While the general public and medical professionals were kept in the dark over surgical stapler risks, there is no doubt surgical stapler manufacturers knew of issues. Since 2011, they have been allowed to enter surgical stapler incidents into a secret FDA database. As of 2018, there were over 9,000 serious injuries and at least 400 deaths in this database. Stapler manufacturers lost their eligibility to report malfunctions through the hidden system in February 2019, and the FDA pledged to make the data public. Now that the hazards are coming to light, many surgical stapler manufacturers are being sued.
Modern surgical stapling was pioneered by Hungarian surgeon Hümér Hültl in 1908 and later refined by the Soviet Union’s Mark M. Ravitch in the 1950s. After seeing these early prototypes, Leon Hirsch founded the United States Surgical Corporation in 1964 to manufacture and sell surgical staplers in America. After a brief monopoly, Tyco Healthcare entered the market in 1960, and Johnson & Johnson’s Ethicon brand began selling their own staplers in 1977. Tyco purchased competitor USSC in 1998 and changed its name to Covidien in 2007 when the company traded publicly. Today, Covidien (owned by parent company Medtronic as of 2015) is one of the two biggest surgical stapler manufacturers in the United States, which account for 80 percent market share.
In January 2012, Covidien issued a voluntary recall of the Duet TRS Universal Straight and Articulating Single-Use Loading Unit staplers used in thoracic surgery after receiving 13 reports of severe injuries, including three deaths. The staplers were found to “injure adjacent anatomical structures within the thorax.”
In May 2018, Medtronic issued a select recall for Covidien Endo GIA staplers after it was discovered the articulating loading units were missing a sled component, making it unable to deploy staples. Use of the product may lead to bleeding or leakage of luminal components, the field safety notice said. The company received four reports of serious injury before initiating the recall.
A month later, in June 2019, Medtronic issued another recall for the Endo GIA staplers’ single-use loading units after it was found to be missing one of two-pin components necessary to maintain device jaw alignment. The missing pin led to incomplete staple formation, which could cause bleeding, anastomotic leak, peritonitis, and increased risk of sepsis infection. No reports of injury were received prior to the recall, according to Medtronic.
In August 2018, Medtronic issued a recall on EEA Circular Staplers with Tri-Staple Technology due to an incorrect tissue gap. This gap resulted in the incomplete formation of staples and an inability to remove the device from tissue, leading to bleeding, anastomotic leaks, and tissue trauma. Though no reports of serious injury were reported, 1,902 devices were recalled.
Johnson & Johnson (Ethicon)
Johnson & Johnson’s Ethicon division is the other largest surgical stapler manufacturer in the U.S. The Johnson Suture Corp dates back to 1921, which began manufacturing sutures made of sheep intestines. Johnson Suture was renamed Ethicon in 1949 when they began sterilizing animal and silk sutures with a revolutionary atom smasher to produce 10 to 15 percent stronger products. By 1971, they were the world’s leading producer of sutures and began manufacturing wound-closing surgical instruments as well. The first Ethicon surgical stapler was introduced in 1977.
On April 11, 2019, the FDA forced Ethicon to issue a Class I recall (the most serious type of recall) of 92,496 Endo-Surgery Curved Intraluminal Staplers after receiving two reports of very serious permanent injury to patients, which included internal bleeding, suture leaks, bleeding, life-long need for an osteotomy bag, sepsis, and increased risk of death. The patients required additional invasive surgeries following surgical stapler complications. The company discovered an error in the manufacturing process in March 2018, which led to uncut washers and malformed staples causing insufficient stapler firing.
On October 3, 2019, Ethicon announced another recall of 8,256 Echelon Flex Endopath Staplers after seven serious injuries and one death were reported among the affected product codes. An out-of-specification component within the jaw of the device led to malformed staples, which caused increased risk of prolonged surgery, postoperative leaks, hemorrhages, shock, and death.
Other Surgical Stapler Manufacturers
Other stapler manufacturers that may be sued include:
- Intuitive Surgical Inc; Dextera Surgical Inc
- Conmed Corporation
- Smith & Nephew
- Becton, Dickinson and Company
- 3M Company
- Braun Melsungen AG
- Purple Surgical
- Frankenman International LTD
- Welfare Medical LTD
- Reach Surgical, Grena LTD
- Meril Life Sciences PVT LTD
Regardless of the manufacturer, as of June 2019, an FDA panel has recommended that ALL surgical staplers be reclassified from a Class I (Low to Moderate Risk) to a Class II (Moderate to High Risk) medical device, which allows for greater regulation and oversight.
Contact Showard Law Firm To Learn More About Filing A Surgical Stapler Lawsuit
Showard Law Firm is currently taking cases from around the country involving dangerous drugs and defective medical devices, including malfunctioning surgical staplers. Typically, a surgical stapler lawsuit will be filed in the court closest to where the manufacturer resides. Sometimes a number of cases are consolidated together into Multi-District Litigation (MDL) proceedings in a location of the plaintiffs’ choosing – perhaps in a jurisdiction where a majority of the lawsuits have been filed. Contact Showard Law Firm for a free consultation and contingency-based representation that costs you nothing upfront and nothing unless you recover compensation as a result of our efforts.