Last year, Johnson & Johnson issued a recall for thousands of the surgical staplers manufactured by its subsidiary Ethicon. Issues with the devices even led to surgical staples lawsuits.

The surgical staplers included in the recall are Endo-Surgery endoscopic and non-endoscopic curved intraluminal staplers with adjustable heights tables, designed to be used in the gastrointestinal tract during surgical procedures.

Reasons Behind Surgical Stapler Recall

Ethicon recalled the staplers for insufficient firing and a failure to completely form staples. The recalled devices were manufactured and distributed for about a year, between March 2018 and March 2019. The recall was initiated on April 11, 2019, according to the U.S. Food and Drug Administration (FDA).

The recall announcement notes specifically in its reason for recall section that “the use of affected product may cause serious patient harm or death.” As of Oct. 2019, Ethicon noted that seven serious injuries and one death had been reported linked with the product codes affected by the recall, and had begun pulling devices from the market early that month. [Source:

In May 2019, the FDA labeled this stapler recall as a Class I, the agency’s most serious. Class II recalls indicate a situation in which a product may cause temporary or reversible adverse health effects or pose a chance of a serious complication, but the likelihood is remote. A Class I recall, however, is “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

At the time of the Ethicon recall, the FDA acknowledged that “many more” device malfunction reports had been reported than the agency previously disclosed to the public. With more than 56,000 reports of surgical stapler malfunctions through non-traditional channels between 2011 and 2018, the total number of reports of malfunctions or injuries during this period surged to nearly 110,000, according to Kaiser Health News.

During this time period, the FDA received 412 reports of deaths associated with these devices, with about one-third of the reported faults related to malformed staples or staple lines—the very issue that triggered Ethicon’s major recall of the devices.

The FDA’s website has a list of Ethicon staplers that have been affected by the recall. These devices include certain lots with the following product codes:

• EC60A
• PCEE60A
• PLEE60A
• PSEE60A

Approximately 100,000 total surgical stapler devices were affected in the recall.

The recall has sparked a rise in Johnson & Johnson lawsuits over surgical stapler complications.

How Do Surgical Staplers Work?

Surgical staples are used both internally and externally, along with surgical staplers to place the staples, according to the FDA. Surgical staples are beneficial because they are easy to place and there is a minimal tissue reaction to the staple. Further, studies have found a low risk of infection and better wound closure.

Surgical staplers are used in a number of settings, from thoracic to gastrointestinal surgeries, says the FDA. They can be used to create connections, cut through organs or tissues, or to remove parts of organs.

Despite the benefits, surgical staplers can present a risk. In 2020, the Emergency Care Research Institute (ECRI) said the devices were one of the most dangerous used in hospitals, based on a review of adverse events and device malfunctions.

Risks associated with surgical staplers prompted the FDA to send a safety letter in March 2019 urging healthcare providers to use caution and follow new safety recommendations.

It is vital that these devices work properly for the health of the patient. Unfortunately, the surgical staplers manufactured by Ethicon failed to perform appropriately, reportedly leading to injuries and even the death of one patient. Despite reports of problems, patients continued to be treated using Ethicon surgical staplers until they were recalled in 2019.

Though these staplers are no longer used in surgery, for years they were used regularly. Allegedly, Ethicon knew of the problems with its surgical staplers, but failed to warn the public. Johnson & Johnson lawsuits have been filed by patients who say they were endangered and even injured by the defective products.

Surgical Complications

The recall was issued after Johnson & Johnson confirmed that its device may contain a substandard component resulting in malformed staples. Malformed staples, in turn, can cause serious complications after surgery.

Surgical staples can result in complications, such as:

• Infection
• Improper placement
• Poor wound healing
• Wound reopening
• Allergic reactions

If not recognized and addressed, malformed Ethicon surgical staples may lead to far more severe complications, including:

• Prolonged surgery
• Postoperative connection leak
• Hemorrhage or catastrophic internal bleeding
• Hemorrhagic shock
• Sepsis
• Bowel leakage
• Fistula formation
• Additional surgical intervention

In the most severe cases, this kind of surgical stapler malfunction could result in death.

How Were Surgical Stapler Malfunctions Hidden for Decades?

According to Kaiser Health News, the FDA held some complaints in a secret database called Alternative Summary Reports (ASR). This database allegedly included reports of medical device issues that normally would have been reported through the FDA Manufacturer and User Facility Device Experience (MAUDE) system.

The FDA’s ASR system not only hid adverse medical device reports from the public, but also from the medical community. Doctors didn’t even have access to the information that they should have, and could have used to prevent them from using faulty surgical staplers.

Physicians and surgeons depend upon the MAUDE database to help them discover if other doctors have had problems or experienced failing medical devices in the past. Without doctors’ knowledge, the FDA kept this ASR database between the years 1997 and 2019.

The ASR system allowed a medical device manufacturer to submit a spreadsheet that summarized any problems with one of their FDA-approved devices, but such information only needed to be submitted quarterly. The summaries were privately handed over to the FDA, which never shared the spreadsheets with health care professionals or the community.

The ASR reporting system allowed a medical device manufacturer to legally say they had satisfied the FDA’s reporting mandate without drawing unwanted attention from doctors or the public.

In May 2019, the FDA issued an executive summary saying that between 2011 and 2018 it had received in excess of 110,000 reports of injuries or device malfunctions related to surgical staplers. More than half of the reports were placed in the secret ASR database.

Surgical Stapler Lawsuits

Patients are increasingly filing Johnson & Johnson lawsuits over complications from malformed surgical staples.

Plaintiff Steven E.’s Johnson & Johnson lawsuit alleges that he suffered a major air leak caused by several staples misfiring after a 2016 laparoscopic sigmoid colectomy surgery using an Ethicon surgical stapler. This required Steven to undergo further surgery to have the staples removed, repair the site, and have a surgeon perform a divert loop ileostomy to protect the area. Since the additional surgery, Steven has suffered several hernias, along with pain, dysfunction, humiliation, and reduced quality of life, according to his lawsuit.

Johnson & Johnson Lawsuit Attorneys

A growing number of patients are coming forward after undergoing surgery with the use of a surgical stapler, alleging that they suffered from complications from the devices, in some cases necessitating further surgery and causing prolonged health issues.

Plaintiffs claim that the surgical staplers used during their surgeries were defective. These lawsuits seek to hold Ethicon and its parent company, Johnson & Johnson, accountable for their allegedly defective devices. Some family members and other relations may be eligible to file wrongful death lawsuits after a loved one’s death from a defective product. Those who may be eligible include family members, life partners, financial dependents, and more.

If you or someone you love has suffered serious complications from surgical staplers, necessitating corrective surgery, you may be able to join the growing number of patients filing Johnson & Johnson lawsuits and pursuing compensation. Of course, filing a surgical complications lawsuit cannot take away the pain and suffering caused by these complications, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a surgical complications lawsuit can be a daunting prospect, especially while dealing with medical complications, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

The Johnson & Johnson Surgical Stapler Lawsuit is Case No. 3:19-cv-05608, in the U.S. District Court for the Western District of Washington at Tacoma.