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.

How Do You Know If Your Baby Has Rickets?

What Is Rickets?

Rickets is a bone disorder that is caused by vitamin D deficiency. It is characterized by the softening and weakening of the bones. Vitamin D absorbs calcium and phosphate in the body, so the lack of vitamin D in a child’s body causes their body to have difficulty maintaining proper calcium and phosphorous levels in the bones.

Calcium and phosphorous are vital minerals for the body. Calcium and phosphorous combine with one another to form a mineral crystal that gives structure and strength to the bones. When a child has rickets, calcium and phosphorous are not properly absorbed into the bones, thus making them weak and soft.

Neocate and Rickets

A 2017 study at Yale revealed that Neocate formulas were linked to bone fractures, broken bones, hypophosphatemia (low phosphate levels), and rickets. When participants in the study were switched to an alternative formula, they saw immediate improvement in calcium and phosphate levels, ultimately improving their skeletal development.

The link between Neocate and rickets is not something the defendant, Nutricia, warns consumers and doctors about.  The only warning given to parents about bone disorders and fractures was a March 2016 statement that children using Neocate as a primary or sole source of nutrition “should be routinely monitored by clinicians.”

Warning Signs of Rickets

If you suspect your child has rickets, there are a few signs and symptoms to look out for. Typical symptoms of rickets, include:

  • Fussy behavior
  • Soft skull
  • Bone tenderness
  • Stunted growth and development
  • Bone pain
  • Bowed legs
  • Wide joints (wrists, elbows, and knees)

If you think your child may have rickets, take them to the doctor immediately. They will conduct a physical exam and run blood tests and x-rays. Rickets can be a serious disease if left untreated.

GoldenbergLaw Can Help

If you’re concerned about Neocate and rickets and the effect on your child, you are not alone. GoldenbergLaw is currently accepting cases in which a child has taken Neocate and experienced serious bone disorders, low phosphate levels, rickets, spontaneous fractures, and/or broken bones. Please fill out the form below or give us a call. We will help you understand your rights and choices.

3M Combat Earplugs Lawsuit

Defective Earplugs

Former Army Sargent Scott Rowe is suing 3M because of its defective earplugs, which he claims caused his permanent hearing loss, tinnitus, and poor balance. In a recently filed lawsuit, Rowe has alleged that 3M knew about the defect but continued to make and sell these 3M combat earplugs and failed to warn consumers of this danger. These earplugs were distributed to U.S. soldiers between 2002 and 2015.

What Is the Defect?

The stem of the earplug may be too short and therefore difficult for the user to insert the plug deep into their ear canal. Due to the shortness of the stem, the earplug is loose in the ear canal and allows sounds to travel into the ear. For service members, this is crucial as they may be close to extremely loud explosions that put their hearing at risk.

3M Combat Earplugs Lawsuit

Last year, 3M reached a $9.1 million settlement with the U.S. Department of Justice stemming from allegations that 3M knowingly sold the U.S. army defective earplugs.  While the Department of Justice was able to secure compensation from 3M for alleged wrongdoing, those individuals who wore the earplugs and were injured by them are now pursuing 3M for the faulty design. The recently filed lawsuit attempts to prove 3M was negligent in selling defective earplugs as well as liable for the serious injuries the service members have endured.

Why Choose GoldenbergLaw?

GoldenbergLaw commends the men and women who put their lives on the line as service members. The last thing they should have to worry about is defective equipment, such as earbuds. We want to hold 3M accountable. If you or a loved one served in the U.S. military and used the 3M combat earplugs between 2002 and 2015 and have experienced hearing loss or tinnitus, please contact the defective product lawyers at GoldenbergLaw.