Firm-Wide blog

FDA Sends Mixed Messages on Consumer Safety

By Burg Simpson
May 9, 2018
3 min read

While it does not get as many headlines as most other agencies, the Food and Drug Administration is one of the most important regulatory bodies in the federal government. Consumers spend 20 cents of every dollar on products regulated by the FDA, which adds up to $2.4 trillion of consumer spending annually. More than half of that is on food alone.

With a variety of products under its watch – everything from mouthwash to bottled water to surgical implants – it is nearly impossible to ensure every consumer product that hits store shelves is perfectly safe. If you have been seriously injured by an unsafe product, you need the help of an experienced tort attorney.

FDA Steps Back

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs, biological products, medical devices, and the nation’s food supply, yet the data from the first six months of 2017 indicate a significant drop in warning letters issued by the FDA to companies and manufacturers.

As reported by Bloomberg, the FDA issued 265 warnings to businesses, letting them know what it believed could be serious violations of federal rules. Not only is that an 8 percent drop from President Obama’s first six months in office, but it’s the fewest round of product warnings issued since 2008, based on Bloomberg research of FDA records. The agency denied this was intentional.

Obviously, the FDA does more than issue warning letters. The agency is also empowered to order recalls of dangerous drugs, seize tainted foods, and go to court to get injunctions against manufacturers. But tallying up warning letters is a simple way to gauge how aggressively the FDA is doing its job.

That being said, the agency issued only three product seizures in 2017, down sharply from 2011, when the agency issued 15 seizures.

Are Medical Devices Getting a Pass?

Some of the most important consumer products regulated by FDA are medical devices.  Yet, as reported by Bloomberg, actions by the FDA’s Center for Devices and Radiologic Health (CDRH) seem to be on the decline.  In 2016, the CDRH division fired off 18 warning letters by the end of July. That is down dramatically from an average of 48 for the same time period over each of the previous eight years.

Even more concerning is that the CDRH division issued no injunctions or seizures at all in 2017. The silver lining, however, is that medical device recalls have been on the rise for the last decade. CDRH recalled more than 3,200 devices in 2017. Notably, and perhaps as a sign of things to come, the FDA recalled a device over cybersecurity fears for the first time in its history last year.

Recalls fall into three different categories, based on descending order of risk and injury:

  • Class I: A situation where there is a reasonable chance a product will cause serious health problems or death.
  • Class II: A situation where a product could cause a temporary or reversible health problem or where there is a slight chance it will cause serious health problems or death. This is, by far, the most common recall classification.
  • Class III: A situation where a product is not likely to cause any health problem or injury.

Burg Simpson’s mass tort lawyers are well-versed in mass tort cases. If you or someone you love has been left seriously injured by a defective medical device or dangerous drug, call our Cincinnati office at 513-852-5600 or 800-713-9340. You can also fill out our Free Case Evaluation Form so we can help.

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