Table Of Contents
- What are Surgical Staplers Used For?
- What’s the Problem?
- Surgical Stapler Injuries
- Surgical Stapler Recalls
- Ethicon Stapler Recall
- FDA Investigation on Surgical Stapler Injury
- Kaiser Investigation
- Gastric Staple-Line Failures in Bariatric Surgery
- Complications from Surgical Staplers in Gastric Surgery
- Have There Been Any Lawsuit Settlements?
- Questions Your Attorney May Ask
- Get a Free Surgical Stapler Lawsuit Evaluation With Our Lawyers
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. The devices are considered faster and easier to use than traditional nylon sutures, and most useful for rapid wound closure when operating time is of concern. The purported benefits of surgical staples is that they may facilitate surgical incisions by averting wound edges, but many of the devices have been found to be allegedly defective, posing a significant health risk to patients treated with the devices.
What’s the Problem?
The Food and Drug Administration has received thousands of reports of stapler devices 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.
Surgical Stapler Injuries
Some of the most commonly reported injuries associated with malfunctioning Ethicon surgical staplers include:
- Intestinal dysfunction (i.e. diarrhea, constipation)
- Occlusion of gastrointestinal tract
- Organ damage
- Severe pain
- Prolonged surgery
- Bleeding/blood loss
- Internal bleeding
- Cancer recurrence / fistula formation
- And more
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.
- Covidien (Medtronic)
- Ethicon US (Johnson & Johnson)
- B. Braun Melsungen AG
- Care Fusion Corporation
- Frankenman International
- Meril Life Science
- Purple Surgical
- Smith & Nephew
- 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.
Ethicon stapler has been previously recalled. Patients may have been harmed by the defective Ethicon staplers. According to the FDA, two patients sustained serious injuries in connection to the surgical staples. Both patients reportedly had to have additional portions of their intestines removed during a resection of a smaller portion of the intestines.
FDA Investigation on Surgical Stapler Injury
A review by the Food and Drug Administration, which included at least 7 years of hidden reports that were not added to the public Manufacturer and User Facility Device Experience (MAUDE) database, found 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 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.
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:
- Dehiscence (separation of areas that are stitched or stapled together)
- Anastomotic leakage
- Leaks from staple lines
Coping with a Gastric Bypass Complication: Although not readily apparent in most cases, a loved one’s infection, re operation, death or other various bariatric injuries may have been caused by a defective surgical stapler manufactured by Ethicon or U.S. Surgical.
Have There Been Any Lawsuit Settlements?
Yes. The largest stapler settlement was nearly $80 million, awarded by a California jury to a former police officer for life-threatening adverse events caused by a stapler malfunction.
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 Stapler-Related Death
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 lawsuit 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.
Related article: Tiger Paw Surgical Staple Recall Lawsuit
See the other medical device lawsuits we’ve taken on.
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 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 required 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 health care providers to find out if the surgical stapler that was used in your procedure has been part of these recalls.
Get a Free Surgical Stapler Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our 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 medical malpractice cases 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.