Reports about the fungal meningitis outbreak traced to the New England Compounding Center (NECC) of Framingham, Massachusetts, rightly focus on contaminated steroid injections found at the NECC’s plant and a recall of more than 17,600 single-dose vials of the steroid methylprednisolone acetate.
But as the scope of the outbreak became clear – jumping from 64 cases and seven deaths on October 6 to 169 fungal meningitis cases and 14 deaths as of October 12 – the NECC recalled everything it had manufactured since the start of the year.
The list of medical products recalled as part of the fungal meningitis outbreak runs more than 50 pages and list hundreds of drugs, from acetaminophen suppositories to repackaged Zymaxid ophthalmic solution.
The list includes many drugs packaged in different dosages and combinations. For example, the muscle relaxer baclofen, is listed in 29 dosages alone, and when combined with the local anesthetic bupivacaine, was distributed in about 30 more dosages. Bacoflin was also combined with clonidine, a drug that relaxes blood vessels and decreases the heart rate, in 14 other iterations.
A very small sampling from the list of recalled NECC products includes:
- Benzocaine, lidocaine and tetracaine combined as creams (topical pain relievers) and separately as injections and other solutions.
- Cardioplegia solutions, used during heart surgery to protect the stilled heart from damage.
- Dextromethorphan, known as DXM or DM, an antitussive (cough suppressant) drug.
- Gentamicin injections, eye drops and IV solutions used to treat bacterial infections.
- Morphine, a powerful narcotic pain reliever.
- Salicylic acid, which is used to treat skin conditions such as acne and psoriasis.
- Saline solutions, which have a variety of uses, such as irrigating wounds or, through IV lines, hydrating patients.
- Sodium bicarbonates, antacids used to relieve heartburn and acid indigestion.
- Trichloroacetic acid (TCA), which is used to treat genital warts and human papillomavirus (HPV).
- Vitamin K, which is administered to promote blood clotting, often in newborn babies.
While there is no evidence that any of these additional medical products from the New England Compounding Center are contaminated or unsafe in any way, the problems found in the investigation of the NECC for its tainted steroid shots are troubling.
The FDA reported that it had seized a sealed vial of the steroid injection that contained levels of fungus visible to the naked eye. Reacting to that report, Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn., said, “The breaches in good manufacturing practice and infection control must have been substantial in order for something like that to occur.”
In addition to the recall of all NECC products, the FDA has advised physicians to not use any products distributed by the plant.
Contaminated or otherwise faulty pharmaceutical products can cause injury and death in unsuspecting patients. The makers and distributors of such drugs carry a liability for the harm that they do. The drug injury attorneys of Salvi, Schostok & Pritchard work with accredited medical experts to determine whether pharmacological and healthcare standards have been met when our clients have been injured, and pursue damages where they are warranted.
Contact Salvi, Schostok & Pritchard P.C.
The Chicago drug injury lawyers at Salvi, Schostok & Pritchard P.C. investigate legal claims on behalf of individuals who have been injured because of defective drugs. If you or a loved one has been harmed by a contaminated steroid shot or another prescribed drug, or medical product administered in a health care facility, call us at 888-617-8526 or use our online contact form to set up a free, initial consultation to discuss your legal rights.