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Fresenius Medical Care may have withheld important information about the potential side effects of NaturaLyte and GranuFlo acid concentrate drugs for dialysis treatment, which may have caused thousands of people to suffer:
- Cardiac Arrest
- Heart Attack
- Sudden Death
STATUS OF FRESENIUS DIALYSIS LAWSUITS: These lawsuits are no longer being reviewed after Fresenius agreed to a $250 million settlement agreement to resolve the litigation.
OVERVIEW: Granuflo dry acid concentrate and NaturaLyte liquid concentrate are used during dialysis treatment together with a bicarbonate buffer to help clean the blood for individuals suffering kidney or renal impairment.
These products are manufactured by Fresenius Medical Care, which operates thousands of dialysis clinics throughout the United States and also sells equipment and medications used at most other dialysis centers, including DaVita Dialysis Clinics, DCR, Renal Ventures and others.
Before 2012, individuals may have faced a serious risk of suffering a sudden heart attacks and cardiac arrest during dialysis treatment with Granuflo and NaturaLyte, due to Fresenius Medical Care’s failure to provide adequate warnings and instructions with their product.
Granuflo and NaturaLyte contain sodium acetate, which is converted into bicarbonate by the body during and shortly after dialysis treatment. However, the manufacturer failed to warn physicians that these products contain higher levels of acetate than most other dialysis treatment products, requiring physicians to carefully monitor and change bicarbonate buffers administered with Granuflo or NaturaLyte, to avoid a risk of cardiopulmonary arrest and sudden death from heart problems.
LAWSUITS OVER FRESENIUS DIALYSIS TREATMENTS: A number of families throughout the United States filed claims after their loved ones died or suffered a catastrophic heart injury during or within 48 hours after dialysis treatment.
According to allegations raised in Fresenius dialysis treatment lawsuits:
- Fresenius Medical Care negligently manufactured and sold unreasonably defective products
- Granuflo and NaturaLyte were insufficiently tested and unsafe as designed
- Inadequate warnings and instructions were provided with Granuflo and NaturaLyte, which did not fully inform the medical community about the nature and extent of the risk of heart attack, cardiac arrest, sudden cardiac death and other health problems
- Even after Fresenius Medical Care knew or should have known about the problems with Granuflo and NaturaLyte, they continued to sell the products and attempted to convert clinics to use of the products by offering pricing discounts and packaging Granuflo and NaturaLyte with other dialysis products
- Fresenius Medical Care provided critical information about the risk of heart attacks and death from Granuflo and NaturaLyte to doctor’s at their own clinics before warning other dialysis centers that used their products
- Information was withheld in an attempt to maintain Fresenius Medical Care’s market share and maximize profits, at the expense of the safety of dialysis patients receiving their products
FRESENIUS DIALYSIS TREATMENT PROBLEMS: According to an internal review of patients treated at Fresenius Medical Care clinics during 2010, there were at least 941 cases where patients suffered a sudden cardiopulmonary arrest at the dialysis center.
In November 2011, Fresenius Medical Care issued an internal memo to their own physicians warning about the potential concerns associated with Granuflo and NaturaLyte, and highlighting that bicarbonate buffers should be regularly monitored and adjusted to reduce the risk of heart attack, cardiac arrest and death. This same information was not provided to other clinics that used Granuflo and NaturaLyte.
In March 2012, after receiving an inquiry from the FDA about the internal memo, Fresenius Medical Care issued an alert to other dialysis clinics that may use their Granuflo or NatruaLyte products during hemodialysis treatment.
In May 2012, the FDA warned about the risk of hemodialysis dosing problems with NaturaLyte Liquid and Granuflo Acid Concentrate, indicating that these products can raise bicarbonate levels in patients going through dialysis treatments, causing a condition known as metabolic alkalosis, which can increase the risk of heart attack, cardiac arrest, stroke, low blood pressure and death.
In June 2012, it was reported that Fresenius dialysis problems have resulted in an FDA investigation, examining whether the manufacturer of Granuflo and NaturaLyte failed to adequately warn doctors that the products could cause heart attacks and other serious injuries during hemodialysis.
In February 2016, Fresenius proposed a $250 million settlement agreement that is expected to be accepted and funded by August 2016.