In other cases, wounds or incisions became infected when the staple line opened up or when the staples loosened, causing bleeding and other problems. As a result of these issues, many patients have suffered serious harm.
Get familiar with the history of surgical staplers and staples and how it’s affecting patients, as well as what the U.S. Food and Drug Administration’s (FDA) previous recalls and more recent reclassification means for these devices and any legal actions underway by patients to recover against the manufacturer. If you were injured by these devices you may be eligible to file a claim against the manufacturers and be awarded compensation.
Brief History
Surgical staplers and staples have been used for centuries as a form of mechanical suturing to close wounds and incisions. The first recorded use of surgical staples dates back to 1908 when they were used to close skin incisions.
Surgical staples were introduced in Europe in the early 19th century and quickly became widely used. By the mid-19th century, surgical staplers were also being used in the United States (US).
Today, surgical staplers and staples are an essential part of many different types of surgery, including (but not limited to):
- cardiovascular surgery
- thoracic surgery
- gastrointestinal surgery
- colorectal surgery
- orthopedic surgery
Due to manufacturing innovation, two types of surgical staplers have been created – linear and circular. Each of these staplers has its own specific procedures for which it’s used. For example, endoscopic staplers are long, thin, and flexible, making them ideal for use in small or difficult-to-reach areas. Cartridge-based staplers are another common type of surgical stapler.
These devices contain a cartridge of staples that can be inserted into the body through a small incision. The cartridge is then activated, firing the staples into the tissue. Surgical staples are typically made from stainless steel or titanium and come in various sizes and shapes. The type of staple that is used depends on the location and size of the wound or incision.
Several companies that manufacture and sell medical devices also manufacture and sell surgical staplers. Most of the surgical staplers used in U.S. hospitals come from either Medtronic (formerly Covidien) or Ethicon – both big medical device companies. Ethicon is a subsidiary of Johnson & Johnson while Covidien was a separate company that manufactured medical devices until Medtronic bought it in 2014.
Dangers of Surgical Staplers
There have been several major recalls of surgical staplers over the years. Most of these recalls resulted from design or manufacturing defects causing the devices to malfunction, resulting in patient injuries. Medtronic and Ethicon initiated most of these recalls. Some of the major reasons for these malfunctions include:
- The stapler has either difficulty firing or is not firing the required staples causing the staple line to open.
- If the staple line opens – that is, the wound or incision is not properly closed – it can cause:
- Infection of the tissue or adjacent organs or sepsis
- Hemorrhaging
- Internal bleeding or anastomotic leakage from the wound
- Organ damage
- Nutritional and digestive issues
- Death
- The stapler can misfire into nearby organs.
FDA Actions and Recalls
In 2019, the FDA started tightening limitations and reporting safety issues with surgical staplers. It gave doctors and hospitals new instructions on how to use the devices and made an effort to reclassify specific surgical staplers as moderate-risk devices. It also reported myriad occurrences of stapler malfunctions and injuries that were previously undisclosed.
Furthermore, Ethicon recalled 92,496 surgical staplers in April 2019 because there were concerns that the stapler didn’t fire with enough force to form the stapler. The FDA branded this a Class 1 recall, the most serious type of recall.
The recall affected two of the company’s Endo-Surgery Intraluminal Staplers used in gastrointestinal tract surgeries. In its recall, the FDA warned of serious injuries and even death resulting from these malfunctioning staplers.
More recently, on October 7, 2021, the FDA reclassified surgical staplers and internal use staples from Class I (general controls) to Class II (special controls) devices. From this point on, surgical staplers will need an FDA premarket review before they can be marketed in the US.
After this reclassification, the FDA issued a final guidance to assist manufacturers in developing labeling that indicates these devices’ risks, restrictions and safe use directions.
What’s to Be Done?
The FDA’s decision to reclassify surgical staplers and staples was based on a data review showing an increased risk of serious complications associated with their use. The most common complications include bleeding, infection, and wound closure problems. In some cases, these complications can lead to death.
The FDA’s guidance on surgical staplers intends to help manufacturers ensure that their devices are safe and effective. It includes requirements for testing, labeling, and post-market surveillance. Manufacturers who do not comply with the guidance, may face civil or criminal penalties.
Lawsuit History
Litigation is ongoing and individual lawsuits have been filed against surgical stapler manufacturers. Some people who have been injured by malfunctioning devices have suffered serious injuries and filed surgical stapler lawsuits. In the lawsuits filed against the manufacturers of surgical staplers, the complaints generally claim that the staplers are defective and caused serious injuries or even death. In some cases, the manufacturers have been aware of the defects but failed to warn consumers or correct the problem adequately.
Some of these cases were settled, and the victims were compensated. However, most of these cases ended with confidential settlements meaning the amount of compensation is not disclosed. Below are three of the verdicts that are publicly available that has gone on trial and were awarded the highest amount of compensation:
Kuhlman v. Ethicon
A jury awarded almost $80 million in damages to Florence Kuhlmann, a woman who claimed she suffered serious injuries after hemorrhoid surgery. The jury found that the Ethicon surgical staplers and staples used in the procedure were defective, and that the manufacturer failed to warn patients about the risks associated with the devices. This case highlights the importance of choosing a qualified surgeon who is experienced in performing this type of surgery. It also underscores the need for patients to be fully informed of the risks and benefits of any procedure before undergoing treatment. However, on appeal, this amount was reduced to $19.6 million.
Strange v. Covidien
In this case, an Illinois court awarded compensation of $5.5 million when a woman died after undergoing surgery to remove her colon. During the surgery, Covidien’s surgical stapler failed to properly seal, cut a blood vessel and caused the victim to bleed to death. The family accused Covidien of negligence, claiming that the company failed to warn about the potential risks associated with their device.
Selpec v. Ethicon
In this case, the patient was scheduled for gastric bypass surgery during which an Ethicon endocutter was used. The patient experienced significant postoperative complications, including the tissue not properly sealing causing sepsis and ultimately death. The deceased patient’s family argued that the company knew or should have known about the risks associated with their product and failed to warn consumers.
They brought a wrongful death case where the jury found the surgical stapler defective and awarded $5 million in damages. The deceased patient’s family argued that the company knew or should have known about the risks associated with their product and failed to warn consumers.
Class action lawsuit in Canada
In related news, a class action lawsuit has been filed in Canada against Medtronic and its Covidien subsidiary over allegedly defective surgical staplers. The plaintiffs allege that the staplers have caused serious injuries, including organ damage and in some cases even led to death. Medtronic is one of the world’s largest manufacturers of surgical staplers, and Covidien is one of its subsidiaries. The lawsuit alleges that the companies knew or should have known about the defects in the staplers, but failed to warn consumers or take appropriate action.
Were You Injured by Surgical Staplers?
If you or someone you love has been injured during surgery by a surgical stapler, it is important you understand your legal rights and options. These device makers should not be allowed to evade justice for the harm they caused you and your family.
The legal system can be a confusing place, but you don’t have to navigate it alone. Join the Many. We’ll stand by you every step of the way and connect you with the best legal resources available to fight on your behalf.
