If you or someone you care about has suffered a heart attack while undergoing
dialysis treatment or within 24 hours after dialysis treatment, you should
speak with our lawyers at Sullivan & Brill, LLP who is knowledge about
GranuFlo and NaturalLyte dialysis products and the lawsuits that have
been filed against Fresenius Medical Care. Your initial consultation is
complimentary, and if your case is accepted, you will not be required
to pay any fees or expenses unless a recovery is obtained on your behalf.
FDA Issues Class 1 Recall of GranuFlo
Fresenius Medical Care is the manufacturer and seller of GranuFlo and NaturaLyte
dialysis products, which have been associated with serious cardiac arrest
and cardiac death reactions. The U.S. Food and Drug Administration (FDA)
deemed a Fresenius Medical Care warning a Class I recall. A Class I recall
is the agency's most serious designation and indicates that the recalled
product may cause serious adverse health consequences, including death.
Both GranuFlo and NaturaLyte have been on the market since 2003 and are
used during dialysis treatment to minimize the acid in the blood of patients
with poorly functioning kidneys. Before the Class I recall designation,
GranuFlo and NaturaLyte were used in 1,800 Fresenius-run dialysis clinics
in the United States, as well as thousands of other non-Fresenius-run
facilities that bought the medications from Fresenius. In 2012, Fresenius
finally changed NaturaLyte and GranuFlo labels.
Despite the Class I designation, the FDA did not suggest changes to the
way in which GranuFlo is produced and its clearance to market remains in place.
GranuFlo and NaturaLyte Tied to Serious Cardiac Reactions and Death
Competitor products provide similar functions to the Fresenius products;
however, GranuFlo and NaturaLyte are made with more of one particular
ingredient that the body converts into bicarbonate. This increase places
patients at risk for serious cardiac injury and death when not appropriately
prescribed. The FDA indicated that increased bicarbonate levels in the
blood may be a contributing factor for a metabolic condition known as
which is a key risk factor for the following adverse health conditions:
- Cardiac arrhythmia
- Hypercapnia (high concentrations of carbon dioxide in the blood)
- Hypoxemia (low blood oxygen pressure)
- Low blood pressure
- Hypokalemia (low blood potassium levels)
If these conditions are not appropriately treated, significant reactions,
including sudden cardiopulmonary arrest and death may occur.
Fresenius Issued Limited, Internal Warning, but Did Not Warn Non-Fresenius
Centers of Deadly Risks
Evidence indicates that Fresenius warned its own physicians about the issues
with GranuFlo and its association with sudden cardiac arrest, but did
not issue a warning outside of its clinics, despite the fact that the
drugs were used in dialysis treatments outside of Fresenius facilities.
Finally, after an internal Fresenius memo was released to the FDA, Fresenius
issued a warning, according to a
The New York Times report.
During hemodialysis, the dialysis machine filters waste, extra salt, and
water from the blood of people whose kidneys are no longer functioning
well enough to manage this process. One critical part of the dialysis
process involves neutralizing acid in the blood, which is accomplished
by supplying the patient with bicarbonate, an alkaline substance. According
to reports, physicians who did not account for the additional bicarbonate
in GranuFlo and NaturaLyte when considering separately administered bicarbonate
were placing patients at risk for the effects of excessive bicarbonate,
which has been tied to cardiac issues.
Serious cardiovascular injuries include:
- Cardiac arrest
- Myocardial infarction (heart attack)
- Cardiopulmonary arrest
- Cardiovascular death
- Catastrophic cardiovascular injuries
- Congestive heart failure
- Sudden cardiac death
An internal investigation conducted by Fresenius reportedly revealed that
increased serum bicarbonate levels increase cardiac arrest risk. According
to a 2010 internal Fresenius memo, 941 patients who had been treated at
Fresenius-owned dialysis clinics underwent cardiac arrest; a data review
revealed that these patients' risk of cardiac arrest was increased
by six-fold if they experienced an increased pre-dialysis bicarbonate
level. Despite these findings, the drugs were aggressively marketed and,
according to GranuFlo and NaturaLyte lawsuits, the drugs were commonly
combined with other products for pricing discounts.
The Fresenius memo warned that the risk of cardiac originated with doctors
not prescribing GranuFlo and NaturaLyte properly and that this matter
should be "addressed urgently." The memo was circulated to Fresenius'
own dialysis centers in November 2011; however, reports indicate that
Fresenius never advised customer clinics about possible cardiac issues
even though more than 100,000 dialysis patients were receiving GranuFlo
and NaturaLyte at non-Fresenius facilities.
It took until March 2012, after the memo was provided anonymously to the
FDA, that the information was released and, even then, according to allegations,
the information provided to customers and clinics lacked clarity, as well
as the details and urgency indicated in Fresenius' original memo that
was released internally. What's more, some allege that the external
memo only contained one of ten medical references that were indicated
in the internal Fresenius memo and that the external memo did not mention
the populations who were at greatest risk.
Since then, the FDA has implemented a probe to determine if Fresenius broke
any federal laws when it neglected to warn customers of the potentially
dangerous cardiac risk, according to a report issued by
The New York Times.
Federally Filed GranuFlo Lawsuits
All federally filed GranuFlo lawsuits were consolidated on March 29, 2013
in the U.S. Federal Court for the District of Massachusetts. This type
of consolidation enables a coordinated pre-trial and discovery process.
As of February 2014, 515 lawsuits were pending against Fresenius in the
GranuFlo multidistrict litigation (MDL).
It was the lack of clinical knowledge and appropriate labeling and instructions
by Fresenius that lead to GranuFlo and NaturaLyte to be prescribed in
such a way that was neither safe nor effective, according to lawsuit allegations.
Allegations in lawsuits brought against Fresenius Medical Care also include
that Fresenius knew or should have known about increased risk for cardiac
death and other serious injuries tied to its GranuFlo and NaturaLyte products.
Some lawsuits specifically allege that use of GranuFlo and NaturaLyte
present increased risks of serious, potentially deadly cardiovascular
injuries, and that Fresenius Medical Care hid and misrepresented these
risks. Allegations also include that GranuFlo and NaturaLyte were marketed
as being safe for dialysis treatment, despite that Fresenius was aware,
or had reason to be aware, that its products were not safe and could lead
to serious medical problems.
Lawsuits also accuse Fresenius of intentionally concealing potentially
deadly problems with its now-recalled GranuFlo and NaturaLyte products
and that patients' who were treated with the Fresenius products tested
with increased acetone concentrations. This in turn led to abnormally
high blood bicarbonate levels, which, then, led to fatal heart problems
GranuFlo and NaturaLyte lawsuits also allege that Fresenius neglected to
sufficiently warn physicians and other healthcare professionals who work
in the field of hemodialysis about the potentially deadly risks tied to
GranuFlo and NaturaLyte. According to the lawsuits, it is Fresenius'
responsibility to appropriately inform and train medical professionals
involved in dialysis treatment and to ensure that these professionals
are clear on the proper use of its dialysis products in a safe, efficacious manner.
One lawsuit involved a patient who underwent dialysis treatment with GranuFlo
and / or NaturaLyte and died following treatment. The lawsuit alleges
that the patient was unaware of the risks associated with the medications
and, through meticulous attempts, would not be able to discover information
on risks, serious injuries, or death tied to GranuFlo and NaturaLyte.
The lawsuit also alleged that the drugs, despite having been properly
and reasonably used, caused the patient to suffer a fatal cardiovascular
event shortly after use. The lawsuit also indicated that GranuFlo and
NaturaLyte labeling, packing, and instructions did not provide adequate
instructions or warnings about the way in which to use the GranuFlo and
NaturaLyte dialysis concentrates and that Fresenius neglected to include
these warnings despites its complete knowledge of the drugs' risks.
Lawsuits brought against Fresenius also allege that physicians, treating
clinicians, and nurses were unaware of the so-called increased "buffer
level" tied to GranuFlo and NaturaLyte products. This buffer level
could potentially lead to a significant increase in bicarbonate levels,
placing patients at serious risk for heart attack, cardiopulmonary arrest,
and sudden cardiac death.
Federal Regulator Warnings
In 2013, the U.S. Food and Drug Administration (FDA) issued a third warning
to Fresenius to improve procedures at its sites. The latest issue concerned
Fresenius' Puerto Rico plant where blood bags are manufactured. Also
mentioned was the way in which complaints and labeling are handled.
Prior to the 2013 warning, the FDA issued a warning letter involving an
inspection of a Fresenius cancer drug facility located in India. Prior
to that, a Fresenius subsidiary, Fresenius Medical Care, considered the
largest dialysis company in the world, was told by the FDA to improve
the way in which it sterilized its dialyzers for filtering patients'
blood. That same year, the India plant recalled some of its magnesium
sulphate and benztropine mesylate injections in the United States over
the potential for glass particles in the products' vials.
A Fresenius Medical Care North America dialysis center shut down previously
over infection-related deaths and hospitalizations. And, a 2012 inspection
found that a center, among other issues, did not meet a number of infection
control standards, including that the facility neglected to ensure that
"patient care staff wore gloves and washed hands appropriately during
patient care," according to the inspection conducted by the state
health department for the firm's participation in the Medicaid and
Medicare programs. The deficiencies cited, the report indicated, "had
the potential to affect all patients served by the facility." In
a two-year period involving these health department surveys, 11 Fresenius
dialysis centers in Alabama, alone, were cited with deficiencies.
Considering a GranuFlo or NaturaLyte lawsuit?
If you, or someone you love, experienced complications due to dialysis
treatment in which GranuFlo or NaturaLyte were used, you may want to consider
filing a lawsuit to seek compensation for any alleged injuries, pain and
suffering, mental anguish, medical care, lost wages and loss of earning
capacity, and other losses. To learn more about your rights,
contact our lawyers today. Sullivan & Brill, LLP offers
free consultations and we work on a contingency fee basis. If we are unable to provide recovery,
you do not owe us any attorney fees.