A surgical stapler lawsuit is a mass tort claim by a victim against the device manufacturers. In these lawsuits, plaintiffs allege that a design defect caused the staplers to misfire. And this malfunction caused their organ damage and other complications.
The frequency of surgical stapler misfires has been under-reported for years. Only recently the FDA made public the thousands of non-fatal incident reports. And hundreds of others died from their injuries.
Shouse Law Group is helping surgical stapler victims sue the device-makers. We are pursuing substantial financial compensation to pay for doctor’s bills, lost wages, and pain and suffering.
The statute of limitations to bring a claim is short. So victims are advised to consult with an attorney quickly.
In this article, our surgical stapler lawyers explain:
- 1. What are surgical staplers and staples? Who makes them?
- 2. Are surgical staples safe? What injuries do they cause?
- 3. Have there been recalls?
- 4. How does the FDA monitor the safety of surgical staplers?
- 5. What are the grounds for a lawsuit? Are they individual or collective?
- 6. What money damages can surgical stapling victims recover?
1. What are surgical staplers and staples? Who makes them?
Surgeons use surgical staplers to close wounds or incisions. Staples are an alternative to sutures and stitches. And they work more quickly and with less inflammation.
There are many types of staples:
- Plastic – for patients with metal allergies.
- Polymer – used in plastic surgeries to reduce scarring.
- Dissolvable – preventing the need for a second surgery to remove them.
- Titanium – which does not affect MRI scans.
- Circular – for specific operations, like esophagogastric surgery.
There are also several types of surgical stapler devices: Disposable, reusable, large, and small. Companies that manufacturer surgical staplers and staple lines include:
- B. Braun
- Covidien, a subsidiary of Medtronic
- Ethicon, a subsidiary of Johnson & Johnson
- Meril Life Science
- Purple Surgical
- Reach Surgical
- Smith + Nephew
- U.S. Surgical, a subsidiary of Medtronic
- Welfare Medical
- Zimmer Biomet
2. Are surgical staples safe? What injuries do they cause?
Surgical stapling carries numerous risks. Risks that are not present with sutures or stitches.
Four problems associated with staples include:
- The staple can break during placement. Or at some point afterwards.
- The staple can cause an allergic reaction in the patient.
- Bacteria on the staple can cause an infection at the incision site.
- Metal or plastic from the staple can leach into the bloodstream.
Four problems associated with staplers include:
- The stapler can jam during the surgical procedure. The surgical staff then scramble for other tissue-binding methods. This may cause blood loss. And while the incision is open, infection risks increase.
- The stapler can fire with too much or too little force. This causes damage to the tissue. Or it fails to close the incision.
- The stapler can fire inaccurately. This sends a staple into the wrong place. This can cause serious complications.
- The stapler can fire accidentally. This may create an unforeseen medical condition.
All this may cause new wounds. And it may prevent wounds from healing correctly. Just some injuries caused by defective surgical staplers include:
- Excessive bleeding,
- Internal bleeding,
- Cardiac arrest from blood loss,
- Fistula formation, and
- Tearing and damage to internal tissues and even internal organs
- Permanently damaged digestive systems and other digestive issues
- gastrointestinal surgeries
- heightened risk of cancer recurrence
- anastomotic leaks
- Need for permanent ostomy bags
- Need for additional surgeries
In some cases, surgical stapler injuries cause fatal complications.
3. Have there been recalls?
Yes. Recent surgical stapler and staple recalls include:
Stapler / Staple
|2019||Ethicon||Class I recall of Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples (and endoscopic)|
|2019||Medtronic||Endo GIA Articulating Reloads with TriStaple Technology|
|2018||Medtronic||Endo GIA “Auto Suture” Universal Articulating Loading Unit|
|2015||Ethicon||Endopath Echelon Flex Powered Vascular Staplers|
|2013||Ethicon||ECHELON 60mm Endoscopic Linear Cutter Reloads|
Some reasons for the recalls are:
- Missing components
- Bad alignment
- Reload problems
- Other defects and malfunctioning problems
For a full list of recalled devices including the Ethicon surgical staplers, visit the FDA surgical stapler recall page.
4. How does the FDA monitor the safety of surgical staplers?
The U.S. Food and Drug Administration (FDA) regulates surgical staplers as Class I medical devices. Class I devices are supposed to have minimal potential harm. And their design should be simple.1 Other examples of Class 1 devices include:
- Elastic bandages,
- Latex gloves,
- Tongue depressors, and
Class I devices are exempt from many FDA regulations. This exemption includes the mandatory reporting of malfunctions and injuries. Therefore, non-fatal surgical stapler malfunctions are not on MAUDE. This stands for Manufacturer and User Facility Device Experience. MAUDE is a public database that tracks medical device failures.
Medical providers rely on MAUDE for safety data. They use it to make informed decisions about medical devices. But the only data on MAUDE for surgical staplers involve fatalities. This is a tiny fraction of the total number of incidents.
Instead, non-fatal incident reports went to ASRP. This is short for Alternative Summary Reporting Program. This FDA database was not accessible to the public until June 2019. (This formerly hidden database can now be accessed here.)2
Surgical stapler companies took advantage of the Class 1 classification. They could hide evidence of the stapler-caused injuries. They could report non-fatal incidents to ASRP instead of MAUDE.3 It took doctors a while to catch on. Many surgeons became suspicious of the low numbers on MAUDE.4
The number of surgical stapling incidents submitted to ASRP was high. Finally, the FDA issued a letter to health care providers warning them of the danger.5 From 2011 through March 31, 2018, there had been more than 41,000 medical device reports claiming stapling malfunctions. These caused such adverse events as:
- 366 deaths, and
- More than 9,000 serious injuries
Many of these injuries and fatalities resulted from a defective stapler.6
The FDA said it would reconsider its Class I classification of surgical staplers.7 It also issued draft guidance for surgical stapling companies.8
5. What are the grounds for a lawsuit? Are they individual or collective?
Victims can bring a defective design claim against the surgical stapler manufacturer. Plaintiffs would need to prove:
- The device’s defective design posed a foreseeable risk, and
- The device was manufactured and used as it was supposed to be
Manufacturers try to pin all blame on the surgeon. They claim the medical professionals using the stapler was negligent and committed medical malpractice. Not that the device was faulty and lacked proper disclaimers.
Nevertheless, many lawsuits led to sizeable trial verdicts. In 2015, Ethicon was ordered to pay $80 million to a surgical staple victim. That included $70 million in punitive damages. The victim had nearly died from complications. Her anal canal was sealed shut by a defective stapler. The stapler model was subsequently recalled.9
6. What money damages can surgical stapling victims recover?
Plaintiffs’ attorneys pursue settlements that cover all compensatory damages. These are costs and losses the injuries caused. Examples include:
- Past and future medical expenses,
- Lost wages,
- Future inability to earn a living, and
- Pain and suffering (often the highest cost)
Most cases resolve through negotiation. But if a case goes to trial, plaintiffs’ attorneys would also fight for punitive damages. These are meant to punish defendants for wrongful conduct. Such as refusing to recall a dangerous surgical stapler. And punitive damages are often greater than compensatory damages.
Contact us for help…
Are you or a loved one the victim of surgical staples gone wrong? Call our mass tort attorneys for a free consultation on bringing a legal action. Or fill out the form on this page. We will fight for the largest settlement possible. And you pay nothing unless we win.
- See Medical Device Regulation Act.
- See Christina Jewett, “Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices,” Kaiser Health News (March 7, 2019).
- See Kwazneski D, Six C, Stahlfeld K, “The unacknowledged incidence of laparoscopic stapler malfunction,” Surgical Endoscopy 27(1):86-9 (January 2013).
- FDA, “Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers,” (March 8, 2019).
- Id. (“The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.”)
- FDA, “Surgical Staplers and Staples for Internal Use – Labeling Recommendations,” (April 23, 2019).
- Evan Sernoffsky, “Retired San Jose officer awarded $80 million over botched surgery,” SFGate (December 16, 2015).