Coby v. Fresenius Med. Care Holdings, Inc. (In re Fresenius Granuflo/ Naturalyte Dialysate Prods. Liab. Litig.)

Decision Date02 January 2015
Docket NumberCivil Action No. 14–11965–DPW.,MDL No. 13–02428–DPW.
Citation76 F.Supp.3d 279
PartiesIn re FRESENIUS GRANUFLO/ NATURALYTE DIALYSATE PRODUCTS LIABILITY LITIGATION This order relates to: James E. Coby IV, individually and on behalf of decedent Beverly D. Coby, Plaintiffs, v. Fresenius Medical Care Holdings, Inc. d/b/a Fresenius Medical Care North America, Inc., Fresenius USA, Inc., Fresenius USA Manufacturing Inc., Fresenius USA Marketing, Inc., Dialysis Clinic, Inc., USA, INC., Defendants.
CourtU.S. District Court — District of Massachusetts

Bradley D. Honnold, Kirk J. Goza, Goza & Honnold, LLC, Leawood, KS, Roger Dean Nail, The Nail Law Firm, Lee's Summit, MO, for Plaintiff.

Kevin C. Newsom, Philadelphia, PA, Leigh Anne Hodge, Bradley Arant Boult Cummings LLP, Birmingham, AL, Megan S. Heinsz, James F. Bennett, Dowd Bennett LLP, St. Louis, MO, for Defendants.


DOUGLAS P. WOODLOCK, District Judge.

The plaintiff, James Coby, individually and on behalf of his deceased mother, Beverly Coby (“the decedent”), filed this lawsuit in Missouri state court seeking recovery for injuries sustained by and the wrongful death of the decedent allegedly resulting from the use of NaturaLyte Liquid (“NaturaLyte”) or GranuFlo Acid (“GranuFlo”) Concentrates during a dialysis treatment she received in October 2010. The named defendants, collectively “Fresenius,” are various corporate entities engaged in the business of manufacturing, labeling, promoting, and distributing NaturaLyte and GranuFlo, as well as the owners and operators of two dialysis centers in Kansas City: Dialysis Clinic, Inc., a Tennessee corporation that owns and operates a free-standing dialysis clinic bearing the same name in Kansas City, and Midwest Division—RMC, LLC (“RMC”), a Delaware foreign limited liability company that owns and operates Research Medical Center in Kansas City. Defendant Dialysis Clinic, Inc., has moved to dismiss the claims against it pursuant to Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief can be granted, and in the alternative for summary judgment. For the reasons discussed below, I will grant the motion to dismiss on all counts.1

A. Factual Background
1. Basis for the Multidistrict Litigation Against Fresenius

The underlying negligence claim is part of a multidistrict litigation proceeding in this District involving product liability actions against Fresenius arising from injuries or deaths allegedly caused by use of GranuFlo and NaturaLyte during hemodialysis. See In re: Fresenius GranuFlo/NaturaLyte Dialysate Prods. Liability Litig., 935 F.Supp.2d 1362 (Multidistrict Panel on Litigation, 2013).

Hemodialysis is a form of treatment for patients with late-stage kidney failure that cleanses and removes waste from the blood by drawing blood from the patient, passing it through a dialysis machine that utilizes dialysate solution and then a filtering device that cleanses the blood, and returning the blood to the body. Compl. ¶ 12. In three-stream dialysis machines, dialysate solution is made by mixing water with a bicarbonate (base) concentrate and an acid concentrate. Id. ¶ 14. The organic acid used in the acid concentrate may be in the form of acetic acid, citric acid, or sodium diacetate. Id. Sodium diacetate creates a different reaction with bicarbonate when used to form dialysate than when other acids are used. Id. ¶¶ 17–18. Bicarbonate acts as a pH buffer in the blood stream to neutralize metabolic acidosis that may be present in hemodialysis patients. Id. ¶ 16. Physicians prescribe the amount of bicarbonate, and therefore the composition of the dialysate fluid, to be delivered during hemodialysis to individual patients. Id.; see Fresenius Answer ¶ 16 (Doc. 11).

Fresenius develops, manufactures, markets, and sells dialysis solutions, including GranuFlo and NaturaLyte.See Compl. ¶ 49. GranuFlo is a dry concentrated dialysate marketed and distributed by Fresenius beginning in 2003. Id. ¶ 19. It uses acetic acid and sodium acetate to form the final dialysate and metabolizes quickly in the bloodstream. Id. ¶ 20. This quick metabolism rate, attributable to the combination of acetic acid and sodium diacetate, results in elevated bicarbonate levels, which may cause metabolic alkalosis. Id. ¶¶ 20, 23. Alkalosis is correlated with an increased risk of cardiopulmonary arrest and sudden cardiac death during or after dialysis treatment. Id.

Coby, like other plaintiffs in this MDL, asserts that these risks of elevated bicarbonate levels and resulting metabolic alkalosis were known in the medical community as early as 2004, but that Fresenius failed to inform physicians GranuFlo increases the level of bicarbonate in patients and therefore could lead to such risks. Id. ¶¶ 21–23. Coby further asserts that Fresenius employees were aware GranuFlo caused unintended elevated bicarbonate levels prior to May 2005 and were aware its dialysis machines required special instructions to reduce the risks of elevated levels from GranuFlo use. Id. ¶ 24. However, Fresenius did not inform the dialysis medical community at large, including other dialysis providers who administered GranuFlo to patients. Id. ¶ 24. In 2009 or 2010, Fresenius revised the operator's manual for certain Fresenius-manufactured dialysis machines to instruct users to use half of the acetate value listed on the label for GranuFlo concentrate. Id. ¶ 27. Fresenius did not, however, provide notification to all users of GranuFlo that it was necessary to use half of the listed acetate value. Id. ¶ 28.

A 2011 study conducted by Fresenius of patients who suffered cardiopulmonary arrest and sudden cardiac death in Fresenius clinics in 2010 revealed that patients with elevated pre-dialysis bicarbonate levels were six to eight times more likely to experience such events than patients with lower bicarbonate levels. Id. ¶ 34. Fresenius thereafter instructed its dialysis centers to consider lower bicarbonate prescriptions when using GranuFlo and NaturaLyte in light of these findings. Id. ¶ 34–36. It was not until March 2012 that Fresenius informed other dialysis centers using Fresenius products by way of a large-scale notification that certain dangers existed in following label and prescription instructions for GranuFlo, and that users should decrease the amount used to avoid elevated bicarbonate levels and resultant cardiovascular events. Id. ¶¶ 38–40.

2. Claims Specific to This Case

Coby contends in his complaint, based on information and belief, that his mother (the decedent) received dialysis treatment using GranuFlo or NaturaLyte during a routine dialysis appointment “at Research Medical Center and ... Dialysis Clinic, Inc. in October 2010.” Compl. ¶ 47. After the decedent returned home, she went into cardiac arrest, was taken to Shawnee Mission Medical Center, and “was eventually pronounced dead on November 1, 2010 from cardiopulmonary arrest.” Id. In his response to Dialysis Clinic's statement of undisputed facts in support of its alternative summary judgment motion, Coby clarifies this chain of events. He alleges that the decedent received treatment at a Dialysis Clinic location on September 7, 2010, during which she developed chest discomfort and afterwards was taken to the RMC Emergency Department. Doc. 812, Pltf.'s Add'tl Opp., ¶ 6. She was diagnosed with a heart attack and remained hospitalized there for a week.Id. ¶¶ 7–8. On September 14, 2010, the decedent received dialysis treatment at RMC, was discharged, and thereafter suffered a cardiac event at home. Id. ¶¶ 8–9. She was taken to Shawnee Mission Medical Center, where she died on November 1, 2010. Id. ¶ 9.

Coby asserts, like other plaintiffs in this MDL, that GranuFlo and NaturaLyte, and the Fresenius dialysis machines when used with these dialysate solutions, are defective, unreasonably dangerous products, and that the decedent died as a result of receiving these unreasonably dangerous dialysis chemicals.2 Compl. ¶¶ 42, 47. He contends that neither the decedent nor her health care providers were warned that GranuFlo and NaturaLyte are unreasonably dangerous products, or that only half the acetate level of GranuFlo should be used with the Fresenius dialysis machines.

Id. ¶¶ 43, 47. He alleges that instead of warning of known dangers associated with use of GranuFlo and NaturaLyte consistent with the instructions accompanying these products, Fresenius promoted and marketed GranuFlo and NaturaLyte to the decedent, other consumers, and health care providers as a safe product. Id. ¶ 44, 47. In short, he alleges that these products were defective in their design, unreasonably unsafe for their intended purposes, and carried foreseeable risks that exceeded the benefits associated with them. Id. ¶¶ 51–52. He contends that the decedent's injuries and death were the direct and proximate result of GranuFlo and NaturaLyte's defective condition and Fresenius' failure to warn of these defects. Id. ¶ 53.

Accordingly, the plaintiff brings claims of strict liability for a defective product (Count I), strict liability for failure to warn (Count II), negligent design/failure to warn (Count III), breach of express warranty (labeled as Count III also but referred to as Count IV here), breach of implied warranty (labeled as Count IV but referred to as Count V here), fraudulent misrepresentation (labeled as Count V but referred to as Count VI here), and violation of the Missouri Merchandising Practices Act (labeled as Count VI but referred to as Count VII here), and for punitive damages (labeled as Count VII but referred to as Count VII here). See Compl. ¶¶ 48–120.

All counts are alleged against all named defendants, including the Fresenius defendants and two dialysis clinics in Kansas City that are owned and operated by entities other than Fresenius: RMC and Dialysis Clinic. RMC has been dismissed from this case by stipulation. In response to the plaintiff's allegation that the decedent's health care providers were not warned...

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