FDA Releases Millions of Records of Incidents Involving Medical Devices
On Friday, June 21st, the Food and Drug Administration (FDA) published previously undisclosed reports of incidents and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants. Here, the product liability attorneys at The Law Offices of Peter Angelos outline the details of these incidents.
Advocates for public transparency cheered the announcement after approximately six million reports covering a wide array of devices secretly filed with the FDA from 1999 to April of this year were made available to the public. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants and heart monitors to pediatric breathing machines.
By law, medical device companies are required to file reports within 30 days of learning that a device may have caused patient harm or death, though the law contained a loophole that allowed millions of files to remain hidden and labeled as “summaries.” The FDA claimed that many of the summary reporting arrangements were allowed because new files were duplicative and wouldn’t add to the body of knowledge about existing problems in Manufacturer and User Facility Device Experience (MAUDE), the FDA’s public database of adverse event reports.
Madris Tomes, a former FDA device reviewer who left the agency and started an independent company to analyze the agency’s public-facing files lauded the move, saying, “Consumers can now see what the FDA has seen over the years (i.e., the true numbers of adverse events), and physicians can make better-informed decisions about which device(s) to recommend to their patients.”
Medtronic, the world’s largest medical device company, gave a statement saying that although the company works hard to reduce or eliminate product malfunctions and events, its employees also make an effort to tell regulators, clinicians and the public about failures when they do occur. Medtronic spokesman, Jeffrey Trauring, said in an email, “We applaud the FDA for their ongoing efforts to drive transparency and openness around medical device performance, and we will continue to work with the FDA on future, modern programs of reporting.”
It is important to note that filing an adverse event report is not itself an admission that the device in the report caused the problem. Sometimes the reports include such admissions, but more commonly they simply disclose a medical problem following the use of a medical device.
Contact The Law Offices of Peter Angelos For a Consultation Today
The FDA’s decision to revoke the Alternative Summary Reporting (ASR) program has provided the public insight into millions of undisclosed medical device reports that may shed new light into previous medical product liability cases. Each year in the United States, unsafe or defective products injure and kill thousands of consumers. If you or a loved one suspects that they suffered from an injury due to an unsafe medical device, we urge you to contact the medical device liability attorneys at The Law Offices of Peter Angelos for s no fee consultation today.