Twelve Items from DePuy Discovered to Not Be FDA-Approved

Medical equipment must always be inspected for errors or malfunctions before it is sold in order to ensure the protection and health of a patient. However, it was recently reported that over twelve items made by DePuy Orthopaedics Inc., a company that services Johnson & Johnson orthopaedic equipment, were not FDA-approved. While the devices were made according to the order given by a doctor, they never underwent the mandatory approval process. Therefore, it does not matter that the items were custom-made.

Mandatory FDA-approval was called into question by a DePuy representative who claimed that skipping the approval step for custom-made devices has been acceptable for over 30 years. Nevertheless, the representative said that DePuy has stopped making custom-designed devices. This may also be due to the fact that the company failed to meet other requirements, as well. After receiving a Warning Letter issued by the U.S. Food and Drug Administration, DePuy is taking the necessary measures to begin adhering to the FDA regulations.

Whenever an apparatus fails to go through a mandatory FDA inspection, it could cause extensive harm to the recipient of the device. If you have been the recipient of a non-approved medical device, it is essential that you seek the help of a pharmaceutical injury attorney who will aggressively fight for your rights. You may be eligible to be compensated for your circumstances. The experienced team at Arnold & Itkin, LLP has successfully won cases for clients with pharmaceutical injuries, and they are prepared to take on your case. Do not hesitate to contact a pharmaceutical injury lawyer from our firm today.