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Knowledge, experience, and dedication have brought the lawyers of The Epstein Law Firm to the forefront of their profession. From personal injury to civil litigation, they have built a strong record of success in achieving justice for their clients.
Our practice is diverse and well-established. Recognizing that every case is unique, we always begin by listening to you.
The Epstein Law Firm, P.A. has been successfully representing clients throughout New Jersey since 1973
Medical devices and implants are sold with the promise that they will improve a patient’s life or, at the very least, not make a medical condition worse. However, device manufacturers are often more concerned with their own bottom lines than they are with the health of those who depend on their products. Companies spend millions of dollars trying to get the Food and Drug Administration to approve products before they are truly ready. Unfortunately, too many people become victims of the devices that they thought would help them. Our New Jersey defective medical device lawyers are here to help.
At The Epstein Law Firm, we represent people in Bergen County, Essex County, Passaic County and throughout New Jersey who have been harmed by dangerous and defective medical devices. We also pursue wrongful death claims on behalf of families who have lost a loved one due to a faulty medical device. With decades of personal injury experience, our team has the resources and the skill needed to go up against even the largest and most powerful device manufacturers in America.
If a device that was supposed to restore your health instead left you facing more surgery, more pain, or a new medical problem, this page explains how these claims work in New Jersey: the kinds of devices involved, the ways a device can be legally defective, who may be responsible, what evidence matters most, and the deadlines that can affect your rights. You can also contact our Rochelle Park office online or call 201-231-7847 for a free initial consultation.
From our Rochelle Park office, our dangerous medical device injury attorneys represent clients from across the state who have suffered injuries due to a wide range of products. Devices that commonly appear in injury claims include:
That list is not exhaustive. Almost any implanted or body-worn device can become the subject of a claim if it breaks, degrades, migrates, malfunctions, or causes harm its maker failed to warn about. Joint implants can loosen or shed debris. Hernia and pelvic mesh can erode into surrounding tissue. Cardiac devices can fail to pace or shock correctly, or their leads can fracture. Infusion pumps, catheters, filters, and surgical staplers have all been associated with serious complications. What matters legally is not the brand name but whether the device was defective, whether that defect caused your injury, and whether the warnings and instructions that came with it were adequate for patients and doctors to make informed decisions.
Many people first learn that a device may be dangerous from a news report, a letter from a hospital, a notice from the manufacturer, or a recall announcement. Others learn it from their own surgeon, who finds a failed implant during a follow-up visit or a revision procedure. However you learned of the problem, the questions that follow are usually the same: Is this device really the cause? Who is responsible? And what should you do next to protect both your health and your legal claim?
New Jersey product liability law generally recognizes three kinds of defects. A design defect means the device was dangerous as designed, even when it was made exactly as intended — for example, an implant design that wears out far sooner than patients were led to expect, or a metal-on-metal joint that releases debris into the body. A manufacturing defect means something went wrong in production, so the particular unit you received differed from its intended design — contaminated, weakened, or incorrectly assembled components are examples. A warning defect, sometimes called a failure-to-warn claim, means the manufacturer knew or should have known of a risk and did not adequately warn doctors or patients about it, so the choice to use the device was never truly informed.
Most defective device claims are brought under the New Jersey Product Liability Act, which sets the framework for claims against manufacturers and sellers of defective products. Under that framework, an injured patient generally does not have to prove the company acted carelessly in the ordinary negligence sense; the focus is on the condition of the product itself and the adequacy of its warnings. That distinction matters because a device can be carefully manufactured and still be legally defective if its design created unreasonable risks or its labeling understated them.
Defect alone is not enough. A claim also requires proof that the defect caused actual harm — a failed revision surgery, an infection, organ damage, chronic pain, a dangerous blood condition, or another documented injury — and that the harm led to real losses. Causation in device cases is often the most contested part of the case, which is why medical records and qualified expert review sit at the center of nearly every claim described on this page.
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Many patients assume that because a device reached the market, the Food and Drug Administration must have tested it the way it tests new drugs. That is often not the case. Some higher-risk devices go through the FDA’s premarket approval process, which involves a more searching review. Many other devices reach the market through the 510(k) clearance process, which focuses on whether the new device is substantially equivalent to a device already on the market. Clearance through that route is not the same as a finding that the device is safe and effective, and patients are rarely told which pathway their implant took.
Recalls are another source of confusion. A recall does not always mean a device is physically removed from patients’ bodies; in the device context, a recall can mean a correction, a monitoring program, revised instructions, or removal of unsold units from shelves. The FDA classifies recalls by severity, with Class I being the most serious category, involving a reasonable probability of serious adverse health consequences. Whether your device was recalled is relevant evidence, and our page on FDA guidelines for recalls explains that process in more detail. But a recall is not a prerequisite for a claim: many valid claims involve devices that were never recalled, and a recall by itself does not prove that your particular injury was caused by a defect.
For the same reason, FDA action does not set the timetable for your legal rights. Waiting for a recall, a warning letter, or a study can consume the time New Jersey law gives you to file suit. If you suspect a device harmed you, it is safer to have the legal questions reviewed promptly while the medical questions are still being worked out.
The manufacturer is the usual focus of a device claim, and it may be a very large company with substantial legal resources. Depending on the facts, others in the chain of distribution may also bear responsibility, including companies that designed components, distributors that sold the device, and in some circumstances the entities that marketed it under their own label. Identifying every responsible party requires tracing how the device was designed, made, sold, and delivered to the hospital or clinic where you received it.
A device claim is different from a medical malpractice claim, and the two should not be confused. A malpractice claim alleges that a doctor, surgeon, or hospital fell below the accepted standard of care — for example, by implanting a device incorrectly or failing to respond to signs of failure. A device claim alleges that the product itself was defective or inadequately labeled, even if every clinician did everything right. In some cases both kinds of claims are present, and part of a careful early review is separating what the product did from what any provider did, so that each claim is brought against the right party and under the right legal standards.
We believe strongly that the companies who manufacture these products have a responsibility to all the patients who may use them. Too often, in the interest of profit, manufacturers rush things through development and market devices before they are truly tested. It is our privilege to stand up to these pharmaceutical giants and device manufacturers on behalf of each injured client.
Device problems present differently depending on the product, but patients commonly report a recognizable pattern: pain that returns or worsens after an initial recovery, swelling, instability, clicking or grinding in a joint, reduced range of motion, numbness, infection that does not resolve, unusual test results, or a device that simply stops doing what it was implanted to do. Cardiac patients may experience dizziness, shocks that fire without need, or alarms from home monitoring equipment. Mesh patients may experience pain, recurrence of the original hernia, or signs of infection long after surgery.
None of these symptoms proves a defect, and each of them deserves prompt medical attention regardless of any legal claim. What they should prompt, along with treatment, is documentation. Keep the records of every scan, blood test, and follow-up visit. Ask for copies of your operative reports, which usually identify the device by manufacturer, model, and lot or serial number. If a device is removed in a revision procedure, what happens to it afterward can matter a great deal, which brings us to the single most important practical step in these cases.
In most product cases, the product itself is the best evidence. If your device is scheduled for removal, tell your surgical team — in writing if possible — that you want the explanted device and any removed tissue or components preserved and not discarded or returned to the manufacturer without your authorization. Hospitals and manufacturers sometimes have routine pathways for handling removed devices, and once a device is destroyed, altered, or lost in that process, proving exactly how it failed becomes far harder.
Beyond the device itself, preserve the paperwork that surrounds it: implant cards, stickers from the operative record, discharge instructions, device booklets and warnings, billing statements, and any letters you receive from the manufacturer, the hospital, or the FDA about the product. Photograph visible symptoms where that is appropriate, keep a simple diary of pain, limitations, and missed work, and save correspondence about time off and treatment. Our guide to the steps to take after a defective product injury walks through this preservation process in more detail.
Evidence also includes what experts can learn from records. Device claims typically require engineering and medical expert review to connect a failure mode to an injury. The earlier that review begins, the more options remain open — including, in appropriate cases, coordinated or consolidated litigation involving other patients harmed by the same product, which courts sometimes use to manage large numbers of similar device claims efficiently.
The Epstein Law Firm can review the evidence, insurance issues, and next steps that may matter in your products liability claim.
A successful claim may compensate you for the losses the defective device caused. Depending on the facts, that can include the cost of past and future medical care, revision or removal surgery, rehabilitation, and monitoring; lost wages and diminished earning capacity when the injury limits your work; and compensation for pain, suffering, disability, and the loss of normal activities. When a defective device causes a death, surviving family members may pursue a wrongful death claim for the losses the law allows.
These cases are rarely quick, and honest counsel matters. Device litigation against major manufacturers is document-heavy and expert-driven, and outcomes depend on proof specific to your device, your medical history, and your damages. What a lawyer can promise is not a result but a process: a serious investigation, candid advice about the strengths and weaknesses of your claim, and advocacy aimed at full and fair compensation rather than a fast, discounted settlement.
New Jersey personal injury claims, including product liability claims, generally carry a two-year statute of limitations under N.J.S.A. 2A:14-2, usually measured from when the injury was discovered or reasonably should have been discovered. Device injuries complicate that measurement because harm may develop slowly and the connection to a device may not be obvious at first. Questions about when the clock started are fact-specific, and missing a deadline can end an otherwise valid claim. Do not guess at your deadline; have it calculated from your records.
Our work begins with your medical story: what device you received, when, why, and what has happened since. We obtain and organize the records that identify the product and document your course of treatment, evaluate whether the facts point to a design, manufacturing, or warning defect, and consult appropriate experts where the claim requires them. Device claims are part of our broader product liability practice, which also includes claims involving dangerous and defective products generally and machinery defects.
If you were injured by a dangerous or defective medical product in New Jersey, talk to one of our dangerous medical device injury attorneys in Rochelle Park, NJ about your potential legal claim. Call 201-231-7847 or contact our Rochelle Park office online. We can meet you at your home or in the hospital if your injuries prevent you from traveling to us.
Many patients hesitate because they signed surgical consent forms, and they worry a signature waived their rights. A consent form acknowledges the known risks of a procedure as explained at the time; it is not a release of a manufacturer whose device was defective or whose warnings understated a risk you were never told about. Bring the consent paperwork to your consultation anyway, because what you were and were not warned about is itself evidence in a warning-defect analysis.
Patients also ask whether joining a claim means traveling or testifying about private medical details in public. Device litigation does involve your relevant medical records, and a deposition is possible, but the records at issue are those connected to the device and the injury. A candid early conversation about what the process actually requires — records authorizations, expert evaluation, and realistic timelines measured in months and often longer — lets you decide with full information rather than assumptions.
Finally, patients ask what to do about ongoing care. Never delay medically recommended monitoring, testing, or revision surgery to suit a legal timetable. Treat first, document everything, and let the legal claim follow the medicine; courts and juries understand treatment decisions made for health reasons, and your records of that care become the backbone of the claim.
Our attorneys have recovered substantial verdicts and settlements for clients across New Jersey, including:
Every case is different, and past results do not guarantee a similar outcome. What they do show is the level of preparation and persistence our firm brings to serious claims. Read more about our case results, or call (201) 231-7847 to talk about what your own claim may involve.
Client reviews describe the responsiveness and care our team aims to deliver in every case:
“I had an excellent experience working with George on my workers’ compensation case. He was wonderful—always professional, patient, and incredibly helpful every step of the way. George took the time to explain everything clearly, answered all my questions, and made sure I felt supported throughout the process.” — Eric, Google review
“My case was very complicated and stressful. The Epstein Law Firm’s representation was truly a blessing. They made it easy to be confident and trusting in their judgment and efforts on my behalf. Michael Epstein and his colleagues worked hard for me and always had my best interest.” — Barbara, Google review
Read more from our clients on our Google reviews for the Rochelle Park office.
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The answers below are general information about defective medical device claims in New Jersey, not legal advice for a specific situation. Whether you have a claim depends on your device, your medical records, and the deadlines that apply to you.
A device may be defective in three general ways: its design was dangerous even when made as intended, something went wrong in manufacturing so your unit differed from the design, or the manufacturer failed to adequately warn doctors or patients about a known or knowable risk.
Most New Jersey device claims are evaluated under the New Jersey Product Liability Act, which focuses on the condition of the product and the adequacy of its warnings. You must also show the defect caused your injury, so the legal analysis always runs through your medical records.
Sources: Cornell Law Institute: Products Liability; U.S. FDA: Implants and Prosthetics.
No. Many devices reach the market through 510(k) clearance, which focuses on substantial equivalence to an earlier device rather than an independent finding that the device is safe and effective. Higher-risk devices go through premarket approval, a more demanding review, but approval is not a guarantee against later-discovered defects.
Which pathway your device took, and what the manufacturer disclosed during it, can be relevant evidence. Do not assume that because a device was legally sold, you have no claim — have the device’s history reviewed alongside your records.
Sources: U.S. FDA: 510(k) Clearances; U.S. FDA: Premarket Approval (PMA).
No. A recall is relevant evidence, and the most serious Class I recalls involve a reasonable probability of serious adverse health consequences, but a recall alone does not prove your device was defective or that a defect caused your particular injury.
The opposite is also true: many valid claims involve devices that were never recalled. Do not wait for a recall announcement before seeking advice, because New Jersey filing deadlines keep running while regulators act.
Sources: U.S. FDA: Medical Device Recalls; MedlinePlus: Joint Replacement.
Follow your doctor’s medical advice first — your health comes before any legal consideration. At the same time, ask, in writing if possible, that the removed device and related components be preserved and not discarded or returned to the manufacturer without your authorization.
The explanted device is often the most important physical evidence in the case, because experts can examine how it actually failed. Also keep your implant card and operative reports, which identify the manufacturer, model, and lot or serial number.
Sources: U.S. FDA: Implants and Prosthetics; MedlinePlus: Joint Replacement.
The manufacturer is usually the central defendant. Depending on the facts, responsibility may also extend to companies that designed or supplied components and to others in the chain of distribution that sold or marketed the device under their own label.
Identifying every responsible party requires tracing how the device was designed, made, and delivered to the facility where you received it. That tracing is an early investigative step, because suing only one party when others share responsibility can limit a claim.
Sources: Cornell Law Institute: Products Liability; U.S. FDA: Medical Device Recalls.
A malpractice claim alleges a health care provider fell below the accepted standard of care, for example by implanting a device incorrectly or missing clear signs of failure. A device claim alleges the product itself was defective or inadequately labeled, even if every provider acted properly.
The two claims have different defendants, proof, and expert requirements, and sometimes both are present in the same case. A records review can usually identify whether the problem lies with the product, the care, or both.
Sources: Cornell Law Institute: Products Liability; New Jersey Courts: Civil Division.
Depending on the facts, compensation may include past and future medical expenses, revision or removal surgery and rehabilitation, lost wages and reduced earning capacity, and damages for pain, suffering, and disability caused by the defective device.
If a defective device caused a death, eligible family members may pursue a wrongful death claim for the losses the law allows. Because every case turns on its own records, your specific losses should be evaluated individually rather than by comparison to other cases.
Sources: New Jersey Courts: Civil Division; Cornell Law Institute: Products Liability.
New Jersey personal injury claims generally carry a two-year statute of limitations under N.J.S.A. 2A:14-2. In device cases the starting point often turns on when the injury was discovered, or reasonably should have been discovered, which can be well after the original surgery.
That discovery question is fact-specific, and a missed deadline can bar an otherwise valid claim. Have your deadline calculated from your own records as early as possible instead of estimating it yourself.
Sources: New Jersey Legislature: Statutes; New Jersey Courts: Civil Division.
Keeping the device helps a great deal, because experts can examine its actual failure mode rather than reconstructing it from records alone. If the device was already discarded under a routine hospital or manufacturer process, that does not automatically end the inquiry, but it can make proof harder.
Implant records, imaging, operative reports, and your treatment history remain important evidence either way. Bring whatever you have to a consultation, and ask about preservation immediately if a removal procedure is still ahead of you.
Sources: U.S. FDA: Implants and Prosthetics; U.S. FDA: Medical Device Recalls.
We offer a free initial consultation for defective medical device claims, as stated on this page. At that consultation, an attorney can review what device you received, what happened afterward, and whether further investigation, including expert review, is warranted.
Call 201-231-7847 or contact our Rochelle Park office online to arrange a consultation. If your injuries prevent you from traveling to us, we can meet you at your home or in the hospital.
Sources: U.S. FDA: Medical Device Recalls; New Jersey Courts: Civil Division.
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The Epstein Law Firm
The Epstein Law Firm