Compared to conventional sutures, surgical staplers, and staples have advantages. Several surgical staplers can be safe and are often used in different operations, but they are not risk-free. According to the US Food and Drug Administration, surgical stapler injuries cause 8,000 to 9,000 reported problems yearly, many of which end in fatalities.
What are Surgical Staplers?
The tools that medical personnel use to insert staples into surgical incisions are known as surgical staplers. They don’t resemble the type of stapler one may see in an office. In contrast, they reach for industrial or construction staplers.
Staplers for surgery are medical tools frequently used to repair wounds during surgery, either internally or externally. Medical staplers can be reusable or disposable (made of plastic or stainless steel). They are often equipped with a disposable cartridge of surgical staples in either situation.
In addition to being used inside to seal incisions and lacerations on the skin, surgical staplers and staples can also be used externally. They can occasionally be used in place of stitches. Unfortunately, staplers can break down, leading to surgical stapler injuries.
What Issues Have Been Brought on by Surgical Staplers?
Following a review of medical device records, the FDA declared in March 2019 that it had grown concerned by the rising frequency of adverse events related to surgical staplers and staples for internal use.
The FDA received approximately 41,000 separate medical device reports for surgical staplers and staples for internal use between January 1, 2011, and March 31, 2018. More than 360 fatalities and more than 9,000 severe injuries have been connected to defective surgical staplers.
Due to flaws, the FDA has issued extensive recalls for several of the surgical staplers that are most often used in the United States.
Additionally, the agency stated that it “believes that many of the issues raised in these complaints may be primarily ascribed to surgical staplers for internal use since appropriate staple creation is substantially dependent upon proper function and usage of the stapler.”
The reports listed the following as the most typical issues:
- Malformed staples
- Failing to shoot the staple from the stapler
- Misshapen staples
- Surgical stapler misfire
- Difficulty in firing
Why are the Risks and Surgical Staplers Injuries?
There is hardly much tolerance for error when using surgical staplers. Surgical stapler injuries typically affect delicate organs, including the gastrointestinal system, heart, lungs, or kidneys.
There are several ways in which surgical stapler injuries might occur. According to the FDA, incorrect stapler firing is to blame for 90% of surgical stapler injuries. Suture lines falling apart, staplers becoming entangled in patients’ tissue, and improperly formed staples are all issues with surgical staples.
In certain instances, surgical stapler injuries can happen as a result of faulty surgical staplers or staples. The FDA states that problems with surgical staplers or staples “may result in extended surgical procedures or unexpected, additional surgical operations that may result in other consequences,” such as:
- Fistula development
- Sepsis
- Increased chance of a cancer relapse
- Interior organs and tissues are torn
- Bleeding
- Additional surgeries
- Death
Recall of Surgical Staplers
The majority of surgical staplers sold in the United States are produced by two companies: Covidien, a Medtronic company, and Ethicon, a Johnson & Johnson affiliate.
These two firms make four out of every five surgical staplers used in American hospitals. Ethicon and Medtronic have witnessed a rise in equipment recalls, and litigation since the FDA revised its supervision procedure in 2019, and several flaws and faults have been exposed.
Medtronic Stapler Recall: The Endo GIA surgical stapler was one of the products the manufacturer recalled. Additionally, plaintiffs filed three separate claims against Medtronic in January 2020.
Each entailed gastrointestinal procedures that needed accurate staple placement to rejoin the tissues when the procedure was finished. The necessity for corrective procedures, serious infections, and heart issues was among the surgical stapler complications.
According to the complaint, Medtronic neglected to alert physicians and patients to the possible risks associated with the flawed design and manufacturing of the staplers.
Echelon Stapler Recall: The Ethicon surgical stapler recall 2019 included devices from other nations and the United States. The FDA ordered a Class 1 recall of Ethicon’s Echelon Flex Endopath staplers on October 30, 2019. The Johnson & Johnson subsidiary notified the FDA about several products earlier in October, including the following:
- ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
- ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)
These single-user staplers were created for use on internal tissue during general, pediatric, thoracic, gynecologic, and urologic procedures that needed little or no incision. The FDA claims that these devices may have a component that is not in compliance, resulting in distorted staples. Serious surgical problems might result from improperly shaped staples.
Numerous harmed patients have brought surgical staplers lawsuits and surgical staples lawsuits this year and have been compensated for damages.
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Lawsuits against Surgical Stapler Injuries
A woman from North Carolina has filed a product liability claim against Medtronic and its Covidien subsidiary, alleging that a surgical stapler malfunction left her with significant injuries, necessitating more operations and tissue damage.
The case is one of many surgical stapler injuries lawsuits being brought against Covidien and other manufacturers, all of which allege the same thing: that due to design flaws, the devices misfire, don’t fire, or produce misshapen staples, which can lead to severe internal surgical stapler injuries and organ perforations.
She developed atrial fibrillation later in the month and was hospitalized for 30 days, including two weeks in critical care and another week using a ventilator. After a two-week rehab center stays, she was discharged and given another two weeks of home health care.
Ryan Strange of Illinois consented to a $5.5 million settlement in 2017 for the 2013 surgical stapler injuries that caused the death of his wife.
Following surgery to remove a non-cancerous tumor from her liver, his wife bled to death. Covidien consented to contribute $250,000 toward the wrongful death case. In 2014, Medtronic purchased Covidien.
Covidien maintained that there was no proof to back up the assertion that a flaw in their product caused the woman’s death because the stapler had been discarded after the procedure.
Surgical Stapler Lawsuit Settlements
In January 2010, Ms. Kuhlmann, a former San Jose police officer, underwent a hemorrhoidopexy. Doctors employed the Ethicon PPH 03 surgical stapler to reposition prolapsed hemorrhoidal tissue.
According to reports, the doctor had trouble using the stapler, which was later recalled. Ms. Kuhlman was hurt during the procedure when the stapler malfunctioned and closed her anal canal. Ms. Kuhlman was forced to undergo a 21-day emergency hospital stay, severe infections, and many primary operations to repair her damaged gut. Kuhlmann still has internal and exterior scars and still uses a colostomy bag.
In that faulty Ethicon PPH 03 surgical stapler case, a California jury awarded Florence Kuhlmann and her husband $79,813,000 in December 2015.
In addition to $70 million in punitive damages against Ethicon, the judgment includes $4 million for past pain and suffering, $4 million for future pain and suffering, $513,000 in past and future medical expenditures, and $1.3 million in the past and future loss of consortium.
Many cases settled with personal resolutions, so it is unable to predict the amount that the plaintiffs received.
Update in Surgical Stapler Lawsuit 2023
In the case of Asby v. Medtronic, Inc., heard in 2023 in North Carolina, a lawyer recently requested a settlement amount related to a surgical stapler. The court dismissed the entire case, but the decision is subject to reconsideration.
The people who filed the lawsuit said that a surgical stapler got stuck. They claimed this caused permanent injuries. They said that the stapler was poorly designed and that there were no proper warnings. They also claimed the company was negligent, broke warranty promises, and violated North Carolina’s law against unfair and deceptive practices.
The company asked the court to dismiss the case using a legal rule called 12(b)(6). The court agreed and dismissed the case.
Surgical Stapler Lawsuit Update 2024
The FDA had received nearly 125,000 reports related to issues with surgical staplers as of 2024. This significant rise in reports highlights growing concerns in the medical community regarding the safety of surgical staplers.
What is the Recovery Payment for Your Injuries?
Medical device manufacturers’ goods should be held accountable when they cause unintentional injury. Recently, multiple awards totaling millions of dollars have been made against careless manufacturers of surgical staplers. By filing a legal claim with your assistance, your attorneys will strive to secure the highest possible settlement for the damage you have endured.
Patients who have been hurt may be able to collect damages with the use of money from a surgical stapler compensation from an Ethicon stapler lawsuit. This could comprise:
Medical costs: This covers paying for hospital stays, X-rays and other treatments, prescription medication charges, and other medical expenses associated with your surgical stapler injury. It also covers paying for doctor’s bills.
Lost revenue: Indemnification for lost wages may include days missed from work while recovering from accidents and diminished or lost capacity to work.
Both suffering and pain: Surgical staples puncture organs, cause serious bodily injury, and frequently cause excruciating pain. Damages for pain and suffering compensate you for the physical suffering and mental anguish brought on by your surgical stapler injuries.
Loss of enjoyment: Loss of enjoyment makes up for the fun you no longer have in your life.
Negotiations are the norm for case resolution. However, plaintiffs’ surgical stapler injury lawyers would also seek punitive damages if the case went to trial. These are intended to hold defendants accountable for improper behavior, such as delaying the recall of a potentially harmful surgical stapler. Additionally, punitive damages sometimes exceed compensatory damages.
These cases involving surgical staples can aid in holding Ethicon and parent firm Johnson & Johnson responsible for marketing allegedly defective goods. Due to earlier recalled surgical staple products, Ethicon has previously encountered accusations of a similar kind. Deals of $5 million to $80 million have been reached in similar litigation settlements with Medtronic and other companies.
Who is Eligible to File a Surgical Stapler Lawsuit?
A few surgical stapler lawsuits have started and are still pending. Some individual cases have been filed concerning the items that Ethicon recalled on April 11, 2019, although they are now in the pre-trial phases of litigation.
Patients who have had surgery with internal staples are at risk of surgical stapler problems. Patients may find it challenging or impossible to determine which staples were used during their operation and whether they are subject to the recall.
Have you or a loved one suffered harm from a surgical stapler? You could have a case for a surgical stapler. You should, at the very least, choose a lawyer who has handled cases involving defective products and personal injury claims. Some surgical staplers lawyers, particularly those specializing in surgical litigation, have the expertise and a solid track record.
If you had internal staples implanted during surgery that later required corrective surgery, you may be impacted by the recalled items and could meet the criteria for the Ethicon lawsuit. LezDo TechMed can help assess your medical records, which is a crucial stage in your case.
Unleash your case’s full potential with expert record reviews!
Keep in mind that there are statutes of limitations for cases involving surgical staplers and surgical staples. This indicates that you have a limited opportunity to initiate a surgical staple lawsuit or stapler lawsuit or become aware of it once the accident happens. Once this statute of limitations has passed, your ability to file a lawsuit will expire.
States have different statutes of limitations. Be sure to understand the statute of limitations applicable in your state. If you believe you may have a claim, contact a surgical staplers attorney as soon as possible to avoid missing the deadline.
To sum up,
Medical device manufacturers must adhere to high safety standards in the design, production, and use of their equipment to protect medical personnel and patients. If they don’t, anyone hurt by the manufacturer’s products may sue them and hold them legally liable.
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1/5 Surgical staplers are employed in various surgical procedures, and their use has increased.
Patients who had surgery when a surgical stapler was used are at risk for the consequences.#lezdomedlegal #surgicalstaplerinjuries #surgicalstaplerlawsuit pic.twitter.com/OUJlObL3RV— LezDo MedLegal (@LezDoMedLegal) November 4, 2022
