Medical devices are supposed to help you heal. When a defective implant, surgical tool, or diagnostic machine causes harm instead, the manufacturer can and should be held accountable.
At Breit Biniazan, our attorneys represent patients injured by defective medical devices in individual lawsuits and large-scale multidistrict litigation. If you or a loved one has suffered because of a medical device failure, we want to hear your story. The consultation is free, and you pay nothing unless we recover for you.
Call us at (855) 659-4457 or submit a contact form online.
What Qualifies as a Medical Device Malfunction Lawsuit?
Not every negative outcome after using a medical device gives rise to a lawsuit. But when a device causes harm because of a defect in how it was designed, how it was manufactured, or how its risks were communicated, you may have grounds for a medical device malfunction lawsuit: a product liability claim against the manufacturer, distributor, or another party in the supply chain.
The three legal theories that typically apply:
Design defects exist when the device's blueprint or engineering is fundamentally flawed — meaning every unit produced carries the same dangerous characteristic, regardless of how it was assembled. A hip implant design that causes metal ions to leach into surrounding tissue, for instance, is a design defect.
Manufacturing defects occur when a specific unit or batch deviates from the intended design during production — contamination, incorrect materials, assembly errors, or quality control failures. The design may have been sound; the execution wasn't.
Failure to warn arises when a manufacturer knows about serious risks associated with its device (infection rates, mechanical failure modes, adverse reactions) but fails to adequately disclose those risks to physicians or patients. A stronger or clearer warning might have changed a doctor's recommendation or a patient's informed consent decision.
Common Types of Medical Device Failures
Medical device injury lawsuits have been filed across a wide range of device categories. The following are among the most frequently litigated:
Orthopedic Implants
Hip replacements, knee replacements, and spinal implants have generated some of the largest medical device lawsuits in history. Failures include premature loosening, metal-on-metal corrosion, fracture, and dislocation. Revision surgery to remove and replace a failed implant is painful, costly, and carries its own surgical risks.
Pacemakers and Cardiac Devices
Malfunctions in implantable cardiac devices can be fatal. Issues include lead fractures, premature battery depletion, software errors, and failure to pace or defibrillate when needed. Patients may have no warning before a life-threatening event.
Hernia Mesh
Surgical mesh used in hernia repair has been the subject of thousands of lawsuits involving mesh erosion, migration, infection, organ perforation, and bowel obstruction. Many affected patients required additional surgeries to address complications.
IVC Filters
Inferior vena cava filters, designed to prevent blood clots from reaching the lungs, have fractured and migrated in a significant number of patients, causing punctured organs and potentially fatal complications.
Malfunctions in these devices can result in dangerous insulin overdoses or underdoses. Software bugs and sensor errors have caused serious harm in patients managing diabetes.
Surgical Robots
As robotic-assisted surgery becomes more common, so do injury lawsuits involving equipment malfunctions, inadequate physician training protocols, and software errors that compromise surgical precision.
Breast Implants
Linked in some cases to a rare form of cancer (BIA-ALCL) and a constellation of systemic symptoms now referred to as breast implant illness, these devices have been the subject of growing litigation and significant FDA scrutiny.
Transvaginal Mesh
Similar to hernia mesh, pelvic floor repair mesh has been linked to erosion, chronic pain, nerve damage, and organ perforation, resulting in one of the largest medical device litigation dockets in U.S. history.
How a Medical Device Injury Lawsuit Works
Step 1: Case Evaluation
Your attorney reviews your medical history, device records, and the timeline of your injury. This includes identifying what device was used, who manufactured it, whether the device has been subject to recalls or FDA safety communications, and what the current litigation landscape looks like for that device type.
Step 2: Establishing the Defect and Causation
Winning a medical device injury lawsuit requires proving both that the device was defective and that the defect caused your specific harm — not an underlying condition, not a surgical complication unrelated to the device. Your legal team will work with medical experts and engineers to build that causal chain.
Step 3: Individual Lawsuit or MDL
Depending on how many patients have been harmed by the same device, your case may proceed as an individual lawsuit or be coordinated into multidistrict litigation (MDL) — a federal process that consolidates pretrial proceedings across thousands of similar claims while preserving each plaintiff's right to individual damages. MDL is not a class action. Your injury, your medical history, and your recovery are evaluated on their own merits.
Step 4: Resolution
Most medical device cases resolve in settlement, either through individual negotiation or as part of a global MDL settlement program. If a fair resolution cannot be reached, Breit Biniazan is prepared to take your case to trial.
What Compensation May Be Available
Victims of defective medical devices may be entitled to recover:
- Medical expenses for treatment of the device-related injury, including revision surgery costs
- Future medical care and monitoring
- Lost wages and reduced earning capacity
- Pain and suffering
- Permanent disability or disfigurement
- Wrongful death damages for surviving family members
Where a manufacturer's conduct was particularly reckless (concealing known failure rates, falsifying clinical trial data, or paying improper kickbacks to physicians to increase device utilization) punitive damages may also be available. The 2022 case against Biotronik, in which the company paid $12.95 million to resolve False Claims Act allegations involving kickbacks tied to pacemakers and defibrillators, is one example of the type of corporate misconduct that underlies many of these claims.
The FDA and Medical Device Regulation: What You Should Know
The FDA regulates medical devices, but approval does not mean a device is safe — and it does not shield manufacturers from civil liability.
Many high-risk devices enter the market through the 510(k) clearance pathway, which allows manufacturers to bypass full clinical trials by demonstrating that their device is "substantially equivalent" to a device already on the market — even if that predicate device was itself later recalled. Devices cleared through this pathway have not necessarily been independently tested for safety and efficacy.
Even when a device goes through the more rigorous PMA (Premarket Approval) process, post-market surveillance failures, off-label promotion, and concealed adverse event reporting have all led to significant patient harm and successful litigation.
A recall or FDA safety communication about your device is meaningful evidence — but its absence does not mean you lack a claim. Many medical device malfunction lawsuits precede formal recalls, and some manufacturers resist recalls for years.
Statute of Limitations for Defective Medical Devise Cases
Medical device injury lawsuits are subject to statutes of limitations that vary by state — typically ranging from two to four years from the date of injury or the date the injury was discovered. In complex cases where symptoms develop gradually or a connection to a device isn't immediately apparent, the discovery rule may extend your filing window.
Physical evidence also degrades: devices are revised, disposed of, or lost; hospital records become harder to obtain; expert witnesses become unavailable. If you believe a medical device caused your injury, contacting a lawyer promptly is essential to preserving your claim.
Frequently Asked Questions
What if my device has not been recalled?
A recall is not required to bring a lawsuit. Many successful medical device injury lawsuits involve devices that were never formally recalled or were recalled only after litigation exposed the defect.
What if I signed a consent form before my procedure?
Informed consent is not a waiver of product liability rights. You consented to a procedure performed with a device assumed to be reasonably safe. If the device was defective and the manufacturer failed to disclose that, consent does not bar your claim.
What if my doctor recommended the device?
Your physician's recommendation does not insulate the manufacturer from liability. In many cases, manufacturers failed to give physicians adequate information about failure rates and risks. This means that the doctor's recommendation was itself based on incomplete or misleading data.
How long will a medical device lawsuit take?
Individual cases may resolve in months. Large MDL proceedings can take several years, particularly when bellwether trials are needed to establish settlement frameworks. Your attorney should give you a realistic timeline based on the specific litigation landscape for your device.
Contact a Medical Device Lawsuit Lawyer at Breit Biniazan
If you or a loved one was injured by a defective or malfunctioning medical device, Breit Biniazan's attorneys are ready to evaluate your case at no cost. We handle medical device injury lawsuits on a contingency basis — no fees unless we recover for you.
Call (855) 659-4457 or contact us online to schedule your free consultation.
