Product Liability

Medical Devices & Implants

Medical Devices & Implants

A device meant to save a life should never be the reason it’s lost.

When a medical device fails, the consequences are rarely “minor.” A defective implant or critical device can trigger a cascade: hemorrhage, stroke, infection, organ damage, device migration, loss of function, or emergency revision surgery. For many patients, that becomes catastrophic injury. For families, it can become wrongful death.

These cases also feel uniquely isolating: patients did what they were told, trusted a product marketed as safe, and then suffered a life-changing outcome. Product liability law exists for exactly that scenario when a device is unreasonably dangerous because of its design, manufacturing, instructions, or warnings, or because companies ignored known safety signals.

Medical Device
Philly Skyline
Coughing, sick and a person feeling chest for pain

Where catastrophic harm happens in medical device cases

Medical device and implant failures often involve high-stakes events such as:

  • Cardiac events when pacemakers/defibrillators malfunction, prematurely enter a safety mode, or require early replacement
  • Stroke, thrombosis, or death risk when vascular or neurovascular implants don’t deploy correctly or fail to appose to vessel walls
  • Early implant wear and failure in joint replacements leading to bone loss, severe pain, falls, and complex revision surgeries
  • Dangerous readings from glucose monitoring systems that lead to critical treatment decisions and severe outcomes

This isn’t “just a complication.” The question becomes: Was this preventable with reasonable design, manufacturing controls, and warnings?.

Medical Device Failures and Safety Issues We Follow

Neurovascular implants (aneurysm devices / flow diverters)


These are implanted in brain vessels to treat aneurysms. Recent FDA recall activity includes Medtronic Pipeline Vantage embolization devices, where the FDA noted concerns such as devices not attaching properly or failing to stay attached events that can raise the risk of stroke or death.

Implantable cardiac rhythm devices (pacemakers / CRT pacemakers)


These devices help regulate heart rhythm. The FDA issued recall information involving Boston Scientific ACCOLADE pacemaker devices due to a manufacturing issue that may lead to early device replacement and serious clinical consequences if the device malfunctions. 

Orthopedic implants (joint replacements)


Recall/safety actions have involved joint replacement systems where packaging or component issues can contribute to premature wear, early failure, pain, and revision surgery which can be especially devastating for medically fragile patients. The FDA has issued safety communications regarding Exactech joint replacement devices with defective packaging.

Continuous glucose monitoring sensors (CGMs)


These aren’t implanted like a joint or pacemaker, but they are body-worn medical devices that drive treatment decisions. The FDA issued an Early Alert for certain Abbott FreeStyle Libre 3 / Libre 3 Plus sensors due to reports of incorrect low glucose readings, which can lead to dangerous treatment decisions; public reporting tied the issue to serious injuries and deaths worldwide.

Infusion pumps


These devices deliver fluids, medications, or nutrition directly into the body and are widely used in hospitals and other care settings. Safety actions have involved infusion pump systems where software errors, device shutdowns, or flow problems can interrupt treatment or cause under-delivery or over-delivery of medication. In serious cases, these failures can lead to catastrophic injury or death, especially for critically ill patients who depend on accurate drug delivery.

Reusable Medical Scopes (Duodenoscope, Endoscope)


Endoscopic procedures, such as colonoscopies, bronchoscopies, and ERCPs, are meant to diagnose and treat serious conditions. But when the scopes used in these procedures are not capable of being properly cleaned or disinfected, they can transmit dangerous bacteria from one patient to another. This can lead to dangerous infection, resulting in hospitalizations or, in some cases, death.

What to do if you suspect a device or implant failure

If there has been a serious injury, focus on safety and evidence:

  1. Get medical care and follow your clinicians’ guidance. Don’t delay urgent treatment.
  2. Preserve the product evidence when possible: packaging, implant cards, device identifiers (UDI), manuals, chargers, home monitoring equipment, and app logs.
  3. If a device is removed or revised, ask that explanted components be retained and documented (chain-of-custody matters).
  4. Keep a timeline: symptoms, appointments, emergency visits, revision procedures, and any provider notes you receive.
Pacemaker
Lawyer going through papers

How we investigate catastrophic device cases

These are proof-driven cases. We typically focus on:

  • Device identification (model, lot, UDI, implant date, revision date)
  • Failure mode (migration, fracture, wear, software behavior, deployment failure, sensor inaccuracies)
  • Standards and warnings (what the company knew, what it communicated, what it didn’t)
  • Causation and damages in real life: ICU stays, stroke deficits, amputations, infection cascades, repeat surgeries, and long-term care needs

Damages in catastrophic injury and wrongful death cases

Depending on the facts, compensation can address:

  • Past and future medical costs, revision surgeries, rehabilitation, long-term care
  • Lost income and diminished earning capacity
  • Pain, suffering, loss of life’s pleasures, disfigurement, disability
  • Wrongful death damages for surviving family members (where applicable)
Patient with nurse
mom holding hands trust comfort

When the “solution” becomes the harm

Medical devices and implants are marketed as protection: mobility, stability, rhythm control, safer procedures, better management of chronic disease. When a product fails, it can take away independence, health, and life itself.

If you or your family is dealing with catastrophic injury or a death after a device malfunction or implant failure, we can help you evaluate whether there is a product-liability path forward and move quickly to preserve the evidence that matters.

Learn More

Sepsis and Serious Infections Linked to Product Defect: Contaminated Reusable Scopes

In a number of occurrences, people have gone in for routine or necessary scope procedures and come out with severe infections, repeat hospitalizations, IV antibiotics, and in some cases, death. The danger is not limited to one brand or one…

Insulin Pump / CGM Failures: Over-Delivery, Under-Delivery, and Severe Outcomes

A defective or malfunctioning insulin pump does not just create inconvenience. It can lead to under-delivery or interruption of insulin, dangerous hyperglycemia, and emergency care. FDA reports on recent corrections describe hundreds of adverse events and dozens of injuries tied…

Untraceable Firearm Product Liability: The Legal Theories Families Ask About

When a shooting involves an untraceable firearm, families often ask the same painful question: how did a weapon with no serial number and no paper trail end up in someone’s hands? These cases are sometimes described as “ghost gun” incidents,…

Surgical Mesh Complications: What “Design Defect vs. Complication” Looks Like

Surgical mesh is used in many common procedures, including hernia repair and certain pelvic surgeries. When it works, it can reinforce weakened tissue and support healing. But when patients develop serious problems afterward like chronic pain, infection, erosion, adhesion, bowel…

Spinal Cord Stimulator Paralysis Claims: What Patients Should Know After KARE 11 Investigation

A recent KARE 11 investigation reported that multiple Minnesota patients say they were left paralyzed or seriously injured after receiving spinal cord stimulator implants for pain relief at Nura Pain Clinic in Edina. According to the reporting, three patients filed…

Cleaning Agents & Product Liability

Product Liability and Cleaning Agents: What Consumers Need to Know Household cleaning agents are marketed as products that protect families from germs and harmful bacteria. When these products are contaminated, improperly manufactured, or defectively designed, they can do the opposite,…