A pharmacy that produced tainted drugs linked to a meningitis outbreak sits next to a waste recycling plant that might have been the source of contamination, according to the latest round in a wave of lawsuits.
The allegations are made in six lawsuits, filed recently in Roanoke's federal court, that bring the total number of cases in the region to at least 31.
In all of the cases, patients seeking relief from pain claim their suffering was worsened by injections of a dirty steroid, produced by New England Compounding Center of Massachusetts, that gave them fungal meningitis.
One of the doses proved fatal, alleges a wrongful death lawsuit brought on behalf of Douglas Wingate of Salem.
The latest lawsuits advance a new claim: The drug made by New England Compounding might have been contaminated by debris and dust from a recycling plant next door.
Knowing the risks posed by the operation, New England Compounding "engaged in what amounted to 'Russian Roulette' with its practices," lawyers from the Roanoke firm of Gentry Locke Rakes & Moore alleged on behalf of six patients.
The lawsuits strongly suggest, but do not state definitively, that operations at New England Compounding's facility in Framingham, Mass., were affected by an adjacent waste recycling center called Conigliaro Enterprises.
Owned by Gregory Conigliaro, who also co-owns New England Compounding, the dump "receives many varieties of garbage that are sorted, stored and manipulated just outside the back door" of New England Compounding's facility, the lawsuits state.
Officials at New England Compounding "knew or had reasons to know" of the risks posed by Conigliaro Enterprises, lawyers allege.
The recycling facility is not named as a defendant in the lawsuits. New England Compounding has declined to comment in the past on the lawsuits.
Lawsuits have alleged a number of other violations of state and federal laws at the pharmacy, which mixes — or compounds — drug products for specific patients.
It's unclear just how many lawsuits have been filed against the pharmacy in state and federal courts across the country.
"But it stands to reason there will be hundreds filed," said Scott Sexton, an attorney at Gentry Locke who filed the recent cases in U.S. District Court in Roanoke.
Since the outbreak began in September, 39 people have died and 620 have fallen seriously ill from fungal meningitis in 19 states, according to the Centers for Disease Control and Prevention.
Court records on Tuesday showed 25 lawsuits filed in Roanoke's state court and six in federal court. Most seek either $5 million or $10 million per plaintiff.
One exception is the wrongful death case filed by the family of Douglas Wingate, one of the first people in the country to die in the fungal meningitis outbreak. Wingate's lawsuit seeks $25 million from New England Compounding; its marketing arm, Medical Sales Management; and Barry Cadden, who co-owns the compounding center and was the pharmacist in charge of its operation.
Wingate, 47, was seeking relief from neck pain when he received an epidural steroid injection on Sept. 6 at Insight Imaging in Roanoke. He died 12 days later.
Although many of the lawsuits filed in state court include Insight Imaging as a defendant along with New England Compounding, the Franklin Road clinic is not named in Wingate's lawsuit.
Like the five other cases filed in federal court, Wingate's lawsuit cites the recycling center as a possible source of contamination of methylprednisolone acetate, the pain-relieving steroid manufactured by New England Compounding.
The recycling center is also mentioned in a report by the Massachusetts Office of Health and Human Services. The October report, which found flawed sterilization procedures and dirt and debris in parts of the New England Compounding building, listed the recycling center as one of the subjects of an ongoing investigation.
Meanwhile, a dispute is developing over whether the lawsuits filed in Roanoke should be tried in federal or state court.
Lawyers for New England Compounding have sought to have some of the state cases moved to federal court, citing the possibility of a designated judge handling pretrial matters in all of the cases filed across the country.
John Fishwick, a Roanoke attorney who represents one of the plaintiffs in state court, recently filed a motion recently opposing its transfer.
Because the lawsuit involves issues of state law, "we believe under current law" that Roanoke Circuit Court is the proper venue, Fishwick said.
Staff researcher Belinda Harris contributed to this report.
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