Schneider nears agreement with troubled dialysis company
Published: August 21, 2013
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ST. THOMAS - Schneider Regional Medical Center may be on the verge of entering into an agreement for the partial takeover of dialysis services on St. Thomas with a company that has been named in litigation following deadly heart attacks in at least one of its clinics.
Additionally, the chemical brand additive at the center of the lawsuits still is being used in Schneider's dialysis unit, although it is a different chemical formula, and safeguards are in place to ensure that the machines protect against adverse reactions following an FDA-initiated recall of the additive.
No heart attacks or adverse reactions in Schneider patients had resulted from the use of the additive, called GranuFlo, according to the dialysis unit's Clinical Care Coordinator Monica Bet.
Hospital executives said during Senate hearings in May that, because the hospital's dialysis unit is at capacity, it had identified DaVita, Inc., to provide hemodialysis services on the island after it was the only outstanding respondent to a request for proposals for a public-private venture.
Two companies had submitted proposals, but a second had dropped out, Schneider Hospital's Chief Executive Officer Bernard Wheatley said at the time.
The hospital has become incapable of meeting dialysis needs on St. Thomas and has been seeking a private partner to help stop a revenue loss of $2 million annually from the dialysis unit, according to Wheatley.
Since Wheatley's testimony, hundreds of people have filed lawsuits in U.S. District Court against Fresenius Medical Care - a medical company that supplies DaVita with GranuFlo. The suits cite adverse reactions to GranuFlo, including fatal heart attacks, which is supposed to help regulate acid-base levels in patients' blood.
As of last month, more than 300 lawsuits had been compiled into a class action suit against Fresenius and its subsidiaries in the Massachusetts district of the federal court.
Schneider Hospital still is in negotiations with DaVita, Vice President of Patient Care Services Eunice Gumbs said Tuesday.
Of the recently filed litigation, Gumbs said: "I don't know anything about that" and deferred all questions to Wheatley, who did not respond to requests for interviews on the matter.
The additive, called GranuFlo, and sometimes known as Naturalyte, was the subject of a June 2012 Food and Drug Administration Class 1 recall, after the regulatory agency was alerted to an internal Fresenius memo, sent from its corporate offices to its clinics but not to other clinics Fresenius supplies, according to the plaintiffs' lawsuit.
Court documents contend that the link between GranuFlo and cardiac arrest was confirmed by a Fresenius study, during which one-third of almost 1,000 patients treated with GranuFlo suffered cardiac arrest. Other allegations include that GranuFlo is linked to a six- to eight-fold increase in the risk of heart attack and death, a risk that is not seen in other, similar products.
In March, a Colorado man filed a suit in the state's district court alleging that his wife died from a heart attack as a result of her treatment at a DaVita clinic. The GranuFlo risks were known to DaVita and Fresenius as early as 2010, according to court documents.
Fresenius maintains 23 dialysis clinics on Puerto Rico, according to Kent Jarrell, a Fresenius spokesman.
"We believe these lawsuits based on GranuFlo and Naturalyte are without merit, and we will defend them vigorously," Jarrell said in a statement sent to The Daily News on Tuesday.
The FDA recall took the form of "required labeling changes" for GranuFlo and Naturalyte, according to Jarrell's statement.
"The FDA has not suggested any change in the production formula or asked that the products be returned by clinics to FMC," the statement reads.
"We continue to cooperate with FDA and have an ongoing dialogue with the agency about ensuring that dialysate products are used as intended."
Bet said that the recall was specific to a "catalog number" of GranuFlo that was not used at Schneider's dialysis unit. Since the recall, doctors at Schneider have altered the dialysis unit's machine settings to safeguard against improper formulations of GranuFlo, Bet said.
"We can adjust to ensure patient safety," she said.
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