LINX Device Lawsuit Alleges GERD Implant Broke and Failed Due to Manufacturing Defects

A Minnesota man has filed a product liability lawsuit against the manufacturers of the LINX device, alleging that the implant designed to help with management of his gastroesophageal reflux disease (GERD) was defective and broke inside his body, resulting in the need for surgical removal.

The complaint (PDF) was filed by Stephen Tilghman in the U.S. District Court for the District of Minnesota on June 3, naming Torax Medical, Inc. and Ethicon, Inc. as defendants, indicating that the LINX reflux device was defective and failed only a few years after it was implanted in his body.

The LINX device is a small ring of magnetic beads linked by titanium wires, designed to be surgically implanted around the lower esophageal sphincter (LES). Its function is to strengthen the LES to prevent the backward flow of stomach acid, which is the primary cause of acid reflux symptoms and GERD.

The implant was approved for use in March 2012, and FDA records show that there were 9,131 devices in the stream of commerce when a LINX recall was issued in April 2018, after it was discovered that manufacturing problems may cause some of the devices to fail, allowing a bead component to separate from an adjacent wire link while it is inside the body.

According to the lawsuit, Tilghman had a 15-bead LINX reflux management system implanted on December 20, 2018, to help manage his gastroesophageal reflux disease (GERD).

Tilghman claims that the LINX devices were manufactured below FDA-approved standards, citing poor material handling, insufficient quality control, and non-compliance with required manufacturing processes. The lawsuit alleges that due to these defects, Tilghman’s LINX device broke within a few years, necessitating its surgical removal on May 10, 2024.

Specifically, Tilghman‘s lawsuit states that the defect involved an “out of specification condition” leading to a bead component separating from an adjacent wire link. This alleged defect is critical because the integrity of the LINX device depends on the continuous loop of beads and wires. If a bead separates, the device can fail to function as intended, leading to a recurrence of acid reflux and the need for surgical intervention.

Furhtermore, the lawsuit accuses Torax and Ethicon of failing to establish and maintain a quality system adequate to prevent the manufacture of defective devices. This includes alleged failures in inspecting, measuring, and testing both the manufacturing equipment and the materials used in the LINX devices.

LINX Reflux Implant Lawsuits

Tilghman‘s complaint joins nearly a dozen similar LINX device lawsuits filed against Ethicon and Torax since the beginning of 2023.

Late last month, a similar LINX reflux implant lawsuit was brought by a Pennsylvania woman, indicating that her device also failed years after the recall was issued, causing the LINX to break inside her body.

As these devices continue to age, there is a growing concern that more individuals may encounter failures or breaks in their LINX implants, potentially leading to permanent injuries in the future. In response, lawyers are actively investigating these cases, seeking compensation for individuals who have suffered any of the following injuries caused by a defective LINX device;

• LINX device failures (breaks)
• LINX device migration
• Organ punctures or scratches
• Surgical removal of LINX device
• Other injuries caused by LINX failures