GranuFlow Class Action

GranuFlo and NaturaLyte are brand names of dialysates (commonly called “solutions”) manufactured by Fresenius Medical Care, Inc., the largest provider of kidney dialysis services and products in the world. These solutions are used in dialysis centers across America, and around the world, to treat patients with kidney disease or failure.

However, after investigating the harmful effects of GranuFlo and NaturaLyte the US Food and Drug Administration (FDA) issued a recall for both solutions on March 29, 2012, and ordered Fresenius to revise prescribing instructions. According to the recall, use of these two products can lead to low blood pressure and result in sudden cardiac arrhythmia (heart attack).

In its order, the FDA stated these conditions, “may culminate in cardiopulmonary arrest” or other conditions, including death. Class 1 recalls are the most serious form of recall as they address situations that create a “reasonable probability that products will cause serious health consequences; or death,” according to the FDA.

According to theFDA, GranuFlo and NaturaLyte can create elevated bicarbonate levels in patients, leading to hemodialysis – related metabolic alkalosis, a significant risk factor for a variety other health problems including:

  • Stroke
  • Arrhythmia
  • Altered mental status (confusion)
  • Low blood pressure

Manufacturer Hides Drug Dangers from Public

On November 4, 2011, Fresenius issued an internal memo concerning its GranuFlo and NaturaLyte medications. It revealed that almost 950 patients who died in their clinics in 2010 after receiving these solutions during dialysis treatments exhibited elevated levels of bicarbonate in their blood, which is a contributing factor in heart attacks.

The memo warned staff members at Fresenius’ clinics regarding the drugs’ risks. Fresenius failed to warn doctors and/or the third-party clinic providers of these serious dangers until after the FDA and public learned of the internal memo via a New York Times article. Even then, the public warning wasn’t nearly as direct as the internal memo.

As a result, a growing number of people who were injured by GranuFlo and NaturaLyte have begun lawsuits, claiming that Fresenius’ dialysis solutions caused severe, permanent injuries, and damages that included:

  • mental and physical pain
  • cost of additional medical care
  • lost wages and future earning capacity
  • and death

Plaintiffs have further alleged that the manufacturer intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.

GranuFlo and NaturaLyte Legal Cases On the Rise

Thousands of lawsuits have been filed against Fresenius for injuries and wrongful deaths believed to be the fault of GranuFlo and NaturaLyte products. Many people have lost close family members to this tragedy. And many severely injured patients must live with serious health issues due to the damage their bodies have suffered.

In 2013, nearly 200 individual GranuFlo and NaturaLyte injury lawsuits against Fresenius were consolidated into a multidistrict litigation (MDL) in Massachusetts. You can view of a copy of the Massachusetts MDL here. In an environment where many plaintiffs sue the same defendant for similar injuries many cases can be heard for a temporary period of time in a single court in order to establish the formula for each individual trial.

The cases are then returned to their respective jurisdictions. This is what makes MDL’s different from class action suits, where plaintiffs band together and have their case argued by a single legal representative or firm.

Have you or a beloved family member suffered a heart attack or other injuries after dialysis procedures involving NaturaLyte or GranuFlo? If so, you may be entitled to fair and full compensation from Fresenius Medical Care for your injuries and other damages.

To best determine whether this is the course of action you should take, you should speak with a dedicated GranuFlo attorney who has experience fighting for compensation on behalf of victims of dangerous drugs and defective medical products.