Malfunctioning surgical staplers manufactured by Johnson and Johnson’s Ethicon unit were recently recalled after at least seven patients were seriously injured and one person died. When these devices fail to operate properly, connection leaks post-operation, hemorrhages, or infection can result. Victims can pursue medical malpractice claims against the surgeon who performed the procedure and product liability claims against Johnson and Johnson.
How Do Surgical Staplers Work
Surgical staplers operate by folding tissue over itself and applying a flat staple to the fold. This may require making a small incision to ensure a proper connection. These biodegradable staples are designed to allow the body to absorb them as the patient heals. However, when a surgical stapler malfunctions it can result in the device insufficiently firing or staples becoming malformed. This can lead to incomplete closure of the wound. Hemorrhage and infection can result. Even when promptly detected, patients can require additional surgery and prolonged recovery to heal from their wounds. In some cases, the hemorrhage or subsequent infection can cost patients their lives.
FDA Recalls Echelon Flex Endopath Staplers
In October 2019, the FDA issued a Class I recall of surgical staplers. The recall covers more than 92,000 Ethicon-manufactured devices. Unfortunately, the recall didn’t come in time to protect the more than 41,000 people that reported adverse events and fatalities stemming from the use of these devices between January 2001 and March 2018. Likewise, the FDA is currently considering proposals to reclassify the surgical stapler from a Class I general control device into a Class II special control device. At this time, Johnson and Johnson and Medtronic support this move.
There are four types of Echelon Flex Endopath staplers that are included in the recall.
- Flex 60 Endopath Stapler
- Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
- Flex 60 Powered Plus Articulating Endoscopic Linear Cutters with either the 44 cm or 34 cm shaft lengths.
While these are the only surgical staplers currently under recall, it is quite possible that the list will grow as increased scrutiny is placed upon devices manufactured by Johnson and Johnson as well as other surgical stapler manufacturers.
Documenting Surgical Injuries
Surgical injuries are common in the United States. It’s estimated that more than 4,000 patients per year suffer serious injuries that never should have occurred. Surgical injuries can include burns, lacerations, infections, wrong-site surgeries, etc. When patients are injured by the negligence or malfeasance of a surgeon or member of the surgical team, patients should thoroughly document the extent of their injuries. This can include medical records, photographs, eyewitness statements, and other documentation that establishes the cause of the injury and those responsible.
Patients or their surviving family members should start documenting their injuries from surgical procedures at the earliest possible opportunity. This helps ensure that evidence doesn’t get lost and that it can be properly preserved to support the claim. In Illinois, patients have two years from the date of injury to pursue a product liability claim. Similarly, they have two years to file a medical malpractice claim from the date they knew or should have known it occurred. This can occur anytime up to four years following the date of the actual injury. Patients should be mindful of these timelines because the courts are likely to dismiss the claim if it is filed after the statute of limitations has expired.
Liability for Surgical Stapler Injuries
The risk of stapler failure and subsequent injury has long been established yet surgeons employed in hospitals and outpatient surgical centers continued to use these staplers. Their decision to use these during surgery negligently placed their patients at risk. At this time, it’s advisable for anyone who underwent surgery in the last half of 2019 to contact their surgeon to determine whether these devices were used during their operation. For individuals who are preparing for surgical procedures in the immediate future, these individuals should verify that the devices will not be used to perform the operation.
When surgical staplers cause serious injury, victims can pursue compensation from a number of parties. Individuals can sue the product manufacturer if the injury is caused by a defective product. This includes component failures that cause the device to malfunction. Manufacturer liability also includes design flaws and faulty manufacturing processes. Manufacturers of defective surgical staplers can be held liable for the pain and suffering, wrongful deaths, and medical expenses associated with the cost of correcting surgical damage, hospitalization, lost wages, etc. Similarly, surgeons, hospitals, and operators of outpatient surgical centers can be pursued for their decision to utilize a device with known defects.