Surgical Stapler Lawsuits

• Anybody who has had a surgical operation involving a surgical stapler, and then discovered that the stapler had misfired or malfunctioned, causing them pain or other medical complications.
• Family members of people who have died as a result of malfunctioning surgical staplers and its complications.

• Florence Kuhlmann vs. Ethicon: In 2018, the jury awarded Florence $19.8 million as damages
• Steven Ergler vs. Ethicon: Steven was compensated for the damages he suffered because of Ethicon’s staplers
• David Bakos vs. Ethicon: In April 2019, David won the case against Ethicon

As science advances, the medical community comes up with superior options and alternatives to already existing practices and procedures. Scientists, doctors, and researchers are continuously experimenting to find out better, safer, easier, and cheaper substitutes in medicine, surgical tools, and procedures.

One such technology that entered the medical industry a few years ago was the surgical stapler. The surgical stapler can be used internally or externally to close wounds and surgical incisions after a bad injury or to close a patient up after a surgical operation. The traditional method in use before the surgical staplers was manually sewing the skin shut. The removable surgical staples are easy and convenient, providing a strong and safe wound closure that can be removed when the skin has healed itself.

Surgical staples, though, have come under scrutiny in recent times, as, more often than not, they’ve caused further pain and complications for some people, ranging from patients developing infections to certain cases where the infections have proved to be fatal. While some cases might be the result of wrongful administration or use of the staplers, several hundred cases came up that accused the manufacturer, Ethicon, of not manufacturing the staplers according to the medical guidelines and approved safety and quality standards.

Surgical tools and implants are supposed to be made with extreme precision and hygiene, right down to the very last detail. Any deviance from the norm could result in grave complications in patients, and could even cost them their lives. This is why care and rigid compliance with the quality standards of surgical tools are extremely necessary, and there should be grave consequences for any manufacturer that does not follow them religiously.

In such cases, the victim deserves to be compensated for the harm that they have endured due to the negligence of the manufacturing company. If you need any assistance in cases where surgical staplers were the cause of someone’s pain or death, contact the team of lawyers at Frankl Kominsky, for guidance and advice. We try to work diligently to get you the justice you deserve and compensatory reward for what you have suffered.

Ethicon is a subsidiary of Johnson and Johnson that primarily manufactures medical devices, such as sutures, scalpel shears, skin adhesives, etc.to facilitate and improve various surgical processes. In fact, they are the manufacturers of the first sutures ever made. In recent years, they have also introduced several types of surgical staplers, such as Proximate, Echelon Flex, and many others. The company owns 80% of the US market for medical sutures and sells its products in 52 countries worldwide.

While Ethicon was once a renowned company, after the incidents with their staplers started pouring in, the FDA announced a total recall of their staplers and put these products on their high-priority list, because of the potential harm and even death that they could cause.

Ethicon is currently facing several product liability lawsuits after several of its surgical staplers misfired during surgeries and caused the failure of surgeries, which needed additional surgeries to correct the damage. In light of the lawsuits and the thousands of skin stapler lawsuits, the FDA has classified surgical staplers as medium-risk (class II) medical devices instead of low-risk (class I) ones. It also issued a draft guidance for stapler manufacturers to responsibly label their products and warn users of the risks associated with them.

Surgical staples are normally made out of high-grade stainless steel and are used to close wounds and ruptures. They’re also used to close organs and skin after surgery. The reason they started becoming popular and used as an alternative to traditionally stitching the wound were:

• They are quicker to put on. Stitching a wound closed takes time and extreme care. With staples, the wound is shut much faster and more conveniently, which means that doctors and surgeons get to save precious time.
• They have a lower risk of infections than stitches and other alternate methods of closing wounds. This comes with a caveat, however. Staples also have to be applied with care and in the appropriate way. Once they are, they have a lesser chance of causing infections.
• They trigger minimal tissue reactions and are generally more stable. They don’t disturb the surrounding tissues or irritating them.
• They provide strong wound closure. Stitches are prone to opening and breaking if the patient doesn’t exercise extreme caution in the days or weeks after the stitches are applied. With staplers, it is unlikely that a staple will come out and leave the wound open.
• Their ease of removal is also the reason why doctors prefer them over stitches. Staple removers come in a variety of shapes and sizes, and, in emergency situations, can even be taken off using surgical forceps.

Because of their ease of application and the extra safety involved, surgical staplers started becoming popular among surgeons and doctors. Then, reports started pouring in from people who had terrible experiences with surgical staplers, where patients started to get infected due to the use of these staples in their surgeries.

The matter was taken up by the FDA, and they ordered a recall of thousands of Ethicon’s surgical staplers. Despite the ease of use and quick placements, it appeared that there was a lot to improve in surgical staplers, and all risks needed to be eliminated before these devices could be deemed absolutely fit for use in surgeries and treatments.

While sometimes, the misapplication of the staplers and reckless handling of the device on the doctors’ and surgeons’ part is what caused the complications, oftentimes, these complications occurred because of faulty and defective products provided by Ethicon.

Reported cases from doctors have unveiled the following information about the problems with surgical staplers during operations.

• Opening of the staple line: Doctors have reported that the Ethicon staplers often do not hold the wound closed. This ends up in the entire staple line coming loose and opening up.
• Misfiring: Misfiring is dangerous as it can cause several other complications in surgery – even death. Several doctors have reported the staplers misfiring during surgical procedures.
• Design Defect: The stapler itself is faulty by design. Even when used with the utmost care, there are chances of misfires and badly applied staples.
• Difficulty in firing: Sometimes, the staples get stuck, and several attempts have to be made to fire a staple, causing unnecessary difficulty, not to mention the loss of blood.
• The stapler not firing at all: Sometimes, the staplers were found to not fire at all, despite repeated attempts. This proved to be an issue in cases where time was of the essence, and staples needed to be closed quickly.
• Misapplied staples: Misapplied staples can delay the healing of the wound, and can cause infections and other complications.

Surgical stapler complications and side effects include:

• Bleeding: Misfiring or the failure of the stapler to fire can cause doctors to look for alternate ways to close the wound. This time spent looking for other means can result in the patient unnecessarily losing a lot of blood.
• Sepsis: Sepsis is when your immune system tries to fight an infection but causes inflammation in your whole body instead. Sepsis, in extreme conditions and if not treated and taken care of properly, can lead to organ failure and death.
• Fistula formation: A fistula forms when a surgeon accidentally joins a vein and an artery together. Though the chances of infection with a fistula are reduced as there are no foreign objects involved, there’s a chance that the steel staples themselves can lead to infections.
• Tearing of tissues or organs: If the stapler fires with too much intensity or accidentally misfires where it wasn’t supposed to, it can rupture tissues and organs, which can cause a host of complications. These complications will also need a set of other surgeries to close them up.
• Increased risk of cancer recurrence: In some cases, it has been reported that vascular stapling can cause the recurrence of lung cancer, too.
• Death: All of the above-mentioned scenarios can result in death. Excessive bleeding, tearing of the organs and tissues, and infections caused by the staples can lead to the death of the patient if not treated on time.

Anybody who has had a surgical operation involving a surgical stapler, and then discovered that the stapler had misfired or malfunctioned, causing them pain or other medical complications is eligible to file a surgical stapler lawsuit.

If you feel any unexpected pain or discomfort after a surgical procedure, do not disregard it. Instead, get it checked by a doctor as soon as possible to see whether the staples that were used internally or externally during your operational procedure are intact and uninfected. If the cause of your complications is determined to be a faulty surgical stapler, you may be eligible to file a claim against Ethicon or the stapler manufacturing company that made the stapler that was used in your surgery.

If you display any of the side-effects listed above, after a surgery involving surgical staplers, get immediate medical attention, and then take the manufacturer to court.

The Statute of Limitations to file a class action lawsuit against Ethicon may vary from state-to-state. Keep in mind that the Statute of Limitations to file a claim could possibly be within two years from the time your symptoms were apparent or from diagnoses. However, if you experience symptoms or have been diagnosed with an illness related to the Surgical Staples, we encourage you to seek immediate legal guidance and representation from an experienced injury firm.

Be sure to report your symptoms to your doctor as soon as possible. Contact the experienced lawyers from Frankl Kominsky to represent you in front of giant corporations such as Ethicon, and to try to reach a fair and just settlement.

While some of the lawsuits have been filed for the doctor’s negligence, there are several that claim product liability in their lawsuits.

In May 2019, after backlash and thousands of lawsuits brought against Ethicon, the company issued a Class I recall of 92,496 units. A further recall of about 2 million staplers was called for.

As the trials started, the manufacturer’s fault and product liability were easily proven in court. The highest sum ($80 million) awarded to a victim, a San Jose police officer whose anal canal was accidentally sealed by the misfiring of a defective Ethicon surgical stapler.

Florence Kuhlmann vs. Ethicon

One of the earliest cases includes the case of Florence Kuhlmann, a woman who underwent surgery and three days later discovered that her bowel had been stapled to the wall of her rectum, causing her bowel to rupture and expose her to the life-threatening condition of sepsis.

The doctors and lawyers concluded that the problem was caused by an Ethicon stapler, which was later recalled. In 2018, the jury awarded her $19.8 million in compensatory and punitive damages.

Steven Ergler vs. Ethicon

Perhaps one of the earliest cases to come to court was the case where Steven Ergler filed a lawsuit against Ethicon for selling a defective surgical stapler that was used during a laparoscopic colectomy surgery on him in May 2016. A few days after the surgery, it was discovered that the staples were completely open and had misfired, leading to several hernias that adversely affected the quality of his life, and caused him regular pain and humiliation.

It also led to further surgeries to correct the failed surgery because of the staples. Steven won the case against Ethicon and was awarded substantial compensatory damages.

David Bakos vs. Ethicon

In April 2019, David Bakos from Los Angeles County underwent a gastrointestinal surgery in which the surgeons had used an Ethicon stapler. A few days later, Mr. David started experiencing high fever and abnormal abdominal pain. He had to undergo other surgeries to correct an anastomotic leak that had occurred due to the staples not staying in place.

It was revealed that the Ethicon staples were malformed and thus ejected by the body. The court granted him compensatory and punitive charges to cover his medical bills and unnecessary pain and suffering that he faced.

There are over 41000 complaints in the FDA database and even more that have not made it to the public eye. Several people are coming forth with surgical stapler claims against Ethicon and are leading the FDA to take the issue more seriously and issue necessary guidelines and strict quality assurance in the production and management of crucial surgical devices.

Victims of surgical stapling accidents are eligible to recover compensatory damages that aim to cover the costs and losses associated with the injuries. These damages are meant to compensate victims for their:

• Past and future medical expenses
• Lost wages
• Loss of potential future earnings as a result of the injuries
• Physical pain and suffering
• Mental distress and agony

In addition to the compensatory damages, the jury may also charge the manufacturer with punitive damages, meant to punish Ethicon and prevent the re-occurrence of such negligence in manufacturing such important medical devices and tools.

At Frankl Kominsky Injury Lawyers, our attorneys have recovered more than $200 million in accident and injury settlements. We have assisted over 7,000 injured clients. If you or a loved one faced medical complications such as cancer, fistulas, tissue tears, bleeding, or sepsis caused as a consequence of a defective surgical stapler, we can try to help you recover compensation for your past and future medical bills, lost wages, and special damages. Get in touch with our experienced lawyers today and get your surgical stapler mishap reviewed for free by filling out the free consultation form on our website. We offer our services on a contingency fee basis.