Legal Action Against Fresenius Draws Nearer Over GranuFlo® and NaturaLyte® Controversy

  Legal Action Against Fresenius Draws Nearer Over GranuFlo® and NaturaLyte®

PR Newswire

NEW YORK, Sept. 20, 2012

NEW YORK, Sept. 20, 2012 /PRNewswire/ --The FDA's Class-I recall of dialysis
drugs GranuFlo and NaturaLyte, issued in June of 2012, is just one of the many
troubling developments against Fresenius Medical Care, America's leading
dialysis treatment provider. The controversy was sparked after an anonymous
informant leaked an internal memo that Fresenius had circulated to its
privately owned dialysis treatment centers in November of 2011. In the memo,
Fresenius warned of an increased risk of cardiopulmonary arrest and sudden
cardiac death related to its GranuFlo and NaturaLyte products, stressing to
their doctors that "this issue needs to be addressed urgently."

Despite the potential danger to patients undergoing dialysis treatment with
Fresenius's products, the information was not made available to the wider
public until March of 2012, and only after the internal memo had been leaked
to the FDA. Since then, The New York Times reported that the FDA had opened an
investigation into Fresenius in order to determine whether or not the company
violated federal regulations requiring the company to notify customers of
potential dangers associated with their product. Nearly two weeks later, on
June 27th, the FDA issued the Class-I recall, the most serious recall of its
kind, of both GranuFlo and NaturaLyte.

The German based Fresenius is the largest operator of hemodialysis treatment
centers in the country, providing dialysis treatment to over 400,000 Americans
a year, a number that amounts to one third of all dialysis patients in the
United States. It is this status as the leading service provider for
hemodialysis treatment that has made their oversight more troublesome.

Christopher Seeger, partner at Seeger Weiss LLP, says that from the facts he's
encountered, it appears to be a case of a corporation putting profits ahead of
the consumers' health. "By not advising the FDA, the medical community and
dialysis patients as soon as possible about the dangers of GranuFlo and
NaturaLyte, Fresenius made the decision to put profits ahead of patient
safety. They aren't the first pharmaceutical company to make that decision
and, unfortunately, they won't be the last."

Mr. Seeger goes on to say that Fresenius's ability to have prevented damage to
patients by acting swiftly in the face of their findings makes the case even
more troubling. "You would not expect a company that makes millions of dollars
a year from dialysis patients to knowingly put those patients at risk for
serious injuries, including death, but that's exactly what Fresenius did.
Fresenius was in a position to prevent these injuries but chose not to do so.
They must be held accountable."

As industry leaders with decades of experience successfully prosecuting injury
cases and recovering large financial awards, the partners at Seeger Weiss LLP
have the expertise to provide just compensation for individuals who have
suffered injuries as the result of GranuFlo and NaturaLyte. If you or a loved
one has suffered from cardiac arrest, heart attack, or other illnesses
following dialysis, visit or call
888.584.0411 for a free case evaluation.

CONTACT: Patricia Isaacson,, 1-212-584-0700

SOURCE Seeger Weiss LLP

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