According to Dr. Michael Carome, of Public Citizen, the fungal meningitis
outbreak associated with 15 recent deaths and over 200 serious illnesses
was completely preventable. In
an article released by CNN, Dr. Carome contends that, "(T)he injectable steroid
medication produced at the center was never approved by the
FDA and was not manufactured in accordance with the FDA’s rigorous manufacturing
standards designed to ensure that drugs are sterile and uncontaminated
with such germs as bacteria or fungi before being sold and distributed.
As a result, as many as 14,000 patients in 23 states were exposed to potentially
contaminated steroids and need to be monitored for signs of fungal meningitis
or other infections."
Dr. Carome contends that many entities are responsible for this preventable
deadly outbreak, "(W)hile numerous probes and investigations are
just getting under way and litigation targeting the producer of the tainted
drug and health care providers who used it will certainly take years to
resolve, blame for this disaster will undoubtedly rest with many parties.
Among them are the compounding pharmacy that produced the contaminated
steroid drugs, health care facilities and providers who chose to use a
dangerous drug lacking approval by the FDA and evidence that the products
were sterile, trade associations and professional groups representing
compounding pharmacies that have vigorously resisted federal regulatory
oversight of their members, state and federal regulators, and Congress."
On October 4, the Federal Drug Administration (FDA) advised health care providers not to use any New England Compounding
Center (NECC) products after a patient was diagnosed with meningitis that
was possibly associated with an epidural injection of a steroid medication.
On October 6, NECC announced a
recall of all of its products. Click here for
a complete list of the products subject to this recall.
The FDA is advising healthcare professionals to follow up with patients
who were administered any injectible medication from or produced by NECC
after May 12, 2012.
We are currently investigating cases involving tainted medication such
as this. If you or a family member has questions about this please call
me for a free consultation. 202-822-1875.
About the author:
Catherine Bertram is board certified in civil trials and was recently nominated again as
a 2012 Best Lawyer in DC for Malpractice, Washingtonian Magazine Best
Lawyers, 50 Top Women Attorneys in DC and a 2012 Super Lawyer for Washington,
D.C. Ms. Bertram has over 20 years of trial
experience and is unique in that she was formerly the Director of Risk Management
for Georgetown University Hospital. Ms. Bertram is a member of the bar
for the U.S. Supreme Court. She is a partner with the firm and lectures
regularly to lawyers and health care providers, nationally and locally,
regarding patient safety, medical negligence and other related issues.
She lives with her family in D.C. and can be reached by email at firstname.lastname@example.org
or by phone 202-822-1875 in her office in Washington, D.C.