Woman Sues Fresenius after Losing Husband to GranuFlo

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When Lorene Spradling’s late husband, Franklin Delano Spradling, began kidney dialysis, she thought they knew all the risks. After all, the process of kidney dialysis itself can be incredibly taxing— but the couple never thought that one of the drugs used in the process would later be recalled for causing dangerous side effects.

Both GranuFlo and Naturalyte are products of Fresenius, the company which operates the most dialysis centers in the country. According to Lorene, GranuFlo allegedly caused her husband’s heart attack. Both GranuFlo and NaturaLyte were recalled in 2012 after they were linked to over 900 deaths.

Her GranuFlo lawsuit was filed on Nov. 4, 2013. She claims that Fresenius “negligently and/or fraudulently represented to the medical and healthcare community, the FDA, the Plaintiff(s), the Decedent, and the public in general that Naturalyte and/or GranuFlo had been tested and were found to be safe and/or effective for their indicated use – as acid concentrates to be administered during hemodialysis.”

Furthermore, Lorene says that Fresenius knew about the risks but purposefully hid them. “When warning of the safety, risks and/or defects of Naturalyte and/or GranuFlo, Defendants negligently and/or fraudulently represented to the medical and healthcare community, the FDA, the Plaintiff(s), the Decedent, and the public in general that Naturalyte and/or GranuFlo had been tested and were found to be safe.” The lawsuit says that it wasn’t true.

In late 2009, an internal memo was leaked which revealed that Fresenius knew that GranuFlo caused heart attacks, but that memo was only meant for a few key doctors at select centers. It was never meant to go public. “These representations and concealments were made by Defendants with the intent of defrauding and/or deceiving the Plaintiff(s), the Decedent, the public in general and the medical and healthcare community, and were made with the intent of inducing the public in general, and the medical community in particular, to recommend, dispense, prescribe, administer and/or otherwise use Naturalyte and/or GranuFlo as acid concentrates during hemodialysis, all of which evinced a callous, reckless, willful, depraved indifference to the health, safety and welfare of the Decedent.”

The influx of GranuFlo class action lawsuits showcases just how common death by the drug is. She claims that Fresenius “negligently and improperly failed to perform sufficient tests, if any, concerning Naturalyte’s and/or GranuFlo’s potential to cause serious and grave health consequences, including but not limited to death, cardiopulmonary arrest, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmias, and/or hypotension, during clinical trials.” Had Fresenius acted responsibly, her husband would likely still be alive today. Instead, Lorene was left a widow.

According to her GranuFlo complaint, “The use of Naturalyte and/or GranuFlo in dialysis treatment caused the Decedent to suffer severe injuries and damages including but not limited to the following: severe adverse cardiovascular event and cardiovascular death on or about December 22, 2009. Due to the negligent, intentional, willful, wanton, fraudulent, and/or otherwise culpable conduct of the Defendants alleged herein, the Plaintiff(s), the Decedent, Decedent’s treating physicians and/or healthcare providers did not discover, nor did they have reason to discover, the serious and severe health risks associated with using Naturalyte and/or GranuFlo, before the FDA issued a notice of release in June 2012.”

Turning Back Time

No amount of compensation will bring her husband back. However, the widow has uncovered a host of information that suggests Fresenius has known for years about the GranuFlo risks. “Upon information and belief, despite the results of their 2004 Retrospective Study and their knowledge of the severe health risks associated with their GranuFlo, Defendants intentionally and willfully concealed their knowledge of these results and/or the increased severe health risks associated with their GranuFlo from the FDA, the medical community, the Plaintiff(s), the Decedent, Decedent’s treating physicians and/or healthcare providers and the public,” reads her GranuFlo claim.

The alleged coverup was immense. “After Fresenius Defendants learned and/or should have learned of the severe health risks associated with their Naturalyte and/or GranuFlo, Fresenius Defendants intentionally and affirmatively elected not to report these risks to the FDA as required by law.”

She’s suing for negligence and negligence per se, strict products liability, breach of warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, wantonness, unjust enrichment, and wrongful death.

The case is Lorene Spradling et al v. Fresenius Medical Care Holding et al, Case No. 2:13-cv-27960, in the United States District Court for the Southern District of West Virginia.

Help for Victims of Kidney Dialysis Injury, Death

If you or a loved one suffered a heart attack, cardiac arrest, stroke, metabolic alkalosis or other injury after undergoing kidney dialysis with GranuFlo and/or NaturaLyte, you may be eligible to take legal action against the manufacturer of the dialysis drugs. Filing a lawsuit may be the only way you’ll be able to obtain compensation for medical bills, pain and suffering and other damages. Learn more and obtain a free case evaluation at the GranuFlo/NaturaLyte Recall Class Action Lawsuit Investigation.