Summary of Court Decision in
United States of America, Plaintiff,
- against -
Blue Ribbon Smoked Fish, Inc., et alia, Defendants.
On November 20, 2001, in U.S. v. Blue Ribbon Smoked Fish, Inc., et
al., 01-CV-3887 (E.D.N.Y.), Judge Sifton granted FDA's motion for
summary judgement to enjoin Blue Ribbon, a fish
processor, from violating adulteration provisions of the Food, Drug
and Cosmetic Act. The case involved the contamination of food with Listeria
monocytogenes (L. mono), a bacterium that can cause a serious
infection in humans called listeriosis, and causes an estimated 2,500
serious illnesses and 500 deaths each year.
Foodborne illness caused by L. mono in pregnant women can
result in miscarriage, fetal death, or severe illness in or death of a
newborn infant. Others at risk for severe illness or death are the
elderly and those with weakened immune systems.
The court found that Blue Ribbon and three of its officers 1) had
inadequate Hazard Analysis Critical Control Point ("HACCP")
plans; 2) processed its fish products under insanitary conditions; and 3)
introduced fish products contaminated with Listeria Monocytogenes
("L. mono.") into interstate commerce. The court also denied the
individual defendants' motion to dismiss the complaint against them,
relying upon earlier decisions from the Supreme Court which placed the
responsibility for protecting the public health on individuals who had the
opportunity to know about poor conditions at food processing companies,
not consumers.
Rejecting Blue Ribbon's defense that new management had alleviated the
insanitary conditions, the court focused instead on
defendants' lengthy history of violations. The court also held that
defendants' HACCP plans were facially inadequate.
Blue Ribbon challenged the adulteration charge based on the presence of
L. mono. in its fish products by arguing that L. mono. is not an added
substance and does not ordinarily present a risk to health because it
affects only some segments of the population. In the alternative, Blue
Ribbon argued that if the court found L. mono. to be an added substance,
the FDA's zero-tolerance policy violates provisions of the Food, Drug and
Cosmetic Act. The court rejected these arguments, finding that 1) L. mono.
is an added substance; 2) L. mono. is "injurious to the health of
significant populations of consumers;" and 3) the FDA is not required
to set a tolerance level for L. Mono. The court granted relief as
requested by the government, recognizing that it was consonant with the
legislative intent behind the Act: "[b]y keeping contaminated fish
processed under conditions of filth off consumer's tables, this permanent
injunction will serve that important purpose."
MORE |