CLINICAL TRIALS LITIGATION: PRACTICAL REALITIES AS SEEN FROM THE TRENCHES

Abstract

Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position.

Notes

Morreim, E.H. (2003). Medical Research Litigation and Standard Tort Doctrines: Courts on a Learning Curve. (2003). Houston Journal of Health Law and Policy, 4: 1–86; Mello, M.M. Studdert, D.M., Brennan, T.A. (2003). The Rise of Litigation in Human Subjects Research. Ann Intern Med 139: 40–45.; De Ville, K. (2002). The Role of Litigation in Human Research Accountability. Accountability in Research 9: 17–43; Resnick, D.B. (2004). Liability for Institutional Review Boards: From Regulation to Litigation. Journal of Legal Medicine, 25: 131–184.

To read the complaints in some of these suits, see http://www.sskrplaw.com.

Complaint accessed at http://www.sskrplaw.com/gene/quinn/. Settlement accepted by Philadelphia County Court of Common Pleas, Case No. 001524 (October 2002).

It is the first such device to emerge since the mid-1980s, when the Jarvik-7 was implanted in Barney Clark and several other patients. Fox, R.C., Swazey, J.P. (1992). Spare Parts: Organ Replacement in American Society (New York: Oxford University Press).

Morreim, E.H. (2001). Innovation in Human Research Protection: The Independent Patient Advocacy Council. Law and Bioethics Report 1: 3–5.

Burling, S. (2002). Life, But at What Cost? Philadelphia Inquirer, Sept. 29; Stolberg, S.G. (2002). On Medicine’s Frontier: The Last Journey of James Quinn. New York Times, October 8. See also Burling, S. (2002). Widow Sues Artificial-Heart Maker. Philadelphia Inquirer, Oct. 17. Available at http://www.philly.com/mld/inquirer/news/local/4301284.htm; Goldberg, C. (2002). Widow Sues for Suffering of Artificial Heart Patient. Boston Globe, Oct. 18. Available at http://www.boston.com/dailyglobe2/291/nation; Goldberg, D. (2002) Artificial Heart Implant Leads to Suit Over Consent Process. Washington Post, Nov. 30. Available at http://www.washingtonpost.com/wp-dyn/articles/A54921-2002Nov29.html.

Milford, M. (2001). Lawsuits Attack Medical Trials: As Claims Arise, Some Fear Tests Will Lose Public Support. The National Law Journal, August 21; Washburn, J. (2001). Informed Consent: Alan Milstein Says He Wants to Rescue Us From Unscrupulous Doctors, Undisclosed Risks and Greedy Institutions. But Is He a Shining Knight, or an Enemy of Medical Progress? Washington Post, December 30: W16.

See “Memorandum of Law in Opposition to Preliminary Objections of Defendant David Casarett, M.D.; available at http://www.sskrplaw.com/gene/quinn/.

Among the alleged failings attributed to the PA, the complaint stated that the PA’s duty “was to advise the Quinns regarding . . . whether it was in Mr. Quinn’s best interest to participate” (Quinn complaint #67), yet he “advocated no position for the Quinns” (#68). Elsewhere, the complaint suggests that the PA should have urged the Quinns not to enroll, not via any allegation that this particular person was unable to make a decision, but on the broader ground that anyone so close to death will embrace the “therapeutic misconception” and regard the trial as therapy rather than research. Thus, the bare fact that the patient was eligible for the trial meant, according to this suit, that the PA should have told him not to enroll. Another part of the complaint faulted the PA because he allegedly “failed to set up communications with the wives of other subjects” (#69(e)).

For a discussion arguing that “patient advocate” is a concept with widely varying meanings and no single standard of care, see Morreim, E.H. (2004). By Any Other Name: The Many Iterations of ‘Patient Advocate’ in Clinical Research. IRB: Ethics & Human Research 26(6): 1–8.

Stacey, Burling S. (2003). Widow of Man Who Received Artificial Heart Settles Lawsuit. Philadelphia Inquirer, June 14. Available at http://www.philly.com/mld/inquirer/living/health/6085284.htm.

Essentially, “wrongful life” in this context meant that the patient would not have agreed to enroll in the trial had he known that the quality of his life in the later months would be as poor as it was. Neither the patient nor the family requested at any time to be designated as “DNR” (do not resuscitate), so there was never any claim that wrongful resuscitation of any kind had been administered.

Technically, “wrongful living” would have been the correct allegation. See, e.g., Anderson v. St. Francis–St. George Hosp., 671 NE2d 225 (Ohio 1996). “Wrongful life” suits are brought by impaired infants who allege that if their condition had been diagnosed prenatally, they would have been aborted, avoiding their suffering. See Black, H.C. (1983). Black’s Law Dictionary, 5th ed., p. 830 (St. Paul: West Publishing Co.).

Bovbjerg, R.R., and Bartow, A. Understanding Pennsylvania’s Medical Malpractice Crisis: Facts about Liability Insurance, the Legal System, and Health Care in Pennsylvania. Pew Project on Medical Liability, 2003, at 25.

“One study found that only 8–13% of cases filed went to trial, and only 1.2–1.9% resulted in a decision for the plaintiff” (U.S. Department of Health and Huyman Services, Office of the Assistant Secretary for Planning and Evaluation. [2002]. Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Costs by Fixing Our Medical Liability System, July 24, at 8).

went to the jury on April 1, 2004. On April 8, 2004, the jury found in favor of the Cancer Center in four of five plaintiffs’ cases. The jury concluded that all five patients had been given adequate informed consent and that a “reasonably prudent patient” would have enrolled in the trial, given what was known at the time. The fifth patient’s bone marrow had actually been lost in a laboratory mishap during the research process, an error previously determined by a judge, as a matter of law, to be negligent. The jury awarded that patient’s estate $1 million.

See, e.g., Heath, D. (2004). Trial to Open in Deaths of Cancer Patients at Hutch. Seattle Times, February 1. Available at http://archives.seattletimes.nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=hutch01&date=20040201&query=uninformed+consent, Heath, D. (2004). Couple Didn’t Know Treatment Was Experimental, Man Testifies. Seattle Times, February 18, Available at http://archives.seattletimes.nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=hutch17m&date=20040218&query=uninformed +consent. See Heath, D. (2004). Hutch’s Former Review Chief Tells of Unease at Experiment. Seattle Times, February 19. Available at http://archives.seattletimes.nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=hutch19m&date20040219&query=uninformed +consent. See Heath, D. (2004). “The Hutch” Begins Presenting Defense. Seattle Times, March 10. Available at http://archives.seattletimes.nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=hutch10m0&date=20040310&query=uninformed+consent. See Heath, D. and Timmerman, L. (2004). Jury Finds Hutch Not Negligent in 4 Deaths. Seattle Times, April 9. Available at http://archives.seattletimes. nwsource.com/cgi-bin/texis.cgi/web/vortex/display?slug=hutchverdict09m&date=20040409 &query=uninformed+consent.

Technically, at least some kinds of disclosures would probably not be a breach of privacy, as substantial case law holds that those who to file a lawsuit have waived the usual privilege guarding any medical records pertinent to the claim.

See, e.g., Merhige v. Gubbles, 657 So.2d 1098, 1098 (La. App. 1995): “Disclosure of part of larger body of privileged communication, during trial, is deemed waiver of all communication on subject. Pre-trial partial disclosure of larger body of privileged information constitutes ‘anticipatory waiver’ of privilege, allowing discovery of privileged material whose use at trial is anticipated.”

Bain v. Superior Court, 714 P.2d 824, 827 (Ariz. 1986): “where a privilege holder … places a particular medical condition at issue by means of a claim or affirmative defense, then the privilege will be deemed waived with respect to that particular medical condition.”

State ex rel. Jones v. Syler, 936 S.W.2d 805, 805 (Mo. 1997): “Once plaintiffs put matter of their physical condition in issue under pleadings, they waive physician–patient privilege insofar as information from doctors or medical and hospital records bears on that issue.”

Capps v. Lynch, 116 S.E.2d 137, 141 (N.C. 1960); Matter of K.S., 405 N.W.2d 78, 82 (Wis. 1987); Shamburger v. Behrens, 380 N.W. 2d 659, 662 (S.D. 1986); Kunz v. South Suburban Hospital, 761 N.E.2d 1243 (Ill. App. 2001); Collins v. Blair, 268 N.E. 2d 95, 101 (Ind. 1971)

Many of these cases are based on state statutes that expressly waive confidentiality within the ambit of the litigated claims.

Silver, C., and Syverud, K. (1995). The Professional Responsibilities of Insurance Defense Lawyers. Duke Law Journal 45: 255–363.

Silver, C., and Syverud, K. (1995). The Professional Responsibilities of Insurance Defense Lawyers. Duke Law Journal 45: 255–363; Morgan, T.D. (1997). What Insurance Scholars Should Know About Professional Responsibility. Connecticut Insurance Law Journal 4: 1–15; Pepper, S. L. (1997). Applying the Fundamentals of Lawyers’ Ethics to Insurance Defense Practice. Connecticut Insurance Law Journal 4: 27–74; Barker, W.T. (1997). Insurance Defense Ethics and the Liability Insurance Bargain. Connecticut Insurance Law Journal 4: 75–100; Moore, N.J. (1997). The Ethical Duties of Insurance Defense Lawyers: Are Special Solutions Required? Connecticut Insurance Law Journal 4: 259–303; Baker, T. (1997). Liability Insurance Conflicts and Defense Lawyers: From Triangles to Tetrahedrons. Connecticut Insurance Law Journal 4: 101–151.

Morgan, T.D. (1997). What Insurance Scholars Should Know About Professional Responsibility. Connecticut Insurance Law Journal, 4: 1–15; Silver, C., and Syverud, K. (1995). The Professional Responsibilities of Insurance Defense Lawyers. Duke Law Journal, 45: 255–363; Moore, N.J. (1997). The Ethical Duties of Insurance Defense Lawyers: Are Special Solutions Required? Connecticut Insurance Law Journal 4: 259–303.

Silver, C. and Syverud, K. (1995). The Professional Responsibilities of Insurance Defense Lawyers. Duke Law Journal 45: 255–363.

Jerry, R.H. (1997). Consent, Contract, and the Responsibilities of Insurance Defense Counsel. Connecticut Insurance Law Journal 4: 153–203; Pepper, S.L. (1997). Applying the Fundamentals of Lawyers’ Ethics to Insurance Defense Practice. Connecticut Insurance Law Journal, 4: 27–74.

Silver, C. and Syverud, K. (1995). The Professional Responsibilities of Insurance Defense Lawyers. Duke Law Journal 45: 255–363, at 292.

Johnson, L. J. (2003). If an Insurer Insists on Settling. Medical Economics 80(13): 96; see also Jerry, R.H. (1997). Consent, Contract, and the Responsibilities of Insurance Defense Counsel. Connecticut Insurance Law Journal 4: 153–203, at 202.

Mello, M.M., Studdert, D.M., and Brennan, T.A. (2003). The Rise of Litigation in Human Subjects Research. Ann Intern Med., 139: 40–45.

Mello, M.M., Studdert, D.M., and Brennan, T.A. (2003). The Rise of Litigation in Human Subjects Research. Ann Intern Med., 139: 40–45.

Morreim, E.H. (2003). Medical Research Litigation and Malpractice Tort Doctrines: Courts on a Learning Curve. Houston Journal of Health Law and Policy 4(1): 1–86.

For further discussion of the idea whether people who are imminently dying are capable of consenting to high-risk research, see Morreim, E.H. (2005). High-Risk Research at the End of Life: Who—If Anyone—Can Consent? Perspectives in Biology and Medicine forthcoming.

Weiler P.C., Newhouse, J.P., and Hiatt, H.H. (1992). Proposal for Medical Liability Reform. JAMA 267: 2355–2358, at 2355, Schwartz, W.B., and Komesar, N.K. (1978). Doctors, Damages and Deterrence. New Engl J Med 298: 1282–1289, at 1286; Studdert, D.M., Thomas, E.J., Burstin, H.R., Zbar, Bi., Orav, E.J., Brennan, T.A. (2000). Negligent Care and Malpractice Claiming Behavior in Utah and Colorado. Medical Care 38: 250–260; Localio, A.R., Lawthers, A.G., Brennan, T.A., et al. (1991). Relation Between Malpractice Claims and Adverse Events Due to Negligence: Results of the Harvard Medical Practice Study III. New Engl J Med, 325: 245–251.

Reynolds, R.A., Rizzo, J.A., Gonzalez, M.L., (1999). The Cost of Medical Professinal Liability. JAMA 257: 2776–2781, at 2778; Anderson, R.E., Billions for Defense: The Pervasive Nature of Defensive Medicine. Arch Intern Med., 159: 2399–2402.

De Ville, K. (2002). The Role of Litigation in Human Research Accountability. Accountability in Research 9:17–43, at 32.

Fed. Rules Civ. Proc. Rule 11, 28 U.S.C.A. See, e.g., Smith v. Ricks, 31 F.3d 1478 (9th Cir. 1994), cert. denied 63 USLW 3706, 3/7/95.

Zamos v. Stroud, 1 Cal.Rptr.3d 484 (Cal. App. 2 Dist., 2003).

Crane, M. (1999). Peer Review: Breaking the Code of Silence. Medical Economics 76(9): 158–171.

Osher, C., and Bumsted, B. (2000). PA Keeps Lawyer Discipline Secret. Pittsburgh Tribune-Review December 1. Available at http://www.pittsburghlive.com/x/tribune-review/yesterday/s_105450.html.

Anderson v. St. Francis-St. George Hosp., 671 NE2d 225 (Ohio 1996)

Bain v. Superior Court, 714 P.2d 824 (Ariz. 1986)

Capps v. Lynch, 116 S.E.2d 137 (N.C. 1960)

Collins v. Blair, 268 N.E. 2d 95 (Ind. 1971)

Fed.Rules Civ.Proc.Rule 11, 28 U.S.C.A

Kunz v. South Suburban Hospital, 761 N.E.2d 1243 (Ill. App. 2001)

Matter of K.S., 405 N.W.2d 78 (Wis. 1987)

Merhige v. Gubbles, 657 So.2d 1098 (La. App. 1995)

Shamburger v. Behrens, 380 N.W. 2d 659 (S.D. 1986)

Smith v. Ricks, 31 F.3d 1478 (9th Cir. 1994), cert. denied 63 USLW 3706, 3/7/95.

State ex rel. Jones v. Syler, 936 S.W.2d 805 (Mo. 1997)

Zamos v. Stroud, 1 Cal.Rptr.3d 484 (Cal. App. 2 Dist., 2003)