Lawsuits Filed in 11 Dialysis Patient Deaths linked to Recalled GranuFlo® and NaturaLyte® Solutions, Announces Janet, Jenner & Suggs, LLC

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Janet, Jenner & Suggs, LLC, announces it has filed 11 lawsuits so far in the deaths of patients who suffered cardiac arrest or stroke within days of dialysis administered using recalled products GranuFlo® and NaturaLyte® manufactured by Fresenius Medical. Court documents show company delayed notifying clinics of improper dosing information on product packaging despite evidence of 941 deaths, the law firm said.

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We are representing a large number of families who have been devastated by Fresenius’ failure to properly label its dialysis solutions.

Lawsuits have been filed in the deaths of 11 dialysis patients in the following states: Georgia (1), Kentucky (1), Ohio (2), Virginia (1), Texas (3), Florida (1), Illinois (1) and California (1) alleging dosing errors associated with GranuFlo® or NaturaLyte®, two products recalled by manufacturer Fresenius Medical Care, the law firm of Janet, Jenner & Suggs, LLC, has announced.

Another lawsuit also has been filed in the serious and permanent cardiac injury of a California man, the law firm reported.

The deaths occurred between 2010 and 2012, and involved patients as young as 23 and as old as 89, the firm added. According to court documents, all of the patients died of a cardiac arrest or stroke or were injured during or shortly after receiving dialysis using one of the two solutions, which were urgently recalled last May for mixing and labeling problems.

“We are representing a large number of families who have been devastated by Fresenius’ failure to properly label its dialysis solutions, instruct doctors and clinic staff about how to mix them, and disclose what the company knew was a much higher risk of cardiac arrest associated with its products,” said medical device injury lawyer Robert K. Jenner.

“As described in our law suits, our investigations have shown that the company knew, or should have known, that confusion about how to properly mix these dialysis solutions was associated with a higher-than-expected rate of fatal heart events at its dialysis clinics,” he said. Fresenius is the largest operator of dialysis clinics in the United States and also manufactures dialysis solutions and equipment.

According to court documents, Fresenius’ internal documents showed the company had known since at least 2010 that 941 patients had suffered cardiac arrest after receiving GranuFlo® – a rate six times higher than competing products. The company notified doctors at its own clinics about the inappropriate dosing instructions in November 2011, however, it waited until March 29, 2012, to notify other clinics, and it didn’t issue an urgent recall of the products until late June, according to the documents and the Federal Drug Administration, as reported in the New York Times.

According to the FDA, GranuFlo® and NaturaLyte® have been linked to alkalosis, a condition caused by high levels of bicarbonate in the blood. Alkalosis has been associated with cardiovascular death and catastrophic heart injuries in patients undergoing dialysis treatment, the agency said.

Many of the lawsuits have been filed in Massachusetts because Fresenius is headquartered there, Jenner explained. Lawsuits have been filed in Massachusetts Superior Court, Commonwealth of Massachusetts, in the deaths of the following persons:

  • Ryan Evans, 23, of Panama City, FL, who died July 23, 2010, after he was hospitalized following a cardiac arrest shortly after dialysis treatment. (Case number 13-0226G).
  • Soledad Guajardo, 89, of Rio Grande City, TX, who died Feb. 1, 2010, after suffering pulmonary arrest and being hospitalized. (Case number 13-022913).
  • Betty Burke, 87, of Pekin, Ill, who suffered a heart attack on Jan. 1, 2011, after dialysis treatment at a clinic, and died Jan. 3. (Case number 12-4640E).
  • Frederick J. Stabell, 69, of Citrus Heights, CA, who died Jan. 11, 2012, a day after receiving dialysis. (Case number 13-0228A).
  • Bryan Doose, 39, of Bloomington, CA, who suffered serious injury to his heart following a cardiac incident associated with his dialysis treatment on Nov. 16, 2011. (Case number 13-022711).

Lawsuits also have been filed in U.S. District Court, District of Massachusetts, in the deaths of the following persons:

  •     Thomas Moore, 64, of Mount Pleasant, Texas, who suffered an acute cardiac arrest on January 4, 2011, shortly after dialysis treatment. (Case number 1:13-cv-10010 ).
  •     Walter Staten, 59, of Nassawadox, VA, who died Jan. 6, 2011, after suffering a heart attack following dialysis two days earlier. (Case number 13-0020A).
  •      Linda Teague, 48, of Hopkinsville, KY, who died Jan. 14, 2011, after receiving dialysis treatment in a hospital. (Case number 1-13-cv-10066).
  •      Santo Pena Hernandez, 68, of Lubbock, TX, who died Jan 17, 2011 at his home after experiencing weakness, bloating and headache following dialysis . (Case number 1:2013-cv-10082).

Lawsuits also have been filed in the deaths of the following other persons:

  •     Charles M. Swigert, 56, of Fayette County, Ohio, who died Nov. 11, 2010, during his dialysis treatment. (Case number 2:12-cv-01046, U.S. District Court, Southern District of Ohio, Eastern Division (Columbus).
  •     Mildred L. McCollum, 59, of Atlanta, GA, who died Dec. 1, 2010, of sudden cardiac arrest after becoming ill and leaving her dialysis treatment early. (Case number 1:12-cv-04158-ODE, U.S. District Court, Northern District of Georgia, Atlanta Division).
  •     Napoleon Harvey, 45, of Columbus, OH, who died Dec. 6, 2010, of a stroke after being hospitalized following a dialysis treatment. (Case number 4-12cv – 328 (CDL), in U.S. District Court, Middle District, Columbus, OH).

Dialysis patients who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo® or NaturaLyte® may be entitled to compensation for medical expenses, lost wages, pain and suffering, and more. To discuss a possible legal case involving GranuFlo® or Naturalyte®, contact Janet, Jenner & Suggs, LLC.

About Janet, Jenner & Suggs, LLC
The law firm of Janet, Jenner & Suggs, LLC, is a nationally recognized law firm representing victims of defective products, medical devices, prescription drugs and medical malpractice. Each of the firm’s principals is named in The Best Lawyers in America® and Super Lawyers®. The firm has offices in Baltimore, Maryland (Commerce Centre East, 1777 Reisterstown Road, Suite 165, Baltimore, MD 21208; local phone number (410) 653-3200); Boston, MA; Columbia, SC; and Asheville, NC. The firm accepts clients and referrals from clients and attorneys throughout the country. For more information contact the firm at (888) 463-3529.

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