FDA Tells Spinal Implant Maker Synthes to Fix Plant Problems
First came the recalls that were initiated against hip implants and infant Tylenol made by subsidiaries of Johnson & Johnson. These were owing to serious safety concerns with the products. Now, another potential Johnson & Johnson company is being warned of its product’s deficiencies by the Food and Drug Administration.
The FDA fired off a warning letter to Synthes, a Swiss maker of medical devices, saying that they either need to fix problems discovered at a Pennsylvania plant or face steep fines. Synthes is in the process of being purchased by Johnson & Johnson to the tune of $23.1 billion, pending approval by antitrust officials.
The purchase should be lucrative, considering that Synthes made $4 billion last year alone in its sales of spinal disc implants, screws, and rods used in spinal surgery and to improve bone damage in trauma patients. A spokesperson has said that they will work to ensure the problems get fixed.
Those problems stem from an FDA inspection of a West Chester plant that uncovered violations that were never corrected. The FDA has stated that the company does not adequately monitor and investigate complaints that arise in association with their devices, and a failure to fix this oversight will result in regulations imposed by the FDA.
As a Los Angeles personal injury lawyer, I hate to think that important medical products that are intended to keep us safe could do harm. However, I also understand that this can happen, which is why it’s so important that corrective action be immediately forthcoming. It’s my wish as a personal injury lawyer in Long Beach that this issue gets rectified.