Hip and knee implants, surgical mesh, cardiac devices, and dozens of other medical devices are implanted or used in Kentucky patients every day on the promise that they were tested and proven safe. When one of those devices fails because of a design flaw, a manufacturing error, or a warning the manufacturer never gave, the harm is often severe and the recovery is often another surgery. A defective medical devices lawyer builds these cases against the manufacturer directly, using the same regulatory record the FDA relies on to track device safety. These claims move on a different legal track than an ordinary injury case, and the deadlines can run before a patient even realizes the device, not their own body, caused the complication.
A defective medical devices claim arises when a patient is harmed by a device that was defectively designed, defectively manufactured, or sold without an adequate warning about its known risks. Kentucky’s product liability statute, KRS 411.300, defines a product liability action broadly to include harm caused by the manufacture, design, testing, warning, or labeling of any product, and medical devices fall squarely within that framework. One detail that surprises many injured patients is that not every medical device goes through the same level of FDA scrutiny before reaching the market.
The FDA’s device classification system sorts devices into three classes, and most Class II devices reach the market through the 510(k) pathway by showing they are similar to an existing device rather than by undergoing the more rigorous premarket approval process required for higher-risk Class III devices. Kentucky law does create a presumption that a product was not defective if it complied with applicable government or FDA standards, but that presumption can be rebutted, and a defective medical devices lawyer’s job often starts with showing exactly why it should be.
Most patients assume that a failed implant or a serious complication from a device was simply bad luck or an unavoidable risk of the procedure, and manufacturers are rarely in a hurry to suggest otherwise. Once a pattern of device failures emerges, manufacturers and their legal teams typically begin preparing their defense long before individual patients realize their own injury fits that pattern. By the time a patient connects their complication to the device itself, critical evidence, including the specific device model and lot number, can already be difficult to trace.
The steps taken after a defective medical device injury directly affect the strength of the claim. Ask your surgeon or treating physician for the exact make, model, and lot number of the device involved, and request your complete medical records, including operative reports. If the device was removed or explanted, ask the hospital to preserve it rather than dispose of it. Report the adverse event to the FDA’s MedWatch program, and keep records of every complication, additional surgery, or treatment connected to the device. Do not sign anything from the manufacturer’s representative, and do not assume a device failure was simply your own bad outcome, before speaking with a defective medical devices lawyer.
Do not assume your surgeon’s operative note or a hospital’s internal report identifies a defective device. These records are written to document the procedure and your care, not to investigate whether the device itself was the cause of the complication. Forman & Associates issues preservation demands as soon as we are retained, securing the device or its packaging where possible, manufacturer communications, FDA adverse event reports, and prior recall history connected to that specific device.
Device-related injuries range from acute complications like infection, device migration, or fracture to the slow onset of symptoms such as pain, metal toxicity, or tissue damage that develop gradually and are easy to attribute to something else at first. Prompt, thorough medical evaluation and consistent follow-up care protect your health and create the medical record a defective medical devices lawyer needs to connect your specific complications to the device that caused them.
A thorough investigation goes well beyond a single patient’s medical chart. Our firm reviews the device’s FDA regulatory history, including its clearance or approval pathway, any prior adverse event reports filed through the FDA’s MedWatch and MAUDE systems, and whether the device has ever been the subject of a medical device recall. We also examine whether the manufacturer knew or should have known about the risk that caused your injury and whether the warnings provided to your physician adequately disclosed that risk.
At Forman & Associates, we take control of the investigation the moment we are retained. We identify the manufacturer and any other party in the chain of distribution who may share responsibility, build the medical and regulatory record needed to prove the device was defective, and communicate directly with manufacturers and their insurers so our clients are not left navigating a complex, document-heavy process alone.
Metal-on-metal hip implants and certain knee replacement systems have been linked to premature loosening, fracture, and metal toxicity, often requiring painful revision surgery years before the implant was expected to fail.
Surgical mesh used to repair hernias can migrate, contract, or cause chronic infection and adhesion, sometimes requiring additional surgery to remove mesh that was never supposed to fail.
Surgical staplers, pacemakers, defibrillators, and other implanted or surgical devices can malfunction due to design or manufacturing defects, sometimes with catastrophic consequences during or after a procedure.
Transit authorities and private carriers that hire drivers with disqualifying records, fail to conduct proper background checks, or provide inadequate safety training can be held directly liable for their drivers' conduct.
Devices that automatically deliver medication or insulin can cause serious harm when a defect leads to incorrect dosing, unexpected shutoff, or a failure to alert the patient to a malfunction.
Certain breast implants have been linked to rupture, capsular contracture, and other complications requiring additional surgery to address.
Kentucky law entitles patients harmed by a defective medical device to pursue full compensation for every consequence of that injury, and revision surgeries, extended recovery, and long-term complications from a failed device often make these damages substantial.
In a Kentucky defective medical devices lawsuit, recoverable damages typically include:
Future damages are the category most often undervalued when a patient assumes their claim ends with the cost of the corrective surgery. Our catastrophic injury and product liability teams work with medical and biomechanical experts to document the full forward-looking cost of a defective device injury, and when the injury proves fatal, Kentucky law also allows the family to bring a separate wrongful death claim against the manufacturer.
Larry Forman has actually stood before juries and won. That track record is known in Kentucky legal circles — and it changes how the other side negotiates.
The device itself, FDA adverse event reports, and manufacturer communications are time-sensitive. We issue preservation demands from the moment we take your case, before evidence can be lost, discarded, or destroyed.
FDA regulatory pathways, and the manufacturer's own safety record is not an abstract legal concept to our team. It is the framework we navigate for defective medical devices clients every day.
From expert witness retention to pattern-of-misconduct research, we build cases designed to win at trial — not just settle quickly to move to the next file.
You pay nothing out of pocket. Our firm advances all costs, and we only collect if we secure a recovery on your behalf. Zero financial risk to you.
Larry Forman is one of the most-watched legal voices online. He knows how to tell your story — in front of a jury, a judge, or a national audience.
Over $5,000,000 recovered for injured people all over the United States.
Past results do not guarantee future outcomes. Each case is unique.
Kentucky law recognizes three main types of product defects: a manufacturing defect, where the specific device was not made according to its own specifications, a design defect, where the device's overall design creates an unreasonable risk even when made correctly, and a failure to warn, where the manufacturer did not adequately disclose a known risk to physicians or patients. A defective medical devices lawyer investigates which of these theories fits your situation.
Not necessarily. Many devices reach the market through the FDA's 510(k) pathway, which requires showing similarity to an existing device rather than independent proof of safety and effectiveness. Devices that went through the more rigorous premarket approval pathway may face additional legal considerations, but FDA clearance or approval alone does not automatically bar a claim. A defective medical devices lawyer can evaluate how your specific device's regulatory history affects your case.
Kentucky's general statute of limitations for personal injury claims is one year under KRS 413.140. Because device-related injuries can develop gradually and are not always immediately connected to the device itself, when that one-year period begins to run can be a complicated legal question. It is important to speak with a defective medical devices lawyer as soon as you suspect a device caused your injury.
If your device was explanted during a revision surgery, ask the hospital to preserve it rather than dispose of it, since the physical device itself can be important evidence. If preservation was not possible, your medical records identifying the device's make, model, and lot number remain critical to the case.
Yes. A recall does not automatically resolve an injured patient's legal claim, and pursuing your own case is generally necessary to recover compensation for your specific injury, medical expenses, and other losses.
No. Many defective medical devices claims arise after a device has already been removed, replaced, or has otherwise stopped functioning as intended. What matters is whether the device caused you harm, not whether it remains in use.
