Ethicon Circular Stapler Lawsuits may potentially be filed by thousands of people who have undergone surgeries in the past year who are at risk of suffering serious injuries because of malformed staples. Johnson & Johnson was forced to recall thousands of its Ethicon circular staplers this year because of misfirings and malformations of staples that resulted in several deaths and injuries. People who learn that they have been injured because of this defective medical device may be entitled to recover compensation from the company by filing a defective product lawsuit against Johnson & Johnson and Ethicon. The attorneys at The Lovely Law Firm in Myrtle Beach, South Carolina are currently reviewing claims.
What are Ethicon circular staplers?
The Ethicon circular staplers include two types of staplers called the Ethicon® Endo-Surgery Curved Intraluminal Stapler and the Echelon Flex™ Endopath® Stapler. These are surgical staplers that surgeons commonly use when they perform a variety of different surgeries, including the following:
- Colorectal surgery
- Gastrointestinal surgery
- Endometrial surgery
- Bariatric surgery
- Urological surgery
- Gynecological surgery
- Thoracic surgery
The staplers contain defects that cause them to misfire and to issue malformed staples. Misfired and malformed staples have resulted in injuries and deaths of people who have undergone these types of surgeries.
Potential injuries and complications
Misfired staples during surgery can cause perforations that further injure patients. The defect in the device can cause malformed staples that surgeons may not be aware of are malformed during surgeries. Patients who have malformed staples in their bodies may suffer from multiple post-op surgery complications and injuries, including the following:
- Internal bleeding
- Sepsis
- Need for additional surgeries
- Need for a permanent ostomy device
- Anastomotic leaks
- Permanent digestive problems
- Permanent nutritional deficiencies
- Additional closures
- Need for more imaging studies
- Death
People who are injured by staplers in internal surgeries may face lifelong medical problems that interfere with their ability to enjoy their lives and require additional treatment. Because of reports of these types of injuries from these defective devices, the Food and Drug Administration recalled them.
FDA recalls
In May 2019, the FDA announced that Johnson & Johnson had recalled its Endo-Surgery Curved Intraluminal Staplers and its Endo-Surgery Endoscopic Curved Intraluminal Staplers that were manufactured between March 6, 2018, and March 6, 2019. These staplers were distributed from March 15, 2018, and March 8, 2019. Johnson & Johnson initiated its recall of the staplers on April 11, 2019. In total, 92,496 surgical staplers were recalled.
The FDA classified the recall as a Class I recall, which is the most serious type of recall because of the high risk of serious injuries and deaths. The defects were reportedly caused by an issue with the manufacturing process for the staplers during the manufacturing period.
On Oct. 30, 2019, the FDA announced another Class I recall of Ethicon staplers. This second recall included multiple types of the ECHELON FLEX™ ENDOPATH® Staplers that were manufactured from July 18, 2019, and Aug. 3, 2019. These devices included components in the jaws of the devices that were out of specification and caused staple malformations leading to seven injured patients and one death. For this second recall, 8,256 devices were affected.
History of problems with surgical staplers
The FDA has become increasingly concerned about the safety of staplers for internal surgeries. Between 2011 and 2018, the FDA received reports of 412 deaths from staplers and internal staples used in surgeries. out of 11,000 malfunctions that were reported to the agency, nearly 33% resulted in malformed staples and problems in the staple lines, which are the same problems that caused the recalls of the Ethicon staplers in 2019.
Staplers impacted by the recalls
Staplers with the following product codes were recalled in the April and October recalls in 2019:
- CDH21A
- CDH29A
- CDH25A
- CDH33A
- ECS25A
- ECS21A
- ECS29A
- ECS33A
- EC60A
- PCEE60A
- PLEE60A
- PSEE60A
Medical professionals who have one of the recalled staplers should immediately stop using them and return them to the company.
Lawsuits against Johnson & Johnson for injuries from defective staplers
If you have suffered injuries and complications such as sepsis from staples used in a gastrointestinal surgery or another type of surgery, you may be entitled to recover compensation for your losses by filing a lawsuit against Johnson & Johnson and its subsidiary, Ethicon. The staplers that were recalled in April contained manufacturing defects that occurred during the manufacturing process. Medical device manufacturers may be strictly liable when people suffer injuries from defective products because of the defects. Proving a strict liability claim does not require plaintiffs to prove that the company was negligent in its design or manufacture of the defective device. Instead, plaintiffs must be able to prove the following elements to prevail in a claim involving a stapler with a manufacturing defect:
- The staplers were unreasonably dangerous when they were manufactured and sold.
- Johnson & Johnson and Ethicon expected that the staplers would reach the consumers without changes being made to them.
- The plaintiffs were injured by the defective staplers.
Defective medical devices can cause serious injuries or deaths and result in substantial losses.
Damages in a lawsuit
The amount of compensation that might be recoverable in a lawsuit against Johnson & Johnson and Ethicon will vary based on the extent and severity of the injuries that you have suffered. An experienced attorney at The Lovely Law Firm can analyze the facts and circumstances of your case and your losses to provide you with a range of potential values. Some of the potential types of damages that you might recover include the following:
- Past medical expenses related to your injuries
- Future medical expenses from your injuries
- Past lost wages
- Future income losses
- Physical pain and suffering
- Emotional trauma
- Disfigurement
- Disability
- Reduction in your ability to enjoy life
If you have lost your loved one, you might be able to recover the following types of damages in a wrongful death lawsuit:
- Medical expenses related to your loved one’s injuries until he or she died
- Funeral expenses
- Burial expenses
- Loss of your loved one’s expected income for his or her life expectancy
- Lost inheritance rights
- Physical pain and suffering that your loved one suffered from the time of injury until his or her death
- Loss of consortium and guidance
Contact The Lovely Law Firm for help
If you have been injured or have lost your loved one because of one of these defective staplers, you may have legal rights. Product liability lawsuits can be complex and require significant discovery and investigation. Hiring an attorney at the South Carolina Lovely Law Firm might increase the likelihood that you will succeed in your lawsuit. Contact us today to schedule a free evaluation of your potential case by calling us at 843.839.4111 or by filling out our online contact form.
