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NaturaLyte & GranuFlo Recall

On March 29, 2012, the FDA issued a Class I recall of the controversial dialysates Naturalyte and GranuFlo. The move came when the federal agency was alerted to the increased risk of heart attack, stroke and fatalities caused by the acid concentrates found in the products, which are used in dialysis treatments.

A Class I recall is reserved for products that exhibit a reasonable probability that those exposed will sustain serious, and even fatal, injuries. The FDA investigated the dialysates – which are produced by Fresenius Medical Care – after a series of post-market studies revealed the risks of Naturalyte and GranuFlo side effects. The company is alleged to have failed in its duty to disclose the risks to patients, healthcare providers and the FDA.

Understanding how GranuFlo and NaturaLyte is used and misused

GranuFlo and NaturaLyte are acid concentrates used in the treatment of kidney failure as part of hemodialysis. The solution comprises a mixture of either the liquid or dry form of the substance, purified water, and sodium bicarbonate.

Because bicarbonate prevents the build-up of bodily acid, the solution must be precisely measured to ensure safe pH levels. Prior to the recall, most physicians who administered dialysis were unaware that the constituent parts of GranuFlo and NaturaLyte caused bicarbonate levels to spike to such a level that patients were at grave risk of serious dialysis injury.

Such bicarbonate levels cause metabolic alkalosis, low potassium levels, low blood pressure, heart problems and stroke.

Side effects of GranuFlo and NaturaLyte 

When GranuFlo and NaturaLyte were first introduced, they immediately proved popular among dialysis providers. Both products were distributed to dialysis centers, clinics, and hospitals all over the country. Though some of the medical facilities were owned by Fresenius Medical Care, others were not affiliated with them in any way.

Shortly after their use was implemented in thousands of clinics across the United States, patients and doctors began reporting a range of complications.

Serious Granuflo and Naturalyte side effects may include: 

  • Metabolic alkalosis
  • Congestive heart failure
  • Heart Attack
  • Irregular heart beat/ cardiac arrhythmia
  • Stroke
  • Sudden Death 

The significant number of people claiming cardiac arrest during or shortly after having dialysis prompted Fresenius to initiate a study aimed at exposing the risks for those using Naturalyte and GranuFlo as part of their dialysis. The study, conducted between January 1, 2010 and December 31, 2011, revealed 941 reports of cardiopulmonary arrest from 667 medical facilities owned by Fresenius. According to the results of the study, patients whose pre-diaylsis were already high were as much as six times as likely to experience cardiac arrest.

An internal memo was released by Fresenius on November 11, 2011 to both physicians and executives working at the clinics detailing the findings of the study and advising physicians to adjust the bicarbonate levels and to carefully monitor patients for signs of adverse effects.

The memo emphasized the seriousness of the problem, and indicated a need for it to be urgently addressed. However, despite their newfound awareness of the dangers associated with GranuFlo, the firm continued to externally promote the dialysates as safe and effective.

Since then, numerous actions have been filed against Fresenius. Plaintiffs allegations include: 

  • Failure to advise healthcare facilities using these products of the risks
  • Failure to adjust dosage to safe levels of use
  • Failure to advise patients of the serious risks associated with GranuFlo and NaturaLyte
  • Failure to report the internal case-control study to the FDA
  • Failure to update the warning label to reflect the safety risks

FDA investigation and lawsuits 

The FDA received a leaked copy of the internal memo in March 2012. Shortly thereafter, the FDA contacted Fresenius. Soon the company was compelled to issue a warning notification to all clinics known to use the products and updated warning labels were applied to all products.

Ultimately, the agency announced the Naturalyte and GranuFlo recall on March 29, 2012. As the steady stream of lawsuits were filed, cases were soon centralized into a multidistrict litigation (MDL 2428) in the Massachusetts District Court.

There are currently around 230 lawsuits pending in the MDL, with more cases filed in local courts around the country. It is anticipated that the number of GranuFlo lawsuits in the MDL could rise to the thousands before the current cases are settled or reach trial.

U.S. District Judge Douglas P. Woodlock is overseeing the MDL. Judge Woodlock issued the order for discovery proceedings with the intent of beginning those proceedings in late October. Deadlines for various points in the process have also been set in this order, including the selection of bellwether trials to begin in January, 2014. These trials, selected by both parties, offer a glimpse of how juries could respond to evidence and testimony during trial.

Fresenius is also at the center of a pending federal investigation by the FDA. According to a June 2012 report by the New York Times, the FDA will continue to examine the possibility that the company violated federal law and regulations by failing to notify the agency and the public of the health risk associated with the recalled products.