However, various deaths allegedly linked to a Granuflo recall due to alkali dosing errors appear to be resulting in a narrow view of the potential issues at hand.As is often the case with most things, there is more to the story…
This past March, GranuFlo and NaturaLyte suddenly appeared in the headlines due to alleged dosing errors associated with the two products used in the dialysis process. Powdered GranuFlo and liquid NaturaLyte utilize acetic acid and sodium acetate, which can lead to additional presence of sodium acetate in the dialysate and, in turn, can result in higher levels of bicarbonate in the bloodstream. Levels of bicarbonate in the blood need to be carefully monitored, due to detrimental effects to the heart in some patients stemming from bicarbonate levels that are too high.
Deaths that occur during dialysis are rare, but they do happen, for various reasons. However, Fresenius Medical Care North America - the manufacturer of GranuFlo and NaturaLyte - noted an increasing trend in dialysis deaths or other cardiac events, and upon investigation, found the potential for alkali dosing errors inherent with the use of GranuFlo and NaturaLyte. Such errors can trigger levels of bicarbonate in the bloodstream that are too high, posing a grievous risk to some patients.
Fresenius issued an alert and a Granuflo recall soon followed - but not before many questions were raised with regard to how that recall happened, and why.
Fresenius is much more than a manufacturer of GranuFlo [the subject of a GranuFlo lawsuit on the part of many] and NaturaLyte. Fresenius is also one of the largest operators of dialysis clinics in the nation. GranuFlo and NaturaLyte are used in Fresenius clinics - but the products are used by other dialysis centers not within the Fresenius umbrella.
What lay behind many a Fresenius lawsuit is the way in which the health alert was handled. In early 2012, Fresenius issued a warning to doctors and health practitioners operating in the Fresenius clinics that there was a problem with the products. The suspicion was that due to dosing errors associated with the products dialysis patients were experiencing serious health and cardiovascular issues. Some died.
Fresenius, it has been reported variously, made no bones about the seriousness of the matter.
However, what has critics up in arms is an apparent unwillingness to share the issue with non-Fresenius clinics at the outset, thereby putting scores of dialysis patients potentially at risk. It wasn’t until the Fresenius memo was leaked to the US Food and Drug Administration (FDA) that a GranuFlo and NaturaLyte recall was undertaken, and the issue finally came to light across all sectors.
But not before some patients had suffered cardiac events. Others did not survive.
Fresenius defended its decision at the time, noting that information was still preliminary, and that the most effective way to communicate an issue is through publication in scholarly and medical journals. There wasn’t time to undertake a study, analyze the results and then publish the findings.
Critics say Fresenius could have maintained their position that findings were preliminary, but nonetheless could have issued the same “dear doctor” memo to other non-Fresenius clinics using GranuFlo and NaturaLyte through a database of any supplier having purchased GranuFlo and NaturaLyte from Fresenius.
Fresenius, it should be noted, has its defenders as well. But that hasn’t stopped a number of Fresenius lawsuits, as plaintiffs take Fresenius to task not only for the products they manufacture and vend, but for the clinics they operate.
There have been issues with some facilities. Recently, two deaths of dialysis patients and five hospitalizations resulted in the closure of a Fresenius dialysis center in Alabama. A subsequent investigation found no conclusive link between the seven cases. Still, the two deaths and five hospitalizations occurred earlier this spring within several days of one another, forcing the closure of the Bessemer Kidney Center, one of several dialysis clinics Fresenius operates in the state of Alabama alone.
However, according to the Birmingham News (6/19/13), the Bessemer facility, which was closed May 8, was to remain shuttered as the investigation found deficiencies at the facility relating to staffing levels and training. And this is not the first time the Fresenius-owned facility has had problems. State records show that Bessemer was cited in 2012 over failure to meet standards for infection control, glove use and disinfection of surfaces. Those Fresenius deficiencies were shown to have been subsequently corrected. And Dr. Tom Geary, director of the Bureau of Health Provider Standards at the Alabama Department of Public Health, noted in the report that about 10 percent of dialysis patients generally die every year.
However, critics remain concerned about circumstances surrounding alkali dosing errors and the subsequent GranuFlo recall, together with deficiencies found in a Fresenius-owned dialysis center that’s been cited twice in two years - then two deaths and five hospitalizations within days. If there is an expected death rate amongst dialysis patients, that rate needn’t be heightened by the potential for errors and deficiencies at dialysis clinics owned or operated by the manufacturer of dialysis products.
Fresenius is not the only clinic operator on the radar, and thus subject of various Fresenius lawsuits.
Various plaintiffs have also filed a DaVita lawsuit over alleged alkali dosing errors and other issues involving GranuFlo and NaturaLyte, leading in some cases, it has been claimed, to a DaVita heart attack. DaVita Healthcare Partners Inc., like Fresenius, is another larger operator of dialysis clinics across the US. No fewer than four class-action lawsuits have been reportedly launched against DaVita, alleging wrongful death or injury and product liability.
While there have been no health issues identified with DaVita clinics beyond the alleged alkali dosing errors fostered through the use of GranuFlo and NaturaLyte, DaVita has nonetheless been facing allegations of a different sort: the operator’s relationship with one of Denver’s largest kidney doctors’ offices.
According to the Denver Post (5/10/13), a federal grand jury has been investigating for more than a year as to whether DaVita paid a kickback to doctors in order to guarantee a steady stream of dialysis patients. The dialysis market, according to the newspaper, is highly competitive. A key is to attract top-flight doctors who can potentially bring a large number of patients into DaVita facilities.
While the allegations have yet to be proven, the Denver Post reports that DaVita recently set aside a $300 million fund to settle criminal and civil anti-kickback allegations.
Beyond all of that - and the potential for alkali dosing errors stemming from use of GranuFlo and NaturaLyte that could foster a DaVita heart attack - is the initial hesitation on the part of Fresenius to issue its NaturaLyte GranuFlo recall warning to clinics outside of the Fresenius jurisdiction. In other words, Fresenius clinics would have received the warning, but not DaVita. At least, not until the Fresenius memo to its own facilities was leaked to the FDA and the regulator started to probe the issue. Only then did Fresenius undertake a Fresenius Medical Care recall, at which point, DaVita would have been informed.
READ MORE GRANUFLO RECALL LEGAL NEWS
Of the 10 percent of dialysis patients who die each year, how many of those patients died or were needlessly injured with a GranuFlo heart attack while Fresenius hesitated?
Hence, renewed focus is being placed not just on the product, but where it was delivered to patients, and by whom. Ultimately it helps to decide if it is to be a GranuFlo lawsuit, a Fresenius lawsuit, a DaVita lawsuit or some combination of all three…