The Food and Drug Administration (“FDA”) has told Medtronic, a manufacturer of medical devices, that it must stop producing its implantable drug pumps. The reason for the FDA’s action is that the numerous problems with the pumps have been reported over a span of many years.
The drug pumps are implanted into patients and release a steady supply of drugs to patients suffering from diseases such as cancer and chronic pain. Most patients who have the pump implanted have some type of adverse reaction, or no reaction at all, to taking drugs orally. In many cases, the pumps have been found to deliver too much or too little medicine, or the pump’s battery dies, all of which could harm the patient.
The FDA has gone so far as to file an action with a federal court to halt the production and distribution of the pumps. In fact, Medtronic entered into a consent decree with the FDA where it agreed to stop production of drug pumps but did not admit fault. The agreement came after multiple warnings from the FDA to Medtronic that its device violated the Food, Drug and Cosmetic Act. Because each warning was ignored, the FDA took further action. Ultimately, Medtronic will now be forced to address the device’s problems.
If you or a loved one was injured by a Medtronic implantable drug pump or any medical device, you may have a product liability claim against the company. Call Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC for help with your case. Contact us today at 973-274-5200.
