Report Reveals that Key Signature on Approval Application May Have Been Forged
DALLAS (Sept. 4, 2015) – According to an NBC News investigation, the signature of a C.R. Bard employee may have been forged on a document sent to the U.S. Food and Drug Administration (FDA) to help gain approval for the company’s Recovery IVC filter, the national law firm of Baron & Budd reports. The story aired on the September 3, 2015 edition of the NBC Nightly News.
The story aired as the second part of an NBC News investigation into Bard’s Recovery IVC filter, which has been linked to nearly 30 deaths and approximately 300 injuries over the last decade. The Recovery filter is implanted into a patient’s inferior vena cava, the body’s largest vein, in order to keep blood clots from entering the heart or lungs. However, the Recovery filter can break, embedding pieces into major organs.
According to the report, Bard hired veteran regulatory specialist Kay Fuller in 2002 to help the company gain FDA clearance for the Recovery filter after a previous effort proved unsuccessful. However, in an interview, Fuller said she began to have significant concerns about the Recovery filter. She stated she was concerned about the results of a human clinical trial as well as the fact that the company failed to provide results of a separate safety performance test.
Fuller told NBC that Bard officials suggested she would no longer be a part of the team if she voiced those concerns. She also stated in the interview that she informed her boss she would not sign the FDA application unless her concerns were resolved. However, according to the report, Bard submitted the application with what appeared to be Fuller’s signature.
Fuller clearly stated that signature was not hers, but would not say it was forged. NBC compared the signature on the application with a sample of Fuller’s signature at the time and they were substantially different. Fuller resigned from Bard after reporting her concerns regarding the safety of the Recovery filter to the FDA. The agency declined NBC’s request for an interview, as did Bard executives. However, in a statement sent to NBC, the company said that any suggestion Bard submitted a forged application to the FDA was “flatly untrue.”
“To say this report uncovered some potentially troubling facts is an understatement,” said Russell Budd, president and managing shareholder of the national law firm of Baron & Budd. “We will keep an extremely close eye on any further potential developments involving this matter.”
About Baron & Budd, P.C.
The law firm of Baron & Budd, P.C., with offices in Dallas, Baton Rouge, New Orleans, Austin and Los Angeles, is a nationally recognized law firm with a nearly 40-year history of "Protecting What’s Right" for people, communities and businesses harmed by negligence. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals and government and business entities in areas as diverse as dangerous pharmaceuticals and medical devices, environmental contamination, the Gulf oil spill, financial fraud, overtime violations, deceptive advertising, automotive defects, trucking accidents, nursing home abuse, and asbestos-related illnesses such as mesothelioma.