Used to close wounds quickly, the staplers misfire, fail to fire, punch holes in the body without injecting a staple, and insert malformed staples. Staples are more popular with doctors than suturing or stitching incisions. Injuries are severe, including:
- Opening of the staple line
- Organ damage
- Fistula formation
“Mishaps like these can be severe or even fatal, especially when a staple is injected into a patient where it should not have been. In many of these cases, a defective stapler or defective staples could have been the root cause of the problem,” says the Shouse Law Group of California. Nearly 80 percent of surgical staplers and sutures used in American hospitals are manufactured by Johnson & Johnson with its subsidiary Ethicon, and by Medtronic with its subsidiary Covidien.
Secret FDA Database
Now is an opportune time for mass tort lawyers to open a practice involving surgical staple injuries. The litigation is in an early stage, and no multidistrict litigation docket (MDL) has been created by the federal courts. The adverse news began to show up at the FDA in 2011, recalls began in 2013, and a California jury awarded $80 million in damages in 2015. The FDA's MAUDE database (Manufacturer and User Facility Device Experience) has found more than 41,000 adverse event reports filed between January 1, 2011, and March 31, 2018. According to this review, surgical staplers have malfunctioned approximately 32,000 times. There have been 9,000 serious patient injuries. More than 350 patients are known to have died as a result of surgeons employing surgical staplers. These numbers represent only what the FDA has publicly admitted. On May 30, 2019, Kaiser Health News reported that an additional 56,000 reports had been submitted over the same time period. However, these reports were never disclosed, nor even made available to the public. The FDA had created an exception for stapler makers to report adverse events in its Alternative Summary Reports database, where it was top secret and not even available to doctors. The program was in effect from 1997 through June 2019, when it was closed. “It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing lawsuit.
Years of recalls
According to the Belluck & Fox law firm, recalls began in 2013:
|Manufacturer||Year||Number Recalled||Products Included||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.|
These recalls covered manufacturing defects, missing components, and failed staples that all had the ability to cause pain, bleeding, leaks, infection, and sepsis throughout the body. They could also cause the need for permanent ostomy bags, antibiotics, additional imaging studies, and even surgery, as well as life-long nutritional deficiencies and life-long digestive issues. The FDA finally warned doctors about reported problems in a letter issued in March 2019.
The FDA’s lack of action and transparency has not held plaintiffs back. A retired San Jose officer was awarded $80 million over a defective stapler in December 2015. A botched hemorrhoid surgery in 2011 nearly killed Florence Kuhlmann. Experiencing severe pain afterwards, she discovered her bowel had been stapled shut against her rectal wall, closing off her intestine. “She was diagnosed with an occlusion,” Kuhlmann’s attorney, Nina Shapirshteyn, said. “Her bowel ruptured, causing a major infection and sepsis. She was really close to death.” It was later determined that the stapler used in the procedure was defective, and the company that manufactured it, Johnson and Johnson subsidiary Ethicon Endo-Surgery, recalled certain models of the device — including the one used on Kuhlmann — later that year. A $5 million settlement was reached on Sep 29, 2017, against surgical device-maker Covidien, Southern Illinois University School of Medicine and an SIU surgeon. The plaintiff was April Ryan, a 33-year-old Charleston woman who bled to death during an elective surgery in 2013. Surgeon Dr. Sabha Ganai used a Covidien surgical stapler during the procedure that cut a blood vessel but failed to properly seal the vessel shut. This led to massive blood loss, cardiac arrest related to the blood loss, and death the same day. Separately, three plaintiffs who say they were seriously injured by Medtronic surgical staplers are sued the company in 2019 for knowingly selling defective devices and intentionally hiding risks from doctors and patients. The three patients had gastrointestinal surgeries in 2017 that required staples to be precisely placed in organs after surgery. The Medtronic staplers allegedly malfunctioned, for example, by creating holes without leaving behind staples or not properly closing implanted staples. Adverse effects included severe infections, cardiac problems, corrective surgeries, and hundreds of thousands of dollars in additional medical expenses.
- Harris County, Texas resident Cynthia Nicholson in her Dec. 20 complaint filed against Medtronic in Hennepin County District Court. Her complaint states, "A reasonable and prudent manufacturer is or should be aware of the risk that if its product is defective, the [surgical] repair it is intended to secure could break loose, causing the contents of an organ undergoing repair to be released into the surrounding area of the body."
- Robert Snyder of Gilman, Iowa, sued Medtronic in Hennepin County District Court on Dec. 24 after experiencing years of negative effects following treatment for stomach pain. Snyder contracted infections and required several surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his small bowel, leading to a serious complication called an anastomotic leak, the lawsuit says.
- Meanwhile, Janet and Randy Adams of Collin County, Texas, filed suit in federal court in the Eastern District of Texas on Dec. 23 alleging that the Medtronic EEA surgical stapler used in a procedure to repair Janet Adams' surgically created stoma misfired and punctured her intestines without engaging the staples.
"Had these incidents been accurately reported, it is highly likely that public notice, FDA scrutiny, and product recalls would have preceded [Janet Adams'] surgery," her lawsuit says, "and … the devices would have been appropriately recalled before being used on [Adams] by her unsuspecting surgeons."