Mark S. Fryman, of the Indiana law firm of Starr Austen & Miller, LLP, announced today that the firm, along with the firm of McNeely Stephenson Thopy & Harrold, have commenced a lawsuit against New England Compounding Pharmacy, Inc., d/b/a New England Compounding Center (“NECC”), and two of its closely related companies, as well as these companies officers, in regard to the recent multi-state fungal meningitis outbreak, linked to tainted vials of a contaminated steroid injection which has harmed Plaintiff, Natalie S. Copass. The case is entitled “Natalie S. Copass v. New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center, et al.,” and was filed on October 18, 2012, in Bartholomew County Superior Court 1 in Indiana, under cause number 03D01-1210-CT-5429.
This complaint centers around the outbreak of a fungal meningitis that has now impacted six states, has resulted in 15 deaths, and at least 205 cases of this potentially life threatening disease. The outbreak has been linked to tainted vials of a steroid, methylprednisolone acetate, which is alleged in the Complaint to be manufactured, mixed, compounded, sold, and delivered by Defendants New England Compounding Center, Ameridose, and Alaunus, at the direction of their owners, Cadden and Conigliaro, among others.
In Indiana alone this contaminated medication was sent to at least six different Indiana communities, according to the map and additional information provided by the CDC. These clinics and cities include:
- Ambulatory Care Center, in Evansville, Indiana
- Fort Wayne Physical Medicine, in Fort Wayne, Indiana
- OSMC Outpatient Surgery Center, in Elkhart, Indiana
- South Bend Clinic, in South Bend, Indiana
- Union Hospital, in Terre Haute, Indiana
- Wellspring Pain Solutions Clinic, in Columbus, Indiana
The plaintiff in this lawsuit, Natalie S. Copass, was a patient at the Wellspring Pain Solutions Clinic, in Columbus, Indiana, and was being treated for back pain. During the course of her treatment she was given three contaminated steroid injections, according to the allegations in the Complaint. Since then the Complaint states she has experienced frequent, intermittent and migratory headaches, episodes of blurred vision, and discomfort when lowering her chin to her chest.
According to the complaint the vials manufactured and sold by the Defendants were contaminated with a fungus which, when injected into an epidural, caused the fungal meningitis, whose symptoms can take between one to four weeks to appear. The vials were sold by the defendants for $15 less than those sold by other manufacturers, with the allegation being that such cost saving was achieved through cutting of corners including designing the business to exploit loopholes leading to lack of FDA regulation, and failure to include a necessary alcohol preservative within the vials.
The Complaint raises five causes of actions against the defendants, including for strict liability for failure to warn, strict liability for a dangerously defective product, negligence, breach of implied warranty, and negligent infliction of emotional distress. The Complaint demands a jury trial, and asks for relief including damages, pre- and post-judgment interest, attorney’s fees and costs, and other equitable relief.
Scott Starr, a partner in the firm, stated, “We hope through the filing of this action that we can compensate our client, Mrs. Copass, for the injuries she suffers now, and may in the future, for being injected with a fungally contaminated medication. Further, we hope to keep such a similar tragedy from happening in the future, by bringing awareness to the egregious violations we have learned about. This tragedy did not have happen to any citizens of the state of Indiana or this nation. Instead, we have learned that the Defendants’ conduct was unregulated by the FDA because the NECC was purportedly a pharmacy, not a drug manufacturer. The patch work of state and federal regulation dealing with drug manufacturing, and the loopholes that result, should never be exploited for profit which puts the citizens of this nation at risk. Further, it appears that defendants corporate culture may have encouraged putting profits above safety, which ultimately resulted in allowing a product without the necessary alcohol preservatives to be shipped and used throughout this country. Basically, the defendants manufactured and shipped a product which, when injected, could cause a lethal disease. This is a tragedy that we hope to rectify and help prevent from happening again.”
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