The pharmacy at the center of a deadly U.S. meningitis outbreak possibly linked to tainted steroid injections faced mounting federal and state scrutiny on Thursday, including a potential criminal investigation, as the national death toll climbed to 14.
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As many as 14,000 people - 1,000 more than previously thought - received injections from suspect shipments of steroid treatments produced by the Framingham, Massachusetts-based New England Compounding Center (NECC).
The outbreak has developed into a major health scandal with authorities scrambling to determine how the steroid treatments were contaminated, track down those affected and treat them.
A woman in Minnesota on Thursday became the first apparent victim of tainted steroid to sue NECC. The suit filed in U.S. District Court in Minnesota said Barbe Puro of Savage, Minnesota, suffered "bodily harm, emotional distress and other personal injuries" after being injected on September 17.
Representatives of the company did not immediately respond to emails and phone calls seeking comment on the suit.
The scare raised questions about how the pharmaceuticals industry operates. NECC engaged in a little-known practice called drug compounding that is not regulated by the Food and Drug Administration, which generally oversees drug makers.
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Massachusetts State Attorney General Martha Coakley announced an investigation of NECC's operations after state health officials said the company appeared to have violated licensing requirements that limited compounding activities to single prescriptions.
In compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient's need.
"We are absolutely engaged with federal and state authorities to determine what led to the distribution of these unsafe drugs," said Coakley spokesman Brad Puffer. "Once we have identified the conduct and circumstances that led to this tragedy, we will identify any potential legal action."
A U.S. House of Representatives committee with oversight of health issues including drug safety called on NECC's co-owner and chief pharmacist to document its role in the crisis, while a Senate Democrat asked the U.S. Justice Department to conduct a criminal probe of possible fraud violations.
As the pressure grew, NECC and two sister companies -Ameridose LLC and Alaunus Pharmaceutical LLC - said they hired attorney Paul Cirel from the Boston law firm Collora LLC, which is known for its high-level criminal defense work.
Otherwise, NECC officials were not immediately available for comment.
'NOT OUT OF THE WOODS'
The Centers for Disease Control and Prevention said 169 people who received epidural steroid injections for back and neck pain have now been infected with rare fungal meningitis, a rise of 32 cases since Wednesday. One more patient had an infection after an injection in the ankle.
Meningitis has not yet been confirmed in that case but it underscored official concern that infections could begin rising among those who received treatments for joint pain.
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis, unlike viral and bacterial meningitis, is not contagious.
Infections have been detected on average within two weeks of a patient receiving the medication and as long as 42 days afterward. Health authorities said more than 50 vials of the steroid had so far been confirmed as contaminated with more tests under way.
Anyone exposed to the NECC-supplied vials of the steroid methylprednisolone acetate should be vigilant for health problems for several months, CDC officials said. Local, state and federal health authorities have contacted more than 90 percent of the patients who may have been exposed.
Florida reported a second death from meningitis and Indiana reported its first death from the outbreak, with cases confirmed in 11 states.
"We are not out of the woods yet," said Dr. Todd Weber, manager of the CDC's response to the outbreak.
The House Energy and Commerce Committee asked NECC to brief its staff on the outbreak sometime before October 18 and preserve "all documents and communications that may be relevant to understanding how the product was contaminated and distributed, as well as business practices of the NECC in general."
Richard Blumenthal, who sits on the Senate's Health, Education, Labor and Pensions Committee, said on Thursday he requested a federal criminal investigation in a letter to U.S. Attorney General Eric Holder.
"I've reached no conclusions but there are at least sufficient facts to warrant an investigation," Blumenthal, a former Connecticut state attorney general and federal prosecutor, said in a telephone interview.
"The company, its officers, employees and maybe others may have violated state and federal criminal laws in their potential misrepresentations to government agencies regarding their products," he said.
The FDA can investigate a pharmacy once a risk to public health arises and it is now part of an investigation of NECC, which operated out of a brick complex next to a waste and recycling operation in a western suburb of Boston. The company has suspended operations and recalled all of its products.
"We're continuing to investigate the facts and make sure we have a thorough understanding of exactly what is happening and exactly what we were or were not told," said Deborah Autor, FDA deputy commissioner for global regulatory operations and policy.
The related pharmacies are owned by Gregory Conigliaro, an engineer, and his brother-in-law Barry Cadden, the pharmacist in charge of pharmacy operations at NECC and the recipient of the House briefing request. The waste and recycling facility is another of Conigliaro's business interests.
In six states - Tennessee, Michigan, Maryland, Virginia, Florida and now Indiana - the outbreak has claimed lives.
Five new cases were reported in Tennessee, which remained the hardest-hit state with 49 cases, the CDC said. Michigan added 10 cases and was at 39 on Thursday, with Virginia adding three to reach 30 and Indiana six to reach 21, the CDC said.
The other states reporting cases are Maryland (13), Florida (7), Ohio (3), Minnesota (3), New Jersey (2), North Carolina (2) and Idaho (1), the CDC said.