Transcript DEADLY FOOD & PRODUCT LIABILITY

ADULTERATION STANDARDS: A Look at
Agency Rulemaking, Judicial Power,
and Food Product Liability Litigation
William D. Marler &
Denis W. Stearns
“Food safety…would seem to be the
least political of food issues. WHO
COULD POSSIBLY NOT WANT FOOD TO
BE SAFE? Consumer do not want to
worry about unsafe food and do not
like getting sick. Unsafe food is bad
for business (recalls are expensive,
and negative publicity hurts sales) as
well as for government (through lost
trust).”
M. Nestle, SAFE FOOD, Preface at x.
So Why
Lawsuits?
“When industry successfully innovates to produce
safe food, a win-win situation arises, with the
innovating firm, consumers, and government all
benefiting from improved food safety.”
Elise Golan, et al., Food Safety Innovation in
the United States, USDA ERS, AER No. 831
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American Public Health
Association v. USDA
“The presence of salmonellae
on meat does not constitute
adulteration within this
definition [of ‘adulterated,’
provided in 21 U.S.C. § 601
(m)]….As it said in its letter of
August 18, 1971 ‘the American
consumer knows that raw
meat and poultry are not
sterile and, if handled
improperly, perhaps could
cause illness." In other words,
American housewives and
cooks normally are not
ignorant or stupid and their
methods of preparing and
cooking of food do not
ordinarily result in
salmonellosis.’” APHA v. Butz,
511 F.2d 331, 334 (1974).
Lawsuit “alleged that [USDA] was wrongfully refusing
to affix to meat and poultry products…labels
containing handling and preparation instructions to
protect the consumer against food poisoning caused
by Salmonellae and other bacteria.”
Sought to enjoin (block) USDA from “affixing the label
‘U.S. Passed & Inspected’…on meat and poultry unless
it is accompanied by an [warning] that product may
contain organisms capable of causing food poisoning”
DISSENT: “The court apparently takes the position
that meat and poultry ‘ordinarily’ pose no threat of
salmonellosis, because American consumers are aware
of the problem…That, however, is a debatable
proposition…”
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Texas Food Industry Ass’n,
et al. v. USDA (Round 1)
“It is disingenuous for the USDA
to express the urgent need for
an emergency rule and then
delay its effectiveness date for
60 days, when [it] could have
followed the standard procedure
for rulemaking under the APA
within such a time period. If
there truly was an epidemic
problem, or anywhere close to
such a problem, the USDA
would have presumably
required a much shorter period
of time for the effective date of
the emergency rule. Further,
the USDA has not rebutted the
Plaintiffs’ showing that an
emergency does not exist to
require an emergency rule.”
TFIA v. USDA, 842 F. Supp.
254, 258 (W. D. Tex. 1993).
Lawsuit sought to block “interim final rule [that]
mandates that all uncooked and partially cooked
packages of meat and poultry products will be
required to contain new labels relating to the safe
handling and processing of such items, primarily to
combat the disease caused by E. coli O157:H7”
Court granted the injunction, and explained that it
was “in no way attempting to substitute its own
judgment for the collective wisdom of the USDA,
the interested parties, and the general public…”
When Court of Appeals refused to lift injunction on
emergency basis, USDA abandoned its appeal, and
went through with formal rulemaking for new rule.
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E. coli O157:H7 as an
Adulterant in Raw Meat
“To clarify an important
legal point, we consider
raw ground beef that is
contaminated with E. coli
O157:H7 to be adulterated
within the meaning of the
[FMIA]. We are prepared to
use the Act’s enforcement
tools, as necessary, to
exclude adulterated
product from commerce.
Finally, we plan to conduct
targeted sampling and
testing of raw ground beef
at plants and in the
marketplace for possible
contamination.”
Michael Taylor, FSIS
Administrator, in Speech to
American Meat Institute,
September 28, 1994.
MEAT INDUSTRY REACTION:
“How can FSIS treat E. coli in hamburger meat as an
adulterant subject to enforcement strategies, while
not applying the same standard to salmonella in
broilers…Such gross policy interpretation favoring the
poultry industry and disfavoring the beef industry is a
travesty indeed.” —Rosemary Mucklow
FOOD MARKETING INSTITUTE:
“It is essential that nothing dilute the consumer
message that the proper cooking of meat eliminates
foodborne pathogens.”
And so, of course, they sued the USDA
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Texas Food Industry Ass’n,
et al. v. USDA (Round 2)
“Plaintiffs’ primary
argument …is that E. coli
contaminated ground beef
is not adulterated because
it is only injurious to health
if improperly cooked.
However, after reviewing
the evidence, the Court
disagrees. …[U]nlike other
pathogens, it is not ‘proper’
cooking but ‘thorough’
cooking that is necessary
to protect consumers from
E. coli…Therefore, E. coli
is a substance that renders
‘injurious to health’ what
many Americans believe to
be properly cooked ground
beef.” TFIA v. USDA, 870 F.
Supp. 143, 148-49 (W. D.
Tex. 1994).
Lawsuit sought injunction “to prevent USDA from
conducting its E. coli sampling program” because:
 Agency “failed to adhere to notice and comment
procedure required by [APA]”;
 Sampling program and adulterant decision are “arbitrary
and capricious exercise of agency authority and that it
exceeds the USDA’s statutory authority under the FMIA.”
Court DENIED the Industry motion for an injunction, ruling:
 Neither the sampling program, nor the decision to treat E.
coli O157:H7 as adulterant, required notice-and-comment
 There are rational bases for the sampling program, and
treating E. coli O157:H7 differently than other pathogens.
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E. coli OI157:H7 and
Intact v. Non-Intact Meat
“The public health risk presented
by beef products contaminated
with E. coli O157:H7 is not limited,
however, to raw ground beef
products. Given the low infectious
dose of E. coli O157:H7 associated
with foodborne disease outbreaks
and the very severe consequences
of an E. coli O157:H7 infection, the
Agency believes that the status
under the FMIA of beef products
contaminated with E. coli O157:H7
must depend on whether there is
adequate assurance that
subsequent handling of the product
will result in food that is not
contaminated when consumed.”
FSIS Policy Statement, 64 Fed. Reg.
No. 11, 2803 (Jan. 19, 1999)
July 25, 1996: FSIS issues Pathogen
Reduction/HACCP Final Rule mandating process
controls in all meat plants
January 19, 1999: FSIS expands E. coli testing to
include “non-intact meat and trimmings,”
deeming (by implication) that E. coli O157:H7
on all “intact” meat is not an “adulterant”
October 7, 2002: FSIS explains : “intact cuts of
beef that are to be further processed into nonintact product prior to distribution for
consumption must be treated in the same
manner as non-intact cuts of beef because
pathogens may be introduced below the surface.
Manufacturing trimmings are an example…”
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A QUICK DIGRESSION TO EXPLAIN
THE SIGNIFICANCE OF
ADULTERATION STANDARDS FOR
PERSONAL INJURY LAWSUITS
STRICT PRODUCT LIABILITY
“one who sells any product in defective
condition unreasonably dangerous to the user
or consumer…is subject to liability for physical
harm thereby caused to the ultimate user or
consumer.”
RESTATEMENT (2d) OF TORTS § 402A (1965)
 Rule applies in the absence of privity, and
without need for any evidence of negligence
 Focus is solely on condition of the product,
not manufacturer’s conduct or level of care
 Due Diligence is absolutely no defense
INJURY + DEFECT + CAUSATION = LIABILITY
“Under the Act, a ''manufacturer' includes
a product seller who designs, produces,
makes, fabricates, constructs, or
remanufactures the relevant product or
component part of a product before its
sale to a user or consumer.' RCW
7.72.010(2)….
Here, the District began the process
with 180 pounds of frozen ground beef.
The frozen beef was thawed and then
cooked in a steam kettle. Once cooked,
the fat was drained off. The meat was
rinsed. And refried beans, tomato paste,
and seasonings were added. The taco
meat was later scooped onto a tortilla
along with other condiments and side
dishes and then
served.
The District thus had a design' for
cooking this meat--its recipe. It made
taco meat by combining ground beef with
other ingredients. It then used the taco
meat as part of its taco lunch. The
District's cooking process falls neatly into
each of the definitions for 'produce,'
'make,’‘fabricate,' and 'construct.'
Webster's, at 1810, 1363, 811, 489.
The District was not merely a
retailer…The District is a manufacturer--a
manufacturer of tacos.”
Almquist v. Finley School District, 114
Wn.App. 395, 405, 57 P.3d 1191 (2002)
Defining Defects (in Manufacture)
A DEPARTURE FROM INTENDED DESIGN
“A product contains a manufacturing defect when the
product departs from its intended design even though
all possible care was exercised in the preparation and
marketing of the product.”
Restatement (3rd) of Torts: Product Liability, 2a (1998)
“the product deviated in some material way from the
design specifications or performance standards of the
manufacturer, or deviated in some material way from
otherwise identical units of the same product line.”
Washington Product Liability Act, RCW 7.72.030(2)(a)
Compare Design Defects & Failure to Warn
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The Death of Brianna Kriefall
“Wisconsin health investigators later concluded Brianna Kriefall died from
eating watermelon that Sizzler workers had inadvertently splattered with
juices from tainted sirloin tips. The meat came from [an Excel meat plant]
where beef repeatedly had been contaminated with feces, E. coli's favorite
breeding ground.” Joby Warrick, “An Outbreak Waiting to Happen,”
Washington Post, April 9, 2001
Excel’s “Winning” Argument
USDA must “inspect” and “pass” all meat (by finding it free of
adulteration) before it can entire interstate commerce.
USDA Policy states “intact” meat can be surface-contaminated
with E. coli O157:H7 and not be deemed adulterated (unlike
ground beef and other non-intact cuts) and so is legally “safe”
State product liability law that would deem intact meat as
defective conflicts with USDA policy and must be preempted
Consequently, as a matter of law, the tri-tips Excel sold to
Sizzler are not defective and all claims must be dismissed
Trial Court Granting Dismissal
“The policy behind preemption in this area makes sense. …The federal
government has acted in this area to provide national standards so that
properly handled and cooked meat products are safe for human
consumption….In an area of such great national concern, it is essential
that the rules be uniform. Federal inspectors are in these meat plants,
testing the meat and monitoring the processing programs of companies
like Excel. The federal regulatory scheme is so long-standing and so
comprehensive that I conclude it preempts any state laws to the contrary.
That includes bringing civil suits against meat processors like Excel.”
The Court of Appeals reverses
“During oral argument, Excel forcefully contended that a failure to apply
federal preemption will subject the meat-processing industry to intractable
dilemmas. But all manufacturers confront difficult cost/benefit choices when
balancing expense and methods of production on the one hand, against, on
the other hand, potential liability for injuries that may be caused by their
products; we see no special burden on Excel or other meat processors
beyond that faced by anyone who puts potentially dangerous products into
the stream of commerce.”
Kriefall v. Excel Corporation, 665 N.W.2d 417, 436 n. 7 (Wis. Ct. App. 2003)
(holding FMIA did not preempt state tort product claims).
And noting the capability problem
“The record here demonstrates in a concrete way how the
claims asserted against Excel supplement the protections afforded by
the meat inspection program.…Only two federal inspectors oversee a
meat fabrication area in Excel’s plants where several hundred workers
daily cut the approximately seven-foot-long, 350 pound split carcasses
into some 8,000 intact cuts of beef weighing approximately two to for
or three to five pounds each. Federal inspectors do not inspect each
one of these smaller cuts of beef. Moreover, the seven-foot-long
carcasses arrive at the fabrication area after whizzing by the Service
inspection area at a rate of one side every six seconds.”
See Kriefall, 665 N.W.2d at 435-36.
Compare Wyeth v. Levine
“The FDA has limited resources to monitor the 11,000
drugs on the market…. State tort lawsuits uncover
unknown drug hazards and provide incentives for drug
manufacturers to disclose safety risks promptly. They
also serve a distinct compensatory function that may
motivate injured persons to come forward with
information….Thus, the FDA has long maintained that
state law offers an additional and important layer of
consumer protection that complements FDA regulation.”
Wyeth v. Levine, 555 U.S. ___ (2009).
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Salmonella as an
Adulterant in Meat
“The difficulty in this case arises, in
part, because Salmonella, present in
a substantial proportion of meat and
poultry products, is not an adulterant
per se, meaning its presence does not
require the USDA to refuse to stamp
such meat "inspected and passed."
This is because normal cooking
practices for meat and poultry destroy
the Salmonella organism, and
therefore the presence of Salmonella
in meat products does not render
them "injurious to health" for purposes
of § 601(m)(1). Salmonella-infected
beef is thus routinely labeled
"inspected and passed" by USDA
inspectors and is legal to sell to the
consumer.” Supreme Beef v. USDA,
275 F.3d 432, 438-39 (5th Cir. 2001).
Supreme Beef sued to stop FSIS from withdrawing
inspectors, “alleging that in creating Salmonella
tests, FSIS had overstepped the authority given to
it by the FMIA.” (113 F. Supp. 2d 1048, at 1051)
Court ruled in favor of Supreme Beef, finding that,
under FMIA, a plant cannot be found “insanitary”
based on failed Salmonella performance standards
“what the court takes issue with today is not the use of
scientific methods in USDA inspections but the agency’s
science-based testing of a processor’s product to evaluate
the conditions of its plant.” (emphasis in original)
“science-based tests of a plant’s end product may be
appropriate when the USDA is determining if a plant’s meat
is adulterated under the several other [FMIA] definitions”
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Lawsuits on the Horizon?
“Since 1990, 13 outbreaks
of non-O157 E. coli have
been reported in the US.
While E. coli O157 is the
principal strain isolated
from implicated food and
clinical isolates in the US,
non-O157 predominate in
other countries…. I will
leave this to scientists
and public health officials
to sort all out. However,
one needs to look no
further than the FMIA and
at the term ''adulterated”
for and answer.…If nonO157 E. coli fits the bill,
then to me that answers
the question.” William
Marler, Statement at 2007
non-O157 STEC meeting
October 17, 2007: FSIS, FDA & CDC host public meeting
on “Public Health Significance of non-O157 Shiga Toxinproducing E. coli (STEC)” at George Mason University
July 22, 2009: FSIS announced “King Soopers, Inc., a
Denver, Colo., establishment, is recalling approximately
466,236 pounds of ground beef products that may be linked
to an outbreak of salmonellosis,”
August 6, 2009: FSIS announced “Beef Packers, Inc., a
Fresno, Calif., establishment, is recalling approximately
825,769 pounds of ground beef products that may be linked
to an outbreak of salmonellosis .”
Pending: Victims of non-O157 STEC infections join with
Marler Clark to file Petition seeking FSIS declaration that
non-O157 STEC will be deemed an adulterant under FMIA
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web: www.marlerclark.com
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