As GranuFlo Lawsuits Move Forward, FDA Reveals One Death Possibly Associated with Recent NaturaLyte Recall, Bernstein Liebhard LLP Reports

Share Article

The Firm is representing numerous clients in GranuFlo Lawsuits, all of which allege the use of GranuFlo or NaturaLyte dialysis concentrates caused serious, and sometimes deadly, heart injuries.

Free Case Review
Our Firm is representing numerous individuals who allegedly suffered serious, and in some cases deadly, heart injuries associated with the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates, which was also designated a Class I recall by the FDA.

As GranuFlo lawsuits ( ) filed in the wake of the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates continue to move forward in U.S. courts, Bernstein Liebhard LLP notes that products included in a second NaturaLyte recall announced earlier this year may have been implicated in a patient’s death. According to a recall notice updated on May 28, 2014, the U.S. Food & Drug Administration (FDA) has received reports of one fatality and two other injuries that may be associated with the recalled product*

Fresenius Medical Care recalled 56 lots of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters, after it was determined that the affected lots could develop higher than acceptable levels of bacteria during their shelf life. According to the FDA, the potential contaminant has been identified as Halomonas, which can cause bacteremia or systemic infection. The FDA has granted Class I status to the most recent NaturaLyte recall, which indicates that there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

“Our Firm is representing numerous individuals who allegedly suffered serious, and in some cases deadly, heart injuries associated with the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates, which was also designated a Class I recall by the FDA. We are monitoring this most recent NaturaLyte recall very closely,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now offering free GranuFlo lawsuit reviews to dialysis patients who allegedly suffered serious heart injuries related to the GranuFlo and NaturaLyte recall announced in 2012.

GranuFlo Lawsuits
The 2012 GranuFlo and NaturaLyte recall was issued after the dialysis concentrates were tied to hundreds of cases of cardiac arrest in patients who underwent dialysis at Fresenius clinics in 2010. According to the recall notice, the two products, which are used during dialysis to remove toxins from the blood, converted to bicarbonate at higher levels than rival products. As such, inappropriate dosage of the medications could result in a dangerous elevation of bicarbonate in a patient’s blood, which may lead to a condition called metabolic alkalosis. This occurrence can increase the risk that a dialysis patient will suffer catastrophic cardiovascular events, including a heart attack, stroke or sudden cardiac death.

Since the 2012 GranuFlo recall was announced, more than 1,700 product liability claims have been filed against Fresenius Medical Care in a federal multidistrict litigation now underway in U.S. District Court, District of Massachusetts. All of these GranuFlo lawsuits were filed on behalf of dialysis patients who allegedly suffered life-threatening heart events associated with the 2012 recall, and accuse Fresenius of failing to provide proper warnings regarding the risks associated with GranuFlo and NaturaLyte. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)

In June 2012, The New York Times reported that the FDA had launched an investigation of Fresenius Medical Care, after learning that the company had circulated an internal memo to its in-network dialysis clinics in November 2011 that detailed the risks associated with inappropriate dosage of GranuFlo and NaturaLyte. The FDA is trying to determine if Fresenius violated any federal regulations by not issuing any type of notification to dialysis clinics outside of its networks at that time.**

Individuals who allegedly experienced heart attacks, strokes, and other catastrophic cardiovascular events within 72 hours of a dialysis treatment where GranuFlo or NaturaLyte were used may be entitled to compensation from Fresenius Medical Care. Find out more about the 2012 GranuFlo and NaturaLyte recall at Bernstein Liebhard LLP’s website, or the Firm’s Facebook page: For additional information, and to arrange for a free case review, please call 800-511-5092.

*, FDA, May 28, 2014
**; New York Times, June 14, 2012

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs’ Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.

Bernstein Liebhard LLP represents the victims of defective drugs and medical devices on a contingency-fee basis, and our clients are never expected to pay attorneys fees unless their case results in a successful recovery on their behalf. New York State’s contingency fee cap rules generally limit those fees to 33 1/3% of the total recovery. As a result, the Firm’s fees can be significantly lower than those assessed by attorneys in other states, which depending on the law may amount to as much as 40% or more of a plaintiff’s recovery.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016

ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP

Share article on social media or email:

View article via:

Pdf Print