Columbus, OH (PRWEB) July 27, 2014
Wright & Schulte LLC has learned that the state of Louisiana has filed a GranuFlo lawsuit against Fresenius Medical Care North America and its nearly 100 clinics in Louisiana over the recalled dialysis drugs GranuFlo and NaturaLyte. The complaint purports that Fresenius defrauded the state’s Medicaid program by not disclosing the heart attack risks associated with the two drugs. Louisiana’s dialysis medication lawsuit contends that Fresenius notified its own clinics, practitioners and physicians about the problems with the dialysis concentrates but did not notify the approximately 1,500 non-Fresenius clinics, practitioners and physicians of the dangers. The Louisiana Attorney General’s Office filed the dialysis treatment lawsuit on June 26, 2014, in the 19th Judicial District Court, Parish of East Baton Rouge. (The State of Louisiana vs. Fresenius Medical Care, Case No. 631586).
In March 2012, Fresenius Medial made public its concerns about GranuFlo and NaturaLyte potentially causing cardiac arrest in dialysis patients and issued a recall of the products. The FDA classified the recall as Class 1, the most serious type of recall issued by the federal agency.
The attorneys at Wright & Schutle continue to investigate GranuFlo lawsuit claims and offer free legal consultations to those who believe they have suffered dialysis side-effects such as sepsis, bacteremia, cardiac events and even death
Louisiana’s dialysis lawsuit further contends that Fresenius violated state law that prohibits unfair and deceptive practices because the company misrepresented GranuFlo and NaturaLyte as safe to administer to dialysis patients and continued to submit claims to Medicaid for reimbursement for its services. Louisiana’s GranuFlo lawsuit seeks civil penalties of $5,000 per violation under the state’s Unfair Trade Practices and Consumer Protection Law. The Nephrology News & Issues reported that Louisiana appears to be the first state to file a dialysis lawsuit against Fresenius, which also faces complaints by individual patients across the country.
[nephrologynews.com/articles/110304-louisiana-sues-fresenius-to-reclaim-payment-over-granuflo-use, July 1, 2014]
In March 2012, Fresenius made public its concerns about GranuFlo and NaturaLyte potentially causing cardiac arrest in dialysis patients and issued a recall of the products. The FDA classified the recall as Class 1, the most serious type of recall issued by the federal agency.
The U.S.Food & Drug Administration (FDA) describes GranuFlo and NaturaLyte as dialysis concentrates used to treat acute and chronic renal failure by neutralizing acid in the blood. Improper use of the products can cause dialysis patients to have metabolic alkalosis, a high serum bicarbonate level that can lead to heart attack, stroke, cardiac arrest, dangerously low blood pressure or sudden cardiac death. [fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm, June 27, 2012]
The New York Times reported that Fresenius only made the information public after an internal company memo was anonymously sent to the FDA about the products. Fresenius’ November 2011 memo warned doctors at its dialysis clinics that improper use of the two products appeared to be a factor in patients dying suddenly from cardiac arrest. The memo mentioned that a company study found that 941 patients experienced cardiac arrest in Fresenius clinics in 2010. The memo was not sent to other clinics that Fresenius did not own. After the FDA questioned Fresenius about the memo, the company warned other non-Fresenius clinics about concerns over the two products.
[nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0, June 14, 2012]
Fresenius recently issued a new recall of more NaturaLyte products. According to the FDA, Fresenius recalled 49 lots of NaturaLyte liquid bicarbonate concentrate on April 10, 2014, due to concerns over the product developing higher than expected bacteria levels during its shelf life. Fresenius expanded the recall in May to include nine additional lots. Just as it did in 2012, the FDA classified the recall as Class 1, the most serious type of recall. The FDA noted in its safety alert that the agency had received one report of a patient’s death and two reports of injury that may be related to the recalled NaturaLyte product. The FDA also warned that the product may cause serious health consequences, including sepsis, bacteremia, and death.
[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm399124.htm, June 5, 2014]
Court documents show that GranuFlo litigation is currently underway in the U.S. District Court, District of Massachusetts. The court’s Master Case List shows 1,863 GranuFlo lawsuits have been filed in the federal litigation as of June 16, 2014. Judge Douglas P. Woodlock, who is presiding over the litigation, has scheduled the first bellwether trial for a GranuFlo dialysis lawsuit will take placen in January of 2016, with a second bellwether trial scheduled for February of 2016. The complaints were filed on behalf of dialysis patients who allege that they suffered heart attacks, strokes, cardiac arrest or sudden cardiac death as a result of being given the recalled GranuFlo or NaturaLyte concentrates during dialysis. (In Re: Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428) The lawsuits also question why Fresenius withheld information from clinics that were not in its network of clinics about the dangers of using GranuFlo and NaturaLyte products during dialysis.[jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-June-16-2014.pdf, June 16, 2014]
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free GranuFlo lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.