Lack of Federal Drug Regulations Linked to Fatal Meningitis Outbreak

October 8, 2012 | Crandall & Pera Law
Lack of Federal Drug Regulations Linked to Fatal Meningitis Outbreak

This is a developing story where anyone who has had steroid injections for pain or orthopedic injuries should keep a close watch.   A manufacturer of this common injectable apparently was not in accordance with safety standards resulting in a virus being injected along with the steroid. This virus has led to a number of deaths and critically ill patients.   Be aware of this situation and ask your doctor before receiving any injection like this.

The rising toll of those affected by the growing national outbreak of meningitis - 8 dead, over 100 ill and thousands potentially exposed,  according to latest reports - have cast a harsh light on drug regulations, according to The New York Times.

The contaminated drugs all came from the New England Compounding Center (Framingham, MA), a compounding pharmacy that mixes up batches of drugs on their own for much lower prices than major manufacturers charge.

There have been a series of complaints against the compounding center in the past decade: the State Health Department inspected in 2006 and, "according to a warning letter sent by the F.D.A. from that year, the company was accused of illegally producing a standardized anesthetic topical cream, inappropriately repackaging a drug, and telling doctors that using an office staff member's name was enough to put in an order, even though the rules require a prescription for a particular patient."

"The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts." said Kevin Outterson, an associate professor of law at Boston University.

Meningitis can be caused by viruses, bacteria or fungi, the latter being the case with the recent outbreak. The fungi type is the hardest to treat because it can cause strokes in patients, which has already occurred in multiple instances.

Dr. Anders Cohen, the chief of neurosurgery and spine surgery at the Brooklyn Hospital Center, said: "We ask for the medication, it's in stock, we use it. I don't know if it's coming from A, B or C. This is kind of a wake-up call about where your stuff is coming from." Read the full details here:

Scant Oversight of Drug Maker in Fatal Meningitis Outbreak

"This article should alarm the general public who likely feel the FDA keeps our citizens safe from the manufacture and distribution of bad drugs in our country," says Steve Crandall, a top-rated medical malpractice attorney throughout Ohio and Kentucky.

"In fact, federal oversight directly led to bad drugs being injected into our citizens.  The result has been a number of dead and injured as a result.  This should not be allowed to occur."

If you have any questions regarding medical malpractice throughout Ohio and Kentucky, contact Steve Crandall. Steve is available to help answer your questions and guide you in determining your next steps.