Modern medicine depends on medical devices. From artificial joints and heart valves to surgical mesh and implanted ports, these products have improved the lives of millions of patients. Most medical devices work as intended. However, when a device is defectively designed, improperly manufactured, or accompanied by inadequate warnings or instructions, the consequences can be devastating.
Medical device litigation holds manufacturers accountable when a product fails to perform safely as intended or when patients and physicians were not adequately warned about known or reasonably knowable risks. The attorneys at CPY Law are here to advocate for patients throughout Missouri.
We’re ready to handle the fight while you heal. Consultations are free, and you pay us nothing unless and until we win. To request a free case review with our defective medical device lawyers in Kansas City, MO, contact our law firm today.
What Is Considered a Medical Device?
The term “medical device” encompasses an enormous range of products used to diagnose, monitor, treat, or prevent disease and injury.
Some medical devices remain outside the body, while others are implanted permanently or for extended periods of time. Examples include:
- Artificial hips
- Artificial knees
- Shoulder replacements
- Hernia mesh
- Transvaginal mesh
- Inferior vena cava (IVC) filters
- Surgical staplers
- Insulin pumps
- Pacemakers
- Defibrillators
- Spinal implants
- Bone fixation systems
- Breast implants
- Catheters
- Implantable infusion ports
- CPAP machines and related components
Because these products often remain inside the body for months or years, patients naturally expect them to function safely and reliably. When they do not, the consequences may extend far beyond the need to replace the device. Patients may require additional surgeries, experience chronic pain, suffer permanent injuries, or face lifelong medical complications.
What Makes Defective Medical Device Litigation Unique
Medical device cases often combine medicine and engineering in ways that few other personal injury cases do. Understanding these claims may require careful analysis of:
- Product design
- Mechanical performance
- Surgical technique
- Human anatomy
- Long-term wear characteristics
- Manufacturing quality
- Regulatory history
- Medical causation
Medical device litigation frequently involves extensive document review, expert analysis, and coordination with specialists from multiple disciplines. These issues are technically complex, but our Kansas City defective medical device attorneys can explain what happened and other key aspects of your case in plain language that you can understand.
Why Do Medical Devices Fail?
One of the first questions clients often ask is simple: “How could something designed to help me end up causing so much harm?”
The answer is not always straightforward. Medical devices may fail for many different reasons, and identifying the cause often requires extensive investigation.
Some failures result from normal wear over many years. Others arise because of surgical technique, patient anatomy, infection, trauma, or unrelated medical conditions.
In other situations, evidence may suggest that the device itself contributed to the injury. Those cases often involve one or more of the following issues below.
Design Defects
A design defect exists when the product’s design itself creates an unreasonable risk of injury.
Unlike a manufacturing defect, which involves an error during production, a design defect affects every device manufactured according to that design.
Examples may include:
- Components prone to premature fracture
- Materials that generate excessive wear debris
- Device geometry that creates abnormal mechanical stress
- Designs susceptible to migration or loosening
- Products that fail under reasonably anticipated conditions of use
Design defect cases frequently require engineers, orthopedic surgeons, biomechanical experts, and materials scientists to evaluate whether safer alternative designs were available and whether the product performed as intended.
Manufacturing Defects
Sometimes the design itself is appropriate, but something goes wrong during manufacturing. Manufacturing defects may involve:
- Contamination
- Improper heat treatment
- Poor welding
- Defective machining
- Incorrect assembly
- Material inconsistencies
- Sterilization failures
- Packaging defects
These problems may affect only certain production lots or batches rather than every device sold.
Investigating manufacturing defects often requires review of production records, quality-control documents, inspection reports, and regulatory findings.
Failure to Warn
Even a properly designed medical device may carry known risks. Manufacturers generally have a duty to provide adequate information regarding those risks so physicians can make informed treatment decisions and properly counsel their patients.
Failure-to-warn claims may involve allegations that the manufacturer:
- Understated complication rates
- Failed to disclose newly discovered risks
- Delayed updating product labeling
- Omitted important contraindications
- Failed to communicate appropriate monitoring recommendations
- Provided misleading marketing regarding device safety or longevity
The legal issue is often not whether complications can occur, but whether physicians were given sufficient information to appropriately balance risks and benefits.
Understanding the FDA Approval Process for Medical Devices
Many people assume that all medical devices undergo the same rigorous approval process. In reality, the regulatory pathway depends on the type of device.
Some higher-risk devices undergo extensive review before entering the market. Others reach the market through regulatory pathways that may rely, in part, on demonstrating substantial equivalence to an existing device.
How FDA Approval Could Affect Defective Medical Device Litigation
Understanding how a particular product reached the marketplace can become an important issue during litigation, although the existence of FDA clearance or approval does not automatically determine whether a manufacturer may be legally responsible for injuries caused by the device.
Regulatory history is often only one piece of a much larger evidentiary picture. Our Kansas City defective medical device lawyers will note the path a product took from development to the market while evaluating your claim.
Defective Medical Device Recalls
Recalls are official requests by a company for consumers to return, remove, replace, or discontinue use of a product because it poses a health or safety risk. Medical device recalls occur for many reasons, including:
- Manufacturing issues
- Sterility concerns
- Labeling errors
- Mechanical failures
- Component defects
- Software problems
- Unexpected complication rates
Do I Automatically Have a Case If a Medical Device Gets Recalled?
No, a recall does not guarantee that you have a valid legal claim.
Not every defective medical device is recalled. Likewise, not every recall means patients have a legal claim. Some recalls are precautionary. Others involve serious safety risks.
Whether a recall supports a legal claim depends on numerous factors, including the reason for the recall, the patient’s injuries, timing, and applicable laws. Our Kansas City attorneys will note medical device recalls in conjunction with other evidence while building your case.
Common Injuries in Medical Device Litigation
Medical device failures can produce a wide range of injuries and health complications. Examples include:
- Chronic pain
- Infection
- Device loosening
- Device migration
- Fractures
- Metallosis
- Tissue destruction
- Organ perforation
- Bleeding
- Blood clots
- Revision surgery
- Nerve injury
- Reduced mobility
- Permanent disability
- Wrongful death
Multiple Surgeries May Be Required for Medical Device Complications
For many patients, the most difficult aspect is not the initial surgery but the additional procedures required to remove or replace a failed device. Revision surgeries are often more complicated than the original implantation and may involve longer recovery periods and increased risk of future complications.
Our medical device attorneys in Kansas City will consider the cost of all treatments to address health complications when seeking compensation.
Evidence Needed to Evaluate a Defective Medical Device Claim
Medical device litigation is highly evidence-driven. Important records for these kinds of lawsuits may include:
- Operative reports
- Implant records
- Device stickers or identification labels
- Hospital records
- Imaging studies
- Revision surgery reports
- Pathology reports
- Infection records
- Physical therapy records
- Product recall information
- FDA communications
- Treating physician opinions
Whenever possible, patients should also retain documentation identifying the specific manufacturer and model of the implanted device.
The Role of Expert Witnesses in Medical Device Claims
Medical device cases often require testimony from multiple experts. These experts help explain how the device was intended to function, what allegedly went wrong, how the failure caused injury, and what long-term consequences the patient may face.
Depending on the issues involved, key expert witnesses may include:
- Orthopedic surgeons
- General surgeons
- Biomedical engineers
- Materials scientists
- Metallurgists
- Radiologists
- Pathologists
- Infectious disease specialists
- Regulatory experts
- Life-care planners
- Economists
Compensation in a Defective Medical Device Claim
Clients in defective medical device cases can seek compensation for losses caused by their injuries. This includes economic damages (measurable financial losses) and non-economic damages (subjective and intangible losses).
- Medical Expenses and Future Care: This includes the cost of initial hospitalization and stabilizing care as well as revisions surgeries. This also covers ongoing health and wellness needs, such as physical rehabilitation, follow-up visits with specialists, and occupational therapy.
- Lost Wages and Future Earnings: This includes time off from work while recovering from injuries or illness. This also includes reduced earning capacity due to long-term or permanent disabilities caused by the medical device.
- Pain and Suffering: This includes mental anguish, emotional distress, and chronic pain from lingering conditions caused by the failed device or treatment.
- Lower Quality of Life: This includes loss of enjoyment in your favorite hobbies, a reduced sense of well-being, and any strain on your relationships after a medical device injury.
Determining accurate compensation for defective medical device litigation can be complicated. At CPY Law, we’ll help you understand how much your claim is actually worth.
How Long Do I Have to File a Defective Medical Device Lawsuit in Missouri?
The statute of limitations for defective medical device claims in Missouri is typically five years from the date of injury or illness (RSMo § 516.120).
If the use of a dangerous medical device resulted in the death of a loved one, you have three years from the loss of your loved one to file a wrongful death claim (RSMo § 537.100).
It’s best to speak with a Kansas City defective medical device lawyer as soon as possible. Your attorney can let you know if you have a valid claim and what steps to take next.
How CPY Law Helps Clients in Defective Medical Device Cases
At CPY Law, we recognize that a failed medical device affects far more than a single surgery or medical procedure. Many clients come to us after months or years of pain, additional operations, uncertainty, and disruption to their daily lives.
Our role begins with understanding the client’s medical history and identifying the specific device involved. We work to gather the records necessary to evaluate the claim, monitor national litigation developments when applicable, and help clients understand what to expect throughout the legal process.
We believe that clear communication is just as important as legal advocacy. Medical device litigation can be complicated, but our goal is to explain each stage of the process in plain language while pursuing the evidence needed to protect our clients’ interests.
Contact Our Kansas City Defective Medical Device Attorneys Near You
If you believe you were injured by a defective medical device, CPY Law can help you understand your legal options. Consultations are free, and you pay our attorneys nothing unless and until we win. To request a free case evaluation with our failed medical device lawyers, contact our Kansas City law firm today.
Frequently Asked Questions About Medical Device Litigation in Kansas City
Below are some of the most common questions we’ve heard from clients during defective medical device cases.
Does every device failure mean the manufacturer is legally responsible?
No. Medical devices can fail for many reasons, including infection, trauma, patient-specific factors, or normal wear over time. Determining whether a legal claim exists requires careful investigation. Our Kansas City medical device injury attorneys will carefully evaluate your situation to ensure you have a valid case.
What if my doctor told me complications are a known risk of the medical device?
You may still have a case even if your doctor informed you of the risks of a medical device.
Many procedures involve known risks. A legal claim may depend on whether the manufacturer adequately disclosed those risks, whether the device was defectively designed or manufactured, and whether the injury was caused by a product defect rather than an expected complication.
Do I need to know the exact device that was implanted?
It helps, but it is not always necessary at the outset of litigation. Implant records, operative reports, and hospital records often identify the manufacturer and model of the device. The team at CPY Law can look through your medical records to help get this specific information.
Should I keep the medical device if it is removed?
If possible, yes. In some cases, preserving an explanted device may provide important evidence. Whenever feasible, patients should discuss preservation of an explanted medical device with our attorneys in Kansas City before disposal.
Will I need another surgery before I can file a medical device claim?
Not necessarily. Every case is different. Some medical device claims involve revision surgery, while others involve ongoing complications that have not yet required removal or replacement of the device.
How long do medical device cases take?
It depends. The timeline varies depending on the litigation, the medical issues involved, and the procedural posture of the case. Complex product liability litigation often requires significant investigation and expert analysis before resolution.
