Granuflo

  • Granuflo Medical Record Review & Outsourcing Services

Fresenius Medical Care manufactured GranuFlo and NaturaLyte dialysate to be used for dialysis in patients suffering from chronic kidney disease and renal failure. The Food and Drug Administration (FDA) approved GranuFlo in 2003 through a process called 510(k) of the Food, Drug, and Cosmetic Act. In this process, a premarketing submission is made which says that the device is substantially equivalent to a drug already placed in the market.

When patients are given incorrect doses, the side effects of GranuFlo and NaturaLyte increase significantly. Reports indicate that hundreds of patients suffered GranuFlo side effects caused by excessive bicarbonate levels, which was underestimated by many medical professionals. One of the major side effects is metabolic alkalosis.

Food Machinery Corporation (FMC) Corporation, an American chemical manufacturing company, released an urgent internal memo to more than 1,800 FMC clinics in 2011. The report suggested that 941 patients in 2010 suffered cardiac arrest and other GranuFlo side effects after receiving dialysis treatment in an FMC clinic. It also emphasized on the importance of proper dosing to patients. However, the company is being accused of misconduct as they notified its own clinics but failed to notify the FDA or the thousands of other facilities that administered GranuFlo and NaturaLyte.

Serious Alleged Injuries may include:

  • Hypoxemia or low levels of blood oxygen
  • Hypokalemia or low levels of blood potassium
  • Hypercapnia or high levels of blood carbon dioxide
  • Metabolic Alkalosis
  • Sudden cardiac arrest
  • Death

FDA Safety Warnings:

March 29, 2012: The FDA issued a Class I recall of GranuFlo and NaturaLyte to revise the prescribing instructions related to life-threatening injuries stating the dialysis acid concentrates in GranuFlo and NaturaLyte were linked to severe health problems, including fatal heart attacks and strokes.

May 25, 2012: The FDA issued a warning document: Safety Alerts for Human Medical Products - Dialysate Concentrates Used in Hemodialysis: Safety communication - alkali dosing errors.

2013: A Class III recall was made by the FDA due to discoloration found in a certain lot numbers of Fresenius Granuflo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis; the FDA determined the product was “nonconforming.”

Legal Updates:

Defendants: 

  • Fresenius Medical Care Holdings, Inc, (FMCH)

  • Fresenius Medical Care North America

  • Fresenius USA, Inc.

  • Fresenius USA Manufacturing, Inc.

  • Fresenius USA Marketing, Inc.

  • Fresenius USA Sales, Inc.

  • Fresenius Medical Care AG &CO. KGaA

  • Fresenius Medical Care Management AG

  • Fresenius SE & CO. KGaA

  • Fresenius Management SE

Defendant Law Firm: Fresenius is represented by James Bennett and Megan S. Heinsz of Dowd Bennett LLP and William H. Kettlewell of Hogan Lovells.

Allegations: Allegations include that the defendants failed to warn doctors, patients, and the FDA about the risk of bicarbonate overdose errors associated with GranuFlo and Naturalyte.

Plaintiff Steering Committee:

  • Richard Golomb - Golomb & Honik, P.C.

  • Bruce Steckler - Steckler Law Firm LLP

  • R. Clay Milling - Henry Spiegel Milling LLP

  • Randi Kassan - Sanders Viener Grossman, LLP

  • Ellen A. Presby - The Nemeroff Law Firm

  • Jim duggan - Duggan Law Firm, LLC

  • Troy Rafferty - Levin Papantonio Thomas Mitchell Rafferty & Proctor, P.A.

  • Richard Phillips - Smith Phillips Mitchell Scott & Nowak, LLP

  • Kristian Rasmussen - Cory Watson Crowder & DeGaris P.C.

  • Frank Woodson - Beasley Allen Law Firm

  • Burton LeBlanc - Baron & Budd 

Lawsuit Status:

April 2013: The U.S. Judicial Panel on Multidistrict Litigation (JPML) established MDL No: 2428 for all Fresenius cases filed throughout the federal court system, centralizing all lawsuits before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.

January 2014: Judge Woodlock approved the use of a master complaint and short form complaint to standardize the process of filing additional Granuflo and NaturaLyte lawsuits in the MDL.

Important Verdicts & Settlements:

February 2016: Fresenius Medical Care agreed to pay $250 million to resolve thousands of NaturaLyte and GranuFlo lawsuits filed by most of the plaintiffs in the MDL. The first two bellwether trials scheduled to take place in early 2016 were pushed back as a result of the pending settlement. Fresenius needed 97 percent of plaintiffs to agree to the settlement for it to move forward.

March 03, 2017: A Massachusetts federal jury cleared Fresenius Medical Care of liability in the first bellwether trial alleging one of its clinics caused a patient's death. The suit was filed by the family of Carley Dial, a North Carolina man who died at a Fresenius clinic in 2012. Dial's family claimed he died of cardiac arrest shortly after he received GranuFlo.

June 27, 2018: A federal jury in Denver, Colorado returned its verdict awarding $383.5M to the families of three patients who suffered cardiac arrest and died after they received dialysis treatment at DaVita dialysis clinics using GranuFlo.

Evidence:

  • Granuflo and NaturaLyte Usage in patients before 2012
  • Evidence of increased bicarbonate levels
  • Cause of Death as Cardiac Arrest, in case of death
  • Details of Dialysis Facility

Medical Record Review and claim validation of Granuflo case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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