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.

Frequently Asked Questions About Zimmer M/L Taper Hip Replacement Failure

Scientific studies have linked the Zimmer M/L taper and Zimmer M/L taper with Kinectiv technology hip devices to causing dangerous metal poisoning when implanted in the human body. A judge recently awarded $2 million to a man injured by a Zimmer M/L taper hip device with Kinectiv technology at a trial in New Mexico. There are currently several dozen lawsuits filed throughout the country against Zimmer for injuries caused by the hip device.

Why Is My Hip Replacement Failing?

Artificial hip replacements are meant to correct conditions of the hip and to provide support and pain relief to a patient. Some metal-on-metal hip devices have the potential to cause more damage than benefit due to metal-on-metal wear and metallosis. Studies have recently concluded that the Zimmer M/L taper hip replacement product can cause such metal wear.

Zimmer M/L Taper Failure Due to Metallosis

The Zimmer M/L taper and Zimmer M/L taper with Kinectiv technology hip prostheses are made up of several component parts. There is a neck piece and femoral stem that are to be inserted inside the human femur bone. The neck piece is connected to an artificial head, which is often the Zimmer VerSys head. The junctions of these pieces, where they connect together, can be problematic because the parts are made of metal.artificial hip joint diagram

While there are varying reasons why a hip implant may cause problems, one such reason has to do with metal-on-metal wear. Hip replacement failure can result from corrosion sustained at certain junctions of artificial hip implants made of metal. Interfaces susceptible to metal-on-metal wear include the area where the metal stem meets the metal neck or where the metal neck meets the head. The body joints move, resulting in these artificial hip parts moving and rubbing together. This can lead to the release of metallic particles into the bloodstream, negative reactions with the tissue, and additional complications that can require revision surgery.

The potential for metal-on-metal wear and resulting metallosis has been known since at least the early nineties. Yet manufacturers such as Zimmer still produced such a product, claiming it was safe.

In 2012, Zimmer recalled certain lots of Zimmer VerSys heads (often paired with the M/L taper neck and stem products) stating that there was a sub-optimal fit between the head and necks.

In 2013, the Australian Orthopaedic Association National Joint Registry reported that the M/L taper with Kinectiv technology sustained revision rates greater than twice that of conventional hips.

In 2015, Zimmer recalled certain lots of its Zimmer M/L Taper with Kinectiv Technology hip products, citing concerns with cytotoxicity levels found within the product.

These products have been implanted in hundreds of patients. Several dozen lawsuits have been filed by individuals injured by the Zimmer M/L taper hip.

Acetabular Component Failure

An acetabular component failure can also occur due to metal-on-metal wear. This is similar to the neck-stem failure in theory, just involving different parts of the artificial hip component. Specifically, metal pieces of the acetabular system, the cup, ball, and liner, can unfortunately rub together, resulting in metallosis, corrosion, and metal wear. This can cause further damage to the surrounding tissue and muscles.

This type of acetabular failure was alleged to have occurred and the subject of thousands of lawsuits in the DePuy ASR and Pinnacle devices, in the Wright Conserve, Dynasty, and Lineage devices, the Zimmer Durom cup device, as well as the Biomet M2a Magnum product.

Billions of dollars in settlements have been awarded as a result of these acetabular failures.

How Do I Know What Kind of Hip I Have?

There are many different types of hip implant products on the market. The best way to find out what kind of hip you have is to go to the facility where your hip was implanted and ask for the sticker sheet for the barcodes or implant lists associated with the product put in your hip.

What Can Metallosis Cause?

Elevated metal levels indicate that a patient has metallosis, or metal poisoning. Metallosis is a common injury that patients experiencing a metal-on-metal hip replacement failure may suffer. Metallosis occurs because the metal-on-metal hip implants shed cobalt and chromium into the bloodstream. Common symptoms of metallosis include:

  • Increased pain
  • Pain at the hip site
  • Difficulty walking

Metallosis can cause damage to the tissue and muscle around the hip site, long lasting and permanent damage, severe pain, and often results in the need for a revision (removal of the hip device) surgery.

Metal-on-metal wear can unfortunately also lead to dissociation, which is the degradation of the components themselves from metallosis. The prosthesis can then detach from itself, often at the head-neck junction, and result in a collapse of the device components.

Dissociation is another risk inherent in the Zimmer M/L taper hip device.

Can I Pursue a Lawsuit?

Several dozen lawsuits have been filed in state and federal courts throughout the country alleging metallosis and need for revision from the Zimmer M/L taper and M/L taper with Kinectiv technology hip devices. One lawsuit filed in New Mexico for injuries sustained from the Zimmer M/L taper with Kinectiv technology hip resulted in a $2 million award to the Plaintiff after a trial.

The Judicial Panel on Multidistrict Litigation recently ordered that Zimmer M/L taper cases in federal court be consolidated before one Judge, the Honorable Paul Crotty. The Zimmer M/L taper multidistrict litigation is currently ongoing in the Southern District of New York.

If you suspect you require or had to have a revision due to issues with a Zimmer hip device, reach out to GoldenbergLaw. Our experienced team will assess your case and determine if we can move forward with a lawsuit on your behalf.

What Should I do Next?

If you or a loved one is experiencing hip replacement failure and has metallosis, you should look no further than GoldenbergLaw. We have represented hundreds of clients with defective hip replacements. Contact GoldenbergLaw, and we will guide you through this process, fighting to get you the compensation you deserve. GoldenbergLaw delivers the gold standard advocacy you deserve.