In a bombshell report, Kaiser Health News is shining a light on a little-known practice of the U.S. Food and Drug Administration (FDA) that puts Americans at risk. The FDA’s “alternative summary” program is a private reporting procedure that allows manufacturers to potentially avoid medical device recalls. That is because the reports of malfunctioning medical devices made through this procedure are hidden from the public.
Now, a lack of transparency is the just the tip of the iceberg as public outrage emerges over the FDA’s hidden database of reports of faulty medical devices. As a publicly-funded agency whose stated mission is to protect American consumers, it is beyond shocking that the FDA would provide a haven for dangerous medical devices that are hurting hundreds of thousands of patients every year.
Risk to American Lives
In 2018 alone, almost 200,000 medical device injuries were reported by unnamed manufacturers about an unknown number of medical devices. The evidence seems to suggest that far fewer medical device recalls take place than are really necessary because the reports of dangers to consumers can be hidden by the FDA’s alternative summary program.
The worst implication of this withheld information is the fact that the medical community also is kept in the dark about the true risks associated with medical devices. Currently, there is an estimated, “about 100”, medical devices known to the FDA to malfunction and injure patients.
This means that medical professionals are not in a position to inform patients of the true risks of treatment options, including surgeries, because doctors themselves don’t even have access to all the information. It also makes it nearly impossible for doctors and surgeons to assess the tools they use for safety and appropriateness.
The FDA’s Side of the Controversy
Former FDA officials who were around when the alternative summary program first rolled out insist the private reporting option was intended to cut down on redundant paperwork and ultimately make it easier for consumers to sift through and access reports from the FDA. Legislative changes at the time caused an influx of reports to the FDA so numerous as to become what one former FDA official described as “mind numbing.”
In response, FDA administrators proposed medical device manufacturers should begin to report certain types of complications and injuries in batches via spreadsheet. Reports would be submitted quarterly or annually so that the agency could identify any alarming data trends or spikes in a particular type of injury. Before this process, all reports were individual.
However, there is no reasonable explanation why the FDA has continued this method of alternative, unpublished reporting two decades later. In fact, one former FDA official questioned about the program expressed surprise that the hidden database is still in use.
Who Could be Affected?
Since information about the hidden database has come to light, the FDA has not been particularly forthcoming with information. Some journalists have been told Freedom of Information Act requests seeking information contained in this hidden database will take 22 months to fulfill.
In the meantime, doctors and nurses could be using dangerous medical devices at this very minute without reliable information about the risk involved. From the very limited information the FDA did provide, certain patients do seem to be more at risk than others.
The following medical devices have been confirmed by the FDA to have reports in their hidden database due to malfunctions, but have not been the subject of medical device recalls:
- Mechanical breathing machines
- Intra-aortic balloon pumps
- Pacemaker electrodes
- Implantable defibrillators
- Pelvic mesh
- Da Vinci surgical robots
- Surgical staplers
Surgical Staplers Are of Particular Concern
One medical device that qualifies for the special “exemption” that allows for private reporting is surgical staplers. This surgical tool is an asset to most procedures. In one action, they both cut and staple. Surgical staples can be a huge benefit for patients, but the staplers are catastrophic when they malfunction.
The Huffington Post reports that the implementation of the alternative summary system has skewed the data available to the public. From 1994 to 2001, 112 stapler-related deaths were reported to the FDA, indicating a dangerous trend of serious concern to the public.
Since the implementation of the hidden database, however, public reports of surgical stapler malfunction slowed to a trickle, which gives the impression that these devices are somehow no longer a danger. Trends in lawsuits show suggest otherwise.
Recent surgical stapler lawsuits detail how quickly malfunctioning surgical staplers can change a smooth procedure to a disastrous one. The problem is widespread, but surgical stapler malfunctions that don’t result in death are not publicly reported. They are rolled into the private FDA database.
Wrongful deaths are not the only injury that concern medical device attorneys. Patients may survive surgeries complicated by misfiring surgical staplers, but their injuries are no less real. If your life has been derailed by a malfunctioning medical device, speak to an attorney about your options.
The Scope of Risk is Unknown
Because the FDA is keeping all the data private, there is no way to know precisely which devices are hurting patients. Devices reported in this alternative summary system are not generating public concern and are not prompting medical device recalls.
Statements available from surgical stapler manufacturers in particular show that Covidien brand staplers manufactured by Medtronic have used the alternative summary reporting system to report malfunctions to the FDA. Covidien is the most widely used brand of surgical stapler. The other leading brand, Ethicon, stated it has not used the private reporting system.
Public information shows Medtronic has reported 250 stapler related deaths in the last 18 years. How many more patients have survived debilitating stapler misfires? We have no way of knowing.
We do know that more than one million incidents have been hidden from the public in this alternative reporting system. Each of these incidents represents a human life affected by this secretive reporting practice. Add to this the families of patients affected and the numbers become truly staggering.
Getting Help with Common Medical Device Injuries
Despite the lack of public information about this practice, the devices included in the alternative summary program are causing harm to Americans, without the benefit of information usually provided in medical device recalls. This private reporting of dangerous devices does not prevent consumers from seeking legal recourse when faulty devices cause injury.
At Drug and Device Watch, we help clients who have been injured by medical devices that are defective or that malfunction. Contact us today if you have suffered one of these common medical device injuries:
- Blood vessels severed by surgical staplers
- Overwhelming infection from pelvic mesh
- Burns from wearable defibrillators
- Early failure of knee replacements
- Heart rate interruption caused by internal defibrillators
The long term effects of the FDA’s practice of withholding vital information from the medical community may never be fully known. Regardless, victims of faulty medical devices have recourse.
Manufacturers protected from public scrutiny by these FDA practices are not exempt from the law. Medical device recalls are not necessary precursors to a lawsuit. If you or a loved one has been injured by any medical device, contact us to speak to an experienced medical device attorney now.