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Months after Recall, Fresenius Rolls Out Overnight Dialysis Treatment

Dialysis machine

Months after a massive recall of dialysis products, Fresenius Medical Care North America (FMCNA) announced that more than 140 nighttime dialysis programs are now available across the country. In 2013, more centers are expected to open.

Dialysis removes waste from the blood and extra fluids that can build up when the kidneys fail. Each year, about 400,000 people undergo dialysis. Patients who are older than 75 are the fastest growing group of people receiving dialysis.

Traditional daytime dialysis typically takes 3-4 hours, and patients undergo treatment three times a week. Patients who choose the nighttime dialysis option still go three times a week, but the dialysis process is slower and takes 8 hours. Because fluids are removed from the body more slowly, the treatment is easier to tolerate. Patients can rest or sleep while undergoing their treatment.

Studies Show Benefits of Nighttime Dialysis

Studies conducted by FMCNA suggest benefits from nighttime dialysis including better blood pressure and mineral level control. One study involved observations of 750 FMCNA patients, and results showed nighttime dialysis had a better rate of removing excess fluid and phosphorus.

The study was conducted by FMCNA's vice president for clinical science, epidemiology and research, Dr. Eduardo Lacson, Jr. Lacson, who was quoted by Business Wire: "In-center nocturnal dialysis is a viable alternative to standard in-center dialysis for patients who require greater fluid and phosphorus removal and who are amenable to spending three nights a week in the dialysis facility."

FDA Investigates Fresenius After Product Recall

While FMNCA has long been the leader in dialysis treatment, the company has also had its share of product liability issues. The company's GranuFlo and NaturaLyte brands of dialysates were recalled on March 29, 2012, after the Food and Drug Administration (FDA) announced that the products "may cause serious adverse health consequences, including death."

GranuFlo and NaturaLyte contain high levels of sodium diacetate that lead to high levels of sodium bicarbonate in the blood. High levels of sodium bicarbonate can cause a number of health problems, such as heart arrhythmia, coma, heart attack and death.

An internal memo dated Nov. 4, 2011, circulated among Fresenius employees advised that more than 900 patients experienced heart attacks in their clinics in 2010. The memo also linked GranuFlo to high levels of sodium bicarbonate and heart attacks. Despite this information, Fresenius failed to inform the public and non-FMNCA doctors of its findings.

Shortly after the product recall, the FDA investigated Fresenius for violating federal regulations by not informing customers of the potential dangers of GranuFlo. Steven Silverman, director of compliance for the FDA's medical devices division, told The New York Times, "Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern."

Fresenius Named in GranuFlo Lawsuits

The internal memo and FMNCA's failure to notify patients and doctors about heart attacks caused by GranuFlo led to a number of injured dialysis patients and their families filing lawsuits against the company.

In complaints, plaintiffs alleged that the manufacturer "intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte."