The surgical stapler market is expected to reach more than $8 billion by 2026, according to Grand View Research. Yet, many of the serious complications of these medical devices remain buried in the FDA’s adverse event report database. From 2011-2018, more than 110,000 surgical stapler incidents — including over 9,000 serious injuries and at least 400 deaths — were accumulating in public and private FDA databases. Now a growing number of surgical stapler lawsuits are being filed by injured patients, with plaintiffs claiming that manufacturers made mistakes in both the design and marketing of their products.
If you or a loved one believe you may have been injured by surgical staples, contact Showard Law Firm for award-winning and compassionate service. Your initial consultation is free, and you only pay us if we win compensation on your behalf.
What Is A Surgical Stapler?
A surgical stapler is a specialized device used to close wounds during surgery. This alternative to traditional sutures is routinely used in surgeries pertaining to the lungs, bowels, stomach, esophagus, scalp, hip, neck, heart, or cosmetically enhanced regions of the body.
Purported benefits of a stapling device include:
- Precise placement
- Faster wound closing
- Minimal skin penetration
- Less irritating material
Surgeons in just about every city and county have been trained to use stapling devices. Internal staples are often made of a dissolvable polylactide-polyglycolide co-polymer, whereas external staples may be fabricated out of metal or plastic and removed in as little as three days or after three weeks.
What Primary Side Effects Are Caused by Surgical Staples?
When a surgical stapler goes wrong, the results can be catastrophic. In one instance, a stapler misfire during a 62-year-old man’s liver surgery severed a vein. After 22 minutes of CPR, the patient remained in a coma for two weeks. When he came out of the coma, he was unable to walk or consistently recognize his wife and son. This is just one of many stories of harm caused during the placement of surgical staples.
Other reported problems include:
- Device Malfunctions – Issues include stapler misfiring unpredictably, jamming or not firing when necessary, failing to hold the tissues together securely, or firing out misshapen staples. More than two-thirds of surgeons say they encountered a surgical stapler malfunction or knew a peer who did.
- Surgeon Errors – Reports have been filed of surgeons stapling together the wrong tissues or using the wrong size/type of staple.
- Surgical Stapler Infection – A 2010 study found the risk of infection was three to four times greater for staples compared to sutures when used in joint replacement surgery.
- Surgical Stapler Injury – Injuries caused during the use of a surgical stapler may include intestinal dysfunctions like uncontrolled diarrhea or constipation, gastrointestinal blockages, organ damage, severe pain, bleeding, sepsis, or even death.
The manufacturer of a surgical stapler could be held liable for damages if the device malfunction can be traced back to a design or manufacturing flaw, a failure to warn doctors and consumers of known risks associated with the product, or complications traced back to the surgical staples themselves.
A surgeon may also be held liable for improperly using the technology. Depending on the unique circumstances of your case, an experienced lawyer will be able to tell you whether you have a product liability case, a medical malpractice claim, or possibly both.
Which Surgical Stapler Manufacturers Are Being Sued?
The two biggest surgical stapler manufacturers in the United States, accounting for 80% market share, are:
- Medtronic (which owns stapler maker Covidien)
- Johnson & Johnson (which owns stapler maker Ethicon)
Other stapler manufacturers include: Intuitive Surgical Inc; Dextera Surgical Inc; Conmed Corporation; Smith & Nephew; Becton, Dickinson and Company; 3M Company; B. Braun Melsungen AG; Purple Surgical; Frankenman International LTD; Welfare Medical LTD; Reach Surgical, Grena LTD; and Meril Life Sciences PVT LTD.
Has There Been A Surgical Stapler Recall?
The FDA received or initiated a total of 168 recalls for surgical staplers and staples from November 2002 to December 2018. One Class I recall, the most urgent type, was for a hemorrhoidal circular stapler that had difficulty firing, resulting in incomplete staple formation. The other recalls (class IIs) had issues related to non-conforming device components, design issues, malformed staples, impeded firing, or a breach in sterility.
In April 2019, the FDA initiated another Class I recall. Some 92,496 Ethicon circular staplers used in colorectal and bariatric gastrointestinal surgeries were recalled for insufficient firing. The malfunction led to death, sepsis, uncontrolled bleeding, the need for a permanent ostomy bag, life-long digestive issues, and the need for additional surgeries.
A surgical stapler recall is not necessary to file a surgical stapler lawsuit.
What Is the Status of Surgical Stapler Lawsuits?
Currently, there is no class action or multi-district litigation (MDL) related to surgical staplers. However, individuals continue to file their complaints in courts across America. Some of the surgical stapler lawsuits include:
- $5 million jury award – after the death of a Pennsylvania man, whose stomach contents spilled into the intestines during a botched gastric bypass surgery. Shortly thereafter, the Ethicon staplers were recalled.
- $5.5 million settlement – after a 33-year-old Central Illinois woman bled to death during a benign liver growth removal procedure, leaving behind a husband and two daughters, 6 and 8. Covidien argued the plaintiff couldn’t prove the stapler had a specific defect but agreed to pay $250,000 anyway. Memorial Medical Center paid another $250,000. The rest was covered by Dr. Sabha Ganai and Southern Illinois University.
- $80 million jury award – after a stapler misfire sealed a retired police officer’s anal cavity shut, causing 21 days of emergency hospitalization, infection, abdominal surgery, a full laparotomy, a colostomy, and the permanent use of a colostomy bag. Ethicon was ordered to pay over $9 million in compensatory damages, as well as $70 million in punitive damages.
While results cannot be guaranteed, the large sums indicate that judges and juries tend to react sympathetically to the suffering endured by surgical stapler patients.
Contact Showard Law Firm for Your Free Consultation
At Showard Law Firm, our exemplary results allow us the opportunity to offer all plaintiffs free consultations and contingency-based representation at no upfront cost. If a lawsuit is successful, damages may compensate you for:
- Past, present, and future medical bills
- Lost past, present, and future wages
- Pain and suffering
- Disability-related expenses
- In the worst cases, funeral and burial costs
No matter where you live, you are subject to your state’s statute of limitations on filing a personal injury lawsuit, contact Showard Law Firm as soon as possible to begin exploring your claim.
- Grand View Research, Global Surgical Stapling Market, https://www.grandviewresearch.com/press-release/global-surgical-stapling-market
- KHN News, More Than Half of Surgical Stapler Malfunctions Went To Hidden FDA Database, https://khn.org/news/more-than-half-of-surgical-stapler-malfunctions-went-to-hidden-fda-database/
- Healthfully, Why Use Staples Instead of Stitches, https://healthfully.com/use-staples-instead-stitches-wound-5879714.html
- FDA, Ethicon Circular Stapler Recall, https://www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-circular-staplers-insufficient-firing-and-failure-completely-form-staples