AdvaMed Urges Georgia Court of Appeals to Enforce Sound Science in Ethylene Oxide Litigation

WASHINGTON—AdvaMed, the Medtech Association, the world’s largest medtech trade association, representing over 650 medical technology innovators, has filed an amicus curiae brief in the Walker v. Becton, Dickinson and Company and C. R. Bard, Inc. case now before the Georgia Court of Appeals, urging the Court to reverse a trial court ruling that allowed unreliable expert testimony on ethylene oxide (EtO) exposure.

In its brief, AdvaMed emphasizes that ethylene oxide is a critical, highly regulated sterilization method used to ensure the safety of medical devices relied upon every day by patients and clinicians. Roughly half of all medical devices in the United States are sterilized using EtO, including many complex, heat‑ and moisture‑sensitive products for which no alternative sterilization method exists.

“This appeal raises issues of profound importance for patient safety and access to care,” said Pat Fogarty, Deputy General Counsel & Senior VP of Legal at AdvaMed. “Allowing liability based on an ‘any exposure’ theory—without a proper scientific foundation—threatens the continued availability of sterile, lifesaving medical technologies.”

AdvaMed also cautions that affirming the trial court’s ruling could undermine federal oversight by agencies such as the FDA and EPA, which regulate EtO emissions, occupational exposure, and residual levels on medical devices based on extensive scientific review.

The association urges the Georgia Court of Appeals to reverse the trial court’s decision and reaffirm the judiciary’s essential gatekeeping role in excluding unreliable expert testimony. Doing so, AdvaMed argues, will help ensure that only truly at‑fault parties are held responsible and that essential medical device sterilization practices are not jeopardized without a sound scientific basis.

Read a copy of the AdvaMed amicus brief.  Phil Goldberg of Shook, Hardy & Bacon served as Counsel of Record on behalf of AdvaMed.

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