LINX Device Lawsuit Set for Trial to Begin in June 2027

Woman was implanted with a LINX device the same year the product was recalled, claiming it failed in 2025 and required removal surgery.

A federal judge has scheduled what could be the first trial involving a lawsuit over LINX device complications, claiming that while the implant was supposed to help control gastroesophageal reflux disease (GERD), design defects caused it to break inside of a patient’s body.

The original complaint (PDF) was filed by Mary Kathleen Colunga, of Florida, in the U.S. District Court for the District of Massachusetts in April. It names Torax Medical Inc., the makers of the LINX Reflux Management System, and Ethicon Inc. as the defendants. Both Torax and Ethicon are subsidiaries of Johnson & Johnson.

According to Colunga, she was implanted with a 13-bead LINX system in November 2018. However, she indicates the device failed and had to be surgically removed in November 2025, arguing that the manufacturer had released a defective device into circulation, as proven by the fact they eventually had to remove the implant from the market.

LINX Implant Concerns

Torax received approval for the LINX system in 2017 for the treatment of GERD among those who did not respond to proton pump inhibitors like Prilosec or Nexium. The device consists of a small ring of magnetic beads held together with titanium wires. It is implanted around the lower esophageal sphincter to help keep stomach acid from seeping back up into the esophagus.  

The U.S. Food and Drug Administration (FDA) issued a LINX device recall in 2018 after reports identified a manufacturing defect that could cause the device’s titanium wire to break.

When the wire breaks, the magnetic beads may detach and migrate to other parts of the body, potentially damaging nearby organs and causing other serious health problems.

Colunga, whose device was affected by the recall, is one of multiple plaintiffs who have filed LINX device lawsuits, each alleging that the implant was defectively designed and manufactured, resulting in serious injuries and complications when the product failed. Former patients argue that the manufacturer knew, or should have known, the device was a risk to recipients and either failed to test the system properly or failed to warn about the risks of breakage.

Defective LINX Implant Trial

On July 10, U.S. Magistrate Judge Elizabeth Cowan Wright issued a pretrial scheduling order (PDF), calling on the parties to prepare Colunga’s case for a jury trial on June 22, 2027. The order includes a series of deadlines for the parties to meet to ensure the case is trial ready in time.

The schedule calls for expert discovery, including any depositions, to be completed by December 15 of this year. All non-dispositive motions will be due by December 29, while dispositive motions have a February 16, 2027, deadline.

The judge anticipates the trial itself will only take three days.

In the complaint, Colunga argues Torax Medical and Ethicon implanted a defectively manufactured LINX Reflux Management System that had already been recalled due to a manufacturing defect, causing a recurrence of severe GERD symptoms and requiring another invasive surgery to remove.

“Specifically, the LINX implanted in Plaintiff was manufactured in violation of the Federal Food, Drug, and Cosmetic Act, the Medical Device Amendments, and federal regulations promulgated under these laws and administered by the FDA.”

— Mary Kathleen Colunga v. Torax Medical Inc. et al.

The lawsuit presents claims of manufacturing defect, negligence, and negligence per se. She seeks compensatory damages for past and future medical expenses, lost wages, physical pain and suffering, mental anguish, physical impairment and physical disfigurement.

LINX Device Lawsuits

Problems with the LINX device were not limited to the United States. The manufacturer also pulled LINX implants from certain foreign markets in September 2025, as concerns about the implants breaking continued to rise.

LINX device lawyers are currently reviewing additional injury claims and pursuing compensation for patients who experienced complications, including:

• The need for revision surgery or removal of the device
• Device breakage or mechanical failure
• Migration of the implant
• Organ punctures or tissue damage

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