state law, except when there is a federal overlay or federal preemption.


Congress created the Medical Device Amendments of 1976 to amend the Food, Drug and Cosmetic Act. The Medical Devices Amendments of 1976 limit damages to specific delineated causes of action. Since the Medical Device Amendments of 1976 are federal laws, all such cases must be brought in federal court.


In a products liability action against a Class III medical device manufacturer there are only certain, clearly defined causes of action on which a plaintiff may proceed. They are:


  • Failure to comply with the manufacturing procedures and processes distinctive to the device approved by the FDA;
  • Failure to adhere to FDA regulations that cover or govern injuries that are linked to the issues that the medical device is intended to remedy;
  • Failure to adhere to the FDA’s Current Good Manufacturing Practices;
  • Some fraud or mistake in the approval of the medical device in issue.


The animating philosophy is that medical devices are some of the most rigorously regulated items in the stream of commerce. After approval, the manufacturer cannot change or alter the engineering in any meaningful way. Any change could potentially create dangerous medical complications or alter the intended target population in a harmful or deleterious way. Given the highly regulated nature of the approval process, Plaintiffs must proceed in an equally regulated manner to recover. Failure to properly allege and factually support a case will result in a dismissal of your cause of action.


If you or a loved one were harmed due to problems with a medical device, you must ensure that you have an aggressive and experienced attorney with a proven track record. The attorneys at Napoli, Shkolnik, PLLC have the experience and tenacity to ensure that not only do you have a strong case but that you also receive wise counsel. You can fill out our online contact information form and someone will call you about your case or you can call us directly at 212-397-1000.