Why Is It So Hard to Track Drug and Device Recalls?
Product recalls happen all the time—and we hear about them for food or baby products on television and in the news whenever they happen. They also make it easy for us to tell if we have one of the affected products by the barcode, expiration date, or lot number. Similarly, drugs and medical devices get recalled fairly often as well. However, the news outlets are a little quieter about it. Unless you as the consumer are specifically looking for recall information regarding your medicine or medical device, it is not too easy to find.
In 2019, there was yet another big recall in the antacid ranitidine, better known as brand name Zantac, for possibly having extremely high levels of human carcinogen. The FDA simply issued an alert in the U.S. while numerous products containing this ingredient were being banned or pulled from the shelves in other countries like Singapore, South Korea, and Canada. It once again begs the question as to why the FDA has such little involvement in the process of a recall which makes consumers aware of the danger.
According to the U.S. Food and Drug Association (FDA), recalls are voluntary actions a company takes to remove a product from the market so it will no longer be available for purchase. They also advise those who have already purchased the product to either trash or destroy it. Most companies do voluntary recalls of their product, but only occasionally, and in extreme cases, will the FDA step up and mandate a recall rather than suggesting one. The majority of the public never hears about them at all.
Drug and device recalls happen more than you may realize
A study which ran from January 2017 to September 2019 focused on recall rates for both drugs and medical devices. It found that during that time, more than 85% of the recalls were for drugs, at 166 total, while almost 15% of the recalls were for medical devices, with 29. These recalls were not for slight errors, either—they were all for quality issues which could affect consumers’ health.
When there are drug recalls, they are categorized into one of the FDA’s three classes:
- Class I: A dangerous or defective medication that can result in health complications or death.
- Class II: A medication that could cause temporary or serious health problems.
- Class III: A medication that violates FDA labeling or manufacturing law but is unlikely to result in any health reaction.
FDA also categorizes device recalls into three classes:
- Class I: A situation where there is a reasonable chance that a product will cause health problems or death.
- Class II: A situation where a product may cause a temporary health problem, a reversible health problem, or where there is a slight chance it may cause a serious health problem or death.
- Class III: A situation where the product is not likely to cause any injuries or health problems.
According to the FDA’s recall database, there have already been 118 Class 1 recalls in 2023. There have also been 789 Class 11 recalls and 127 Class III recalls this year. Knowing that Class I recalls are the most dangerous of them all, it makes you wonder why you may not have even heard about a single one of the 118 recalled this year. So why exactly is that?
There is no real protocol for alerting the public
Both drug and device recalls are completely voluntary for manufacturers which makes the whole recall process a bit confusing. The FDA will give a recommendation on how to handle the recall, but it really is just a recommendation at the end of the day. Because of this, important recall notifications rarely make it through all the necessary channels, like distributors, pharmacies, and medical professionals who would help spread the word to the public.
In fact, the FDA themselves state that not all recalls are even announced on their own website or in the news for public awareness. They claim that the public will be notified in some way if the drug or device poses a serious health risk or has been widely distributed. The only time the FDA will step in to issue a public notification is if they believe consumers need to be protected from the product.
If manufacturers do alert, records are not always available
Even when things go smoothly in terms of communication from the manufacturer down to the hospitals and other medical professionals, there are still errors in the system. For example, there was a major recall in 2005 with pacemakers manufactured by Guidant Corp. They were recalled for excess moisture being able to seep inside and cause them to malfunction.
The lines of communication did work for the most part and people were able to get their recalled pacemakers replaced. However, they noticed there was an issue with patients who used Medicare. There was no way for Medicare to directly track down those who got this exact pacemaker put in, which has left 1,732 people unnotified about the recall to this day.
It is not up to the public to routinely check on their medications
Because there is no clear process for completing a voluntary recall, there is so much room left open for miscommunication or simply lack of communication. As a result, there must be hundreds, if not thousands, of people across the United States who are still taking recalled medication or using their recalled device without realizing that these products may not be okay to use anymore.
People are busy. They work, spend time with their families, and enjoy their hobbies. Realistically, no one will make time to sit down and research to find out if any of their medications or devices are on the recall list every day. The system is broken, and it is up to the manufacturers to fix it.
Manufacturers need to create a better process
Consumers can still be injured or develop serious health problems no matter which class a recall is categorized into. Every person is unique and every person’s body is different. Knowing that, manufacturers need to take the extra step to be sure that every single person taking a medication or using a device is aware of a voluntary recall as soon as it happens. Of course, people can then decide for themselves if they want to continue using the product knowing the risk—but manufacturers will be giving them the choice, unlike they are now.
Knowing whether the drugs you’re taking or medical devices you’re using are considered a threat to your wellbeing is important. Without a proper and effective recall process in place, manufacturers are leaving your health to chance—but it shouldn’t be that way. Until a better system is put in place, drug and device manufacturers need to be held liable for any harm they cause. Be sure to reach out to an experienced dangerous drugs or defective devices attorney as soon as possible if you were injured or developed health problems after a recall that you weren’t notified about.
Please contact Paulson & Nace, PLLC through this contact form or by calling our office.
Christopher T. Nace works in all practice areas of the firm, including medical malpractice, drug and product liability, motor vehicle accidents, wrongful death, and other negligence and personal injury matters.
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