Surgical Stapler Injury and DeathUnpublicized in FDA Secret Database

Surgical Stapler Injury and Death

Surgical Stapler Lawsuit Update - Medtronic Sued For Surgical Stapler Injuries

 January, 2020 - Three personal injury cases against Medtronic were filed in January of 2020. The lawsuits, filed in Minnesota and Texas, were for injuries sustained from surgeries years prior. Each surgery was gastrointestinal.

The plaintiffs claim that the doctors knew about the unreliable stapler devices before the surgery but proceeded anyway. The result was years of complications and additional treatment that were easily preventable.

Companies like Medtronic are required to file a report with the FDA as soon as they learn one of their products is defective. This system was changed last year when it was discovered that Medtronic was filing private reports with the FDA, an unintended mechanic of the reporting policy.

Thousands of additional patients have come forward with complaints of surgical stapler injuries ranging from infection to tissue damage and even death. If you or someone you know has suffered injuries from surgical staplers, call TorHoerman Law to see if you’re eligible for a lawsuit.

Read More Updates

If you or a loved one suffered an injury from a surgical stapler, you may qualify to participate in a surgical stapler lawsuit. Talk to a surgical stapler lawyer about your surgical stapler injury and discuss your legal options with no-obligation required and free of charge.

 

 

Surgical Stapler Lawsuit Filed on Behalf of Injured Patients

Surgical staplers are used in a number of routine surgeries, but what happens when a routine surgery becomes a matter of life and death? That is exactly what has happened for thousands of patients who have suffered potentially fatal injuries resulting from surgical stapler defects.

Many of these surgical stapler adverse events went unreported, or so it would appear, as the reported surgical stapler injuries and deaths were housed in an FDA secret database, referred to as “alternative summary reporting.” The “alternative summary reporting” database skewed the total known adverse events reports, limiting public awareness of the dangerous risks associated with surgical staplers.

In a damaging report released by Kaiser Health News, the FDA supposedly had created and expanded a “vast and hidden repository of reports on device-related injuries and malfunctions.” Included in that hidden database are reports of injuries or deaths caused by surgical staplers.

Surgical stapler lawsuits are now being filed on behalf of patients who suffered surgical stapler injuries, unaware of the adverse effects associated with the medical devices.

 

 

What are Surgical Staplers and Surgical Staples?

Used in “gastrointestinal, gynecologic, thoracic, and many other surgeries”, surgical staplers are used both externally and internally. Removable skin staples, for external use, “close wounds under high tension, including wounds on the scalp or the trunk of the body.” Internally, surgical staples “deliver compatible staples to internal tissues during surgery.”

But, thousands of reports of surgical staplers malfunctioning during surgery have been recorded. In one such instance, a surgical stapler misfired during a man’s liver surgery, severing a vein. CPR was performed for 22 minutes. The individual was in a coma for two weeks, and when he woke, he was unable to walk. His surgical stapler injury story is one of many – men and women injured or killed by surgical stapler malfunctions.

If you were to look up reports of injuries in the public database in 2016, 84 adverse events were reported. The FDA secret database paints a different story. Nearly 10,000 malfunctions were reported to the hidden database – an alarming difference.

 

 

Ethicon Surgical Stapler Lawsuit Filed on Behalf of Injured Patient

In 2012, a Pennsylvania family alleged the death of their loved one was caused by a defective stomach stapler during gastric bypass surgery. The Ethicon stapler, according to the lawsuit, failed to properly seal the surgical area which then allowed the stomach contents to spill into the intestines. A jury awarded the family $5 million in damages. In May 2013, the surgical staplers, like the one used in the botched gastric bypass surgery, Ethicon Echelon 60 mm, and Echelon Flex were recalled due to the high adverse events reported.

In another surgical stapler incident on January 2012, Florence Kuhlmann alleged that an Ethicon proximate surgical stapler misfired and sealed her anal cavity-causing two weeks of hospital care and the permanent use of a colostomy bag. A California jury awarded her $80 million, including nearly $70 million in punitive damages. In October 2012, Ethicon recalled over 157,000 of the hemorrhoid staplers.

 

 

What Causes Surgical Stapler Injury?

While the issue of how injuries are reported is recent, complications as a result of surgical staplers are not and have been occurring for years. Most commonly, injuries and death are caused by:

  • Device malfunction, including misfiring
  • Design defect, which is when the design of the stapler is at fault for an injury
  • Manufacturing defect, which is when the device was assembled incorrectly
  • Complications with surgical staples
  • A failure to warn, which is when the manufacturer failed to warn consumers of risks associated with the stapler

Many surgical stapler lawsuits claim error by the surgeon caused injuries or death of patients, but there have many, many reports of defective surgical staplers that misfired provoking questions of fault.

 

 

Surgical Stapler Risks

Surgical staplers are more convenient than sutures, but it comes at the cost of having some additional risks. Many things can go wrong with the staples which lead to new injuries such as infection or allergic reaction. Furthermore, the stapler sometimes misfires or doesn’t staple with proper force. Issues with the stapler and staples have caused some patients lifelong health troubles that were completely unrelated to the procedure they were undergoing. If your health has been compromised because of a surgical stapler or staples, you may be eligible for a lawsuit.

 

 

Surgical Stapler Injuries

Patients who undergo a surgery that requires surgical staples are subject to many different stapler injuries, including:

  • Excessive bleeding
  • Tissue damage
  • Organ damage
  • Fistula
  • Infection, followed by sepsis
  • Recurring cancer cells

 

 

Surgical Stapler Side Effects

Many side effects come with getting a surgery using staples: scarring, fever, nausea, infection, fatigue, or restlessness. However, the side effects of surgical staplers themselves stand out because the staples have a quick and noticeable effect on the area being operated. It’s possible for surgical staplers to cause bleeding or to tear tissue while the surgery is still in progress, for example. If you aren’t sure whether your injuries are from the staples or something else, ask your doctor or call a surgical stapler lawyer.

 

 

Are Surgical Staplers Safe?

The modern surgical stapler has been around for decades, but the injuries it causes weren’t addressed by the government until around 2013 during the first stapler recall. Properly designed staplers used at the discretion of skilled doctors are generally safe. Many of the faulty devices have been revised or recalled upon causing widespread injuries. If you are expecting to undergo surgery, talk to your doctor about whether they will use staples.

 

 

FDA Announces Surgical Stapler Safety Review

The report released by Kaiser Health News prompted the FDA to release a response to the public on March 8, 2019. The letter announced a plan to review the safety of surgical staplers. As part of the review, the FDA could reclassify the staplers, putting them under tighter control. Also, recommendations to surgical stapler manufacturers could be issued.

 

 

Surgical Stapler Recalls

The first surgical stapler recall happened in 2013, when Ethicon brand staplers were discovered to have a reloading issue that would cause the device to stop stapling. There have been four other recalls since then as more injuries have surfaced. Attorneys are currently investigating if there are more stapler devices that ought to be recalled.

 

 

FDA Recalls Surgical Staplers

The FDA has been continually monitoring surgical staplers for years. Since the first recall in 2013, patients who have suffered injuries have helped the organization learn about the faulty devices. The most recent FDA recall was in late 2019, although the lawsuits coming in against surgical staplers are expected to change that soon. You can read about the latest surgical stapler FDA recalls on this page.

 

 

Which Surgical Staplers Have Been Recalled

The FDA has recalled the following staplers:

  • Ethicon Echelon Flex staplers, recalled in 2019
  • Ethicon Endo-Surgery Curved staplers, recalled in 2019
  • Medtronic Endo GIA Articulating Reloads staplers, recalled in 2019
  • Medtronic Endo GIA Auto Suture staplers, recalled in 2018
  • Ethicon Endopath staplers, recalled in 2015
  • Ethicon Echelon 60mm staplers, recalled in 2013

If you know of a stapler that has not been recalled but caused injuries, contact a surgical stapler lawyer immediately.

 

 

Who Manufacturers Surgical Staplers?

Surgical staplers are primarily manufactured by two companies – Medtronic, and its subsidiary Covidien, and Ethicon. The former acknowledged they had an exemption that allowed them to report adverse events to the FDA privately. Ethicon, on the other hand, has never used the reporting exemption. Yet, Medtronic has been labeled the market leader in surgical staplers. The exemption has led many to believe this provides manufacturers, Medtronic specifically, an advantage.  By privately reporting adverse events, manufacturers can promote their product as a “safer” alternative.

FDA spokesperson, Deborah Kotz, confirmed that any device manufacturer can request an exemption.

 

 

Surgical Stapler FDA Secret Database

The bigger concern is the realization that a hidden database established by the FDA years ago exists. The database essentially allowed adverse events, including deaths, to go unnoticed by doctors and patients alike for years. Since 2016, 1.1 million adverse events, either injuries, deaths, or malfunctions, have been reported to the hidden, internal database instead of being publicly acknowledged. Even former FDA deputy commissioner, Dr. Robert Califf, was unaware of the existence of such a database.

If only evaluating adverse events reported to the public Manufacturer and User Facility Device Experience (MAUDE), surgical staplers would appear safe to use, even efficient, for external and internal usage. But, the hidden database depicts otherwise. Along with hidden adverse reports related to the surgical stapler, the hidden database includes “about 100” other medical devices with similar reporting exemptions.

According to Larry Kessler, a former FDA official, the database was created to avoid under-reporting and alleviate the time it took to review reports of similar context. Device manufacturers would apply for “exemption” status to avoid reporting certain events to MAUDE. As part of that exemption status, the manufacturers would keep track of any injuries or deaths and on a regular basis, either each quarter, half-year or year, report the events to the FDA via spreadsheet.

The program, launched in 2000, originally only included a few devices and was made public, but it has since grown in both size and secrecy.

As part of Kaiser Health News report, Freedom of Information Act requests were filed in September 2018, but none have been fulfilled yet. The FDA cited the lack of urgency for delaying the response. Requests can take up to two years to fulfill.

Since the damaging report was released, the FDA has announced it is ending the program that hid reports of medical device malfunctions and injuries from the public. In addition to the ending of the program, the FDA will be releasing past reports to the public within weeks.

Manufacturers that have exemption status is largely unknown, but the FDA did confirm exemptions have been used for mechanical breathing machines, balloon pumps, pacemaker electrodes, pelvic mesh, MitraCLip, and implantable defibrillators.

The lack of transparency has likely put many individuals at risk. Without a clear picture of the number of injuries and deaths a device has caused, doctors unwittingly conclude that a particular device is safe for consumer use. Unbeknownst to the doctor and patient, the risk is much, much higher than predicted.

In terms of the surgical stapler, the FDA will evaluate its safety, but for the millions of people affected by the internal, hidden database, justice will not be achieved until all of the devices are evaluated for safety.

Dr. Michael Carome, director of the Public Citizen Health Research Group said, “It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

 

 

Filing a Surgical Stapler Lawsuit

If you or a loved one has been injured by a surgical stapler, you may qualify for a surgical stapler lawsuit. Talk to a surgical stapler lawyer about your potential case and legal options today.

Before filing a surgical stapler lawsuit, be sure to familiarize yourself with the process of a civil lawsuit, so that you are aware of what will happen in your own surgical stapler lawsuit.

You should also mitigate injuries by seeking proper medical treatment and following your doctors orders.

You can begin gathering evidence to support your surgical stapler injury claim. Your attorney will be able to help you compile all possible evidence.

Your surgical stapler lawyer will help you to determine liability, which will likely fall on the surgical stapler manufacturer.

You and your surgical stapler lawyer will need to assess damages that you incurred resulting from your injury. In many surgical stapler lawsuits, the injured party will make a demand for both punitive damages and compensatory damages for the losses that they incurred.

Your surgical stapler lawyer will work to gain compensation for those injuries through a surgical stapler lawsuit settlement or verdict.

 

 

Hiring a Surgical Stapler Lawyer

Hiring a personal injury lawyer to represent you as your surgical stapler injury lawyer is an extremely important step in the process of your surgical stapler lawsuit.

You should find a lawyer who is experienced in both personal injury lawsuits and in defective product lawsuits. You should feel comfortable asking your potential surgical stapler lawyer as many questions as you deem necessary for making a final decision. Ask about their experience, their fees, the familiarity with the case, etc.

Your state statute of limitations bars the amount of time you have to take legal action after first being injured or discovering your injury, so do not hesitate to take the first initial step of hiring a surgical stapler lawyer.

 

 

Talk to a Surgical Stapler Injury Lawyer

If you have any questions about a surgical stapler lawsuit or the FDA secret database, contact TorHoerman Law at 1-888-508-6752. An experienced surgical stapler injury lawyer from TorHoerman Law is available to discuss your potential surgical stapler lawsuit, no obligation necessary and free of charge.

At TorHoerman Law, we work on a contingency fee basis for all surgical stapler lawsuit clients – so, we don’t get paid unless our clients do.

TorHoerman Law is your surgical stapler injury law firm.

 

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Litigation Updates

Class 1 Recall of Surgical Staplers

May 17, 2019 - A Class 1 recall of surgical staplers, the strongest the FDA can issue, was initiated in early April. The devices, more than 92,000, were recalled for faults which can potentially cause serious injury or death. The devices do not require premarket submission to the FDA and are used by surgeons during gastrointestinal procedures.

 

Surgical Stapler Lawsuit Filed in CA

July 12, 2019 - A lawsuit was filed by a California man alleging a surgical stapler severely injured him during surgery, requiring extensive pain and additional surgeries. The suit says the manufacturer, Johnson & Johnson and one of its subsidiaries said the device was safe, yet the FDA issued a Class 1 recall.

References

Jewett, Christina, and Heidi de Marco. "Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices." Kaiser Health News, Kaiser Health News, 7 Mar. 2019, khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

Jewett, Christina. "FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers." Kaiser Health News, Kaiser Health News, 8 Mar. 2019, khn.org/news/fda-announces-sweeping-plan-to-review-safety-of-surgical-staplers/

"Letters to Health Care Providers - Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers." U.S. Food and Drug Administration Home Page, Center for Devices and Radiological Health, 8 Mar. 2019, www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm629589.htm

"Products and Medical Procedures - Surgical Staplers and Staples." U.S. Food and Drug Administration Home Page, U.S. Department of Health and Human Services, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm110739.htm

"U.S. FDA Labels J&J Surgical Staplers' Recall as Severest." Reuters, Thomson Reuters, 17 May 2019, www.reuters.com/article/us-johnson-johnson-recall/u-s-fda-labels-jj-surgical-staplers-recall-as-severest-idUSKCN1SN1T4.

Carlson, Joe. Medtronic Facing Litigation over Surgical Staplers and Injury Reporting.” Star Tribune, Star Tribune, 10 Jan. 2020, www.startribune.com/medtronic-facing-litigation-over-surgical-staplers-and-injury-reporting/566855262/.

Center for Devices and Radiological Health. Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers.” U.S. Food and Drug Administration, FDA, 30 Oct. 2019, www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-echelon-flextm-endopathr-staplers-failure-completely-form-staples.

D., Alicia, et al. The History of Surgical Staplers: A Combination of Hungarian, Russian, and American Innovation.” Latest TOC RSS, Southeastern Surgical Congress, 1 June 2019, www.ingentaconnect.com/content/sesc/tas/2019/00000085/00000006/art00017;jsessionid=d504hrqbe054d.x-ic-live-02.

Last Modified: October 6th, 2020 @ 04:22 pm

Are surgical staplers dangerous?

The modern surgical stapler has been around for decades, but the injuries it causes were not addressed by the government until around 2013 during the first stapler recall. Properly designed staplers used at the discretion of skilled doctors are generally safe. Many of the faulty devices have been revised or recalled upon causing widespread injuries. Some potential injuries due to surgical staplers include excessive bleeding, tissue and organ damage, fistula, infection, or recurring cancer cells. Surgical stapler lawsuits are filed on behalf patients who suffered an injury resulting from a surgical stapler during or after an operation.