We believe that around 125,000 patients were prescribed GranuFlo or NaturaLyte in connection with their dialysis treatment. Those products, manufactured by Fresenius, used at Fresenius dialysis centers, and shipped also to non-Fresenius dialysis centers, are nothing to play around with. This year the FDA has issued both a GranuFlo recall and a NaturaLyte recall. In fact, the drug recalls are categorized as Class I—the highest level of recall for products that can cause serious health problems or death.
Status of GranuFlo and NaturaLyte Lawsuits
Attorneys are investigating GranuFlo lawsuits and NaturaLyte claims, and we expect that thousands of these lawsuits will be filed before long. Very shortly after the lawsuits are initially filed, plaintiffs’ lawyers will likely seek certification before the Judicial Panel on Multidistrict Litigation (JPML). If certification is granted, the federal GranuFlo and NaturaLyte lawsuits will be combined together for the purposes of discovery and sent to one judge somewhere in the United States. The judge will shepherd those cases through discovery and probably through to some initial trials. The majority of these consolidations (called Multidistrict Litigation, or MDL) settle after some test trials take place.
GranuFlo and NaturaLyte Injuries
Patients who use GranuFlo or NaturaLyte during their dialysis appear to be more likely to experience cardiac events, particularly heart attacks. Other cardiac events include irregular heart rate, low blood pressure, low oxygen in the blood, low potassium in the blood, and excessive carbon dioxide in the blood. Strokes are also a possibility. In some cases, these heart problems can cause death.
GranuFlo and NaturaLyte Statistics & Timeline
- There are 400,000 dialysis patients in the United States
- Fresenius Medical Care treats over 130,000 dialysis patients (over one-third of the total number of dialysis patients)
- 2010: 941 patients suffered heart attacks at Fresenius dialysis clinics
- November 4, 2011: Internal Fresenius memo whereby Fresenius warned its own doctors about the 941 heart attacks. No effort is made to warn Fresenius patients or patients of other clinics who use Fresenius products. That memo was eventually leaked to the FDA.
- March 29, 2012: Fresenius finally issues a “product notification,” warning about the risks of heart attacks.
- May 25, 2012: FDA warns medical providers about GranuFlo and NaturaLyte dangers
- June 2012: FDA issues Class I GranuFlo and NaturaLyte recalls
If you had a cardiac problem (like a heart attack) while on dialysis, contact our GranuFlo and NaturaLyte product defect lawyers at 1.800.553.8082, or online for a free consultation. We can help you to determine which defective drug was used for your dialysis treatments, and whether that product caused your heart problems.