Surgical Stapler Lawsuit

Over nine million Americans are classified as morbidly obese. Gastric bypass (bariatric) surgery involving stapling has become commonly used as a last resort when diet and other weight-reduction measures fail to control a patient's obesity.

Gastric bypass divides the stomach into two separate parts, one of which is a very small upper pouch and the other which is the remainder of the stomach.

The surgical stapler allows medical professionals to close the incisions made during the procedure, which are too large for stitches. After the surgery, patients eat less because the upper portion of the stomach becomes full more quickly, controlling the appetite.

In the case of morbid obesity, which seriously threatens a person's health and life expectancy, successful gastrointestinal surgeries (gastric bypass surgery) can prove to be a lifesaver.

Ethicon surgical staplers are cited in numerous complaints as unreliable and unsafe. In May 2019, the Food and Drug Administration acknowledged receiving more than 110,000 surgical stapler malfunction reports in the previous decade, more than half of which had never been publicly disclosed.

Approximately 56,000 reports were kept out of the hidden database of the FDA's publicly available online “Manufacturer and User Facility Device Experience” (MAUDE). According to the agency, there have been more than 400 patient deaths related to faulty staplers since 2011.

Problems reported with these devices include their failure to form correct staples, inability to properly “fire,” and staples that later come loose or fail to keep the incision closed.

Serious injuries that can result from the use of a surgical stapler on a patient include:

• Internal bleeding caused by failure to close the wound or from the staple site itself
• The leakage of stomach acid from internal organs that reopen after bypass procedures
• Infection of the staple site or the incision
• Hernia due to stapler malfunction
• Septic shock-an infection that reaches the bloodstream and travels to major organs

These and other surgical complications often require the patient to undergo one or more corrective procedures. In the most severe cases, complications from defective staplers can result in the patient's death.

In recent years, victims and their families have successfully filed surgical stapler lawsuits against medical device-maker Ethicon for product liability, which holds the manufacturer of a product responsible for any serious injuries the product causes when it is used as intended.

Rather than responding to reports of adverse effects by recalling their products or improving their designs, the surgical stapler manufacturers have chosen to deflect blame onto surgeons alleging their medical malpractice is the source of patient injury.

Ethicon has repeatedly claimed surgical stapler malfunctions result from physician error, but it is becoming increasingly difficult to substantiate this claim when the devices, not the surgeons, have become the common denominator in tens of thousands of incidents.

While there is currently no class action suit, many victims are filing a surgical stapler lawsuit to recover compensation through compensatory and punitive damages.

The FDA's MAUDE database lists adverse effects involving surgical staplers. Beginning in 2009, the following Ethicon surgical stapler recall products have been cited most often in public database reports as frequently leading to surgical stapler complications and injury:

• Echelon Flex60
• Echelon Flex45
• Echelon 60
• Echelon Endopath

There have been dozens of reported malfunctions during prolonged surgery involving Medtronic/Covidien staplers, including:

• Endo Gia
• Signia

A device commonly used in open-heart surgery is a surgical stapler called the TigerPaw II, which is used to close the tissue in the heart that was opened during surgery to correct atrial fibrillation.

In March 2015, the TigerPaw was recalled when it was discovered the devices failed to perform their intended function and could cause additional injury that could lead to serious complications or death.

The surgical stapler lawyers at Rosenfeld Injury Lawyers, LLC are actively involved with potential claims and lawsuits involving the Tiger Paw surgical stapler.

If you or a loved one suffered surgical stapler injuries such as internal bleeding, blood clots, infection, heart failure, heart attack, stroke, or death following heart surgery, let our office investigate the matter for you with no up-front cost on your part.

Reports began to surface that patients undergoing the TigerPaw System II surgery experienced serious complications and heart injuries. Among the adverse effects reported: surgical staples tore the atrial wall and caused significant internal bleeding.

In other cases, the device failed to seal the left atrial appendage, which allowed blood clots to form, rendering the procedure ineffective.

Reported injuries caused by the TigerPaw System II surgical staplers include:

• Bleeding from tears in the atrial wall or at the site where the surgical staples were placed
• Infections resulting from bleeding or injuries experienced during the procedure
• Heart failure due to bleeding or infection
• Death from any of the aforementioned complications

The Class I designation given to a recall by the FDA indicates the product is capable of causing serious harm. Most surgical stapler recalls receiving this classification can cause debilitating or fatal injuries.

As a result of the FDA's order, Maquet Medical Systems has recalled over 4,100 of its TigerPaw System II stapling devices and instructed surgeons to discontinue using or remove the devices from patients.

It is anticipated that patients who underwent procedures before this recent surgical stapler recall may have valid claims against Maquet Medical Systems, which purchased the previous device manufacturer in 2013.