Dialysis, NaturaLyte, and GranuFlo Lawsuit Center
After undergoing seemingly routine dialysis treatments, hundreds of patients say they suffered heart attacks, sudden cardiovascular death, and other side effects prompting them to file GranuFLo lawsuits. These claims, which have been filed in courts around the U.S., allege the dialysis drug manufactured by Fresenius USA has the potential to cause the above GranuFlo side effects within 48 hours after its administration.
GranuFlo and NaturaLyte are acid concentrates used to neutralize the acid that builds up during dialysis treatments.
Dialysis lawsuits that have been filed in the U.S. claim the company failed to warn consumers of the risks associated GranuFlo and NaturaLyte, which include:
- sudden cardiac death
- cardiovascular death
- cardiopulmonary arrest
- heart attack; and
- other catastrophic heart injuries
Following the growing number of patients filing Fresenius lawsuits naming these side effects, the U.S. Food and Drug Administration (FDA) took action in June 2012 by announcing a Class I GranuFLo recall. The recall was categorized as Class I, which is the most serious type of recall only issued when the agency determines there to be a high likelihood that a product could cause serious side effects and/or death. More and more alleged victims of this drug have sought the aid of a GranuFlo lawyer.
Dialysis Lawsuits Allege Heart Attacks, Sudden Cardiac Death and Other Catastrophic Heart Problems
Since then, the FDA has continued to investigate the safety and effectiveness of GranuFlo and NaturaLyte, and has discovered some startling information about Fresenius USA in the process.
For example, a New York Times report from June 2012 revealed the findings of an internal memo Fresenius USA sent to doctors operating in the company’s dialysis centers on Nov. 4, 2011, warning them that improper use of GranuFlo and NaturaLyte may be contributing to more sudden dialysis deaths.
“In light of these troubling findings,” the memo said, doctors should take corrective action. “This issue needs to be addressed urgently.”
A spokesman for the F.D.A responded to this letter by saying he was “personally troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”
At the time this internal memo circulated, GranuFlo lawsuits allege 900 deaths had occurred in patients who had received the drug during dialysis treatments.
The memo was also sent several months before the GranuFLo and NaturaLyte recall of June 2012.
Customers were not notified about the dangers of GranuFlo and NaturaLyte until March 29, 2012, when the company issued an Urgent Product Notification to warn of the products’ heart risks. Customer clinics continued to use GranuFLo and NaturaLyte during that time, putting hundreds of patients at risk for heart attacks and other life-threatening heart problems, as well as sudden cardiac death. Prior to the recall, Fresenius supplied GranuFLo and NaturaLyte to more than 125,000 facilities outside its network.
After learning of problems with these medications, the FDA issued a safety communication for health care professionals on May 25th 2013 to discuss the impact of acetate, acetic acid and citrate levels in concentrates given to dialysis patients during treatment. The agency urged physicians to consider these matters when prescribing dialysis drugs to individuals. A month later, the FDA’s Class I GranuFlo and NaturaLyte recall was announced.
Dialysis Lawsuit Filings Underway in Federal Litigation Underway in District of Massachusetts
In the wake of the GranuFlo and NaturaLyte recall, more and more patients have begun to come forward in filing lawsuits on behalf of their loved ones. These cases allege the potential for the acid concentrates, which contain a high level of an ingredient the body converts to bicarbonate during dialysis treatments, to cause life-threatening injuries or even death, in the worst-case scenario. Predicting a large number of claims to be filed in the future, the U.S. Judicial Panel on Multidistrict Litigation (JPML) have since centralized federal Granuflo lawsuits in the U.S. District Court for the District of Massachusetts.
Established in Massachusetts federal court on March 29th, 2013, the decision to centralize claims at this location was influenced by the fact that Fresenius Medical Care is based in the state, and many of the witnesses and documents related to claims would be in close proximity. 11 dialysis lawsuits had been filed in U.S. federal courts at the time this MDL was created, according to court documents.
The federal litigation involving GranuFlo and NaturaLyte cases has continued to move forward since its formation. On June 21st, group of attorneys filed a motion to establish leadership positions for lawyers indicated that over 300 cases were pending in the proceeding. That number represents a significant increase from a MDL Statistics Report released a month earlier, which showed that at least 161 GranuFlo suits had been filed as of May 14th.
About Fresenius Medical Care
Fresenius Medical Care AG & Co KGaA is a kidney dialysis company and Germany-based holding and kidney dialysis company that operates in fields of dialysis services and dialysis products. In addition to treating more than a third of approximately 400,000 individuals in the U.S. who receive dialysis treatments, the company operates over 1,800 kidney dialysis clinics around the country. According to a business profile on Reuters.com, Fresenius operates in North America and International. The North America business segment consists of Renal Therapy Group and Fresenius Medical Services, while the International segment includes one Asia-Pacific unit and Europe and Latin America. In December 2010, Fresenius subsidiary, U.S. Vascular Access Holdings, LLC, acquired National Vascular Care Inc.; which gained the company 168 existing dialysis clinics, as well as Gambro AB’s peritoneal dialysis (PD) unit. Fresenius has a total of 1000 subsidiaries worldwide, states the profile from Reuters.com.
How to File a GranuFlo Lawsuit
If you or a loved one received GranuFlo or NaturaLyte during a dialysis treatment, you may want to consider filing a NaturaLyte or GranuFlo lawsuit seeking compensation for out-of-pocket medical expenses, lost wages and other pain and suffering incurred by the injuries or tragic death of a loved one. Contact a GranuFlo attorney at Bernstein Liebhard LLP to find out how to start the process of filing a claim by calling .