Despite regulation efforts from the Food and Drug Administration (FDA), having a defective medical device is still fairly common in the U.S. In 2021, the FDA reported that there have been around 14,500 annual reports of serious injury or death stemming from defective medical devices over the last 20 years.
"Medical device" is an umbrella term that covers any medical tool – whether it be used for diagnosis, monitoring, assistance, or treatment. As such, pinpointing legal liability could be tricky at times. Generally, it's a toss-up between product liability from the manufacturer or medical malpractice by your healthcare provider.
While most claims cite product liability, patient harm can also occur with insufficient evaluation from your doctor. For this reason, it is advised that you seek legal counsel as soon as you experience any adverse effects from faulty medical devices.
Why Medical Devices Can Malfunction
Medical devices can malfunction for a variety of reasons related to how they are designed, manufactured, labeled, or used. Design-related issues, manufacturing errors, software problems, and inadequate instructions or warnings can all cause devices to malfunction, leading to inaccurate readings, mechanical failure, or unexpected adverse effects.
Human-factors problems such as confusing user interfaces or labeling also appear frequently in FDA recall and MAUDE data, showing that use-error and device design often interact. The FDA uses post-market tools like Medical Device Reporting (MDR), MedWatch, MAUDE, and the Medical Device Recall database to monitor device performance, identify patterns of malfunctions, and support recalls or safety communications where necessary.
Regulating Medical Devices in the US
The FDA plays a crucial role in regulating medical devices in the United States. They must approve all medical devices before these products can be sold legally. This mechanism ensures that devices are reasonably safe and effective for their intended users.
Furthermore, the FDA continuously monitors the safety and efficacy of marketed devices through the MedWatch program, which allows users to report serious problems. The FDA does not regulate healthcare providers' practices, make recommendations for individual clinics, or provide device rating systems.
Legal Grounds for Medical Device Malfunction Claims
Patients harmed by defective medical devices can pursue several legal actions. Negligence, strict liability, or breach of warranty are used to establish such individual's claims. Here are some parties that your legal counsel might consider to legally pursue:
Design Defects
Design defect claims argue that the device's underlying design is unreasonably dangerous even when manufactured correctly. Examples include a software logic flaw or unsafe battery layout that creates inherent risks for users. These parties are typically the primary defendants when defective devices cause harm. The introduction of a faulty medical device to the market makes manufacturers, distributors, and suppliers liable.
Given the likely substantial financial stakes involved, these cases often become lengthy and heavily contested. Expert testimonies are crucial in establishing the device's defect and how it directly led to the plaintiff's injuries.
Manufacturing Defects
Manufacturing defect claims focus on situations where a particular unit or batch departed from the intended design or specifications due to manufacturing error, contamination, or assembly problems. These defects are completely unfair, given that patients are forgoing other options to put their faith in a device. It is really unfortunate to see a medical device cause more harm than good due to subpar quality control and testing.
Testing facilities may also share liability. A third party's failure to conduct proper testing and evaluation poses great health risks for users. On the flip side, the manufacturer might be independently liable if they downplayed certain device risks that were found during testing.
Failure to Warn
Failure to warn claims assert that the manufacturer did not provide adequate warnings or instructions about known risks, correct use, maintenance, or recall actions, contributing to patient harm. Several communication errors contribute to a medical device's underwhelming performance. In some cases, manufacturers fail to provide their clients with sufficiently clear instructions, leading to misuse of their device – which still constitutes product liability.
Inaccurate advertising also poses a great risk as it sets unrealistic expectations for healthcare providers and patients alike. Manufacturers are also responsible for providing timely updates about device recalls, malfunctions, or newly discovered complications. Healthcare providers who recommend faulty products to patients may face medical malpractice lawsuits. Doctors must inform patients of potential risks and provide guidance on proper device use. In certain situations, hospitals and clinics could also bear some responsibility.
Understanding Defective Medical Devices and Product Liability
Assistive medical devices are most often utilized by the elderly, children with disabilities, or individuals with long-term health complications. Given the risks faced by these groups, medical devices have little to no room for errors. Manufacturing defects, design defects, and communication errors are the primary reasons why a medical device fails to perform as intended.
Subpar Manufacturer Quality Control and Testing
While the FDA enforces heavy regulations on every medical device that comes to market, some manufacturers are more complacent than others. Subpar quality control and testing of medical devices can lead to malfunctions and safety issues. This poor quality can be seen in the device itself, packaging, or delivery. In severe cases, faulty devices may cause serious injury, complications, or even death.
Hidden Long-Term Complications
Medical devices are tested rigorously before getting FDA approved. However, these tests are notably limited, considering that some devices are intended for years and years of use. At the same time, every patient is unique. Therefore, reactions to certain medical devices can vary from patient to patient despite the efficacy indicated by initial tests.
With design defects, liability may fall on the manufacturer if they fail to warn users of potential long-term risks. In this context, cases could also be made against healthcare providers for improper monitoring or failing to educate their patients.
Devices Not Performing as Advertised
Several communication errors contribute to a medical device's underwhelming performance. In some cases, manufacturers fail to provide their clients with sufficiently clear instructions. This leads to a misuse of their device – which still constitutes product liability.
Inaccurate advertising also poses a great risk as it sets unrealistic expectations for healthcare providers and patients alike. At the same time, manufacturers are also responsible for providing timely updates about device recalls, malfunctions, or newly discovered complications.
Documented Faulty Medical Devices
There have been several documented cases of emergency FDA recalls. In this segment, we aim to paint a picture of how diverse medical devices are – as well as the risks that defective ones pose.
Allergan Breast Implants – These textured breast implants were recalled due to a significantly higher risk (6 times more than other brands) of causing BIA-ALCL, a rare lymphoma that led to 33 patient deaths globally.
Medtronic Pacemakers – Recalled due to the risk of delivering low or no energy during life-threatening arrhythmias, potentially leading to cardiac arrest, serious injury, or death.
Abbott Glucose Monitors – Recalled due to potential battery swelling, leakage, overheating, and/or fire, which may cause burns or property damage. Affected Readers should be replaced to avoid these risks.
Magellan Blood Testing System – Product may underestimate blood lead levels when using venous blood samples due to thiuram interference from certain BD blood collection tubes, potentially leading to improper patient management and treatment.
Exactech Joint Replacement Devices – Recalled joint replacement devices packaged in defective bags missing an oxygen barrier layer. This can lead to oxidation, causing accelerated wear, fracture, failure, pain, bone loss, and the need for revision surgery.
Identifying Signs of a Defective Medical Device
Detecting issues early allows patients to prevent further harm. Aside from noticeable changes/faults on the device, it is also important to notice early physical symptoms within yourself. These include (but are not limited to):
Unanticipated pain or discomfort associated with a medical device may suggest a potential malfunction and should be investigated immediately.
Inconsistencies in the performance of electronic medical devices, such as erratic readings or signals from a pacemaker, could be indicative of an underlying issue.
The presence of infections or atypical physical reactions in the vicinity of an implanted medical device might point to a problem that requires attention.
For devices like hip or knee implants, abrupt changes in mobility or function could be a warning sign of a possible defect or complication.
You should seek immediate medical help as soon as any of these symptoms come to light. It may also be helpful to contact your peers (individuals using the same medical device) and ask if they are noticing the same problems that you have. Lastly, seek legal advice as soon as symptoms begin to worsen.
How to Check If Your Device Was Recalled
The FDA's Medical Device Recall database allows users to search by product name, manufacturer, product code, or other identifiers to see if a device has been recalled and why. When checking for recalls, patients should compare the recall listing with the exact device name, model number, catalog number, and lot or serial number printed on the device, packaging, or implant card.
Each recall entry generally includes the reason for recall, classification (Class I, II, or III), affected models and lots, and recommended actions such as monitoring, replacement, or return. Users should not stop using or remove an implanted device on their own but instead bring recall information to their treating clinician to discuss next steps. You can access the FDA Medical Device Recall database here.
Request a Free Medical Malpractice Case Review
No fee, no-obligation, confidential.
How to Report a Medical Device Problem
The FDA's MDR (Medical Device Reporting) program requires manufacturers, importers, and certain healthcare facilities to report device-related deaths, serious injuries, and malfunctions under 21 CFR Part 803. Patients, caregivers, and clinicians are encouraged to submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Voluntary MedWatch reports (Form FDA 3500) can be submitted online, by mail, or by fax and should include the device name, model and lot or serial number, description of the problem, and clinical outcome. These reports feed into the FDA's safety monitoring systems and can support later investigations, safety alerts, or recalls. You can submit a MedWatch report here.
Using the FDA MAUDE Database for Research
The FDA's MAUDE (Manufacturer and User Facility Device Experience) database contains over four million reports of suspected device-associated deaths, serious injuries, and malfunctions submitted by manufacturers, user facilities, and voluntary reporters. It is a public post-market surveillance resource that allows users to search by device name, manufacturer, model number, product code, event type, and other parameters.
MAUDE can help patients, attorneys, and experts identify patterns of similar events involving a device, such as repeated malfunctions, injury mechanisms, or recall-related issues. However, it is subject to under-reporting and duplicate reports and does not prove causation on its own. This database serves as an informational tool, and any findings should be discussed with qualified medical and legal professionals. Access the MAUDE database here.
FAQ
How do I check if my medical device was recalled?
Go to the FDA Medical Device Recalls database and search using your device's brand name, manufacturer, and, if possible, model or catalog number. Then compare the recall entry's model, lot, and serial information with the labels on your device, packaging, or implant card to confirm whether your specific unit is included. If you find a matching recall, follow the FDA's listed recommendations and contact your doctor or device provider before stopping use or removing an implanted device.
Where do I report a medical device malfunction?
Patients, caregivers, and healthcare professionals can report serious adverse events, product problems, or suspected malfunctions directly to the FDA through the MedWatch program using the voluntary Form FDA 3500. Reports can be submitted online through the FDA's MedWatch portal or by mail or fax, and should include detailed information about the device, the event, and the outcome. Hospitals, nursing homes, and manufacturers have separate mandatory MDR obligations under 21 CFR Part 803, but patients do not need to rely on these entities and are encouraged to report problems themselves as well.
What evidence do I need for a defective device claim?
Useful evidence includes the device itself (if removable), original packaging, instructions for use, and any labels showing the brand, model, lot or serial number, and expiration date. Copies of medical records documenting implantation or use, operative reports, imaging, and clinical notes describing the malfunction and resulting injuries are also important. Documentation of related FDA recalls, MAUDE reports, and MedWatch submissions can help show that similar problems have occurred in other patients, supporting arguments about design or manufacturing defects or inadequate warnings, though each legal claim still requires case-specific expert analysis.
Injured Because of a Medical Device Malfunction?
Get legal help from experienced medical malpractice lawyers.
Speak to a Legal Expert Today
At the Porter Law Group, our team of experienced lawyers specializes in both product liability and medical malpractice. We help you strengthen and evaluate your case so that you may be rightfully compensated.
Our team legally supports you while you recuperate from any harm caused by faulty medical devices. We work on a contingency basis – meaning you don't have to pay anything unless we win.
If you or a loved one is suffering due to medical device malfunctions, please reach out to us for a no-obligation, free consultation. You may also contact us at 833-PORTER9 or info@porterlawteam.com to schedule an appointment.
