Law Law 6842-01  Fall 2009
American Health Care Law
Professor Vernellia R. Randall
The University of Dayton School of Law


Safety as an Element of Quality
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Unit 1 - Organization                                    x
Unit 2 -  Access                                  x
Unit 3 - Quality                                            x
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 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 or reversed.

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.


17: Promoting Quality                                          x
18 Regulation of Professionals                                     x
19 Regulation of Instituions                                      x
21 - Liability - Professionals                                      x
23: Liability - Hospitals                                 x
24 - Liability - Managed Care                              x
26 Confidentiality                                                     x
27 Informed Consent                                          x






Related Pages:
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Previous Pages:
Home ] Lesson 18: Regulation of Professionals ] Lesson 19: Regulation - Institutions ] Lesson 20: Regulation of Pharmaceuticals ] Lesson 21: Liability -Professional ] Lesson 22: Liability - Professionals- II ] Lesson 23: Liability - Institutions - Part I ] Lesson 24: Liability - Institutions - Managed Care ] Lesson 25: Reforming the Tort System ] Lesson 26 Contract/ Confidentiality ] Lesson 27: Relationship - Informed Consent ]
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Professor Vernellia R. Randall
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The University of Dayton School of Law
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