What qualifies as a defective medical device?

A defective medical device is any medical product that fails to perform safely, including hip implants, heart valves, surgical mesh, insulin pumps, pacemakers, and orthopedic hardware that cause injury due to design or manufacturing flaws.

Can I sue a medical device manufacturer?

Yes. Medical device manufacturers can be held liable under product liability law when their devices are defective and cause injury. This applies even if the FDA approved the device.

Defective Medical Device Injury Attorney

Medical devices are supposed to heal — not harm. When a hip implant fails, a pacemaker malfunctions, or surgical mesh causes devastating complications, patients deserve answers and compensation. Our attorneys have the specialized expertise to take on major medical device manufacturers.

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When Medical Devices Cause More Harm Than Good

Americans rely on medical devices for everything from joint replacements to cardiac care. The medical device industry generates over $180 billion annually in the United States alone. Unfortunately, the rush to bring new products to market sometimes means that safety takes a back seat to profits.

The FDA's approval process for medical devices has significant gaps. Many devices reach the market through the controversial 510(k) pathway, which allows manufacturers to bypass rigorous clinical testing by claiming their device is "substantially equivalent" to an existing product. This means many devices you receive have never been tested in clinical trials on actual patients.

When these devices fail inside your body, the consequences can be devastating — chronic pain, additional surgeries, infections, organ damage, and in the worst cases, death. Our defective medical products injury attorneys understand the unique complexities of these cases and have the resources to challenge even the largest device manufacturers.

Defective medical device injury legal representation

Common Cases

Types of Defective Medical Device Claims We Handle

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Hip & Knee Implants

Metal-on-metal hip implants, knee replacement components, and orthopedic hardware that fail prematurely causing metallosis, bone deterioration, and the need for painful revision surgeries.

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Surgical Mesh

Hernia mesh and transvaginal mesh products that erode, migrate, or cause chronic infections, organ perforation, and debilitating pain requiring multiple corrective surgeries.

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Cardiac Devices

Defective pacemakers, defibrillators, heart valves, and stents that malfunction, leading to cardiac events, electrical failures, and life-threatening complications.

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Insulin Pumps & Drug Delivery

Insulin pumps, infusion systems, and drug delivery devices that deliver incorrect dosages, malfunction, or cause infections at insertion sites.

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Ophthalmic Devices

Defective intraocular lenses, LASIK equipment, and other eye-related medical devices that cause vision loss, chronic dry eye, or permanent eye damage.

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Dental Implants & Devices

Failed dental implants, defective orthodontic hardware, and contaminated dental materials that cause infections, nerve damage, and bone loss.

Signs Your Medical Device May Be Defective

Not every complication from a medical device indicates a defect, but certain symptoms should prompt you to investigate further:

Persistent or worsening pain at the implant site after the expected recovery period
Swelling, redness, or warmth around the device area that doesn't improve
Metallic taste in your mouth (common with metal-on-metal implants)
Unusual sounds like clicking or grinding from an implanted joint
Device migration — the device has moved from its original placement
Your device has been subject to an FDA recall or safety communication
Recurring infections at or near the device location
Unexplained fatigue, cognitive issues, or systemic symptoms after implantation

⚕️ FDA Recalls Don't Automatically Compensate You

When the FDA recalls a medical device, it does not provide compensation to patients. A recall simply removes the product from the market. To receive compensation for injuries, you need to file a product liability claim against the manufacturer. Our attorneys monitor all FDA recalls and can quickly determine if your device is affected.

FAQ

Medical Device Injury Questions

In many cases, yes. FDA approval does not shield manufacturers from liability, particularly for devices approved through the 510(k) process. If the manufacturer failed to report known risks, hid safety data, or did not comply with FDA requirements, they can still be held liable for injuries.

You can check the FDA's medical device recall database online, contact your doctor or surgeon who implanted the device, or consult with our attorneys who maintain comprehensive databases of all recalled medical devices. Manufacturers are also required to notify healthcare providers of recalls.

Compensation can include costs of revision surgery and medical treatment, lost wages during recovery, pain and suffering, reduced quality of life, future medical expenses, and in cases of willful misconduct, punitive damages. Many medical device cases result in significant settlements due to the severity of injuries involved.

When many patients are injured by the same defective device, their cases may be consolidated into a multidistrict litigation (MDL) in federal court. This allows for efficient handling of common issues like expert testimony and discovery while preserving each plaintiff's individual claim. Our firm has experience handling MDL cases.