LINX Reflux Implant Lawsuit Alleges Device Was Defectively Manufactured, Resulting in Recurrence of GERD and Surgical Removal

Lawsuit stems from a LINX recall announced by the FDA in 2018, due to the risk that the loop of titanium beads in the reflux management system may break inside the human body.

A Pennsylvania woman has filed a LINX Reflux lawsuit against the manufacturers of the acid reflux implant, alleging that the device was defective and broke inside her body, resulting in the need for surgical removal this year.

The complaint (PDF) was filed by Mengying Zhang in the U.S. District Court for the District of Minnesota on May 22, naming the Johnson & Johnson subsidiary, Ethicon Inc., as well as Torax Medical, Inc., as defendants. Torax was the original developer and designer of the device, which was acquired by Ethicon in 2017.

The LINX implant involves a titanium loop of beads and wire surgically implanted around a patient’s lower esophageal sphincter, to help prevent acid reflux. It was approved by the FDA in March 2012, and thousands of the devices have been placed in patients. However, a LINX recall was issued in April 2018, following the discovery that manufacturing problems may cause some of the devices to be at risk of failure, because a bead component may separate from an adjacent wire link while it is inside the body.

According to the lawsuit, Zhang had a 13-bead LINX reflux management system implant in November 2017, to help manage her gastroesophageal reflux disease (GERD).

Although Zhang indicates that the manufacturer owed a duty of care to ensure the medical device was safe, she indicates that her LINX broke and failed more than five years later, requiring her to undergo revision surgery in April 2024. Zhang suffered both the surgical procedure and a return of her GERD symptoms.

In April 2018, Torax issued an urgent field safety notice admitting that the LINX device implanted in Zhang and numerous other individuals was defectively manufactured, indicating that an “out of specification condition” could allow the loop of metal beads to break in some LINX implants.

“This means that the LINX device, normally a continuous loop, would become discontinuous and open due a defect resulting from improper manufacture,” Zhang states in her lawsuit. “FDA records show that there were 9,131 LINX devices in the stream of commerce as of May 2018.”

The complaint is one of about a dozen LINX reflux implant lawsuits filed since at least the beginning of 2023, presenting claims for strict liability for manufacturing defect, negligence, negligence per se, against both Ethicon and Torax. However, as the devices continue to age, additional individuals may experience problems where the LINX implant breaks or fails, potentially causing permanent injuries for additional individuals in the coming years.