Nurse Assist Saline Solution Lawsuit Alleges Contamination Caused Severe Infection

Doctors have been unable to remove the infection, which has spread throughout the plaintiffs’ body into her mechanical heart and bloodstream.

A Georgia woman’s lawsuit claims she purchased a sterile wound care kit to clean the site where a driveline connects to her mechanical heart, yet the solution caused a severe infection doctors have been unable to eliminate.

The complaint (PDF) was originally filed by Frances M. Wilbers in Georgia Superior Court in late February, naming Nurse Assist LLC, multiple Cardinal Health Inc. subsidiaries, Orthodynamix Company Inc., and several unidentified entities as defendants. It was removed to the U.S. District Court for the Northern District of Georgia on April 1.

Wilbers filed the lawsuit after allegedly developing a persistent and life-threatening infection she indicates was caused by contaminated Nurse Assist saline solution that she used in routine wound care for her mechanical heart’s driveline site.

Nurse Assist Sterile Water and Saline Recall

The lawsuit references a November 2023 Nurse Assist recall of sterile water and saline solutions announced by the U.S. Food and Drug Administration (FDA).

The agency found the items’ packaging seals could break, compromising sterility and exposing the fluids to bacterial contamination. As a result, the solutions may have been contaminated before use. The FDA urged healthcare providers and consumers to stop using and distributing the affected supplies.

In the wake of that announcement, multiple individuals have filed Nurse Assist infection lawsuits, alleging that the manufacturer failed to ensure the medical products were properly manufactured and packaged before being shipped to unsuspecting consumers.

Nurse Assist Infection Lawsuit

Wilbers’ lawsuit indicates she suffered a major heart attack in 2019, leading to a surgery that replaced her organic heart with a mechanical HeartMate 3 left ventricular assist device (LVAD). This device receives its power from an external battery pack. The battery pack connects to a “driveline” which enters the body and connects to the HeartMate 3.

Knowing the driveline entry site was highly susceptible to infection, Wilbers followed a routine of regularly using sterile saline and wound care kits purchased from ODI, which sourced the products from Cardinal Health. Cardinal Health, in turn, obtained the sterile water used in those kits from Nurse Assist.

The lawsuit indicates that the defendants continued to distribute and sell the potentially contaminated sterile water along with the wound care kits for months after the November 2023 Nurse Assist recall. This resulted in Wilbers developing an infection in February 2024.

Wilbers indicates she went to her doctors at the Mayo Clinic when she first saw the area growing red, fearing an infection. Doctors determined the driveline site was severely infected and admitted her to the hospital, where Wilbers was given IV antibiotics. A culture of the site determined she was infected with Serratia Marcesnes.

In late February 2024, Wilbers underwent a debridement procedure and the installation of antibiotic beads at the driveline infection site. However, doctors discovered that the infection had spread to her bloodstream and throughout her body, including her abdomen, chest and even into the HeartMate 3.

“Without being able to eliminate the infection, despite the doctors’ best efforts, the infection eventually entered Plaintiff’s blood stream and remains there today. As a result, Plaintiff has been placed on a high dose of extremely strong antibiotics (Bactrim) just to keep the infection at bay, with any minor cut or scratch potentially leading to a life-threatening flareup.”

– Frances M. Wilbers v. Nurse Assist Inc. et al

Wilbers presents claims of failure to warn, breach of implied warranty, and violation of the Official Code of Georgia Annotated (OCGA). The lawsuit notes that Wilbers’ medical expenses have so far exceeded $2 million.

Nurse Assist Litigation

The complaint is one of several Nurse Assist lawsuits filed since the recall by consumers who say they used the sterile water and saline solution products on wounds, only to discover too late that the products were not as sterile as advertised.

As individuals continue to learn that prior infections may have been caused by sterile water or saline solutions used during their treatment, lawsuits are being filed nationwide against Nurse Assist and related distributors, alleging the company failed to ensure the sterility of its solutions.

Product liability lawyers currently offer free consultation and claim evaluations for individuals exposed to the recalled products who experienced problems, including:

• Sepsis or septic shock
• Bloodstream infections
• Respiratory infections
• Organ failure
• Necrosis or serious wound-related infections
• Prolonged hospital stays or additional surgeries

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