Surgical Stapler Lawsuits | Malfunctioning Causing Injury
Surgical staplers have been used as a supposedly easier way for physicians to close wounds after a procedure as an alternative to stitches. They are supposed to provide for a quicker and more effective way to close lacerations and incisions. The thought is they shorten the length of a surgical procedure or close a wound more quickly. However, these surgical staplers do not always work as intended. By 2018, there were over 40,000 reports of these medical devices malfunctioning provided to the FDA. Some of these adverse event reports involved serious injuries. Over 9,000 patients were seriously injured by these devices, with 366 fatalities reported during that time span. Some of these injuries were allegedly caused by defects in the surgical staplers. As a result, there have been scores of surgical stapler lawsuits filed against the makers of these products. The real number of adverse event reports related to surgical staplers topped 100,000. While some of these reports related to physician misuse of the staplers, quite a few dealt with situations of possible defects.
There Have Been Tens of Thousands of Reports of Surgical Stapler Malfunctions
The truth is that the injury numbers are even worse than that. For years, the FDA hid many reports of grave injuries from the general public. The agency allowed a secret reporting system that kept consumers from knowing about the true risks of the products that they used that could possibly kill them. As a result, the public did not know the true extent of the injuries associated with surgical staplers. Now, the American public is finally learning exactly how dangerous the manufacturers have made these products.
Update- 9-13-2022- “Medtronic and it’s Covidien subsidiary face a product liability lawsuit filed by a North Carolina woman, who indicates she was left with severe injuries when a surgical stapler malfunctioned, resulting in tissue damage and the need for additional surgeries. The complaint (PDF) was filed by Kimberly Bell in Massachusetts federal court on September 9, indicating that an Endo GIA 45mm stapler with Tri Staple Technology malfunctioned during surgery, causing a “tear” in the surgical area, leading to prolonged hospitalization and extensive medical care. The case joins a growing number of surgical stapler lawsuits being pursued against Covidien and other manufacturers, each raising similar allegations that design defects caused the devices to misfire, fail to fire or issue malformed staples, which can cause devastating internal injuries and organ perforations.” about lawsuits
12-10-19- “Medtronic, one of the top companies in the multibillion-dollar market for staples and staplers used in surgery, declined to comment on the pending litigation. The company filed a 219-page report with the Food and Drug Administration last month arguing that real-world experience with the 23 different internal stapling systems it sells confirmed the “consistent and favorable safety profile of Medtronic staplers.” Overall, deaths were associated with the staplers in 0.0005% of cases, and injuries were associated with the devices 0.017% of the time. In most cases, [the deaths and injuries] are related to the inherent risks of the surgical procedure, patient co-morbidities, or the manner in which the device was used,” the company said in its Dec. 19 filing with the FDA.” Star Tribune
5-30-19 –“The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018… When the FDA initially announced the meeting in March, it acknowledged in a letter to doctors that “many more device malfunction reports” were reported to the agency than it had publicly disclosed. The FDA executive summary published this week shows that the total reports more than doubled when the agency took nonpublic reports into account, totaling nearly 110,000 malfunctions or injuries from 2011 through 2018.” KHN
Defects in Surgical Staplers
The adverse event reports that relate to possible defects involve the following situations.
- Surgical staplers having difficulty in firing
- Misfiring of staples
- Malformed staples being fired
- Failure to fire staples
The FDA Is Regulating Staplers Differently Now that the Public Knows of the Dangers
The FDA is also now committed to being more honest with the American public about the dangers of these devices. Previously, the FDA approved surgical staplers with little by way of review. By classifying these as low-risk devices, the FDA deprived the public of the level of review needed to keep the public safe. Now, the FDA has reclassified surgical staplers as moderate-risk medical devices. This will mean that there will be a higher standard of review for these devices in the future. However, this does little to protect the millions of people who are at risk from potentially defective surgical staplers that are already being used in surgical procedures today.
Injuries from Surgical Staplers
Surgical staplers allegedly malfunction and have caused serious injuries. Some of these injuries can include:
- Internal bleeding
- Organ damage
- Inadvertent sealing of bodily cavities
In severe cases, this can lead to death. The problem with surgical staples is that it can lead to post-surgical complications. In many cases, doctors do not know at first that there has been a problem with the surgical staples. They only realize that there is a problem because the surgical wound can open or become infected. Patients may end up in serious pain after the surgery as the site of the procedure becomes swollen and red. They may even develop a high fever after the procedure. This can lengthen their hospital stay and put their lives in danger.
Surgical Stapler Recalls
Unfortunately, surgical staplers have been the subject of many recalls over the years. Here are some of the examples of FDA recalls:
- In April 2019, Ethicon recalled their Endo-Surgery stapler. This recall affected nearly 100,000 surgical staplers. It is categorized as a Class I recall, meaning that there was a danger to patients’ lives. Here, the issue was that the staplers were misfiring. Two patients received severe injuries from the misfiring, suffering severe cuts to their rectum during surgery.
- Earlier in 2019, Medtronic recalled over three million staplers because there were missing components that impacted staple alignment. These missing components have the potential to cause injury.
- Among other recalls, Ethicon recalled over 50,000 staplers in 2013 because there were issues with reload that prevented a full line of staples from firing. This affected the stapler’s ability to fully close the wound.
While some of these defects sound harmless, they are anything but. Missing components can lead to staple failure and serious infections. Anytime one is talking about something that can close a surgical wound, there is always the possibility for severe bleeding and sepsis. Post-surgical infections are a leading cause of hospital death in the U.S.
The Surgical Stapler Market
The surgical stapler market is a large one. Several research estimates place the size of the global market at over $4 billion in 2018. The market is growing quickly and is expected to reach $8 billion by 2026. Surgical staplers can cost between $300-2000 each. The surgical stapler market is currently dominated by two players: Medtronic’s Covidien and Johnson & Johnson’s Ethicon. Between them, these companies control about 80% of the surgical stapler market. Some other companies that make surgical staplers include:
- Intuitive Surgical Inc; Dextera Surgical Inc
- Conmed Corporation
- Smith & Nephew
- Becton, Dickinson and Company
Medtronic and Johnson & Johnson’s products have faced the bulk of the product defect issues, both in terms of FDA recalls and lawsuits. These are the companies who have also faced the most lawsuits and have the highest legal risk.
Surgical Stapler Lawsuits
The number of lawsuits against surgical staplers is starting to grow in the wake of the massive 2019 Medtronic recall. At this point, there is no multidistrict litigation against these companies. That could be a possibility in the future if the number of court cases continues to grow. Plaintiffs have had some success in surgical stapler lawsuits. One prominent case was decided by a jury in 2016. The plaintiff filed suit after her anal canal was sealed shut by a defective surgical stapler manufactured by Ethicon. The jury awarded her a total of $80 million in damages. $70 million of this award was for punitive damages.
In this particular case, there were numerous complaints about the surgical stapler. However, Ethicon delayed a recall, claiming that they checked the product and there was no problem. The company knew of the problems and the danger of the surgical stapler as it continued to sell the product. The jury found that Ethicon was grossly negligent in selling the defective product. Another surgical stapler lawsuit for wrongful death resulted in a $5.5 million settlement.
Here are some of the common grounds of complaint against surgical stapler manufacturers:
- The device maker should be strictly liable because there was a manufacturing defect in the device. Moreover, many plaintiffs have also alleged design defects in the staplers.
- Defendants were negligent when they designed, manufactured, tested and inspected the surgical stapler.
- Device makers committed fraud or misrepresented the product when they failed to warn the public of certain dangers of these products.
- Defendants owed a duty to disclose the dangers of these staplers to the general public.
When you file a surgical stapler lawsuit, the damages to which you are legally entitled could include the following:
- The cost of all your past and future medical bills
- Pain and suffering
- Emotional distress
- Lost wages for the past and future time that you would miss from work or the reduction in your earnings capacity
- Wrongful death if someone died from their injuries
- Possible punitive damages depending on how badly the defendant acted
- Loss of enjoyment of life
Contact an Experienced Surgical Stapler Lawyer
If you or a loved one has been injured by defective surgical staplers, you may be entitled to substantial financial compensation in a products liability lawsuit. The first step is to file a lawsuit against the maker or the seller of the surgical stapler. Here, you would need the services of an experienced products liability attorney since these surgical stapler lawsuits can be scientific and technical in nature. Call us today to schedule your free consultation and begin work on your surgical stapler lawsuit before the statute of limitations runs out on you.