By Heather Mullinix
The Tennessee Department of Health reports 82 patients in the state were sickened by contaminated epidural steroid injections from the New England Compounding Center. Of those cases, 13 have resulted in death of the patient.
A Cumberland County woman and her husband have filed a lawsuit in Cumberland County Circuit Court against the compounding pharmacy, based in Massachusetts, as well as related corporations and the principals of those corporation.
"Based on the investigation we have done, it appears the principals involved developed a scheme and corporate structure to evade FDA regulation," said Crossville attorney Jimmy P. Smith, who represents Marjorie Helen Lewis and her husband, Ronald, in the court action. "They disguised themselves as a compounding facility rather than a drug manufacturer. We feel like the corporate veils need to be lifted and the individuals responsible should pay out of their own pockets rather than bankrupting these companies."
The lawsuit, filed Nov. 8, names New England Compounding Pharmacy, Inc., doing business as New England Compounding Center, as a defendant along with Ameridose, LLC and Medical Sales Management, Inc. Individuals named in the suite are Barry J. Cadden, a principal owner, officer, manager, director and pharmacist of record for NECC and Ameridose; Gregory A. Conigliaro, principal owner and manager of NECC and Ameridose; Dr. Douglas A. Conigliaro, principal owner, president and manager of Medical Sales Managment, Inc.; Lisa Conigliaro Cadden, owner and director of and serves as a pharmacist for NECC and Ameridose; Carla R. Conigliaro, owner and director of NECC and Ameridose; and Glen A. Chin, chief pharmacist of NECC.
According to the suit, Marjorie Lewis received lumbar epidural injections of methylprednisolone acetate produced by NECC at Specialty Surgery Center of Crossville for treatment of back pain on Aug. 2 and Sept. 13 of 2012. Those injections were contaminated with a fungus that sparked a national fungal meningitis outbreak. According to the Centers for Disease Control, as of Nov. 20, there had been 478 cases of fungal meningitis, stroke due to presumed fungal meningitis or other central nervous system-related infections related to the case, and 34 deaths. There are also 12 peripheral joint infections affecting knees, hips, shoulders or elbows.
The CDC has confirmed contamination with Exserohilum rostratum in 84 laboratory-confirmed cases and one confirmed infection of Aspergillus fumigatus. The CDC notes these are fungi common in the environment and infections are not transmitted from person to person.
The CDC and the Food and Drug Administration have also confirmed the presence of Exserohilum rostratum in unopened vials of two of the three lots of medication suspected.
It's estimated as many as 14,000 patients were exposed to the injections, and so far 97 percent have been contacted for follow-up, but the onset of symptoms varies from patient to patient, and the CDC warns patients and physicians need to continue to watch for symptoms for at least several months following the injection.
Since the outbreak, NECC voluntarily recalled all products compounded at and distributed from its facility in Framingham, MA. A few weeks later, Ameridose, LLC, in Westborough, MA, voluntarily recalled all unexpired products in circulation.
A compounding pharmacy fills a unique niche in the health care industry, mixing hard-to-get medications from raw ingredients according to individualized patient prescriptions. However, the suit states that's not what happened in this case, with the defendants designing and manufacturing the product and delivering it in bulk without personalized patient prescriptions, in violation of federal law, FDA regulations and the laws of both Tennessee and Massachusetts.
"Rather than filling individualized patient prescriptions, as a true compounding pharmacy is permitted to do, the defendant, NECC, with the cooperation and support of the other defendants in this cause, designed and manufactured the product known as methylprednisolone acetate as an injectable steroid and marketed and delivered the drug in bulk throughout the United States including the state of Tennessee and to the Speciality Surgery Center in Crossville," the suit states.
Smith said his client spent about a week in the hospital receiving treatment for the fungal infection and will continue to need medical treatment due to the exposure. There is also the possibility of future medical complications arising from the treatment. The suit states Marjorie Lewis has incurred losses through medical expenses, lost earnings and loss of earning capacity and suffered diminished capacity for the enjoyment of life. Her husband, Ronald, states he has suffered mental distress, anxiety and anguish through the illness of his wife.
"The treatment to kill the fungus is very painful for patients," Smith said. "It's also hard on the kidneys so there's the potential for long-term renal damage. It's an awful thing to go through."
The suit seeks $2.5 million in compensatory damages and an additional $2.5 million in punitive damages for Marjorie Lewis while Ronald Lewis seeks $500,000 in compensatory damagers and an additional $500,000 in punitive damages.
The suit also asks for a trial by jury in the case.
The Cumberland County suit is one of numerous suits filed against NECC across the country. According to a report in The Roanoke Times in Virginia, attorneys for NECC have filed motions seeking all meningitis-related lawsuits in Virginia and other states be consolidated and heard by a single federal judge under multidistrict litigation. That's not the same as a class action lawsuit, Smith explained, but merely takes all the similar court actions and transfers them to one place. However, he would like to see this case stay in Cumberland County.
"So many people were hurt here, from patients who were made ill by the injections to the Specialty Surgery Center that wasn't injured but certainly harmed by the incident and all the other people who have been scared to death because they got bad medicine," Smith said. "That shouldn't happen."