Surgical Stapler Lawsuit | 2025 Latest Updates

Surgical Stapler Lawsuit Overview

Surgical stapler lawsuits involve claims against manufacturers for defective medical devices that have caused severe injuries and deaths during surgical procedures.

The primary allegations focus on staplers misfiring, failing to fire, or creating malformed staples that lead to catastrophic complications.

According to FDA data, from 2011 to 2018, more than 41,000 adverse event reports were filed related to surgical staplers, including 366 deaths, over 9,000 serious injuries, and more than 32,000 malfunctions.

The FDA has reclassified surgical staplers from Class I to Class II medical devices, granting the agency greater authority in testing and restricting these devices due to their significant safety risks.

Also read: Nationwide Bariatric Surgery Lawsuit

Latest Surgical Stapler Lawsuit Updates

May 2023: Depositions in Bell v. Covidien et al. are scheduled to take place through July 2024. The case involves claims of serious injuries caused by a malfunctioning surgical stapler. To date, no trial has been scheduled and there have been no settlements discussed in this particular case.

September 2022: Plaintiff Kimberly Bell filed a surgical stapler lawsuit against Covidien and Medtronic in federal court in Massachusetts, alleging that their defective stapler caused severe internal injuries requiring additional surgeries and ongoing medical treatment.

October 2021: The FDA ordered surgical staplers to be reclassified from a Class I to a Class II medical device over a growing number of adverse events. This reclassification subjects the devices to greater regulatory oversight, including special controls and premarket notification requirements.

March 2021: Plaintiff Dereck Paul Smith filed a surgical stapler lawsuit against Covidien and Medtronic in Louisiana alleging that the companies’ product failed to properly close an incision, resulting in serious complications.

April 2022: A judge in Louisiana dismissed Smith’s lawsuit and canceled a previously scheduled settlement conference.

FDA Reports and Statistics

The FDA has collected extensive data on surgical stapler malfunctions and associated injuries:

• From January 1, 2011, to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use [1].
• These reports included 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.
• In 2016 alone, Kaiser Health Network found nearly 10,000 reports of stapler malfunction were submitted to the MAUDE database, while the public database reported less than 100 injuries or malfunctions that year.
• According to a 2022 study, there were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive surgical staplers [2].
• The reported misfire rate was 0.04% for Medtronic and 0.02% for Ethicon.
• For Medtronic devices, the most common reported events were failure to fire (n = 349) and misfire (n = 186).
• For Ethicon, the most common events were failure to fire (n = 146) and mechanical problems (n = 27).
• For Intuitive, the most common events were leaks (n = 10) and bleeding from the staple line (n = 8).

From January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious surgical stapler injuries, and more than 32,000 malfunctions.

Surgical Stapler Injuries & Side Effects

Malfunctioning surgical staplers can cause catastrophic injuries during and after surgical procedures, often requiring additional operations and leading to long-term health complications or death.

• Bleeding and Hemorrhage: When staplers fail to properly close blood vessels, patients can experience severe blood loss that may be life-threatening.
• Organ and Tissue Damage: Misfiring staplers can tear or puncture internal organs and tissues, leading to serious complications.
• Infection and Sepsis: Inadequate closure of surgical wounds can allow bacteria to enter the body, causing dangerous infections that may progress to sepsis.
• Anastomotic Leakage: When staple lines fail in gastrointestinal surgeries, stomach contents can leak into the body cavity, causing severe infection and inflammation.
• Dehiscence: Separation of areas that were stapled together can occur if staples are malformed or improperly placed.
• Cancer Recurrence: Improper stapling during cancer surgeries may increase the risk of cancer recurrence or fistula formation.
• Death: In severe cases, complications from surgical stapler malfunctions can be fatal.

Do You Qualify for a Surgical Stapler Lawsuit?

You may qualify for a surgical stapler lawsuit if:

• You underwent gastric bypass surgery where a surgical stapler was used
• The surgical stapler malfunctioned during your procedure (misfired, failed to fire, or created malformed staples)
• You suffered serious complications such as bleeding, infection, organ damage, sepsis, or required additional surgeries
• Your complications can be linked to the stapler malfunction
• Your surgery occurred within the statute of limitations for filing a product liability claim in your state

Evidence Required for a Surgical Stapler Lawsuit

To build a strong case for a surgical stapler lawsuit, you will need to gather:

• Medical records documenting the use of a surgical stapler during your procedure
• Surgical notes indicating any complications or malfunctions that occurred during surgery
• Records of subsequent treatments, surgeries, or hospitalizations related to the stapler complication
• Documentation showing which specific stapler model was used and who manufactured it
• Expert medical testimony linking your injuries to the stapler malfunction
• Evidence showing the stapler was defective or unreasonably dangerous

Damages You Can Recover

Victims of defective surgical staplers may be eligible to recover compensation for:

• Medical Expenses: Costs for additional surgeries, hospitalizations, medications, and ongoing care
• Lost Wages: Compensation for time off work during recovery and reduced earning capacity
• Pain and Suffering: Damages for physical pain and emotional distress caused by your injuries
• Permanent Disability: Compensation for long-term or permanent health issues resulting from stapler complications
• Punitive Damages: Additional compensation in cases where manufacturers showed gross negligence
• Wrongful Death: Compensation for families who lost loved ones due to surgical stapler malfunctions

Surgical Stapler Settlements

Several notable settlements and verdicts have been reached in surgical stapler cases:

• $80 Million Verdict (2015): A California jury awarded Florence Kuhlmann nearly $80 million after she suffered a bowel rupture and life-threatening infection due to an Ethicon PPH 03 surgical stapler malfunction. This included $70 million in punitive damages and $9.8 million in compensatory damages. In 2018, an appeals court reduced the award to $19.6 million.
• $5.5 Million Settlement (2017): Ryan Strange received a $5.5 million settlement after his wife April died due to massive blood loss when a Covidien stapler cut a blood vessel but failed to properly close the wound. Covidien agreed to pay $250,000 of this settlement.
• $5 Million Verdict (2007): A jury awarded $5 million to the family of a woman who died after an Ethicon stapler failed to form proper staples, allowing stomach contents to leak into her intestinal cavity.

These cases demonstrate that substantial compensation may be available for serious injuries and deaths caused by defective surgical staplers.

Surgical Stapler Recall Information

Several major manufacturers have issued recalls for defective surgical staplers in recent years:

Ethicon Stapler Recall

In August 2019, Ethicon (a Johnson & Johnson subsidiary) recalled two of their internal surgical staplers designed for gastrointestinal surgeries:

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

The FDA reported these devices failed to properly form staples and ejected uncut washers and malformed staples.

An investigation traced the issue to a manufacturing process shift that occurred between March 2018 and March 2019.

According to the FDA, at least two patients sustained serious injuries requiring additional portions of their intestines to be removed.

This was not the first recall for defective Ethicon staplers. Previous recalls have been issued for the PPH 03 surgical stapler and other models due to similar defects and patient injuries.

Affected Manufacturers

Medtronic (Covidien) and Johnson & Johnson (Ethicon) control approximately 80% of the surgical stapler market in the United States.

Other manufacturers with products that may be subject to defect claims include:

• 3M
• B. Braun Melsungen AG
• Cardica
• Care Fusion Corporation
• CONMED
• Frankenman International
• Meril Life Science
• Purple Surgical
• Smith & Nephew
• Stryker
• U.S. Surgical
• Welfare Medical
• Reach Surgical
• Zimmer Biomet

Statute of Limitations for Surgical Stapler Lawsuits

The statute of limitations for filing a surgical stapler lawsuit varies by state, typically ranging from 1-6 years from the date of injury or discovery of injury.

Key considerations include:

• Discovery Rule: In many states, the statute of limitations begins when you discovered (or reasonably should have discovered) that your injury was caused by a defective surgical stapler.
• Product Liability Laws: Different states have different deadlines for product liability claims, which apply to defective medical devices.
• Wrongful Death Claims: If you lost a loved one due to a surgical stapler malfunction, wrongful death claims typically have their own limitations periods.

Because these timeframes vary significantly and have numerous exceptions, it’s crucial to consult with an experienced attorney as soon as possible after suffering complications from a surgical stapler to ensure your legal rights are protected.

Related Article: Tiger Paw Surgical Staple Recall Lawsuit

FAQs

Get Your Free Surgical Stapler Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for injuries caused by defective surgical staplers. State laws impose strict deadlines (statutes of limitations) that can permanently bar your right to compensation if missed.

These deadlines typically range from 1-6 years from the date of injury, depending on your state. Don’t risk losing your right to pursue the compensation you deserve.

Our experienced legal team at Schmidt & Clark, LLP offers:

• Free, confidential case evaluations to determine your eligibility
• No upfront costs or attorney fees – we only get paid if you receive compensation
• Nationwide representation with specialized experience in medical device litigation
• Dedicated attorneys who will fight aggressively to maximize your recovery

We understand the devastating impact that surgical stapler malfunctions can have on victims and their families.

Let us help you hold the manufacturers accountable and secure the compensation you need for medical expenses, lost wages, and pain and suffering.

References:

1. https://kffhealthnews.org/news/fda-announces-sweeping-plan-to-review-safety-of-surgical-staplers/
2. https://pubmed.ncbi.nlm.nih.gov/35281706/