FDA Won’t Honor FOIA Request to Release Undisclosed Medical Device Malfunctions

medical device, FOIA, FDA

When Kaiser Health News (KHN) first reported on the hidden database of medical device recalls, the news agency submitted a Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA).  The FDA said at that time that it would take almost two years to fulfill the request and denied KHN’s appeal asking that the agency expedite the process.

Dangerous Medical Device Reports Hidden for Years

KHN says it began submitting FOIA requests to the FDA in September 2018, asking for information about the hidden adverse events reports made via the alternative summary reporting pathway.  This pathway allowed device manufacturers to record adverse events associated with dozens of medical devices, but these reports were never released to consumers or the healthcare community.

After more than six months of little cooperation from the FDA, KHN went public with what they knew about malfunctioning surgical staplers.  Their bombshell article in March, 2019 prompted a chain of events that led to the FDA publishing 20 years of hidden event reports as well as taking steps to dismantle the alternative summary reporting program.

As such, the FDA contacted KHN to advise them that the agency will not be fulfilling the news hub’s FOIA request because the information sought “is now posted online.” KHN subsequently published the communication.

What is the Freedom of Information Act?

The Freedom of Information Act (FOIA) is a federal law enacted in 1967. It allows the American public the right to request access to records from any federal agency.  Federal agencies like the FDA must disclose any information requested through a FOIA request unless the information qualifies for certain exemptions.  Exemptions include records that compromise national security or are part of an ongoing criminal investigation.

Though federal agencies must comply with FOIA requests, the law provides a lot of lassitude for the timeline during which agencies must act.  According to FOIA.gov, the time it takes to fulfill a FOIA request “will vary” depending on how many requests an agency processes concurrently, as well as the complexity of the request.

The FDA probably considered KHN’s request for information about 20 years worth of hidden adverse event data to be complex.  Perhaps that is the explanation for the time the agency offers for completing the request.  On the other hand, the FDA did, in fact, publish the hidden database online in June, 2019.

The FOIA does allow for journalists and other citizens to request acceleration in the request fulfillment process.  KHN did just that in April, 2019.  The FDA claimed they had an exemption and subsequently did not take any action to fulfill the KHN FOIA request at that time.  According to the news agency, they received no further communication directly from the FDA until the final refusal to comply, which came this week.

Which Medical Devices were in the Hidden Database?

The months-long battle over the FOIA request for the data in the hidden collection of adverse events appears to be over.  According the FDA, the entirety of the previously secret data is now online for public perusal.

Since the public and members of the press have had access to the database, millions of unreported injuries caused by medical devices have come to light.  Once again spearheading the story, KHN reported disturbing findings from the alternative summary reporting database.  Among the most alarming are reports related to the following:

Glucose Meters

In the newly-published reports, there are 2.4 million adverse events involving blood glucose meters alone.  Almost all the meters are manufactured by LifeScan, a subsidiary of Johnson & Johnson.   Adverse events commonly included:

  • The device arriving damaged prior to customer use
  • Displaying inaccurate readings
  • Unexpectedly losing power

There are also a high volume of public adverse events in the MAUDE database about glucose meters.

Dental Implants

The newly-published reports also include 2.1 million reports about dental implants.  More than 100,000 reports were filed in 2018 alone.  Many of the adverse events reports are due to connections between the medical device and the bone of the jaw.  Often times, poorly applied dental implants cannot be replaced because they cause permanent damage to the bone.

Surgical Staplers

Surgical stapler malfunctions represented 66,000 incidents in the hidden FDA reports.  KHN’s initial report in March highlighted the adverse events caused by misfiring surgical staplers.  Compared to public reports about stapler misfires, the new report is certainly alarming.  There are 10,000 reports of adverse events in the hidden database. There are just 84 reports in the publicly available MAUDE database.

The most common adverse events hidden from the public and from medical professionals were misfiring surgical staplers or staplers that fired misshapen staples.   Malfunctioning surgical tools can lead to catastrophic bleeding or prompt infection.  The FDA recently reclassified surgical staplers to a higher risk category with more strict safety requirements.

Breast Implants

As the debate continues over what the safety guidelines should be for breast implants, it is not surprising that implants make up a substantial number of adverse events reports.  In fact, more than 500,000 unique reports were for breast implant issues.  Most of the adverse event reports were for implants that leaked, migrated, or deflated.

Horribly, however, the most frequent report hidden from the public includes a complete rupture of the implant.  Three companies appear in the half-million reports including Allergan, Mentor, and Sientra.

Medical Device Related Deaths

What is, perhaps, the most alarming of all hidden reports is the number of deaths.  A staggering 176 deaths remained hidden by the alternative summary program.  The alternative summary reporting database should not have included reports of any deaths, except for certain deaths. These deaths should only be those related to cardiac arrest associated with certain kinds of heart valves.

Other deaths hidden from both the public and the medical community included reports of fatalities due to:

  • Breast implants
  • Intra-aortic balloon pumps
  • Ventilators
  • Pacemakers

Have Questions about a Medical Device and Your Rights?

Medical devices are to serve a particular purpose in bettering your health and wellbeing.  If you are struggling to recover from a medical device injury, you likely have questions about your rights.  Drug and Device Watch can help.  Contact us to schedule a free consultation with a medical device lawyer.  We will review your situation and determine if you have a claim.

If you have a claim, we can help you hold the device manufacturer responsible for your pain and financial burdens.   Call 1-888-458-6825 to get started.  You can also contact us online.