We’ve been involved in pharmacy error cases for many years with special emphasis on compounding pharmacies. Since they are not closely monitored, this company (New England Compounding Center) has an obligation to be as transparent as possible.
Minneapolis, Minnesota (PRWEB) October 09, 2012
Attorney Fred Pritzker and his Bad Bug Law Team are investigating cases associated with a multi-state outbreak of fungal meningitis among patients who received an epidural steroid injection prepared by New England Compounding Center, a compounding pharmacy located in Framingham, MA. A number of the outbreak victims suffered strokes that are believed to have resulted from their meningitis. To date, the CDC has confirmed 8 deaths associated with this outbreak. Most of the CDC-confirmed cases – 105 so far – have come from 9 states with Tennessee being the hardest hit (35 cases, including 4 deaths). It is expected that many more cases will be diagnosed in the days to come.
Investigation into the source of this outbreak is ongoing. However, interim data show that all infected patients received injection with preservative-free methylpredinsolone acetate (80mg/ml) prepared by New England Compounding Center, according to the FDA.
According to Fred Pritzker, a national product safety lawyer who recently won over $40 million for clients injured by another medical product, “This is one of the largest outbreaks ever associated with a compounding pharmacy.” Pritzker is calling on New England Compounding Center to make an immediate disclosure about key safety practices. “It is vitally important for New England Compounding Center to answer the questions below:
1. What practices and procedures were employed by New England Compounding Center to prevent harm to patients that could result from fungal contamination?
2. What testing did New England Compounding Center perform on the implicated preservative-free methylpredinsolone acetate to determine its safety and what were the results of such testing?
3. What kind of quality assurance program did New England Compounding Center have in place to prevent and detect contamination of its methylpredinsolone acetate?
4. Did the company hire any outside auditors to review/examine the efficacy of its safety procedures and, if so, what were the results of the audits?
5. Did New England Compounding Center belong to or follow the recommended safety practices of any trade group, regulatory agency or standards organization?
6. What procedures did New England Compounding Center follow to clean and disinfect the equipment and surfaces used to produce, package and store its methylpredinsolone acetate?
7. What has New England Compounding Center done to investigate the source of this fungal contamination and what has it found so far?”
Pritzker also noted that compounding pharmacies are not heavily regulated and are not subject to the same level of scrutiny as drug manufacturers. “We’ve been involved in pharmacy error cases for many years with special emphasis on compounding pharmacies. Since they are not closely monitored, this company (New England Compounding Center) has an obligation to be as transparent as possible. They need to provide outbreak victims with information and must do so without further delay,” Pritzker said.
New England Compounding Center distributed the implicated steroid product to 23 states, including California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. Pritzker has a list of the clinics that received the NECC steroids used for back pain shots on his website.
PritzkerOlsen, P.A. has a national practice representing victims of pathogenic adulteration of both food and drug products. The firm has obtained some of the largest verdicts and settlements in product liability cases. Attorneys Fred Pritzker and Elliot Olsen can be reached at 1-888-377-8900 (toll free). More information can be found on their website http://www.pritzkerlaw.com, where they have more information about a steroid meningitis lawsuit. The firm has offices in Minneapolis, MN.