Surgical stapling lawsuits are mass tort claims against doctors, hospitals, and device-makers seeking compensation for the injuries that happen after a surgical stapling procedure has gone wrong. Staples are increasingly being used during surgeries as an alternative to stitches or sutures. But the staplers that surgeons use can misfire during a procedure, leading to serious injuries and medical complications. The frequency of these misfires has likely been underreported for years, prompting the FDA to consider taking action.
In this article, our products liability lawyers explain how surgical stapling works and the problems that can arise. We will then discuss recent developments that have revealed that surgical stapling injuries are far more widespread than previously thought. Finally, we will look at current lawsuits dealing with surgical stapling injuries, the compensation that victims can recover, and what to do if you think you have been hurt by a surgical stapling mishap.
- 1. Surgical staplers and staples
- 2. Problems with surgical stapling
- 3. Poor oversight fails to detect magnitude of surgical stapling injuries
- 4. Surgical stapling lawsuits
- 5. Compensation available to victims of surgical stapling problems
1. Surgical staplers and staples
Just like sutures or stitches, surgical staplers and staples are used during internal or external surgical procedures to quickly close wounds or incisions, or to bind tissue together. The increased speed and reduced inflammation have made stapling an increasingly more popular solution than suturing or stitching incisions.
The specific stapler and the staples that a surgeon uses, depends on the circumstances. For example, there are numerous different types of staples, like:
- Plastic staples for patients who might react adversely to metal ones,
- Polymer staples, which are used in plastic surgeries because they can leave less scarring,
- Dissolvable staples, which are especially useful for internal procedures that would otherwise require another surgery to remove them,
- Titanium staples, which do not affect subsequent MRI scans, and
- Circular staples for specific surgeries, like esophagogastric surgery.
There are also several types of surgical stapler, including:
- Disposable staplers,
- Reusable staplers,
- Large staplers, which look like those used on construction sites, and
- Small staplers, which look more like those used in an office, without the room for extra staples.
A handful of companies are involved in designing and manufacturing surgical staplers and staples, with the major players being:
2. Problems with surgical stapling
Surgical stapling, however, is not perfect. There are numerous risks associated with surgical stapling that are not present when doctors and surgeons elect to suture or stitch an incision, instead.
Some of these problems are caused by the staple:
- 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 site of the incision, or
- Metal or plastic from the staple can leach into the bloodstream,
Other problems are caused by the stapler:
- The stapler can jam during the procedure, forcing nurses and the surgeon to use another way of closing an incision, complicating the procedure and causing blood loss and increasing the risk of infection while the incision is open,
- The stapler can fire with too much or too little force, causing damage to the tissues or failing to adequately close an incision,
- The stapler can fire inaccurately, sending a staple into the wrong place, damaging the tissue there, and causing serious medical complications, or
- The stapler can fire accidentally, creating a serious and unforeseen medical condition.
Still other problems are caused by the surgeon's negligence, like:
- The wrong size staple was used for the procedure,
- The wrong type of staple was used,
- The staple was improperly placed so the wound did not heal or close correctly,
- The staple is removed too quickly, letting the wound or incision reopen, or
- The surgeon misfires the stapler, sending the staple into the wrong place and causing serious damage.
Mishaps like these can be severe or even fatal, especially when a staple is injected into a patient where it should not have been. In many of these cases, a defective stapler or defective staples could have been the root cause of the problem.
3. Poor oversight fails to detect the magnitude of surgical stapling injuries
As of April, 2019, the U.S. Food and Drug Administration (FDA) has regulated surgical staplers and staples as Class I medical devices. Class I medical devices are supposed to be those that present minimal potential for harm to a patient, and have a relatively simple design.1 Surgical staplers and staples are outliers in Class I, though, as they are found alongside far more mundane things like:
- Elastic bandages,
- Latex gloves,
- Tongue depressors, and
Importantly, almost all Class I devices are exempt from the bulk of the FDA's regulatory process, including the mandatory reporting of device malfunctions and the injuries they cause. As a result, non-fatal surgical stapler malfunctions cannot be found on the Manufacturer and User Facility Device Experience, or MAUDE, a publically-accessible database run by the FDA that tracks medical device failures.
Importantly, MAUDE is not just frequented by interested members of the public and journalists – doctors, surgeons, medical engineers, and even hospitals also use MAUDE to find safety data on medical devices so they can make informed decisions and provide better care for patients. Unbeknownst to the medical field, the only data available on MAUDE for surgical stapling devices involved fatalities – a tiny fraction of the total number of incidents.
Instead of being reported on MAUDE, non-fatal incidents involving surgical staplers or staples had been sent to the FDA's Alternative Summary Reporting Program (ASRP) – a database of incident reports that was not accessible to the public and that was conspicuously devoid of many important details.2
Companies that designed and manufactured surgical stapling devices had seen an opportunity to hide evidence that their Class I medical devices were linked to numerous injuries. They sought the exemptions necessary to report non-fatal incidents to the ASRP instead of MAUDE, and got them.3 It took medical professionals awhile to catch on: Many surgeons became suspicious of the low numbers on MAUDE after finding that a shocking number of their peers had experienced a surgical stapling malfunction.4
The number of surgical stapling incidents submitted through the ASRP was so high that the FDA issued a letter to health care providers to warn them of the danger.5 According to the FDA's figures, from 2011 through March 31, 2018, reports indicated that there had been over 32,000 surgical stapling malfunctions that caused:
- 366 deaths, and
- Over 9,000 serious injuries.
Many of these injuries and fatalities were the result of a defective stapler.6
Some of the injuries in the reports were severe, including:
- Excessive bleeding,
- Fistula formation, and
- Tearing and damage to internal tissues and even organs.
The FDA has announced that it would revisit its classification of surgical stapling devices as Class I medical devices.7 It also issued draft guidance for surgical stapling companies.8
4. Surgical stapling lawsuits
Numerous lawsuits have been filed on behalf of victims who have been hurt by a malfunctioning surgical stapler. These lawsuits are partially medical malpractice claims against the doctors and hospitals involved in the surgical stapling procedure, and partially products liability claims against the makers of the stapling devices.
In nearly every one of them, though, the surgical stapling companies have tried to pin blame on the operating surgeon by saying the surgeon's negligence was responsible for the stapler's misfire.
Nevertheless, many lawsuits have gone to trial and led to sizeable verdicts for the victim. Most prominent among them was a recent California case that ended with a victim being awarded $80 million – including $70 million in punitive damages and surgical stapler manufacturer Ethicon. The victim had nearly died from complications after her anal canal was sealed shut by a defective surgical stapler that was subsequently recalled.9
5. Compensation available to victims of surgical stapling problems
Victims of surgical stapling mishaps can recover compensatory damages that aim to cover their costs and losses associated with the injuries. These damages compensate victims for their:
- Past and future medical expenses,
- Lost wages and professional repercussions from the injury and the recovery from it,
- Future inability to earn a living due to the injuries sustained,
- Physical pain, and
- Mental suffering and anguish.
Additionally, prior lawsuits over defective surgical staplers have led to punitive damages, as well. These are meant to punish defendants for especially wrongful conduct, like refusing to recall a device that is known to be putting innocent people at risk.
Contact us for help...
If you have discovered that a surgical stapling procedure has gone wrong and that you or a loved one has been hurt, call the medical malpractice, products liability, and mass tort attorneys at the Shouse Law Office at 855-LAWFIRM for help.
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).