Lawsuit Alleges Recalled Torax LINX Failed, Resulting in Surgical Removal of Acid Reflux Device

A Texas woman has filed a product liability lawsuit over the Torax LINX acid reflux device, indicating that the esophageal implant placed in her body to treat gastroesophageal reflux disease (GERD) was defective and failed, causing a resurgence of her symptoms, and the need for additional revision surgery to remove device.

The complaint (PDF) was brought last month by Terri Lynn Rubin in the U.S. District Court for the District of Minnesota, pursuing damages from the acid reflux device manufacturers Torax Medical, Inc. and Ethicon, Inc., who were named as the defendants.

The LINX device is a small ring of magnetic beads linked by titanium wires, which is designed to be surgically implanted around the lower esophageal sphincter (LES). While it is marketed as a treatment option to help strengthen the LES and prevent the backward flow of stomach acid, which is the primary cause of acid reflux symptoms and GERD, there have been growing reports of severe complications experienced when the Torax LINX failed, when the bead components detached from the connecting wire.

Torax LINX Failed One Year After It Was Implanted

The FDA approved the LINX device in March 2012, there were at leats 9,131 of the implants 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, resulting in reports of the device migrating, puncturing organs and causing other injuries.

As a result of the complications, nearly a dozen LINX lawsuits have been filed in recent years, often involving failures that occurred years after the acid reflux implant was placed in the body. However, complaints have also been filed by individuals like Rubin, who received the device years after the recall was issued.

Rubin indicates in the lawsuit that she had a 13-bead LINX implanted in September 2022, and the device failed about a year later, resulting in the need for it to be surgically removed in December 2023.

In addition to having to undergo additional surgery, Rubin also indicates that the Torax LINX failure resulted in a return of the GERD symptoms the device was supposed to prevent.

“Plaintiff alleges that Defendants Torax and Ethicon manufactured the LINX which was implanted in Plaintiff and subsequently failed due to a manufacturing defect,” Rubin’s lawsuit states. “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. The device implanted in Plaintiff was manufactured in deviation from the manufacturing specifications approved by the FDA and provided by Defendant Torax for its pre-market approval.”

Rubin presents claims of manufacturing defect, strict liability, negligence, and negligence per se.

LINX Reflux Implant Lawsuits

The complaint filed by Rubin will join a number of similar lawsuits already pending in the U.S. District Court for the District of Minnesota, which is the state where the headquarters are located for Torax Medical, which originally devolved the device.

As Torax LINX implants continue to age and fail, there are growing concerns that more individuals may encounter issues where the implants break, potentially leading to permanent injuries in the future. As a result, LINX injury lawyers are actively investigating these additional cases as they arise, 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