Products Liability
Surgical staplers are often used in place of sutures in certain types of surgeries. Unfortunately, many surgical staplers are prone to malfunction resulting in serious injuries to the patient. Surgical stapler injuries include infections, internal bleeding, organ damage and even death.
Hundreds of surgery patients who were injured by a malfunctioning surgical stapler have filed lawsuits against the manufacturer of the stapler and recovered financial compensation. On this page we will look at surgical stapler lawsuits and their potential settlement value.
About Surgical Staplers
Surgical stapler devices have been around since the early 1990s and today they are widely used in a number of surgical procedures. Surgical staplers function much like a paper stapler. The surgeon places tissue to be connected between the stapler jaws, then pulls a trigger and the stapler shoots a staple into place with compression.
Innovations in the manufacturing of surgical staplers have led to the creation of two different types of staplers for specific procedures. The two types of surgical staplers are: (1) Linear Staplers, and (2) Circular Staplers.
These staplers are used in general surgery as well as thoracic surgery, bariatric surgery, and colo-rectal surgery. Most staplers are categorized as either linear or circular. Circular staplers are often used in surgeries of the digestive tract and colon. Linear staplers are used primarily to connect tissues after the removal of organs.
Typically, linear staplers fire two staggered rows of staples from a linear cartridge, which allows the stapler to connect two sections of tissue, after a portion has been cut. A built-in blade then cuts off the overlaying tissue, sealing the new connection.
The main benefit of surgical staplers is that they allow surgeons to staple together tissue inside the body during minimally invasive (laparoscopic) surgical procedures. This makes large incisions unnecessary because the surgical stapler can fit into a small external opening. For this reason, surgical staplers are most frequently used in laparoscopic surgeries.
Surgical Stapler Failures and Malfunctions
Despite their advantages, surgical staplers have a long history of failures, defects and malfunctions. When these events occur, they tend to cause major injuries to the patient. Some of the more common types of surgical stapler malfunctions resulting in injuries include
- Misfires: misfires occur when the mechanism that compresses the staple does not function properly for some reason. This can cause the staples to become disfigured or not properly formed when implanted, resulting in an improper or weak tissue connection or worse.
- Jamming: when the surgical stapler jams during a procedure the device frequently becomes stuck in the patient’s tissue, resulting in major internal damage.
- Missing Staples: one of the most frequent malfunctions with surgical staplers occurs when the device does not fire or insert all of the staples, leaving blank spaces and an unseal incision.
In many cases, the manufacturers promote surgical staplers for use in dangerous situations. In some types of surgery, it can be difficult or impossible to determine how thick the tissue being stapled is. Not knowing means that the surgeon can choose the wrong staple—too small and the area won’t be totally closed, causing leakage or bleeding; too large and the staple can cause more internal damage.
When damage is done, particularly during internal surgery, the patient may appear to be fine for a few days. However, internal bleeding and leakage can cause symptoms such as pain, vomiting, and infection. Doctors must be prepared to address those problems in order to determine the cause.
FDA Adverse Event Reports on Surgical Staplers
The evidence of just how often surgical staplers malfunction can be found in the sheer volume of adverse event reports reported to the FDA through the Manufacturer and User Facility Device Experience (MAUDE) database. During the first decade that surgical staplers were on the market, the FDA received a total of 22,204 adverse event reports, including 112 deaths and 2,180 injuries.
As the use of surgical staplers became more widespread, the number of adverse events and reports of device malfunction skyrocketed. From 2011 through 2018, the FDA received close to 110,000 adverse event reports related to issues with surgical staplers. Of these, 412 were submitted as deaths, 11,181 were submitted as serious injuries, and 98,404 were submitted as device malfunctions.
Injuries Caused by Surgical Stapler Malfunctions
Injuries caused by malfunctioning internal surgical staplers are often very serious and can have permanent consequences, including death. Some of the more common serious injuries related to surgical stapler malfunctions include:
- Damage to internal organs and tissue
- Internal infections
- Abnormal tissue connections between organs and adjacent tissue
- Uncontrolled internal bleeding
- Death (usually from sepsis or internal bleeding)
Who Manufacturers Surgical Staplers?
Surgical staplers are manufactured and sold by various medical device companies. However, 80% of the surgical stapler devices used in U.S. hospitals come from one of two major medical device companies: Medtronic (formerly Covidien) and Ethicon. Ethicon is a wholly owned subsidiary of Johnson & Johnson. Covidien was an independent medical device company until it was acquired by Medtronic in 2014. Other manufacturers include Smith & Nephew, Cardica, Care Fusion, U.S. Surgical, and Reach Surgical.
Surgical Stapler Recalls
Over the years there have been a number of major recalls of surgical stapler devices due to manufacturing and/or design defects that caused significant increases in device malfunctions and patient injuries. Nearly all of these recalls have been initiated by the 2 primary manufacturers of surgical staplers, Medtronic and Ethicon.
| YEAR | MANUFACTURER | # RECALLED | REASON |
| 2019 | Ethicon | 92,000 | Misfiring malfunction caused staples to go too deep and damage adjacent tissue. |
| 2019 | Medtronic | 3,100,000 | Missing component caused staple misalignment. |
| 2018 | Medtronic | 171,000 | Component defect caused staple misalignment resulting in injuries. |
| 2015 | Ethicon | 6,700 | Staplers were prone to firing blanks resulting in missing staples in line. |
| 2013 | Ethicon | 57,000 | Reloading problem causing misfiring and blanks. |
Many of these surgical stapler recalls came only after reports of serious patient injuries or deaths. For instance, in 2019 Medtronic recalled nearly 200,000 staplers after receiving 5 reports of very serious patient injuries related to a manufacturing defect.
Injured Patients Can Bring Surgical Stapler Lawsuits
Patients who have been injured by malfunctioning surgical staplers can bring a surgical stapler product liability lawsuit against the manufacturer and get financial compensation for their injuries. Ethicon, Medtronic, and other surgical stapler manufacturers have a duty to ensure that their stapler products are safe and effective for their intended use. When a stapler device causes serious injuries, it is most likely the result of a device malfunction, design defect, or manufacturing defect that the manufacturer can be held liable for.
Verdicts and Settlements in Surgical Stapler Lawsuits
Over the year, hundreds of injured patients have filed surgical stapler lawsuits and received financial compensation for their injuries. Most of the cases have resulted in confidential settlements so we don’t know how much compensation the plaintiffs received. List below are verdicts in some of the surgical stapler cases that have gone to trial across the country and settlements that were publicly reported.
- Strange v. Covidien (Illinois 2017) $5.5 million: woman bleed to death after Covidien surgical stapler failed to properly seal. Husband agreed to settle for $5.5 million.
- Kuhlman v. Ethicon (California 2016) $79.8 million: plaintiff, a former police officer, underwent surgery during which an Ethicon surgical stapler was used. 3-days after the procedure it was discovered that her bowel had been stapled against her rectal wall. The resulting blockage caused a rupture and a life-threatening sepsis infection. Jury found that the injury was caused by defective surgical stapler and awarded $9.8 million in compensatory damages, plus $70 million in punitive damages. Award was reduced on appeal to $19.6 million.
- Selpec v. Ethicon (Pennsylvania 2007) $5 million: 40-year-old patient underwent gastric bypass surgery. Ethicon endocutter surgical stapler was used during procedure. Surgical stapler did not properly seal tissue resulting in sepsis and death of patient. In wrongful death case, jury found that the surgical stapler was defective and awarded $5 million in damages.