GranuFlo and NaturaLyte lawsuit and complications

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GranuFlo and NaturaLyte are both products that are used to aid kidney patients in their dialysis treatments. Both are intended to remove acid or waste from the blood when a patient’s kidneys can no longer perform the function. Both of these products, however, have been alleged to cause serious side effects in the patients that are taking receiving dialysis treatments that contain these products. Complications have been as severe as cardiac arrest that can lead to death. There have been recalls issued for these products. There have been a large number of lawsuits filed against the manufacturer of these two products as well as centers that administered dialysis. These granuflo lawsuits are in various stages and there is the possibility that those who have suffered harm can achieve some sort of recovery for the complications that they have suffered. If you are seeking a granuflo lawsuit lawyer, contact us.

Granuflo

A large number of Americans suffer from kidney ailments. As many as 14 percent of the population suffers from reduced kidney function based on National Institutes of Health statistics. According to the NIH, nearly half a million Americans required dialysis to treat their kidney failure. Dialysis is when the toxins and excess water in the blood is removed by machine to compensate for the lack of kidney function. There is a solution that is used when administering that contains various products.

 GranuFlo lawsuit update: 

Blow you will find a Fresenius lawsuit update:

Febuary 2016: “Fresenius Medical Care AG & Co. KGaA (NYSE:FMS) agrees to pay $250M to resolve U.S. litigation related to its GranuFlo and NaturaLyte products. Under the terms of the agreement, 97% of the plaintiffs must agree to the settlement by July to receive funding in August. Insurers will pay $220M (88%) of the total settlement amount. The company intends to record a $60M charge to finalize the matter. The item will be reflected in its 2015 results that will be released on February 24. GranuFlo and NaturaLyte are dialysates (fluids used in dialysis that clean the blood). The FDA recalled them in March 2012 in order to revise prescribing instructions.” https://seekingalpha.com/news/3117586-fresenius-pays-250m-settle-granuflo-naturalyte-lawsuits

“According to the recall, the use of the products could lead to low blood pressure and cardiac arrhythmia, possibly leading up to cardiopulmonary arrest and death. The lawsuits (1,800+) began after it was discovered that Fresenius was aware of the risks and failed to inform healthcare providers and patients. A November 2011 internal company memo revealed that 900 patients experienced heart attacks in company clinics the previous year. Fresenius medical personnel concluded that patients with excessive levels of bicarbonate in their blood were six times more likely to experience cardiac arrest that those with normal levels. The memo linked GranuFlo use to increased bicarbonate levels and heart attacks. GranuFlo is a powdered compound that creates bicarbonate. NaturaLyte works in a similar fashion but is in liquid form. Both remain on the market in their original formulations.” Id.

383 million verdict

“National dialysis provider DaVita Inc. was recently ordered to pay $383.5 million to the families of three patients who died after they were treated with a solution called GranuFlo. A federal jury in Denver on June 27 sided with plaintiffs who lost family members after receiving the treatments at DaVita clinics.

The patients suffered cardiac arrests, according to a statement from Hagens Berman, a law firm representing the plaintiffs. “DaVita ignored many red flags that preceded the loss of life of these three patients and many others,” lead trial attorney Rob Carey of Hagens Berman said in a statement. DaVita Inc. pledged to appeal the verdicts issued in the U.S. District Court for the District of Colorado.” https://www.drugwatch.com/news/2018/06/29/davita-dialysis-giant-hit-with-383m-verdict-in-death-lawsuits/

“DaVita Inc. pledged to appeal the verdicts issued in the U.S. District Court for the District of Colorado.
“GranuFlo is an FDA-approved product that has been in continuous use for more than 25 years,” DaVita Inc. said in a statement. “The issues raised regarding its alleged negative clinical side effects have been debunked and nephrologists use it daily for their patients. The plaintiffs in this case did not even claim that the product itself was dangerous.” Id.

How GranuFlo and NaturaLyte are Intended to Work

When dialysis is being administered, it is necessary to act against the acid in the blood. Some sort of substance is necessary to help clean the blood. Generally, it is a solution that contains different substances that can neutralize the acid. GranuFlo and NaturaLyte are both different parts of this solution. The products are intended to achieve the same result. The difference between the two products is that GranuFlo is dry acid powder and NaturaLyte is in the form of a liquid. Sometimes dry acid powder is easier to handle and ship, so the product is more convenient for facilities to use. The ultimate end result when these products work well is the proper balance between acid and alkaline in the blood.

These products are both manufactured by Fresenius Medical Care. Fresenius is a German company that makes products to aid in dialysis. The company makes both dialysis machines as well as products to be used in dialysis treatments and runs dialysis centers.

While the two products are meant to facilitate dialysis, in reality, these two products have both caused issues for those who have used it for their dialysis treatments. As mentioned before the products are supposed to maintain the balance between acid and alkaline. GranuFlo and NaturaLyte are supposed to act to reduce the acid to better achieve the balance. However, the balance can also get skewed in favor of excess alkaline in the blood. This presents a set of problems on its own for patients that can have deadly consequences. Specifically, this problem is known as metabolic alkalosis.

“GranuFlo and NaturaLyte are products that control acid, sodium, potassium, calcium and magnesium levels in a dialysis patient’s blood. These products are manufactured by Fresenius Medical Care, the world’s largest supplier of dialysis machines, which operates more than 2,700 dialysis centers worldwide. In the United States, Fresenius manages more kidney dialysis clinics than any other company, treating more than 130,000 patients. In addition, it is estimated that approximately 100,000 patients have been treated with GranuFlo and NaturaLyte in non-Fresenius clinics.” Motley Rice

Complications From NaturaLyte and GranuFlo

This issue has caused patients to suffer many harmful complications when using these two products. The most pronounced and deadly of these side effects is an increased risk of cardiac arrest. Beyond the risk of sudden heart attack, the other deadly possible complication is an elevated risk of stroke. These risks are particularly acute for those who have taken large doses of the products. Additionally, there are other side effects for these two products such as low blood pressure, hand tremors, nausea as well as a myriad of other complications.

In 2012, the FDA issued a recall notice for these two products. According to the FDA, the reason for the recall was false and misleading labeling of the products. Customers were advised to discontinue use of the products and either quarantine them or return them to Fresenius. However, despite the recall, the FDA did not direct Fresenius to make changes to the product or remove it from the marketplace. Fresenius reportedly knew of the dangers to the product a year before the FDA recall notice was issued, but did not take any action until the FDA issued the recall.

NaturaLyte recall

“The purpose of this letter is to inform you that Fresenius Medical Care North America (FMCNA) is initiating a voluntary recall involving 49 lots of NaturaLyte® Bicarbonate Concentrate 6.4 Liter Bottle (Product Code 08-4000-LB). FMCNA has determined the product may contain higher levels of bacterial contamination than allowed by our internal specification. FMCNA is currently conducting testing to identify the organism/s. When testing is complete, the identity of the organism/s will be provided.” NaturaLyte Recall

Read more about the Fresenius recall

Lawsuits Filed Against Fresenius

There have been numerous lawsuits filed against Fresenius in connection with the side effects experienced by users of both of the products. Some of the lawsuits related individually to one of the two products. Some users who had used both products and sustained injuries filed suit relating to their usage of both of the products. The grounds of suit are similar between the two categories of lawsuits. Even multiple states joined in the lawsuits as public interest matter given the gravity of the harm suffered by users of these products. The states specifically filed suit to recover for expenses that were incurred by their Medicaid program due to the defects in the products.

The lawsuits generally allege that Fresenius knew of the increased risk of heart attack as far back as 2004, which was one year after the FDA gave approval for these products. According to one of the complaints, the problem was so bad that Fresenius advised its own technicians administering dialysis to manually adjust the machines to use only half of the recommended amount of GranuFlo.

naturalyte lawsuit

Both GranuFlo and NaturaLyte have been alleged to be defectively designed and dangerous. Nonetheless, the lawsuits allege that Fresenius placed it into commerce and continued to do so even after it had evidence of the dangers. According to the lawsuits, even before beginning to sell the product, Fresenius did not conduct adequate testing on the product. Had it done so, it would have learned of the dangers of the side effects that patients experienced. Fresenius allegedly failed to warn potential customers of the dangers and did nothing until the FDA issued the product recall. There were no warnings on the label or safety announcements issued by the company.

granuflo lawsuit news 

Recently, a jury in Denver, CO awarded the families of three patients who suffered fatal heart attacks after taking GranuFlo $383.5 million. The verdict was against DaVita Kidney Centers, where the patients received dialysis. In addition, in 2017, Fresenius agreed to establish a fund to compensate  (granuflo settlement) those who suffered complications from using these two products. The amount of the granuflo settlement fund is $250 million. The fund was established as a settlement to a multi-district litigation. Readers should check back about a fresenius lawsuit update or a granuflo lawsuit update. Many readers are interested to know about: granuflo lawsuit settlement amounts and dialysis lawsuit update.

Granuflo lawsuit

As with any product liability suit, plaintiffs can sue anyone who was a part of placing the product into the stream of commerce. In addition to applying for a share of the settlement fund, those who have suffered harm may also bring suit against the dialysis center that administered the dialysis which caused the harm. If you or anyone in your family has received dialysis that has relied upon GranuFlo or NaturaLyte and has suffered any type of harm, you should promptly contact a granuflo lawsuit attorney. This granuflo lawsuit lawyer can advise you of your legal rights and the prospects for receiving compensation.

Sources

https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=109861

https://ag.ky.gov/pdf_news/20160901_complaint.pdf