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As Meningitis Deaths Rise, Many Question the Lack of Regulation

Oct 10, 2012

As the fungal meningitis outbreak continues to widen daily, federal lawmakers have finally begun to discuss potential increased regulations on the companies that manufacture the contaminated drug responsible for the current situation.

Reuters reports that, as of early Wednesday, a total of 12 people have died and at least 124 people have fallen seriously ill with fungal meningitis after they received a contaminated epidural steroid injection. The latest victim of the outbreak to die as a result of the infection is a 70-year-old man from Florida.

The toll in this outbreak has been rapidly increasing in the last week and previous reports indicate that as many as 13,000 people received a potentially contaminated injection of methylprednisolone acetate. The injection contains more than one drug ingredient and was compounded for distribution to pain management centers and other health care facilities at New England Compounding Center in Framingham, Mass.

Methylprednisolone acetate is commonly prescribed to patients suffering from back pain and inflammation. And while the drugs that are eventually compounded fall under the regulatory umbrella of the Food and Drug Administration as any other prescription and over-the-counter drug would be, the compounding centers like NECC are not subject to those same regulations.

Instead, compounding centers like NECC are only beholden to state regulations where the business is established. Some states do not allow compounded drugs to be dispensed there but NECC did distribute the suspect methylprednisolone acetate injection vials to at least 30 states. Victims of the fungal meningitis outbreak have been identified so far in 10 of those states but health officials indicate they expect the number of diagnoses to increase in the new few weeks. Symptoms of fungal meningitis could take up to a month to develop.

Reuters reports that officials with the FDA and CDC have been contacted by lawmakers on Capitol Hill to discuss potentially increasing regulatory oversight on companies like NECC. Unless the FDA’s system of plucking contaminated drugs or drug ingredients failed before those that make up the methylprednisolone acetate injection reached the compounding center, the outbreak is likely the fault of NECC.

House and Senate leaders from both sides of the aisle have requested briefings from the FDA and any other health officials with information on the outbreak. Reuters indicates these meetings should take place by the end of the week.

This specific drug compounding center received FDA warning about six years ago after it was determined a topical anesthetic cream it was producing was responsible for causing serious and some life-threatening side effects.

In Tennessee, health officials estimate the infection rate is about 1 in every 20 patients. It is there that most cases of fungal meningitis have been reported, with at least 40 illnesses and 6 deaths attributed to the contaminated injection.

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