Schmidt & Clark, LLP | A National Law Firm

Granuflo Lawsuit


GranuFloThe recent Class I Recall of the widely-used dialysis treatment GranuFlo has prompted the Defective Drug Lawyers at Schmidt & Clark, LLP, to begin reviewing potential GranuFlo lawsuit claims nationwide. According to the U.S. Food & Drug Administration (FDA), GranuFlo may cause a number of serious side effects, and patients may not have been properly warned of these risks prior to its use. Individuals who have been treated with GranuFlo and subsequently suffered from a heart attack, stroke, arrhythmia, cardiac arrest, or any other adverse health complication are encouraged to contact us today to learn more about their legal rights.

GranuFlo Lawsuit Update 9/5/12: Fresenius Medical Care (FMC), the largest dialysis provider in the United States, faces a wrongful death lawsuit filed on behalf of an Alabama man who died from a heart attack after being treated with the company’s GranuFlo product. According to the complaint, GranuFlo side effects caused the man’s heart attack because inadequate warnings were provided about the risks associated with the dialysis treatment. The lawsuit claims that FMC knew – or should have known – about GranuFlo’s potential to cause adverse health complications, but that it failed to warn the public and medical communities about these dangers.

Free GranuFlo Lawsuit Evaluation: If you or a loved one has been injured by GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

Michael Schmidt Elected to The Granuflo and Naturalyte Plaintiffs’ Steering Committee For Granuflo and Naturalyte Injury Claims Throughout The Country

Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP and The Schmidt Firm, LLP, was recently elected to the Plaintiffs’ Steering Committee in the Judicial Council Coordination Proceeding No. 4749 in Los Angeles Superior Court. The coordination proceeding applies to Granuflo and Naturalyte injury claims nationwide. This appointment establishes Mr. Schmidt in a leadership position in the litigation along with rest of the JCCP leadership panel.

A nationwide recall was issued for NaturaLyte and GranuFlo on March 29, 2012. Use of Fresenius Medical Care’s popular dialysis treatment products GranuFlo and NaturaLyte has been linked to a six-fold increased risk of cardiopulmonary arrest and sudden cardiac death.

What’s the Problem with GranuFlo?

Manufactured and marketed by Fresenius Medical Care (FMC), GranuFlo is a powder concentrate designed to be used during dialysis treatments to help patients with kidney failure remove toxins from their blood. To reduce acid buildup in the blood, GranuFlo is mixed with bicarbonate to neutralize the acid. However, unbeknownst to many prescribing physicians, GranuFlo already contains higher levels of bicarbonate than other similar dialysis treatment products, so the addition of extra bicarbonate has the potential to lead to serious side effects such as heart attacks, strokes, and fatal overdoses. Studies have found that elevated bicarbonate levels in the blood can increase the risk of heart attack six-fold. In 2010 alone, 941 patients suffered heart attacks while receiving dialysis treatments at FMC clinics, raising alarms within the company.

Side Effects of GranuFlo

The main problem with GranuFlo seems to be that it has the potential to cause metabolic alkalosis, a condition that has been linked to serious side effects including:

  • Low blood pressure
  • Cardiopulmonary arrest
  • Cardiac arrhythmia
  • Hypokalemia
  • Hypoxemia
  • Hypercapnia
  • Sudden heart attack
  • Stroke
  • Hemodialysis cardiopulmonary arrest

FMC Internal Memo Re. GranuFlo Side Effects

In November 2011, FMC executives sent an internal memo describing the risk of elevated bicarbonate levels to staff working in the company’s dialysis treatment centers. The memo reportedly discussed ‘troubling findings,’ and alerted staff that ‘this issue needs to be addressed urgently.’ However, FMC did not pass this information along to the estimated 125,000 patients being treated with GranuFlo at clinics not operated by the company. Instead, federal health regulators were not warned of GranuFlo’s dangers until early 2012, when the internal memo was leaked to the FDA. Only on March 29, 2012, over four months later, did Fresenius issue a public warning about GranuFlo.

GranuFlo Recall

In response to these revelations, the FDA issued a Class I Recall for GranuFlo and a companion dialysis treatment product called NaturaLyte on June 27, 2012. In its recall announcement, the administration stated that “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” According to an article published in the New York Times, the FDA is currently in the process of determining whether FMC’s failure to warn the public and medical communities about GranuFlo’s side effects violated federal laws.

Do I Have a GranuFlo Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in GranuFlo lawsuits. We are handling individual litigation nationwide and currently accepting new injury lawsuits in all 50 states.

Free GranuFlo Lawsuit Evaluation: Again, if you or a loved one has been injured by GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

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