Fungal Meningitis Outbreak - Was There a Warning?October 19, 2012 | Category: Meningitis Outbreak
The Wall Street Journal, October 15, 2012, reports that 12 years ago David Kessler, while serving as the commissioner of the FDA (Food and Drug Administration)warned Congress that "tiny drug-compounding pharmacies would spawn a shadow industry of unapproved drugs that could result in serious adverse effects, including death."
There are close to 3,000 compounding pharmacies in the United States today. Some of these pharmacies are filling bulk orders, not filling individual prescriptions, for which they are State licensed. According to The Wall Street Journal, October 13-14, 2012, the New England Compounding Center (NECC) "supplied dozens of medicines in bulk to clinics around the country. The company promoted its products in marketing materials and at medical conferences alongside big drug companies and developed a reputation as a fast, polished operation that could supply products when competitors were hampered by shortages."
This week the NECC recalled all of its 2000 products nationwide. On October 18, 2012 the CDC (Center for Disease Control) and FDA clinically confirmed that the steroid injections from NECC is the cause of the fungal meningitis and joint infection outbreak.
A Massachusetts Health and Human Services spokesman said NECC "was licensed to deliver compounded products in response to individual patient-specific prescriptions." They believe NECC violated this aspect of the license. Reuters News Agency has reported on seeing records indicating that 17,000+ doses of this steroid were made over three days. This is not consistent with any allowed behavior on the part of a State licensed compounding pharmacy. It is the type of quantity that would be made by a manufacturer, not just for named patients as required by the State law for compounding pharmacies.
Meningitis outbreak attorney, Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P. A. recommends that the public check the NECC Recalled Product List and with their doctors to determine whether they need to be concerned about their health.
"The fungal meningitis outbreak which has been attributed to contaminated steroid injections from the NECC, nationwide recalls, and the resulting State and Federal investigations are "wake up calls" to Congress and the American people that something has to be done to protect us all. Changing regulations and oversight of the drug industry and compounding pharmacies needs to be a priority," says Attorney Spivey. "The FDA's apparent lack of legal authority to regulate compounded drugs and compounding pharmacies poses a serious threat to the public."
If you, a loved one, or someone you know has suffered because of a defective product, please contact us at the Spivey Law Firm, Personal Injury Attorneys, P.A. specializing in personal injury and wrongful death.
Randall L. Spivey is a Board Certified Civil Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by less than 2 percent of Florida attorneys. He has handled over 1,500 personal injury and wrongful death cases throughout Florida. For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., in Lee County at 239. 337.7483 or toll free at 1.888.477.4839, or by email to Randall@SpiveyLaw.com. Visit SpiveyLaw.com for more information. You can contact Spivey Law Firm, Personal Injury Attorneys, P.A. in Charlotte County at 941.764.7748 and in Collier County at 239.793.7748.