Categories
Medical Devices & Implant Personal Injury

FDA Regulating Medical Devices

What happens when a public health agency forfeits responsibility and allows medical device manufacturers to police themselves? As recent third-party assessments reveal, manufacturers become emboldened to cut corners, withhold crucial information from the public, and contribute directly to patient deaths.

The lax stance taken by the Food and Drug Administration (FDA) has given rise to what one reporter calls the “Wild, Wild West” of the medical device business. It’s an environment where pro-business, anti-regulatory lawmakers and profit-hungry manufacturers reign supreme – the patient is just a means to an end.

Keep reading to learn more about the studies that helped bring this issue to light, as well as the steps you can take if you or a family member were affected by a medical device.

 

What’s the issue?

A disturbingly large number of medical device adverse event reports were miscategorized by manufacturers but continued to be listed in the FDA’s database. 

Researchers found that 23% of a 1,000-person sample was improperly categorized in the FDA’s Manufacturer and User Facility Device Experience (MAUDE). Two hundred and thirty people who died from a medical device adverse event were actually included in the “injury,” “malfunction,” or “other” categories. Unlike the “patient death” category, these categories are not routinely inspected by the FDA.

As explained in the study, many of the adverse event reports involving patient death were classified in categories other than death. This greater issue is bigger than simple misreporting; patients’ lives are affected by these intentional actions, and many families may never receive closure about the truth behind their loved one’s death.

But there is a positive side. As evidenced in the study, improving adverse event reporting will likely enhance patient safety moving forward. 

Defective medical device lawsuits can also play an instrumental role in improving patient safety. Call Langdon & Emison if you or a family member were injured due to a medical device. 

 

Background

The FDA is responsible for ensuring the safety of drugs and devices for human and veterinary use. Part of that responsibility is keeping track of any adverse or undesirable outcomes related to the drug or device.

Not all drugs and devices are subject to the same laws. The Medical Device Reporting (MDR) Regulation is the main framework for manufacturers to follow in reporting certain adverse events related to medical devices, such as ventricular assist bypass devices. 

These are some of the mandatory provisions included in the Regulation:

  • Manufacturers must report to the FDA within 30 calendar days after learning that any of their devices may have caused or contributed to a death or serious injury.
  • Manufacturers must report to the FDA within five work days when they learn that any of their devices have malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction were to occur again.

Whoever reports the adverse event, whether it be a hospital or a manufacturer, must choose a category in which to classify the event. They’ll select “death,” “injury,” “malfunction,” or “other.” FDA instructions require the reporter to list the adverse event as an official death if the cause of death is unknown, or if the device may have caused or contributed to a death.

In the study titled “Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death,” researchers identified the three most common product codes among adverse event reports: ventricular assist bypass devices, dialysate concentrate for hemodialysis, and transcervical contraceptive tubal occlusion devices.

 

How was the issue discovered?

People in and outside the medical community have had concerns about adverse event reporting for decades. However, the extent of the problem was mostly unrealized until a group of researchers conducted an original investigation into the matter.

Researchers included Christina Lalani, MD; Elysha M. Kunwar, BA; Madris Kinard, MBA; Sanket S. Dhruva, MD, MHS, and Rita F. Redberg, MD, MSc. Using a natural language processing algorithm, they flagged terms associated with death (i.e. patient died, patient expired).

Sorting through all reports including death-related terms, the algorithm identified 290,141 reports in which a serious injury or death was reported. Of these, they found that 52.1% were reported as deaths, and 47.9% were reported as injury, malfunction, or missing (not put in any category). 

However, 23% of the overall sample included reports that were deaths but had not been classified as such. According to the study, 17% of the reports were found to be missed deaths, meaning actual deaths were classified into different categories.

 

An Extensive Problem

Almost all of the reports analyzed in the study (95.9%) were submitted by manufacturers. The authors of the study point out this is an obvious conflict of interest and cite instances of manufacturers delaying or outright failing to report serious malfunctions and deaths associated with their devices.

This isn’t a new issue. The study references a massive reporting failure that occurred from 2002 to 2013. During this time, 32,000 women reported adverse events associated with Essure, a permanent birth control device. However, the FDA only received 1,023 adverse event reports from the manufacturer during those 11 years.

 

Defective Medical Device Attorney

Misreporting and failing to report adverse events isn’t just an ethical issue – it’s a legal one. Manufacturers have an obligation to alert the FDA as soon as they realize that any of their products has the potential to cause harm, or have already caused harm. Unfortunately, many manufacturers fail to follow through, a failure that continues to contribute to patient deaths.

If you were injured or a loved one killed due to a medical device, you may be able to receive compensation. Call Langdon & Emison now to speak with an experienced and compassionate lawyer.