When it comes to less invasive surgeries, surgical staplers have proven to be fast and easier to use when cutting and sealing tissues or vessels. Many health providers prefer them because they avert wound edges facilitating healing. However, some of these devices have been found defective, and many people have been injured or died as a result. Consumer Alert Now has provided the following new information on malformed surgical staplers to enable you to recover compensation and seek justice for the injuries caused by the malfunction.

Why are Surgical Staplers Used?

A surgical stapler is a medical instrument whose purpose is to cut and seal vessels and tissues. The devices are conventional in vascular, gynecologic, and thoracic surgeries. Compared to traditional nylon sutures, surgical staples are more effective. Doctors use them externally to seal wounds on the scalp or internally to staple internal tissues during operations.

Manufacturers of Surgical Staplers

Johnson & Johnson and Medtronic manufacture the majority of surgical staplers used in the U.S. Other manufacturers include:

  • 3M
  • Ethicon which is a subsidiary of Johnson
  • Covidien, a Medtronic subsidiary
  • Cardiac
  • Welfare medical
  • Stryker
  • People surgical
  • Reach surgical
  • Zimmer Biomet

What is the Problem with Surgical Staplers?

The FDA has received many adverse reports of surgical staplers malfunctioning. A malfunction or faulty surgical stapler may result in additional corrective surgeries and severe injuries. If you undergo surgery with a defective stapler, you may not notice the adverse effects right away.  In most of these cases, the devices misfire or fail to fire during surgery resulting in:

  • Excessive blood loss
  • Internal organ and tissue damage
  • Increased possibility of cancer recurrence
  • Death
  • Severe pain
  • Infections
  • Intestinal dysfunction
  • Opening of the staple line
  • Fistula formation

Surgical staplers are associated with specific problems. Some of these problems are:

  • The stapler can fail to fire during surgery, forcing surgeons and support staff to opt for alternative binding procedures. As these medical experts scramble to seal the tissue or vessel, there may be a lot of blood loss. The open incision also risks getting infected.
  • Sometimes the stapler might fire with a lot of force or little force. When it fires with excessive force, it may result in organ damage. On the other hand, if the firing occurs at low energy, it might fail to seal the incision.
  • The stapler may also fire in the wrong place resulting in serious health problems
  • Surgical staplers also fire accidentally resulting in startling medical conditions

When these problems arise, wounds take long to heal while others don’t heal correctly.

Secret FDA Database

If you have undergone surgery recently and, in the process, sustained adverse injuries or effects because of the surgical stapler, you may file a voluntary report with the FDA. Reporting these cases helps the FDA protect patients and prevent future harm from the device. The adverse experiences of surgical staplers were reported to the FDA in 2011, and the first recall happened in 2013.

According to an investigation conducted by the FDA, including years of reports not included in the MAUDE database, more than 41,000 adverse experience reports were filed between 1st January 2011 and 31st march 2018. Based on the review, surgical staplers have malfunctioned thirty-two thousand times, and of these, 366 people have lost their lives while nine thousand others have sustained serious injuries.

The FDA is mandated to protect patients from defective medical devices and, in this case, the surgical staplers. However, the big concern here is that the agency had a secret database that they used to hide adverse reports on malfunctioning surgical staplers called ASRP. Instead of acknowledging the deaths, injuries or malfunctions stemming from these devices, the FDA decided to conceal the information from doctors and patients for years. The public was only allowed access to adverse reports on MAUDE which makes surgical staplers appear safe and efficient for both internal and external use, which is untrue.

A separate investigation conducted by Kaiser Health Network found out that close to 10,000 adverse experiences of surgical staplers were reported in 2016. But on the FDA’s MAUDE, the reports submitted in the same year were less than 100, which shows the agency hid many stories in their secret database.

The purpose of creating the secret database was to reduce the time for evaluating reports of a similar situation and prevent under-reporting. The move enabled surgical staplers’ manufacturers to apply for exemption status so that they cannot report specific events into MAUDE. As part of the exemption status, manufacturers would monitor the injuries or deaths caused by the defective devices regularly and report to the FDA through a spreadsheet.

After the report by Larry Kaiser, a former FDA official, the agency announced that it was ending the program. The FDA has also promised to release all the reports they have been hiding to the public. However, despite doing this, the damage has already been done because many patients have suffered injuries, and others lost lives due to these defective staples. The lack of transparency by the agencies puts many people at risk because there is no precise number of injuries or deaths from the secret database.   

Have there been Surgical Stapler Recalls?

Yes. Since 2013, there have been several recalls. In 2013, 57,540 ECHELON 60mm Endoscopic Linear Cutter Reloads manufactured by Ethicon were found to have a possibility for reloading damage that prevents a complete reload of staples from firing.

The other recall happened in 2015 when 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip, and White Reloads manufactured by Ethicon were recalled after an inspection showed staplers might not insert a full line of staples when fired.

In 2018, five people suffered harm due to missing components that could affect staple alignment. For this reason, there was a recall of 171,271 Endo GIA Universal Articulating Unit manufactured by Medtronic. Another recall happened in 2019 when 3,113,280 Endo GIA Articulating Reloads with TriStaple Technology manufactured by Medtronic were recalled because missing components affected staple alignment.

The latest recall happened in 2019. 92,496 Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staple and Endo-surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples manufactured by Medtronic were recalled after two patients suffered injuries due to misfiring cutting parts of the rectum.

The reasons for these recalls were:

  • Missing components
  • Bad alignment
  • Reload problems
  • Misfiring

These defects could cause sepsis, infections, bleeding, need for permanent ostomy bags, additional surgeries, pain, and lifetime digestive issues, hence the reason for the recalls.

How does the FDA Monitor the Safety of Surgical Staplers?

In a letter dated March 2019, the FDA warned doctors about the problems reported on surgical staplers used for internal purposes. In the letter, the FDA shared recommendations that would help reduce the various risks associated with these staplers. Also, health providers were asked to review their labeling instructions on the usage of surgical staplers and to pick a staple size based on the thickness or type of tissue. Health providers were also encouraged to use alternatives of surgical staplers where the tissue of the patient is prone to bleeding or necrotic. Doctors also received suggestions on what to do when the device malfunctions and how to know when it malfunctions.

The purpose of the letter was to remind doctors of the benefits surgical staplers provide during operations and how to select the right device to lower the risks of malfunction.

Take note that these devices were regulated as a Class I medical device. The classification means that the devices pose minimal harm to users and have a simple design. These devices are, therefore, exempt from the monitoring process. The manufacturers don’t require clearance from the FDA when introducing the instruments in the market. The manufacturer, however, must register the company with the agency and list its generic products. But they are required to report fatal surgical staplers’ malfunctions to the MAUDE which is the public database that tracks medical device malfunctions.

All other device failures that are not fatal didn’t appear on the database until June 2019. To prevent manufacturers from taking advantage of the class, FDA reclassified surgical staplers to class II medical devices in April 2019. The classification means these medical devices pose moderate to high risk for patients. And unlike before, where the FDA didn’t require any premarket submission from the manufacturer, today, surgical staplers require premarket review by the FDA.

Complications from Defective Surgical Staplers in Gastric Bypass Surgeries

If a surgical stapler malfunctions during gastric bypass operation, it may result in severe injuries or complications that endanger your life. Some of the snags are:

  • Bleeding
  • Hernia
  • Sepsis
  • Leaks from the staple line
  • Death
  • Reoperation
  • Dehiscence
  • Hemorrhage

Although these cases are uncommon, you might die, sustain serious injuries, or get infections due to a defective surgical stapler. If this happens, you should turn to the manufacturer and sue them for compensation.

Do I have a Lawsuit?

As mentioned earlier, the FDA issued a Class I recall for Endo-Surgery Curved Intraluminal Stapler manufactured by Ethicon due to high malfunction rates and complications. A class I recall means that there were chances the use of the staplers may cause death or result in severe health conditions. Ninety-two thousand staplers were recalled from the market for misfiring and causing organ damage instead of sealing the envisioned areas. They also produced malformed staples that have adverse health effects on the patients.

Many patients who suffered injuries because of the malformed staples are filing lawsuits against the company. In some of these suits, patients are blaming the doctors for medical malpractice while others are suing Ethicon and other manufacturers for defective medical devices.

Note that manufacturers are not taking these blames. They are trying to pin the blame for misfiring on the surgeons and doctors. They argue that doctors are negligent hence the reason for the misfiring.

Keep in mind that when filing a product liability lawsuit, you may opt to do it individually or collectively. If you file a lawsuit against the manufacturers of surgical staplers for defective design, you must prove the following elements:

  • The medical instrument’s faulty design posed a probable threat
  • The device was produced and used as per the guidelines

Despite manufacturers trying to pin the blame on surgeons, litigation has been on the increase. In some of the lawsuits, courts have given verdicts, and the victims awarded compensation for their injuries. For instance, in December 2015, Ethicon, a subsidiary of Johnson & Johnson, was sued by Florence Kuhlmann because of a defective surgical stapler. In 2011, the officer had a failed hemorrhoid surgery that almost took her life. 

After the surgery, she began experiencing a lot of pain, and later it was discovered that her intestines were closed off after her bowel was stapled against the rectal walls. She then developed an occlusion or obstruction that resulted in bowel rapture. The rapture caused primary infections and sepsis that almost killed her. After thorough scrutiny, it was determined that the surgical staplers were defective. Later the same year, Ethicon, who was the manufacturer of the device, recalled the faulty devices from the market. The officer who had filed the lawsuit received $80 million as compensation. Because the victim almost died from the injuries, $70 million of the money was an award as punitive damages.

In 2017, a settlement of $5 million was arrived at against Covidien. The plaintiff in the lawsuit was April Ryan, who experienced blood loss leading to death after a surgical stapler made by Covidien was used to cut and seal a blood vessel but failed to seal the vessel adequately. Failure to shut the blood vessel correctly led to excessive blood loss, which resulted in cardiac arrest and, finally, death on the same day.

Medtronic is the latest surgical stapler manufacturer to be sued by three claimants for selling defective staplers and deliberately hiding the risks of the device from doctors and patients. The three plaintiffs suffered injuries during gastrointestinal surgeries that involved the use of Medtronic surgical staplers. The staplers were for accurately placing organs, but unfortunately, they malfunctioned by not adequately closing the implanted staples or by creating holes without leaving behind staples. The victims of the malfunction suffered cardiac issues, severe infections while others underwent corrective operations. These issues resulted in hundreds of thousands of dollars in extra medical costs.

If there were public notice, FDA investigation, and recalls for these defective products, the products wouldn’t have been used for surgery by unsuspecting surgeons.  

Defective Surgical Staplers and Mass Class Action

Mass torts are civil lawsuits that involve a large number of patients or individuals usually from the same geographical location. The number of people involved in mass torts is much less than that of class actions. In the case of defective surgical staplers, victims can file a mass tort because the injuries sustained are distinct and outweighs the common issues that warrant a class action.

Some of the features of mass torts are:

  • They involve multiple claimants with claims regarding the same product and, in this case, surgical staplers.
  • The underlying facts or rows are almost similar in all cases
  • Different claims have a different value

Mass torts address parties injured by a single product like surgical staplers. The lawsuit is meant to help the victims of the injuries that have occurred in the same manner to have their joint claims tried synchronously.

How to Tell if a Surgeon Used a Recalled Surgical Stapler

There are chances that your surgeon may not tell whether a surgical stapler has malformed. However, those who reported malfunction claim that they were alerted by the noise produced by the device when it didn’t work correctly.

Take note that a surgeon may know when a stapling procedure goes wrong because there are visible signs. But in some incidences, they will notice something went wrong only after you begin to experience health complications. A post-surgery exam is usually conducted to find out if the staples might have been the source of the injuries.

Before a product goes to the market, the FDA requires makers of the medical devices to conduct thorough testing and clinical trials to enable doctors to make informed decisions regarding which medical device to use based on the safety information provided after the clinical trials.

Monetary Damages Available for Victims of Defective Surgical Staplers

Your attorney may pursue financial compensation for all the costs and losses from the injuries caused by the defective surgical staplers. Some of the damages you may seek as a victim of a malfunctioning surgical stapler include:

  • Physical pain
  • Past, current and future medical bills
  • Mental suffering and pain
  • Future incapability to earn a living due to the damages or injuries sustained
  • Lost wages and other professional consequences the harm caused when you spent time healing from the losses.

The majority of these cases are determined through negotiations. But if you fail to settle with the surgical stapler manufacturer, you may proceed to court where you may even pursue punitive damages. The damages are aimed to punish manufacturers for failing to recall defective surgical staplers. Seeking punitive damages is an excellent idea because they are higher than compensatory damages.

Find a Mass Tort Against Manufacturers of Defective Surgical Staplers Near Me

People all over the United States are sustaining extensive and life-changing injuries due to defective surgical staplers. In the event you are a victim of these medical devices, reach out to Consumer Alert Now at 800-511-0747 and learn about the damages you can recover.