Surgical Stapler Lawsuits

Surgical stapler lawsuits claim that surgical staplers malfunctioned and caused infections, serious injuries such as internal bleeding and organ damage, or death when used in operations. The largest surgical stapler lawsuit verdict was $80 million for a woman who suffered injuries during an operation that nearly killed her.

Last Modified: May 16, 2024
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Latest Surgical Stapler Lawsuit Updates

As of June 2024, Drugwatch’s legal partners are not accepting surgical stapler lawsuit cases. Over the years, however, there have been a few public and confidential settlements as well as jury verdicts against surgical stapler makers.

  • May 2023: The Massachusetts judge in Bell v. Covidien et al. scheduled depositions take place through July 2024. No trial has been scheduled yet and there have been no settlement discussions.
  • September 2022: Kimberly Bell filed a surgical stapler lawsuit against Covidien and Medtronic in Massachusetts federal court.
  • April 2022: A Louisiana judge dismissed Smith’s claim and cancelled a previously scheduled settlement conference.
  • October 2021: FDA issued an order to reclassify surgical staplers from a Class I to a Class II device because of a growing number of adverse events.
  • March 2021: Dereck Paul Smith filed a surgical stapler lawsuit against Covidien and Medtronic in Louisiana after he claimed the company’s stapler product failed to properly close and incision.
  • June 2018: An appellate court reduced Florence Khulman’s $70 million-dollar punitive damages award verdict to $19.6 million. A jury originally awarded Khulman $9.8 million and $70 million in punitive damages against Ethicon 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.

Some of the most recent lawsuits have been against Covidien and Medtronic. Because surgical stapler lawsuits have been filed in courts across the country and have not been consolidated into multidistrict litigation in a single court, it’s difficult to tell how many lawsuits are pending across the country.

Why are People Filing Surgical Stapler Lawsuits?

Surgical staplers, which are sometimes preferred to sutures for minimally invasive surgeries, can cause serious injuries by firing malformed staples into organs or other tissue in the body. Defective staplers may not fire all staples necessary to bind an incision, causing bleeding or leaving an incision unsealed.

The risk reclassification of these devices, product recalls and media reports about stapler malfunctions being hidden from the public are likely to drive an increase in surgical stapler lawsuits.

Settlements and verdicts in surgical stapler cases have ranged from $5 million to $80 million. As of June 2024, there have been no recent updates on these cases.

Surgeons using surgical stapler during surgery

Injuries Claimed in Lawsuits

Surgical stapler lawsuits claim that malfunctioning devices caused severe injuries and prolonged surgery and may have required further surgical procedures. Some lawsuits claim faulty medical staplers resulted in patients’ deaths.

Serious Injuries Caused by Surgical Staplers & Staples

  • Torn or damaged internal organs and tissues
  • Sepsis, a potentially fatal reaction to infection
  • Increased risk of cancer recurrence
  • Fistula formation, an abnormal connection between organs or other tissue in the body
  • Death
  • Bleeding

Source: U.S. Food and Drug Administration, May 8, 2019

Manufacturers and Surgical Stapler Recalls

Medtronic, which acquired Covidien in 2014, and Johnson & Johnson subsidiary Ethicon control the vast majority of the surgical stapler market in the United States. The two companies produce 4 out of 5 surgical staplers used in American hospitals.

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

Manufacturing Defects Led to Recalls

Medtronic and Ethicon products account for some of the largest surgical stapler-related recalls in recent years. The two companies combined have recalled more than 3.4 million staplers, staples and components since 2013.

Recent Surgical Stapler & Staple Recalls
Ethicon201992,496Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples

Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
Two patients were injured after devices misfired, cutting portions of their rectums.
Medtronic20193,113,280 Endo GIA Articulating Reloads with TriStaple TechnologyMissing components could affect staple alignment.
Medtronic2018171,271Endo GIA "Auto Suture" Universal Articulating Loading UnitFive people were injured related to missing components that could affect staple alignment.
Ethicon20156,744Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White ReloadsInspections found certain staplers may not insert a full line of staples when fired.
Ethicon201357,540ECHELON 60mm Endoscopic Linear Cutter Reloads BlackManufacturer identified a potential for reload damage that would prevent a complete line of staples firing.

Medtronic reported at least five people injured prior to a May 2018 recall. The companies often found manufacturing defects that could cause injuries.

In a 2019 recall of more than 3 million TriStaple reloads, Medtronic reported that a missing component had the potential for staples to fail, leading to “bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.”

Other defects leading to recalls had the potential to cause bleeding or the leaking of intestinal contents into surrounding body parts.

Surgical Stapler Risks Were Underreported for Years

Medical device manufacturers are required to report serious injuries and deaths related to the use of their products to the U.S. Food and Drug Administration. The FDA maintains a public database of reported medical devices problems. But the majority of surgical stapler complications reported between 2011 through 2018 were submitted to a hidden database.

While 41,000 malfunctions were reported to the public database, another 56,000 were concealed from public view. Among the 41,000 public reports, there were at least 366 deaths and more than 9,000 serious injuries related to surgical staplers in that eight year period. When reports from both databases were combined, the number of deaths rose to 412, and injuries rose to 11,181.

In 2016 alone, the FDA posted fewer than 100 stapler-related injury reports to the public MAUDE database. But nearly 10,000 reports were hidden from the public as so-called “alternative summary” reports, according to Kaiser Health News.

FDA Takes Action

When Kaiser Health News reported on the secret database in 2019, the FDA took quick steps to release the hidden reports and tighten regulations around surgical staplers.

FDA Actions on Surgical Staplers
  • TOUGHER REGULATION, April 24, 2019
    The FDA proposed reclassifying surgical staplers from low-risk to moderate-risk devices, which would impose a stricter approval process.
    The agency issued draft guidance for manufacturers on labeling changes for surgical staplers, including proper use and safety hazards.
    The FDA sought expert input on its analysis of all reported injuries.
    The FDA sent out a letter to doctors, hospitals and others who routinely use surgical staplers. It warned about the high number of deaths and injuries related to staplers and provided recommendations to prevent patient injuries.
Show More

Verdicts and Settlements in Stapler Lawsuits

The largest surgical stapler verdict was nearly $80 million awarded by a California jury to a former police officer for life-threatening injuries from a defective stapler.

Three days after Florence Kuhlmann underwent surgery in 2012, doctors found her bowel had been stapled against her rectal wall. The blockage caused her bowel to rupture causing sepsis, a life threatening response to infection.

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

The jury awarded her $70 million in punitive damages and $9.8 million in compensatory damages. In 2018, an appeals court reduced the award to $19.6 million, citing a “constitutional maximum” for punitive damages.

$5.5 Million Settlement for Stapler-Related Death

In 2017, Ryan Strange of Illinois agreed to a $5.5 million settlement over the death of his wife due to a surgical stapler injury in 2013.

The lawsuit named 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.

Covidien agreed to pay $250,000 as its part of the wrongful death lawsuit. Medtronic acquired Covidien in 2014.

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 seal it, causing “massive blood loss, cardiac arrest related to the blood loss, and death the same day.”

This risk 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 a defect in its product.

Potential Compensation for Surgical Stapler Injuries

Surgical stapler injuries can be serious or even deadly. They can cause people to be incapacitated for long periods of time or cost families their loved ones. People can seek compensation for both past and future injuries from these devices.

Past and Future Compensation in Surgical Stapler Lawsuits

  • Medical expenses
  • Funeral expenses for deaths resulting from stapler injuries
  • Pain and suffering, both physical and mental
  • Lost wages
  • Loss of earning capacity
  • Loss of enjoyment of life
  • Punitive damages to punish the manufacturer

People considering filing a surgical stapler lawsuit may wish to consult a lawyer who specializes in medical device cases. These types of lawsuits can be complex and involve issues of medicine, engineering and manufacturing as well as product liability law.

Please seek the advice of a medical professional before making health care decisions.