A group of 70 plaintiffs have filed suit against Orthopedic and Sports Medicine Center of Northern Indiana over contaminated epidural steroid injections they received from the Elkhart medical practice.
The case results from a widespread outbreak of fungal meningitis and other infections from medicine made at a Massachusetts compounding pharmacy in 2012 that affected people in at least 20 states and caused more than 64 deaths.
The Centers for Disease Control and Prevention has identified 751 cases of individuals diagnosed with meningitis, fungal infections and other related conditions in the outbreak, with 93 cases in Indiana, according to the lawsuit filed in Elkhart Superior Court 1 on Wednesday, April 2, by South Bend-based personal injury attorneys Foley & Small.
The 44-page complaint details not only the "deplorable conditions" and what went wrong at the NECC, but also how OSMC should have known about it.
At a compounding pharmacy, drugs are mixed according to prescriptions written for particular patients. The NECC was not authorized by the U.S. Food and Drug Administration to manufacture drugs, nor was it licensed by the state of Massachusetts to mix prescriptions in bulk, the suit alleges. OSMC should have known as much, and had bought the steroids from NECC because they cost less than other sources, the suit alleges.
"Clinics disregarded the prevailing industry guidelines and state pharmacy regulations requiring individual medications to be compounded in response to receiving a prescription from a particular patient," the suit alleges. "Clinics did this to save money and for convenience ..."
OSMC spokeswoman Jaimie Wrigley declined to answer questions when contacted Thursday.
"We believe this lawsuit is without merit and the responsible party at fault is New England Compounding Center," Wrigley wrote in an email.
Neither Douglas Foley nor Edmond Small returned a call seeking comment Thursday. In November 2012 they filed suits in the U.S. District Court for Northern Indiana, on behalf of some of the plaintiffs in the new Elkhart Superior suit, naming NECC and its operators as defendants rather than OSMC. However, those suits, transferred to the U.S. District Court in Massachusetts, have been in limbo since early last year after NECC and its officers sought protection in bankruptcy court.
But earlier this month, the bankruptcy trustee told the judge that NECC and its officers have come up with about $100 million for a settlement that would be paid out to victims in the 321 cases that have been consolidated in Massachusetts federal court, according to court records. The trustee, Boston attorney Paul D. Moore, expects that money to be distributed to victims by the end of the year.