Surgical Stapler Lawsuit: Verdicts, Settlements, and Recalls

If a surgical stapler malfunctioned during your operation and left you with serious complications, you can bring a surgical stapler lawsuit as a product liability claim against the device’s manufacturer. These suits generally target Ethicon, a Johnson & Johnson subsidiary, or Medtronic, which owns Covidien; together the two companies control roughly 80 percent of the U.S. market. Jury verdicts in individual cases have ranged from about $3 million to nearly $80 million, though most cases settle confidentially. There is no consolidated multidistrict litigation for these claims as of mid-2026, so cases are filed one by one in state and federal courts.

The Injuries That Drive These Cases

Surgical staplers are used to close or reconnect tissue in bariatric, colorectal, lung, and other internal procedures. When they fail, the results can be severe. The malfunctions plaintiffs most often allege are misfires that deploy malformed staples, a failure to fire all staples in the line, jamming inside the patient’s tissue, and staple lines that leak — allowing bodily fluids, including intestinal contents, to escape into the abdominal cavity.

The downstream injuries include internal bleeding, organ damage, fistulas, sepsis, the need for a permanent ostomy bag, and death.¹ The FDA has reported that 90 percent of surgical staple injuries involve the device failing to fire correctly.² Between January 2011 and March 2018 the agency logged more than 41,000 adverse event reports for internal staplers, including 366 deaths and over 9,000 serious injuries.³ By 2024 the FDA’s MAUDE database contained nearly 125,000 total reports, including over 450 deaths and 12,000 serious injuries.⁴

What You Have to Prove

A surgical stapler case is a product liability claim, not a medical malpractice claim. The argument is that the device itself was defective, not that the surgeon made a mistake. Plaintiffs generally bring one or more of three theories:

Design defect — the stapler’s design was inherently unsafe.
Manufacturing defect — a specific unit was assembled incorrectly.
Failure to warn — the manufacturer did not adequately disclose the device’s risks.²

One doctrine shapes almost every case: the learned intermediary rule. Under it, a device maker owes its duty to warn to the physician, not directly to the patient. So a failure-to-warn plaintiff has to show both that the warnings given to surgeons were inadequate and that better warnings would have changed the surgeon’s decision to use the device. That causal link is where these cases most often fail.

What Recent Rulings Show

Two 2024–2025 decisions frame where the litigation stands.

In Corrigan v. Covidien, Judge Denise Casper of the U.S. District Court for the District of Massachusetts granted Covidien summary judgment on all claims in September 2024. The plaintiff had developed an anastomotic leak after surgery with a Covidien EEA stapler.⁵ His lawyers advanced a novel theory: that Covidien’s use of the FDA’s Alternative Summary Reporting program, which routed malfunction reports to a nonpublic database instead of the searchable MAUDE system, was itself a failure to warn. The court rejected it, holding that “a duty to warn doctors under the learned intermediary doctrine does not correspondingly impose a duty to report to the FDA.” Causation was also fatal: the operating surgeon testified he had never reviewed the manufacturer’s instructions, marketing materials, or FDA adverse event reports before the surgery.⁶

In Kane v. Covidien, decided in February 2025, Judge Nusrat Choudhury of the Eastern District of New York took a partly different path in a wrongful death case involving a 60mm stapler used in a December 2021 surgery. She dismissed the design and manufacturing defect claims, finding the plaintiff had not identified a feasible alternative design or ruled out other possible causes such as user error. But she let the failure-to-warn claim proceed, finding it plausible that Covidien had given surgeons insufficient guidance on selecting staple height for different tissue thicknesses and had concealed failure rates through the ASR program.⁷ Whether that claim survives further litigation is an open question — Corrigan shows defendants have strong arguments at summary judgment.

The ASR program itself ran from 1997 through mid-2019 and, over that period, accounted for roughly two-thirds of all reported malfunctions and injuries involving approved medical devices.⁸ A 2019 KFF Health News investigation found that from 2011 to 2018, more than 56,000 stapler malfunctions were routed through the hidden channel; in 2016 alone, fewer than 100 stapler injuries appeared in the public database while nearly 10,000 reports went into the nonpublic system.⁹ The FDA ended the program in 2019 and made the data public. Plaintiffs continue to build failure-to-warn theories around it, with mixed results.

Verdicts and Settlements

Most surgical stapler cases resolve confidentially, but the public verdicts give a sense of range.

The largest is Kuhlmann v. Ethicon. A California jury awarded Florence Kuhlmann and her husband $79.8 million in December 2015 — $9.8 million in compensatory damages and $70 million in punitive damages. Kuhlmann had undergone a hemorrhoidopexy in January 2010 with an Ethicon PPH 03 stapler, which she alleged misfired and closed her anal canal. She suffered severe infections, needed multiple surgeries, and was left with a permanent colostomy bag.¹⁰ In June 2018, the California Court of Appeal reduced the total to $19.6 million, finding Ethicon’s conduct only “moderately reprehensible” and ruling that any punitive-to-compensatory ratio above two-to-one would violate due process.¹¹

Other reported outcomes include:

Garcia v. Ethicon (New York, 2023): $10.5 million for bowel perforations and infections.⁴
An $8.5 million verdict for the family of a 45-year-old man who died after a stapler misfired during weight-loss surgery.¹²
Ergler v. Ethicon (California, 2019): $8 million for hernias and pain after the device left open staples.
Strange v. Memorial Medical Center (Illinois, 2017): a $5.5 million wrongful death settlement following surgery in 2013. Covidien paid $250,000 of the total.¹
Selpec v. Ethicon (Pennsylvania, 2007): $5 million in a wrongful death case tied to a gastric bypass.
Carter v. Medtronic (Florida, 2022): $4.2 million for bariatric surgery complications.
Johnson v. Covidien (Texas, 2021): $3.7 million after a misfire during gastric surgery caused a leak.
Owen v. Medtronic (Kentucky, 2020): $2.9 million for a malfunction during liver surgery.⁴

Recalls That Can Support a Claim

Medtronic and Ethicon have collectively recalled more than 3.4 million staplers, staples, and components since 2013.¹ A device involved in a recall doesn’t automatically prove liability, but it often supplies the factual backbone for a claim. Notable actions include:

Medtronic, 2019: about 3.1 million units pulled after a missing component caused staple misalignment.⁴
Ethicon, 2019: 92,000 circular staplers recalled as Class I after misfires caused staples to penetrate too deeply; and, separately, 8,256 Echelon Flex Endopath Staplers recalled as Class I after an out-of-spec component produced malformed staples, linked to seven serious injuries and one death.¹³
Ethicon, 2025: the FDA classified a correction covering 57 lots of the Endopath Echelon Vascular White Reload as its most serious category, after reports of the device locking out mid-surgery, failing to cut or staple tissue, and contributing to one death and one injury.¹⁴
Intuitive Surgical, 2026: a Class I recall of 8mm SureForm 30 gray reloads used with the da Vinci robotic system, after incomplete staple lines on blood vessels led to four serious injuries and one death. Customers were told to quarantine and stop using the affected products.¹⁵

How Long You Have to File

Product liability deadlines vary by state, but most fall between two and four years from the date of injury or the date the injury was discovered. California, Texas, Pennsylvania, and Illinois apply a two-year deadline. New York allows three years. Florida moved from four years to two years for claims arising after March 2023.¹⁶ Some stapler injuries don’t produce symptoms right away, so the discovery rule — which starts the clock when a patient knew or should have known about the injury — can extend the window in some states.

What This Litigation Is Not

Two boundaries are worth flagging. There is no MDL consolidating surgical stapler cases into a single federal court, so a claim proceeds on its own timetable rather than joining an existing group. Bell v. Covidien, filed in Massachusetts federal court in September 2022, had depositions scheduled through July 2024 and still had no trial date as of mid-2026.¹ And Canadian residents have separate proposed class actions against Ethicon and Medtronic, filed by Siskinds LLP; those cases had not been certified as class actions as of mid-2026 and cover a different group of claimants than the U.S. suits.¹⁷

1
Drugwatch.com. Surgical Stapler Lawsuits
2
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3
U.S. Food and Drug Administration. FDA Takes Steps to Help Reduce Risks Associated With Surgical Staplers and Implantable Staples
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Miller & Zois. Surgical Stapler Lawsuit
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CaseMine. Corrigan v. Covidien L.P.
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Harris Martin Publishing. Covidien Awarded Summary Judgment in Mass. Federal Surgical Stapler Case
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CCH Product Liability. Kane v. Covidien LP
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UCLA Anderson Review. How Medical Device Makers Reacted to Publication of a Once-Secret Database of Millions of Adverse Events
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KFF Health News. More Than Half of Surgical Stapler Malfunctions Went to Hidden FDA Database
10
Borges & Associates. Jury Awards $79.8 Million in Ethicon Surgical Stapler Trial
11
Horvitz & Levy. Court of Appeal Reduces $70 Million Punitive Damages Award to $19.6 Million, Kuhlman v. Ethicon Endo-Surgery
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Douglas & London. Ethicon Surgical Stapler Lawsuit
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14
U.S. Food and Drug Administration. Disposable Surgical Stapler Cartridge Correction – Ethicon Endo-Surgery LLC
15
U.S. Food and Drug Administration. Surgical Stapler Reload Recall – Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
16
Woolsey Morcom. Legal Deadlines for Filing a Personal Injury Lawsuit in Florida
17
Siskinds LLP. Surgical Staplers Class Action