Johnson & Johnson's subsidiary DePuy Orthopaedics has decided to stop selling all custom fitted orthopedic devices following a warning letter from the FDA.
The FDA's letter dated December 8, 2011 warned DePuy that it had manufactured and marketed 14 devices, including knee and hip systems that never received pre-market clearance and approval from the agency.
DePuy has issued a statement that it believed that the devices in question were custom-made and provided at a physician's request to meet a specific patient need, allowing an exemption to the FDA premarket review; however, the FDA has said that the devices did not meet the agency criteria, in part because once the devices were completed, they could have been made available by other physicians. The FDA further cited DePuy for its failure to comply with quality regulations, including DePuy's lack of sufficient procedures in place to ensure devices met users' needs and that it did not have appropriate procedures in place for complaint review.
According to DePuy spokesperson Jessica Masuga, the company has made the decision at this time not to provide custom devices, which includes all of their custom devices, not just the 14 cited in the FDA warning letter.
Dreyer Boyajian LLP has extensive experience in products liability in products liability litigation. If you or someone you know has an orthopedic device manufactured by DePuy, please contact one of our product liability attorneys for a free consultation.