Sadly, NBC News reported that approximately 300 non-fatal injuries and 27 deaths have been linked to the medical devices, which were manufactured by C.R. Bard for three years about a decade ago.
The news outlet released follow up story recently indicating that Bard may have forged the signature of a person involved in getting the device clearance from the U.S. Food and Drug Administration on paperwork for approval. The device was only approved by the agency after several attempts.
NBC News spoke to Kay Fuller, a veteran regulatory specialist who helped Bard get government clearance to sell the device. When she was interviewed, Fuller said that she had “serious concerns about the Recovery,” following a human clinical trial.
She said that when she voiced these concerns to Bard, the company did not want to hear them.
NBC News presented paperwork to Fuller including an application it submitted to the FDA, which she claimed she did not sign. The news outlet compared her signature at the time to the one on the application, saying it is markedly different.
Meanwhile, Bard denied that it submitted forged documents to the agency. To read the NBC News follow-up report about the Recovery implants, you can visit the source link below.
We will continue to follow this story over the upcoming weeks. If you have been hurt by a defective medical device or your loved one has been killed, speak to our attorneys about how you can recover from this trauma.
We hold manufacturers liable for negligence. The allegations that are being made against Bard when it comes to the Recovery device are disturbing. Follow our social media sites for news about defective products and recalls.
Koonz, McKenney, Johnson, DePaolis & Lightfoot, LLP