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.
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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:
| Manufacturers, Distributors, and Suppliers | These parties are typically the primary defendants when defective devices cause harm. The introduction of a faulty medical device to the market makes any of them 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. |
| Testing Facilities | Such 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. |
| Healthcare Providers | Doctors 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.
Manufacturing 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.
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.
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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.
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.
