Have you suffered complications or harm because of a defective surgical stapler? You are not alone. Most patients might have suffered the same complication from the medical device. Fortunately, you can recover the damages by joining a mass tort. The most effective way to do this is by engaging a skilled mass tort attorney.

What are Surgical Staplers?

A surgical stapler is primarily used in a minimally invasive procedure (those involving small incisions and use of endoscopic devices). They are used to close wounds under high tension, including trunks of your body or injuries on your body. The medical device is tailored to replace sutures or stitches. Initially developed in 1908, a surgical stapler has numerous advantages compared to sutures, including:

  • Ease of removal
  • Reduced surgery time
  • Reduced tissue reaction
  • Reduced rate of infection
  • Robust wound closure

When used with implantable staples, the medical devices in question could be used to:

  • Resect (remove a part of your organ)          
  • Transect (cut through tissues and organs)
  • Anastomoses (create connections between your structures)

However, surgical staples have been linked to severe complications. There are few ways of telling that something is wrong until life-threatening symptoms manifest. These symptoms include:

  • Infection
  • Digestive and nutritional challenges
  • Damaged or torn tissues or internal organs
  • Sepsis
  • Fistulas formation (the abnormal connection between organs or other body tissues)
  • Need for a permanent ostomy bag
  • Need for a repeated surgical repair
  • Leaks at the closure of the surgical site
  • Uncontrolled bleeding from the incision
  • Death
  • Need for more imaging studies
  • Need for antibiotics
  • Additional surgical procedures

The complications can happen during the surgery or appear a couple of days following the surgical procedure. Make sure you tell your experienced lawyer when you first experienced the symptoms.

Why Were Ethicon Surgical Staplers Recalled?

Since surgical staples and staplers are primarily the systems, the U.S. Food and Drug Administration reviewed the reports sent for implantable staples and surgical staplers. The move aimed to get a detailed image of the medical devices’ safety profile. According to the analysis between 2011 and 2018, the Food and Drug Administration received more than forty-one thousand reports, including:

  • Over thirty-two thousand malfunctions
  • None thousand severe injuries
  • Three hundred and sixty-six fatalities

It is believed that most of the challenges identified in the reports could be attributed to medical devices for internal use since significant formation is primarily dependent on the proper use and function of the surgical stapler.

The affected products include:

  • Endo-surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staple
  • Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples

The product codes include: ECS29A, ECS25A, ECS33A, ECS21A, CDH33A, CDH25A, and CDH21A (You can get the product code on the carton)

After analyzing returned products and complaints, Ethicon confirmed malformed staples and uncut washers in a stapler happen with the intraluminal circular stapler because of inadequate firing. It could compromise the staple line’s integrity. When a washer is complete and a firing cycle is complete, the physician experiences a tactile and audible crunch. Failing to cut the washer means a three-hundred-and-sixty-degree staple failure.

Other reported problems include:

  • Misfiring
  • The stapler failing to fire staples
  • Misapplied staples (user applying the wrong staple size to the tissue or using a staple in the incorrect tissue)
  • Malformation of staples or opening the staple line

Moreover, the investigation discovered a change in the process that happened between March 2018 and March 2019.

Some of the affected persons include:

  • Physicians who performed gastrointestinal surgical procedures
  • People who had, have or might undergo gastrointestinal surgical procedures, like bariatric and colorectal cancer patients.

Call to Action

Recently the FDA sent a letter to hospitals on the medical device that included the recommendations for doctors. Physicians who use the staplers have the following alternatives:

  • Powered staplers from different manufacturers, including Ethicon
  • Manual staplers from other brands

Also, the surgeons could consider performing the following alternative approaches to surgery:

  • Minimally invasive surgery
  • Delayed surgery
  • Anastomosis (open surgery using a hand sewn closure)

Ethicon notified distributors, customers, and hospitals that bought the medical staplers and offered instructions. They should:

  • Analyze their inventory to decide if they have the product(s) affected by the recall and quarantine the product
  • Remove the affected product and communicate the challenge to the relevant physician.

Did Ethicon Staplers Manufacturer Hide the Risk?

According to Kaiser Health News, the U.S FDA acknowledged that it had received several reports about Ethiconsurgical staplers through the agency’s alternative summary reporting database. Therefore, the reports were not accessible to medical experts looking for details on the device’s safety.

By October 2019, Ethicon was only aware of one death and seven severe injuries.

What are the Food and Drug Administration Actions?

To promote the effective and safe use of the surgical staples and staplers, in April 2019, the Food and Drug Administration issued a guide with recommendations to surgical staplers’ manufacturers about the details to embrace in the product labeling.

Because of the high number of events reported, the FDA held a meeting in May 2019 to determine whether to reclassify surgical staplers as a Class II medical device or not. Currently, the staplers are Class I devices and don’t need submission to the regulating agency. Classifying them as Class II devices could subject the device to premarket notifications and permit the agency to establish compulsory controls to mitigate risks.

Moreover, the FDA analyzed reports received from March 2018, and both the outcome of the analysis and the advisory committee meeting materials (held in May) are accessible to the general public.

The agency continues working together with professional societies and hospitals to encourage education and training related to the surgical stapler’s use.

How to Report Issues to the Food and Drug Administration

Reporting adverse events could help the FDA know and comprehend the surgical staplers’ risks.

Should you experience or suspect a challenge with the medical device, bring a report via MedWatch (safety information and adverse event reporting program). You can report either through mail or online.

A Mass Tort Can Help

If you’ve been injured by the surgical staplers, joining a mass tort lawsuit could be a perfect way to recover compensation for the losses incurred. The civil action lawsuit will allow all injured persons to benefit from collective legal representation and a percentage of the settlement.

Generally, a mass tort begins when a defective medical device causes harm to a lot of people. While some cases are publicized, others do not make headlines. However, irrespective of the media coverage, a tort case is closely associated with an extensive legal issue that causes pain to plaintiffs.

A mass tort is different from a class action in that the cases don’t always involve injury cases and cover a single complaint with similar characteristics. On the contrary, a mass tort could include diverse complaints against one defendant and involve harm or complications from medical devices and prescription drugs.

How to Join a Mass Tort

If you want to join a mass tort, you should contact a competent attorney. You should then wait until the attorney interviews you. Your injury’s details should be relevant to your mass tort. If your injury or case circumstances are not connected or related directly, you should press charges against the defendant separately.

Typically, the mass tort case will use experts, witness testimony, and evidence from all victims. It is always essential to identify all the defendants; it increases the success rate of the case. As a result, your lawyers should thoroughly investigate the case with all victims and witnesses before taking your case to court.

Relation to the Mass Tort

When you want to sue the defendant for the defective surgical staplers that caused your harm, you might consider joining a tort. However, following the interview with an attorney, you should explain how you have a relation to the mass tort. The proof is critical, and your medical records can form the ground for the association. Before becoming a witness, you should have an interrelated case.

Some of the proof you can use to prove the claim includes:

  • Expert witness testimonies
  • Medical reports and test results
  • Proof of causation (photos of your injuries)
  • Proof of your income
  • Medical records
  • Your doctor’s affidavits

Every plaintiff should have a file with their evidence. The lawyer should establish every case individually.

What are the Stages of a Tort?

The section below discusses the different stages of a mass tort. Your case could settle at any stage. You can also lose the case at any phase. Consequently, any experienced mass tort lawyer will not file the case until they are sure the claim is valid.

The Lawyer Will Review Records

To determine whether your case is valid, your attorney will review several records. The attorney may review your medical history. It confirms the time when you claim the injuries or symptoms manifested. Additionally, the attorney can determine if you have a pre-existing health condition.

The Attorney Identifies Injury Consistencies

The lawyers should identify consistencies among the plaintiffs. The case is built against a single defendant. While every victim will have his/her claim, the structure of all cases is similar. It’s because only a few claims will determine the direction of the remaining cases.

The attorneys should classify cases based on the duration of complications, the victim’s age, and the seriousness of injuries. After the mass tort settles, the attorney will assign compensation by the category the claim falls in.

Bringing the Lawsuit

A mass tort case is filed in a federal court. Even if the plaintiffs may live in various regions, it is advisable to consolidate the claims. Filing the lawsuits together makes it more convenient and faster for the involved parties.

Trialing Bellwether Cases

Before all claims are tried, the court will try a few. They are called bellwether trials. Typically, the attorney will select the most severe cases. It can involve persons who succumbed to the defective surgical staplers’ complications or those with the most significant damages.

Bellwether cases test how the rest of the claims will go. Should the jury find the evidence in the bellwether trial weak, the remaining claims will not continue to trial.

Settlement Stage

The settlement is the last phase, and most cases settle. It could take a couple of months or years.

Trials are both costly and time-consuming. Most skilled attorneys and judges prefer settling the claims out of court.

How Compensation is Handled in a Mass Tort Case

Since a mass tort has many plaintiffs with different damages, the parameters bring the question of how compensation is distributed. Settlement in a mass tort is handled differently from a class action. Every victim in a mass tort is treated individually.

Because each victim is subject to their trial, a tort could take years to settle. Fortunately, having multi-district litigation brings resources together and speeds up the process. The compensation varies with plaintiffs, allowing all plaintiffs to recover compensation proportionate to their losses and injury.

While compensation is different, the legal experts might share details of the evidence to support the claims and investigation and consolidate your cases. For example, an expert witness might give their testimony once instead of repeating one thing over and over again.

Getting a significant compensation amount from the defendant can be challenging. The defendant has sizable resources and a seasoned legal team that looks for gaps to counteract responsibility. Nevertheless, with legal representation, you can receive compensation for:

  • Medical expenses
  • Transportation expenses linked to the injuries.
  • Lost wages
  • Lost earning capacity
  • Emotional damages
  • Disability
  • Physical therapy

The amount of time it takes to recover damages vary from one case to the other. When a settlement agreement is reached, numerous requirements should be met. Many involve governmental lien and subrogation interest. The defendant might also require time to resolve the challenges before awarding compensation to the alleged victims.

Find an Experienced Mass Tort Attorney Near Me

It is frustrating and painful when a surgical stapler designed to promote healing does the opposite. When the manufacturer fails to warn of the potential side effects or sell a defective medical device, it should be held responsible for the negligence. Joining a mass tort could help you recover compensation for the losses incurred. If defective surgical staplers have hurt you, the skilled legal team at Consumer Alert Now can assist. We have the resources and experience needed to prosecute high-stakes, high-profile, and complicated litigation. Call us today at 800-511-0747 to schedule your initial consultation.