NaturaLyte & Granuflo Lawsuits

NaturaLyte and GranuFlo are dialysates, used during hemodialysis to help filter toxins from the blood. Both products are produced by Fresenius Medical Care, the world’s biggest kidney dialysis service. They operate over 2,000 dialysis clinics in North America and supply GranuFlo and NaturaLyte to thousands of other clinics.

In March of 2012, the FDA issued the most serious recall (known as “Class I”) for both products. The move came after growing indications that the dialysates have harmful, potentially deadly side effects, including heart rate problems and hypotension. The Food and Drug Administration indicates that these complications can result in cardiac arrest.

There has been strong evidence presented in GranuFlo lawsuits that Fresenius Medical Care was aware of the high risk levels months prior to officially informing the clinics they supplied to.

In March of 2012, a leaked memo reached the FDA. The memo was initially distributed internally on November 4, 2011, and stated that 941 patients in Fresenius clinics had experienced a heart attack that year. The incidents occurred during or shortly after treatment with GranuFlo or NaturaLyte. The memo linked the incidents of heart attack to an overdose of bicarbonate, caused by improper dosages.

After news of the internal memo became publicly known, many hundreds of people came forward claiming to have been affected. The resulting litigation accused Fresenius of causing life-altering, long-term damage, such as pain and suffering, lost earnings and earning capacity, emotional and psychological distress, and in unfortunate instances, wrongful death.

Additionally, plaintiffs filing a GranuFlo and NaturaLyte lawsuit allege that defendant Fresenius Medical Care willfully, knowingly, and with wanton disregard for the public’s safety, suppressed information about the dangers of their hemodialysis products.

Plaintiffs are seeking monetary compensation as a result of Fresenius’s alleged misconduct.

GranuFlo side effects spark litigation

Hemodialysis is used to help patients who suffer from renal failure, known commonly as kidney failure. During dialysis, the work performed by the kidneys in a healthy person is done by machines which use dialysates to clean the blood. This treatment affords patients some semblance of a normal life while they await a new kidney.

The treatment administers a dialysate via a filtering machine that works like a mechanical kidney, cleaning the patient’s blood, filtering waste products, and then re-introducing the blood to the patient’s body.

The chemical composition of NaturaLyte and GranuFlo can result in unusually high bicarbonate levels if they are given in equivalent dosages as alternative dialysates. According to GranuFlo lawsuits, Fresenius failed to warn doctors about the higher levels of bicarbonate.

Side effects caused by an overdose of bicarbonate can be fatal:

• Alkaline blood-pH levels (metabolic alkalosis)
• Hypokalemia (low levels of potassium)
• Hypoxemia (diminished oxygen levels in the blood)
• Hypercapnia (excess carbon dioxide)
• Cardiac arrhythmia
• Low blood pressure

Without proper treatment, side effects of bicarbonate overdose can cause serious problems:

• Cardiopulmonary arrest
• Stroke
• Heart attack
• Death

Product recall follows FDA warning

In May 2012, after the release of the November 2011 memo, the FDA distributed a Public Safety Warning.

A month later, on June 25, the FDA conducted a Class I recall on GranuFlo and Naturalyte.

Who can file a GranuFlo and NaturaLyte lawsuit

NaturaLyte and GranuFlo lawsuits have levelled a variety of allegations against manufacturer Fresenius Medical Care. The information contained in the Fresenius internal memo obtained by the FDA strongly suggested that Fresenius was fully aware of the risks linked to their dialysates, and that they failed in their duty to provide this critical information to the medical community, health care practitioners, or the public.

Status of Fresenius dialysis lawsuits

There are an estimated 40 GranuFlo and Naturalyte lawsuits currently lodged in 11 states. More than 700 suits in over 40 states are proceeding towards trial. In March of 2013, the JPML (U.S. Judicial Panel on Multidistrict Litigation) voted to coordinate proceedings into a multidistrict litigation (MDL), taking place in Massachusetts District Court.

The MDL consolidates lawsuits that have reached court dockets in multiple states, including New York, New Jersey, California, Massachusetts, Pennsylvania, Ohio, Florida, and more. More states are expected to be involved over the coming months. The centralized litigation aims to consolidate all the evidence across various cases – which is often similar or identical – and help speed up the process for all parties. MDL formation also reduces the risk of conflicting jury awards by establishing a precedent for compensation payouts.

Noteworthy GranuFlo lawsuits

Some recent examples of Fresenius dialysis litigation include:

• In July of 2012, a products liability lawsuit was filed by plaintiff Arthruine Williams on behalf of her husband, who suffered a fatal heart attack following dialysis treatment with GranuFlo.
• Plaintiff Betty Lemmond launched a lawsuit In August of 2010, following her husband’s death from heart attack. The decedent had received dialysis treatment hours before his death.
• Waddell Bishop lodged a claim for damages in late 2012 following the fatal heart attack of his mother. The lawsuit contends the decedent died as a direct and indisputable result of treatment with Granuflo and Naturalyte.

A GranuFlo lawyer is ready to help

A lawyer versed in the intricate details of GranuFlo and NaturaLyte complaints understands all the information pertaining to filing a successful lawsuit. A GranuFlo attorney can help inform you of your legal rights, and help you pursue compensation for physical and psychological pain & suffering, lost wages and other damages.

While the outcome of a GranuFlo lawsuit concerning a fatality can never compensate for losing a loved one, the manufacturer can at least be held to account for any negligent actions they may be responsible for. At the very least, victims of medical malpractice are entitled to damages to cover medical costs, lost earnings and – in tragic cases where death has occurred – funeral expenses.

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