Defective Medical Devices in Georgia: Hip Implants, Pacemakers, and Product Liability

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The path an implanted device took to market shapes which state-law claims over its failure survive. A device that received the Food and Drug Administration’s premarket approval is shielded from state-law claims that challenge its safety or effectiveness, while a device cleared as substantially equivalent to an earlier one is not shielded in the same way. Georgia law then decides whom the manufacturer had to warn and which sale starts the ten-year limit on a claim against the manufacturer.

How the Device Reached the Market

The Supreme Court of the United States described the federal scheme in Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008). The devices receiving “the most federal oversight” are Class III devices, “which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators.” The statute “established a rigorous regime of premarket approval for new Class III devices,” which the Court called “a ‘rigorous’ process”: the FDA “spends an average of 1,200 hours reviewing each application” and grants approval only if it finds “a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.'” A new device “need not undergo premarket approval if the FDA finds it is ‘substantially equivalent’ to another device exempt from premarket approval,” a review “known as the §510(k) process.”

When Federal Law Displaces a State Claim

Federal law provides that no state may establish or continue in effect, for a device intended for human use, any requirement “which is different from, or in addition to, any requirement applicable under this chapter to the device,” and “which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter” (21 U.S.C. 360k(a)).

In Riegel, a catheter that had received premarket approval ruptured during a coronary procedure. The Court held that premarket approval “imposes ‘requirements'” specific to the device and that state tort claims can be such requirements, explaining that state tort law requiring a device “to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme.” It gave a pacemaker example: federal law “would pre-empt a jury determination that the FDA-approved labeling for a pacemaker violated a state common-law requirement for additional warnings.” The Court also stated what survives: the statute “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations,” because such duties “‘parallel,’ rather than add to, federal requirements.”

The result differs for devices cleared through the 510(k) process. As Riegel described Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court there “rejected the manufacturer’s contention that §510(k) approval imposed device-specific ‘requirements,'” and held that the common-law negligence and strict liability claims in that case were not pre-empted. Which path a particular hip implant or pacemaker took is a fact about that device.

The Warning Goes to the Physician

In McCombs v. Synthes (U.S.A.), 277 Ga. 252 (2003), a spinal plate installed during surgery later fractured. The Supreme Court of Georgia described the learned intermediary doctrine: “the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.” Because the manufacturer relied on the doctrine, “the trial court had to conclude that the warning given by Synthes Spine to McCombs’s physician was adequate or reasonable as a matter of law,” so the patient could challenge the adequacy of that warning on appeal.

The Sale That Starts the Ten Years

Georgia’s manufacturer liability statute bars an action brought more than ten years after the first sale for use or consumption of the device that caused the injury (OCGA 51-1-11(b)(2)). In Campbell v. Altec Industries, Inc., 288 Ga. 535 (2011), the Supreme Court of Georgia held that the ten years start when the finished product is sold new to the consumer meant to receive it. It relied on Pafford v. Biomet, 264 Ga. 540 (1994), a case about a metal plate surgically installed in 1988 that had been sold to the hospital years earlier, quoting its “distinction between the individual who initially purchased a manufactured product for mere static retention in his inventory and that individual whose actual employment of the product was ultimately intended.”

Frequently Asked Questions

Is a hospital that implants a device treated as the manufacturer?
Not in a strict liability action, in which an entity that installs a product counts as a “product seller” rather than a manufacturer and cannot be held liable as one (OCGA 51-1-11.1(a), (b)). Whether a hospital is liable on another theory is a separate question.

Does a device sitting in hospital inventory start the ten-year clock?
No. Under Campbell, which relied on Pafford, the period runs from the sale of the finished device, as new, to the patient meant to receive it, so the time a device spends in a hospital’s stock before implantation does not start it (OCGA 51-1-11(b)(2)).

Does the ten-year limit also apply to negligence claims against a device maker?
Yes, with exceptions. The ten-year limitation also governs a negligence action against a manufacturer, except for negligence in manufacturing products that cause a disease or birth defect and for conduct showing a willful, reckless, or wanton disregard for life or property (OCGA 51-1-11(c)).

  • 21 U.S.C. 360k(a)
  • Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008); Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (as described in Riegel)
  • McCombs v. Synthes (U.S.A.), 277 Ga. 252 (2003)
  • OCGA 51-1-11(b)(2), (c); Campbell v. Altec Industries, Inc., 288 Ga. 535 (2011); Pafford v. Biomet, 264 Ga. 540 (1994) (as described and quoted in Campbell)
  • OCGA 51-1-11.1(a), (b)

Disclaimer

This article provides general information about medical device claims under federal and Georgia law. It is not legal or medical advice and does not create an attorney-client relationship. Whether a claim can be brought depends on the device, how it reached the market, the sales, and the specific facts. A person with a failed medical device should seek medical care and consult a licensed Georgia attorney promptly about the particular situation.

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