Surgical staplers and implantable staples have been linked to thousands of patient injuries and hundreds of deaths. A surgical stapler lawsuit is an option for those harmed because of a device malfunction.
Bernstein Liebhard LLP is offering free, no-obligation legal consultations to victims of surgical stapler injuries, including:
To learn more about filing a surgical stapler lawsuit, please call our office today at (888) 994-5118.
Surgeons use internal staplers in roughly 100,000 procedures annually, including:
Surgical staplers and implantable staples have actually outpaced sutures in recent years, partly due to the rise in minimally-invasive surgery. However, stapling also offer certain advantages over traditional suturing, including quicker placement and stronger wound closure. Yet surgical staplers often malfunction, and it’s unclear if these advantages outweigh the potential for serious patient injury.
According to the U.S. Food & Drug Administration (FDA), internal surgical staplers and implantable staple systems were associated with more than 41,000 adverse event reports during a seven-year period from January 1, 2011 to March 31, 2018. These events included 366 deaths, more than 9,000 serious injuries, and over 32,000 stapler malfunctions.
“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,” the agency noted.
The FDA’s adverse event reports echo allegations contained in several recent surgical stapler lawsuit filings. These cases also detail how quickly a device malfunction can turn catastrophic for patients.
For example, one recent complaint claims that a patient actually lost a lung after a Covidien stapler malfunction prevented his doctor from sealing a major blood vessel. Although it denied the allegation, Covidien agreed to a confidential settlement in 2017.
In 2013, a young mother allegedly died because another Covidien stapler malfunctioned during a procedure to remove her benign live tumor. The company once again denied liability, but agreed to pay her family $250,000.00 as part of a larger settlement.
And according to a still-pending complaint, another patient lost 3 quarts of blood when a Covidien surgical stapler misfired during a procedure to remove a liver abscess. The patient survived, but remained on life support and in a coma for weeks. Once he awoke, however, the man could no longer walk, comb his hair, or recognize the letters of the alphabet.
According to Kaiser Health News, surgical stapler injuries and deaths are an acknowledged problem, largely because the FDA allowed manufacturers to report adverse events to a secret database that isn’t accessible to doctors and patients.
Generally, the agency requires medical device companies to report complications to the publicly-available MAUDE database. But in 2000, the FDA began allowing manufacturers to apply for exemptions via an “Alternative Summary Program.” Once a company received an exemption for a certain device, they could report adverse events to the hidden database.
During the first 28 months of its existence, surgical stapler manufacturers submitted more than 5,000 adverse event reports to the FDA’s secret database. In 2016 alone, over 10,000 stapler-related reports were logged with the program.
Meanwhile, information from the MAUDE database suggests surgical stapler malfunctions and injuries are relatively rare. In 2016, for example, stapler manufacturers submitted just 84 adverse event reports to the public database. They only reported 18 adverse events to MAUDE in 2011, while 79 public reports were logged last year.
One day after Kaiser Health News published its findings, the FDA announced a sweeping safety review of surgical staplers.
“The FDA intends to issue a new draft guidance for public comment this year, which will describe proposed recommendations for manufacturers of surgical staplers and staples for internal use about information to include in their product labeling, which will help health care providers better understand the appropriate use and the risks of these products,” the agency said in March 8th News Release.
The FDA is analyzing surgical stapler injury reports from the Alternative Summary Program database as part of the review. It will make that information public once the analysis is complete.
Among other things, the regulator suggested it might reclassify internal surgical staplers to bring the devices under tighter control.
“Currently, surgical staplers for external and internal use are regulated as Class I medical devices, which do not require a premarket submission to the FDA,” the agency said. “Reclassifying surgical staplers for internal use as a Class II device would subject them to premarket notification and allow the FDA to establish mandatory special controls to help mitigate known risks of the device.”
Victims of surgical stapler malfunctions may be entitled to compensation for all of their injury-related damages, including:
To learn more about filing a surgical stapler lawsuit, please contact Bernstein Liebhard LLP today by filling out the form on this page, or call the office directly at (888) 994-5118.
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