GranuFlo and NaturaLyte Lawsuits
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 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.
GranuFlo and NaturaLyte Lawsuit Updates
In October 2023, the last cases in the Granuflo and NaturaLyte multidistrict litigation in Massachusetts were resolved, and the MDL was closed. Fresenius had offered a $250 million settlement in 2016.
The last of the cases in the MDL are resolved and the MDL is closed.
All MDL cases are resolved, but the MDL remains open.
Only 17 active cases are left open in the MDL, out of 4,516 originally filed.
Courts in Denver award $383.5 million to the families of three patients who died from cardiac arrest after GranuFlo treatment. But this case was a malpractice case against the dialysis provider DaVita and not Fresenius.
Fresenius Medical Care wins the first bellwether trial filed by plaintiffs. A jury in Massachusetts determined the plaintiffs didn’t prove that using Naturalyte in hemodialysis treatments was the “proximate cause” of a man’s death.
Fresenius Medical Care reaches a $250 million settlement with most of the plaintiffs in the MDL. A small group of plaintiffs decline the settlement.
The Judicial Panel on Multidistrict Litigation transfers a handful of cases to multidistrict litigation in Massachusetts.
More than 4,500 lawsuits were included in the MDL at one time. Patients sued Fresenius, alleging injuries and/or death as a result of the company’s purported fraud, negligence and misrepresentation.
Why Did People File GranuFlo and NaturaLyte Lawsuits?
People began filing GranuFlo and NaturaLyte lawsuits after an internal company memo anonymously shared with the U.S. Food and Drug Administration in 2012 surfaced insinuating that Fresenius knew about risks associated with the dialysis products and failed to share that information with the public. The memo advised the company’s own physicians of an increased risk of cardiac arrest in patients due to metabolic alkalosis (too much bicarbonate — or carbon dioxide — in the blood) because of the improper use and dosing of Granuflo and Naturalyte in dialysis treatments.
The memo followed a study Fresenius conducted in its facilities between Jan. 1 and Dec. 31, 2010. The study identified 941 patients in 667 Fresenius facilities who experienced cardiopulmonary arrests within the facilities.
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. This was done “too late,” according to injured plaintiffs.
The company memo was internally distributed on Nov. 4, 2011, about 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.
Injuries in GranuFlo and NaturaLyte Lawsuits
Injuries in GranuFlo and NaturaLyte lawsuits claim the dialysis chemicals caused injuries, from irregular levels of electrolytes in the blood to sudden heart attacks. 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.
- Cardiac arrhythmia (irregular heartbeat)
- High levels of carbon dioxide in the blood
- Low oxygen in the blood
- Low potassium
- Metabolic alkalosis
- Sudden cardiac arrest or other adverse cardiopulmonary events
Plaintiffs allege patients suffered or died as a result of the use of Granuflo and Naturalyte. The lawsuits allege that after using these products, patients 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.
- Breach of express warranty (what a seller represents to a buyer)
- Breach of implied warranty of fitness for a particular purpose
- Loss of consortium (damages suffered by a spouse or family member of an injured person)
- 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)
- Violation of consumer protection laws
- Wrongful death
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 patients’ safety.
People Who Filed Lawsuits
All of the cases against Fresenius 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.
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.
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. He said he still experiences “serious impacts” as a result of an 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 an aneurysm and associated complications.
He claimed that he was never warned of the “significant and serious risks” associated with the use of Granuflo and/or Naturalyte in his dialysis treatments.
Alabama resident Arthurine Williams filed a wrongful death lawsuit on behalf of her deceased husband, Johnny Williams. Williams alleged that her husband experienced a fatal heart attack from using Fresnius’ dialysis products.
Williams’ complaint said that her husband was prescribed Granuflo and Naturalyte three times a week beginning in June 2010. On July 28, 2010, he received a hemodialysis treatment at a DaVita center in Ensley, Alabama. Granuflo was used in his treatment.
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 filed a lawsuit on behalf of her deceased husband, Dizzy Dean Lemmond, and his estate. He also suffered a heart attack resulting in his death after using one of Fresenius’ dialysis products.
Lemmond’s complaint alleged that on Aug. 11, 2010, her husband received a hemodialysis treatment at a DaVita center in Sylacauga, Alabama. He was also provided Granuflo during the treatment. He experienced a sudden heart attack following his treatment and died the same day.
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 Sept. 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’ $250 Million GranuFlo and NaturaLyte 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 has not disclosed how many cases the settlement will include. According to its 2022 annual report, the company’s insurer, AIG, agreed to fund the settlement in 2017. However, AIG and Fresenius sued each other to recover costs and fees related to the settlement. Both of those motions were denied and the litigation is at an impasse.
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 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.
First Bellwether Trial Ends in Defense Verdict
The first bellwether trial to be heard in the Fresenius litigation took place in February 2017. A trial that began on Feb. 8 ended on March 3 when a Massachusetts federal jury returned a verdict in favor of Fresenius. Plaintiff Florella Dial pressed forward with the bellwether trial after opting out of the $250 million settlement proposed by Fresenius.
Judge Douglas 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. Dial alleged her husband died of cardiac arrest following a dialysis session using Granuflo and/or Naturalyte.
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.
The plaintiff filed an appeal in 2017, but both parties agreed to stay the trial pending settlement negotiations. Dial consequently withdrew her appeal.
Kentucky Attorney General Sues Fresenius
In 2016, then 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 “the Defendants knew or should have known of the increased risk of metabolic alkalosis attributed to the use of Granuflo.” It also alleged that Fresenius violated Medicaid guidelines by failing to warn clinics and doctors of the risk.
Fresenius offered $10.3 million to settle allegations in 2019, according to the law firm Beasley Allen. Five million was returned to Kentucky Medicaid.
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