Bariatric Surgery Lawsuit – How to Bring a Claim

Bariatric surgery lawsuits center on surgical staplers. Surgeons use them in gastric bypass and sleeve gastrectomy. Most target Ethicon staplers. Patients say the staplers were faulty. Some staples did not close. That let stomach fluid leak into the belly.

The claimed harm includes internal bleeding and infection. It also includes extra emergency surgery and death. The FDA recalled some Ethicon staplers in 2019. It later called internal-use staplers higher-risk devices. That came after thousands of injury reports.

No class action or MDL covers these claims today. People who were harmed are filing lawsuits on their own. Some law firms are looking into new cases too. These cases are tied to the recalled staplers.

Latest Bariatric Surgery Lawsuit Updates

October 8, 2021: FDA Moves Surgical Staplers to a Higher-Risk Class

A final FDA order took effect on October 8, 2021 [1]. It moved internal-use surgical staplers from Class I to Class II. That is a higher level of oversight.

The change followed years of device failures, injuries, and deaths. The order also set new labeling rules for makers. It added a premarket-review step meant to catch design flaws earlier. That step applies before staplers reach surgery.

May 30, 2019: FDA Panel Reviews Surgical Stapler Safety

The FDA’s General and Plastic Surgery Devices Panel met in public on May 30, 2019. It reviewed whether to reclassify internal-use staplers, after adverse-event reports kept rising [2].

Panel members weighed the failure and death figures against the staplers’ benefits before the vote. All of them then agreed to back the stricter Class II rule. The agency adopted that rule two years later.

May 15, 2019: FDA Records Ethicon’s Class I Stapler Recall

The FDA’s recall database recorded Ethicon‘s Class I recall on May 15, 2019. The recall (Number Z-1272-2019) covered Endo-Surgery Curved Intraluminal Staplers, including the 25 mm Model ECS25A [3].

A Class I recall is the FDA’s most serious type, reserved for defects that could cause serious injury or death. The FDA recorded the recall’s status as Completed, tied to product code GDW.

April 11, 2019: Ethicon Tells Customers About the Stapler Recall

Ethicon began telling hospitals and distributors on April 11, 2019. It said certain staplers could have a weak firing stroke. That flaw could leave staples not fully formed, as the same FDA recall record describes.

The firm told customers to quarantine the flagged inventory at once. It told them to return it to Stericycle, the firm handling the recall, instead of using it on patients.

March 11, 2019: FDA Alerts Providers to Rising Stapler Reports

The FDA wrote to health care providers on March 11, 2019. The letter flagged a rising number of reports. Those reports were tied to staplers and staples [4].

It told surgeons to review sizing and labeling before each use. The FDA also issued draft labeling guidance for device makers. It urged them to warn against using staplers on dead tissue or near large blood vessels.

What Is Bariatric Surgery?

Bariatric surgery is a group of operations that help people lose weight by changing the digestive system, according to the National Institutes of Health [5]. Some make the stomach smaller. Others change the small intestine.

Surgeons use surgical staplers in these operations. FDA describes internal-use staplers as devices that deliver staples to tissue inside the body during surgery. The lawsuits on this page concern staplers that allegedly failed.

What Is the Bariatric Surgery Lawsuit About?

The lawsuits say Ethicon and other makers sold defective surgical staplers. This includes Medtronic, formerly known as Covidien and U.S. Surgical.

Some staples did not close all the way. Some staplers did not fully puncture tissue. Either flaw can let gastric contents leak inside the body during gastric bypass, sleeve gastrectomy, or another weight-loss surgery.

Plaintiffs raise three main claims. The stapler’s design was flawed. The specific unit was built wrong. Or Ethicon failed to warn surgeons about known misfiring risks. Courts have not yet ruled on these claims.

Ethicon’s own recall notice blamed some problems on an out-of-spec part that could leave staples incompletely formed. That is separate from any single complaint about how a surgery went. Ethicon has not said the flaw caused any one patient’s injury.

The Judicial Panel on Multidistrict Litigation‘s current docket list shows no combined case for these claims [6]. Right now, each lawsuit stands on its own.

Who May Be Affected?

You may be affected if you had one of the weight-loss procedures named above. This matters most if your surgery used an Ethicon or other stapler.

It matters even more if that device falls within the recall’s date window. That window is described in the recall section below.

Relevant signs include a staple-line leak. They also include sudden internal bleeding or an infection at the surgery site. A quick return to surgery after your first surgery counts too.

None of these signs alone proves a faulty stapler caused your problem; confirming that takes a legal review of your surgery and medical records.

Reported Injuries or Damages

From January 2011 to March 2018, the FDA got over 41,000 medical device reports. These covered staplers and staples. The same FDA safety statement cited above lists the count.

Those reports had more than 32,000 malfunctions and over 9,000 serious injuries. They also counted 366 patient deaths. The most common problems were staple-line opening or malformation, misfiring, and difficulty firing.

A 2018 peer-reviewed review looked at bariatric surgery. It found staple-line leaks in about 2 percent of sleeve gastrectomy cases. That is the procedure’s second most common cause of death [7].

Bleeding and stenosis rates changed too, in the same review. They varied based on the stapler cartridge and technique used.

Lawsuit complaints add their own claims. These include emergency surgery, longer hospital stays, and wrongful death. Those claims go beyond the figures above.

Recall and Regulatory Background

The FDA’s May 2019 Class I recall covered specific Ethicon circular staplers. They were made between March 2018 and March 2019. The firm found an out-of-spec part in the devices. That part could keep staples from forming all the way.

Ethicon closed the recall on its own. It used its own return process. That process is detailed in the FDA record above.

A recall does not, on its own, prove that a maker is liable. It also does not mean you qualify for compensation. See Schmidt & Clark’s surgical stapler lawsuit page for more on the recalled models.

Evidence to Preserve

If you plan to file a claim, gather these records before they get harder to find:

• Surgery record: the stapler’s brand, model, and lot number. It should also have the surgeon’s notes on how the surgery went
• After-surgery records: notes on any leak, bleeding, or infection. Include notes on any repeat surgery in the days or weeks after
• Hospital and billing records: proof of any extra care or urgent surgery. This also covers a longer hospital stay tied to your problem
• Communications: messages or call notes with your surgeon or hospital about the problem. Include notes on its cause and any follow-up care
• Photographs: images of the surgery site and cut. Also include drainage or any other visible sign of a problem
• Pay records: proof of wages lost during recovery or while you had follow-up care

Filing Deadlines

Deadlines to file a bariatric surgery lawsuit come from state law. They depend on where you live, when the surgery took place, and when the stapler-related injury was found.

A leak or other injury may surface days or weeks after surgery. Some states start the clock at discovery, not surgery. Missing the deadline can end a claim even with strong facts. Check yours with a lawyer without delay.

Potential Compensation

A stapler claim may cover a few kinds of loss tied to a stapler-related problem. This can include treating a blocked or torn bowel. It can also include medical bills, pain and suffering, and lost wages during recovery.

In a wrongful-death claim, payments may also go to surviving family members under state law. Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation depends on your own case.

Frequently Asked Questions

How Did the FDA Panel Vote on Reclassifying Surgical Staplers?

The FDA panel voted unanimously to move surgical staplers to Class II. It was the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. It met in public on May 30, 2019. The final order came in 2021.

What Does Class II Status Require Before a Stapler Is Sold?

Class II status means a stapler must clear FDA review before it is sold. That review is called a 510(k) premarket notification. The October 8, 2021 order set the rule. It also came with new labeling guidance for makers.

Does a Bariatric Surgery Lawsuit Cover Every Type of Weight-Loss Procedure?

No, a bariatric surgery lawsuit does not cover every type of weight-loss procedure. These claims involve procedures that used a surgical stapler, such as gastric bypass or a sleeve gastrectomy. A weight-loss procedure that did not involve one of the named stapler brands falls outside the claims described here.

Who at the FDA Reported the Injury Figures Behind the Bariatric Surgery Lawsuit?

The injury figures behind the bariatric surgery lawsuit came from a 2019 statement by Jeffrey Shuren, then director of the FDA’s Center for Devices and Radiological Health. His statement counted the reports the agency received from January 1, 2011 through March 31, 2018, the window behind the totals above.

How Fast Did Ethicon Ask Customers to Confirm the Stapler Recall Notice?

Ethicon asked customers to confirm the stapler recall notice within three business days. Its April 11, 2019 letters also said to set the staplers aside and send them back to Stericycle. The FDA recall record describes those steps.

How Do I Find My Stapler in the FDA’s Recall Database?

You find your stapler in the FDA’s recall database under recall number Z-1272-2019, listed as Event ID 82539. Compare the model and lot number in that entry with the ones in your surgery record. A match places your device inside the recall.

References

1. https://www.federalregister.gov/documents/2021/10/08/2021-22041/general-and-plastic-surgery-devices-reclassification-of-certain-surgical-staplers
2. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/surgical-staplers-and-staples
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=171793
4. https://www.fda.gov/news-events/press-announcements/statement-jeffrey-shuren-md-jd-director-fdas-center-devices-and-radiological-health-new-steps-help
5. https://www.niddk.nih.gov/health-information/weight-management/bariatric-surgery/definition-facts
6. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-2-2026.pdf
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC5759613/