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Granuflo and Naturalyte Litigation

Granuflo and Naturalyte are acid concentrates used in dialysis solutions and manufactured by the world’s largest dialysis provider, Fresenius Medical Care. But an internal company memo pointed to Fresenius’ knowledge of a defect in its product that led to patient injuries, including sudden cardiac arrest and death. Patients and their loved ones filed lawsuits against the company alleging fraud and negligence.

*Please seek the advice of a medical professional before discontinuing the use of this product.

Granuflo and Naturalyte Litigation Facts

Number of Lawsuits: Over 4,000 in MDL; possibly over 10,000 total

Plaintiff Injuries: Sudden cardiac arrest and/or death

Plaintiff Locations: New York, Louisiana, Pennsylvania, Virginia, Washington, Mississippi, Florida, Georgia, Ohio, Massachusetts, South Carolina, Alabama

Defendants: Fresenius Medical Care

MDL Location: District of Massachusetts (Sr. District Judge Douglas P. Woodlock) – MDL 2428

Litigation Status: Trials pending for plaintiffs that opted out of the settlement; two bellwether trials ended in favor of the manufacturer

Settlements/Payouts: $250 million settlement to plaintiffs pending

Fresenius Medical Care, with corporate headquarters in Germany and U.S. headquarters in Waltham, Massachusetts, is the manufacturer of Granuflo and Naturalyte, which are acid concentrates used in dialysis solutions (dialysate). It is also currently the largest dialysis provider in the United States and worldwide with more than 3,400 dialysis clinics treating more than 290,000 patients globally. More than 184,000 of those patients were treated in the U.S., a 2016 publication shows.

However, an internal company memo anonymously shared with the U.S. Food and Drug Administration (FDA) in 2012 led many injured patients to believe that Fresenius had prior knowledge regarding risks associated with the use of its dialysis products but failed to share that information with the public. The memo advised the company’s own physicians of an increased risk of cardiac arrest to patients due to metabolic alkalosis (too much bicarbonate — or carbon dioxide — in the blood) due to the improper use and dosing of Granuflo and Naturalyte in dialysis treatments.

An internal company memo anonymously shared with the FDA in 2012 led many injured patients to believe that Fresenius had prior knowledge regarding risks associated with the use of its dialysis products.

The memo came following a study Fresenius conducted in its facilities between January 1 and December 31, 2010. The study identified 941 patients in 667 Fresenius facilities who experienced cardiopulmonary arrests within the facilities.

Bicarbonate Molecule
Bicarbonate (a.k.a carbon dioxide) overdose is one cause of metabolic alkalosis

The results showed that hemodialysis patients were up to six times more likely to be at risk of cardiopulmonary arrest if they had elevated pre-dialysis bicarbonate levels. This conclusion caused Fresenius to research the issue of bicarbonate overdose and resulting metabolic alkalosis following dialysis treatments “too late,” according to injured plaintiffs.
The company memo was internally distributed on November 4, 2011, nearly four to five months prior to it coming to the attention of the FDA and other dialysis centers using the company’s products. A Class I recall (the most serious type of recall as classified by the FDA) followed for all lots of Granuflo acid concentrate, with the FDA determining that the company violated regulations regarding false and misleading labeling by not including such relevant information.

Patients sued Fresenius, alleging injuries and/or death as a result of the company’s purported fraud, negligence and misrepresentation.

Pending Litigation and Plaintiffs’ Allegations

Plaintiffs from across the country filed suits against Fresenius for injuries they incurred after using Granuflo and/or Naturalyte, or for injuries incurred by their loved ones that resulted in death.

Some of the injuries alleged include:

  • Metabolic alkalosis
  • Low potassium
  • Low oxygen in the blood
  • High levels of carbon dioxide in the blood
  • Cardiac arrhythmia (irregular heartbeat)
  • Sudden cardiac arrest or other adverse cardiopulmonary events

The cases, now reaching into the thousands, were consolidated into a multidistrict litigation (MDL) in 2013. At the time there were only 11 pending lawsuits filed in seven different district courts. Over 4,000 lawsuits are now pending in the District of Massachusetts, where the litigation was centralized. U.S. District Judge Douglas P. Woodlock is presiding over the MDL.

Other cases are still pending in state courts, including Louisiana and Mississippi, where plaintiffs argued to have their cases remanded (returned) from federal jurisdiction (control) in 2015. The total number of lawsuits filed against Fresenius is unknown, but may exceed 10,000.

All plaintiffs involved in the MDL allege that they suffered injury or death as a result of the use of Granuflo and Naturalyte. The lawsuits allege that after using these products, they experienced an unusually high level of bicarbonate in their blood and that this consequently increased their risk of sudden cardiac arrest or other cardiopulmonary injury.

Man Experiencing Chest Pain
Lawsuits allege that these products lead to high levels of bicarbonate in their blood which increased their risk of sudden cardiac arrest

They also assert that the injuries and deaths could have been prevented if Fresenius had adequately investigated and properly studied its products prior to marketing them for use in dialysis treatments. Furthermore, after learning about the risks, Fresenius concealed the information from the medical community rather than ensuring the patients’ safety.

All of the cases contain some common factual questions, including whether the products were defectively manufactured, whether Fresenius knew or should have known about the risks to patients as a result of the defect, and whether Fresenius provided adequate instructions and warnings in order to prevent or minimize such risks.

Plaintiffs assert the following allegations against Fresenius:

  • Fraud
  • Negligence
  • Negligent design
  • Negligent failure to warn
  • Negligent misrepresentation
  • Survival action on behalf of the decedent’s estate
  • Strict liability (does not depend on negligence or intent to harm)
  • Wrongful death
  • Violation of consumer protection laws
  • Breach of implied warranty of fitness for a particular purpose
  • Breach of express warranty (what a seller represents to a buyer)
  • Loss of consortium (damages suffered by a spouse or family member of an injured person)

Steven Roberts

Steven Roberts alleged he experienced a stroke following the use of Granuflo. In January 2012, Roberts received his dialysis treatment at Davita Greer Kidney Center.


Within two hours of receiving his treatment, Roberts claimed he exhibited symptoms of dizziness, disorientation, lack of focus, slurred speech, impaired motor functions and difficulty walking.


His wife took him to the hospital where he was diagnosed with a brain aneurysm.

Roberts spent approximately one week in the intensive care unit (ICU). He said he still experiences “serious impacts” as a result of the aneurysm allegedly brought on by Fresenius’ defective product.

Roberts continues to suffer from neck pains, difficulty speaking, and weakness and motor impairment on his left side. He also experiences diarrhea, nausea, vomiting, irritability and difficulty breathing as a result of the aneurysm and associated complications.

Roberts claimed he was never warned as to the “significant and serious risks” associated with the use of Granuflo and/or Naturalyte in his dialysis treatments.

Arthurine Williams

Alabama resident Arthurine Williams filed a wrongful death suit on behalf of her deceased husband, Johnny Williams. Williams alleged that Johnny experienced a fatal heart attack from using Fresnius’ dialysis products.

Williams’ complaint said that Johnny was prescribed Granuflo and Naturalyte three times a week beginning in June 2010. On July 28, 2010, Johnny received a hemodialysis treatment at a DaVita center in Ensley, Ala. Granuflo was used in his treatment.

Williams claimed that after the use of the product and following his dialysis treatment, Johnny suffered a heart attack and died the following day.

Williams also claimed that her husband relied upon “the misrepresentations and actions” of Fresenius “in so far as that the hemodialysis products he was being provided were safe and effective for use in his treatments.”

Betty Lemmond

Betty Lemmond filed her lawsuit on behalf of her deceased husband, Dizzy Dean Lemmond, and his estate. Dizzy Dean also suffered a heart attack resulting in his death after using one of Fresenius’ dialysis products.

Lemmond’s complaint alleged that on August 11, 2010, Dizzy Dean received a hemodialysis treatment at a DaVita center in Sylacauga, Ala. He was also provided Granuflo during the treatment.

Dizzy Dean experienced a sudden heart attack following his treatment and died the same day.

Waddell Bishop

In 2012, Waddell Bishop sued Fresenius after his mother, Frances Carol Bishop, died following the use of Granuflo and Naturalyte. Bishop claimed that his mother suffered “an adverse cardiovascular event” on September 16, 2010, after receiving a dialysis treatment that used Fresenius’ dialysis products.

Bishop’s complaint alleged that his mother and her health care providers were “not aware and through diligent effort not able to discover the risk of serious injury and/or death associated with and/or caused by using Granuflo and/or Naturalyte.”

The lawsuit further alleged that her “injuries and damages directly resulted from using Granuflo and/or Naturalyte,” and that Fresenius “knew or should have known, or could have learned through reasonable diligence that Granuflo and/or Naturalyte caused and/or was associated with an increased risk of death and serious injuries.”

Fresenius Proposes $250 Million Settlement

In February 2016, Fresenius requested a stay (halt of proceedings) in the MDL to propose a $250 million settlement to the more than 4,000 plaintiffs awaiting trial. The first two bellwether trials scheduled to take place in early 2016 were pushed back as a result of the pending settlement.

Fresenius Requirements

Fresenius needed 97 percent of plaintiffs to agree to the settlement for it to move forward.

Fresenius needed 97 percent of plaintiffs to agree to the settlement for it to move forward. Fresenius has not disclosed how many cases the settlement will include.

It was reported that Fresenius issued a statement on March 3, 2017, that the company is court-ordered to either confirm or void the $250 million settlement proposal on May 10, 2017. The company also stated that that date is “subject to change.”

Fresenius Wins First State Jury Trial

The settlement proposal followed a win for Fresenius in the first case to go to trial in a Massachusetts state court.

The jury found that while Fresenius was negligent in not immediately distributing the information in its internal company memo to the general medical community and the public at large, the patient’s death could not be attributed to Granuflo.

In 2016, a spokesperson for Fresnius, Kent Jarrell, stated to the New York Times that “the initial internal memo was actually incorrect and contradicted by further careful analysis.” He also said that the warning language that was added to labeling for Granuflo in 2012 was later removed.

Jarrell said the settlement following their initial win was not an admission of wrongdoing but just a way to put an end to the litigation.

Insurer Debates Claims

In 2016, Fresenius insurer, National Union Fire Insurance Company in Pittsburgh, filed suit against the dialysis products’ manufacturer, following its settlement announcement. The insurer is seeking a declaratory judgement, which will establish its rights based on its agreement with Fresenius.

According to Fresenius, most of the proposed settlement, about $220 million, is expected to be covered by the insurer, with the medical company only paying out a portion of approximately $60 million towards the remainder of the settlement and associated costs.

National Union claimed that some exclusions may apply to some of Fresenius’ claims for coverage in its $250 million settlement proposal, thereby reducing the insurer’s presumed contribution.

The case is pending in the Supreme Court of the State of New York.

First Bellwether Trial Ends in Defense Verdict

Bellwether trials are essentially test trials to see how each sides’ arguments will likely play out. A small group of lawsuits is selected from a larger group of similar cases, and verdicts received are relied upon to bring the litigation to a more timely resolution.

The first bellwether trial to be heard in the Fresenius litigation took place in February 2017. A trial that began on February 8 ended on March 3 when a Massachusetts federal jury returned a verdict (decision) in favor of Fresenius.

Plaintiff Florella Dial pressed forward with the bellwether trial after opting out of the $250 million settlement proposed by Fresenius.

Dialysis Machine
Patients alleged that Fresenius failed to provide proper warnings and instructions for its dialysis product.

Judge Woodlock also found in favor of Fresenius on a claim under North Carolina law for unfair and deceptive trade practices.

Dial’s husband, Carley Dial, was treated at a Fresenius clinic in 2012. Following a dialysis session using Granuflo and/or Naturalyte, Dial alleged her husband died of cardiac arrest.

Dial alleged that Fresenius failed to provide adequate warnings and instructions for its dialysis product, thereby putting patients at risk. She also alleged that Fresenius’ own physicians were confused by the company’s failure to warn users about the proper handling of its products and the risks involved.

Dial claimed in her lawsuit that Fresenius’ actions were cause for an award of exemplary damages (by example, as a warning to others) due to the company’s “willful or wanton” (deliberate) conduct.

Kentucky Attorney General Sues Fresenius

In 2016, Kentucky Attorney General Andy Beshear filed a public interest lawsuit on behalf of the Kentucky Medicaid program against Fresenius. The complaint requested recovery of damages, statutory civil penalties and injunctive (compelling or restraining a person or entity from action) relief.

Beshear alleged that the lawsuit was the result of Fresenius’ “unlawful, unfair, false, misleading and deceptive practices related to Granuflo Dry Acid Concentrate.”

The Complaint stated, “Due to Granuflo’s combination of both acetic acid and sodium diacetate, Granuflo can dangerously increase bicarbonate levels beyond the levels prescribed by a patient’s physician. Based on the Defendants’ [Fresenius’] knowledge of the chemical structure, and resulting metabolic process in the human body, combined with the knowledge readily available to the Defendants as early as 2004, the Defendants knew or should have known of the increased risk of metabolic alkalosis attributed to the use of Granuflo.”
The Complaint also alleged that Fresenius began informing its own employees of the need for bicarbonate adjustments and dangers associated with the improper dosing of its product as early as 2008, but chose not to inform other non-Fresenius clinics or the medical community at large.

Drugwatch.com Author

Author

Kristin is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer, journalism and marketing.

View Sources
  1. Castellucci, M. (2017). Jury clears Fresenius dialysis treatment in patient death lawsuit. Retrieved from: http://www.modernhealthcare.com/article/20170303/NEWS/170309965
  2. Complaint. 2:3; 4:11; 9:39-42. (2012). Retrieved from: http://www.aboutlawsuits.com/wp-content/uploads/2012-07-27-Fresenius-Complaint.pdf
  3. Complaint. 2:3; 4:11; 9:39 & 42. (2012). Retrieved from: http://www.aboutlawsuits.com/wp-content/uploads/2012-08-10-Lemmond-Granuflo-Complaint.pdf
  4. Complaint. 6:32-34, 38-39; 8:50-51. (2012). Retrieved from: http://www.aboutlawsuits.com/wp-content/uploads/2012-09-14-Bishop-Fresenius-Complaint.pdf
  5. Complaint. 1:1; 15:48-50. (2016). Retrieved from: http://ag.ky.gov/pdf_news/20160901_complaint.pdf
  6. Complaint and Jury Trial Demand. 2:7; 3:9-10. (2013). Retrieved from: https://www.hbsslaw.com/uploads/case_downloads/files/case_pdfs/Fresenius/Roberts%20v%20Fresenius%20Complaint.pdf
  7. Fresenius Medical Care. (N.D.). Company Profile. Retrieved from: https://fmcna.com/company-profile/
  8. Fresenius Medical Care. (2011). Internal Memo. Retrieved from: http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
  9. Kass, Dani. (2016). Fresnius Requests Stay In Dialysis MDL To Ink Settlement. Retrieved from: https://www.law360.com/articles/767249/fresenius-requests-stay-in-dialysis-mdl-to-ink-settlemen
  10. Lexis Legal News. (2016). Fresenius Dialysis Soultion Litigation Settles For $250M, Company Announces. Retrieved from: http://www.lexislegalnews.com/articles/6114/fresenius-dialysis-solution-litigation-settles-for-250m-company-announces
  11. Lexis Legal News. (2017). Fresenius Gets Defense Verdict In Naturalyte MDL Wrongful Death Trial. Retrieved from: http://www.lexislegalnews.com/articles/15380/fresenius-gets-defense-verdict-in-naturalyte-mdl-wrongful-death-trial
  12. Lowrey, B. (2016). Insurer Seeks To Cut Claims After Fresenius’ $250M Deal. Retrieved from: https://www.law360.com/articles/806572/insurer-seeks-to-cut-claims-after-fresenius-250m-deal
  13. Neumann, M. E. (2016). The largest dialysis providers in 2016: Poised for change. Retrieved from: http://www.nephrologynews.com/largest-dialysis-providers-2016-poised-change/
  14. Pollack, A. (2012). Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry. Retrieved from: http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0
  15. Pollack, A. (2016). Dialysis Equipment Maker Settles Lawsuit for $250 Million. Retrieved from: https://www.nytimes.com/2016/02/19/business/dialysis-equipment-maker-settles-lawsuit-for-250-million.html?_r=1
  16. Reuters. (2016). FMC takes $60 mln pretax burden on GranuFlo settlement. Retrieved from: http://www.reuters.com/article/fresenius-medi-settlement-granuflo-idUSASN0000J8
  17. U.S. Government Publishing Office. Memorandum And Order. (2015). Retrieved from: https://www.gpo.gov/fdsys/pkg/USCOURTS-mad-1_13-md-02428/pdf/USCOURTS-mad-1_13-md-02428-2.pdf
  18. U.S. Judicial Panel on Multidistrict Litigation. Transfer Order. (2013). Retrieved from: http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2428-Initial_Transfer-03-13.pdf