If a defective implant or medical device injured you, Georgia product liability law may allow you to seek compensation from the company that made it. The most important steps are to get medical care, keep the device if it is removed, collect records that identify the exact device, and act before Georgia’s deadlines run. Most injury claims must be filed within two years, and product claims also face a 10-year outer limit measured from the device’s first sale.
Medical device cases are different from other injury claims. Federal law can block some claims involving high-risk devices, and a device failure can overlap with questions about how a doctor implanted or monitored it. Knowing how these rules fit together helps you protect your rights early.
Key Takeaways
- Under O.C.G.A. § 51-1-11, a manufacturer can be strictly liable when a product was not reasonably suited to its intended use when sold and that condition caused your injury.
- Most claims must be filed within two years of the injury (O.C.G.A. § 9-3-33), and product claims generally face a 10-year statute of repose from the first sale, with limited exceptions.
- Federal law may preempt some claims about high-risk devices that received FDA premarket approval, but claims based on violations of FDA requirements may still go forward.
- If your device is removed, ask in writing that it be preserved, because it is often the most important evidence.
Examples of Medical Device Failures
Device problems take many forms, including:
- Hip and knee replacements that loosen, wear out early or shed metal, leading to pain and revision surgery.
- Pacemakers and defibrillators that malfunction, fire incorrectly or lose battery power early.
- IVC filters, placed in the inferior vena cava to catch blood clots, that tilt, fracture, move or puncture the vein.
- Surgical mesh that erodes, shrinks or causes infection.
- Pumps, monitors and other electronic devices that deliver the wrong dose or give false readings.
A device failure does not automatically mean the device was defective. Some complications happen even with a well-made product, which is why a careful review of your records and the device itself matters.
Legal Theories in Defective Device Claims
- Design defect: The device’s design made it unreasonably dangerous even when made and used correctly, and a safer design was reasonably available.
- Manufacturing defect: Something went wrong in production, so your device did not match its intended design or specifications.
- Failure to warn: The manufacturer did not give adequate warnings or instructions about known risks. For prescription medical products, Georgia generally looks at the warnings given to your doctor, who acts as the “learned intermediary” between the manufacturer and you.
- Negligence and breach of warranty: Claims that the manufacturer failed to use reasonable care or broke promises about the product.
Georgia’s strict liability statute, O.C.G.A. § 51-1-11, applies to manufacturers of products sold as new. Sellers and distributors are often treated differently, so identifying the actual manufacturer matters.
FDA Approval and Federal Preemption
How a device reached the market can shape your case. Many devices are cleared through the FDA’s 510(k) process, which is based on similarity to devices already on the market. In Medtronic, Inc. v. Lohr (1996), the U.S. Supreme Court held that state-law claims about a 510(k) device were not preempted.
High-risk Class III devices usually go through premarket approval (PMA), a more rigorous review. In Riegel v. Medtronic, Inc. (2008), the Court held that many state-law claims challenging the safety or design of a PMA device are preempted. Claims that “parallel” federal law, such as a claim that the manufacturer did not follow its FDA-approved manufacturing requirements, may still be allowed. Courts do not always agree on where that line falls, so this issue should be reviewed early.
Is It a Device Claim, a Malpractice Claim or Both?
Sometimes the problem is not the device but how it was chosen, implanted or monitored. A claim against a doctor or hospital is a medical malpractice claim with its own rules, including a two-year filing deadline and a five-year statute of repose in most cases (O.C.G.A. § 9-3-71), and an expert affidavit filed with the complaint. Some cases involve both a manufacturer and a medical provider, and each claim must be evaluated on its own deadline.
Steps to Take If You Were Injured by a Device
- Get medical help right away. Report every symptom and ask your doctor whether the device may be involved.
- Preserve the device. If it is removed, ask in writing that the hospital keep it rather than return it to the manufacturer or discard it. Keep a record of who has it.
- Collect identifying information. Your implant card, operative report and hospital records usually list the manufacturer, model and lot or serial number.
- Keep your medical records and bills. They show your condition before and after the failure and link your injuries to the device.
- Report the problem. You or your doctor can report a device problem to the FDA through its MedWatch program.
- Be careful with manufacturer contacts. Before you sign releases or hand over the device, get legal advice.
- Talk to a lawyer promptly. Many device cases are grouped with similar claims in federal court, and deadlines keep running while you wait.
Deadlines and Compensation
Most personal injury claims in Georgia must be filed within two years (O.C.G.A. § 9-3-33). Under § 51-1-11, product claims generally cannot be brought more than 10 years after the device was first sold, although the statute makes exceptions for negligent manufacturing of products that cause a disease or birth defect, conduct showing willful, reckless or wanton disregard for life or property, and the manufacturer’s continuing duty to warn. Read our guide to Georgia personal injury deadlines for more on how time limits work.
A successful claim may include medical expenses, including revision surgery and future care, lost income and pain and suffering. Punitive damages require clear and convincing evidence of willful misconduct or conscious indifference. In product liability cases they are not subject to the usual $250,000 cap, but 75% of the award, less a share of litigation costs and fees, is paid to the State (O.C.G.A. § 51-12-5.1). For claims arising on or after April 21, 2025, Georgia’s SB 68 may also affect how medical expenses are proven.
Frequently Asked Questions
Can I Sue If the FDA Approved My Device?
It depends on how the device reached the market. Claims about devices cleared through the 510(k) process are generally not preempted, while many claims about devices with premarket approval are. Even then, claims based on the manufacturer’s violation of FDA requirements may still be possible.
Does My Device Have to Be Recalled for Me to Have a Claim?
No. A recall can be helpful evidence, but it is not required, and a recall alone does not prove your device caused your injury. What matters is whether the device was defective and whether that defect caused your harm.
How Long Do I Have to File a Defective Medical Device Claim in Georgia?
Generally two years from the injury, and no more than 10 years from the device’s first sale for most product claims, with some exceptions. Because injuries from implanted devices can develop slowly, talk to a lawyer as soon as you suspect a problem.
Should I Return the Device to the Manufacturer?
Not before getting legal advice. The device is often the most important evidence in your case, and testing by the manufacturer could alter it. Ask the hospital in writing to preserve it.
If you were harmed by a defective medical device, The Gunn Law Group can review your situation in a free, no-obligation consultation. There is no attorney fee unless we win, and hablamos español. Call 888-BIG-GUNN (888-244-4866).
