NaturaLyte & GranuFlo Lawsuit
NaturaLyte & GranuFlo Lawsuit
GranuFlo lawsuit numbers continue to rise in the wake of the Class I recall of both GranuFlo Dry Acid Concentrate and NaturaLyte Acid Concentrate. While both products showed promise when used on hemodialysis patients with acute renal failure, they have been linked with a marked increase in the chances of cardiac arrest due to a build-up of bicarbonate in the blood. The link between cardiac arrest and GranuFlo and NaturaLyte was not suspected until 2010, when an internal memo sent by manufacturer Fresenius Medical Care (FMC) to its facilities warned administering doctors to take proper precautions in regard to the added bicarbonate in these drugs. The memo reported that 941 patients in Fresenius dialysis centers had experienced cardiac arrest linked to use of GranuFlo and/or NaturaLyte.
Fresenius Medical Care did not initially share this information with outside facilities using either dialysis product in their therapies, putting thousands of patients at risk.
If you or a loved one have suffered a serious injury, such as heart attack or even death, after undergoing dialysis treatment with GranuFlo and/or NaturaLyte, you may be able to hold Fresenius liable for the company’s inexcusable failure to put the safety of patients over profit margins.
In late November of 2011, internal Fresenius Medical Center documents were leaked to the FDA concerning the internal study. The company still failed to share all of its information with the FDA at that point. On June 25, 2012, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products. A Class I recall is reserved for the most dangerous products, which could potentially cause a life-changing injury or death.
Serious side effects linked to GranuFlo & NaturaLyte include:
- Cardiopulmonary arrest
- Heart problems
- Low blood pressure
- Metabolic alkalosis
- Sudden heart attack or Myocardial Infarction
- Irregular heartbeat
- Low blood potassium (Hypokalemia)
- Low blood oxygen (Hypoxemia)
- Increased blood carbon dioxide (Hypercapnia)
Warning signs of metabolic alkalosis include:
- Aching bones
- Muscle twitches
- Abdominal pains
The cause of most deaths (59%) for Fresenius dialysis patients is cardiac related. They were not due to stiffening arteries or plaque build-up. Instead, they are characterized by left ventricular hypertrophy, dysfunction, and dilation (due to elevated bicarbonate levels).
Fresenius didn’t just know that people using their products could die; they knew and continued to promote it. That’s why The Sanders Firm is committed to fighting for justice for victims of GranuFlo and/or NaturaLyte injuries. Big drug companies have a duty to protect the wellbeing of their customers, and when that duty is violated, the law is on the side of innocent victims. If you or a loved one has been harmed after undergoing dialysis with Fresenius products, you do not have to suffer alone. We urge you to contact a product liability attorney at The Sanders Firm today for a free, friendly and comprehensive discussion of your legal rights.
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Lawyers at The Sanders Firm can help
If you or someone you love has suffered dialysis injuries related to GranuFlo or NaturaLyte, you may be entitled to monetary damages for your past and future medical expenses, lost income, pain, suffering and other intangible losses. Contact the Sanders Firm for a complimentary case evaluation to discuss your legal rights and options with an experienced personal injury lawyer. Call us toll-free at 1.800.SANDERS.
Dialysis injury from GranuFlo and NaturaLyte
GranuFlo and Naturalyte were authorized by the FDA in 2003. There were no officially reported concerns about either drug until 2010. This is when Fresenius chose to disclose to doctors in its own facilities only that 941 confirmed cases of cardiac arrest had occurred in company-owned facilities between January 1, 2010 and December 31, 2010. The data compiled in that study found that a patients’ risk of cardiopulmonary arrest was up to six times higher if they had elevated pre-dialysis bicarbonate levels. Fresenius was fully aware of this information at the beginning of 2011 but failed to share this concern with outside doctors or facilities. Between 2011 and the recall of GranuFlo and NaturaLyte in 2012, there were over 100,000 patients in non-Fresenius facilities being administered the dialysis concentrates.
Compensation for dialysis injuries
There have been more than 100 lawsuits filed against Fresenius over its dialysis products, with over 700 more in pre-file status. In May of 2013, the Judicial Panel on Multidistrict Litigation (JPML) voted to consolidate federal GranuFlo and NaturaLyte lawsuits into multidistrict litigation (MDL). All lawsuits will go through the U.S. District Court for the District of Massachusetts. These cases, although consolidated, are not the same as class action lawsuits. They share a pool of information, but each trial is held separately.
NaturaLyte and GranuFlo lawsuit plaintiffs allege that Fresenius, “intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte,” citing the FDA announcement that the products “may cause serious adverse health consequences, including death.”
Allegations against Fresenius include:
- Intentional withholding of information about adverse cardiac events.
- Failure to report risks to the FDA and general public.
- Failure to warn dialysis patients of increased risks due to GranuFlo or NaturaLyte.
- Failure to give adequate dosage instructions to doctors outside their network.
- Misleading the public regarding product safety.
- Intentional failure to remedy known product defects before marketing and making them publicly available.
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