11:32AM EST October 11. 2012 - Long
before the current rash of fungal meningitis, the compounding pharmacy
suspected in the outbreak settled a lawsuit alleging it produced a
tainted shot that caused a man's death in 2004.
Earlier this
summer, a separate pharmaceutical firm with common owners was accused of
failing to separate sterile and non-sterile supplies. That
pharmaceutical company was shut down Wednesday for inspections, the
latest example of fallout from the growing outbreak.
Officials
have identified Framingham, Mass., based-New England Compounding Center
as the source of steroid shots suspected in the outbreak of rare fungal
meningitis that has killed at least 12 people and made more than 130
others sick in 10 states.
Allegations that a shot tainted with
bacteria caused a man to contract a different form of meningitis were at
the heart of a lawsuit filed against the company over the 2004 death.
An 83-year-old man died about a year and a half after receiving a shot
produced by the company.
Another drug company that has some of the
same owners, Ameridose LLC, agreed to temporarily stop its compounding
and manufacturing operations as a precaution while regulators inspect
its facilities, but the measure is being done as a precaution, not
because of evidence of contamination, officials said Wednesday.
Ameridose, based in Westborough, Mass., was accused by a business
customer this year of failing to separate sterile and non-sterile
products in its warehouse.
Andrew Paven, a spokesman for both
companies, said: "Ameridose is a separate entity from New England
Compounding Center, with distinct operational management."
"We
have separate production facilities, separate processes and operate at
separate locations in different cities. Although there is common
ownership, the two companies operate under separate registrations and
different licensure," the statement from Paven said.
On Wednesday,
Massachusetts Gov. Deval Patrick said the New England Compounding
Center may have misled regulators and done work beyond the scope of its
state license. The company was licensed to fill specific prescriptions
for specific patients but exceeded that, he said.
"What they were
doing instead is making big batches and selling them out of state as a
manufacturer would, and that is certainly outside of their state
license," he said.
A company spokesman declined to comment on
Patrick's assertion beyond a statement that company officials are
focused on cooperating with the investigation. The company has shut down
operations and recalled the fungus-contaminated steroid.
A 2004
lawsuit filed in upstate New York's Monroe County claimed New England
Compounding Center produced a tainted shot that caused William Koch to
contract bacterial meningitis at Rochester General Hospital on July 17,
2002. Koch died Feb. 28, 2004, at the age of 83.
The lawsuit said the shot was the source of Koch's meningitis, but did not explain how that determination was made.
Bacterial
meningitis is contagious and much more common than the fungal
meningitis involved in the current outbreak. Fungal meningitis is more
difficult to catch, according to the Centers for Disease Control and
Prevention.
The compounding pharmacy reached a settlement with
Koch's widow in 2007 before the case went to trial, according to her
lawyer Mark S. Nunn. He declined to elaborate Wednesday because the
terms were confidential.
"Really all I can say is that the case settled prior to trial," Nunn said.
Two
of the people who founded New England Compounding Pharmacy Inc. in 1998
— Gregory Conigliaro and Barry Cadden — formed Ameridose in 2006,
according to documents filed with the Massachusetts Secretary of State's
office. The company's website says it provides hospitals around the
country with products including intravenous solutions and prefilled oral
syringes of painkillers and other medications.
This summer, an
organization that represents hospitals in purchasing deals with drug
suppliers canceled a contract with Ameridose over allegations that it
had poor quality control practices that "rose to a level of concern for
patient safety," according to a lawsuit that Ameridose filed in August.
Ameridose
denies those allegations and filed a defamation and slander lawsuit in
U.S. District Court in Massachusetts on Aug. 8, saying Novation LLC hurt
its reputation by making allegations including that there was "no
separation between sterile and non-sterile products" in an Ameridose
warehouse.
The lawsuit doesn't say what the products were or
elaborate on how they were stored. Novation declined to release a copy
of its report.
Novation, which leverages hospitals' combined
buying power to get better prices on medical goods, sent two employees
to audit Ameridose on July 15 and terminated its contract, the lawsuit
said.
"Novation has determined that Ameridose does not meet the
quality systems requirements needed to maintain a Novation agreement,"
Novation told its members in an Aug. 2 newsletter, according to the
lawsuit.
Ameridose strongly objected to the allegations and said
in its defamation lawsuit that the Novation auditors were unqualified
and made false and misleading statements. Ameridose also said it had
been audited in recent years by several other organizations that
determined its quality control system "meets or exceeds their high
quality standards." Ameridose is regulated by the U.S. Food and Drug
Administration.
The lawsuit ended in a confidential settlement Sept. 24.
Paven,
the Ameridose and New England Compounding Center spokesman, said
Wednesday in his email that the "suit involved contractual commercial
issues between the companies that have since been resolved."
A
statement from Novation said that while it "vigorously disputed each and
every claim made in the lawsuit, the parties ultimately agreed to
settle the lawsuit."
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