Agriculture Reference
In-Depth Information
care a producer should use in processing fresh produce.
28
To the extent that the FDA
is defi ning an expected standard of care, it is one that is in a near-constant state of
reactive fl ux. Either way, though, food processors should always expect to have their
conduct judged against whatever guidelines or recommendations exist, whether they
are legally binding or not.
Still, one might assume, if a regulation exists, that standard would control the
determination of whether a grower or processor used suffi cient care to avoid liability.
But this is not necessarily the case either. Although a law or regulation certainly
establishes a standard, it does not establish the only standard.
29
As a result, proven
compliance with an applicable regulation is not a legally suffi cient defense to liability.
In contrast, proven noncompliance with an applicable regulation is a legally suffi cient
way to establish liability. Such liability is referred to as negligence
per se
.
The doctrine of negligence
per se
is a precursor to strict liability and is often com-
pared to it. To employ the doctrine, a person injured by a defective food product need
only show that:
1. There is an applicable statute that was enacted to protect a class of persons that
includes the person claiming injury;
2. The injury complained of is the kind contemplated by the statute;
3. The company that is alleged to be negligent violated the statute; and
4. The violation must have caused the injury.
30
Court decisions have, however, been generally disinclined to fi nd that a violation of
the FDCA constitutes negligence
per se
.
31
There has been no such disinclination to
fi nd that a violation of a regulation promulgated pursuant to the FDCA is legally suf-
fi cient evidence for a jury to fi nd negligence. For example, in
Allen v. Delchamps,
Inc
., the Supreme Court of Alabama reversed a trial court's dismissal of a lawsuit
against a grocery store for injuries related to an allergic reaction to sulfi des on fresh
celery.
32
In any case, regardless of whether there is a regulatory violation or compliance, it
must be remembered that neither is relevant to the issue of strict liability. Although
the doctrine of negligence
per se
is still around, it is unnecessary. Recall that a person
does not get to recover damages for each liability theory established. Only one theory
of liability is needed to recover damages. Thus, the real lesson to be learned here is
that regulatory compliance is no defense. The only real defense is to exercise the care
necessary to prevent the defect. Only without injury can there be no liability.
The Politics of Regulations: Setting the Safety Bar Low
The inability of consumers to discern the relative safety of their food purchases limits
all but a generalized demand for safer food. This generalized demand for safer food,
applicable to an entire industry or product category, is ineffective in causing the market
to enhance food safety. As a result, there is little economic incentive for producers to
manufacture food that is safer than that required by government regulations. Such
regulations, therefore, tend to act as a ceiling not a fl oor, and they effectively suppress
most competition in the realm of food safety. Rather than worrying about a competitor
doing more to improve the relative safety of a product category (e.g., bagged fresh
