Before I get into the specifics of GranuFlo, and the manufacturer Fresenius, you should know that I am a Florida attorney who is passionately opposed to nearly the entire pharmaceutical industry because I strongly believe that far too many drugs and medical devices are unacceptably dangerous. I have rarely taken a drug, particularly long-term, that did not have significant and often intolerable side-effects, often outweighing any helpful effects. I have also spoken with far too many people and potential clients regarding many negative health effects of numerous drugs, about which they were rarely warned. The reality is that drugs and medical devices in this country rarely receive sufficient testing so that we can be sure they are truly safe. Plus, the overriding goal of large drug companies, really their only concern if you ask me, is making an obscene fortune, while our collective health has always been unacceptably low on their priority list. Therefore, if I can help anyone who has been harmed obtain at least financial relief from any pharmaceutical company, I feel good about doing my small part to counter their corporate greed and often reckless behavior.
How Many People Might Have Suffered Due To GranuFlo Problems?
Regarding kidney disease and treatment in particular, although less than .5 percent of people under 39 suffer from chronic kidney disease, nearly 25% of those over 60 have the disease. Some of the afflicted people, usually those with End Stage Renal Disease, must be placed on dialysis. Meanwhile, there is a company called Fresenius Medical, which is the nation’s largest operator of dialysis clinics, and which manufactures, markets, sells and distributes an allegedly dangerous dialysis product called GranuFlo. Fresenius treats more than one-third of the roughly 400,000 Americans who receive dialysis each year and also distributed GranuFlo to an estimated 125,000 additional patients who were treated in non-Fresenius clinics.
GranuFlo Dangerous But Allegedly Used To Treat Patients
Unfortunately, between 2003 and 2012, Fresenius used GranuFlo to treat scores of dialysis patients who had been receiving treatment at their dialysis clinics. Fresenius also distributed Granuflo to non-Fresenius clinics, which meant that the majority of patients receiving hemodialysis were receiving GranuFlo. One group of non-Fresenius clinics was operated by DaVita Healthcare Partners, which company is also a potential defendant in pending GranuFlo lawsuits.
Fresenius Allegedly Knew Their Product GranuFlo Was Dangerous But Failed To Warn Others
Fresenius finally warned their own company doctors in 2010 (by way of this internal memo) that GranuFlo was causing many of their patients to have a much greater risk of dying suddenly from cardiac arrest, although the allegations are that Fresenius officials in other departments of this huge company had known about the dangers since 2003, according to RenalWEB. Fresenius, the manufacturer of this dangerous product GranuFlo, is now the defendant in Multi-District Litigation because Fresenius allegedly failed to notify their own doctors prior to 2010, and other doctors and centers using GranuFlo prior to approximately March of 2012, of the increased risk of cardiac arrest from patients receiving GranuFlo as part of their dialysis.
Other Allegations Against Fresenius
Additional allegations include that top Fresenius officials knew about this potential problem since they introduced the product to the marketplace in 2003. Further, Fresenius did not properly report this known problem to the FDA until FDA officials questioned Fresenius about the internal memo in 2012.
Why Was GranuFlo Dangerous?
Dialysis replaces the kidneys by trying to clean toxins from the blood. But this requires a product called acetate, which causes the body to produce bicarbonate, an alkaline substance which offsets the acid used to clean the blood. In very basic terms, due to the chemical composition of GranuFlo, some patients were receiving too much acetate and therefore their bodies were producing too much bicarbonate, which caused them to suffer from alkalosis (that is, their bodily fluids had too much base). This is the opposite of having too much acid, which is the condition that normally afflicts patients who need dialysis. So the allegaions are that these patients were essentially receiving an overdose of bicarbonate by way of GranuFlo. Since pH balance is needed for many bodily functions, some studies have suggested that there is a causal link between the bodily-flood base-boosting components of GranuFlo and cardiac arrest and/or stroke. For that reason, Fresenius warned their own clinic doctors that their patients using GranuFlo and NaturaLyte would have a six times higher risk of cardiac arrest than patients using other products.
What’s Happening With Lawsuits Related To GranuFlo Or NaturaLyte?
Hundreds of lawsuits have been filed against Fresenius Medical Care, alleging that patients were harmed by use of GranuFlo. Federal GranuFlo cases have been consolidated into a larger lawsuit called multidistrict litigation, which is currently pending in federal district court in Massachusetts (under order by the US Judicial Panel on Multidistrict litigation; MDL No. 2428). Basically, all of these cases will progress and be heard at the same time, to conserve party resources and allow for consistent resolution. (Other suits against DaVita Healthcare Partners are also pending.) Former patients and their loved ones are seeking damages for what they consider intentional, reckless and/or negligent conduct related to the design, testing, marketing, manufacturing and selling of an allegedly dangerous product.
What If You Do Not Know Whether You Or Your Loved One Received GranuFlo?
I have access to a list of clinics that distributed GranuFlo, so please give me a call.
If You Or A Loved One Have Been Harmed By GranuFlo
If you or a loved one experienced a heart attack or stroke within a short period after receiving dialysis between 2003 and 2012, you may have a product liability lawsuit against Fresenius, the manufacturer of GranuFlo, and/or DaVita Healthcare Partners.
My office is located in Orlando, but I accept cases throughout the states of Florida and Georgia (including Miami, Tampa, Tallahassee, Jacksonville, Valdosta, Macon, Atlanta, and all points above and below in both states). Further, if you are considering hiring a high volume settlement mill, I strongly encourage you to read this article, then give me a call. Lawsuits have strict time limits, so please do not delay.
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