GERD Implant Lawsuit Alleges Defective LINX Failed After Surgery

Lawsuit claims a manufacturing defect caused the LINX implant to fail, resulting in the return of severe GERD symptoms.

A Texas woman has filed a product liability lawsuit alleging she received a defective LINX implant that had already been included in a recall months before her surgery.

The complaint (PDF) was brought by Cheryle Barbisch in the U.S. District Court for the District of Minnesota on September 29, naming Torax Medical Inc. and Ethicon Inc. as defendants.

Barbisch argues her LINX device was manufactured by Torax and Ethicon outside the U.S. Food and Drug Administration’s (FDA) approved specifications and Current Good Manufacturing Practice requirements, and that the companies failed to prevent defective devices from reaching patients.

LINX Reflux Device Problems

LINX Reflux Management Systems are small rings made of magnetic beads connected by titanium wires, which are surgically placed around the lower esophageal sphincter to reinforce the muscle and reduce the backward movement of stomach acid associated with gastroesophageal reflux disease (GERD).

The FDA approved the LINX system in March 2012, but subsequent reports raised concerns about device failures that could allow components to separate, potentially resulting in migration, organ damage and additional medical complications. A LINX recall was initiated in 2018 after a manufacturing problem was identified that could cause a bead to separate from an adjoining wire.

Barbisch’s complaint now joins a number of LINX device lawsuits filed in courts nationwide, which raise allegations that manufacturing and design problems caused the implants to fail, exposing recipients to preventable health risks.

LINX System Failure Allegations

According to the complaint, Barbisch underwent surgery to receive a LINX implant on August 28, 2018. However, the device she was implanted with was allegedly subject to the May 2018 recall, which identified an “out of specification condition” that could allow a bead to separate from an adjacent wire link. This could potentially cause the normally closed LINX ring to become discontinuous or open.

Barbisch claims the implant subsequently failed because of this manufacturing defect, resulting in a severe recurrence of her GERD symptoms. She ultimately underwent another surgery in August 2026 to have the LINX removed.

The filing argues that Barbisch’s LINX implant was manufactured outside FDA-approved specifications and Current Good Manufacturing Practice requirements. It claims Torax and Ethicon failed to adequately control manufacturing, inspect and test devices and prevent nonconforming implants from reaching patients.

“Defendants Torax Medical, Inc. and Ethicon, Inc. manufactured a defective medical device such that Plaintiff suffered significant injury.”

— Cheryle Barbisch v. Torax Medical Inc. et al.

The lawsuit raises allegations of strict liability, negligence and negligence per se against both defendants. It seeks damages for past and future medical care, lost wages, physical pain and suffering, mental anguish, physical impairment and disfigurement.

LINX Implant Lawsuits

Barbisch’s complaint is among a growing number of similar LINX implant lawsuits being pursued in the District of Minnesota, where Torax Medical is headquartered and the reflux device was initially developed.

Lawyers handling LINX implant claims expect additional lawsuits to be filed as more individuals experience device failures and learn that problems with their implants may be linked to an alleged manufacturing defect.

Attorneys are continuing to evaluate potential LINX lawsuits on behalf of individuals seeking compensation for injuries or complications involving:

• Device failures
• Migration and organ punctures
• Need for additional revision surgery to remove a failed device

Product liability lawyers pursue LINX reflux system claims on a contingency fee basis, meaning individuals pay no legal fees or expenses unless a settlement or other financial recovery is obtained.

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