Toward a Duty to Report Clinical Trials Accurately: The Clinical Alert and beyond

Canterbury v. Spence, 464 F.2d 772 (1972); Hopp v. Lepp, [1980] 2 S.C.R. 192; Reibl v. Hughes, [1980] 2 S.C.R. 880; Barber B. , “The Ethics of Experimentation with Human Subjects,” Sci. Am., 234 (1976): 25–31; Annas G. Glantz L. and Katz B. , Informed Consent to Human Experimentation: The Subject's Dilemma (Cambridge: Ballinger, 1977); Freedman B. , “A Moral Theory of Informed Consent,” Hastings Cent. Rep., 5 (1975): 32–39; and Faden R. and Beauchamp T. , A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

Young D.A. , “Communications Linking Clinical Research and Clinical Practice,” in Roberts E.B. , eds., Biomedical Innovation (Cambridge: MIT Press, 1981), pp. 177–99.

Stinson E.R. and Mueller D.A. , “Survey of Health Professionals” Information Habits and Needs,” JAMA, 243 (1980): 140–43; and Young, supra note 2.

Friedman M.A. , “The Clinical Announcement Policy of the National Cancer Institute,” in Williams C.J. , ed., Introducing New Treatments for Cancer: Practical, Ethical and Legal Problems (Chichester: John Wiley, 1992), pp. 411–19.

DeVita V.T. , “Is a Mechanism Such as the NCI's Clinical Alert Ever an Appropriate Alternative to Journal Peer Review?,” in Important Advances in Oncology 1991 (Philadelphia: J.B. Lippincott, 1991), pp. 2241–46.

Id. The Clinical Alert is only one mechanism that the NIH uses to distribute information.

Friedman , supra note 4, at 414.

Id.

DeVita , supra note 5.

Hellman S. , “Clinical Alert: A Poor Idea Prematurely Used,” in Important Advances in Oncology 1991 (Philadelphia: J.B. Lippincott, 1991), at 256.

Id.

DeVita , supra note 5, at 243.

Id. at 244.

Id.

Shapiro S. Weijer C. and Freedman B. , “The Reporting of Eligibility Criteria in the Dissemination of the Results of Clinical Trials,” manuscript in preparation.

Id.

The following clinical scenarios were suggested to me by Charles Weijer, M.D.

See, for example, Canadian Pharmaceutical Association, Compendium of Pharmaceuticals and Specialties (Toronto: Canadian Pharmaceutical Association, 1993).

National Institute of Allergy and Infectious Diseases, Clinical Alert: Important Therapeutic Information on Prevention of Recurrent Pneumocystis Pneumonia in Persons with AIDS (Bethesda: National Institutes of Health, Oct. 21, 1991).

Hardy WD , “A Controlled Trial of Trimethoprim-Sulfamethoxazole or Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in Patients with the Acquired Immunodeficiency Syndrome,” New. Engl. J. Med., 327, no. 26 (1992): 1842–48.

National Institute of Neurological Disorders and Stroke, Clinical Alert: Benefit of Carotid Endarterectomy for Patients with High-Grade Stenosis of the Internal Carotid Artery (Bethesda: National Institutes of Health, Feb. 25, 1991). This information was included in the journal article. See North American Symptomatic Carotid Endarterectomy Trial Collaborators, “Beneficial Effect of Carotid Endarterectomy in Symptomatic Patients with High-Grade Carotid Stenosis,” New Engl. J. Med., 325, no. 7 (1991): 445–53.

The SOLVD Investigators, “Effect of Enalapril on Survival in Patients with Reduced Left Ventricular Ejection Fractions and Congestive Heart Failure,” New Engl. J. Med., 325, no. 5 (1991): 293–302.

National Heart, Lung, and Blood Institute, Clinical Alert: Effect of Enalapril on Survival in Patients with Reduced Left Ventricular Ejection Fractions and Congestive Heart Failure (Bethesda: National Institutes of Health, July 31, 1991).

Beck R.W. , “A Randomized, Controlled Trial of Corticosteroids in the Treatment of Acute Optic Neuritis,” New Engl. J. Med., 326, no. 9 (1992): 582–88.

National Eye Institute, Clinical Alert: Findings from the Optic Neuritis Treatment Trial (Bethesda: National Institutes of Health, Jan. 21, 1992).

Beck, supra note 24.

Simon R. and Wittes R.E. , For the Editorial Board, “Methodologic Guidelines for Reports of Clinical Trials,” Cancer Treatment Reports, 69, no. 1 (1985): 1–3.

“Uniform Requirements for Manuscripts Submitted to Medical Journals,” Ann. Intern. Med., 108 (1988): 258–65.

Bailar J.C. III and Mosteller F. , “Guidelines for Statistical Reporting in Articles for Medical Journals,” Ann. Intern. Med., 108 (1988): 268.

Id.

Id.

Id.

DerSimonian R. Charette L.J. McPeek B. and Mosteller F. , “Reporting on Methods of Clinical Trials,” New Engl. J. Med., 306, no. 22 (1982): 1334.

Id.

International Committee of Medical Journal Editors, “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” New Engl. J. Med., 324, no. 6 (1991): 424–28.

Id. at 425.

DeVita , supra note 5.

Friedman , supra note 4, at 414.

Shapiro Weijer and Freedman , supra note 15.

Friedman , supra note 4, at 414.

For practical reasons (that is, difficulties in making proof, appeal of negligence arguments to juries, and existence of situations such as hybrid sale-service transactions of used products in which courts have not definitively established a right to sue in strict liability), negligence has a role to play in product liability cases despite the modern remedy of strict liability applicable to many situations. See Allee J.S. , Product Liability (New York: Law Journal Seminars-Press, 1993), at §§ 6.01–6.02.

Picard E.I. , Legal Liability of Doctors and Hospitals in Canada (Toronto: Carswell, 1984), at 150.

Fleming J.G. , The Law of Torts (Sydney: The Law Book Company, 8th ed., 1992), at 129; and Giesen D. , International Medical Malpractice Law (Tubingen: Martinus Nijhoff, 1988), at 74.

Keeton WE Dobbs D.B. Keeton R.E. and Owen D.G. , Prosser and Keeton on the Law of Torts (St. Paul: West Publishing, 5th ed., 1984), at 53.

Fleming , supra note 43, at 482–83.

See, for example, Morris Lord in Hedley Byrne & Co. Ltd. v. Heller & Partners Ltd., [1964] A.C. 465, at 502–03.

Giesen , supra note 43, at 80.

Conflict of interest may exist in cases where litigation is involved and the defendant lawyer must also represent the estate of a deceased client. See Bowman F.J. , “Lawyer Liability to Non-Clients,” Dickinson L. Rev., 97 (1993): at 270 and 282.

Id.

First National Bank of Bluefield v. Crawford, 386 S.E.2d 310, 312 (W.Va. 1989) (Supreme Court of Appeals of West Virginia relying on the position taken in the Restatement (Second) of Torts, (1977) at § 552).

Caparo Industries v. Dickman, [1990] 1 All E.R. 568 (H.L.). Based on the financial picture presented in defendant's audited accounts, a company shareholder purchased additional shares and eventually took over. Dickman sued the accountants after discovering that the company was worth much less than he thought.

Id., per Lord Oliver of Alymerton, at 589.

Ivankovich I.F. , “Back to the Future,” Ottawa L. Rev., 23 (1991): at 516 et seq.

Id. at 518–21.

See, for example, Chapman v. Hearse, (1961) 106 C.L.R. 112, where the High Court of Australia held that it was “reasonably foreseeable” that a physician who stopped by the roadside to aid a negligent driver thrown from his car in an accident might be injured by another negligent driver. The Manitoba Court of Queen's Bench (Urbanski v. Patel (1978), 84 D.L.R. 3d 650, at 671) awarded compensation to a father who donated a kidney to his daughter whose only functioning kidney was mistakenly removed as an ovarian cyst. Wilson J. , found that it was “entirely foreseeable that one of her family would be invited, and would agree, to donate a kidney for transplant.” Cases involving dangerous health products may also be relevant. See Sindell v. Abbott Labs, 163 Cal. Rptr. 132 (1980); and Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741 (11th Cir. 1986).

Allee , supra note 41, at § 6.02[3].

Fleming , supra note 43, at 488.

Buchan v. Ortho Pharmaceuticals (Canada) Ltd., (1986) 54 O.R. (2d) 92, 100.

See, for example, Mauldin v. Upjohn Co., 697 F.2d 644 (1983); and Keeton , supra note 44, at 688.

Allee , supra note 41, at § 7.04[1]

Bigbee v. Pacific Tel. & Tel. Co., 665 P.2d 947,952 (1983).

Keeton , supra note 44, at 685.

Id.

Fleming , supra note 43, at 176.

Allee , supra note 41.

Fleming , supra note 43, at 173.

Id.

[1932] A.C. 562 (H.L.)

Fridman G.H.L. , The Law of Torts in Canada (Toronto: Carswell, Vol. 1, 1989), at 263.

Fleming , supra note 43, at 175.

Id.

Id. See Shirt v. Wyong C., [1978] 1 N.S.W.L.R. 631; Kubach v. Hollands, [1937] 3 All E.R. 907; and Brocklesby v. United States, 753 F.2d 794 (1985).

Fleming , supra note 43, at 564.

(1894), 3 R.J. 461 (Que. Q.B.)

See Filipewich v. University Hospital Board, unreported July 1937 No. 432 (Sask. Q.B.), cited by Picard, supra note 42.

Salgo v. Leland Stanford, Jr., University Board of Trustees, 154 Cal. App. 2d 560, 317 P.2d 170 (1957); Canterbury v. Spence, 464 F.2d 772 (1972); and Reibl v. Hughes, [1980] 2 S.C.R. 880.

Keeton , supra note 44.

Picard , supra note 42, at 152.

Keeton , supra note 44, at 187 and 189.

Id. at 156.

Deschamps P. Glass K.C. Knoppers B.M. and Morneault B. , Health Care Liability in Canada (Montreal: Quebec Research Centre of Private and Comparative Law, 1989), at 43.

Smith J. , “Legal Cause in Actions of Tort,” Harv. L. Rev., 25 (1911): 109.

Picard , supra note 42, at 190.

Id.

Kennedy I. and Grubb A. , Medical Law: Text and Materials (London: Butterworths, 1989), at 426–27.

National Heart, Lung, and Blood Institute and the National Institute on Aging, Clinical Alert: Antihypertensive Treatment for Isolated Systolic Hypertension in Those Over 60 (Bethesda: National Institutes of Health, June 26, 1991); and “Prevention of Stroke by Antihypertensive Drug Treatment in Older Persons With Isolated Systolic Hypertension,” JAMA, 265, no. 24 (1991): 3255–64.

Perry S.R. , “Protected Interests and Undertakings in the Law of Negligence,” U. of Toronto L. J., 42 (1992): 309.

Furrow B.R. , “Quality Control in Health Care: Developments in the Law of Medical Malpractice,” J. Law, Med. & Ethics, 21 (1993): 175.

Id.

In 1987, the House of Lords held that where a lost chance of avoiding a debilitating condition was less than even, and the chance was lost due to the negligent failure to diagnose the plaintiff properly, no liability in tort would exist. See Hotson v. East Berkshire Area Health Authority, [1987] A.C. 750. In 1991, the Supreme Court of Canada, in Laferrièere v. Lawson, [1991] 1 S.C.R. 541, decided that a lost chance of avoiding a debilitating condition (cancer, in that particular case) should not in general be recognized as a separate head of damages in medical malpractice actions.

See Anns v. Merton London Council Borough, [1978] A.C. 728, [1977] 2 All E.R. 492 (H.L.); Just v. British Columbia, (1989), 1 C.C.L.T.(2d) 1 (S.C.C.); Dalehite v. United States, 346 U.S. 15, 73 S. Ct. 956 (1953); and Allen v. United States, 527 F. Supp. 476 (D.Utah 1981). Immunity of the federal government from liability and exceptions to that immunity are established in the Federal Tort Claims Act, Tit. 28, U.S.C.A.

For a discussion of liability of the Medical Research Council of Canada, a Crown agent, see the Medical Research Council of Canada, “Report of the Working Group on Liability,” (1992): unpublished.

Bailar and Mosteller , supra note 29.