11998 Robert Heidt
† Professor of Law, Indiana University at Bloomington.
2. Biotechnology refers to any technique to modify the products of living organisms. Examples include hybridoma and recombinant DNA technology. Hybridoma technology entails the fusion of two types of cells, an antibody-producing B lymphocyte and a certain tumor cell line (i.e., a myeloma). See U.S. CONGRESS, OFFICE OF TECHNOLOGY ASSESSMENT, NEW DEVELOPMENTS IN BIOTECHNOLOGY: OWNERSHIP OF HUMAN TISSUES AND CELLS - SPECIAL REPORT, OTA-BA-337, 31-58 (1987) [hereinafter OTA REPORT]. The resulting immortal hybrid cells, called hybridomas, secrete large amounts of monoclonal antibodies and lymphokines. Because of their exquisite specificity and reduced toxicity, these molecules may help in the treatment of a spectrum of diseases. Recombinant DNA technology (also known as genetic engineering) entails the insertion of genes into microorganisms (typically bacteria) that will express a desired protein which can then be purified. Id.
3. Throughout this article, in order to clarify the party being discussed, the researcher is referred to by the impersonal pronoun and the subject by the personal pronoun.
4. For the sake of brevity, the subject's "consent" refers both to the subject's consent that his samples be used for the research and commercial purposes of the researcher, and to the subject's assignment of all his interests in the cell lines and end products developed from his samples to the researcher.
With research governed by the guidelines of the Protection of Human Subjects issued by the Department of Health and Human Services, subjects may not be able to waive their interests in their cells because of the existing ban on the use of exculpatory language in consent agreements. See 45 C.F.R. § 46.116 (1998). Because the purpose of that ban was to preserve a subject's right to sue should he be injured during the research, this impairment of the subject's ability to aid research by clarifying the researcher's rights seems unfortunate. See Hearings: The Use of Human Biological Materials in the Development of Biomedical Products 233 (October 29, 1985) (statement of Dr. Charles R. McCarthy, Director, Office for Protection From Research Risks, National Institute of Health).
5. Individuals with valuable cells are found disproportionately among members of isolated groups. See OTA REPORT, supra note 1, at 54-56. Examples of such groups include the Guyami tribe of northwest Panama (cells useful in retarding the progress of AIDS), the Hugahai tribe in Papua New Guinea (cells useful in combating leukemia) and a remote community in the Sudan (cells useful in avoiding heart disease). See Philip L. Bereano, Patent Pending: The Race to Own DNA-Guaymi Tribe Was Surprised to Discover They Were Invented, THE SEATTLE TIMES, Aug. 27, 1995, at B5; Patent Blather: Biotechnology, THE ECONOMIST, Nov. 25, 1995, at 87; Linda Marsa, Whose Ideas Are They Anyway: Intellectual Property in the Information Age, OMNI, Dec. 22, 1995, at 36.
6. Examples of successful end products of biotechnology include: EPO, which prevents anemia during kidney dialysis; Neupogen, which decreases the risk of infection during chemotherapy; and Acromegaly, which aids growth. See generally Sandra Cuttler, The Food & Drug Administration Regulation of Genetically Engineered Human Drugs, 1 J. PHARMACY & L. 191 (1992).
7. "[B]iological materials involved [in commercial biotechnology] are almost always replenishable and often constitute waste materials, at least from the point of view of the donor." Arthur L. Caplan, Blood, Sweat, Tears and Profits: The Ethics of the Sale and Use of Patient Derived Materials in Biomedicine, 33 CLINICAL RESEARCH 448, 450 (1985).
8. The probability of maintaining a cell line from a given sample is low. Even with strict adherence to nutrient and temperature requirements, established cell lines can not always be maintained. Contamination and damage during storage is the most common culprit. Interview with Dr. Derrick Stempel of Massachusetts General Hospital (Oct. 3, 1996).
One simplifying assumption throughout this article is that the researcher, perhaps because of its failure to maintain the cell line, is unable to obtain any patent.
9. See Ahern v. Scholz, 85 F.3d 774, 792-94 (1st Cir. 1996); see also Haberman v. Greenspan, 368 N.Y.S.2d 717, 720 (1975); RESTATEMENT (SECOND) OF CONTRACTS § 162 (1979).
10. See Procter & Gamble Co. v. Bankers Trust Company, 925 F. Supp. 1270, 1289 (D. Ohio 1996).
11. See RESTATEMENT (SECOND) OF TORTS § 525 (1974); see also WILLIAM PROSSER, LAW OF TORTS §§ 105-06 (6th ed. 1994).
12. See supra note 8.
13. See, e.g., Shannon v. Russell, 203 B.R. 303, 311-12 (Bankr. S.D. Cal 1996) (reiterating the doctrines of fraud and misrepresentation in a non-dischargeability action); Kahn v. Flood, 550 F.2d 784 (2d Cir. 1977) (perjury invalidates evidence obtained with a search warrant); IND. CODE § 6-3-11 (1997) (criminal liability for submitting false statements on tax returns); NEW YORK PENAL LAW § 210.00 (McKinney 1997) (felony to commit perjury during testimony before a court).
One reason fraud is undesirable is because it increases the amount of misinformation in the market and therefore reduces the market's ability to allocate resources efficiently. See Michael R. Darby & Edi Karni, Free Competition and the Optimal Amount of Fraud, 16 J.L. & ECON. 67 (1973).
14. I do not claim that the dilemma faced by the returning researcher in the story presented rises to the level of a pressing social problem. The stylized story primarily provides a convenient context for applying economic principles. Nevertheless, the Office of Technology has found that uncertainty about how courts will resolve various claims by subjects against researchers who have profited from the subject's cells presents the single greatest obstacle to continuing developments in biotechnology. See OTA REPORT, supra note 1, at 58. Moreover, previous discussion of the subject's claims has largely ignored the need to preserve the researcher's incentive to search. See, e.g., Roy Hardiman, Comment, Toward the Right of Commerciality: Recognizing Property Rights in the Commercial Value of Human Tissue, 34 UCLA L. REV. 207 (1986); Richard Delgado & Helen Leskovac, Informed Consent in Human Experimentation: Bridging the Gap Between Ethical Thought and Current Practice, 34 UCLA L. REV. 67 (1986).
15. This discussion assumes the suspicious subject can find some way to assess the value of his samples while still retaining his control over the use of the samples for research and commercial purposes. For this assumption to be true, some laboratory, testing service, or research institution must be able to assess the cells' value in return for compensation and must also be willing to refrain from using the cells itself.
16. The subject's hold-up problem would not destroy the incentive to search if that search gave the researcher a decisive head start in developing and marketing the end products over the rival companies with which the knowledgeable subject might eventually decide to deal. Just as the need for patent protection is most acute when research is difficult but imitation easy, the need for the right to lie is most acute when the search for valuable cells is difficult but the development of the end products from those cells relatively easy.
17. The subject's threat must be taken seriously even when the researcher has a patent on the cell line derived from the subject's cells. This is because of the severe practical problems of enforcing the patent once an infringer has obtained access to the cell line. See Alan J. Lemin, Patenting Microorganisms: Threats to Openness, in OWNING SCIENTIFIC AND TECHNICAL INFORMATION 196 (Vivian Weil & John Snapper eds., 1989).
18. Of course, society would not want the researcher to search when the expected costs of searching (primarily the costs to the researcher and to the subjects) exceed the expected social value of the search-the latter being the social value of a successful search discounted by the chance the search will not succeed. But as long as the costs of searching are internalized on the searcher, society can rely on the searcher's self-interest to assure that searches which are not cost-justified are not undertaken. The need for the searcher to compensate the subject for his voluntary participation, or to induce that voluntary participation some other way, internalizes the subject's costs of allowing the search unto the searcher. In short, the danger here is not too many searches but too few.
19. Like patents the proposed right to lie subjects the key information, here that this subject's cells are valuable, to the researcher's exclusive control. Assuming the demand curve for the information is negatively sloped, exclusive control imposes some allocative or dead weight loss. Here, for instance, the information once discovered would be most efficiently used if it was distributed to all biotechnology companies, the marginal benefits of distribution clearly exceeding the marginal costs. The dead weight loss primarily consists of the foregone gain from more widespread use of this information. See Frank Easterbrook, Insider Trading, Secret Agents, Evidentiary Privilege and the Production of Information, 1981 SUP. CT. REV. 309, 313. The case for patents and property rights hinges on the assumption that the gains to society from improved incentives exceed this short-term allocative loss which all quasi-rents create. But see Edmund W. Kitch, The Nature and Function of the Patent System, 20 J.L. & ECON. 265, 275-80 (1977) (calling for patent protection whenever the information sought is valuable and costly to acquire). Here the social gain from more widespread use of the information seems modest in part because the searching researcher's exclusive possession of the information gives it a powerful incentive to exploit that information vigorously by developing and marketing the end product itself or by transferring the information to some company who can.
20. The National Organ Transfer Act [hereinafter NOTA], 42 U.S.C. § 274(e) (1988), and its state complements, which condemn the sale of body parts, might seem to condemn the subject who attempted the holdup as well. But even if the transaction for the right to collect cells was deemed a sale of the subject's cells, NOTA would not apply. The Act expressly exempts the sale of replenishable tissues such as blood or sperm. In addition, NOTA may only forbid sales for transplantation, rather than research, purposes.
21. If the appropriation fails because the researcher denies reason to believe the cells valuable, the subject by asking will at least set up the researcher for a later suit should the cells prove valuable. Given that asking is costless to the subject, that should be reason enough to ask.
22. The verb, "to incent," while not formally established grammar, enjoys an increasingly accepted status in various industries. The author uses it here because he feels that it most accurately captures the concept he intends to convey. Eds.
23. See Anthony T. Kronman, Mistake, Disclosure and the Law of Contracts, 7 J. LEGAL STUD. 1 (1978); see also Victor Brudney, Insiders, Outsiders and Informational Advantages under the Federal Securities Laws, 93 HARV. L. REV. 322, 339-43, 371-76 (1979).
24. 15 U.S. (2 Wheat.) 178 (1817).
25. Id. at 186.
26. Id. Kronman was offering an explanation for why courts did not require disclosure in some mistake cases. See Kronman, supra note 22. However the modern trend is to require disclosure in all such cases. See RESTATEMENT (SECOND) OF CONTRACTS § 153 (1979).
Kronman's model better explains the rationale courts should be using when they refuse to require disclosure than the rationale courts actually use in such cases. Other models, such as the contractarian model suggested by Professor Scheppele, better explain the rationales courts actually use. See KIM L. SCHEPPELE, LEGAL SECRETS 124 (1988).
27. 1 O.R. 469, 492-93 (1969); see also Holly Hill Lumber Co. v. McCoy, 23 S.E.2d 372 (S.C. 1942); Simpson Timber Company v. Palmberg Construction Co., 377 F.2d 380 (9th Cir. 1967).
28. See, e.g., CHARLES FRIED, CONTRACT AS PROMISE 82-84 (1981).
29. See Laidlaw, 15 U.S. (2 Wheat.) at 178; see also In re Verifone Securities Litigation, 784 F. Supp. 1471 (N.D. Cal. 1992).
30. See Files v. Brown, 124 F. 133 (8th Cir. 1903).
31. In Laidlaw, Chief Justice Marshall emphasized in dictum that while nondisclosure was permitted, more active measures to mislead, such as a lie, would not be. Laidlaw, 15 U.S. at 195. Mere silence in the face of the ignorant party's question may even have been fraudulent.
32. See Saul Levmore, Securities and Secrets: Insider Trading and the Law of Contracts, 68 VA. L. REV. 117, 139-41 (1982).
33. Granted, a refusal to answer may not arouse the subject's suspicions as much if the researcher has clearly warned the subject from the start that it will never provide feedback about the value of a subject's cells. See infra notes 57-58 and accompanying text.
34. Courts have been willing to stretch the law to avoid severe hold-up problems in other contexts. See generally RICHARD A. EPSTEIN, SIMPLE RULES IN A COMPLEX WORLD 122 (1995) (denying injunction to resident whose property is polluted by manufacturer).
The power of eminent domain illustrates that the wish to avoid hold-up problems sometimes justifies coercion. Indeed some may feel allowing the researcher to use coercion to obtain a further collection no more odious than allowing it to lie. But while both coercion and lying trigger moral objections, lying seems a less serious offense. The lie still preserves the subject's control over whether he will allow a further collection in return for the nominal compensation offered. The lie merely removes the possibility of significant financial gain as a factor in the subject's decision.
In this context giving the researcher the right to force the subject to provide a further collection (i.e., a private right of eminent domain) will not avoid hold-up problems as successfully a right to lie. For if the exercise of the right to eminent domain alerts the subject to the value of his cells, he will be able to hold up the researcher for payment in return for promising to refrain from providing collections to the researcher's rivals. See infra notes 57-58 and accompanying text.
35. The costs of creating and administering property or contract rights in information often need to be incurred only because the information whose production society wishes to incent could not be kept secret in fact. One who develops a trade secret, say, has no need for any legal protection if he can actually keep what he has developed a secret. The law of trade secrets comes into play only when actual secrecy can no longer be maintained. Thus, laws that help an actor keep his information secret in the first place may economize on the costs of laws that are needed only after secrecy is lost. Here, keeping the subject free from any suspicion that his cells have proven valuable avoids all the costs of granting property rights or contractual rights in the key information.
36. Formal property rights in information can be granted through tort doctrines such as unfair competition as well as through trade secret and copyright law.
37. See, e.g., RICHARD POSNER, ANTITRUST LAW: AN ECONOMIC PERSPECTIVE (1976).
38. See, e.g., Fashion Originators Guild of America v. Federal Trade Commission, 312 U.S. 457 (1941) (self-help effort to avoid style piracy condemned as violation of the Sherman Act). In contrast, the courts of England are more inclined to view these self-help efforts favorably. See Robert Heidt, Populist & Economic v. Feudal: Approaches to Industry Self-Regulation in the United States and England, 34 MCGILL L.J. 39, 50 (1989).
39. See OTA REPORT, supra note 1, at 52.
40. Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991). This famous case was brought by a cancer patient against his doctor and his doctor's associates and employer. See id. at 480. In his treatment of the plaintiff over a course of years, the defendant doctor never alerted the plaintiff to the doctor's research interest in the plaintiff's tissues nor did he obtain the plaintiff's consent to any research or commercial use of those tissues. See id. at 481. The plaintiff was allowed to believe the tissues were taken solely for therapeutic purposes whereas in fact some tissues were taken solely for research purposes. See id. In a dramatic and widely publicized opinion the California Court of Appeals found that the defendant's research constituted the tort of conversion, entitling plaintiff to a share of the revenues from the end products of that research. See Moore v. Board of Regents of University of California, 249 Cal. Rptr. 494, 504 (Cal. Ct. App. 1988), rev'd, 793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991). In reversing, the California Supreme Court denied plaintiff's claim for a share of the revenues from the end products. See Moore, 793 P.2d at 479. But the court held that the doctor, as part of his obligation under the informed consent doctrine, needed to disclose his research interest in any treatment he was recommending. Id. at 484-85.
41. See generally Valerio Barrad, Genetic Information and Property Theory, 87 N.W.U. L. REV. 1037, 1083 (1993).
42. See JACQUES BARZUN, BURKE & HARE: THE RESURRECTION MEN (1974).
43. Alan J. Lemin, Patenting Microorganisms: Threats to Openness, in OWNING SCIENTIFIC AND TECHNICAL INFORMATION 196 (Vivian Weil & John Snapper eds., 1989).
44. Perhaps the surest way for the researcher to avoid the holdup would be to collect enough cells during the initial collection so that extra cells could be stored against the possibility that the cell line could not be maintained. The researcher could then recreate the cell line from the stored supply if necessary, and the subject need never be contacted.
Although certain types of cells are more fragile than others, most samples can be frozen and stored. And the survival rate when they are thawed, and recovery attempted, can approach 95%. See OTA REPORT, supra note 1, at 53.
45. Of course, a researcher who insists that its subjects promise to allow not just the immediate collection but future ones as well will predictably persuade fewer subjects to participate.
46. Telling the subject the truth will still enable the subject to exercise the second holdup, namely, "Pay me or I'll tell your rivals what you've learned and allow collections by them." Even if the original agreement contained an enforceable provision barring the subject from allowing collections by others, the subject's threat to allow such collections sub rosa would certainly be credible. Whether explicit or implicit, those threats create a risk for the researcher that it can never eliminate entirely once the subject knows the truth. The wish to avoid this second holdup gives the researcher ample reason to lie despite its contractual protection. For further discussion on the danger presented by the second holdup, see infra text accompanying notes 50-52.
47. See E. ALLEN FARNSWORTH, CONTRACTS § 12.7, at 836 (2d. ed. 1990).
48. Even if courts do everything within their power to force the subject to allow a further collection, a practical researcher must consider the possibility of the knowledgeable subject flouting the courts' orders by fleeing to another jurisdiction or going into hiding. The knowledgeable subject may hope the researcher stands to gain enough from his cells that it will quickly offer financial payment rather than endure delays or risks or incur enforcement costs.
49. See Leitch Gold Mines, Ltd. v. Texas Gulf Sulfur, 1 O.R. 469 (1969).
50. See J.P. ALLENBRIGHT, THE T