If you received a LINX reflux management device from one of the lots recalled in 2018 and later had to have it removed, you may have grounds for a LINX device lawsuit against manufacturers Torax Medical and Ethicon. Individual product liability cases are pending in the U.S. District Court for the District of Minnesota, built on the theory that a manufacturing defect caused the titanium-and-magnet ring to come apart inside patients’ bodies. The first trial is scheduled for May 12, 2028.1AboutLawsuits.com. Lawsuit Over LINX Device Complications Set for Trial in May 2028
Who Is Suing and What They Say Went Wrong
The lawsuits trace back to a Class 2 recall that Torax Medical initiated on April 20, 2018. The FDA determined that a titanium bead could separate from its adjacent wire link because of nonconforming material in a bead component, leaving the ring in a “discontinuous” state and letting reflux symptoms return.2FDA. LINX Reflux Management System Recall Z-2039-2018 The recall covered 9,131 devices from specific manufacturing lots (Lot No. 6100 through 14055 and additional lots), with five separate recall numbers issued on May 31, 2018 for different models and MRI-compatibility configurations.3FDA. LINX Reflux Management System Recall Event
Plaintiffs in the pending cases were implanted with devices from those lots, watched their GERD symptoms come back, and then had to undergo a second surgery to remove the device. They allege the manufacturers shipped a product that did not meet the FDA-approved manufacturing specifications the company was legally required to follow.
The Active Cases
Two individual suits are driving the current docket, both in federal court in Minnesota.
Tilghman v. Torax Medical, Inc. et al (Case No. 0:24-cv-02066) was filed on June 3, 2024. Stephen Tilghman alleges his LINX device, implanted in December 2018, was defectively manufactured, caused his reflux symptoms to return, and had to be surgically removed in May 2024.4Case Filings Alert. Tilghman v. Torax Medical Complaint A July 2024 scheduling order set the case to be trial-ready by May 29, 2026.5PACER Monitor. Tilghman v. Torax Medical, Inc. et al
In February 2026, Janett Wingett of Camano Island, Washington filed a similar suit against Torax and Ethicon. Wingett had her LINX device implanted in August 2018 and surgically removed in December 2025 after a severe recurrence of reflux. She alleges the device came from the recalled lots and was defectively manufactured.6Yahoo News. Camano Island Woman Sues Manufacturer A pretrial scheduling order set jury trial for May 12, 2028, with fact discovery due by July 2027 and expert discovery by November 2027.1AboutLawsuits.com. Lawsuit Over LINX Device Complications Set for Trial in May 2028
There is no consolidated multidistrict litigation for LINX cases at this point. Each case is proceeding individually.
The Legal Theories and Damages
The complaints bring three overlapping claims against Torax and Ethicon:
- Strict liability, on the theory that the device was defective when it left the manufacturer’s control.
- Negligence in the manufacturing, testing, and inspection of the device.
- Negligence per se, based on alleged violations of FDA quality-system regulations at 21 CFR Part 820, the Federal Food, Drug, and Cosmetic Act, and the Medical Device Amendments, with those violations said to breach parallel state-law duties.
Both the Tilghman and Wingett complaints seek compensatory damages exceeding $75,000, plus past and future medical expenses, lost wages, pain and suffering, and physical impairment.4Case Filings Alert. Tilghman v. Torax Medical Complaint6Yahoo News. Camano Island Woman Sues Manufacturer
Why Preemption Is the Central Legal Fight
The LINX device was approved through the FDA’s premarket approval process (PMA number P100049, granted March 2012), not the lighter 510(k) clearance pathway.7FDA. LINX Reflux Management System PMA P100049 That distinction matters. Under the Supreme Court’s 2008 decision in Riegel v. Medtronic, state-law tort claims against PMA-approved devices are generally preempted if they would impose requirements different from or in addition to what the FDA already requires. The narrow exception is for “parallel claims,” where state law imposes a duty identical to an existing federal requirement, such as the duty to follow FDA-approved manufacturing specifications.
The LINX plaintiffs frame their claims as manufacturing-defect cases rather than design or warning cases specifically to fit through that opening. Their argument is that Torax and Ethicon violated their own FDA-approved manufacturing standards, and that state negligence and strict liability law impose the same duty. No dispositive ruling on preemption has issued in the LINX cases so far; they remain in discovery. Federal courts are divided on how much specificity plaintiffs need at the pleading stage, with some circuits demanding detailed links to particular FDA requirements and others letting claims proceed with less granular allegations.
Complications Patients Have Reported
The recalled defect is not the only problem patients have raised. A 2023 analysis of the FDA’s MAUDE adverse event database, covering January 2011 through October 2021, identified 918 patient-related adverse events and 101 device failures tied to the LINX system.8Practical Gastroenterology. Patient-Related Adverse Events and Clinical Device Failures Associated With the LINX Magnetic Sphincter Augmentation Device The most common were difficulty swallowing (275 patients) and painful swallowing (271 patients), followed by recurrence of GERD symptoms (135). Device-specific failures included removal because symptoms returned (61 cases), the ring unexpectedly opening (14 cases), migration from the implant site (7 cases), bead separation (7 cases), and erosion of the beads through the esophageal wall (38 cases). The study’s authors noted MAUDE reports are voluntary and may undercount actual complications. Reoperation to remove the device has been estimated at 3 to 6 percent in larger case series, most often for persistent swallowing difficulty.9SAGES. TAVAC Safety and Effectiveness Analysis – LINX Reflux Management System
The pending lawsuits focus on the manufacturing defect covered by the 2018 recall rather than on complications generally. A patient who experienced dysphagia or erosion but whose device was not from a recalled lot faces a different, and harder, legal path because of the preemption barrier described above.
Where Things Stand
The LINX device is still on the market in the United States and remains actively marketed by Johnson & Johnson MedTech.10Johnson & Johnson MedTech. LINX Reflux Surgery11MedTech Dive. J&J Pulling GERD Device From Global Market12MassDevice. Johnson & Johnson to Pull LINX From OUS Markets
No settlements or verdicts have been reported in any LINX case. The Minnesota cases remain in pretrial proceedings, and the Wingett trial in May 2028 is the earliest date currently on any court’s calendar. If you were implanted with a LINX device from one of the recalled lots and had it removed, the operative records identifying the device serial number and manufacturing lot are the documents a plaintiff’s attorney will want to see first; statutes of limitations for product liability claims vary by state and typically run from when the injury was discovered.