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In recent years, after years of keeping secret reports of defects in certain medical devices, the FDA has begun to reveal the contents of these secret reports. One of the devices that have had many reports of injuries and other adverse events is defective surgical staplers. According to reports, this medical equipment has caused hundreds of injuries and close to 400 deaths. One way to receive financial compensation is by filing a defective surgical stapler lawsuit. A defective medical device lawyer can help file this claim and argue on victims’ behalf throughout the process.

What Are Surgical Staplers?

When patients have open skin wounds or internal wounds, surgeons will use surgical staplers to help close the laceration. They are intended to help close wounds in the strongest and quickest manner possible. Surgical staplers work in several different ways. The uses of this device include:

  • Removing part of an internal organ
  • Cutting transversely through organs or tissue
  • Connecting two or more structures together

When the surgeon uses the stapler to perform any of the above functions, the wound closes quickly. When staples are used to close an external wound, they will usually remain in place for a week or two until the area is sufficiently healed. Once the tissue is strong enough, the staples are able to be removed. Sometimes, patients can remove them at home and on other occasions, the doctor will remove the staples in their office using a specialized piece of equipment. Internal staples are made out of titanium and remain in the body.

The staplers come in a variety of different types. There are staples that work laparoscopically and those that work on the skin. Some staplers are reusable while others are used once and are disposable. The type of stapler that is used depends on the part of the body staples are meant to be applied. The largest company in the surgical stapler market is Medtronic, with Ethicon being another major manufacturer.

What Is the Issue with Defective Surgical Staplers?

There have been over 40,000 reports of complications and injuries that have resulted from the use of surgical staplers that have been hidden from the general public for many years. The public is usually alerted to the possibility of defective surgical staplers by adverse event reports that would generally be in the public domain. However, the FDA had previously had a secret system where reports were not released to the general public. Manufacturers of this device had requested an exemption that allowed the adverse reports to be kept from the public and the FDA granted the request. This made surgical staplers seem safer than they really were since the number of reports released was suppressed in order to reduce “redundant paperwork.” Had the true number of reports been known, it could have led to more timely action to warn about the issues encountered. It was only after word of this secret system had emerged that steps were taken to release these secret reports.

Prior to news of this secret database becoming public, there had been a few reports of defects in surgical staplers in some medical journals. There were also a handful of reports to the FDA that were in the public database. However, the number of public reports is dwarfed by the number of reports that were kept secret. Surgical staplers are one of the most prevalent reports in this secret database. As far back as 2004, it was noted that there was an abundance of reports about surgical staplers in the secret database. Prior to that, there were reports of nearly 100 deaths caused by the medical device.

What Is In the FDA’s Secret Reports?

The adverse event reports describe a variety of different complications with defective surgical staplers. These problems with defective surgical staplers include:

  • Malformation of staples
  • Opening of the staple line
  • Failure to fire staples
  • User error in applying the staples to the wrong tissue
  • Misfiring
  • Use of the wrong size staples

When defective surgical staplers misfire, they can sever blood vessels and cause damage to internal organs. Malfunctions can cause routine surgery to become a life-threatening event. Alternatively, defective surgical staples can cause severe issues after the surgery. If the staples are the wrong size or have been applied incorrectly, they can become infected and lead to sepsis.

Malformation of the staples occurs when the staples are not formed tight enough. This compromises the integrity of the staple line. Malformed staples can lead to a postoperative anastomotic leak or a gastric hemorrhage.

Side Effects of Defective Surgical Staplers

Malfunctioning or defective surgical staplers may cause severe injuries, prolonged surgeries, and additional corrective surgeries. Patients who have undergone surgery with defective staples may not notice any side effects immediately and will feel normal for a few days.

Staples improperly placed in a patient because of either doctor negligence or a defective device can cause many health-related issues. One of the main risks is infection around the wound area, which happens when bacteria gets near the wound and proper care is not given. There are some patients who may even be allergic to the staples’ materials.

Other health-related complications of defective staples include:

  • Bleeding
  • Fistula formation
  • Sepsis
  • Tearing of internal organs and tissues
  • Increased risk of cancer recurrence
  • Death

All of these risks and side effects can be avoided if proper medical equipment is used and doctors are performing the procedure correctly. These devices are used in many surgeries and adverse events usually arise when the staplers are being used on delicate organs with high risks of leakage. Some of the surgeries that have resulted in lawsuits include:

  • Appendectomy
  • Colostomies
  • Gastric bypass surgery (bariatric surgery)
  • Heart surgery
  • Lung surgery
  • Neck/Thoracic surgery

The FDA’s Reevaluation and Potential Reclassification

As the extent of the issues with surgical staplers have become known, the FDA has initiated a re-evaluation of the safety status of surgical staplers. These devices have been previously categorized as a Class I device. A defective medical device lawyer will advise that this represents the lowest risk of any FDA approved device. There is a proposed order to reclassify these as a Class II device, which denotes a higher risk. While this is short of the highest risk level, the FDA will be able to place special control on surgical staplers as a result of this new classification.

In addition to possible FDA reclassification, there was also recently a major product recall. Johnson & Johnson subsidiary Ethicon recalled its circular surgical staplers. The problem with these defective surgical staplers was that they failed to fully form, resulting in either a staple line that lacked integrity or misfiring of the surgical staplers. The recalled Ethicon circular surgical staplers include:

  • Endo-Surgery Curved Intraluminal Stapler w/ Adjustable Height Staples
  • Endo-Surgery Endoscopic Curved Intraluminal Stapler w/ Adjustable Height Staples

Why Patients Need a Defective Surgical Stapler Lawyer

When one is injured by defective surgical staplers, they need a defective surgical stapler lawyer. Medical device manufacturers unfortunately have all too much experience in being sued, so a defective surgical stapler lawyer is a must to take them on in court. A defective medical device lawyer is a necessity when it comes to fighting these product liability cases as they can become extremely complex.

A defective surgical stapler lawsuit has been the course of action for many affected families over the past decade. Defective surgical stapler lawyers have been able to help families with a multi-million settlement or recovery from the manufacturer of the defective medical device. The defective surgical stapler lawyer will file this lawsuit as a product liability action. This type of lawsuit will usually seek to prove one or more of the following claims:

  • The surgical staplers are defectively designed in a manner that leads to injury
  • There was a manufacturing defect while the surgical stapler was being made that caused it to misfire or fail to otherwise work
  • The manufacturer was negligent in designing or manufacturing the surgical stapler
  • The surgical stapler is defective and the manufacturer should be liable no matter what

A defective surgical stapler lawsuit is not necessarily the easiest type of case to provide in court so patients will need to seek legal representation with a defective surgical stapler lawyer. Defective surgical staplers are proven by a combination of scientific and medical evidence. The attorney will have to delve into the details of the design in order to show that the device is defective. Attorneys will also need to submit and prove evidence as to how a defective surgical stapler was used on the patient and how it caused their injuries.

Surgical Stapler Lawsuit Settlements

2012 – A settlement of $5 million was awarded to the surviving family of a patient whose cause of death was a defective stomach stapler that failed to seal the surgical area and allowed stomach content to spill out into the intestines. Ethicon was the manufacturer of the defective stapler and later in 2013, their Ethicon Echelon 60 mm and Echelon Flex staplers were recalled.

2015 – A settlement of $9.8 million was awarded to a woman who suffered massive infections and major abdominal injuries after an Ethicon surgical stapler misfired and sealed her anal canal.

2017 – A settlement of $5.5 million was paid to the surviving family of a woman who bled to death because a surgical stapler failed to seal a blood vessel shut. The manufacturer of the surgical stapler, Coviden, and the Memorial Medical Center agreed to pay the settlement.

Case Criteria for Defective Surgical Stapler Lawsuits

The following are qualification criteria for a potential defective surgical stapler lawsuit. Injured patients who meet the following criteria should contact KBA Attorneys immediately to begin filing a defective surgical stapler lawsuit against the negligent manufacturers.

  1. Was the PNC’s procedure between Jan. 1, 2011 – March 31, 2018?
  2. Did the PNC experience the opening of the surgical staple line or malformation of staples?
  3. Did the surgical stapler misfire, have difficulty firing or fail to fire the staple?
  4. Did the PNC experience misapplied staples? (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)
  5. Did the Stapler and/or staple malfunctions result in prolonged surgical procedures or unplanned, additional surgical interventions?
  6. Did the PNC experience any of the following complications due to Stapler and/or staple malfunctions:
  • Bleeding
  • Sepsis (a serious condition resulting from the presence of harmful microorganisms in the blood or other tissues and the body’s response to their presence, potentially leading to the malfunctioning of various organs, shock, and death.)
  • Tearing of internal tissues and organs
  • Increased risk of cancer recurrence
  • Death

More Lawsuits Against Surgical Stapler Manufacturers

There have been reports of jury awards and settlements over the years, but surgical stapler manufacturers have yet to face the same torrent of lawsuits that other manufacturers of defective medical devices have faced. In December 2015, a defective surgical stapler lawyer helped their client receive a large jury award in a lawsuit against Ethicon. The case involved a misfiring stapler that accidentally stapled the plaintiff’s anal canal shut. The mishap resulted in permanent injuries and the plaintiff had to undergo a colostomy. The plaintiff was awarded $80 million by the jury, who found that Ethicon was grossly negligent in manufacturing the product. $70 million of the amount was for punitive damages. These are awarded when a defective surgical stapler lawyer convinces the judge or jury that the company’s behavior was so egregious that the jury needs to take some action to punish the company. This followed two separate recalls of the product by Ethicon.

It is likely that, in the wake of the secret adverse event reports coming to light, more lawsuits will be filed against the manufacturers of these devices. A defective surgical stapler lawyer stands ready to assist those who have been injured by these products. An initial conversation with an attorney can reveal whether there is a viable legal cause of action and whether the case is still within the statute of limitations. Here, the publicity will likely spur plaintiffs who previously had no idea how widespread the problems were with this product.

How KBA Attorneys Can Help With a Defective Surgical Stapler Lawsuit

Expert legal assistance is needed to file a defective surgical stapler lawsuit. Contact KBA Attorneys if you or a loved one have been injured from a surgical stapler for any of the following reasons:

  • Malformation of staples
  • Opening of the staple line
  • Failure to fire staples
  • User error in applying the staples to the wrong tissue
  • Misfiring
  • Use of the wrong size staples

KBA Attorneys are experienced in cases dealing with defective medical devices.

Our law firm has filed many lawsuits against medical device makers, and we understand what needs to be done to fight a surgical stapler lawsuit. Trust KBA Attorneys to guide you through the litigation process and help you fight for the justice you deserve.

Call or fill out an online form for a free case evaluation.