MediHoney Infection Lawsuit Claims Wound Care Gel Contaminated Skin Lesion

Earlier this year, federal officials urged consumers to stop using certain MediHoney wound gel products following reports of more than a dozen infections potentially linked to contaminated packaging.

A California family has filed a MediHoney infection lawsuit alleging contaminated wound care gel introduced dangerous bacteria into an open skin lesion, causing a severe infection that resulted in a woman’s death.

The complaint (PDF) was originally brought by Barbara Penney, through her successors in interest Shalonda Tillman, Romina Johnson and James Penney in California Superior Court, and was removed to the U.S. District Court for the Northern District of California on July 13. It names Integra LifeSciences Corporation and Derma Sciences Inc. as defendants.

The plaintiffs indicate Penney used the manufacturers’ MediHoney Wound and Burn Dressing Gel to treat a skin lesion, believing the product was sterile and safe for application to an open wound.

However, the lawsuit claims the MediHoney gel was contaminated with harmful bacteria during the manufacturing process, which entered Penney’s body through the lesion and caused a serious infection that resulted in her death.

MediHoney Wound Care Gel Recalls

Earlier this year, federal officials warned consumers to immediately stop using certain lots of MediHoney wound and burn care products after more than a dozen infections were potentially linked to contaminated packaging.

The warning followed an earlier Class 2 recall involving more than 120,000 units of MediHoney Wound Gel. Regulators indicated that tiny holes could develop in the applicator pin pouch, allowing contamination to enter and potentially compromising the product’s sterility.

Similar packaging concerns previously led to a Nurse Assist recall involving sterile water and saline products used for wound care. In that case, defects in the packaging also raised concerns that the supposedly sterile products may have become contaminated before use.

Numerous patients have since filed Nurse Assist infection lawsuits alleging the contaminated wound care products caused serious and potentially life-threatening infections.

MediHoney Wound Care Gel Death Allegations

According to the complaint, Integra and Derma Sciences designed, manufactured, marketed and sold MediHoney products for direct application to damaged skin and open wounds.

Plaintiffs allege the companies had a duty to ensure the wound care gel was properly manufactured and free from harmful bacteria and other contaminants that could cause infections.

However, the lawsuit claims the MediHoney gel used by Penney was defective and unreasonably dangerous.

After applying the gel to her skin lesion, Penney allegedly developed a severe infection that required extensive medical treatment. The complaint maintains the infection caused significant pain, physical injuries, emotional distress and other damages, which eventually resulted in Penney’s death.

Plaintiffs argue that Integra and Derma Sciences failed to use adequate quality control procedures, properly inspect and test the products for contamination or warn consumers and medical providers about the potential infection risks.

The lawsuit claims Penney used the MediHoney gel as intended and would not have suffered the infection and resulting injuries if the product had been properly manufactured.

“Defendants failed to provide adequate warnings and instructions regarding the risk of infection associated with use of the product on or near skin lesions, causing Plaintiff to use the product without knowledge of the danger and resulting in infection and injury.”

— Barbara Penney et al. v. Integra LifeSciences Corporation et al.

The filing raises claims of strict liability, negligence and breach of warranty. It seeks compensatory damages for medical expenses, pain and suffering, emotional distress and other losses.

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