Product defect lawyers call on FDA to improve transparency in medical device injury reporting
DALLAS – Nationally known product defect lawyers at the Fears Nachawati law firm praised disclosures that the U.S. Food and Drug Administration is conducting a sweeping review of the high failure rates and complications caused by defective surgical staplers amid concerns about whether medical device makers are accurately reporting complications caused by these devices.
Dallas-based Fears Nachawati is investigating reports that surgical staplers made by Medtronic subsidiary Covidien and Johnson & Johnson subsidiary Ethicon are prone to malfunction, often during critical surgical procedures. Such incidents have been blamed for thousands of serious, sometimes fatal, surgical complications, including internal bleeding, fistula formation, sepsis, tearing of internal tissues and organs, and increased risk of cancer.
“It’s time for manufacturers to come out of the shadows and embrace the kind of transparency that we all expect. There is simply no room for error in surgical procedures, and consumers and the medical community deserve to have as much data as possible about the safety of these commonly used devices,” said Fears Nachawati co-founder Majed Nachawati. “When these devices malfunction, the results are often catastrophic and life-threatening.”
Devices under federal scrutiny include Covidien products Signia, Endo GIA, iDrive Ultra Powered, Multifire Endo TA, DST Series GIA, Poly GIA, and MultiFire GIA. Ethicon products under review include Endopath, Echelon, Contour, and Proximate.
Gauging the full scope of the problem has been complicated by an internal FDA practice that allows medical device manufacturers to obtain a special exemption allowing them to hide reports from doctors and the public by filing adverse reports in a private FDA database. This hidden repository includes at least 1.1 million incidents involving serious injuries and malfunctions caused by surgical staplers and other devices, according to published reports.
A separate FDA exemption process also allows manufacturers to avoid reporting requirements for a range of risky and controversial products. That database reportedly holds more than 1 million reports of malfunctions or harm spanning 15 years, according to Kaiser Health News.
Fears Nachawati represents individuals and businesses in cases involving public entities, private entities, mass torts, serious personal injury, auto accidents, drug and medical device cases, and wrongful death. For more information on the firm, visit https://www.fnlawfirm.com.
If someone you know has suffered complications from surgical staplers, please contact Fears Nachawati at 866-705-7584 to discuss a potential lawsuit.