Defective Medical Device Lawyers in Georgia & South Carolina
Medical devices — from hip and knee implants to surgical mesh, pacemakers, insulin pumps, and diagnostic equipment — are supposed to improve health outcomes. When these devices are defectively designed, manufactured, or marketed, they can cause catastrophic harm: implant failures requiring revision surgery, internal bleeding, organ damage, infection, chronic pain, and even death. The FDA receives hundreds of thousands of medical device adverse event reports annually, and major device recalls affect millions of patients.
At Roden Law, our defective medical device lawyers represent patients throughout Georgia and South Carolina who have been harmed by devices that failed to perform safely. We pursue claims against device manufacturers under strict liability, negligence, and breach of warranty theories. When defective devices cause injury through improper surgical implantation or use, we pursue claims against both the manufacturer and the healthcare provider.
Common Defective Medical Devices
Medical device failures span a wide range of products:
- Joint replacement implants: Hip and knee implants that fail prematurely, release metal ions into the bloodstream (metallosis), or cause bone deterioration — DePuy ASR hip implant and similar metal-on-metal devices have been the subject of massive litigation
- Surgical mesh: Hernia mesh and transvaginal mesh products that erode, contract, or cause chronic pain, infection, and organ perforation
- Cardiac devices: Pacemakers, defibrillators (ICDs), and heart valves that malfunction — including devices with defective leads that fracture or fail to deliver therapy
- Spinal implants: Spinal fusion hardware, artificial discs, and bone growth stimulators that fail or cause nerve damage
- Insulin pumps and infusion devices: Devices that deliver incorrect dosages, malfunction, or fail to alert to dangerous conditions
- Surgical instruments: Power morcellators, robotic surgery systems, and other surgical tools that malfunction during procedures
- Intrauterine devices (IUDs): Devices that migrate, perforate the uterus, or break during removal
Three Types of Medical Device Defects
Medical device claims typically involve one or more of three defect categories:
- Design defect: The device’s design is inherently unsafe — every unit produced has the same dangerous characteristic. For example, a metal-on-metal hip implant design that inevitably generates toxic metal debris
- Manufacturing defect: The design is sound, but a particular unit was improperly manufactured — contaminated during production, assembled incorrectly, or made with substandard materials
- Marketing defect (failure to warn): The manufacturer failed to adequately warn physicians and patients about known risks, side effects, or contraindications
Georgia and South Carolina Product Liability Law for Medical Devices
Georgia’s product liability statute (O.C.G.A. § 51-1-11) provides strict liability for defective products that are unreasonably dangerous. The “learned intermediary” doctrine, recognized in both Georgia and South Carolina, provides that a medical device manufacturer may satisfy its duty to warn by providing adequate warnings to the prescribing physician rather than directly to the patient — making it critical to prove that warnings to physicians were inadequate.
South Carolina recognizes strict liability for defective products under common law, following the Restatement (Third) of Torts. Georgia’s comparative fault rule (O.C.G.A. § 51-12-33) applies, with a 50% bar in Georgia and 51% in South Carolina.
FDA Preemption Challenges
Device manufacturers frequently argue that FDA approval “preempts” (blocks) state law product liability claims. The legal landscape is complex:
- PMA devices: Devices that received FDA Premarket Approval (PMA) have greater preemption protection under the Supreme Court’s Riegel v. Medtronic (2008) decision, though claims based on manufacturing defects and violations of FDA requirements may survive
- 510(k) devices: Devices cleared through the 510(k) “substantially equivalent” pathway receive less preemption protection under Medtronic v. Lohr (1996) — most state law claims can proceed
Our attorneys analyze the specific FDA pathway for each device to craft claims that survive preemption challenges.
Filing Deadlines
Georgia’s statute of limitations is 2 years from the date of injury (O.C.G.A. § 9-3-33) with a 10-year statute of repose. South Carolina allows 3 years (S.C. Code § 15-3-530). For medical devices, the injury may not be discovered until years after implantation — the “discovery rule” may toll the statute of limitations until the patient knew or should have known of the defect.