Ethicon Surgical Stapler Lawsuit: Misfiring Flaws Create Serious Risks for Patients
- Defective Medical Devices
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Thousands of American medical patients are coming forward with complaints about surgical stapler injuries. In particular, Ethicon (a subsidiary of Johnson & Johnson) surgical staplers are associated with injuries that include infection, tissue damage, and even death. Legal action may help injured patients and their families recover losses caused by the defective product.
Affected patients may include anyone who has received surgical staples in connection with gastrointestinal surgeries, such as bariatric patients and those with colorectal cancer.
Unfortunately, issues with defective medical devices are common. If you or a loved one have been harmed in any way by defective Ethicon surgical staplers, we strongly encourage you to contact a lawyer regarding your legal rights and options.
Critical Flaws With Ethicon Surgical Staplers May Cause Severe Injury
Surgeons typically use staplers during gastrointestinal tract surgeries to create connections between sutures during the procedure. Ethicon stapler products have already caused serious injuries to patients, and the company issued a recall for the products.
The U.S. Food and Drug Administration (FDA) has included the following in the list of risks associated with defective staplers:
- Tearing of organs and internal tissues
- Leaks in the closure
- Increased risk of cancer recurrence
- Fistula formation
- Possible death
As a result of these issues, patients may need:
- Additional imaging procedures
- Additional surgeries and closures
- A permanent ostomy bag (a pouch attached to the person’s body externally where food waste is stored for disposal)
As you can imagine, the injuries associated with Ethicon surgical staplers can be severe and life-changing. The injuries can lead to long-term changes in one’s lifestyle and abilities, such as nutritional and digestive issues, including the need for an ostomy bag. The injured person may require ongoing medical treatment or specialized care and assistance with their daily lives.
Ethicon points to flaws with the device that can compromise staple lines during routine gastrointestinal surgeries. These defects include issues with the staple firing and the formation of the staples.
The U.S. regulator stated, “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.”
Settlements in Stapler Lawsuits
Damages in an Ethicon surgical stapler lawsuit can cover a wide range of losses and setbacks caused by a surgical stapler injury. Though a verdict or settlement can never really undo the tragic experiences of an injury victim, it serves the purpose of helping a victim recover and make life better moving forward.
A damages award can help with:
- Medical costs: Costs of treatments, therapy, and medicines
- Earnings losses: Lost wages (for instance, due to missed work while recovering), or a loss of the ability to generate income in the future
- Lifestyle adjustments: Loss of consortium, loss of enjoyment of life
- Various other costs
Thousands of Americans are being affected by surgical stapler injuries. Reports warn health care providers of an increase in the number of adverse events associated with defective surgical stapler products.
Taking legal action can help you get back on track after a surgical staple injury. Contact an attorney at Searcy Denney at (800) 388-3905 if you need legal representation for an Ethicon surgical stapler lawsuit. Our attorneys have extensive experience in helping clients obtain significant settlements and verdicts against large manufacturing corporations.
Ethicon Surgical Stapler Recall
In 2019, Ethicon recalled its reloadable surgical staplers due to the flaws mentioned above.
A little more than one month after the initial announcement, more than 92,000 Ethicon reloadable surgical staplers were recalled. The devices are known as endo-surgery endoscopic curved intraluminal staplers and endo-surgery endoscopic curved intraluminal staplers.
FDA Recall Information
The FDA classified this as a Class I recall, which is the most serious type of recall.
A Class I recall basically means that there is a “reasonable probability” that the use of such a product will cause serious injuries, adverse health consequences, or death.
The recall officially affects the following products:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A
The recalled products were manufactured from March 6, 2018, to March 6, 2019. They were in distribution from March 15, 2018, to March 8, 2019.
Additional Surgical Stapler Recalls
About a month before the Ethicon stapler recall, the FDA issued a letter outlining the dangers and risks associated with surgical staplers in general. In the letter, they particularly identified surgical staplers used for internal procedures as presenting high risks of harm to patients.
They also noted an increase in the number of adverse events and injury incidents from internal surgical staplers. For instance, from January 2011 to March 2018, the FDA compiled over 41,000 medical device reports for surgical staples. Medical device reporting is the procedure the FDA uses to get information on potentially dangerous devices. Such reporting helps the FDA detect and correct issues quickly. The reports uncovered adverse events like:
- 366 fatal cases
- Over 9,000 serious injuries
- At least 32,000 product malfunctions
You should contact a lawyer if you or a loved one have suffered any type of surgical staple injury, regardless of the brand or manufacturer. It is also possible that additional surgical stapler product recalls may be issued in the future.
Contact a Lawyer for Representation in an Ethicon Surgical Stapler Lawsuit
The types of injuries caused by Ethicon surgical staplers can be permanent and may create various hardships for the victim and their families. If you or a loved one have been affected in any way by a surgical stapler injury, it is in your best interest to get in touch with an injury attorney. The lawyers at Searcy Denney have experience in dealing with defective medical device claims to obtain an appropriate legal remedy for you.
Our team of attorneys is on hand to provide you with the guidance and expertise needed for your case. Contact us at (800) 388-3905 for a no-cost, no obligation consultation on your legal options. Getting the legal process started is the first step toward regaining your life.
Surgical Stapler Injury FAQs
How Does a Surgical Staple Work?
Surgical staples are used in many gastrointestinal, thoracic, and other types of surgeries. They are used in procedures where a surgeon has removed part of an organ, cut through tissues, or created connections between bodily structures.
In the case of Ethicon surgical staplers, firing issues are causing serious health and injury risks for patients.
Who Can Remove Surgical Staples?
Only a licensed medical professional should remove or adjust surgical staples. You should never try to handle or alter surgical staples by yourself at home. If you are experiencing pain, discomfort, or additional medical conditions in relation to surgical staples, contact your health professional immediately. If you suspect any issues with defective stapler products, contact a lawyer as well.
Can Surgical Staples Be Left in Too Long?
Surgical staples are only meant to remain in the patient for a specific period of time. After the appropriate time determined by the surgeon or doctor, they will remove the staples. In many cases, certain types of staples are designed to dissolve on their own.
If there are complications with the length of time the staples are left in a patient’s body, the patient may also have a claim for medical malpractice or medical negligence. This is on top of potential issues with a defective product. Such instances can involve many layers, and will require the assistance of a lawyer to sort out liability issues.
How Can a Defective Product Attorney Help Me?
Injuries caused by Ethicon surgical staplers can involve complex issues that are best handled by an attorney. A qualified lawyer can help you organize materials for litigation, gather evidence on your behalf, and construct a suitable litigation strategy. Again, get in touch with the legal team at Searcy Denney at (800) 388-3905 if you have questions on how to proceed with a surgical stapler lawsuit.
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