60 Minutes special on the contaminated New England Compounding Center.
Contaminated Steroid Injections and Fungal Meningitis
On September 26, 2012, New England Compounding Center (NECC) issued a recall on three lots of its Methylprendisolone Acetate, an injectable steroid medication mostly used for patients with lower back pain. The recall was due to contamination that would eventually cause a deadly outbreak of fungal meningitis. Since that time, an ongoing investigation of Aspergillus meningitis has revealed a growing number of patients affected by these contaminated medications.
The Center for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have since recommended that all health care professionals cease use of Methylprendisolone Acetate and all other products produced by the NECC. At the time of the recall, it was believed that 75 clinics in 23 different states had used the contaminated products. A list of clinics that used the recalled products can be found here.
According to the FDA, pharmacy compounding is a practice in which a licensed pharmacist fills a prescription by combining, mixing or altering ingredients to create a medication tailored to the medical needs of an individual patient.
Although pharmacy compounding can play a very important role in treating patients, there are risks involved. Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA regulation or approval. Poor compounding practices at these pharmacies can result in contamination and render a product harmful and, in some cases, deadly.
Compounding can serve important needs when a patient’s individual circumstances prevent them from using the FDA–approved form of a drug. However, the FDA has expressed concern over the lack of medical necessity behind some of the products produced by compounding pharmacies. By slightly changing a drug, a facility is able to exist under the guise of a compounding pharmacy even if its operations and goals are more in line with those of a drug manufacturing facility. This presents a loophole that the FDA finds troubling.
In addition to the meningitis outbreak due to contamination at the NECC facility, there were at least two other incidents in 2011 involving contamination at compounding pharmacies. In August of 2011, contaminated Avanstin syringes causing serious eye infections were traced back to a compounding pharmacy that had repackaged the Avastin from vials to syringes. At least 12 patients were infected, and some lost the remaining vision in the eye being treated. Two months later, eye-surgery patients in seven states suffered a rare fungal eye infection that caused them vision loss as well. The infections were tied to injectable products made by a pharmacy in Ocala, FL.
According to the CDC, Apergillus and Exserohilum are two types of fungi that have been identified in specimens obtained from patients.
Meningitis is swelling of the protective membranes that cover the brain and spinal cord. Although virus or bacteria are more common causes, meningitis can also be caused by fungi and parasites. Fungal meningitis is not contagious, and the current outbreak is associated with a contaminated medication that was injected directly into the body.
According to the CDC, typical symptoms of meningitis can include headache, fever, nausea and neck stiffness. Those suffering from fungal meningitis may also present with confusion, dizziness, new weakness or numbness in any part of the body, increased pain, redness or swelling at the injection site, and discomfort from bright lights. Patients may only have a couple of these symptoms.
CDC-Confirmed Case Criteria:
1: A person with meningitis1 of sub-acute onset (1-4 weeks) following epidural injection after July 1, 2012.
2: A person, who has not received a lumbar puncture, with basilar stroke 1-4 weeks following epidural injection after July 1, 20122.
3. A person with evidence of spinal osteomyelitis or epidural abscess at the site of an epidural injection diagnosed 1-4 weeks after epidural injection after July 1, 2012.
1clinically diagnosed meningitis meaning 1 or more of the following symptoms: headache, fever, stiff neck, or photophobia and a CSF profile consistent with meningitis (elevated protein/low glucose/pleocytosis)
2These people, if possible, should have an LP.
(From CDC website)
Cases No Longer Limited to Fungal Meningitis:
As a result of the September 26th, 2012/October 6th, 2012 recall of contaminated preservative-free Methylprendisolone Acetate steroid injections and all other products from the New England Compounding Center (NECC), 44 individuals have died, over 700 are very sick, hundreds live in fear and 14,000 have been potentially exposed to a fungal nightmare.
Tragically, the contaminated injections subjected patients to the contraction of fungal meningitis and other related conditions, such as, epidural abscess, basilar stroke, joint infection on top of subjection to unneeded fear and anxiety.
We believe there are three kinds of meritorious scenarios resulting from exposure to tainted Methylprendisolone Acetate:
1. Diagnosed fungal meningitis or other exposure-related condition,
2. Symptoms mimicking meningitis or infection without confirmed diagnosis which require testing; or
3. Exposure to tainted steroids with no specific symptoms but fear and anxiety of developing symptoms and possible medical monitoring.
The CDC recommends symptomatic patients undergo a lumbar puncture (spinal tap) to look for evidence of meningitis. Unfortunately, the identification of fungal meningitis or other exposure-related conditions is not straightforward. A negative fungal result does not rule out infection.
Symptoms of fungal meningitis also include headache, fever, stiff neck, and photophobia.
Since the recall, the NECC pharmacy license has been surrendered. Subsequent investigation into the NECC, previously reprimanded for meningitis-linked steroid production in 2004, concludes the company negligently distributed the recalled lots of methylprednisolone in the following manners:
· Distributed the recalled lots prior to receiving results of sterility testing
· Failed to sterilize the product following proper standards for autoclaving
· Failed to properly test their autoclaves pursuant to USP 797
· Produced a product containing visible foreign substances from the recalled lot
· Failed to properly clean and maintain materials in the compound facility
· Failed to adequately train staff on cleaning and sterilization procedure
· Violated Federal and State law on proper compound procedure which requires an individual prescription for each compound medication. Instead, the NECC both manufactured and distributed in bulk compound steroid injections in violation of Federal and State law.
Since the recall, the NECC has filed for Bankruptcy. Recently, the bankruptcy court froze the assets of the four owners of NECC, estimating that the company paid out at least $70 million to company insiders in the last six years. Other potential defendants have been identified as well:
1. Affiliated entities of NECC
2. Individual owners of NECC
3. Individual employees of NECC and affiliated entities; and
4. Physicians and Clinics.
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Speak with a contaminated steroid injection attorney
If you have been notified that you received one of the potentially contaminated medications, it is vital to seek medical help right away. It is also important to speak with an attorney regarding your legal rights. At GoldenbergLaw, PLLC, we take your health seriously and we do not think it is acceptable to make patients pay for negligent compounding practices. If you would like to speak with someone about your potential contaminated steroid injection claim, please contact our office toll free at 1-877-544-1757.
GoldenbergLaw is currently handling contaminated steroid injection cases in Minnesota and throughout the nation. We have been litigating mass tort drugs and devices for over 29 years. We have the desire and the resources to successfully hold the responsible parties accountable.