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Surgical Stapler Lawsuit in 2024 (Latest Updates)

The U.S. Food and Drug Administration (FDA) recently announced a sweeping overhaul of the safety protocol involved with the handling of medical surgical stapler devices, which have been linked to more than 41,000 severe injury reports since 2011.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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What are Surgical Staplers Used For?

Surgical staplers are medical devices used to cut and seal blood vessels and tissue during gynecologic, colorectal, vascular, and gastrointestinal surgery.

According to Kaiser Health News 2019 research, the devices are considered faster and easier to use than traditional nylon sutures and are most useful for rapid wound closure when operating time is of concern [1].

There were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive. Approximately 3.5 million staple reloads were sold in the study period.

The reported misfire rate for Medtronic was 0.04% and for Ethicon was 0.02%. Data for Intuitive was unavailable. The most common reported event for Medtronic was failure to fire (n = 349), followed by misfire (n = 186).

According to this 2022 study by Benjamin Clapp from the Department of Surgery, Texas Tech HSC Paul Foster School of Medicine, El Paso, TX, USA, for Ethicon, the most common event was a failure to fire (n = 146), followed by mechanical problems (n = 27). The most common event with the Intuitive stapler was a leak (n = 10) and bleeding from the staple line (n = 8) [2].

The purported benefit of surgical staples is that they may facilitate surgical incisions by averting wound edges, but many of the devices are allegedly defective, posing a significant health risk to patients treated with the devices.

Universal Articulating Loading Unit

What’s the Problem?

The Food and Drug Administration has received thousands of malfunction reports of surgical staple products misfiring, or failing to fire during use, which have resulted in “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death,” the agency said.

Serious Injuries Associated With Stomach Staplers

According to Kaiser Health News, some of the most commonly reported risks associated with surgical staple products include:

  • Intestinal dysfunction (i.e. diarrhea, constipation)
  • Occlusion of the gastrointestinal tract
  • Organ damage
  • Severe pain
  • Infection
  • Prolonged surgery
  • Bleeding/blood loss
  • Internal bleeding
  • Sepsis
  • Cancer recurrence/fistula formation
  • Death
  • Other serious injuries

Intraluminal Stapler With Adjustable

Surgical Stapler Recalls

Medtronic and Johnson & Johnson subsidiary Ethicon control most of the stapler market in the United States. The two companies produce 4 out of 5 surgical staplers used in U.S. hospitals.

Stapler Manufacturers

  • Covidien (Medtronic)
  • Ethicon US (Johnson & Johnson)
  • 3M
  • B. Braun Melsungen AG
  • Cardica
  • Care Fusion Corporation
  • CONMED
  • Frankenman International
  • Meril Life Science
  • Purple Surgical
  • Smith & Nephew
  • Stryker
  • U.S. Surgical
  • Welfare Medical
  • Reach Surgical
  • Zimmer Biomet

Ethicon Stapler Recall

In August 2019, Ethicon recalled two of their internal surgical staplers which were designed to create connections between structures during gastrointestinal surgeries.

According to the FDA, the Endo-Surgery Curved Intraluminal Stapler and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples reportedly failed to achieve their goals and instead harmed patients.

Misfiring of the medical devices reportedly caused uncut washers and malformed surgical staples to be ejected from the staplers. As a result, surgical staples from these devices could be compromised, the FDA reveals. An investigation of Ethicon’s manufacturing process reportedly traced this issue to a shift in the processes which was in effect from March 2018 to March 2019.

The Ethicon stapler has been previously recalled. Patients may have been harmed by the defective Ethicon staplers. According to the FDA, two patients sustained serious surgical stapler injuries. Both patients reportedly had to have additional portions of their intestines removed during a resection of a smaller portion of the intestines.

Surgical Stapler Lawsuit Updates

May 2023: Depositions in Bell v. Covidien et al. are scheduled to take place through July 2024. To date, no trial has been scheduled and there have been no settlements discussed.

September 2022: Plaintiff Kimberly Bell filed a surgical stapler lawsuit against Covidien and Medtronic in federal court in Massachusetts.

April 2022: A judge in Louisiana dismissed Smith’s lawsuit and canceled a previously scheduled settlement conference.

October 2021: The FDA ordered surgical staplers to be rescheduled from a Class I to a Class II medical device over a growing number of adverse events.

March 2021: Plaintiff Dereck Paul Smith filed a surgical stapler lawsuit against Covidien and Medtronic in Louisiana alleging that the companies’ product failed to properly close and incision.

June 2018: An appellate court reduced Florence Khulman’s $70 million punitive damages award verdict to $19.6 million. A jury originally awarded Khulman $9.8 million in actual damages and $70 million in punitive damages in 2015.

September 2017: Covidien agreed to a surgical stapler settlement of $250,000 and Memorial Medical Center agreed to pay a $5.5 million settlement to widower Ryan Strange for the wrongful death of his wife, April.

FDA Investigation on Surgical Stapler Injury

A review by the FDA, which included at least 7 years of hidden malfunction reports that were not added to the public Manufacturer and User Facility Device Experience (MAUDE) database, stated that:

From January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious surgical stapler injuries, and more than 32,000 malfunctions.

The Food and Drug Administration in March 2019 sent a letter to healthcare providers stating that it is reevaluating the safety of surgical staplers, and may choose to place them in another category which would grant the agency greater authority in testing and restricting the devices.

Kaiser Investigation

A separate investigation conducted by Kaiser Health Network found that in 2016 alone, nearly 10,000 reports of stapler malfunction were submitted to MAUDE. That same year, the database reported less than 100 injuries or malfunctions associated with the devices.

Gastric Staple-Line Failures in Bariatric Surgery

In May 2007, a jury found that a woman’s wrongful death was caused by a defective stapler, manufactured by Ethicon, Endo-Surgery, Inc., a subsidiary of pharmaceutical giant Johnson & Johnson. It was determined that the Ethicon stapler was defective because it failed to form proper staples, allowing her stomach contents to leak into her intestinal cavity. The jury in this case awarded the family of the victim $5 million.

Also read: Nationwide Bariatric Surgery Lawsuit

Complications from Surgical Staplers in Gastric Surgery

Defective surgical staplers used during gastric bypass surgery may cause serious, life-threatening complications and injuries including:

  • Bleeding
  • Dehiscence (separation of areas that are stitched or stapled together)
  • Anastomotic leakage
  • Hernia
  • Hemorrhage
  • Leaks from staple lines
  • Infection(s)
  • Sepsis
  • Re-operation
  • Death

Coping with a Gastric Bypass Complication: Although not readily apparent in most cases, a loved one’s infection, reoperation, death, or other various bariatric injuries may have been associated with surgical staplers manufactured by Ethicon or U.S. Surgical.

Have There Been Any Settlements in Surgical Stapler Lawsuits?

Yes. The largest stapler settlement was nearly $80 million, awarded by a California jury to a former police officer for life-threatening adverse events associated with surgical staplers.

Shortly after Florence Kuhlmann underwent a botched surgery in 2012, doctors found that her bowel had been stapled against her rectal wall. The blockage caused her bowel to rupture causing fistula formation, a life-threatening response to infection.

The problem was blamed on an Ethicon PPH 03 surgical stapler later involved in a recall, according to her attorneys.

The jury awarded her $70 million in punitive damages and $9.8 million in compensatory damages for her Ethicon surgical stapler lawsuit. In 2018, an appeals court reduced the award to $19.6 million, citing prior results for punitive damages.

$5.5 Million Settlement for Surgical Stapler Lawsuits

In 2017, Plaintiff Ryan Strange of Illinois agreed to a $5.5 million settlement with device manufacturers over the death of his wife who suffered injuries from malformed staples in 2013.

The Surgical Stapler Lawsuits named as defendants Memorial Medical Center in Springfield, Ill., the Southern Illinois University School of Medicine’s group practice doctors, and Covidien. All parties agreed to pay a share of the settlement due to the injuries caused.

Covidien agreed to pay $250,000 for the defective stapler.

April Strange bled to death following surgery to remove a noncancerous mass on her liver. The stapler cut a blood vessel but failed to properly close wounds, causing “massive blood loss, cardiac arrest related to the blood loss, and death the same day.”

This risk of patient injuries has been cited as a reason behind surgical stapler recalls in recent years.

The stapler had been disposed of following surgery, and Covidien argued that there was no proof that Strange’s death was a result of defective staplers.

Questions Your Attorney May Ask

How did your surgical stapler malfunction during your procedure?

People filing surgical stapler lawsuits against surgical stapler manufacturers claim the devices malfunctioned during surgery. The most common surgical stapler malfunctions reported to the FDA include misfiring or difficulty in firing, failure of the stapler to fire the staple, and the user applying auto-suture implantable staples to the wrong tissue.

What complications did you experience?

The severe complications linked to surgical stapler malfunctions include torn or damaged internal organs and tissues, sepsis, and an increased risk of cancer recurrence from adjustable height staples. Let your surgical stapler lawyer know if you’ve experienced these or any other serious complications.

When did your serious injuries occur?

Surgical stapler complications can occur during surgery or show up days after the surgery. Be sure to let your attorney know when you first felt symptoms or if you require additional surgeries.

Has the surgical stapler device that was used during your procedure been recalled?

An Ethicon surgical stapler recall has resulted in the removal of more than 3.4 million surgical staplers and other related products. Contact your healthcare providers to find out if the surgical stapler that was used in your procedure has been part of these recalls.

Related Article: Tiger Paw Surgical Staple Recall Lawsuit

See the other medical device lawsuits our attorneys covered so far.

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The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus exclusively on the representation of injured patients in surgical stapler lawsuits. We are pursuing individual litigation nationwide and currently accepting new surgical stapler lawsuits in all 50 states.

Again, if you suffered an injury after being treated with a surgical stapler device, you should contact us immediately. You may be entitled to compensation for your injuries, and our lawyers can help.

References:

  1. https://kffhealthnews.org/news/fda-announces-sweeping-plan-to-review-safety-of-surgical-staplers/
  2. https://pubmed.ncbi.nlm.nih.gov/35281706/

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