Surgical Stapler Lawsuits
The largest surgical stapler lawsuit verdict was $80 million for injuries suffered by a California woman during an operation that nearly killed her. As of 2019, the number of lawsuits is expected to climb in response to 56,000 reports of stapler malfunctions from to a hidden FDA database became public.
Surgical stapler lawsuits claim the devices caused serious internal injuries or death when used in operations.
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.
Attorneys are currently taking new cases. Settlements and verdicts in surgical stapler cases have ranged from $5 million to $80 million.
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.
- 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
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.
- 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
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.
|MANUFACTURER||YEAR||NUMBER RECALLED||PRODUCTS||REASON FOR RECALL|
|Ethicon||2019||92,496||Endo-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.|
|Medtronic||2019||3,113,280||Endo GIA Articulating Reloads with TriStaple Technology||Missing components could affect staple alignment.|
|Medtronic||2018||171,271||Endo GIA "Auto Suture" Universal Articulating Loading Unit||Five people were injured related to missing components that could affect staple alignment.|
|Ethicon||2015||6,744||Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads||Inspections found certain staplers may not insert a full line of staples when fired.|
|Ethicon||2013||57,540||ECHELON 60mm Endoscopic Linear Cutter Reloads Black||Manufacturer 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.
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.
NEW LABELING REQUIREMENTS, April 24, 2019
The agency issued draft guidance for manufacturers on labeling changes for surgical staplers, including proper use and safety hazards.
PUBLIC ADVISORY COMMITTEE, May 30, 2019
The FDA sought expert input on its analysis of all reported injuries.
LETTER TO HEALTH CARE PROVIDERS, June 5, 2019
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.
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 threating 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.
- 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.