A product liability lawsuit has been filed against Covidien and Medtronic, two manufacturers of surgical staplers, after their product caused the need for additional surgery and a severe case of sepsis in a patient.
This lawsuit was filed just days after the U.S. Food and Drug Administration (FDA), issued new guidelines that are aimed at improving surgical stapler safety. Issues with surgical staplers have been known about for years, and these problems have only been getting worse. If you were injured or suffered sepsis after receiving surgical staples, you may be entitled to compensation via a product liability, or class action lawsuit. The surgical error lawyers at McEldrew Young will fight for you and your family.
Surgical Stapler Lawsuit
According to this recent lawsuit, the plaintiff underwent surgery for diverticulitis and the removal of a mass from his colon. Following the surgery, his heart rate became elevated and he began to run a high fever. He was then diagnosed with sepsis and had to undergo emergency surgery.
During surgery, his doctors discovered he had what is known as an anastomotic leak. Anastomosis is a surgical connection between two structures, such as when two ends of a loop of intestine are stapled or sewn together. The anastomotic leak that the victim had was caused by “non-functional staples”, and resulted in numerous additional surgeries.
Common Problems With Surgical Staplers
The FDA has released information on common surgical stapler issues, stating that the most common problems are:
- Opening of the staple line
- Malformation of staples
- Staplers misfiring
- Staplers being too difficult to fire
- Staples failing to fire
- Staples that are misapplied (such as applying staples of the wrong size)
Complications of Surgical Stapler Malfunctions
When a surgical stapler malfunctions, it can lead to additional surgeries, or a prolonged surgical procedure. In addition, a surgical stapler malfunction can cause complications, such as:
- Formation of a fistula
- Tearing of internal organs or tissues
- Increased risk of recurring cancer
Sepsis Caused by Surgical Stapler
The cause of the non-functional staples in the lawsuit was the use of a stapler that was known by the manufacturers to frequently malfunction. In fact, the model used in this particular surgery was later subject to recall. The lawsuit names Covidien and Medtronic, and states that both manufacturers knew that their device could fail to form a proper seal.
The plaintiff in this lawsuit developed sepsis, an extreme response to an infection. Sepsis occurs when an infection triggers a chain reaction throughout the entire body, and without timely treatment can lead to organ failure and even death. When the patient’s staples failed to create a seal, it allowed bacteria to spill out of the site and into the patient’s body cavity, triggering sepsis to spread throughout his body.
FDA Data on Surgical Staplers
In 2019, Kaiser Health News reported that many manufacturers of surgical staplers had requested and received special exemptions from the FDA, that allowed them to report malfunctions of their devices “in a database hidden from doctors and from public view” Following this report, the FDA issued a warning about the rising rate of problems with surgical staplers.
In their report, the FDA indicated that there were at least 41,000 adverse event reports related to surgical stapler malfunction between 2011 and 2018. These numbers included 366 patient deaths. The FDA has now proposed new rules designed to make surgical staplers safer, and have classified the products as Class II, moderate risk medical devices, instead of low-risk medical devices. It will also require any new surgical stapler to undergo a review before receiving FDA approval.
Surgical Stapler Lawyer
Manufacturers of surgical staplers are facing a growing number of surgical stapler lawsuits similar to the one described above. These lawsuits are being brought forth after individuals have suffered severe medical complications, such as sepsis, or lost a loved one due to surgical stapler malfunctions.
The team at McEldrew Purtell Young Merritt are gathering complaints from victims of surgical staplers that have failed to work properly. If you or your loved one were the victim of a surgical stapler, we want to hear from you. Contact us today for a free consultation at 1-866-333-7715 or online via our form.