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From Health Law Daily, February 21, 2017

Action against Baxter’s recalled peritoneal dialysis solution continues

By Harold Bishop, J.D.

Product liability claims brought against Baxter Healthcare Corporation and Baxter International, Inc. (Baxter) for injuries a patient allegedly sustained as a result of using Baxter’s Dianeal® Peritoneal Dialysis (PD) Solution were dismissed in part. The court dismissed all of the patient’s claims that were brought outside the Louisiana Products Liability Act (LPLA), which establishes the exclusive theory of liability for manufacturers for damages caused by their products. With regards to the patient’s LPLA claims, the court sustained his construction defect claim, but dismissed his remaining claims based on design defect, failure to warn, and breach of express warranty due to factual deficiencies, but granted the patient 30 days to amend these claims (Lewis v. Baxter International, Inc., February 17, 2017, Fallon, E.).

Background. The case arose from injuries to a patient allegedly sustained as a result of using Baxter’s Dianeal PD Solution while undergoing dialysis treatments. The Dianeal PD Solution is a dialysis solution administered via the abdominal cavity through a catheter to filter waste from the blood. On March 5, 2014, certain lots of Baxter’s Dianeal PD Solution were voluntarily recalled due to the presence of mold in the solution, which could cause life-threatening fungal peritoneal infections or sepsis. The patient claimed that after treatment with Dianeal PD Solution, he developed peritonitis and sepsis, which required extensive medical treatment, including nine surgical procedures. He asserted claims based on the LPLA, as well as state law claims based in negligence, vicarious liability, and the doctrines of respondeat superior (i.e., a doctrine that says party is responsible for the acts of his agents) and res ipsa loquitur (a doctrine that infers negligence from the very nature of an accident or injury, without direct evidence of causation).

Motion to dismiss. Baxter moved to dismiss the patient’s claims on three grounds: (1) the factual allegations in the complaint were mere speculation and did not state a claim upon which relief could be granted: (2) the patient’s non-LPLA negligence claims should be dismissed because the LPLA provides the exclusive remedy for products liability actions against manufacturers under Louisiana law; and (3) the complaint failed to plead facts sufficient to support claims under the LPLA.

Analysis. As an initial matter, the court dismissed all of the patient’s non-LPLA claims. According to the court, the LPLA establishes the exclusive theory of liability for manufacturers for damages caused by their products. As such, a claimant may not recover from a manufacturer for damage caused by a product on the basis of any theory of liability that is not set forth in the LPLA. The court also found that respondeat superior, vicarious liability, and res ipsa loquitur are theories of liability, not causes of action, so to the extent that the patient sought recovery under these theories, the claims were also dismissed.

LPLA claims. Four claims remained under the LPLA: construction defect, design defect, failure to warn, and breach of express warranty. The court addressed them all individually:

  • Construction defect. The complaint alleged that Baxter manufactured the Dianeal PD solution, contamination in the solution caused the patient’s fungal peritoneal infection and sepsis, the contamination in the solution made it unreasonably dangerous, and the patient’s injuries were a direct result of using the product during dialysis, as intended by Baxter. The court found it axiomatic that the Dianeal PD Solution, which is placed in a patient’s abdominal cavity through a catheter to filter blood during dialysis, should not become contaminated such that it grows mold. As such, the court concluded that the patient alleged facts sufficient to support a claim for a construction defect.
  • Design defect. The court found the patient’s design defect claim factually insufficient because it failed to adequately plead two essential elements of a design defect claim: (1) that at the time the Dianeal PD Solution left Baxter’s control, there was an alternative design for the product that was capable of preventing the patient’s damage; and (2) the danger of the damage outweighed the burden on Baxter to develop the alternative design.
  • Failure to warn. The court found that to allege a failure-to-warn claim under the LPLA, the patient was not required to detail what an adequate warning would be and how an adequate warning would have caused the patient's treating physician to act differently. However, the court decided that the patient was required to allege that Baxter did not adequately warn the patient's treating physician of risks associated with the product that are not otherwise known to the patient or physician, and that the inadequate warning constituted the proximate cause of the patient’s injuries. The court concluded that the patient’s allegations fell short of this standard.
  • Breach of express warranty. In his complaint, the patient merely alleged that Baxter warrantied their product was "suitable and safe for use." This statement, according to the court, without more, was insufficient to demonstrate that Baxter made an express warranty beyond generally praising their own product. The court also noted that the patient’s complaint failed to indicate to whom Baxter made such a warranty.

The court denied Baxter’s motion to dismiss with regard to the patient’s construction defect claim under the LPLA. However, it granted Baxter’s motion with respect to the patient’s non-LPLA claims. In addition, the court granted the patient 30 days to file an amended complaint with respect to his claims for design defect, failure to warn, and breach of express warranty under the LPLA.

The case is No. 2:16-cv-16391-EEF-DEK.

Attorneys: Brent Paul Frederick (Dodson, Hooks & Frederick, APLC) for Ross Lewis; Deborah Bila Rouen (Adams & Reese, LLP) for Baxter International, Inc. and Baxter Healthcare Corp.

Companies: Baxter International, Inc.; Baxter Healthcare Corp.

MainStory: TopStory CaseDecisions PLDrugNews AdulterationNews DrugBiologicNews GMPNews LabelingNews PrescriptionDrugNews LouisianaNews

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