On March 29, 2012, the FDA issued a Class I recall against Fresenius medical Care North America for its dialysis medications GranuFlo and NaturaLyte. According to the New York Times in an article from June 14, 2012, the health care company, which cares for nearly a third of U.S. dialysis patients, sent out a memo to the doctors at its own dialysis centers in 2011. However the company, which also produces the questioned medications along with running the dialysis centers, did not appear to have sent warnings about the drugs to other dialysis centers or properly inform patients about the risk of the drugs, exposing over 150,000 people to deadly consequences.
Fresenius appears to have neglected to inform the FDA of the risk of its product to dialysis patients as well, and the FDA only issued the recall about six months after the memo was sent to the clinics after someone anonymously sent it to the federal agency. The leaked Fresenius memo found that nearly 950 patients had suffered cardiac arrest while getting dialysis in Fresenius clinics in 2010 alone.
According to the New York Times, GranuFlo is used during dialysis to help eliminate acid in the blood by helping the body convert a chemical in the drug to bicarbonate. However, it appears that doctors were unaware of this extra bicarbonate in the systems of patients when prescribing additional bicarbonate, leading to an overdose. The result, studies have shown, could lead to heart problems, even cardiac arrest and death.
The online legal news source LawyersandSettlements.com has been covering the resulting lawsuits by dialysis patients that have had heart attacks during or directly after given the drugs. There have been resulting class action lawsuits against Fresenius both for product liability and for the drugs and medical malpractice for the administration of the drugs in its dialysis centers. A number of negligence lawsuits have been filed against DaVita, a competing chain of dialysis centers, for use of the drugs and failure to warn of the possibility of heart attacks caused by using GranuFlo and NaturaLyte.
According to LawyersandSettlements.com, one such lawsuit involves a 47 year old father of three from Las Vegas, Nevada who suffered a heart attack while getting dialysis from a DaVita center in June, 2012, just a few months after the FDA recall was issued. While this patient survived, the article states that there have been many wrongful death suits filed against the companies as well, such as in the case of an Alabama man who died of a heart attack after being treated with GranuFlo.
GranuFlo and NaturaLyte are still being used in dialysis centers nationwide and continue to expose dialysis patients to danger. According to the Fresenius website, GranuFlo is “safe for patients and staff”. No reference is made on the GranuFlo product website about the FDA recall. Additionally, no press release can be found on the corporate website’s news section relating to the product recall.
According to the New York Times article, Fresenius did not notify dialysis centers outside of the Fresenius system about the potential risk of the drugs because they felt there was no effective way to do so outside of medical journals. They also claim that not enough research had been done on the risks of the drugs and that there could not be any direct connections made between use of the drugs and a heart attack event, although users of the drugs seem to be up to six times more likely to suffer from heart problems sue to the high levels of bicarbonate in the blood after taking the drugs. In addition to the third of all dialysis patients that were directly treated by Fresenius, up to 150,000 more were given GranuFlo in outside dialysis centers whose doctors were not warned between when the memo came out in November 2011 and the FDA recall in March 2012.
The GranuFlo and NaturaLyte cases are especially complex because it doesn’t involve just medical malpractice or product liability but a combination of both. It is extremely rare that a company handles both the manufacturing of drugs while at the same time handling the care of patients as Fresenius does. As a result, Fresenius patients have a two-tiered approach to their litigation with one case for medical malpractice for being given the drug in the company’s clinics while also having product liability suit against the same company for the risk of the drug and failure to adequately warn patients and doctors. On the other hand, patients at other dialysis centers could have both a product liability case against Fresenius, while also having a medical malpractice case against the clinic where they got the drugs if there is proof of some sort of liability by the dialysis center when they were administering the drugs. At this point, many of the product liability cases against Fresenius have been consolidated into various class action suits, while the medical malpractice claims are going forward in separate malpractice suits against both Fresenius and other dialysis centers that administered the suspect drugs such as DaVita.
If you or a loved one suffered a heart attack during or after getting dialysis, contacting an attorney is essential to protect your rights against both the drug company that manufactures the dangerous drugs they were given and also the dialysis center that prescribed the drug during dialysis. GranuFlo and NaturaLyte may have caused thousands of heart attacks and the drug company, Fresenius, may have purposely hidden the risk of the drug to patients outside of its own system of dialysis centers for up to six months, causing a risk of a heart attack to nearly 150,000 people. The result is risk of severe health consequences or even death to thousands of patients who were already suffering from severe health problems. Contact the Brooks Law Group right away if you or a loved one has had a heart attack after getting dialysis at 1-888-WE-MEAN-IT so that an investigation can be started in your case.