The U.S. House Energy and Commerce Committee has issued a subpoena to Barry J. Cadden, the chief pharmacist and a co- owner of the New England Compounding Center (NECC), as part of its probe into a multistate outbreak of fungal meningitis and other infections that have sickened 419 people and killed 30. Epidural steroid injections supplied by Massachusetts-based NECC have been blamed for the outbreak.

According to The Boston Globe, Cadden has been ordered to appear before the House Committee on Energy and Commerce, Oversight and Investigations Subcommittee on November 14 at 10 a.m. The subpoena was issued after Cadden indicated he would not appear voluntarily.

“Our committee has a long, bipartisan history of conducting drug safety oversight. Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain,” top committee members said in a written statement. “The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006 — we want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again.”

According to the U.S. Centers for Disease Control (CDC), 409 cases of meningitis have been reported in people who received NECC steroid shots to treat back pain, while 10 peripheral joint infections have been reported in patients who received the injections in knees, hips and other joints. Earlier this week, The New York Times reported that some meningitis victims have developed a second infection, epidural abscesses, at the site if their steroid injection. In a disturbing development, many of those who developed the abscesses were in the midst of being treated with powerful antifungal drugs when the new infection occurred.

NECC has since issued an epidural steroid injection recall, and later pulled all of its products from the market. In addition, the company voluntarily surrendered its license to operate. An inspection conducted by the U.S. Food & Drug Administration (FDA) turned up unsanitary conditions, including mold contamination, at the NECC facility in Framingham, Massachusetts. A sister pharmacy owned by some of the same people, Ameridose, Inc., also recalled its products after federal inspectors determined that conditions at its Massachusetts facility could not ensure their sterility.

The meningitis outbreak linked to NECC has focused attention on compounding pharmacies, which are lightly regulated by the FDA. Among other things, such facilities are not bound by the FDA’s good manufacturing practices standards, and most oversight is left to the state. Compounding pharmacies, including NECC, are only licensed to prepare custom drugs for individual patients. But the state and federal probe of NECC has found evidence that it may have been operating as a large-scale drug manufacturer. According to The New York Times, prior to the outbreak, NECC supplied drugs to some of the nation’s most prestigious hospitals, including some connected with Harvard and the Mayo Clinic.

Several meningitis lawsuits have already been filed against NECC by alleged victims of the company’s recalled steroids. If you or a loved one developed meningitis or another fungal infection following a steroid injection, you may be eligible for compensation for your pain and suffering. To learn more about filing a fungal meningitis lawsuit, please contact an attorney at Bernstein Liebhard LLP by calling 1-877-779-1414 today.

Published November 7, 2012 by