Outbreak Victims Still Face Roadblocks to Aid

By Walter F. Roche Jr.

Martha Schulz, a 77 year-old Columbia resident, was injected three times with a steroid produced by a now defunct Massachusetts compounding firm. Not long after the last shot she became ill and suffered a stroke and several other ailments.
That was the same fate suffered by dozens of other Tennessee victims who were injected with tainted drugs from the then little known drug firm.
Like others sickened by drugs produced at the New England Compounding Center, she and her husband applied for funds set up in the NECC bankruptcy. They applied and were qualified. They also qualified and received payment from a separate fund set up for Tennessee victims of the outbreak.
So when they learned that $40 million had been allocated by the U.S. Justice Department to a separate fund to provide assistance to NECC victims they submitted an application to the Massachusetts Attorney General's office, the agency designated as the administrator of the Crime Victims Compensation Fund.
Under the program victims of NECC can collect up to $25,000 to reimburse them for out of pocket and other expenses incurred as a result of the injections. Survivors of victims who died can collect even more.
But the Schulz family was in for a surprise. Their claim was rejected not because the cause of her illness was disputed but because she became ill too soon.
Massachusetts officials contend they can only make awards to victims who were injected with methylprednisolone acetate in three specific lots of the drug produced by NECC between May 1, 2012 and Oct. 15, 2012.
Records show Martha Stuart was injected from an NECC lot shipped to the Saint Thomas Outpatient Neurosurgical Center on June 16 of 2011.
A physician who examined her after she suffered a stroke in August of 2011 signed a statement concluding that in his medical opinion "it was more likely than not" that her illnesses "occurred as a direct result of bacterial contaminated methylprednisolone acetate manufactured by the New England Compounding Center."
Terri Lewis, a Tennessee resident and patient advocate, is not an outbreak victim, but has helped dozens of victims who have run into a variety of roadblocks in getting assistance. She says the Schulz family is but the latest example of victims being denied assistance on a technicality.
Lewis said that despite loud and repeated protests the U.S. Centers for Disease Control and Prevention (CDC) limited the class of victims to those injected with the three 2012 lots.
She said this was so even though all unused NECC drugs were eventually ordered recalled, including some produced in 2011.
"The exposure was in my estimation completely and inappropriately delimited," Lewis wrote in an email response to questions," adding that the arbitrary boundary omitted victims sickened by other NECC products contaminated by bacteria and fungus.
In fact in criminal cases stemming from the outbreak federal investigators have testified about several other contaminants found in other NECC products. And NECC owners have been charged with conducting a criminal enterprise dating back to at least 2008.
Two of the 14 originally indicted already have been convicted on the racketeering charges and are serving jail terms. Six more are now on trial in U.S. District Court in Boston.
Schulz noted that the Tennessee Health Department issued a notice of recall for any NECC products issued from May of 2011 till the company's Oct.3, 2012 shutdown.
Stuart Schulz said a bacteria found at NECC's production facility in Framingham, Mass. was related to the same bacteria that infected Martha's heart, damaging her heart valves and leading to the stroke.
"Many more organisms of illness were producing sick people who were never included in the recall class," Lewis said.
Stuart Schulz said his wife has never fully recovered from the illnesses brought on by the 2011 injections,
"My wife has dementia now, hastened by the stroke, and cannot recall what has happened. I'm trying to cover all of her bases that are out there for her and this "Victims Fund" is one of them," he said.