Thousands of people have filed GranuFlo lawsuits against Fresenius Medical Care for heart injuries that were allegedly caused by GranuFlo and NaturaLyte, two acid concentrates used during dialysis treatments. Both products were named in a Class I GranuFlo recall in 2012, after they were tied to hundreds of deaths and injuries at Fresenius-owned dialysis clinics. GranuFlo and NaturaLyte lawsuits accuse Fresenius of concealing these risks from the public in order to protect the profits it earned from sales of the drugs.
You may be entitled to compensation if you or a loved one suffered catastrophic cardiovascular complications following a GranuFlo or NaturaLyte dialysis treatment, including:
- Cardiac Arrest
- Heart Attack
- Low Blood Pressure
- Cardiac Arrhythmia
- Hypoxemia (low blood oxygen)
- Hypercapnia (high blood carbon dioxide)
- Sudden Death
As both an attorney and practicing physician, Dr. François Blaudeau possesses a unique understanding of the medical and legal questions at issue in GranuFlo lawsuits. To learn more about your legal rights, please call Dr. Blaudeau as soon as possible for a free, no-obligation case review.
GranuFlo and NaturaLyte Recall
GranuFlo and NaturaLyte are used during dialysis treatments to cleanse the blood. While both contain the same active ingredient, GranuFlo is a liquid and NaturaLyte is a powder formulation. In addition to using the two products at its own dialysis clinics, Fresenius Medical Care supplied the concentrates to thousands of other facilities throughout the U.S. As such, it is believed that as many as 50% of U.S. dialysis patients were treated with either GranuFlo or NaturaLyte prior to the announcement of the 2012 recall.
In March 2012, Fresenius issued an Urgent Product Notification to dialysis clinics around the country to inform them of potentially dangerous dosage issues affecting GranuFlo and NaturaLyte. Because they were formulated differently than rival concentrates, adjustments needed to be made in order to avoid a dangerous buildup of bicarbonate in the blood. If not, patients were at risk of developing a condition called metabolic alkalosis, which increases the risk that an individual will experience a sudden, catastrophic cardiac event.
In June of that year, the U.S. Food & Drug Administration (FDA) declared Fresenius’s GranuFlo and NaturaLyte notification a Class I recall – its most serious type of recall. Though the products were never removed from the market, Fresenius did update their labeling to better inform healthcare providers of their unique dosage requirements.
It was also revealed in June 2012 that the FDA was investigating the timing of the GranuFlo recall, after the agency became aware of an internal memo the company sent to its own dialysis clinics in November 2011 advising doctors of a sudden spike in cardiac arrests that had occurred at Fresenius facilities the prior year. Like the public notification the company would issue months later, the memo warned of GranuFlo’s association with elevated bicarbonate levels, as well as the need to adjust dosage to avoid life-threatening heart problems. It is still not clear why Fresenius then waited until March 2012 to issue a similar warning to the thousands of out-of-network clinics that also used GranuFlo and NaturaLyte to treat patients.
In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a consolidated litigation in the U.S. District Court, District of Massachusetts for all federally-filed GranuFlo and NaturaLyte lawsuits. By the end of 2014, nearly 3,000 claims had been filed in that proceeding. All of the GranuFlo cases pending in U.S. courts accuse Fresenius of placing profits ahead of patients, and claim that the warnings and instructions for use included on the products’ labels were not adequate to ensure their safety. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
Legal Help for Victims of GranuFlo and NaturaLyte Lawsuits
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for the victims of dangerous and defective drugs. If you or a loved one were harmed by GranuFlo or NaturaLyte, please contact the Firm today to learn more about your legal rights. You can arrange for a free, no obligation GranuFlo lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.