medical malpractice lawyer in baltimore

Fungal Meningitis Lawsuits: Facts about NECC New England Compounding Center

If you are suffering from fungal meningitis from a steroid injection, call our office to seek compensation from the drug maker NECC – (410) 694-7291.

Call the office at (410) 694-7291 to speak with attorney G. Randolph Rice, Jr., for immediate help if you have been diagnosed with fungal meningitis and received a steroid injection.

Updated Fungal Infection Case: October 16, 2012

October 16, 2012 update on the number of cases nationwide:
Patients affected by the fungal steroid injections: 233
Patients killed by a contaminated fungal steroid injection: 15
Maryland patients affected by the contaminated fungal steroid injections: 16
Maryland patients killed by a contaminated fungal steroid injection: 1
The CDC should be releasing updated numbers at 2:00 p.m. on October 17, 2012.

What can you do if infected by a steroid injection?

Contact the fungal infection steroid lawyers at the Law Offices of G. Randolph Rice, Jr., LLC, at (410) 694-7291.  Let our medical malpractice and defective product attorneys fight the drug maker, New England Compounding Center (NECC), and make sure you receive the compensation for medical bill, lost wages, and pain and suffering.

What did New England Compounding Center (NECC) do wrong?

New England Compounding Center is believed to have sold defective and dangerous steroids that were contaminated.  Figures place the number of infected steroid injections shipped by NECC to be almost 14,000.

What is fungal meningitis?

Fungal meningitis is a spread of fungus to the spinal cord.  It is very rare and is not contagious.

What are signs and symptoms that you may have fungal meningitis?

Some signs that you may be affected by fungal meningitis can be:

  • Fever;
  • Headache:
  • Stiff neck;
  • Nausea and vomiting;
  • Sensitivity to light;
  • Altered Mental state.

What should you do if you have any of the symptom of fungal meningitis?

Contact your primary health care provider as soon as possible and schedule a review.  The doctors will collect a sample of blood and test that sample to determine if you are suffering from fungal meningitis.

What is the name of the steroid that was shipped by NECC believed to be infected?

Injectable steroid methylprednisolone acetate.

How was this fungal infection outbreak discovered?

In October of 2012, the FDA and their investigators located fungal contaminated steroids in a sealed vial at NECC’s facility.

What did NECC do is response to the discovery of the infected steroid injections?

NECC immediately recalled 17,676 single-dose vials of the steroid.

Which facilities in Maryland received infected steroid injections?

Important Recourses for Patients that received a possibly infected steroid injection in Maryland

Multi state Fugal Meningitis Outbreak Facilities Shipped Steroids
CDC Main Page for Fungal Outbreak Investigation
Contact the Law Offices of G. Randolph Rice, Jr., LLC, at (410) 694-7291 to learn more on how to file a claim in Maryland for a steroid injection resulting in fungal meningitis.

Law Offices of G. Randolph Rice, Jr., LLC
6914 Holabird Avenue, Suite A
Baltimore, Maryland 21222

Maryland Medical Malpractice and Defective Prodcut attorneys at the Law Offices of G. Randolph Rice, Jr., LLC, maintain all information in a confidential manner and there is no fee if no recovery.

What did NECC offer to medical providers?

Medications that are:

  • No Longer Manufactured
  • Persistently Backordered, because of Production Shortages
  • Not Commercially Available in the Dosage Form the Patient Needs (e.g., preservative-free)

What type of Interventional Pain Management medications did NECC offer?

Steroids (Preservative-Free): Methylprednisolone Acetate, Triamcinolone Acetonide, Betamethasone Repository, Betamethasone Sodium Phosphate “Particulate-Free”, Dexamethasone Sodium Phosphate “Particulate-Free”
Intrathecal Pump Refills: Baclofen, Morphine, Hydromorphone, Clonidine, Bupivacaine, Fentanyl, Sufentanil, Meperidine Custom Combinations
Neurolytic Agent: Phenol 6-10% / Glycerol
“Racz” Procedure: “Hypertonic” Saline 10%, Hyaluronidase 1500u

How did NECC claim their medications were formulated?

  • USP 797 Compliant
  • All CSPs are compounded for your patients by pharmacists and technicians extensively trained in aseptic compounding
  • Medications are prepared in a Class 10 Microenvironment (barrier isolator)
  • Medications are comprised of USP quality ingredients

How did NECC claim they prepared the medications they sold?

What is Compounding

Because every patient is different and has different needs, customized medications are a vital part of quality medical care.

Compounding: Defined

Compounding is the art and science of combining, mixing, or altering pure, active ingredients to create customized medications for an individual patient in response to a licensed practitioner’s prescription.

Compounding: the Need

The basis of the profession of pharmacy has always been the “Triad,” the patient-physician-pharmacist relationship. Through this relationship, patient needs are determined and decisions are made about treatment regimens that may include a compounded medication, including but not limited to:

Medications that are Not Commercially Available

Manufacturers have limited product lines due to a variety of economic and chemical restrictions. Therefore, there are limited chemical forms, dosage forms, strengths, flavors and packaging that are available for the physician to prescribe and the pharmacist to dispense. A compounding pharmacy allows the physician to prescribe a custom-tailored medication that is not available commercially.

Medications that are Not Stable

Some pharmaceutical preparations have a limited shelf-life due to chemical instabilities and therefore can’t be mass-produced by pharmaceutical manufacturers. These “short-shelf life” formulations can be compounded by pharmacists who have the ability to produce smaller lots more frequently ensuring stability for the intended patients. Physicians who utilize the services of a compounding pharmacy can prescribe the most appropriate medications for their patients.

Altered Commercially Available Medications

A patient may be allergic to a preservative or dye in a manufactured product. Some patients have difficulty swallowing a capsule and require a troche or lozenge. Many pediatric patients are non-compliant because their medications are bitter, but become compliant when the medication is flavored to their liking. All of these problems can be addressed by a compounding pharmacy.

Compounding pharmacists can prepare dye-free or preservative-free dosage form and change the look and taste of a dosage form. This allows physicians to prescribe a commercially available medication in a different dosage form to meet a specific patient need and ensure patient compliance.”

How did NECC describe their facility?

NECC Pharmacy Facility:

  • Was designed and constructed as a “compounding-only” lab to provide an ideal environment for our staff to produce only the highest quality compounded medications.
  • Is USP Chapter 797/795 compliant.
  • Utilizes only state of the art compounding equipment.
  • Contains Class-10 barrier isolators within a Class-1000 clean room.

NECC Highly Trained Pharmacists:

  • Are licensed and regulated by the Massachusetts Board of Registration in Pharmacy.
  • Have completed American Council on Pharmaceutical Education-accredited aseptic training courses.
  • Follow national standards of practice for sterile product preparation as set forth by professional associations such as the American Society of Health-System Pharmacists (ASHP) and the United States Pharmacopeia (USP).
  • Are members of the International Academy of Compounding Pharmacists (IACP) and the Massachusetts Pharmacists Association (MPhA).

NECC Quality Control System Overview:

  • Chemicals are obtained only from FDA registered chemical distributors.
  • Samples from final product batch lots are sent to an independent FDA registered analytical lab for sterility, endotoxin (pyrogen) testing, quantitative analysis (potency) and extended stability testing.
  • Tested medications are quarantined and dispensed only after the sample has tested negative for endotoxin and microbial contamination.
  • The Quality Assurance Team (QAT), made up of employees from all departments within NECC, meets regularly to review all quality related items.
  • All aseptic compounding actions are performed in compliance with NECC’s Standard Operating Procedures (SOPs). These SOPs have been “mapped” against USP 797 “Pharmaceutical Compounding – sterile preparations” to ensure that all USP 797 requirements are observed.”

What types of medications did NECC provide for Ophthalmology and Retina Surgeons?

“Pre-Cataract” Dilation Drops (Preservative-Free): (T) Tropicamide,
(C) Cyclopentolate,
(PE) Phenylephrine,
(K) Ketorolac
#1) T -C-PE 1%-1%-2.5%
#2) T -C-PE 1%-1%-10%
#3) T -C-PE-K 1%-1%-2.5%-0.5%
#4) T -C-PE-K 1%-1%-10%-0.5%
Avastin-“Unit-dose Syringe”: 1.25mg-0.05ml
light-resistant mylar bag
Triamcinolone Acetonide: 40mg/ml (PF), 1ml vial
Frozen/Unit-Dose Antibiotics: Vancomycin 10mg/ml, 1ml vial
Ceftazidime 22.5mg/ml, 1ml vial

What types of medications did NECC provide for Aesthetics?

Mesotherapy/ Lipolysis: Phosphatidylcholine, PPC-Premix, Collagenase, L-Carnitine, Hyaluronidase
Chemical Peels: Glycolic Acid, Salicylic Acid, Trichloracetic Acid, Lactic Acid, Jessner’s Solution, TCA/SA, Retinoic Acid Solution
Triple Anesthetic Cream: 20%-6%-4% (30g or 60g), 20%-8%-8%
Bleaching Creams: Hydroquinone, Retinoic Acid, Kojic Acid
Sclerotherapy: Hypertonic Saline, Glycerin, Dextose/Sodium Chloride

Was NECC Licensed?

NECC is licensed and may legally dispense prescription medications in all 50 states”

Where is NECC located?

NECC (New England Compounding Center)
697 Waverly Street
Framingham, MA 01702

What Speciality Medications did NECC provide for hospitals?

Pain Management: P/F Steroids, Intrathecal Pump Refills, Phenol Inj. / Ethanol Inj., Hypertonic Saline
Radiology/ Nuclear Medicine: Talc (sterile), Sulphan Blue
Surgery: Irrigation Solutions (provided individually and in combinations of Bacitracin, Polymyxin & Neomycin)
Ophthalmology: “Pre-Cataract” Dilation Drop Combos, Avastin™ (Unit Dose)
Emergency: LET Gel/Solution
Miscellaneous: Alum Irrigation Solution, Methacholine Kits, Glutaraldehyde, Hydroxyprogesterone Caproate 250mg/ml inj. (10ml or 1ml)

What should I do if I have be diagnosed with fungal meningitis in Maryland?

Contact us as soon as possible to begin the legal claim process and ensure you protect your legal rights.  We here to help and manage the legal process so you can concentrate on healing.  Contact the office at (410) 694-7291 for immediate help.