Hidden FDA Reports on Medical Devices May Have Prolonged the Use of Dangerous Surgical Staplers Causing Injury
We put faith in our government, including elected representatives and people working in appointed agencies. We expect them to provide safety, security, and honesty, and while most government agencies do a fine job of delivering on this trust, every so often that trust is betrayed.
It appears that this may be the case with the FDA and their system for tracking medical-device failures. The FDA may not have been intentionally harmful, but it seems that their inability to properly track the failures of medical devices, including surgical staples, has led to the continued use of these potentially harmful tools, which may have caused serious injury.
Why Does Clear, Honest, Transparent Reporting of Injuries, Complications, Device Failure, etc., Matter?
In the medical field, reliable reporting on a variety of factors, like injuries and side effects, is crucial. Quite literally, it’s a matter of life and death. Suppose a new prescription drug is causing a reaction, say a rash, on 5% of the total population, but, for some unknown reason, it causes a severe rash on 85% of red-haired women who use this medication. By properly logging the information, doctors can avoid prescribing this drug to their redhead female patients. In this way, past instances, when properly logged, organized, and made available to medical staff and the public, can be used to enhance medical care and protect patients from injury and wrongful death.
The same principle applies to medical devices, such as surgical staples. By properly logging information on device failure, the industry as a whole, including physicians, nurses, patients, insurance providers, and surgeons, can determine whether or not to use a medical device. If, after looking at data on a certain device, they discover that it fails 50% of the time, they can stop using these devices.
But it appears the overall system of trust may have broken down, allowing information on surgical staples to be buried in a secretive, hard-to-find information repository known as “alternate summary reporting.”
How and Why the FDA Implemented “Alternate Summary Reporting”
Alternate summary reporting, which started out as a noble effort, appears to have evolved into a way for medical-device manufacturers to hide product failures.
Roughly two decades ago, there were numerous scandals connected to under-reporting of device problems. (Which sounds eerily similar to what we see today.) To address the issue of misinformation and dishonest reporting, laws were created that allowed for criminal charges against device companies if information was not delivered in a complete, honest, and appropriate manner. Suddenly the issue, from the manufacturer’s perspective, was not just financial, but could literally threaten their personal freedom in certain situations.
In reaction, device manufacturers started flooding the FDA with data. Not taking any chances, they logged every detail, no matter how insignificant. With only about 15 members dedicated to the task of reviewing the information, the agency couldn’t keep up.
To address this subsequent problem, leaders and legal expert at the agency worked with device manufacturers to create a solution: a special exemption that would allow reporting to be avoided in certain situations. Instead manufacturers could send a simple spreadsheet of injuries or malfunctions; these could be sent quarterly, twice a year, or annually.
This would allow the FDA staff to quickly review for potential problems or numerical spikes in malfunctions, injuries, or other issues. Initially, the list of exempted devices was made public, but after a while the list was not public, leaving scores of information in the dark.
According to a report from Kaiser Health News, one of the most prominent medical-care news outlets, there were over 450,000 hidden medical reports in both 2016 and 2017. The article states that the FDA has not provided a list of roughly 100 medical devices that were granted an exception.
It appears that this list of exceptions is not familiar to many people in the medical industry. In the news report, biomedical engineers, leaders of engineering firms, and spokespeople from major healthcare institutes expressed an unfamiliarity with the system of the FDA alternate summary reporting.
Medical Reporting and Surgical Stapler Malfunctions Have Personal Consequences
Medical practices, reporting systems, and government procedures can seem bureaucratic, but they are often critical in protecting patients from injuries or worse caused by medical devices and drugs.
The report from Kaiser Health News made this clear, bringing stories of personal suffering to a story that is largely about filing medical information. For example, the article tells the story of a man who suffered catastrophic injury and “nearly lost his life” because of a surgical stapler malfunction. During a liver surgery, a stapler misfired, severing a vein. Staff performed CPR for 22 minutes, and the man was left unable to walk or even recognize his wife on a consistent basis.
Another story from the article details the surgery of a man who was having part of his lung removed when a major vessel was cut by a stapler. The surgeon could not seal the wound, and the decision was made to remove his lung completely. The man sued the manufacturer of the stapler, and although the case was brought to a confidential settlement, this is another example of a person who was seriously injured by surgical staplers.
In some cases, however, life isn’t just impacted by surgical staples. Sometimes life can be lost.
When a 33-year-old woman went under surgery for a benign liver growth, a stapler malfunction caused severe bleeding, eventually resulting in the death of a wife and mother of two.
These stories are important, as they shed a light on the real personal consequences of mismanagement and misinformation when it comes to medical devices. It seems logical that with better reporting, more doctors, medical administrators, and patients would be aware of the risks involved with surgical staples.
Get a Free Case Review from a Medical Device Injury Lawyer
If you or a family member has been injured by surgical staplers, medical malpractice, or negligence, please contact our team today. We’ll take an honest look at your case and provide clear, reliable guidance on how you should move forward. Our toll free number is 1-877-943-9378.
Although West Law Firm’s main office is located in Charleston, West Virginia, we serve clients throughout the country who have been injured by medical devices, dangerous drugs, and defective products.
Brooks West is a West Virginia personal injury lawyer who helps people who have been injured by negligence or wrongful conduct. He is the President and founder of West Law Firm and has been an attorney since 2005. Brooks is a Multi-Million Dollar Advocates Forum member and has been awarded the AV Preeminent Rating from Martindale-Hubbell.