GranuFlo and NaturaLyte are acid concentrates in dialysis solutions that are used to treat kidney failure. Made by Fresenius Medical Care North America (FMCNA), GranuFlo and NaturaLyte were approved by the U.S. Food and Drug Administration (FDA) in May 2003.1
Since then, GranuFlo and NaturaLyte have been associated with some serious complications, the worst of which can be deadly.
While compensation may never change the permanent losses caused by GranuFlo or NaturaLyte complications, financial recoveries from these claims can be the key to restoring lives.
GranuFlo and NaturaLyte are dialysis solutions that have been linked to life-threatening complications. Anyone by injured by these solutions may have the right to file a claim for financial recovery.
Background on GranuFlo & NaturaLyte: How They Work
Classified as medical devices by the FDA, GranuFlo and NaturaLyte are acid concentrates that are mixed with water and some type of base concentrate (like bicarbonate) to make a dialysis solution, known as dialysate. Either GranuFlo or NaturaLyte is used to create dialysate, and the difference between these options is that:
GranuFlo is a dry powder concentrate that also contains the chemical sodium diacetate.
NaturaLyte is a liquid concentrate that does not contain sodium diacetate.
In dialysis treatment, GranuFlo and NaturaLyte assist in the removal of waste from the body while helping restore electrolyte levels and pH balance in patients with kidney failure.
Fresenius is the largest provider of dialysis machines and products in the U.S. Every year, Fresenius treats about 1 in every 3 dialysis patients (roughly 400,000 people) in its clinics across the nation.
Common, milder side effects associated with GranuFlo and NaturaLyte include (but may not be limited to):
Mild skin irritation
GranuFlo & NaturaLyte: Serious Side Effects & Complications
While GranuFlo and NaturaLyte can play an important role in the effectiveness of dialysis treatments, these concentrates have been linked to some serious complications, including (but not necessarily limited to):
Hypokalemia – Marked by dangerously low potassium levels, this condition can arise in dialysis patients who have been overexposed to GranuFlo or NaturaLyte. Hypokalemia can lead to arrhythmia, loss of consciousness and cardiac arrest.
Heart problems – GranuFlo and NaturaLyte can increase patients’ base and pH levels, possibly causing a condition known as alkalosis. Alkalosis can elevate the risk of heart complications, like heart attack and cardiac arrest.Fresenius has claimed that dosing errors contributed to this risk. Specifically, Fresenius has alleged that mistakes were made in evaluating how GranuFlo and NaturaLyte would breakdown in the body, resulting in dialysis patients being overdosed with these concentrates and being exposed to excessive amounts of base.
Investigations have revealed that Fresenius:
Was aware of the heart-related complications associated with GranuFlo and NaturaLyte
Sent an internal memo to its dialysis clinics to warn medical professionals about this risk
Failed to distribute this warning memo to dialysis clinics outside of its network, thereby preventing other medical professionals from being able to take the proper measures to protect patients and minimize their risk of GranuFlo and NaturaLyte complications.
GranuFlo & NaturaLyte: FDA Recalls & Actions
GranuFlo and NaturaLyte have been the subjects of various recalls and FDA actions in recent years, including (but not limited to) a:
2014 NaturaLyte Recall – This Class I recall was voluntarily issued by Fresenius due to findings that 56 lots of NaturaLyte were potentially contaminated with bacteria (Class I recalls are the most serious level of recalls, indicating that drug or device has the potential to cause serious, life-threatening complications).2
2013 Adverse Event Report – In this report, the FDA announced that it had been notified of a dialysis patient experiencing fatal complications after exposure to NaturaLyte.3
2013 GranuFlo & NaturaLyte Recall – This Class III recall was issued by the FDA due to “nonconforming material” in GranuFlo and NaturaLyte concentrates.4
2012 GranuFlo Recall – This Class I recall was issued by the FDA due to the GranuFlo’s “risk of alkalosis” and Fresenius’ violations of FDA regulations, particularly with regards to using false and misleading labels on GranuFlo.5
Thousands GranuFlo and NaturaLyte lawsuits have already been filed in courts across the U.S. by injured patients and families. These claims generally allege that Fresenius:
Fraudulently and negligently failed to warn the public about the serious risks associated with GranuFlo and NaturaLyte
Engaged in illegal, deceptive marketing practices, misrepresenting the safety and efficacy of these dialysis concentrates.
The amassing GranuFlo and NaturaLyte claims spurred the Judicial Panel on Multidistrict Litigation (JPML) to issue a transfer order in March 2013, consolidating many pending claims in an MDL based in the U.S. District Court, District of Massachusetts.6 The GranuFlo and NaturaLyte MDL (MDL No. 2428) is focused on promoting consistent pretrial rulings, preventing duplicative discovery and conserving the resources of all involved parties.7
Newly filed GranuFlo and NaturaLyte claims may join the ongoing MDL or proceed independently. The details of a given case, as well as a plaintiff’s needs and goals, will impact the best choice for that claim and plaintiff. The dedicated attorneys at the Amaro Law Firm are ready to explain your best options and get you on the path to financial recovery and justice.
Get Answers about Your Potential Claim: Contact a Dangerous Medical Device Lawyer at the Amaro Law Firm
A dangerous medical device lawyer at the Amaro Law Firm can help you hold Fresenius accountable for the harm and losses you have suffered due to GranuFlo and/or NaturaLyte.
Call (877) 892-2797, text (281) 612-8024 or email our firm for your FREE consultation and essential information regarding your potential claim.
Known for providing exceptional, effective legal services, our lawyers will help you navigate the road ahead, working tirelessly and diligently to maximize your financial recovery.
The Amaro Law Firm’s history of unparalleled representation and success in GranuFlo, NaturaLyte and other medical device claims has earned us glowing testimonials from former clients and 5-star ratings on Google and Facebook.