Defective Medical Products
Defective Medical Products — Legal Help When Medical Devices Fail
Board-Certified Medical Malpractice Attorneys at The Kelly Firm
Defective medical products can cause severe injury, prolonged suffering, and even death. When devices meant to improve health instead cause harm, it’s critical that injured patients exercise their rights. At The Kelly Firm, our board-certified medical malpractice attorneys investigate complex cases involving defective medical devices and hold negligent manufacturers and other responsible parties accountable.
What Are Defective Medical Products?
A medical product may be considered defective for one of three primary reasons: design defects, manufacturing defects, or marketing (failure-to-warn) defects.
- Design Defects — The inherent design of the device poses an unreasonable risk, even when manufactured exactly as intended. A hip implant, for example, may fail prematurely or shed particles because of flawed engineering.
- Manufacturing Defects — A device deviates from its intended design during production. A pacemaker might fail to deliver correct impulses due to faulty components or contamination.
- Marketing (Failure to Warn) Defects — The manufacturer fails to provide adequate instructions, warnings, or disclosures of known risks. Even a properly designed and built device can be dangerous if doctors or patients are not warned about potential complications.
Patients trust that medical devices are safe, effective, and thoroughly tested. When that trust is violated, the consequences can be devastating—and legal remedies may be available.
Common Types of Defective Medical Devices
Defective medical device claims can involve a wide range of products, from implants to surgical instruments and monitoring equipment. Frequently litigated devices include:
- Hip and knee implants — Defective joint replacements can loosen, fracture, or fail prematurely, leading to pain, inflammation, and revision surgeries.
- Pacemakers and defibrillators — Malfunctioning cardiac devices can result in irregular heart rhythms, shock injuries, or death.
- Surgical mesh — Used in hernia and pelvic repair, defective mesh can cause infections, organ perforation, and chronic pain.
- Insulin pumps and infusion devices — A malfunction can trigger dangerous highs or lows in blood sugar, leading to serious complications.
- IVC (inferior vena cava) filters — Intended to prevent blood clots, some filters can fracture or migrate to vital organs, creating life-threatening conditions.
These examples show that even highly regulated, FDA-approved devices can fail catastrophically when design, testing, or manufacturing processes are insufficient.
Why Defective Medical Product Claims Are Complex
Defective medical device cases are among the most technically complex areas of personal injury law. They often involve:
- Scientific and medical evidence — Proving a defect typically requires testimony from engineers, materials scientists, and medical experts who can demonstrate how and why the device failed.
- Causation challenges — Plaintiffs must prove the device directly caused the injury, not an underlying condition or surgical error.
- Multiple responsible parties — Liability may extend beyond the manufacturer to include designers, component suppliers, and distributors; in limited circumstances, a healthcare facility could share responsibility.
- Regulatory layers — FDA approval, clearances, and recalls can affect the timing and strategy of a claim, adding procedural complexity.
Because these cases blend medicine, science, and law, experienced attorneys who understand both product liability and medical malpractice are essential.
Legal Theories in Defective Medical Device Lawsuits
Defective medical device claims are typically brought under product liability law rather than traditional malpractice. Common legal theories include:
- Strict Liability — The manufacturer can be held responsible because the product was unreasonably dangerous, regardless of intent or negligence.
- Negligence — The company failed to exercise reasonable care during design, testing, manufacturing, or in warning users about known risks.
- Breach of Warranty — The product failed to meet promised safety or performance standards or violated implied assurances of quality.
To succeed, your legal team must establish three elements: the device was defective, the defect caused your injury, and measurable damages resulted.
Proving Causation and Identifying Responsible Parties
Demonstrating that a device defect directly caused an injury can be challenging. Patients may have preexisting conditions or other factors that complicate causation. Expert testimony and a careful review of medical records, device logs, and testing data are often required to connect the failure to the specific harm suffered.
Determining who is responsible involves tracing the device’s lifecycle—from design and testing to distribution and use. Liable parties may include the device manufacturer, design firms, component suppliers, importers, distributors, and in rare circumstances a healthcare provider who knew or should have known about a defect. Thorough investigation is key to holding every responsible party accountable.
Damages Available in a Defective Medical Product Lawsuit
- Economic Damages — Medical expenses, hospitalization, rehabilitation, lost income, and loss of future earning potential.
- Non-Economic Damages — Pain and suffering, emotional distress, loss of enjoyment of life, and loss of consortium.
- Punitive Damages — In certain cases, when the manufacturer’s conduct shows extreme negligence or willful disregard for safety.
The long-term nature of many device-related injuries often means extensive medical treatment, rehabilitation, and ongoing emotional and financial hardship.
Statutes of Limitations
Every state imposes strict deadlines for filing defective medical product claims. Missing these deadlines can permanently bar recovery. If you suspect a device defect caused harm, consult an attorney promptly—delays can lead to lost evidence or expired claims.
Why Choose The Kelly Firm
- Board-Certified Experience — Proven expertise in medical malpractice and complex product liability cases.
- Comprehensive Investigation — Collaboration with top medical and engineering experts to analyze design, manufacturing, and safety data.
- Client-Focused Advocacy — We understand how device injuries affect your health, family, and finances, and we fight for the maximum compensation you deserve.
- No Fee Unless We Win — We handle defective product cases on a contingency basis; you pay nothing unless we recover compensation for you.
What To Do If You Suspect a Defective Medical Device
- Preserve all evidence — Keep the device (when possible), packaging, serial/model numbers, and all related medical documentation.
- Seek medical evaluation — Get prompt treatment and request complete medical records.
- Document symptoms and expenses — Track your symptoms, missed work, out-of-pocket costs, and impacts on daily living.
- Consult an experienced attorney — Do not sign manufacturer or insurance documents before legal review.
- Act quickly — Time limits apply, and early investigation strengthens your case.
Frequently Asked Questions
Can I sue the hospital or doctor for a defective device?
Usually, primary liability rests with the device manufacturer or distributor. However, if a provider knew or should have known the device was defective, or used it contrary to instructions, there may be shared responsibility. An attorney can evaluate all potential defendants.
What if my device was recalled?
A recall can support your case by showing the manufacturer recognized a problem, but it does not guarantee compensation. You must still prove that the defect caused your injury and quantify your damages.
Does FDA approval mean the device was safe?
No. FDA approval or clearance does not prevent defects from occurring. Some products receive expedited review that may not reveal all risks. Post-market failures and inadequate warnings can still lead to serious injuries.
How long will my case take?
Timelines vary based on complexity, the number of defendants, and whether the case settles or goes to trial. Many cases resolve within 12–24 months; complex matters can take longer due to expert discovery and court schedules.
What compensation can I recover?
Compensation may include medical expenses, lost income, diminished earning capacity, pain and suffering, and, in certain cases, punitive damages. Your specific recovery depends on the facts, the severity of injury, and applicable law.
Protecting Your Rights After a Defective Medical Device Injury
When a medical device fails, the physical, emotional, and financial toll can be overwhelming. You deserve answers—and justice. The Kelly Firm helps victims of defective medical products take on major manufacturers and insurers to pursue the compensation they deserve.
If you or a loved one suffered harm from a device such as a hip implant, pacemaker, surgical mesh, insulin pump, or IVC filter, contact The Kelly Firm for a free case evaluation. Our attorneys will review your records, explain your rights, and outline next steps.
Hospital mistakes are wrong. Patients have rights. Let us help you protect yours.
