“Approved” Medical Devices Can Still Put Patients in Danger

Jun 20, 2018
by Adler Markoff & Associates

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    “Approved” Medical Devices Can Still Put Patients in Danger

    Patients place a great deal of trust in their doctors as well as the drugs, procedures, and devices those doctors recommend. For most people, this is a necessary part of receiving medical treatment since very few people have the time or technical training to weigh the pros and cons of every treatment option. 

    In addition to their trust in their doctor, most of these patients operate on faith that the government wouldn’t allow dangerous devices and medications onto the market. Unfortunately, the systems that review and approve medical devices in the United States sometimes allow problem devices to slip through the cracks.  

    In this blog article, we’ll explore the loopholes and regulatory gaps that allow defective medical devices to reach the market and sometimes stay there. We’ll also discuss what questions you should ask before using medical devices and the steps you can take if you’ve been harmed by one.

    Medical Devices Harm Thousands Every Year

    Every year, the U.S. Food and Drug Administration (FDA) receives several hundred thousand reports of suspected medical device malfunction. Many of these reported malfunctions cause injuries or even death for victims. And in the worst cases, unsafe devices remain in use and continue to harm vulnerable patients even though those devices have been reported to the FDA. 

    So how does this happen? To get the answer, it’s important to understand how the FDA handles medical devices and how its procedures for devices differ from those for prescription drugs. 

    Why the FDA Treats Medical Devices Differently Than Drugs

    The FDA observes similar processes for approving medical drugs and devices. Each process has five basic steps that follow the path from discovery to FDA approval to post-market monitoring. However, the FDA’s approval steps for prescription drugs tend to be lengthier and more rigorous than its steps for medical devices.  

    Unfortunately, the reason for this has nothing to do with patients’ best interests. The FDA’s standards are looser for medical devices mainly because of lobbying by medical device manufacturers, who want to get their devices to market quickly and with minimal regulation. 

    The current approval processes for drugs and devices originated in 1976 when a law called the Medical Device Regulation Act created separate standards for prescription drugs and medical devices. This law created three different classifications for medical devices, which we’ve listed below. 

    • Class III: This category, which makes up about 10 percent of all medical devices, is for those devices that pose the highest risk for patients. It includes life-supporting medical implants like pacemakers and heart valves. Devices in this category require ample evidence of their safety from human clinical trials before the FDA will approve them.    
    • Class II: These devices pose a medium risk and could harm people if misused. Powered wheelchairs are one example of a device that falls into this category. For Class II devices, if the manufacturer successfully argues that the device is substantially similar to a device that’s already on the market, the FDA will forego the approval requirement for safety and efficacy data. 
    • Class I: This category includes “low-risk items” like dental floss, bandages, and thermometers. The FDA only requires that these devices are suitable for intended use, properly packaged and labeled, manufactured under a “quality system,” and registered with a fee.  

    Many people don’t realize that devices with a supposedly low level of risk aren’t necessarily approved by the FDA at all. They are registered with the FDA, but they don’t go through a process of scientific evaluation and FDA approval.  

    In addition, there are a few loopholes that make it even easier for manufacturers to get devices to market without significant safety testing: 

    1. The Medical Devices User Fee Act of 2002 requires the FDA to provide the “least burdensome route” to approval. This allows manufacturers to get approval for some devices without even going through patient trials.
    2. For Class II devices, the FDA will approve them without significant safety and efficacy data if the manufacturer can show that a similar device already exists on the market. However, sometimes that similar device may not be safe and reliable. For example, there are still medical devices on the market that existed before modern approval processes and were “grandfathered in” as a result. 
    3. The quality standards for medical devices are simply loose compared to those for drugs. Even Class III medical devices sometimes receive approval based on questionable data that would never be enough to get a prescription drug approved. 

    While medical device manufacturers have long argued that the lax standards for their devices help to spur innovation and get devices to patients faster, the real result is that many devices hit the market without adequate data showing they’re safe and effective. 

    How to Protect Yourself from Unsafe Medical Devices

    The weak regulatory landscape for medical devices is a serious problem, but it doesn’t appear that this will change anytime soon. As a result, patients who use medical devices (especially those in Classes II and III) should remain aware of current recalls. The FDA maintains an up-to-date list of medical device recalls on its website.   

    In addition, The National Center for Health Research suggests asking your doctor the following questions before you commit to using a medical device: 

    • Has the device in question been associated with any serious harm? 
    • How long has the device been in use, and how much experience do you have with it? 
    • What percentage of patients need surgery to correct a problem with this device? 
    • Does the manufacturer notify you if this device gets recalled or has an issue?  
    • What are the signs and symptoms that occur when something goes wrong with the device? 

    Unfortunately, even the most careful and sensible consumers can still suffer harm because of unsafe medical devices, and this will likely continue as long as the FDA continues to apply regulations that prioritize device manufacturers’ profits over consumers’ health. 

    If you’ve been injured or even lost a loved one because of an unsafe medical device, it’s important to get help right away from an attorney who has experience handling cases that involve medical devices. You may be entitled to compensation for your medical bills, lost wages, and suffering, but the legal cases that following from medical device injuries are complex and require thorough investigation, so it’s critical to get an attorney involved as soon as possible. 

    Contact AMA Law if You’ve Been Injured by a Defective Medical Device

    A serious medical device malfunction can leave you feeling confused and betrayed in addition to the devastating consequences for your long-term health. If this is where you are right now, the dedicated team of lawyers at AMA Law are ready to help.  

    Our attorneys have years of experience handling complex medical device and prescription drug claims, and if we’re able to take your case, we’ll fight relentlessly to get you the justice and compensation you deserve. And thanks to our “no recovery, no fee” policy for personal injury claims, you won’t pay any attorney’s fees unless we win your case or get you a settlement.   

    If you or someone you love has suffered because of a medical device, please call Atkins & Markoff at (405) 607-8757 or fill out our quick and easy online contact form to get a free, no-risk assessment of your case from an experienced attorney.


    Brownlee, S. & Lenzer, J. (2010, September). Medical devices that can kill. Reader’s Digest. Retrieved from https://www.center4research.org/medical-devices-can-kill/ 

    Learn about drug and device approvals. (2018, January 4). U.S Food and Drug Administration. Retrieved from https://www.fda.gov/ForPatients/Approvals/default.htm  

    Medical device reporting. (2018, March 28). U.S Food and Drug Administration. Retrieved from https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

    The content provided here is for informational purposes only and should not be construed as legal advice on any subject.

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