Fatal Meningitis Outbreak--Lax Regulatory Rules Responsible?

October 9, 2012 by Mark Siesel

Pain Management has become a major growth industry in this country, with wide spread addiction to Oxycodone and Hydrocodone a large part of the problem. For many of our clients who are injured in automobile accidents, construction accidents or trip and fall accidents, when the pain becomes intractable and surgery is not necessarily an option, it is now a common practice for the clients to undergo lumbar or cervical epidural steroid injections. For example, in 2011, approximately 2.5 million Medicare recipients and a similar amount of younger patients received the injections.

Spinal injections for back or neck pain is now under significant scrutiny as the result of a meningitis outbreak which has spread across the United States. The drug which is responsible for the meningitis outbreak is known as mehtylprednisolone acetate, which was apparently made by a company called New England Compounding Center (NECC) in Framingham, Massachusetts. According to an article by Denise Grady, Andrew Pollack and Sabrina Tavernise in the New York Times on October 9, 2012, the company sold 17,676 vials of the mehtylprednisolone acetate to 75 pain clinics in 23 states across the United States. The New York Times has reported that compounding centers are used by doctors and hospitals to obtain certain medications for two major reasons. First, when medications are in short supply, compounding centers such as NECC are a potential alternative, and second, the prices for the drugs from the compounding centers are often much lower than if the hospitals had to purchase the medications from a pharmaceutical company.

So far, there are 7 reported fatalities, 57 people who have become ill from the tainted medications, and potentially thousands more who could be endangered. It appears that the medication was contaminated with a fungus, which is the worst of three possible ways to contract meningitis, the others being through a virus or bacteria. Doctors note that the fungal meningitis is hardest to treat and leads to strokes. The only means to determine if the person is suffering from meningitis is to perform a spinal tap. If the spinal fluid is cloudy, it is likely that the person has the fungal infection.

The New York Times article discussed the tragic case of Eddie C. Lovelace, a judge in Kentucky who was still on the bench in his late seventies. Judge Lovelace was suffering from severe neck pain from a car crash. He underwent spinal injections for pain relief, and within several months, he was dead at the age of 78. Doctors and hospitals frequently do not have any idea where the medication they are prescribing and requesting comes from. Dr. Anders Cohen, the chief of neurosurgery at Brooklyn Hospital Center, notes: “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 a wakeup call about where your stuff is coming from.”

Compounding centers are able to provide the medications less expensively since they are not subject to the federal oversight of the Food and Drug Administration, (FDA), which requires stringent testing before a drug offered by a pharmaceutical company can be approved for public use. The approval process takes several years and costs the drug companies several million dollars. New England Compounding charged $25.00 for a vial of five 80 milligram doses, whereas a similar vial of Depo-Medrol, manufactured by Pfizer, costs in the range of $40-$46.00. Compounders are able to register as pharmacies, placing them under the review of state agencies and regulations, not the federal government. The F.D.A. reports that problems with products be reported to the agency, whereas there is no equivalent procedure under state laws, allowing compounding centers like NECC to flourish.

Ironically, The New England Compounding Center had significant problems in the past, with several complaints lodged against the company over the past decade. The Massachusetts State Health Dept. inspected the company in 2006, and as a result, the letter sent a letter to the company accusing them of among other things, illegal production of an anesthetic topical cream and allowing a doctor’s office to order products without prescriptions for patients. It is also tragic to note that there is a significant question as to whether the injections are even effective, so that many patients risked their health or their lives for a questionable treatment to alleviate their suffering.

As a precaution, the F.D.A. is advising health care professionals and consumers not to use any product manufactured by the NECC until further notice.

If you or a loved one suffer serious injuries due to a dangerous or defective product or medication, or due to medical malpractice, you must have aggressive lawyers representing you who have the experience, skill and knowledge to obtain full compensation for your past and future pain and suffering, loss of earnings and future earning potential, past and future medical and hospital expenses, and loss of enjoyment of life. Contact the Westchester County Personal Injury Attorneys at the White Plains, New York Law Office of Mark A. Siesel, as we are dedicated to obtaining the maximum possible compensation for our clients. Call us toll free at 888-761-7633 or contact us online for your free consultation today.