As consumers of medical services, we often take for granted that the medical devices doctors implant in our bodies or use on us while delivering care will function as intended and, even more importantly, will not cause us harm. Unfortunately, despite government oversight of the medical device industry, from time-to-time defective medical devices find their way into doctors’ offices and operating rooms. Defective devices that fail to work as intended can inflict serious and even fatal injuries.
If you have sustained an injury because a medical device failed, then contact the experienced medical device injury attorneys at Abels & Annes to learn about your rights.
Medical Device Safety
The federal Food and Drug Administration (FDA) oversees the medical device industry to ensure the safety and efficacy of medical devices. To sell a medical device, a manufacturer must obtain permission from the FDA by following a procedure by which the FDA reviews the product and deems it safe. In theory, once medical devices have gone through this process, the public can rest assured the product will work as it is intended and not cause harm.
But, the system is not foolproof. Even with this layer of federal oversight, manufacturers make mistakes in designing and manufacturing medical device products, and in giving appropriate warnings about how to use them. The law refers to these unsafe products as “defective.” Once defective medical devices enter the so-called “stream of commerce,” it often takes a patient suffering harm for the FDA and the public to learn about the defect.
The FDA maintains a running list of medical device product recalls and publishes other information to inform the public about dangerous medical devices. A quick scan of the list reveals recalls of all types of medical devices that could cause serious injury or death. For just the first few months of 2019, for instance, the list included:
- Needles used in cardiac procedures that have a risk of “detached plastic fragments” that could “potentially enter the patient’s bloodstream and result in serious adverse health consequences such as a longer procedure to retrieve the plastic pieces, injury to blood vessel walls, embolism, stroke, or death.”
- A defibrillator that “freezes” and must restarted before it can continue providing life-saving cardiac therapy. According to the FDA, the “resulting delay in delivering a shock could and has resulted in serious patient injury including death.”
- Test strips used to monitor patients’ response to the blood thinner Warfarin. The strips provide inaccurate results, putting patients at risk of being “prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots.”
- A surgical stapler used in gastrointestinal surgeries that misfires and fails to form properly-shaped staples. The manufacturer has already confirmed “serious injuries to two patients,” and the complications from the defect could include “death, sepsis, bleeding, the need for permanent ostomy “bag,” life-long nutritional and digestive issues, leak in the closure (anastomotic leak), additional surgeries, need for additional closures (anastomoses), need for antibiotics, and the need for additional imaging studies.”
This is just a sample of the many, many medical device product recalls and other safety alerts the FDA has published. We encourage anyone who has had an adverse health outcome and suspects a defective medical device is to blame to contact us and to consult the list of recalls and alerts linked above.
How to Find Help After a Defective Medical Device Injury
Medical device injuries differ from injuries caused by “ordinary” consumer products. People usually know if a product they use in their day-to-day life, like a kitchen appliance or a child’s toy, has failed and caused an injury. Defective medical devices, however, often fail when patients are under general anesthesia, or fail after having been implanted in a patient’s body, or are so technically sophisticated that an ordinary person can’t know if it has failed or not - at least, not until the person gets sick because of the device.
This uncertainty about when, how, and whether a device has failed has caused our clients at Abels & Annes some stress and difficulty in the past. They wonder how to find out if they’ve been hurt by a medical device or if they’re at risk. Here is what we suggest:
- Be an informed healthcare consumer. We know it’s not easy to read through pages and pages of medical-related information, but in this day-and-age, it’s important to know as much as possible about your own and your loved ones’ healthcare. Instead of throwing away mailings from your medical insurance company summarizing the care you or a loved one received, give them a quick once-over. If there are procedures or information you don’t understand, ask your medical provider to explain them, especially if you or someone you love has suffered an adverse health outcome.
- Be a defective device detective. You might not be a doctor, but you probably have a gut instinct for when something seems “off.” If you or someone you love had a bad medical outcome after a procedure or treatment that involved the use of a medical device, check whether there has been a recall of that device on the FDA’s medical device recall database.
- Talk to a lawyer. Experienced defective medical device injury lawyers like the team at Abels & Annes stay on top of medical device recalls and have the know-how to explore whether a device caused you or a loved one harm. Whether you’ve done your own detective work, or just have a feeling that something went wrong with your or someone else’s medical care, a lawyer will often be willing to help you uncover what went wrong.
If a defective medical device causes you or a loved one harm, then you likely have the right to recover compensation from the device manufacturer and others who used the device and/or ignored recalls of it. Damages you may recover include medical costs, lost wages, costs associated with long-term disabilities, and compensation for pain and suffering, among others.
Your Chicago Defective Medical Device Attorneys
Abels & Annes is a personal injury law firm with the resources and experience to investigate and litigate the most complicated medical device injury matters. Contact us online or call us at (312) 924-7575 to learn about how we can help after a defective medical device harms you or a loved one. A consultation with us is always free, confidential, and carries no obligation. Mówimy Po Polsku. Hablamos Español.