Public Access to Medical Device Problem Files – FDA Says

FDA says secret files on medical device problems will be opened to the public

One of the ways that consumers should be able to stay informed about the side effects from medical devices is through adverse event reports. When consumers are able to see whether other recipients of these devices have experienced any complications of their own, they are better able to make their own informed decision about whether or not to use the medical device. The major drawback, however, is that the Food and Drug Administration does not make all of these reports publicly available. Regardless of the reason for this nondisclosure, the lack of information keeps consumers from being able to exercise their informed judgment. Now, the FDA promises that it will take steps to ensure that all of the adverse event reports are available to the general public.

The agency maintains the FDA Adverse Event Reporting System in order for the FDA to be informed of any side effects of medical devices or other pharmaceuticals. In practice, doctors are able to review these reports before they decide to undertake a procedure or prescribe a medication that involves any device or drug found in this database. Patients may also know the risks of these products based on what has been disclosed in the database.

Missing Medical Device Information In Database

The database has not functioned as intended due to an exception that has kept a significant amount of information away from doctors and the general public. There is a program whereby key data from some adverse events has been shielded from doctors and the general public. Specifically, the FDA has maintained a separate database that allows for the information to be included in the “alternative summary reporting” form. Over a million reports were put into this database and withheld from doctors and the general public. This has allowed adverse event reports for over 100 medical devices to be hidden and their contents unknown. Doctors have reported being unaware of major side effects from devices since they were unable to find information about them in the FDA’s database when there was a multitude of information on these products in the hidden database.

The FDA had previously claimed that this particular program was only for medical devices whose associated injuries and issues were already well-known to the FDA. In operation, however, this would have meant that the public should have known of the general issues that were the basis of the reports. That has not always been the case.

The program had been shrouded in such secrecy that not even some senior FDA officials were aware of it. The FDA has allowed “registry exemption” for manufacturers in certain circumstances. While the FDA has legal obligations to inform the general public of regulatory events, there was no public notice of this alternative reporting mechanism.

FDA Plans to Release Hidden Reports

For nearly 20 years, the FDA has been giving major manufacturers an exemption from the full reporting requirements. However, this entire process was not known outside of the manufacturers and a handful of people at the FDA. Now, the FDA promises to make all of the adverse event reports available to the public as well as to uncover all of the previously hidden reports.

This alternative database has allowed the reported upon events to escape public exposure. Currently, the information in these reports is known only to the FDA and is not available to doctors and the general public. This has meant that critical information about complications from these devices is not known by the people who need to know it. As a result, doctors have been using medical devices that can be dangerous to consumers. It was not until lawsuits had been filed that the general public learned of many of these side effects.

The FDA recently announced that it intends to end the program. The FDA claims that it had already begun to phase out the program in 2017, but will now end it in its entirety. Kaiser Health News reported on this secret program for the first time in March 2019, ending a shroud of secrecy that had been attached to the program. The report generated considerable outrage from both doctors and the public given that doctors had used these medical devices for years without knowing the nature and prevalence of some of the associated side effects. The resulting outcry put pressure on the FDA to permanently end the program.

Known Defective Medical Devices Reported by FDA

One of the specific issues that was connected to this secret database was breast implants. This is one of the devices that had a large number of adverse events that were hidden from the general public. There have been thousands of injuries from breast implants that have been hidden from doctors and consumers because of this alternative reporting system.

Another medical device that had a large number of adverse events was surgical staplers. In 2015, when this program was in effect and the manufacturer had an exemption from full reporting, there were approximately 1,000 reports of adverse effects that were available to the general public. In 2018, after the manufacturer’s exemption had ended, there were over 11,000 reports of side effects from the surgical stapler. This does not mean that there was a large uptick in incidents related to this product. It simply means that these side effects were occurring all along, but they were not being reported to the general public.

Have You Been Injured By a Defective Medical Device?

Doctors may be held liable for implanting a defective medical device in a patient. Usually, however, it is the manufacturer who is the one who faces the lawsuit for obvious reasons. The lawyers at KBA Attorneys can advise as to some of the legal ramifications of the program and how it would impact a possible claim for compensation from one who has suffered damages from a medical device. KBA Attorneys has a deep reservoir of expertise in product liability lawsuits that it has built through years of representing injured consumers against the makers of the device that hurt them. They are not afraid to square off against medical device makers and their high-priced lawyers.

Contact KBA Attorneys today to learn how we can help.

References

Joe Carlson. “FDA says secret files on medical device problems will be opened to public”, StarTribune, http://www.startribune.com/fda-says-it-will-make-more-info-available-on-medical-device-problems/507788372/. Accessed May 15, 2019.