Jackson-Pratt Surgical Drain Infection Lawsuit Filed Over Recalled, Contaminated Products

Lawsuit alleges that an implanted Jackson-Pratt surgical drain was part of a Class II recall issued after the manufacturer admitted certain lots were distributed without proper sterilization.

A California man has filed a product liability lawsuit claiming that a recalled Jackson-Pratt surgical drain was not properly sterilized before being implanted during surgery, leading to a serious post-operative infection that required emergency treatment and ongoing medical care.

The complaint (PDF) was brought by Brian Poe in the U.S. District Court for the Northern District of California on February 2, naming Cardinal Health Inc. and Cardinal Health 200 LLC as defendants. Poe alleges the companies manufactured, distributed and sold Jackson-Pratt drains that were shipped to hospitals without undergoing required sterilization, despite being labeled and marketed as sterile medical devices.

Jackson-Pratt drains are commonly used during surgical procedures to remove blood and fluid from operative sites after an incision is closed. The flexible tubing and bulb-style reservoir are designed to remain inside a patient’s body for days following surgery, making sterility a critical safety requirement. According to the lawsuit, however, surgeons rely on manufacturers’ representations that the devices are sterile and suitable for implantation.

An unsterilized Jackson-Pratt surgical drain can pose serious, potentially life-threatening risks since they are implanted directly into the body during a critical healing period. Contamination can introduce bacteria into surgical wounds or around implants, increasing the risk of infections, abscesses and sepsis. These complications may delay recovery, require extended antibiotic treatment or additional surgery, and can lead to permanent tissue damage, chronic pain, long-term disability or life-threatening systemic infection.

Poe alleges he underwent a right anterior total hip replacement on February 8, 2024, during which a Jackson-Pratt surgical drain identified as part number SU130-402D and lot number 231151D2, was implanted near the surgical site. The complaint states that neither Poe nor his surgeon was aware at the time that the drain may not have been properly sterilized.

According to the lawsuit, Poe soon experienced worsening pain and post-surgical complications that were not consistent with a typical recovery. His surgical wound allegedly showed signs of infection, including abnormal drainage and tissue breakdown, ultimately requiring emergency surgical debridement on March 12, 2024.

The following month, Poe claims his surgeon informed him that the drain used during the procedure had been recalled due to sterility concerns. Cardinal Health issued a voluntary recall on March 28, 2024, acknowledging that certain Jackson-Pratt drains were distributed before sterilization and warning they could increase the risk of surgical site infections.

FDA records classify the action as a Class II recall, indicating a risk of medically significant health consequences, and include the same product and lot number allegedly implanted in Poe. The lawsuit claims Cardinal Health was responsible for sterilization, quality control and distribution, and that failures at multiple stages allowed unsterilized devices to reach patients, creating a foreseeable risk of infection.

“As a result, Plaintiff has endured prolonged immobility, months of physical therapy, and a delayed return to work, among other damages.”

— Brian Poe v. Cardinal Health Inc. et al

Poe raises allegations of strict product liability, manufacturing defect, failure to warn, negligence, negligent misrepresentation, and breach of express and implied warranties. He is seeking compensation for medical expenses, lost wages, pain and suffering, loss of enjoyment of life and other damages, as well as punitive damages.

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