Washington, DC (PRWEB) October 12, 2012
In the wake of the recent national health crisis surrounding steroid injections tainted with a deadly fungus, The Cochran Firm has uncovered information that the New England Compounding Center, the pharmacy that produced the steroid injections that have caused at least 12 deaths, was not accredited by the Pharmacy Compounding Accreditation Board (PCAB).
The Cochran Firm is a national law firm that was started by the late Johnny Cochran, and has been dedicated to the representation of people injured by corporations that put profits before people. Paul D'Amore, an attorney with the firm's D.C. office states
"The first question we asked when we were contacted about these cases was how this could happen,” said Paul M. D'Amore, a medical malpractice lawyer at The Cochran Firm. “With such a high degree of danger to so many people, where was the oversight? What we have discovered so far is extremely concerning."
Pharmacy compounding involves the mixing of standard drugs and ingredients to create patient specific medications. However, most drugs that are FDA approved are manufactured in a "one-size-fits all" model. Rather than spend the time, effort and money necessary to obtain FDA approval for these customized medications, the drug industry often turns to the increasingly popular alternative of compounding, according to an FDA consumer report.
However, according to a recent ABC report, the compounding industry is not Federally regulated , despite the fact that the compounding pharmacies are able to ship their products across state lines.
"These compounding companies are not subject to any standardized federal safety regulations. In fact, we have also learned that many of these companies have spent huge sums of money to fight federal regulation of their business," said D'Amore.
Enter the Pharmacy Compounding Accreditation Board. This non-governmental organization was started by eight of the nation's leading pharmacy organizations in response to the industry's own recognition that standards were necessary to ensure quality and safety. Certification by the PCAB is voluntary, and requires the compounding company seeking accreditation to ensure compliance with PCAB standards and then allow PCAB inspection of its operations.
"Our preliminary investigation has determined that the New England Compounding Center was not accredited by the PCAB", said D'Amore. "That is a huge problem. Here you have a voluntary organization dedicated to patient safety, and this company elects not to participate. Why not?"
The New York Times has reported that one of the owners of the New England Compounding Center, Gregory Conigliaro is also associated with a real estate company and a recycling company. The Boston Globe has reported that one of New England Compounding Center's board members, Sophia Pasedis, is also a member of the Massachusetts Board of Registration in Pharmacy. These facts no not sit well with D'Amore: "So, the preliminary picture is a pharmacy operation owned by a real estate developer/recycling plant owner, and that has one of its own board members on the only State Agency that has the power to regulate it." Does it surprise anyone that the result is the national crisis we are seeing right now?"
Maryland and Virginia rank at the top of locations where the deadly drugs were distributed. The CDC estimates that 13,000 people may have received doses of the tainted drugs. But D'Amore and The Cochran Firm are resolute. "Based upon the numbers, this is going to have a terrible impact on our region. The Cochran Firm is going to do whatever we can to help the people affected by this get answers and get justice for the tragic and avoidable harm they have suffered."
About The Cochran Firm
The Cochran Firm is one of the premier trial advocacy firms in the United States. With some of the most highly-experienced and respected men and women dedicated to bringing quality representation for injured people, their families and the ordinary citizen, The Cochran Firm has been involved in high profile cases including environmental, pharmaceutical and medical device products liability litigation. Recognized nationally for their achievements in the courtroom, attorneys with The Cochran Firm have obtained litigation results which have significantly impacted the law, communities, and industry practices.