McKesson Sterile Solution Lawsuit Claims Compromised Corticosteroid Resulted in Partial Foot Amputation

Lawsuit claims a routine injection for foot arthritis was contaminated with black particulate matter and not sterile when administered.

A West Virginia woman has filed a product liability lawsuit alleging that a contaminated corticosteroid injection administered for the treatment of arthritis caused her to suffer a severe infection.

The complaint (PDF) was originally brought by Garnet Ann Davis in West Virginia Circuit Court on March 27, naming Sagent Pharmaceuticals Inc. and McKesson Medical-Surgical Inc. as defendants. It was later removed to the U.S. District Court for the Southern District of West Virginia on April 6.

Davis accuses the companies of selling a defective and contaminated injectable drug that was later subject to a recall, which eventually resulted in the amputation of part of her right foot.

Sterile Solution Risks

This is not the first time that a recalled sterile solution has been linked to severe infections. A November 2023 Nurse Assist recall of sterile water and saline solutions announced by the U.S. Food and Drug Administration (FDA) affected certain McKesson products as well.

At the time, the agency found that 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 filed Nurse Assist infection lawsuits, alleging that the manufacturer failed to ensure that medical products distributed by McKesson, Cardinal Health and others were properly manufactured and packaged.

McKesson Foot Amputation Lawsuit

According to the lawsuit, Davis received an injection of methylprednisolone acetate on March 28, 2024, as part of routine treatment for arthritis in her right foot. The medication, which is designed to reduce inflammation, allegedly contained black particulate matter and was not sterile at the time it was administered.

Within days of the injection, Davis reportedly developed severe pain, redness and swelling in her foot, which led to an emergency hospitalization where doctors identified a serious infection. The complaint indicates she was diagnosed with MSSA bacteremia and cellulitis, requiring surgical debridement and intravenous antibiotics.

Despite aggressive treatment, the infection worsened, progressing to osteomyelitis and septic arthritis, ultimately forcing doctors to amputate her right great toe and first ray in June 2024. The lawsuit claims the infection was directly caused by the contaminated injection.

Davis indicates she did not learn the drug had been recalled until after the amputation, when her healthcare provider sent a notice warning that she may have received an affected lot. The complaint alleges the manufacturers and distributors had the ability to identify affected products and patients, yet failed to provide timely warnings that could have prevented her injuries.

Following the amputation, Davis claims she developed long-term complications, including complex regional pain syndrome, phantom limb pain and chronic disability, which have severely impacted her mobility and daily life. The lawsuit states her medical expenses already exceed $156,000, with ongoing care expected.

“At no time did Plaintiff know, or have reason to believe, that the Methylprednisolone Acetate Injectable Suspension, USP administered to her was contaminated, subject to recall, or in any condition unsuitable for its intended use.”

— Garnet Ann Davis v. Sagent Pharmaceuticals Inc. et al

The case raises allegations of strict liability, manufacturing defect, failure to warn, negligence, negligence per se, and breach of express and implied warranties. It is seeking compensatory and punitive damages for the injuries, as well as compensation for medical costs, pain and suffering and permanent disability.

The defendants have denied liability, and the litigation is expected to proceed in federal court.

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