Michael D. Green
excerpted from: Michael D. Green, Safety as an Element
of Pharmaceutical Quality: the Respective Roles of Regulation and Tort
Law, 42 Saint Louis University Law Journal 163 (Winter 1998)
Safety, or perhaps its reciprocal, risk, is surely an element of
quality. Thus, the risk posed by a pharmaceutical is an important
element of its quality and one about which we should rightly be
concerned. To a greater degree than virtually any other consumer
product, pharmaceuticals are subjected to rigorous regulatory control.
The model of regulation employed, requiring pre- approval testing with
the burden of proof on the manufacturer before the drug may be marketed,
is a particularly arduous scheme that provides greater assurance that a
drug's risks have been considered and deemed acceptable in light of its
therapeutic benefits before the drug is permitted to reach consumers.
Tort law also serves a regulatory role, albeit one that operates
after an incident has caused harm. But the instrumental effect of tort
liability has been recognized since at least the turn of the century.
The growth of law and economics *164 and its application to tort law has
accentuated the deterrent role that tort law plays.
Although there is much contemporary criticism of the United States
Food and Drug Administration ("FDA"), very little of it
concerns underregulation or a failure to protect the public from
pharmacologic risk. Rather, since the pathbreaking work by Sam Peltzman
in the 1970s, much of the criticism of the FDA is that it is
overcautious about approving new and beneficial drugs. Complaints about
the "drug lag" have been given new political and popular life
in the quest to find drugs to treat AIDS victims. Current reform
proposals focus not on the need for greater consumer protection but on
the need to accelerate the approval of new drugs so that the public can
gain from their therapeutic benefits.
With careful oversight of prescription drug safety by the FDA, we
might ask why is tort law also necessary? The FDA has technical
expertise, the luxury of time, the benefit of deferring decision when
the evidence is inadequate, and operates in a style that is more
conducive to accurate scientific fact-finding than the adversary system.
The tort system is suffering through difficult times. Tort reform,
which in almost all instances is designed to limit liability, has been
popular in many state legislatures for over a decade. On the federal
level, product liability reform finally was approved by Congress in 1996
after almost Moodlety years of efforts. In the common law arena, much of
the expansion of tort law in the post New Deal era has been ameliorated
In the area of drugs and medical devices, there are a number of
specific episodes that have blackened tort law's eye. Bendectin was a
prescription drug marketed for over Moodlety years before it was removed
from the market *165 because of a large number of lawsuits alleging that
it caused birth defects. The scientific evidence, which is quite
well-developed today, does not support those claims. Peter Huber, who
popularized the term "junk science," has repeatedly returned
to the Bendectin litigation to demonstrate the ills of the tort system.
For a period of time, there were concerns about the supply and
availability of vaccines because of liability concerns. This drought
proved sufficient for Congress to pass legislation designed to
ameliorate the situation. Norplant, the five- year wonder contraceptive
introduced in 1991 has been bogged down in messy litigation for several
years. The litigation over breast implants and criticism of it is now
sounding like a reprise of what occurred with Bendectin. Concern has
even been raised that tort law stands as an impediment to the
development of vaccines for AIDS.
The reality is that a substantial movement toward displacing tort law
in favor of regulatory standards in the prescription drug (and medical
device) arena exists. Several states have enacted statutes that are
specific to the FDA and its approval of a drug, although most of those
statutes do not provide complete immunity from tort actions. Congress
has considered enacting such a statute *166 as part of its continuing
national tort reform effort. Numerous commentators have advocated such a
regulatory compliance defense for pharmaceuticals regulated by the FDA.
Some critics of an FDA regulatory-compliance defense argue that the
FDA is not so accurate and reliable as the proponents claim. Instances
of drugs approved by the FDA that subsequently were revealed to cause
serious adverse effects, often requiring their removal from the market,
are often cited in support. Although not often mentioned, the
infrequency of pharmaceutical products liability suits and their
concentration in a relative handful of quite prominent case
congregations might also be asserted as grounds for believing that *167
any need for (or potential effect of) a regulatory compliance defense is
quite limited. This article does not rely on these arguments to assess
the desirability of a regulatory-compliance defense. Instead, it
sketches the requirements of any such defense and thereby reveals that
any such defense is far more problematical than most have realized.
Indeed, such a defense may be so difficult as to be unworkable, despite
accepting the superiority of the FDA over common law courts in resolving
theissue of pharmaceutical risk.
Thus, we begin by recognizing that when the FDA approves a new drug
application, it is based on a determination that the social benefits of
the drug outweigh its risks. FDA approval of a new drug is not setting a
"floor" for safety--rather it seeks to ensure that any drug
approved provides a net benefit and that the labeling of the drug
accounts for all material adverse effects that are known. Of course, the
FDA may make a mistake, as will any human-driven entity, but accept, for
purposes of evaluating a regulatory- compliance defense that the FDA's
judgments are about as good as any human system can provide and
certainly of greater accuracy than is provided by the tort system.