The LINX reflux management system is a medical device. Some of the LINX device are subject to a recall. The LINX device can injure people per the recall or recent lawsuits.

KBA is a product liability law firm. Our product liability attorneys have litigated hundreds of product liability cases. We have particular experience with medical device cases.

Our medical device attorneys are leading authorities. They teach other lawyers at conferences, publish peer-reviewed articles, and litigate complex cases. We serve in leadership committees and try cases. Our practice includes monitoring recalls like the LINX recall concerning the LINX device.

What is the LINX Device?

The LINX reflux management system is a medical device. The Ethicon LINX device involves laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing. These patients sought an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. They had the LINX device.

The lower esophagus is a hollow, muscular tube that controls the flow of food between your throat and stomach. If the esophagus does not function properly, a variety of medical issues can occur, including GERD. That’s where the LINX device comes into play.

The LINX device is used to treat gastroesophageal reflux disease. The device is composed of a ring of magnetic beads held together by titanium wires. The design resembles a bracelet and is designed to wrap around the lower esophagus sphincter (LES).

The manufacturer designed the LINX device to help regulate the esophagus. It opens and closes a ringlet of magnetic beads that wraps around the esophagus. However, if the LINX device does not function properly, that can lead to recurrence of the original problems. This also creates potential for a whole host of new medical problems. Learn more about the LINX device here:

https://www.stonybrookmedicine.edu/sites/default/files/linx.pdf

Potential Claims from the LINX Recall with a LINX removal

Not all problems with the LINX device are compensable. There are meaningful distinctions between a LINX device that is broken or separated, slipped, eroded, or causing some other complication. One specific mechanism of action at issue is when a bead component separates from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

The FDA approved the LINX device. They recalled the device years later. In a 2018 recall, Defendant Torax noted that many devices suffered from an “out of specification condition”. This condition would allow “a bead component to separate from an adjacent wire link.” Because it is a PMA device and potential claims may be preempted by federal law, only a manufacturing defect claim concerning specific recalled devices may be viable. The LINX device lawsuit is difficult even if the matter concerns a LINX device recall.

The specific product codes included in the LINX device recall are:

• Product Code LXMC-13;
• Product Code LXMC-14;
• Product Code LXMC-15;
• Product Code LXMC-16;
• Product Code LXMC-17

A LINX removal involves surgery to take out a LINX device. If it was one of the ones on this list, it may be eligible for LINX device lawsuit or settlement. The LINX device recall led to several LINX device lawsuits.

Ethicon LINX and Torax LINX Acid Reflux Device Lawsuit

Some patients suffering from a LINX recall device failure filed a LINX device lawsuit. Plaintiffs are suing  Torax Medical, Inc. and Ethicon, Inc. These LINX device lawsuits are complex.

Plaintiffs allege in a LINX device lawsuit that after receiving the LINX device, the GERD recurred. The paitnet suffered a second surgery to remove the failed device and correct the problems.

Plaintiff claims within the LINX device lawsuit allege the device manufacturer produced it in a faulty condition. The defects allegedly violate federal rules the FDA established. These rules come from the Federal Food, Drug, and Cosmetic Act. They keep consumers safe when using medical devices. When companies do not follow the Rules or make mistakes, manufacturing or other defects arise.

These defects could result in malfunction of the device. Malfunctions can cause injury in patients and/or causing the device to simply not work properly. Reports indicate that the LINX devices did not work properly while manufacturers still made them. Users suffered injuries including device migration causing puncturing of organs. These injuries can give rise to a LINX device lawsuit.

Injuries From LINX Device Complications 

If you have received injuries from a defective LINX device, you may be entitled to compensation. Some of the following LINX device complications and recurring injuries include:

• LINX device failures and breaks
• LINX device migration/movement
• Punctures to the organs
• Removal surgery of LINX device

LINX Device Failure Symptoms

When Should You call Your Doctor Concerning a LINX Device?

Next Steps for a LINX Device Removal Patient

More and more people are reporting injuries from the LINX reflux device. At our law firm, we are actively investigating cases where patients have suffered injuries after receiving medical devices. The LINX device is just one of them.

Contact us if you had a LINX device. We will provide a no-cost consultation to see if we can assist.