LINX Device Failure Lawsuit Claims Manufacturing Defect Caused Severe GERD Symptoms to Return

Implants were recalled eight years ago after reports that device wires holding a string of titanium magnets in place could break.

A California man is pursuing a product liability lawsuit against the manufacturers of the LINX implant, alleging that the medical device was defectively designed and failed.

The complaint (PDF) was brought by Abner Betech in the U.S. District Court for the District of Minnesota on November 4, naming Torax Medical Inc. and Ethicon Inc. as defendants.

Betech’s lawsuit accuses the manufacturers of putting a defective and dangerous device on the market without providing adequate warnings about the risks of mechanical failure. Now, he is left to decide whether to undergo additional surgery to remove the broken device.

Torax LINX Failures

The Torax LINX system is an implantable device designed to treat gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus, causing chronic heartburn and other complications. First approved in 2012, the device consists of a ring of magnetic titanium beads connected by small wires.

During surgery, the LINX device is placed around the lower esophageal sphincter, where the magnetic beads are intended to help keep the passage between the stomach and esophagus closed to prevent acid reflux, while allowing it to open when swallowing food or liquids.

However, reports of LINX device failures have raised concerns that the connecting wires can break, allowing the magnetic beads to separate and potentially migrate from their intended position. These failures can cause difficulty swallowing, persistent pain and other serious complications, often requiring additional surgery to remove the defective implant.

In May 2018, Torax Medical announced a LINX recall after identifying a manufacturing defect that could cause the magnetic beads to separate. The U.S. Food and Drug Administration (FDA) classified the action as a Class II recall, affecting 9,131 devices distributed in the United States and internationally, including models containing between 12 and 17 magnetic beads.

Torax instructed medical facilities to quarantine and return unused devices affected by the recall, while physicians were advised to monitor patients who had already received the implants.

Following the recall, recipients began filing LINX device failure lawsuits against Torax Medical and Ethicon, alleging that defects in the implant caused magnetic beads to separate, resulting in painful complications, device failures and the need for additional surgery to remove or replace the implant.

LINX Device Failure Allegations

According to the lawsuit, Betech underwent surgery to receive a LINX implant in October 2017. The device has since allegedly failed, although Betech has not yet undergone surgery to have it removed.

The complaint alleges that Torax failed to comply with FDA manufacturing requirements, allowing a defective LINX device to enter the market and be implanted in patients despite posing an unreasonable risk of injury.

“Plaintiff alleges that Defendants Torax and Ethicon manufactured the LINX which was implanted in Plaintiff and subsequently failed due to a manufacturing defect. Plaintiff alleges that Defendants Torax and Ethicon placed Plaintiff’s LINX device into the stream of commerce. Plaintiff alleges that Defendants Torax and Ethicon are corporations who regularly design, test, assembly, manufacture, sell, and distribute medical devices intended for human use.”

– Abner Betech v. Torax Medical Inc. et al.

The lawsuit presents claims of manufacturing defect, negligence and negligence per se. It seeks punitive and compensatory damages.

Torax LINX Lawsuits

Torax LINX lawsuits, including Betech’s complaint, are being filed directly in the U.S. District Court for the District of Minnesota, where Torax Medical is headquartered.

Attorneys continue to investigate potential LINX lawsuits on behalf of individuals who received the recalled implants and experienced serious complications, including:

• Device failures: Broken connecting wires or separation of the magnetic beads.
• Device migration and organ damage: Displaced components that may cause tissue damage, perforations or other internal injuries.
• Revision or removal surgery: Additional procedures required to remove or replace a failed LINX implant.

LINX lawsuit attorneys are offering free consultations and case evaluations to help individuals determine whether they may qualify for financial compensation through a LINX reflux lawsuit or settlement involving injuries caused by an allegedly defective implant.

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