UPDATE 5-US meningitis outbreak widens amid demands for criminal probe


* Death toll rises to 14; total sickened jumps to 169

* Officials say compounder may have violated state license

* U.S. senator calls for federal probe

* Minnesota woman sues pharmacy in federal court

(Adds Minnesota woman first apparent victim to sue company in4th paragraph)

By David Morgan and Tim McLaughlin

WASHINGTON/BOSTON, Oct 11 (Reuters) - The pharmacy at thecenter of a deadly U.S. meningitis outbreak possibly linked totainted steroid injections faced mounting federal and statescrutiny on Thursday, including a potential criminalinvestigation, as the national death toll climbed to 14.

As many as 14,000 people - 1,000 more than previouslythought - received injections from suspect shipments of steroidtreatments produced by the Framingham, Massachusetts-based NewEngland Compounding Center (NECC).

The outbreak has developed into a major health scandal withauthorities scrambling to determine how the steroid treatmentswere contaminated, track down those affected and treat them.

A woman in Minnesota on Thursday became the first apparentvictim 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 otherpersonal injuries" after being injected on Sept. 17.

Representatives of the company did not immediately respondto emails and phone calls seeking comment on the suit.

The scare raised questions about how the pharmaceuticalsindustry operates. NECC engaged in a little-known practicecalled drug compounding that is not regulated by the Food andDrug Administration, which generally oversees drug makers.

Massachusetts State Attorney General Martha Coakleyannounced an investigation of NECC's operations after statehealth officials said the company appeared to have violatedlicensing requirements that limited compounding activities tosingle prescriptions.

In compounding, pharmacies prepare specific doses ofapproved medications, based on guidance from a doctor, to meetan individual patient's need.

"We are absolutely engaged with federal and stateauthorities to determine what led to the distribution of theseunsafe drugs," said Coakley spokesman Brad Puffer. "Once we haveidentified the conduct and circumstances that led to thistragedy, we will identify any potential legal action."

A U.S. House of Representatives committee with oversight ofhealth issues including drug safety called on NECC's co-ownerand chief pharmacist to document its role in the crisis, while aSenate Democrat asked the U.S. Justice Department to conduct acriminal probe of possible fraud violations.

As the pressure grew, NECC and two sister companies-Ameridose LLC and Alaunus Pharmaceutical LLC - said they hiredattorney Paul Cirel from the Boston law firm Collora LLC, whichis known for its high-level criminal defense work.

Otherwise, NECC officials were not immediately available forcomment.


The Centers for Disease Control and Prevention said 169people who received epidural steroid injections for back andneck pain have now been infected with rare fungal meningitis, arise of 32 cases since Wednesday. One more patient had aninfection after an injection in the ankle.

Meningitis has not yet been confirmed in that case but itunderscored official concern that infections could begin risingamong those who received treatments for joint pain.

Meningitis is an infection of the membranes covering thebrain and spinal cord. Symptoms include headache, fever andnausea. Fungal meningitis, unlike viral and bacterialmeningitis, is not contagious.

Infections have been detected on average within two weeks ofa patient receiving the medication and as long as 42 daysafterward. Health authorities said more than 50 vials of thesteroid had so far been confirmed as contaminated with moretests under way.

Anyone exposed to the NECC-supplied vials of the steroidmethylprednisolone acetate should be vigilant for healthproblems for several months, CDC officials said. Local, stateand federal health authorities have contacted more than 90percent of the patients who may have been exposed.

Florida reported a second death from meningitis and Indianareported its first death from the outbreak, with cases confirmedin 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 briefits staff on the outbreak sometime before Oct. 18 and preserve"all documents and communications that may be relevant tounderstanding 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 herequested a federal criminal investigation in a letter to U.S.Attorney General Eric Holder.

"I've reached no conclusions but there are at leastsufficient facts to warrant an investigation," Blumenthal, aformer Connecticut state attorney general and federalprosecutor, said in a telephone interview.

"The company, its officers, employees and maybe others mayhave violated state and federal criminal laws in their potentialmisrepresentations to government agencies regarding theirproducts," he said.

The FDA can investigate a pharmacy once a risk to publichealth arises and it is now part of an investigation of NECC,which operated out of a brick complex next to a waste andrecycling operation in a western suburb of Boston. The companyhas suspended operations and recalled all of its products.

"We're continuing to investigate the facts and make sure wehave a thorough understanding of exactly what is happening andexactly what we were or were not told," said Deborah Autor, FDAdeputy commissioner for global regulatory operations and policy.

The related pharmacies are owned by Gregory Conigliaro, anengineer, and his brother-in-law Barry Cadden, the pharmacist incharge of pharmacy operations at NECC and the recipient of theHouse briefing request. The waste and recycling facility isanother 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 remainedthe hardest-hit state with 49 cases, the CDC said. Michiganadded 10 cases and was at 39 on Thursday, with Virginia addingthree 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.

(Additional reporting by Ros Krasny in Boston, Tim Ghianni inNashville; Writing by Michele Gershberg; Editing By Greg McCune,Cynthia Osterman and Bill Trott)

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