Surgical Staples Lawsuits
A surgical stapler is a common tool used in many types of surgeries in US hospitals. Surgical staples are commonly used to close wounds and surgical openings. However, surgical staplers can sometimes jam, misfire, or fail to close wounds.
The problem with surgical staples is widespread and potentially life-threatening.
A jury recently awarded $80 million in one surgical stapler lawsuit against manufacturer Ethicon, and many more are pending in courts across the country.
Deadly Consequences of Surgical Stapler Malfunctions
According to the Food & Drug Administration (FDA), 109,997 surgical stapler malfunctions were reported between 2011 and 2018. These surgical stapler malfunctions were associated with 11,181 serious injuries and 412 deaths.
Deaths were reported in incidents involving Ethicon and Covidien brand surgical staplers. Ethicon and Covidien are subsidiaries of Johnson & Johnson and Medtronic, respectively.
Manufacturers may have known about the risks of such devices for years, and many recalls have been issued.
This year, the United States’ largest surgical stapler manufacturer, Ethicon, recalled more than 90,000 units alone.
Since 2014, more than 2 million surgical staplers have been recalled across all brands due to risk of malfunction, surgical staple injury and even death.
In March 2019, the FDA warned medical providers about potential safety risks associated with malfunctioning surgical staplers. The FDA also announced that it was considering reclassifying surgical staplers as Class 2 medical devices, which would subject the products to more stringent testing prior to market approval.
Hidden Surgical Staple Injury Reports
To make matters worse, surgical stapler manufacturers may have concealed reporting on injuries and deaths associated with product malfunctions from doctors, hospitals, and the general public. Kaiser Health News recently reported that malfunction reports were being submitted to a secretive FDA database inaccessible to the public.
As a result, doctors were able to see only a small fraction of malfunction reports. In 2018, for instance, only 84 injuries or malfunctions were reported publicly, while almost 10,000 cases were recorded in the non-public database.
“It seemed like a cover-up,” said Dr. Doug Kwazneski, a Michigan surgeon who began investigating surgical stapler injuries in 2013. “Going into something without data is dangerous. If the information exists, we should have access to it.”
In February 2019, the FDA revoked manufacturers’ right to submit malfunction and injury reports to the non-public database and announced that all data would soon be made public.
Injuries from Surgical Staples
The risks associated with surgical stapler malfunction can be serious and even life-threatening.
Misfired staples can injure tissues and organs that were not intended to be stapled, resulting in serious injury and infection.
Staples that fail to close a wound or surgical opening can also result in:
- Internal bleeding
- Organ damage
- Nutritional and digestive issues
- Anastomotic leak
Stapler failures are not always immediately recognized, and damage can be permanent and, in some cases, irreversible.
Additional surgeries may be required to treat the problem, and these surgeries can lead to potentially fatal complications of their own.
Brands of Surgical Staplers
Two manufacturers account for the majority of surgical staplers on the US market today: Ethicon, a subsidiary of Johnson & Johnson, and Covidien, a subsidiary of Medtronic.
In May 2019, the FDA issued a Class 1 recall — its most serious type of recall — for Ethicon circular staplers, warning that “use of these devices may cause serious injury or death.”
The Ethicon surgical staplers covered by the recall were commonly used in gastrointestinal surgeries.
For more information on the Class recall, please visit the FDA Ethicon recall page.
Surgical Stapler Lawsuit
If you’ve been injured by a malfunctioning surgical stapler, you deserve justice — and you may be entitled to significant financial compensation.
A jury in California recently awarded $80 million to a victim who suffered serious internal injuries due to a malfunctioning stapler, and many more lawsuits are pending.
If you’ve suffered injury due to a malfunctioning Ethicon or Covidien surgical stapler, please contact our experienced defective medical device attorneys at 1-800-525-7111 or complete the short form below.
There is no obligation, and there are no upfront costs or attorney fees unless we win your case and you receive financial compensation.
The personal injury and wrongful death attorneys at Riddle & Brantley have more than 220+ years of combined legal experience fighting for injury victims and have won multiple five, six and even seven-figure settlements and judgments for our clients.
If you’ve been injured by a defective surgical stapler, you deserve justice.
Please call 1-800-525-7111 for a FREE consultation and case review.
Justice Counts, and we would love to help if we can.