Defective LINX Device – The LINX Recall
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August 24, 2024
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KBA Attorneys
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August 24, 2024 
KBA Attorneys 
No Comments
LINX is a medical device that is subject to a LINX recall.
The LINX Recall
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.
Our firm focuses on LINX device failures that involve a breaking of the device. For example, it looks like a C instead of a complete O. Learn more about LINX GERD device here.
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
What is the LINX Recall about?
The Linx device is an anti-gastroesophageal reflux implant. FDA approved this device to market in 2012. The device was indicated for patients diagnosed with GASTROESOPHAGEAL REFLUX DISEASE (GERD) as defined by abnormal Ph testing and who had persistent GERD symptoms despite maximum therapy for reflux treatment. The original safety data can be found here: https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100049B.pdf
Torax Medical, Inc. recalled the device in April 2018 due to a possible out of specification condition that could allow a bead component to separate from an adjacent wire link. That would result in a discontinuous or open LINX device. The LINX recall impacted over 9,000 LINX devices.
What LINX products did the recall cover?
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17
| Code Information | a. Product Code LXC-12, Part No. 3718-12, GTIN 00855106005134; b. Product Code LXC-13, Part No. 3718-13, GTIN 00855106005141; c. Product Code LXC-14, Part No. 3718-14, GTIN 00855106005158; d. Product Code LXC-15, Part No. 3718-15, GTIN 00855106005165; e. Product Code LXC-16, Part No. 3718-16, GTIN 00855106005172; f. Product Code LXC-17, Part No. 3718-17, GTIN 0085510 |
|---|
FDA Notices Concerning the LINX device
There were five notices associated with this LINX recall.
![Sort by Recall Class [0-9]](https://www.accessdata.fda.gov/scripts/cdrh/images/arrow_up-black.GIF){kind=icon}
![Sort by Recall Class [9-0]](https://www.accessdata.fda.gov/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
LINX Symptoms
- Persistent heartburn or acid reflux: This is the most common symptom, indicating that the device is not effectively preventing reflux.
- Difficulty swallowing (dysphagia): The device may interfere with swallowing, leading to discomfort or choking.
- Regurgitation of food or liquid: Food or liquid may come back up into the mouth or throat, even after eating small amounts.
- Chest pain or discomfort: This can occur due to irritation or inflammation caused by the device.
- Belching or gas: The device may prevent belching, leading to excessive gas or bloating.
- Nausea or vomiting: These symptoms may be caused by irritation of the stomach or esophagus.
- Coughing or wheezing: This can occur if food or liquid enters the airway.
- Fever or infection: In rare cases, the device may become infected, leading to fever and other symptoms.
Medical Report Concerning a LINX Failure
At KBA Attorneys, now KBD Attorneys, we review scientific literature. We present to you an article concerning the LINX device.
Specifically, a patient had LINX device for five years. They presented to the doctor with persistent dysphagia refractory despite multiple endoscopic dilations. They conducted a barium swallow study, which evidenced a disruption in the LINX device. A surgeon had to remove the LINX device. They found a disruption in the titanium wire connecting two posterior beads. The LINX removal surgery resolved the dysphagia. The full write-up can be found here.
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
- Pain: Pain or soreness in the throat, or increased abdominal pain
- Difficulty swallowing: Difficulty swallowing or an inability to swallow
- Regurgitation: Regurgitation of food and drink
- Coughing: Nighttime cough, wheezing, or shortness of breath
- Fever: Fever above 100.4°F or signs of infection
- Nausea or vomiting: Nausea or vomiting
When Should You call Your Doctor Concerning a LINX Device?
We cannot give medical advice, but we found the following online. This provides information concerning the LINX reflux management system and when to contact a doctor.
“In general, you should contact your doctor if you have:
- Fever topping 100.4 degrees or signs of infection
- Difficulty swallowing or inability to swallow
- Painful swallowing
- Increased abdominal pain
- Nausea or vomiting
- Cough or difficulty breathing”
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. 855-KBA-LAWS (522-5297). We will provide a no-cost consultation to see if we can assist.
Complications and Injuries Linked to the LINX Device
Although the LINX device was intended to help GERD sufferers, it has been associated with serious side effects, including:
- Severe pain and difficulty swallowing (dysphagia)
- Device migration or displacement
- Device erosion into the esophagus
- Esophageal perforation or damage
- Chronic nausea and vomiting
- Inability to eat certain foods
- Need for additional surgery to remove the device
Some patients require emergency surgery due to complications, and in some cases, the damage caused by the LINX device is permanent.
If you or a loved one have experienced these or other side effects, you may be eligible to file a lawsuit.
Is There a Lawsuit Against the LINX Reflux Device?
Yes, some firms are filing lawsuits against Ethicon and Johnson & Johnson for their failure to warn patients and doctors about the risks associated with the LINX device. These cases argue that:
- The company defectively designed the LINX device
- They did not properly test the device before release
- They did not adequately warn about potential complications
- The device caused severe injuries requiring additional medical treatment
Can a Surgeon Remove the LINX Device?
We cannot give medical advice, but we understand surgeons do remove the device. So yes, but removal can be complex and risky. Some patients who have undergone LINX device removal report:
- Scarring and long-term damage to the esophagus
- Persistent pain and swallowing issues
- The return of severe GERD symptoms
- The need for further medical treatment, such as a Nissen fundoplication
If your LINX device has failed and requires removal, you may have grounds for legal action against the manufacturer.
Who Qualifies for a LINX Device Lawsuit?
You may qualify for a lawsuit if:
- You received a LINX Reflux Management System implant
- You suffered severe side effects such as pain, dysphagia, or device migration
- You required additional surgery to remove or correct the device
- The device failed because it broke apart, it went from an O share to a C shape for example.
- You were not properly warned about the risks before implantation
- Even if you are unsure whether your case qualifies, our attorneys can review your medical history and help determine your legal options.
Get a FREE case review today. 855-KBA-LAWS (522-5297)
What Compensation Can You Recover?
Victims of defective medical devices may receive an amount that would cover:
- Medical expenses – Hospital visits, surgery, medication, and ongoing care
- Lost wages – Compensation for time missed from work due to complications
- Pain and suffering – Physical and emotional distress caused by the LINX device
- Future medical costs – Coverage for future treatments and corrective surgeries
- Punitive damages – In cases of gross negligence by the manufacturer, which can be tough to prove
At Ketterer, Browne & Associates, LLC, we fight for maximum compensation for our clients.
How Can KBA Attorneys Help?
Our experienced product liability attorneys are committed to helping victims of defective medical devices seek justice. When you work with us, we will:
- Investigate your case to determine liability
- Gather medical evidence to support your claim
- Negotiate with manufacturers for a fair settlement
- Take your case to court if necessary to secure compensation, which will likely be with other law firms at no additional cost
- We work on a contingency fee basis—you pay nothing unless we recover money for you
Call us today for a free consultation and learn how we can help you: 855-KBA-LAWS (522-5297)
Frequently Asked Questions (FAQs)
1. How do I know if my LINX device is defective?
If you are experiencing severe pain, difficulty swallowing, or other unexpected complications, your device may be defective. Consult with a doctor and an attorney to discuss your legal options. If the device broke apart, if it went from an O share to a C shape for example, that may evidence a product failure.
2. Can I still file a lawsuit if my LINX device was removed?
Yes. If you suffered complications that required removal or corrective surgery, you may have a case. Time is of the essence though. There are also difficult legal issues like preemption at play. We need to know more information, but it is worth investigating.
3. What if my doctor didn’t warn me about the risks?
Manufacturers are responsible for providing adequate warnings about potential dangers. If you were not properly informed, you may have grounds for a failure-to-warn lawsuit. We do not sue doctors in these cases because we believe the device company had information it did not share adequately.
4. How much does it cost to hire a lawyer for a LINX lawsuit?
Our firm works on a contingency fee basis, meaning you pay nothing unless we get money for you. Then we get our expenses back and an attorney fee. Our fee agreement spells it all out for you.
Take Action Today – Contact KBA Attorneys
If you or a loved one has suffered complications from the LINX Reflux Management System, don’t wait to seek legal help. You may be entitled to significant compensation for your injuries and suffering.
Call KBA Attorneys today or fill out our online form for a FREE case review. 855-KBA-LAWS (522-5297).
🔗 Schedule Your Free Consultation
Citations and Resources:
- https://www.stonybrookmedicine.edu/sites/default/files/linx.pdf
- https://houstonheartburn.com/long-term-poorly-understood-linx-complications/
- https://practicalgastro.com/2023/05/08/patient-related-adverse-events-and-clinical-device-failures-associated-with-the-linx-magnetic-sphincter-augmentation-device-a-maude-database-analysis/
- https://ccpatientinfo.org.au/patientinfo/CCLHD%20-%20PID%20Treatemtn%20Options.pdf#:~:text=This%20is%20to%20help%20avoid%20irritation%20to,vomiting%20and%20mild%20irritation%20of%20the%20oesophagus.
- https://www.pectuslab.com/en/post/effects-of-shoemaker-s-breast-on-the-digestive-system#:~:text=This%20condition%20can%20cause%20irritation%20and%20inflammation,Chest%20to%20the%20Patient:%20Potential%20Health%20Risks).
- https://www.facs.org/for-medical-professionals/news-publications/journals/case-reviews/issues/v4n6/09-lippincott-linx/#:~:text=For%20patients%20with%20post%2DLINX%20dysphagia%2C%20chest%20pain%2C,particularly%20high%20in%20those%20with%20persistent%20symptoms.
- https://practicalgastro.com/2023/05/08/patient-related-adverse-events-and-clinical-device-failures-associated-with-the-linx-magnetic-sphincter-augmentation-device-a-maude-database-analysis/#:~:text=Device%20failures%20following%20Linx%20implantation%20are%20detailed,symptoms%20such%20as%20dysphagia%2C%20odynophagia%20and%20GERD.
- https://www.sages.org/publications/tavac/tavac-safety-and-effectiveness-analysis-linx-reflux-management-system/#:~:text=Symptomatic%20outcomes%20and%20the%20ability%20to%20discontinue,vomit%20if%20needed%20was%20better%20following%20LINX.
- https://link.springer.com/chapter/10.1007/978-3-319-14821-2_7#:~:text=Irritative%20voiding%20symptoms%20and%20physical%20signs%20of,that%20adhere%20to%20mucosal%20tissue%20(e.g.%20patches).