ELPO files suit for 34 plaintiffs in KY, TN in meningitis cases

by Mandy Hicks

Three separate lawsuits representing 34 victims in Kentucky and Tennessee were filed today in U.S. District Court, Middle District of Tennessee, against the manufacturers, distributors and prescribers of epidural steroid injections tainted with fungus that can cause meningitis.

All of the patients were originally seen at Howell Allen, a medical practice in Nashville. The patients were prescribed an epidural steroid injection to treat back-related issues. The shots were manufactured by New England Compounding Co., which has since filed bankruptcy.

Four of the patients represented by ELPO attorneys Bob Young and Kyle Roby have been diagnosed with fungal meningitis and receive ongoing treatment for it. There is no cure for it, however. Others have not been diagnosed, but could develop fungal meningitis at any point in their lives. Fungal meningitis can sit dormant in the body for years and once it comes to life, it can be deadly.

“The patients involved in this case will spend the rest of their lives wondering if they will be affected by this terrible infection,” Young says. “They went to see a doctor for debilitating back pain, and now are facing this huge, life-altering uncertainty, due to utterly lax and incompetent care.”

The lawsuit alleges that the lapses began at NECC, which manufactured the injections in a non-sterile environment. The company that was hired to test the injections before they were shipped failed to do so adequately. The Nashville physician who ordered the injections for patients signed off on ordering the injections in batches of 500 to save money, even though federal law prohibits this practice unless the compounder is specifically licensed to do so. The clinic used past patient lists, sometimes with added fake names that included such names as Mickey Mouse, to order the injections. When the injections arrived at the clinic, they were stored at room temperature, violating the standard of care that called for refrigerated storage.

Clinic officials were told on Sept. 19, 2012, that the injections were tainted, but still administered the injections on Sept. 20, 2012.

Those being sued include:

–         Ameridose LLC and its affiliates, which are related companies to the bankrupt NECC, which sold the tainted injections;

–         Analytical Research Laboraties, which was hired to test the injections before they were shipped to doctors and hospitals;

–         Howell Allen Clinic in Nashville, which prescribed the injections;

–         St. Thomas Outpatient Neurosurgical Center, LLC, in Nashville, which administered the injections;

–         St. Thomas Network and St. Thomas West Hospital, formerly known as St. Thomas Hospital and St. Thomas Health, which co-own the St. Thomas Outpatient Center with Howell Allen;

–         Dr. John Culclasure and Debra Schamberg, R.N., who ordered the injections in batches, which was a violation of federal law, which requires that the injections be ordered one at a time for each patient.

Nationally, there have been 70 deaths from the tainted steroid injections.

A PDF of the lawsuit is posted here: U.S. District Court lawsuit KY plaintiffs Sept 2013