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Medical devices and equipment are designed to improve lives, but what happens when they fail? Defective medical products can cause serious injuries, complications, or even death. Whether it’s a faulty pacemaker, a malfunctioning insulin pump, or a recalled hip implant, defective medical devices can lead to devastating consequences for patients and their families.
If a defective medical product has harmed you or a loved one, you may have legal options. This guide will help you understand what qualifies as a defective medical product, your rights as a victim, and how legal action can help you seek compensation.
A defective medical product is any medical device, implant, or equipment that is unsafe due to a design flaw, manufacturing defect, or inadequate warning labels. These defects can cause the product to malfunction, leading to serious health risks for patients.
The U.S. Food and Drug Administration (FDA) regulates medical devices and monitors safety issues. However, even FDA-approved devices can be defective, and many have been recalled after causing harm.
Many different medical products can be defective. Some of the most commonly reported ones include:
Hip replacements, knee implants, pacemakers, and breast implants can be faulty, leading to painful complications or the need for revision surgery.
Insulin pumps, ventilators, CPAP machines, and defibrillators may malfunction, putting patients at serious risk.
Faulty surgical staplers, defective robotic surgery tools, and improperly sterilized instruments can cause severe harm during medical procedures.
MRI machines, X-ray scanners, and blood pressure monitors with defects may provide inaccurate readings, leading to misdiagnosis or improper treatment.
Medical products can become defective for several reasons:
Errors during production, such as faulty wiring in pacemakers or contamination during the manufacturing process, can make medical devices unsafe.
Some medical devices are inherently dangerous due to poor design. For example, certain hip implants have been known to wear down quickly, releasing toxic metal particles into the body.
If manufacturers fail to provide adequate instructions or warnings about a device’s risks, patients and doctors may misuse it, leading to injuries.
The FDA oversees medical device safety and has a classification system for recalls based on the severity of risk.
“The FDA reports that between 2018 and 2022, over 100 million medical devices were recalled due to safety issues, with Class I recalls posing the highest risk to patients.”
Medical device recalls are categorized as:
| Recall Class | Description | Examples |
| Class I | Most serious; product may cause severe injury or death. | Defective pacemakers, faulty heart valves. |
| Class II | May cause temporary or medically reversible health effects. | Malfunctioning insulin pumps, surgical staplers. |
| Class III | Least serious; unlikely to cause harm. | Incorrect product labeling, packaging defects. |
Apart from FDA regulations, defective medical product cases fall under product liability laws, which allow injured patients to file lawsuits under three legal theories:
Manufacturers are responsible for defective products, even if they were not negligent during production.
If a manufacturer failed to properly test a device before releasing it, they could be held liable for injuries caused.
When a medical device does not perform as promised, the manufacturer can be sued for breaking their warranty.
If a defective medical product has harmed you, you have the right to pursue legal action.
Patients can sue medical device manufacturers, distributors, or suppliers if a defective product causes harm.
It’s important to distinguish between product liability and medical malpractice.
“Strict liability laws hold manufacturers responsible for defective medical products, even if they were not negligent in the manufacturing process.”
While medical malpractice lawsuits target doctors and hospitals for negligence, product liability lawsuits focus on the manufacturer’s responsibility for a faulty product.
Each state has a statute of limitations that sets a time limit for filing a lawsuit. This can range from two to four years from the date of injury or discovery.
Many high-profile defective medical device lawsuits have resulted in massive settlements. One of the most well-known cases involved Johnson & Johnson’s hip implants, where thousands of patients suffered serious injuries due to a design flaw. The company paid billions in settlements to victims.
These cases highlight the importance of holding manufacturers accountable and ensuring safer medical products.
If you suspect that a medical device has harmed you, take the following steps:
Your health is the priority. Get a medical evaluation to determine if the device has caused harm.
Keep detailed records of your medical treatments, expenses, and symptoms. Retain the defective product if possible.
You can file a complaint through MedWatch, the FDA’s reporting program for defective medical devices.
An experienced attorney can help you explore your legal options and file a lawsuit for compensation.
“Patients who suffer injuries from defective medical devices may be entitled to compensation for medical expenses, lost wages, and pain and suffering.”
Check for unusual side effects, device malfunctions, or recall notices from the FDA. If you experience problems, consult a doctor and research any safety warnings.
Yes. You can file a product liability lawsuit against the manufacturer, distributor, or supplier responsible for the defective device.
Victims may receive compensation for medical expenses, lost wages, pain and suffering, and, in some cases, punitive damages for negligence.
The statute of limitations varies by state, typically ranging from two to four years from the date of injury or discovery.
Stop using the device, seek medical care, report it to the FDA, and contact a lawyer to discuss your legal options.
No. Some involve design flaws, while others result from manufacturing defects or inadequate warnings. Each case requires a legal review.
Defective medical products pose serious health risks, and manufacturers must be held accountable. If you or a loved one has suffered due to a faulty medical device, you may be entitled to compensation.
Taking legal action can help you recover damages for medical costs, lost income, and emotional distress while preventing others from facing similar risks.
A knowledgeable product liability attorney can guide you through the legal process and help you seek justice. If you need assistance, consider consulting a law firm that specializes in defective medical product cases to discuss your options.
Contact Gina Corena & Associates for a free consultation today.
As founder of Gina Corena & Associates, she is dedicated to fighting for the rights of the people who suffer life-changing personal injuries in car, truck and motorcycle accidents as well as other types of personal injury. Gina feels fortunate to serve the Nevada community and hold wrongdoers accountable for their harm to her clients.
