Coordinated litigation involving the dialysis products, GranuFlo and NaturaLyte,
is moving forward in order for thousands of injured plaintiffs to eventually
have their day in court. The judge who is currently overseeing the litigation
reviewed the preparation of early trials which may provide important insight
into how more than 4,300 cases could potentially be settled in the future.
The GranuFlo and NaturaLyte lawsuits, which are currently pending in a
Massachusetts U.S. District Court, allege manufacturer Fresenius did not
provide necessary warnings regarding the risks of heart attack associated
with the two products.
First Two Bellwether Trials Set for Early 2016
As the first state court trial heads toward a verdict, bellwether trials
in the Federal Court MDL will begin early next year. In that case, the
plaintiff filed a complaint in 2013 following a fatal cardiac event his
wife experienced during dialysis at a Mississippi Fresenius clinic. The
second bellwether trial will begin in February 2016. In that case, the
plaintiff claims her husband died of a cardiovascular event in February
2012 after undergoing dialysis at a North Carolina Fresenius clinic. In
both of these cases of wrongful death, NaturaLyte or GranuFlo was used
during the dialysis procedures. Some believe these two products may have
been the cause of both fatal cardiac events. These bellwether cases will
provide valuable information to both sides as far as how future trials
may be decided. The bellwether trials could also convince the manufacturer
to consider global settlement negotiations with plaintiffs.
What are NaturaLyte and GranuFlo?
Both NaturaLyte and GranuFlo are concentrates manufactured by Fresenius,
which remove waste from the blood during hemodialysis. In 2012, several
serious cardiac events and deaths were linked to NaturaLyte and GranuFlo,
both of which call for extremely specific mixing instructions. When the
not precisely mixed, patients can suffer heart attack, metabolic alkalosis,
and even death. Fresenius was cited in 2012 for failure to alert the public
and medical community about the potential risks associated with the products.
Fresenius Medical Care neglected to warn physicians that NaturaLyte and
GranuFlo contain more of an ingredient that is converted to bicarbonate
in comparison to other similar products. Fresenius eventually warned doctors
in its own clinics but did not notify other clinics who used the products
until a memo was leaked to the FDA nearly a year later. Fresenius’s
decision to not inform other clinics of the dangers left more than 100,000
dialysis patient, who received the products at facilities other than Fresenius,
at serious risk.
Class I Recall Issued in 2012
Also in 2012, Fresenius Medical Care voluntarily changed the labeling on
GranuFlo and NaturaLyte products—a Class I recall. The recall did
not involve removal of the products; however, the FDA did indicate there
was a reasonable probability that exposure to the product could result
in severe health consequences or even death. When a patient undergoes
hemodialysis, the machine sifts waste, extra salt, and extra water from
the patient’s blood when the kidneys are unable to do so. A part
of the process includes neutralizing acids in the blood by administering
bicarbonate to the patient.
Apparently, doctors were unaware of the additional bicarbonate in GranuFlo
and NaturaLyte, putting patients at risk for ingesting excessive bicarbonate.
High bicarbonate levels can create the following symptoms: low blood pressure,
a high concentration of CO2 in the blood, low potassium levels, and low
blood oxygen pressure. Cardiac arrest and death can occur if these conditions
are not promptly and properly treated. If you or someone you love has
suffered serious, adverse effects as a result of NaturaLyte or GranuFlo,
it could be extremely helpful to speak to an attorney who can determine
whether you are entitled to compensation for your injuries.
National Dangerous Drug Attorneys Ready to Fight for You
If you have used NaturaLyte® or GranuFlo® dialysis products and
believe you have suffered harm as a result, we encourage you to
get in contact with our Philadelphia dangerous medical device lawyers at Golomb &
Honik, P.C. today. When you contact our firm, we will provide you with
a no-cost evaluation. When you work with us, you can rest easily knowing
we have the necessary resources and skills it takes to fight against large
pharmaceutical companies. Contact our Philadelphia dangerous medical device
attorneys for seasoned legal advocacy or complete our confidential