Chapter 4.B.3--Forensic Medicine, Medical Evidence, and Discovery

The supplemental materials on this page include:

Daubert. This is the leading decision on the admission of scientific evidence. The notes that follow provide an overview of forensic medicine.

Daubert v. Merrell Dow Pharmaceuticals, Inc.
509 U.S. 579 (1993)

Justice Blackmun delivered the opinion of the Court.

In this case we are called upon to determine the standard for admitting expert scientific testimony in a federal trial.

Petitioners Jason Daubert and Eric Schuller are minor children born with serious birth defects. They and their parents sued respondent in California state court, alleging that the birth defects had been caused by the mothers' ingestion of Bendectin, a prescription anti-nausea drug marketed by respondent. Respondent removed the suits to federal court on diversity grounds.

After extensive discovery, respondent moved for summary judgment, contending that Bendectin does not cause birth defects in humans and that petitioners would be unable to come forward with any admissible evidence that it does. In support of its motion, respondent submitted an affidavit of Steven H. Lamm, physician and epidemiologist, who is a well-credentialed expert on the risks from exposure to various chemical substances. Doctor Lamm stated that he had reviewed all the literature on Bendectin and human birth defects--more than 30 published studies involving over 130,000 patients. No study had found Bendectin to be a human teratogen (i.e., a substance capable of causing malformations in fetuses). On the basis of this review, Doctor Lamm concluded that maternal use of Bendectin during the first trimester of pregnancy has not been shown to be a risk factor for human birth defects.

Petitioners did not (and do not) contest this characterization of the published record regarding Bendectin. Instead, they responded to respondent's motion with the testimony of eight experts of their own, each of whom also possessed impressive credentials. These experts had concluded that Bendectin can cause birth defects. Their conclusions were based upon "in vitro" (test tube) and "in vivo" (live) animal studies that found a link between Bendectin and malformations; pharmacological studies of the chemical structure of Bendectin that purported to show similarities between the structure of the drug and that of other substances known to cause birth defects; and the "reanalysis" of previously published epidemiological (human statistical) studies.

The District Court granted respondent's motion for summary judgment. The court stated that scientific evidence is admissible only if the principle upon which it is based is "sufficiently established to have general acceptance in the field to which it belongs." The court concluded that petitioners' evidence did not meet this standard. Given the vast body of epidemiological data concerning Bendectin, the court held, expert opinion which is not based on epidemiological evidence is not admissible to establish causation. Thus, the animal-cell studies, live-animal studies, and chemical-structure analyses on which petitioners had relied could not raise by themselves a reasonably disputable jury issue regarding causation. Petitioners' epidemiological analyses, based as they were on recalculations of data in previously published studies that had found no causal link between the drug and birth defects, were ruled to be inadmissible because they had not been published or subjected to peer review.

The United States Court of Appeals for the Ninth Circuit affirmed. Citing Frye v. United States, 54 App.D.C. 46, 47, 293 F. 1013, 1014 (1923), the court stated that expert opinion based on a scientific technique is inadmissible unless the technique is "generally accepted" as reliable in the relevant scientific community. . . . The court emphasized that other Courts of Appeals considering the risks of Bendectin had refused to admit reanalyses of epidemiological studies that had been neither published nor subjected to peer review. . . .

In the 70 years since its formulation in the Frye case, the "general acceptance" test has been the dominant standard for determining the admissibility of novel scientific evidence at trial. Although under increasing attack of late, the rule continues to be followed by a majority of courts, including the Ninth Circuit.

The Frye test has its origin in a short and citation-free 1923 decision concerning the admissibility of evidence derived from a systolic blood pressure deception test, a crude precursor to the polygraph machine. In what has become a famous (perhaps infamous) passage, the then Court of Appeals for the District of Columbia described the device and its operation and declared:

Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.Because the deception test had "not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made," evidence of its results was ruled inadmissible.

The merits of the Frye test have been much debated, and scholarship on its proper scope and application is legion. See, e.g., Green, Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation, 86 Nw.U.L.Rev. 643 (1992) (hereinafter Green); Black, A Unified Theory of Scientific Evidence, 56 Ford.L.Rev. 595 (1988); Imwinkelried, The "Bases" of Expert Testimony: The Syllogistic Structure of Scientific Testimony, 67 N.C.L.Rev. 1 (1988); Gianelli, The Admissibility of Novel Scientific Evidence: Frye v. United States, A Half-Century Later, 80 Colum.L.Rev. 1197 (1980). Petitioners' primary attack, however, is not on the content but on the continuing authority of the rule. They contend that the Frye test was superseded by the adoption of the Federal Rules of Evidence. We agree. . . . Rule 702, governing expert testimony, provides:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.Nothing in the text of this Rule establishes "general acceptance" as an absolute prerequisite to admissibility. . . . [A] rigid "general acceptance" requirement would be at odds with the "liberal thrust" of the Federal Rules and their "general approach of relaxing the traditional barriers to 'opinion' testimony." Beech Aircraft Corp. v. Rainey, 488 U.S., at 169, 109 S.Ct., at 450 (citing Rules 701 to 705). . . .

That the Frye test was displaced by the Rules of Evidence does not mean, however, that the Rules themselves place no limits on the admissibility of purportedly scientific evidence. . . . The adjective "scientific" implies a grounding in the methods and procedures of science. Similarly, the word "knowledge" connotes more than subjective belief or unsupported speculation. . . . Of course, it would be unreasonable to conclude that the subject of scientific testimony must be "known" to a certainty; arguably, there are no certainties in science. But, in order to qualify as "scientific knowledge," an inference or assertion must be derived by the scientific method. . . .

Rule 702 further requires that the evidence or testimony "assist the trier of fact to understand the evidence or to determine a fact in issue." This condition goes primarily to relevance. . . . See United States v. Downing, 753 F.2d 1224, 1242 (CA3 1985)("An additional consideration under Rule 702--and another aspect of relevancy--is whether expert testimony proffered in the case is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute"). This consideration has been aptly described by Judge Becker as one of "fit." "Fit" is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes. . . .

That these requirements are embodied in Rule 702 is not surprising. Unlike an ordinary witness, see Rule 701, an expert is permitted wide latitude to offer opinions, including those that are not based on first-hand knowledge or observation. Presumably, this relaxation of the usual requirement of first-hand knowledge--a rule which represents "a 'most pervasive manifestation' of the common law insistence upon 'the most reliable sources of information,' " Advisory Committee's Notes on Fed.Rule Evid. 602--is premised on an assumption that the expert's opinion will have a reliable basis in the knowledge and experience of his discipline.

Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue. We are confident that federal judges possess the capacity to undertake this review. Many factors will bear on the inquiry, and we do not presume to set out a definitive checklist or test. But some general observations are appropriate.

Ordinarily, a key question to be answered in determining whether a theory or technique is scientific knowledge that will assist the trier of fact will be whether it can be (and has been) tested. . . . K. Popper, Conjectures and Refutations: The Growth of Scientific Knowledge 37 (5th ed. 1989) ("[T]he criterion of the scientific status of a theory is its falsifiability, or refutability, or testability").

Another pertinent consideration is whether the theory or technique has been subjected to peer review and publication. Publication (which is but one element of peer review) is not a sine qua non of admissibility; it does not necessarily correlate with reliability, and in some instances well-grounded but innovative theories will not have been published. Some propositions, moreover, are too particular, too new, or of too limited interest to be published. But submission to the scrutiny of the scientific community is a component of "good science," in part because it increases the likelihood that substantive flaws in methodology will be detected. The fact of publication (or lack thereof) in a peer-reviewed journal thus will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.

Additionally, in the case of a particular scientific technique, the court ordinarily should consider the known or potential rate of error, see, e.g., United States v. Smith, 869 F.2d 348 (7th Cir. 1989) (surveying studies of the error rate of spectrographic voice identification technique), and the existence and maintenance of standards controlling the technique's operation.

Finally, "general acceptance" can yet have a bearing on the inquiry. . . . Widespread acceptance can be an important factor in ruling particular evidence admissible, and a known technique that has been able to attract only minimal support within the community may properly be viewed with skepticism.

The inquiry envisioned by Rule 702 is, we emphasize, a flexible one. Its overarching subject is the scientific validity--and thus the evidentiary relevance and reliability--of the principles that underlie a proposed submission. The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate.

Throughout, a judge assessing a proffer of expert scientific testimony under Rule 702 should also be mindful of other applicable rules. Rule 703 provides that expert opinions based on otherwise inadmissible hearsay are to be admitted only if the facts or data are "of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject." Rule 706 allows the court at its discretion to procure the assistance of an expert of its own choosing. Finally, Rule 403 permits the exclusion of relevant evidence "if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury. . . ." Judge Weinstein has explained: "Expert evidence can be both powerful and quite misleading because of the difficulty in evaluating it. Because of this risk, the judge in weighing possible prejudice against probative force under Rule 403 of the present rules exercises more control over experts than over lay witnesses." Weinstein, 138 F.R.D., at 632.

. . . Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence. See Rock v. Arkansas, 483 U.S. 44, 61, 107 S.Ct. 2704, 2714, 97 L.Ed.2d 37 (1987). Additionally, in the event the trial court concludes that the scintilla of evidence presented supporting a position is insufficient to allow a reasonable juror to conclude that the position more likely than not is true, the court remains free to direct a judgment, and likewise to grant summary judgment. Cf., e.g., Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349 (CA6) (holding that scientific evidence that provided foundation for expert testimony [about Bendectin], viewed in the light most favorable to plaintiffs, was not sufficient to allow a jury to find it more probable than not that defendant caused plaintiff's injury). These conventional devices, rather than wholesale exclusion under an uncompromising "general acceptance" test, are the appropriate safeguards where the basis of scientific testimony meets the standards of Rule 702. . . . Accordingly, the judgment of the Court of Appeals is vacated and the case is remanded for further proceedings consistent with this opinion.

Notes:  Forensic Medicine and Epidemiological Evidence

1. The relevance of Daubert, a products liability case against a drug manufacturer, to medical malpractice cases against doctors, may not be readily apparent. This case appears in these materials for two main reasons: (1) it is the Supreme Court's most important statement of the general qualifications for scientific expert testimony; (2) law and medicine has strong historical roots in the field of forensic science; and (3) epidemiological and statistical evidence of the sort at issue in Daubert is increasingly important in medical and other litigation. The implications of the first point for medical malpractice cases are explored in the next set of readings. These notes focus primarily on the second and third points.

2. Junk Science. Daubert was decided after several years of controversy over whether judges were allowing too much "junk science" to prevail in court. The accusation is frequently made that a paid expert can always be found to testify on both sides of any proposition. See, e.g., Peter W. Huber, Galileo's Revenge: Junk Science in the Courtroom (1991). The Bendectin drug is often cited as a leading example of how the unjustified threat of liability can cause a beneficial medical product to be pulled from the market even though virtually the entire scientific community believes it is safe.

One way to conceive of the difference between Frye and Daubert is that Frye deferred to collective opinion of the scientific community whereas Daubert asks judges themselves to determine what constitutes "good science," employing factors such as those mentioned in the opinion. Are judges up to this task? How does this compare with how the medical standard of care is determined?

Some commentators, harshly critical of the way the adversarial system distorts scientific truth, call for more sweeping reforms. One possibility is greater use of neutral, court-appointed experts or special masters, which is standard practice in Europe and was long ago the norm in the U.S. In the U.S., this practice is still allowed by the federal rules but is infrequently done. Another potential reform is to create specialized tribunals (often call "science courts") composed of adjudicators who themselves possess scientific expertise. For an introduction to these proposals, see James Martin, The Proposed "Science Court," 75 Mich. L. Rev. 1058 (1977); Samuel Gross, Expert Evidence, 1991 Wis. L. Rev. 1113 (1991); Symposium, Expert Evidence, 16 Law & Human Behav. 253-379 (1992); K. Kreiling, Managing Expert Evidence: An Overview, 36 Jurimetrics J. 121 (1996); Margaret Farrell, Coping with Scientific Evidence: The Use of Special Masters, 43 Emory L. J. 927 (1994).

3. Daubert's Impact. Initially, it was thought that Daubert made it easier for "junk science" to be introduced than was the case under the Frye rule. Increasingly, it appears, however, that Daubert may have had just the opposite effect. Bert Black, Francisco J. Ayala, and Carol Saffran-Brinks, Science and the Law in the Wake of Daubert: A New Search for Scientific Knowledge, 72 Tex. L. Rev. 715, 722 (1994). On remand, the 9th Circuit reaffirmed its prior opinion. It reasoned: (1) the plaintiffs' experts had developed their positions specifically in response to litigation and therefore deserved heightened skepticism; (2) no independent scientists agreed with them; and (3) the evidence flunked Daubert's "fit" test because it showed at most only an increased risk, not actual causation of birth defects for any of these particular plaintiffs. Daubert v. Merrell Dow Pharmaceuticals, 43 F.3d 1311. Does this violate the Supreme Court's command not to confuse the underlying methods with the scientists' conclusions? In a subsequent decision, the Court affirmed a trial judge's decision to exclude opinion testimony from established scientists based on animal studies and epidemiological evidence that the plaintiff's lung cancer was caused by his exposure to PCBs. The Court held that it was not an abuse of discretion for the judge to conclude that "there [was] simply too great an analytical gap between the data and the opinion proffered." General Electric Co. v. Joiner, 118 S. Ct. 512 (1997). For other courts who excluded apparently conventional scientific evidence applying the Daubert standards, see Chikovsky v. Ortho Pharmaceutical Corp., 832 F.Supp. 341 (S.D. Fla. 1993) (obstetrician not allowed to testify that Retin-A causes birth defects); Wade-Greaux v. Whitehall Lab., 874 F.Supp. 1441 (D.V.I. 1994)(animal studies not sufficient to show nasal decongestant caused birth defe cts).

4. State Law. Recognize that Daubert states only federal law. Prior to Daubert, the majority of states adhered to the Frye rule, and following Daubert, of the handful that have reconsidered the issue, almost half have reaffirmed Frye. Joseph R. Meaney, From Frye to Daubert: Is a Pattern Unfolding?, 35 Jurimetrics 191 (1995) ("Frye supporters can send get well cards, but the funeral has been postponed."). For general commentary and critique on Daubert and the state of the law, see Symposium, Translating Science into Law: Lessons from Doctors, Judges, and Lawyers about the Use of Medical Evidence in the Courtroom, 36 New Eng. L. Rev. 573 (2002); Symposium, Scientific Evidence after the Death of Frye, 15 Cardozo L. Rev. 1745 (1994); Lee Loevinger, Science as Evidence, 35 Jurimetrics J. 153 (1995); Developments, Confronting the New Challenges of Scientific Evidence, 108 Harv. L. Rev. 14881 (1995); P. Giannelli & E. Imwinkelried, Scientific Evidence (1986). For discussion prior to Daubert, see the sources cited in the opinion.

5. Daubert's Scope. Daubert has generated extensive debate over the range of experts and topics of testimony to which it applies.  Rule 702 allows expert testimony on an unlimited range of technical or specialized topics; scientific knowledge is only one subset. For a time, courts and commentators thought Daubert might be limited to only scientific theories or techniques.  However, in Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) , the Court clarified that Daubert also applies to "technical or other specialized knowledge," and so it sustained a trial court's decision to exclude as unreliable the proffered testimony of an expert on tire failure, in a case claiming that a manufacturing defect caused a tire to blow out.  Similarly, it seems clear that Daubert factors can be used to evaluate economic testimony going to damages calculations in medical malpractice cases (that is, the extent and measure of injuries), and medical expertise on causation issues (whether the injuries resulted from the physician's error or would have happened anyway). See, e.g., North Dallas Diagnostic Ctr. v. Dewberry, 980 S.W.2d 90 (Tex. App. 1995); Moore v. Ashland Chemical Inc., ___ F.3d ___ (5th Cir. en banc 1998). See generally, D.H. Kaye, The Dynamics of Daubert: Methodology, Conclusions, and Fit in Statistical and Econometric Studies, 87 Va. L. Rev. 1934 (2001); Note, Navigating Uncertainty: Gatekeeping in the Absence of Hard Science, 113 Harv. L. Rev. 1467 (2000).  Consider, for instance, that in the Bendectin controversy, plaintiffs had one physician, Dr. Palmer, who was willing to state unequivocally that the drug caused the plaintiff's defects. He stated:

It is my opinion . . . that [animal in vivo and in vitro studies, and epidemiological and other human data] shows that Bendectin and specifically its component, doxylamine succinate, has teratogenic properties. . . . I have also examined the medical records pertaining to Brandy Turpin and it is my opinion . . . that Bendectin did cause the limb defects from which she suffers.Nevertheless, the 9th Circuit in Daubert agreed with the 6th Circuit in Turpin (which the Supreme Court cites favorably) in concluding that this failed to create a jury issue: "This testimony is [no]thing more than a personal belief or opinion. . . . Dr. Palmer does not testify on the basis of the collective view of his scientific discipline, nor does he take issue with his peers and explain the grounds for his differences. Indeed, no understandable scientific basis is stated. Personal opinion, not science, is testifying here." 959 F.2d 1349.
As discussed in the main text, however, just this type of qualitative opinion testimony is exactly what malpractice litigants almost always rely on. More rigorous quantitative proof is seldom available because the medical mistake at issue is rarely common and widespread enough to be subjected to the large epidemiological studies that the courts favor in suits against pharmaceutical companies. Presumably, more is demanded in the drug cases because better evidence is available. Is this a correct application of Daubert, or should scientific evidence that is admissible in any case be admitted in every case (assuming it is equally relevant to a fact in issue)? Is weak scientific evidence "prejudicial" just because a jury might use it to reject stronger evidence?  See generally Jerome P. Kassierer & Joe S. Cecil, Inconsistency in  Evidentiary Standards for Medical Testimony, 288 New Eng. J. Med. 1392 (2002).

Much more controversial is whether  Daubert might be used to block expert testimony on the medical standard of care.  Although this requires a certain type of scientific or technical expertise, it relates to standards of professional practice and clinical judgment, not the use of a scientific method to arrive at conclusions about facts in the case. See, e.g., Reese v. Stroh, 907 P.2d 282 (Wash. 1995).

6. Epidemiological Evidence. Focussing on the kind of epidemiological evidence that prevailed in the Bendectin case, consider situations where that evidence favors the plaintiff. How strong a statistical association must be shown before causation is actually proven? If the study is well designed, it will control for "confounding factors" that might offer an innocent explanation for the observed harm. A good study also uses an observation technique that attempts to sample objectively a random or representative selection from the population at large. Even when these criteria for sound methodology are met, a difficulty arises from using probability figures for a large number of cases to decide what happened in the particular case under litigation. A pressing example of this dilemma comes from the current litigation over silicone breast implants. The largest study to date (400,000 respondents and 10,000 patients), conducted at Harvard, shows a 24 percent increased risk of "connective tissue disease," amounting to 1 in 3000 women each year attributable to the implants. The authors interpreted this study as ruling out any "large hazard," but plaintiffs' attorneys hailed it as confirming their previously-discredited allegations. Numerous other physicians are willing to testify that they are convinced that implants cause these illnesses because their patients often improve markedly when the implants are removed. N.Y. Times, Feb. 28, 1996, at A14. Is this the type of evidence that should go to the jury? On remand, the 9th Circuit in Daubert agreed with a number of other courts that, under a civil standard (preponderance of the evidence), plaintiffs must show an increased risk of at least 200 percent in order to create a jury issue on causation, because only then can it be said with scientific certainty that the hazardous agent "more likely than not" caused the injury compared with all other possible causes. In medical malpractice cases, many of these difficulties over statistical uncertainty are avoided using the "loss of chance" theory, which allows partial recovery even when causation is less likely than not. Also, contrast the different levels of proof necessary to justify regulation as opposed to compensation in tort. Even a slight and uncertain elevated risk may be sufficient to ban or regulate a carcinogen, environmental hazard, or medical drug. See generally Lucian Leape, Quantitative Risk Assessment in Regulation of Environmental Carcinogens, 4 Harv. Envtl. L.Rev. 86 (1980); Public Citizen v. Young, 831 F.2d 1108 (1987).

For additional commentary on these and other aspects of statistical proof and jury competence, see The Evolving Role of Statistical Assessments as Evidence in the Courts (Feinberg ed. 1989); Stephen E. Feinberg, et al., Understanding and Evaluating Statistical Evidence in Litigation, 36 Jurimetrics J. 27 (1995); Daniel Shaviro, Statistical-Probability Evidence and the Appearance of Justice, 103 Harv. L. Rev. 530 (1989); Craig R. Callen, Adjudication and the Appearance of Statistical Evidence, 65 Tul. L. Rev. 457 (1991); Symposium, Decision and Inference in Litigation, 13 Cardozo L. Rev. 253-1079 (1991); M. Dore, A Commentary on the Use of Epidemiological Evidence in Demonstrating Cause-in-Fact, 7 Harv. Envtl. L. Rev. 429 (1983); Bert Black & David Lilienfeld, Epidemiological Proof in Toxic Tort Litigation, 52 Ford L. Rev. 732 (1984); T. Brennan, Causal Chains and Statistical Links: The Role of Scientific Uncertainty in Hazardous Substance Litigation, 73 Cornell L. Rev. 469 (1988); Harold Ginzburg, Use and Misuse of Epidemiological Data in the Courtroom: Defining the Limits of Inferential and Particularistic Evidence in Mass Tort Litigation, 12 Am. J.L. & Med. 423 (1986); Steve Gold, Causation in Toxic Torts: Burdens of Proof, Standards of Persuasion, and Statistical Evidence, 96 Yale L.J. 376 (1986); Scott Brewer, Scientific Expert Testimony and Intellectual Due Process, 107 Yale L. J. 1535 (1998); Lars Noah, Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking, 59 U. Pitt. L. Rev. 677 (1998).


Sample medical records in McCourt v. Abernathy

Emergency Department Record,
History and Physical,
Progress Record,
Daily Nurses Record,
Medication Administration Record,
Clinical Laboratory Report


Duquette
This case, and the notes that follow, explore various aspects of discovery and confidentiality that are of special importance in medical malpractice cases.

Duquette v. Superior Court
778 P.2d 634 (Ariz. App. 1989)

Contreras, Judge.

In this special action, we consider the issue of whether defense counsel in a medical malpractice action may engage in ex parte communications with the plaintiff's treating physicians without having obtained plaintiff's consent. . . .

[One-year old Eric Lamberty] was diagnosed as having a dermoid tumor in and around his spinal column. The tumor required surgery. . . . Following the surgery, the Lambertys filed a civil action against Dr. Duquette alleging that he committed medical malpractice by failing to: (1) treat Eric properly during his birth hospitalization, and (2) diagnose the tumor in a timely fashion. Scottsdale Memorial Hospital was also a named defendant under an agency theory of liability.

In the summer of 1987, defense attorneys for petitioners conducted ex parte interviews of approximately thirteen of plaintiff's treating physicians without the express consent of plaintiff, his parents, or his counsel. . . . [P]laintiffs filed a motion to bar testimony and to disqualify counsel. . . . Petitioners seek special action review of that portion of Judge Moroney's order barring plaintiff's treating physicians from testifying as expert witnesses unless first offered as witnesses by plaintiffs. . . .

[P]etitioners first contend that the ex parte communications between plaintiff's treating physicians and defense attorneys were not improper because the physician-patient privilege had been waived. . . . The Arizona statute precludes a physician from being examined about any communications made by the patient concerning his condition or any knowledge of the condition obtained through personal examination of the patient without the consent of the patient. . . . [P]etitioners contend that the real parties in interest waived the privilege when they: 1) placed Eric's medical condition in issue by filing suit, and 2) claimed Eric's medical expenses as damages in their civil complaint. . . .

[T]he Arizona Supreme Court [has] stated that when a plaintiff "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." In accordance with [this ruling], we conclude that Eric's parents have waived the physician-patient privilege by placing their son's medical condition at issue through initiation of litigation.

This waiver is not absolute however, and we believe petitioners' reliance on implied waiver in support of the propriety of ex parte communications is misplaced. In this regard, we agree with those cases which conclude that even where the physician-patient privilege has been impliedly waived, the holder of the privilege waives only his right to object to discovery of pertinent medical information which is sought through the formal methods of discovery authorized by the applicable Rules of Civil Procedure. . . .

Those courts which have taken the view that a defendant's counsel may interview the plaintiff's treating physicians ex parte have identified a number of factors and policies for allowing such informal methods of discovery. These include decreased litigation costs, the potential to eliminate non-essential witnesses, early evaluation and settlement of claims, the ease of scheduling interviews as opposed to depositions, and greater spontaneity and candor in the interview than in the deposition. Annot., 50 A.L.R. 4th 714.

Those courts which have taken an opposite view and have held that the defendant's counsel is limited to the formal methods of discovery listed within the Rules of Civil Procedure have based their decisions on varying propositions. Among the reasons relied upon in refusing to grant permission for informal ex parte interviews are the broad privacy interest underlying the physician-patient relationship, the potential tort liability of physicians for breach or invasion of privacy, the potential that defense counsel may seek to improperly influence plaintiff's treating physicians or may discourage the physician from testifying, the duty of loyalty from the physician to the patient, and the view that discovery rules determine the extent of the physician-patient privilege. Id. . . .

We note, . . . that a ban on ex parte communications does not preclude defense attorneys from contacting plaintiff's treating physicians. Rather, such a ruling merely limits the methods of contact available to the defense attorney to those methods authorized by our Rules of Civil Procedure. . . .

[W]e believe that the unique nature of the physician-patient relationship justifies a ban on ex parte communications. We recognize that such a ban allows the plaintiff to engage in ex parte communications with his physician witnesses while it prohibits the defendant from gaining equal access. However, this inequality of access to the physician witnesses does not preclude the defendant from availing himself of the full panoply of discovery devices. . . . [W]e do not believe that such practical concerns as cost efficiency and ease of scheduling are of paramount concern to a proper resolution of the issue. . . . We believe the public has a widespread belief that information given to a physician in confidence will not be disclosed to third parties absent legal compulsion, and we further believe that the public has a right to have this expectation realized. See Petrillo v. Syntex Laboratories, Inc., 499 N.E.2d 952, 959-62 (1986). We agree with the Petrillo court when, in limiting physician disclosure to court authorized methods of discovery, it stated:

 Discussion of the patient's confidences under any other circumstances, such as the ex parte conference, could be inconsistent with the duties of a fiduciary for the physician would, in effect, engage in conduct which may be contrary to a fiduciary's obligation of good faith and, in addition, may be potentially harmful to the interests of the patient which are unrelated and irrelevant to the mental or physical condition placed at issue in the lawsuit. . . .A second set of considerations supporting a prohibition on ex parte communications involves the pressure brought to bear on the physician. . . . Although the physician is free to reject such a request and thereby force the defense attorney to utilize formal methods of discovery, we believe that this option does not acceptably reduce the pressure on the physician. . . . [A] substantial number of physicians are insured by a single "doctor owned" insurer. Realistically, this factor could have an impact on the physician's decision. In other words, the physician witness might feel compelled to participate in the ex parte interview because the insurer defending the medical malpractice defendant may also insure the physician witness.

An additional factor that must be taken into consideration is that a physician who allows himself to be interviewed ex parte embarks, perhaps unknowingly, on a course which may involve a breach of professional ethics and potential liability. First, participation in an ex parte interview may constitute a breach of the physician's professional code of ethics. . . . Thus, the physician's voluntary participation in the ex parte interview may subject him or her to professional discipline as well as potential tort liability. . . .

An additional consideration supporting a ban on ex parte interviews involves the practical difficulty in determining the scope of the waiver of the physician-patient privilege. The scope of the waiver is often in dispute, and absent court participation in the discovery process, resolution of that dispute is left to the defense attorney and the physician witness. We believe that this scenario places both the defense attorney and the physician in an untenable position. As the Iowa Supreme Court stated in Roosevelt Hotel Ltd. Partnership v. Sweeney, 394 N.W.2d 353, 357 (1986):

Placing the burden of determining relevancy on an attorney, who does not know the nature of the confidential disclosure about to be elicited, is risky. Asking the physician, untrained in the law, to assume this burden is a greater gamble and is unfair to the physician. We believe this determination is better made in a setting in which counsel for each party is present and the court is available to settle disputes.. . . . Accordingly, we hold that defense counsel in a medical malpractice action may not engage in non-consensual ex parte communications with plaintiff's treating physicians.

We now consider the sanction imposed by the trial court. . . . Prior to today's decision, the law on this issue in the State of Arizona was unsettled. . . . Given this situation, we believe that it was an abuse of discretion for the trial court to summarily impose the sanction of preclusion of testimony. . . . Remanded.
 

Notes:  Discovery and Confidentiality

1. Waiver of Confidentiality. Although a malpractice plaintiff waives her right to confidentiality in the medical records and treatment relationship at issue in the litigation, that waiver does not extend to any treatment the plaintiff might have ever received, even by the same doctor. Courts tailor the waiver to fit the allegations of the complaint in order to avoid deterring suit by unnecessarily forcing a plaintiff to expose all embarrassing or private aspects of her medical past. See, e.g., R.K. v. Ramirez, 887 S.W.2d 836 (Tex. 1994).

2. Ex Parte Interviews. In Duquette, the court declined to impose a penalty the first time the prohibition on ex parte interviews was announced in the state. Other courts, however, have barred defendants from using physician witnesses that were improperly contacted. Additional penalties might include a tort action against the interviewed physician for breach of confidence, or a disciplinary action against the lawyer.

The waiver of the physician-patient privilege, and the corresponding prohibition of informal discovery, apply equally to any civil action such as automobile accidents or products liability in which the plaintiff's medical condition is placed at issue. As should be obvious, the prohibition against contacting the plaintiff's doctor informally applies only to non-party physicians. A defendant doctor can talk all he wants with his own lawyer. Acosta v. Richter, 671 So.2d 149 (Fla. 1996). The issue is cloudier, however, if the defendant and non-party doctors practice together in the same partnership, or if they both work at the same hospital that is named in the suit. Testin v. Dryer Medical Clinic, 605 N.E.2d 1070 (Ill. App. 1992) applied the ban on ex parte interviews to a plaintiff's subsequent treating physician who was director of the clinic in which the defending physician worked. Ritter v. Rush Presbyterian-St. Luke's Med. Ctr., 532 N.E.2d 327 (Ill. App. 1988) applied the ban to a hospital lawyer's communication with other treating physicians in the same hospital, but observed in dictum that this prohibition should not be carried so far as to "effectively prevent [a] hospital from defending itself by barring communication with [a] physician for whose conduct the hospital is allegedly liable." What strategy does this suggest for a plaintiff's lawyer in deciding whether to name a hospital as a defendant? In deciding how many physicians to name as defendants? What may a hospital lawyer safe possible claim when the plaintiff's precise allegations and theories of liability are unknown? According to Keith Emmons, an Illinois lawyer, "the best present option would appear to be the early identification of all potentially liable practitioners and entities and the appointment of separate defense counsel for [each one] even before they become named defendants." Each lawyer can interview her own client, and nothing in the ex parte rule appears to prevent the lawyers from talking amongst themselves, or does it?

For recent cases pro and con on the ex parte rule, see Brandt v. Pelican, 856 S.W.2d 658 (Mo. 1993)(allowing informal interviews); Domako v. Rowe, 475 N.W.2d 30 (Mich. 1991) (same); Samms v. District Court, Fourth Judicial District of the State of Colorado, 908 P.2d 520 (Colo. 1996)(same, but only if opposing attorney is given notice and chance to attend informal interview); Heller v. Mutual Ins. Co., 32 Cal. Rptr.2d 200 (Cal. 1994) (refusing to impose civil damages against doctor who gave ex parte information); Burger v. Lutheran Gen. Hosp., _______ (Ill. 2001) (upholding statute that allowed ex parte communications between hospital and physician's lawyers); Crist v. Moffatt, 389 S.E.2d 41 (N.C. 1990) (prohibiting ex parte contact); Kitzmiller v. Henning, 437 S.E.2d 452 (W.Va. 1993)(same); Scott v. Flynt, 704 So. 2d 998 (Miss. 1996) (same). For commentary and analysis, see Elliot B. Oppenheim, Physicians as Experts Against Their Own Patients? What Happened to the Privilege?, 63 Def. Couns. J. 254 (1996); W. McVisk, A More Balanced Approach to Ex Parte Interviews by Treating Physicians," 20 Loy. U. Chi. L.J. 819 (1989); P. Corboy, Ex Parte Contacts Between Plaintiff's Physicians and Defense Attorneys: Protecting the Patient-Litigant's Right to a Fair Trial, 21 Loy. U. Chi. L.J. 1001 (1990); Note, The Permissibility of Ex Parte Communications Between Plaintiff's Treating Physicians and Defense Counsel, 59 Mo. L. Rev. 441 (1994); Annot., 50 A.L.R.4th 714 (1986).

3. Defense Doctrines. Other sources of confidentiality and evidentiary privilege protect the defendant in a malpractice action. The primary sources are: (1) peer review confidentiality statutes like those discussed in the main text; (2) the attorney-client communication privilege; and (3) the lawyer's work product privilege.

Peer review confidentiality attaches by statute in most states to various standing hospital committees that investigate the competence of individual practitioners and the quality of care rendered within the institution. Examples include the credentialing committee, which investigates matters relating to physicians' membership on the medical staff, the quality assurance committee, which sets policies and reviews performance with respect to various technical components of medical treatment (preventing infection, ensuring sterilization, etc.), and more specialized committees such as a tissue committee or blood loss committee which monitors the performance of surgeries. In order to assure candor and vigorous participation in these activities, state statutes protect from discovery any records generated by these committees. The constitutionality of one such statute was upheld in Eubanks v. Farrier, 267 S.E.2d 230 (Ga. 1980), where the court observed that the statute represented a legislative balance "between the competing public concerns of fostering medical staff candor, on the one hand, and impairing medical malpractice plaintiffs' access to evidence, on the other hand." A few decisions have recognized a common-law privilege protecting protecting self-evaluation or self-improvement efforts even in the absence of such statutes. See Bredice v. Doctor's Hosp., 50 F.R.D. 249 (D.D.C. 1970), aff'd, 479 F.2d 920 (D.C. 1973); Comment, Criticizing the Self-Criticism Privilege, 1987 U. Ill. L. Rev. 675; Notes, The Privilege of Self-Critical Analysis, 96 Harv. L. Rev. 1083 (1983).  For an especially strong statement of the public policy in favor of peer review confidentiality, see Virmani v. Presbyterian Health Services, 515 S.E.2d 675 (N.C. 1999) (finding that harm to peer review participants from disclosure overrides constitutionally-protected right of public to open access of the courts).  In a related decision arising from the same litigation, however, the Fourth Circuit declined to recognize a federal evidentiary privilege, at least in a context where a disciplined physician is claiming racial discrimination, reasoning that the public policy balance is different than in a medical malpractice case.  Virmani v. Novant Health Inc., ___ F.3d ___, 2001 WL 868022 (4th Cir. 2000). 

The concern that the threat of liability deters reporting medical errors and therefore hampers quality improvement led recently to Congress adopting a discovery privilege and liabilitiy protection in the Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41).  This protects from discovery any reportsof medical errors made by health care providers to certified "patient safety organizations," such as the Joint Commission (JCAHO).  However, any such records must be maintained only for patient safety evaluation purposes, and not for patient care or billing purposes.

These statutes produce a steady stream of litigation over precisely which committees and records they cover. Consider, for instance, whether the privilege extends to the proceedings of ethics committees or to personnel files maintained by central administration. See Andrew Merritt, The Tort Liability of Hospital Ethics Committees, 60 S. Cal. L. Rev. 1239 (1987). Answers to these questions depend on the variability of statutory wording in each state. For a sampling of decisions, see Estate of Pastore v. Samson, (R.I. 2006) (privilege does not apply to records that originate elsewhere and are given to the peer review committee); Sisters of Charity Health Sys. v. Raikes, 984 S.W.2d 464 (1998) (statute applies only to actions directly challenging peer review decisions and not to medical malpractice actions); Babcock v. Bridgeport Hosp., 742 A.2d 322 (Conn. 1999) (statute applies only to documents that directly relate to a particular health care professional's performance, and so not to documents prepared by an infection control committee relating to hospital-wide infection control statistics and protective measures); Carr v. Howard, 689 N.E.2d 1304 (Mass. 1998) (incident reports and other peer review records cannot even be reviewed by judge in camera); Harston v. Campbell Co. Mem. Hosp., 913 P.2d 870 (Wyo. 1996) (statute does not create an absolute privilege; court must balance plaintiff's need to know with hospital's interest in secrecy); Trinity Med. Ctr. v. Holum, 544 N.W.2d 148 (N.D. 1996) (statute covers only enumerated, mandatory committees and not every aspect of hospital "quality assurance"); Willing v. St. Joseph Hospital, 531 N.E.2d 824 (Ill. App. 1988) (statute does not cover material in physician's application for staff privileges or committee's decision on the application, only its investigation and deliberation); Memorial Hosp. v. McCown, 927 S.W.2d 148 (Tex. 1996) (statute covers both initial admission to medical staff and review of those already on staff); Variety Children's Hosp. v. Mishler, 670 So.2d 184 (Fla. App. 1996) (privilege applies to documents prepared for JCAHO accreditation inspection); McClellan v. HMO of Pennsylvania, 686 A.2d 801 (1996) (statute does not cover IPA model HMOs); Fulton-Dekalb Hop. Auth. v. Dawson, 509 S.E.2d 28 (Ga. 1998) (peer review immunity does not apply to peer review organization that conducts utilization review for reimbursement purposes under Medicare and Medicaid). See generally S. Scheutzow & S. Gillis, Confidentiality and Privilege of Peer Review Information: More Imagined than Real, 7 J. L. & Health 169 (1992) (containing extensive analysis of individual states); Comment, The Medical Review Committee Privilege: A Jurisdictional Survey, 67 N.C.L. Rev. 179 (1988); Janet Rowland, Enforcing Hospital Responsibility through Self-Evaluation and Review Committee Confidentiality, 9 J. Leg. Med. 377 (1988); Randall Butler, Records and Proceedings of Hospital Committees Privileged Against Discovery, 28 S. Tex. L. Rev. 97 (1987); Reed Hall, Hospital Committee Procedures and Reports: Their Legal Status, 1 Am. J. L & Med. 245 1978; Annot., 81 A.L.R.3d 944 (1977); Annot., 60 A.L.R. 4th 1273 (1988).

The major area of dispute that concerns all three sources of evidentiary privilege is whether any of them apply to "incident reports" and investigations conducted by hospital risk management departments. As discussed in Chapter 4.F.1, most hospitals have a risk manager whose job is distinct from hospital counsel, to establish policies and protocols to minimize legal exposure. One standard risk management task is to investigate certain, defined adverse events such as improper medication or unexpected deaths. In addition to these "routine" investigations for purposes of quality improvement, risk managers investigate incidents individually targeted as likely to generate liability claims. Naturally, it is often difficult to classify an incident report as quality improvement rather than liability investigation.

Hospitals might seek to protect internal investigations first under the peer review privilege. Their success often depends on whether a committee designated in the statute requested the report. Compare Ware v. Miami Valley Hops., 604 N.E.2d 791 (Ohio App. 1992) (incident reports are absolutely privileged) and Gregory v. Heritage Hosp., 594 N.W.2d 455 (Mich. 1999); with Cochran v. St. Paul Fire & marine Ins. Co., 909 F.Supp. 641 (W.D. Ark. 1995) (incident reports are discoverable); Columbia/HCA Healthcare Corp. v. Eighth Judicial District Court, 936 P.2d 844 (Nev. 1997) (same). The hospital might next seek to protect these reports as attorney work product, but this extends only to reports prepared specifically in anticipation of litigation, and only to the opinions and conclusions drawn by the attorneys themselves. See Sims v. Knollwood Park Hosp., 511 So. 2d 154 (Ala. 1987); Shotwell v. Winthrop Community Hosp., 531 N.E.2d 269 (Mass. App. 1988). Third, incident reports might contain confidential attorney-client communications. See Mlynarski v. Rush Presbyterian-St. Luke's Med. Ctr., 572 N.E.2d 1025 (Ill. App. 1991). However, some courts have ruled that reports prepared as a matter of hospital routine or not directed to or ordered by attorneys fail to arise in a legal counseling context. Clark v. Norris, 734 P.2d 182 (Mont. 1987).

When one of these three evidentiary privileges attaches, observe that it protects only communications and records, not facts. Parties may not protect facts by disclosing them to a lawyer or a peer review committee, nor may witnesses be barred simply because they participated in these privileged communications. They are still required to testify from their independent recollection. Moretti v. Lowe, 592 A.2d 855 (R.I. 1991); Freeman v. Piedmont Hosp., 448 S.E.2d 378 (Ga. 1994). The ability to protect specific communications may, however, keep the opposing lawyer from using these records to refresh recollection or impeach a witness. In Samaritan Foundation, infra, for instance, three nurses who had witnessed an operation leading to a child's death could not recall two years later anything that happened in the operating room. The Court held that the hospitals' investigative report was not privileged. If it were privileged, however, the plaintiff's attorney would have been barred from introducing these records of the nurses' contemporaneous observations.

4. Like other evidentiary privileges, these privileges covering hospital reports and committees can be waived. Consider, for instance, a hospital that responds to negative publicity about a bad accident by reporting that an internal committee has investigated the incident and taken corrective steps to make sure it doesn't happen again. This might be viewed as constituting a waiver that subjects the hospital's internal deliberations and fact-gathering to full discovery.

5. Where the attorney-client or work product privilege applies, substantial controversy exists over how broadly it should extend, in the context of large corporations such as hospitals that have many employees. Corporations, like individuals, must be able to seek legal advice and prepare a defense, but because mistakes in medical treatment occur entirely within the confines of the defending institution, there are unlikely to be many witnesses who are not employees. Therefore, the corporate attorney-client privilege could severely hamper a plaintiff's ability to investigate and prove an allegation of medical malpractice. To balance these concerns, the Arizona Supreme Court in one case took the position that hospitals may claim attorney-client protection only for information gathered from potential defendants, that is, employees concerned about their own liability. A hospital may not protect information from employees who merely witnessed the potential wrongdoing of others. The court was unimpressed with the hospital lawyers' attempt to categorize employee witnesses as "clients" by having them sign a form agreeing to be represented by the lawyers in the event of suit. Samaritan Foundation v. Goodfarb, 862 P.2d 870 (Az. 1993). In contrast with this "functional test" (i.e., the purpose of the communication), most other courts extend the attorney-client privilege more broadly to cover all communications with hospital employees about events in the course of their employment (the "subject matter test"), while a few other courts restrict the privilege to communications only with management employees who make litigation decisions (the "control group test"). See Samaritan Foundation for a review of authorities.

6. Access to Medical Records. The primary source of evidence for potential plaintiffs is their own medical records. Historically, doctors and hospitals have been highly protective of these records, not only to preserve the patient's confidentiality in them, but to assert their ownership and custody of the records as against the patient or against other medical providers. While the doctor or hospital does own the tangible paper on which the records are kept, they are obliged to provide copies to patients, who have a privacy right to know their contents. In many states, litigation or statutory action has been required to establish this right. Plaintiffs obviously face much greater difficulty, however, in obtaining the medical records of other patients of the same physician. This requires filing a discovery request and usually obtaining a court order. The order is usually given where the plaintiff agrees to accept redacted records that delete any identifying information. See, e.g., Amente v. Newman, 653 So.2d 1030 (Fla. 1995).



Miscelaneous Notes about Sources of Medical Evidence and Qualification of Experts.

Additional analyses of forensic medicine topics can be found at:  Edward J. Imwinkelried, The admissibility and legal sufficiency of testimony about differential diagnosis (etiology): of under-and over-estimations, 56 Baylor L. Rev. 391-421 (2004).

Examples of practice guidelines can be located at the National Guideline Clearinghouse, maintained by AHRQ.  For additional legal analysis, see Carter L. Williams, Evidence-Based Medicine in the Law Beyond Clinical Practice Guidelines: What Effect Will EBM Have on the Standard of Care?, 61 Wash. & Lee L. Rev. 479 (2004).

Regarding professional disciplinary actions against expert witnesses for testimony judged to be inappropriate, see Fred L. Cohen, The Expert Medical Witness in Legal Perspective, 25 J. Leg. Med. 185 (2004).

Regarding the evidentiary privilege for peer review materials, see  Lisa M. Nijm, Pitfalls of Peer Review, 24 J. Legal Med. 541 (December 2003).

In Boehm v. Mayo Clinic Rochester, 690 N.lW.2d 721 (Minn. 2005), the court refused to allow a nurse practitioner to testify about the standard of care for restraining the head movement of a patient after surgery by a thoracic surgeon.  Reciprocally, in Sullivan v. Edqard Hospital, 806 N.E.2d 645 (Ill. 2004), the court refused to allow a physician to testify about the standard of care for nurses in restraining a patient from falling out of bed.


Two Problems

These two problems can be used to test your understanding of various evidentiary and procedural issues in malpractice litigation.

Problem:  Practice Guidelines

Jane Austere is a 62 year old female with a history of severe diabetes and high blood pressure. She lives in a small town in a rural county of a state that follows the national standard of care for specialists. Following surgery on her left knee performed under general anesthesia at the local public hospital, she was suddenly unable to speak normally. This is consistent with brain damage caused by decreased oxygen to the brain, among other possible causes. Jane brings a medical malpractice action against her anesthesiologist.

Several national organizations have issued guidelines for monitoring ventilation (breathing) during surgery. Two years before Jane's operation, the anesthesiology department at the hospital studied all these guidelines and adopted the following as its view of the best compromise among all their various nuances:

Every patient receiving general anethesia shall have the adequacy of ventilation evaluated regularly and frequently. Quantitative monitoring of the CO2 content and the volume of expired gas is encouraged, but not required. . . . These guidelines are not intended to displace the physician's discretion to conform treatment to the particular clinical circumstances of the individual patient.Jane's anesthesiologist admits that he did not perform quantitative measures of CO2 and volume of exhaled air because he considers visual observation of breathing to be sufficient in all cases. Jane's expert testifies that she could have suffered decreased oxygen because her breathing slowed or paused for a minute or two. In his opinion, quantitative measures are advisable for a patient in Jane's condition. The hospital had recently purchased new equipment that can make these measures continuously and much less obtrusively than was the case before.

The defense lawyer tries to introduce this hospital guideline as evidence of the standard of care. What objections are likely, and what response would you make? If the guidelines were admitted, what instruction should the judge give to the jury, assuming this jurisdiction follows a national standard of care?

Review Questions:  Defense Privileges

Recall the scenario in Samaritan Foundation v. Goodfarb, supra, in which nurses observed an anesthesia mishap but, two years later at trial, could not remember what they had seen. What objections could be raised when the plaintiff attempts to present the following documents to refresh their recollection, and what would the likely rulings be, if:

(a) The nurses gave statements at the time to hospital risk managers who were conducting an incident report.

(b) The nurses gave statements to a hospital quality assurance committee reviewing the anesthesiologist's performance over the past two years.What if the nurses can remember at trial what happened two years ago, but they gave statements to the hospital's credentialing committee, which was considering whether to renew the anesthesiologist's medical staff membership? Could the defense lawyer claim a peer review confidentiality privilege?

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