* Lawsuit seeks to freeze owners' personal assets
* NECC owners spent millions on luxury homes
* Meningitis death toll hits 21; 268 cases in 16 states
(Adds statement from Massachusetts Dept of Public Health)
BOSTON/NEW YORK, Oct 19 (Reuters) - Executives at the
Boston-area pharmacy whose steroid shots have been linked to a
deadly U.S. meningitis outbreak have been sued in a bid to
freeze their personal assets, while the death toll in the
scandal rose to 21, with 268 cases of infection reported.
Peter McGrath, a lawyer who is a former federal prosecutor,
said he was spearheading a civil case that blames
Massachusetts-based NECC and company officers Barry and Lisa
Cadden and Greg Conigliaro for the tainted drugs. The lawsuit
was filed on behalf of an unnamed plaintiff in Middlesex County
Superior Court in suburban Boston, court records show.
"We want to pierce the corporate veil and go after the
individuals," McGrath said Friday in a telephone interview.
Fourteen new cases of fungal meningitis in patients who
received the contaminated shots for back pain were reported on
Friday, bringing the total to 268, and the death toll rose by
one to 21, the U.S. Centers for Disease Control and Prevention
said.
There were four new cases reported in both Michigan and
Florida, one each in Indiana, Ohio and Virginia, and three in
Tennessee, which has been the hardest hit of the 16 states with
confirmed cases. The latest death was in Michigan, its fifth.
There have also been three cases of peripheral infections
from injections into joints.
Florida Surgeon General John Armstrong said NECC would no
longer be allowed to do business in the state.
"The company will cease to operate as a pharmacy in our
state, immediately," Armstrong said. "Further, the NECC may
never re-apply for a pharmacy permit in the state of Florida."
U.S. health regulators confirmed on Thursday the presence of
the deadly Exserohilum fungus in vials of the NECC steroid used
for the pain injections. They estimate that as many as 14,000
people may have been exposed to the contaminated medication.
Three potentially contaminated lots of the drug,
methylprednisolone, were shipped to 76 facilities in 23 states.
After confirming contamination in one of the three lots, the
U.S. Food and Drug Administration and the CDC said they were
checking the other two lots for the fungus, as well as
additional injectable NECC drugs as a precautionary measure.
A Tennessee clinic that received more potentially
contaminated steroid than any facility in the nation has
temporarily closed to cope with the fallout from the outbreak.
The Nashville clinic received 2,000 vials of the NECC drug.
Federal authorities are investigating how NECC supplied
hospitals, clinics and other healthcare providers with large
orders of compounded drugs and whether it violated state laws
regulating pharmacies.
The FDA and CDC said that about 97 percent of potentially
exposed patients have been contacted so far. The agencies
cautioned doctors and patients to be on the lookout for
potential meningitis symptoms for months after injections.
According to a paper published online on Thursday in the
Annals of Internal Medicine, based on a 2002 outbreak of fungal
meningitis linked to contaminated steroids, the incubation
period from exposure could be up to six months.
Doctors have warned that early diagnosis and treatment with
a powerful antifungal drug is vital to prevent meningitis from
attacking the brain.
LUXURY HOMES
In the lawsuit filed in Massachusetts, the plaintiff
identified as "John Doe" is seeking a court order on Nov. 6 to
freeze the assets of NECC and the named officers. Such a
"prejudgment remedy" is allowed in Massachusetts state courts
during pending litigation.
"My clients are in a lot of pain," said McGrath, whose New
Hampshire-based firm is representing several people affected by
the meningitis outbreak. NECC's public relations firm did not
return a call seeking comment.
Members of the Boston-area family who own the pharmacy and
related companies spent several million dollars on luxury homes
in the months before U.S. authorities shut down their
operations. Greg Conigliaro is a recycling entrepreneur who
joined forces with his pharmacist brother-in-law, Barry Cadden,
and other family members to start NECC in 1998. His sister Lisa
is also a pharmacist and is married to Cadden.
The real estate transactions, disclosed in publicly
available deeds filed in March and April, provide a glimpse into
the Conigliaro family's fortune before authorities moved in and
shut down the pharmacy operations of NECC and Ameridose LLC, a
related, but larger drug manufacturer and compounder.
In March and April, Greg Conigliaro paid $2.4 million for a
beach front home on Cape Cod, while his brother Doug Conigliaro
paid $4.2 million for a penthouse condo on Beacon Street in
Boston's fashionable Back Bay neighborhood, the deeds show.
About the same time, a real estate venture owned and managed
by the two brothers paid $4.6 million to buy the
state-of-the-art facility that Ameridose used to win new
customers and rapidly expand its business, real estate records
show. Ameridose previously leased the building.
Ameridose said on Friday that the Massachusetts Board of
Registration in Pharmacy had requested an extension of its
closure to allow authorities to continue and complete an
inspection that has been under way since Oct. 10.
The Ameridose license suspension will remain in place until
Nov. 5, but there has been no request for a recall of any
Ameridose products, according to the Massachusetts Department of
Public Health.
"Our shared investigation with our federal partners at the
FDA continues and includes concerns about corporate ownership
and business practices at NECC and Ameridose," Madeleine
Biondolillo, director of the department's Bureau for Health Care
Safety and Quality, said in a statement.
Ameridose products have not been linked to the meningitis
outbreak.
"As this extension agreement states, neither the Board nor
the Registrants are aware that any product compounded or
produced by the Registrants is in any way unfit for use or
consumption," Ameridose said in a statement.
Doug Conigliaro, who is president of Medical Sales
Management, the sales arm for NECC and Ameridose, is not named
in the lawsuit filed in Middlesex County.
The Caddens, Greg Conigliaro and Doug Conigliaro did not
immediately respond to messages seeking comment.
(Additional reporting by Aaron Pressman, Toni Clarke, David
Bailey and Michael Peltier; Editing by Gerald E. McCormick, Lisa
Von Ahn, Andre Grenon and David Brunnstrom)
