FDA RECALL: Serious Complications from Colorectal, Bariatric, or Gastric Surgeries? A Surgical Stapler may be to Blame

On May 16th, 2019,  the U.S. Food and Drug Administration (FDA) required Ethicon, a division of Johnson & Johnson, to recall more than 92,000 Circular Staplers that are used in gastrointestinal and bariatric surgeries.

The FDA has identified this as a Class I recall, the most serious type of recall. They have stated, “Use of these devices may cause serious injuries or death​.”

Who May be Affected

Patients who have had or may undergo gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients.

The FDA Recall Notice states: “The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”

What are the injuries?

Potential injuries to patients include:

  • Death
  • Infection
  • Bleeding
  • Need for permanent ostomy “bag”
  • Life-long nutritional and digestive issues
  • Leak in the closure (anastomotic leak)
  • Additional surgeries
  • Need for additional closures (anastomoses)
  • Need for antibiotics
  • Need for additional imaging studies

FDA’s Reason for Recall

The FDA states:

“Complaints of  uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.

In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.

The use of affected product may cause serious patient harm or death. Ethicon confirmed serious injuries. Misfiring of the stapler resulted in an additional resection — of the middle rectum in one patient and the lower rectum in another patient — during the planned resection of the upper rectum.”

What Should I Do Now?

If you or a loved one has suffered an injury after colorectal, bariatric, or bypass surgery, please contact the Minnesota Defective Medical Device Attorneys at GoldenbergLaw. With over 30 years of experience litigating complex medical device case, we will deliver the Gold standard advocacy you deserve.

Jury Awards $2.055 Billion In Roundup Cancer Case

If Roundup is safe, drink it. That was the message that one California juror wanted to send Bayer AG in issuing a shocking $2.055 billion verdict on behalf of a man and his wife claiming Roundup caused their cancer. The May 13 verdict represented the third consecutive plaintiff victory and the largest monetary damages issued to-date in the increasingly high profile litigation centered on one of the world’s most popular weed killers.

The verdict includes $55 million in compensatory damages to plaintiffs Alva and Alberta Pilloid and $2 billion in punitive damages. The couple claimed they had used Roundup on their properties for decades and that extended exposure eventually caused them to develop rare forms of non-Hodgkin lymphoma (NHL). The Pilloids are currently in remission, but each suffered brain damage and other lasting injuries from their battles with NHL.

The trial focused on the key question of whether Roundup’s active ingredient, glyphosate, is a carcinogen. Glyphosate was first found to be an effective herbicide in 1970 and was introduced to the market in 1974 by Monsanto under the name brand Roundup. Monsanto was acquired by Bayer AG in 2016.

Plaintiffs alleged that the product’s initial approval by the Environmental Protection Agency (EPA) was based off of fraudulent studies conducted by Industrial Bio-Test Laboratories. The studiesRoundup Container were later invalidated by the EPA after IBT was found to have falsified its data. However, the EPA continued to cite the IBT study as recently as 2016 in its efforts to maintain that glyphosate is not a carcinogen.

The EPA’s close relationship with Monsanto was heavily scrutinized by the plaintiffs, who produced internal Monsanto e-mails that suggest an EPA official had offered to kill another government agency’s review of the safety of glyphosate. That review, conducted by the Agency for Toxic Substances and Disease registry, was completed earlier this year and concluded that “multiple studies” have found an increased risk of NHL after use of Roundup.

The plaintiffs also produced evidence that a Monsanto executive had discussed ghost writing a study to combat a 2015 announcement by the International Agency for Research on Cancer (IARC) that glyphosate is “probably carcinogenic to humans.” The IARC report relied on evidence from studies that found glyphosate can damage DNA, which can lead to the development of cancer. The report also analyzed studies that found increased rates of malignant tumors in mice and rates that were exposed to glyphosate. Many of the tumors were linked to rare types of cancer that typically don’t occur by themselves. These studies were also used by the Pilloids to show how exposure to glyphosate can cause cancer.

Perhaps the most damaging testimony came from plaintiffs’ toxicology expert, Dr. William Sawyer, who argued that Monsanto made glyphosate up to 50 times more toxic by selling Roundup that contained a surfactant called polyethoxylated tallow amine (POEA). Dr. Sawyer told the jury that POEA can allow glyphosate to easily penetrate the skin, and from there the body can store it under the skin and transfer doses of the chemical to bones, where NHL develops, for up to a week.

Despite the massive verdict, Bayer AG continues to maintain that Roundup is safe and plans on appealing the decision. The company has consistently pointed to findings by the EPA, the European Chemicals Agency, and other world health bodies that use of Roundup is not linked to cancer. However, three California juries have now disagreed with Bayer’s arguments to the tune of $289 million last August, $80 million in March 2019, and now $2.055 billion.

If you or a loved one has been diagnosed with non-Hodgkin lymphoma after using Roundup, contact the Minnesota Cancer Attorneys at GoldenbergLaw. With over 30 years of experience litigating complex cancer cases, we deliver the Gold standard advocacy you deserve.

Rome Escalator Collapse: How a Defective Product Lawyer Can Help in an Accident Like This

On October 23, a malfunctioning escalator in Rome rapidly accelerated downward and caused a pileup of people at the bottom of the stairs. A total of 24 people were injured, some suffering serious perforation wounds due to the shattered stairs bunched at the bottom acting like knife blades. Three people are in serious condition, including a man who partially lost his foot. One person suffered a complex trauma that prompted an immediate surgery.

ATAC, Rome’s public transport company, said “all maintenance checks of the escalator were carried out regularly and the results were in accordance to the norms.” A full investigation into the maintenance and safety of the escalator has been requested. If it uncovers any defective design or potential danger that should have been warned about, the manufacturer of the escalator could be found liable.

The Rome escalator collapse is an example of how everyday products that we assume are safe are also at risk of failing. All products must be made reasonably safe. Manufacturers have a duty to identify foreseeable hazards and ensure they are designed away, guarded against, or warned about. An experienced defective product lawyer at GoldenbergLaw will have the necessary resources and experience to prove this.

If you or a loved one has suffered a severe injury as the result of a defective product, contact GoldenbergLaw. Our defective product lawyers can determine if there is a design, manufacturing, or warning issue with the product. Call us, and leave the sleepless nights to us.

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