New Jersey Surgical Stapler Lawyers
Mazie Slater Katz & Freeman is investigating and filing claims on behalf of people nationwide who have suffered severe injuries and complications as a result of Surgical Staplers for Internal Use. If you or a loved one has died or suffered severe surgical complications, such as sepsis, bleeding, the need for a permanent ostomy “bag,” life-long nutritional and digestive issues, a leak in the closure (anastomotic leak), or the need for additional closures (anastomoses) or additional surgeries as result of a surgery involving a surgical stapler or staples for internal use, please contact our Surgical Stapler Lawyers for a free consultation.
Mazie Slater is a highly respected law firm located in Roseland, New Jersey. Our presence in New Jersey has us uniquely positioned to bring claims against New Jersey based manufacturers such as Johnson & Johnson and Ethicon on behalf of people all over the country. Our attorneys are currently serving as lead counsel in numerous medical device and pharmaceutical litigations, including numerous trial verdicts for our clients who have been injured by medical device defects in the past several years alone.
The FDA’s Warning Letter
On March 8, 2019, the FDA notified doctors that it is “concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”
“Because surgical staplers and staples for internal use are used as a system, the FDA analyzed the medical device reports submitted for both surgical staplers and implantable staples to obtain a comprehensive picture of the safety profile for these devices. Our analysis, which is ongoing, found that from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:
- 366 deaths,
- over 9,000 serious injuries, and
- over 32,000 malfunctions.”
Some of the most commonly reported problems in these adverse event reports include:
- difficulty in firing,
- failure of the stapler to fire the staple,
- misapplied staples (e.g., user applying staples to the wrong organ or tissue or applying staples of the wrong size to the tissue), and
- opening of the staple line or malformation of staples.
Stapler and/or staple malfunctions or misuse may result in severe surgical stapler complications, such as prolonged surgical procedures or unplanned, additional surgical procedures and operations, which may lead to other complications, such as:
- fistula formation,
- tearing of internal tissues and organs, and
The FDA’s Proposed Rules and Draft Guidance
On April 24, 2019, the FDA proposed reclassifying surgical staplers for internal use as Class II devices, which are subject to more regulations than Class I devices. “To mitigate the risk of complications associated with device failure or device malfunction, adequate performance testing is needed to ensure that the stapler with compatible staples performs as intended under anticipated conditions of use. FDA believes that adequate performance testing must include an evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type; measurement of the worst-case deployment pressures on stapler firing force; and a measurement of staple line strength. Performance testing must also demonstrate confirmation of staple line integrity (e.g., through the absence of vertically contiguous malformed staples), as well as in vivo confirmation of staple line hemostasis following staple deployment.” The “FDA believes that the device must be demonstrated to be biocompatible because the risk of adverse tissue reaction may result from contact of the materials of the device with the body. Additionally, because the risk of infection can arise from a contaminated device, sterility testing must demonstrate the sterility of the device. If any components of the device are reusable, the labeling must include validated methods and instructions for cleaning and sterilization of these reusable components. Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling. In addition, loss of package integrity can result in compromised sterility and compromised device performance over time. Therefore, shelf-life testing must demonstrate that the device maintains its performance characteristics and the packaging of the device maintains its integrity for the duration of the proposed shelf-life. Finally, the labeling must also specify an expiration date to inform users of the shelf-life of the device based on the shelf-life testing.”
The FDA also recommended significant changes to the labeling of these staplers as well as the staples that they use. The FDA repeated its concerns from its March 8, 2019 letter and added that “[b]oth device misuse and device malfunctions are root causes of these adverse events. Device misuse may be exacerbated by inadequate instructions for use, and insufficient warnings or precautions in the device labeling.” “The types and incidence of malfunctions and clinical consequences to patients seen in the adverse event reports are also corroborated by the published literature.”
Recall of Ethicon’s Endo-Surgery Intraluminal Staplers
After the FDA’s March 8, 2019 letter, Ethicon notified customers that it was recalling:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A (Product codes are located on the front of the single unit carton.)
- Manufacturing Dates: March 6, 2018 to March 6, 2019
- Distribution Dates: March 15, 2018 to March 8, 2019
- Devices Recalled in the U.S.: 92,496
These Staplers are used “in the gastrointestinal tract for creating connections between structures (anastomoses) in surgical procedures.”
“Through investigation of complaints and returned products, Ethicon confirmed uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.”
“In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.”
“The use of affected product may cause serious patient harm or death. Ethicon confirmed serious injuries to two patients. Misfiring of the stapler resulted in an additional resection — of the middle rectum in one patient and the lower rectum in another patient — during the planned resection of the upper rectum. Potential risks to patients include death, sepsis, bleeding, the need for permanent ostomy ‘bag,’ life-long nutritional and digestive issues, leak in the closure (anastomotic leak), additional surgeries, need for additional closures (anastomoses), need for antibiotics, and the need for additional imaging studies.”
The FDA wrote that “[p]atients who have had or may undergo gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients” may be affected by this recall.
Can I File a Surgical Stapler Lawsuit?
Our law firm can help determine whether you can file a lawsuit against Ethicon and potentially other companies, for selling defective Surgical Staplers and Staples for Internal Use and the failure to warn doctors and patients about their risks.
How Can Filing a Lawsuit Help Me?
If the Surgical Stapler lawsuit is successful, you may be entitled to collect compensation for current and future medical expenses related to the defective device and the failure to warn of its risks, as well as for pain, suffering, disability, impairment, loss of enjoyment of life, and for lost income and wages.