CHARLESTON — A Kanawha County couple has sued Sagent Pharmaceuticals and two India-based drug manufacturers, alleging a recalled steroid injection contaminated with black particulate matter caused a serious infection and permanent damage to a man’s left foot.
Roger Darren Wines and his wife, Kelly Wines, filed an amended complaint September 10 in federal court after Sagent Pharmaceuticals removed the case from Kanawha Circuit Court to federal court.
The lawsuit alleges Wines received injections of methylprednisolone acetate in both feet on March 28, 2024, to treat plantar fasciitis. The drug was labeled as a Sagent Pharmaceuticals product, according to the complaint.
The plaintiffs contend the injection administered to Wines’ left foot was contaminated with particulate matter and impurities. They allege it caused “significant physical injuries, infections, and permanent damage to his left foot and surrounding anatomy.”
According to the complaint, Sagent recalled certain lots of methylprednisolone acetate injectable suspension on or about April 25, 2024, because of black particulate contamination, according to the amended complaint. The plaintiffs allege Sagent’s recall notice identified Sagent as the manufacturer but did not disclose the company that actually made the medication.
“The actual manufacturer of the contaminated and adulterated methylprednisolone cannot be identified despite good-faith exercise of due diligence,” the complaint says.
The original suit, filed March 20 in Kanawha Circuit Court, named Sagent and Gland Pharma Ltd. as defendants. Sagent removed the case to federal court September 4, arguing the parties are citizens of different states or countries and that the amount in dispute exceeds the $75,000 threshold for federal diversity jurisdiction. Sagent said it is a Wyoming corporation with its principal place of business in Illinois.
In its removal notice, Sagent denied liability and disputed Gland Pharma’s connection to the recalled product. It said Gland Pharma “played no role whatsoever in the formulation, design, manufacture, packaging, testing, promotion, handling, distribution, labeling or any other role related to the sale of the recalled” drug allegedly injected into Wines.
Sagent argued Gland Pharma had been fraudulently joined as a defendant because there was “no possibility” the plaintiffs could recover from the company. Nevertheless, the removal filing said Gland Pharma consented to the transfer to federal court while reserving its defenses.
The amended complaint adds SteriScience Specialties Private Limited, another India-based pharmaceutical company, as a defendant. The amended complaint says Sagent identified SteriScience for the first time in a sworn declaration filed with its removal notice as the manufacturer of the contaminated drug.
The complaint says the plaintiffs were unable to independently verify that assertion and says publicly available information identified Gland Pharma as a manufacturer of methylprednisolone for Sagent. It alleges the plaintiffs could not determine from available records whether Gland Pharma or SteriScience made the particular contaminated medication.
“Due to the conflicting public information and sworn declaration, Plaintiffs cannot determine which entity manufactured the adulterated and contaminated methylprednisolone,” the amended complaint states.
The Wineses accuse all three companies of strict product liability, negligence and breach of the implied warranty of merchantability. They allege the companies failed to use adequate safety, quality-assurance and contamination-detection procedures before distributing the drug.
The amended complaint alleges Sagent packaged the drug under its own brand and label without identifying the actual manufacturer. It says the company’s branding, the lack of manufacturer identification and the plaintiffs’ alleged inability to serve the foreign manufacturer make Sagent liable under West Virginia product-liability law.
The suit seeks compensatory and punitive damages, attorney fees, interest and other relief. Kelly Wines also seeks damages for alleged loss of consortium, care and services resulting from her husband’s injuries.
The couple is being represented by James R. Fox of Fox Law Office in Hurricane. Sagent is being represented by Clem C. Trischler of Pietragallo Gordon Alfano Bosick & Raspanti in Pittsburgh.
U.S. District Court for the Southern District of West Virginia case number 2:26-cv-558
