Requirements Imposed By State Licensing Boards and Medical Professional Societies

The involvement of medical professionals in disciplining physicians for dubious litigation testimony, whether through state licensing authorities or voluntary medical associations, raises some difficult questions:

1. Does a physician’s rendering an opinion on a medical issue in litigation, such as diagnosing silicosis, asbestosis, welding-induced encephalopathy, or fenfluramine-related cardiac injury, constitute the “practice of medicine” within the meaning of state law regulating the practice of medicine?

2. If a physician deviates from the standard of care in rendering such an opinion, either negligently or intentionally, what remedies are available, and to whom?

3. How should we consider the partitioning of the diagnostic process, when an essential part of the diagnosis is provided by physicians who do not testify at trial, such as radiologists who conduct screenings for lawyers?

4. What professional standards have been adopted by the medical profession (or licensing agencies or others) for giving testimony in litigation on medical subjects?

5. Are the views of professional associations such as the American Medical Association properly invoked by litigants?

The record of medical boards and professional societies’ efforts to curb abusive medico-legal testimony is uneven.[1] In one closely followed case, the North Carolina Medical Board revoked a physician’s license on the basis of finding of “unprofessional conduct” in the form of testimony given in a medical malpractice case. The Board found that Dr. Lustgarten had misrepresented the applicable standard of care and accused one of the malpractice defendants of having intentionally falsified medical records without a good faith basis.[2]

A reviewing trial court reversed the finding of misrepresentation of the standard of care, but agreed that Lustgarden had wrongly asserted the defendant’s fabrication of records, and modified the revocation to a one year suspension.[3] On appeal to the North Carolina Court of Appeals, the court held that the Board had the power to suspend or revoke a physician’s license for “unprofessional conduct,” and that providing expert witness testimony was a form of practicing medicine subject to peer review and discipline. Upon reviewing the factual record, however, the Court of Appeals held that the lower court’s finding was unsupported:

“Dr. Lustgarten did not actually state that the defendant had ‘falsified’ a medical record or use the terms ‘liar’ or ‘lying’ to describe the other physician or his conduct. Rather, these terms were introduced by the attorneys representing the defendant.”

Dr. Lustgarten had couched his opinion as a “difficulty believing” the defendant’s record notations, in the appellate court’s view did not merit the sanctions imposed. Although such licensure suspensions or revocations for “testimonial misadventures” remain rare, the Lustgarten case illustrates that Medical Boards have the power to police medico-legal testimony.[4]

Medical societies, although voluntary, may have considerable influence on teaching and hospital privileges and positions.  Most medical societies have shown no interest in taking disciplinary action against members on the basis of testimony given while serving as expert witnesses.[5] One notable exception is the American Association of Neurological Surgeons (AANS).  In 1996, the AANS suspended member Dr. Donald Austin over negligent testimony given as an expert witness in a medical malpractice action.  Dr. Austin, claiming substantial loss in revenues from work as an expert witness, sued the association.  The federal district court dismissed Dr. Austin’s claims, and the Seventh Circuit of the U.S. Court of Appeals affirmed.[6]

Involvement in Litigation as the “Practice of Medicine”

The “practice of medicine” is generally defined and regulated by state statutes.[7] The terms of the respective state statutes vary significantly, but certain of the statutes, or regulations adopted under them, define what constitutes the “practice of medicine,” and some of these provisions expressly address the subject of expert testimony.

The relevant Utah statute was interpreted in an asbestos products case, in which the defendants asserted that:

“the physician who rendered the diagnoses and the technician who administered the pulmonary function tests did so without the required licenses.  Indeed, contend Defendants, these tests and diagnoses were not by treating physicians licensed in Utah, but by a physician who traveled to Utah with the sole purpose of generating asbestos claims at motels.  Consequently, assert Defendants, these diagnoses and tests are flawed, unreliable, untrustworthy and illegal and should, therefore, be inadmissible under Utah law governing the admissibility of expert testimony and under Utah’s public policy.  Moreover, contend Defendants, without these diagnoses, Plaintiffs have no proof of medical causation and, as a result, their claims must be dismissed.”[8]

The Utah asbestos plaintiffs invoked the following statutory exemption from the medical licensure requirement of the Utah statute, which permits an expert witness to provide testimony, in Utah, without a Utah license.[9] The Utah trial court rejected plaintiffs’ reliance upon the statutory exemption, essentially because the doctor in question had rendered diagnostic reports rather than simply testifying in a court proceeding.  The court thus concluded that the doctor had in fact:

“practiced medicine in Utah, without a licence [sic], and [that] these practices resulted in the diagnostic reports that now serve as the basis for Plaintiffs’ law suits.”[10]

Since a case cannot be brought unless the plaintiff has first been diagnosed with a compensable condition, the court’s conclusion as a practical matter means that Utah plaintiffs must first be diagnosed by Utah physicians, or at least by a physician with a current temporary or other license to practice in the state.  More important, the opinion necessarily implies that a medico-legal diagnosis of diseases such as asbestosis or silicosis must comply with the professional standards applicable to medical opinions.

A decision from a Seattle area trial court sustained a challenge similar to the Utah challenge to an expert witness proffered by plaintiffs’ firm Brayton Purcell. Judge Sharon Armstrong considered defendants’ challenge to a physician who participated in union screenings of plaintiffs.[11] The physician in question examined and diagnosed the plaintiffs, and recommended treatment, in Washington State, where he was not licensed. The physician in question also relied upon radiographic interpretations form unregistered and uncertified technicians and radiologists, who had used unregistered and uncertified equipment.

Judge Armstrong dismissed the complaint, without prejudice. Accepting the “tainted” evidence generated by the unlicensed practice of medicine would contravene public policy.[12] Although the challenged physician had committed a criminal offense under Washington law, Judge Armstrong did not refer the matter to the King County prosecutor.

In sum, there is support for the proposition that medical screenings, as well as the actual diagnoses of disease, constitute the “practice of medicine” subject to state regulation.  One extraordinary but distinguishable case from the Fourth Circuit suggests that a notorious screening physician, the late Dr. Ray Harron, did not have a patient-physician relationship such that a patient injured as a result of the screening could sue him for malpractice.[13] The plaintiff had received a chest X-ray in a mass screening that resulted from a law firm solicitation. West Virginia radiologist, Dr. Ray Harron, who gained much international notoriety from Judge Jack’s review of his professional misdeeds, read the chest films and suggested that the plaintiff might have lung cancer. Plaintiff’s counsel, however, failed to alert his client. The Court of Appeals affirmed a dismissal of the case on the grounds that there was no patient-physician relationship under West Virginia law.  The per curiam decision does not reveal whether the American Medical Association ethical and practice guidelines, discussed more fully below, were raised in support of the plaintiff’s claim.

Standards of Conduct Adopted by the American Medical Association And Other Professional Associations

The American Medical Association (“AMA”) has adopted a variety of ethical standards for expert testimony that are directly relevant to the issues of abusive medico-legal activities and testimony. Although the AMA’s ethical standards have not been invoked frequently in the reported cases,[14] they provide useful guidance on a number of issues concerning appropriate standards for physician participation in litigation.

To begin with, the AMA has endorsed the proposition that testimony on medical subjects, at least by physicians, constitutes the practice of medicine.  AMA Provision H-265.993, concerning “Peer Review of Medical Expert Witness Testimony,” states that:[15]

“AMA policy is that: (1) the giving of medico-legal testimony by a physician expert witness be considered the practice of medicine, and (2) all medico-legal expert witness testimony given by a physician should be subject to peer review.”

Furthermore, the AMA has adopted standards on the basis for, and quality of, testimony by physicians that at least generally mirrors the types of requirements imposed by courts which have followed Daubert Rule 702 standards.  Code provision E-9.07, concerning “Medical Testimony,” states in part that:

“When physicians choose to provide expert testimony, they should have recent and substantive experience or knowledge in the area in which they testify, and be committed to evaluating cases objectively and to providing an independent opinion. Their testimony should reflect current scientific thought and standards of care that have gained acceptance among peers in the relevant field. If a medical witness knowingly provides testimony based on a theory not widely accepted in the profession, the witness should characterize the theory as such. Also, testimony pertinent to a standard of care must consider standards that prevailed at the time the event under review occurred.

All physicians must accurately represent their qualifications and must testify honestly. Physician testimony must not be influenced by financial compensation; for example, it is unethical for a physician to accept compensation that is contingent upon the outcome of litigation.

Organized medicine, including state and specialty societies, and medical licensing boards can help maintain high standards for medical witnesses by assessing claims of false or misleading testimony and issuing disciplinary sanctions as appropriate… .”[16]

Similarly, AMA Code provision H-265.994, “Expert Witness Testimony,” states, among other relevant provisions, that:

“(2) Our AMA is on record that it will not tolerate false testimony by physicians and will assist state, county and specialty medical societies to discipline physicians who testify falsely by reporting its findings to the appropriate licensing authority… .”[17]

While the AMA has no power to require physicians to comply with its pronouncements, the Association has stated that its official policy is for all physicians who serve as expert witness in medical liability litigation should affirm in writing their intent to adhere to AMA principles for giving expert witness testimony.[18]

The AMA policies, guidances, and principles, if followed, would go a long way towards reducing abusive screenings and meretricious testimony.

[1]  See generally David B. Resnik, “Punishing Medical Experts for Unethical Testimony: A Step in the Right Direction or a Step too Far?” 4 J. Philosophy, Science & Law 45 (2004); Juan Carlos B. Gomez, “Silencing the Hired Guns: Ensuring Honesty in Medical Expert Testimony Through State Legislation,” 26 J. Legal Med. 385 (2005); Robert S. Peck & John Vail, “Blame It on the Bee Gees: The Attack on Trial Lawyers and Civil Justice,” 51 N. Y. L. Sch. L. Rev. 323 (2006-2007).

[2]  In re Gary James Lustgarten, M.D., Opinion and Order (March 30, 2004).

[3]  Lustgarten v. North Carolina Med. Bd., Wake Cty. Super. Ct. N. C., No. 02 CVS 12218 (Apr. 18, 2005).

[4]  In re Gary James Lustgarten, MD, 177 N.C. App. 663, 629 S.E.2d 886 (2006). See generally John M. Luce, “The Development of Professional Standards for Physician Expert Witnesses in Medical Malpractice Litigation in the United States,” Unpublished MS (2014); Ronald M. Sandgrund, Scott F. Sullan, Leslie A. Tuft, and Jennifer A. Seidman, “Crossing the Separation of Powers Threshold: Legislative and Regulatory Control of Expert Testimony,” 37 The Colorado Lawyer 27 (May 2008); Nadia N. Sawicki, “A Theory of Discipline for Professional Misconduct” (Mar. 3, 2009).

[5]  See Opinion of Bill Lockyer, Attorney General of the State of California, and Gregory L. Gonot, Deputy Attorney General dated April 28, 2004, which stated, in a medical malpractice context, that “[w]hen a physician testifies as an expert in a civil proceeding regarding the applicable standard of medical care and whether the defendant has breached that standard, the physician may not, on the basis of his or her testimony, be held liable in a subsequent tort action brought by the adverse party, but may be subject to professional discipline by the Medical Board of California if the testimony constitutes unprofessional conduct.”

[6]  Austin v. American Association of Neurological Surgeons, 253 F.3d 967 (7th Cir. 2001). See Wood, “Professional Oversight of Expert Testimony – Austin v. American Association of Neurological Surgeons,” 7 Virtual Mentor – Ethics J. Am. Med. Ass’n (2005).

[7]  See generally 61 Am. Jur. 2d § 25.

[8]  In re Asbestos Cases of Brayton Purcell v. Asbestos Defendants, Case No. 010900863, Op. at 1-2 (Dist. Ct. of the Third Judicial Dist. for Salt Lake Cty., Utah) (Jan. 25, 2005) [Brayton op.]

[9]  Utah Code Ann. § 58-67-305.

[10]  Brayton op. at 3.

[11]  In re Certain Asbestos Cases (ACR XXIV Cases), No. 89-2-18455-9 SEA (Superior Court for King County, Washington) Order Granting Summary Judgment (Oct.15, 2002) (Hon. Sharon Armstrong).

[12]  See Nickila v. Board of Chiropractic Examiners, 862 P.2d 555 (Or. App. 1993) (affirming sanctions issued by Board of Chiropractic Examiners, against petitioner, for participating in an X-ray procedure while his license was suspended; rejecting petitioner’s argument that he was not practicing medicine because he acted in concert with or through other practitioners); West Virginia Radiologic Technology Board of Examiners v. Darby, 427 S.E.2d 486 (W. Va. 1993) (holding regulations prohibiting unlicensed persons from practicing radiologic technology also prevented licensed medical practitioner from employing unlicensed technician; “If a person is found taking X-rays without a license, the Board can enjoin that individual from engaging in further practice pursuant to W.Va. Code 30-23-12”); Nelson v. Palmquist, 363 N.W.2d 570, 572 (S.D. 1985) (holding defendant practiced chiropractic without a license when he examined and interpreted X-rays; defendant engaged in “diagnosis” in violation of the South Dakota statute); People v. Allied Medical Clearing House Incorporated, 285 N.Y.S.2d 439, 493-94 (N.Y. Sup. Ct. 1967) (holding evaluation by defendant of X-rays of litigants, taken at labs under contract with defendant constituted practice of medicine without a license); Chiropractic Association of New York, Inc. v. Hilleboe, 227 N.Y.S.2d 309, 313 (N.Y. Sup. Ct. 1961) (“When in this state a man whether he calls himself a chiropractor or something else, diagnoses the case of one who comes to him for help as requiring an X-ray and either takes the X-ray himself or sends the one seeking help to someone else to take the X-ray, he is practicing medicine within the meaning of section 6501, subdivision 4. . . .”); Smith v. State Board of Medicine of Idaho, 259 P.2d 1033, 1038 (Idaho 1953) (“The conclusion is inevitable, therefore, that appellant in performing surgery — though classified by him as only minor — using drugs, and diagnosing by the use of X-ray, was, as found by the learned trial court, practicing medicine and surgery without a license; therefore, he was violating the law.”).

[13]  Adams v. Harron, 1999 WL 710326 (4^th Cir. 1999) (per curiam)

[14]       See, e.g., Piscopo v. Secretary of Health and Human Services, 66 Fed.Cl. 49, 52 (Court of Federal Claims 2005); Doe v. Secretary of Health and Human Services, 2004 WL 3321202, *22 n.40 (Court of Federal Claims, Office of the Special Masters, Oct. 5, 2004).

[15]  Res. 221, I-97; Reaffirmed: BOT Rep. 18, I-98; Reaffirmation A-99; Reaffirmation, A-00.

[16]  Code provision E-9.07, “Medical Testimony,” issued December 2004.

[17]  See H-265.992, “Expert Witness Testimony”[17]; H-265.997, “AMA-ABA Statement on Interprofessional Relations for Physicians and Attorneys”; D-265.997, “False Testimony”; D-265.994, “Expert Witness Affirmation”; 265.995, “Physician Testimony Related to Tobacco and Health”; D-490.989, “Expert Witness Testimony by Physicians on Behalf of Tobacco Companies.”

[18]  See H-265.990, “Expert Witness Affirmation,” which provides that “AMA policy is that all physicians, serving as expert witnesses in medical liability litigation, voluntarily sign an expert witness affirmation explicitly stating that they will adhere to the AMA’s principles guiding expert witness testimony. (Res. 7, A-04).”

Adverse event reporting is a recognized, important component of pharmacovigilence. Regulatory agencies around the world further acknowledge that an increased rate of reporting of a specific adverse event may signal the possible existence of an association. In the last two decades, pharmacoepidemiologists have developed techniques for mining databases of adverse event reports for evidence of a disproportionate level of reporting for a particular medication – adverse event pair. Such studies can help identify “signals” of potential issues for further study with properly controlled epidemiologic studies.[1]

Most sane and sensible epidemiologists recognize that the low quality, inconsistences, and biases of the data in adverse event reporting databases render studies of disproportionate reporting “poor surrogates for controlled epidemiologic studies.” In the face of incomplete and inconsistent reporting, so-called disproportionality analyses (“DPA”) assume that incomplete reporting will be constant for all events for a specific medication. Regulatory attention, product labeling, lawyer advertising and client recruitment, social media and publicity, and time since launch are all known to affect reporting rates, and to ensure that reporting rates for some event types for a specific medication will be higher. Thus, the DPA assumptions are virtually always false and unverifiable.[2]

DPAs are non-analytical epidemiologic studies that cannot rise in quality or probativeness above the level of the anecdote upon which they are based. DPAs may generate signals or hypotheses, but they cannot test hypotheses of causality. Although simple in concept, DPAs involve some complicated computations that embue them with an aura of “proofiness.” As would-be studies that lack probativeness for causality, they are thus ideal tools for the lawsuit industry to support litigation campaigns against drugs and medical devices. Indeed, if a statistical technique is difficult to understand but relatively easy to perform and even easier to pass off to unsuspecting courts and juries, then you can count on its metastatic use in litigation. The DPA has become one of the favorite tools of the lawsuit industry’s statisticians. This litigation use, however, cannot obscure the simple fact that the relative reporting risk provided by a DPA can never rise to the level of a relative risk.

In one case in which a Parkinson’s disease patient claimed that his compulsive gambling was caused by his use of the drug Requip, the plaintiff’s expert witness attempted to invoke a DPA in support of his causal claim. In granting a Rule 702 motion to exclude the expert witnesses who relied upon a DPA, the trial judge rejected the probativeness of DPAs, based upon the FDA’s rejection of such analyses for anything other than signal detection.[3]

In the Accutane litigation, statistician David Madigan attempted to support his fatally weak causation opinion with a DPA for Crohn’s disease and Accutane adverse event reports. According to the New Jersey Supreme Court, Madigan claimed that his DPA showed “striking signal of disproportionality” indicative of a “strong association” between Accutane use and Crohn’s disease.[4]  With the benefit of a thorough review by the trial court, the New Jersey Supreme Court found other indicia of unreliability in Madigan’s opinions, such that it was not fooled by Madigan’s shenanigans. In any event, no signal of disproportionality could ever show an association between medication use and a disease; at best the DPA can show only an association between reporting of the medication use and the outcome of interest.

In litigation over Mirena and intracranial hypertension, one of the lawsuit industry’s regulars, Mayhar Etminan, published a DPA based upon the FDA’s Adverse Event Reporting System, which purported to find an increased reporting odds ratio.[5] Unthinkingly, the plaintiffs’ other testifying expert witnesses relied upon Etminan’s study. When a defense expert witness pointed out that Etminan had failed to adjust for age and gender in his multivariate analysis,[6] he repudiated his findings.[7] Remarkably, when Etminan published his original DPA in 2015, he declared that he had no conflicts, but when he published his repudiation, he disclosed that he “has been an expert witness in Mirena litigation in the past but is no longer part of the litigation.” The Etminan kerfuffle helped scuttle the plaintiffs’ assault on Mirena.[8]

DPAs have, on occasion, bamboozled federal judges into treating them as analytical epidemiology that can support causal claims. For instance, misrepresentations or misunderstandings of what DPAs can and cannot do carried the day in a Rule 702 contest on the admissibility of opinion testimony by statistician Rebecca Betensky. In multidistrict litigation over the safety of inferior vena cava (“IVC”) filters, plaintiffs’ counsel retained Rebecca Betensky, to prepare a DPA of adverse events reported for the defendants’ retrievable filters. The MDL judge’s description of Betensky’s opinion demonstrates that her DPA was either misrepresented or misunderstood:

“In this MDL, Dr. Betensky opines generally that there is a higher risk of adverse events for Bard’s retrievable IVC filters than for its permanent SNF.”[9]

The court clearly took Betensky to be opining about risk and not the risk of reporting. The court’s opinion goes on to describe Betensky’s calculation of a “reporting risk ratio,” but found that she could testify that the retrievable IVC filters increased the risk of the claimed adverse events, and not merely that there was an increase in reporting risk ratios.

Betensky acknowledged that the reporting risk ratios were “imperfect estimates of the actual risk ratios,”[10] but nevertheless dismissed all caveats about the inability of DPAs to assess actual increased risk. The trial court quoted Dr. Betensky’s attempt to infuse analytical rigor into a data mining exercise:

“[A]dverse events are generally considered to be underreported to the databases, and potentially differentially by severity of adverse event and by drug or medical device. . . . It is important to recognize that underreporting in and of itself is not problematic. Rather, differential underreporting of the higher risk device is what leads to bias. And even if there was differential underreporting of the higher risk device, given the variation in reporting relative risks across adverse events, the differential reporting would have had to have been highly variable across adverse events. This does not seem plausible given the severity of the adverse events considered. Given the magnitude of the RRR’s [relative reporting ratios], and their variability across adverse events, it seems implausible that differential underreporting by filter could fully explain the deviation of the observed RRR’s from 1.”[11]

Of course, this explanation fails to account for differential over-reporting for the newer, but less risky or equally risk device. Betensky dismissed notoriety bias as having caused an increase in reporting adverse events because her DPA ended with 2014, before the FDA had issued a warning letter. The lawsuit industry, however, was on the attack against IVC filers, years before 2014.[12] Similarly, Betensky dismissed consideration of the Weber effect, but her analysis apparently failed to acknowledge that notoriety and Weber effect are just two of many possible biases in DPAs.

In the face of her credentials, the MDL trial judge retreated to the usual chestnuts that are served up when a Rule 702 challenge is denied.  Judge Campbell thus observed that “[i]t is not the job of the court to insure that the evidence heard by the jury is error-free, but to insure that it is sufficiently reliable to be considered by the jury.”[13]  The trial judge professed a need to be “be careful not to conflate questions of admissibility of expert testimony with the weight appropriately to be accorded to such testimony by the fact finder.”[14] The court denied the claim that Betensky had engaged in an ipse dixit, by engaging in its own ipse dixit. Judge Campbell found that Betensky had explained her assumptions, had acknowledged shortcomings, and had engaged in various sensitivity tests of the validity of her DPA; and so he concluded that Betensky did not present “a case where ‘there is simply too great an analytical gap between the data and the opinion proffered’.”[15]

By closing off inquiry into the limits of the DPA methodology, Judge Campbell managed to stumble into a huge analytical gap he blindly ignored, or was unaware of. Even the best DPAs cannot substitute for analytical epidemiology in a scientific methodology of determining causation. The ipse dixit becomes apparent when we consider that the MDL gatekeeping opinion on Rebecca Betensky fails to mention the extensive body of regulatory and scientific opinion about the distinct methodologic limitations of DPA. The U.S. FDA’s official guidance on good pharmacovigilance practices, for example, instructs us that

“[d]ata mining is not a tool for establishing causal attributions between products and adverse events.”[16]

The FDA specifically cautions that the signals detected by data mining techniques should be acknowledged to be “inherently exploratory or hypothesis generating.”[17] The agency exercises caution when making its own comparisons of adverse events between products in the same class because of the low quality of the data themselves, and uncontrollable and unpredictable biases in how the data are collected.[18] Because of the uncertainties in DPAs,

“FDA suggests that a comparison of two or more reporting rates be viewed with extreme caution and generally considered exploratory or hypothesis-generating. Reporting rates can by no means be considered incidence rates, for either absolute or comparative purposes.”[19]

The European Medicines Agency offers similar advice and caution:

“Therefore, the concept of SDR [Signal of Disproportionate Reporting] is applied in this guideline to describe a ‘statistical signal’ that has originated from a statistical method. The underlying principle of this method is that a drug–event pair is reported more often than expected relative to an independence model, based on the frequency of ICSRs on the reported drug and the frequency of ICSRs of a specific adverse event. This statistical association does not imply any kind of causal relationship between the administration of the drug and the occurrence of the adverse event.”[20]

The current version of perhaps the leading textbook on pharmacoepidemiology is completely in accord with the above regulatory guidances. In addition to emphasizing the limitations on data quality from adverse event reporting, and the inability to interpret temporal trends, the textbook authors clearly characterize DPAs as generating signals, and unable to serve as hypothesis tests:

“a signal of disproportionality is a measure of a statistical association within a collection of AE/ADR reports (rather than in a population), and it is not a measure of causality. In this regard, it is important to underscore that the use of data mining is for signal detection – that is, for hypothesis  generation – and that further work is needed to evaluate the signal.”[21]

Reporting ratios are not, and cannot serve as, measures of incidence or prevalence, because adverse event databases do not capture all the events of interest, and so these ratios “it must be interpreted cautiously.”[22] The authors further emphasize that “well-designed pharmacoepidemiology or clinical studies are needed to assess the signal.”[23]

The authors of this chapter are all scientists and officials at the FDA’s Center for Drug Evaluation and Research, and the World Health Organization. Although they properly disclaimed to have been writing for their agencies, their agencies have independently embraced their concepts in other agency publications. The consensus view of the hypothesis generating nature of DPAs can easily be seen in surveying the relevant literature.[24] Passing off a DPA as a study that supports causal inference is not a mere matter of “weight,” or excluding any opinion that has some potential for error. The misuse of Betensky’s DPA is a methodological error that goes to the heart of what Congress intended to be screened and excluded by Rule 702.

[1]  Sean Hennessy, “Disproportionality analyses of spontaneous reports,” 13 Pharmacoepidemiology & Drug Safety 503, 503 (2004).

[2]  Id. See, e.g., Patrick Waller & Mira Harrison-Woolrych, An Introduction to Pharmacovigilance 68-69 (2^nd ed. 2017) (noting the example of the WHO’s DPA that found a 10-fold reporting rate increase for statins and ALS, which reporting association turned out to be spurious).

[3]  Wells v. SmithKline Beecham Corp., 2009 WL 564303, at *12 (W.D. Tex. 2009) (citing and quoting from the FDA’s Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (2005)), aff’d, 601 F.3d 375 (5th Cir. 2010). But see In re Abilify (Aripiprazole) Prods. Liab. Litig., 299 F.Supp. 3d 1291. 1324 (N.D. Fla. 2018) (noting that the finding of a DPA that compared Abilify with other anti-psychotics helped to show that a traditional epidemiologic study was not confounded by the indication for depressive symptoms).

[4]  In re Accutane Litig., 234 N.J. 340, 191 A.3d 560, 574 (2018).

[5]  See Mahyar Etminan, Hao Luo, and Paul Gustafson, et al., “Risk of intracranial hypertension with intrauterine levonorgestrel,” 6 Therapeutic Advances in Drug Safety 110 (2015).

[6]  Deborah Friedman, “Risk of intracranial hypertension with intrauterine levonorgestrel,” 7 Therapeutic Advances in Drug Safety 23 (2016).

[7]  Mahyar Etminan, “Revised disproportionality analysis of Mirena and benign intracranial hypertension,” 8 Therapeutic Advances in Drug Safety 299 (2017).

[8]  In re Mirena IUS Levonorgestrel-Relaated Prods. Liab. Litig. (No. II), 387 F. Supp. 3d 323, 331 (S.D.N.Y. 2019) (Engelmayer, J.).

[9]  In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, Order Denying Motion to Exclude Rebecca Betensky at 2 (D. Ariz. Jan. 22, 2018) (Campbell, J.) (emphasis added) [Order]

[10]  Id. at 4.

[11]  Id.

[12]  See Matt Fair, “C.R. Bard’s Faulty Filters Pose Health Risks, Suit Says,” Law360 (Aug. 10, 2012); See, e.g., Derrick J. Stobaugh, Parakkal Deepak, & Eli D. Ehrenpreis, “Alleged isotretinoin-associated inflammatory bowel disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System,” 69 J. Am. Acad. Dermatol. 393 (2013) (documenting stimulated reporting from litigation activities).

[13]  Order at 6, quoting from Southwire Co. v. J.P. Morgan Chase & Co., 528 F. Supp. 2d 908, 928 (W.D. Wis. 2007).

[14]  Id., citing In re Trasylol Prods. Liab. Litig., No. 08-MD-01928, 2010 WL 1489793, at *7 (S.D. Fla. Feb. 24, 2010).

[15]  Id., citing and quoting from In re Trasylol Prods. Liab. Litig., No. 08-MD-01928, 2010 WL 1489793, at *7 (S.D. Fla. Feb. 24, 2010) ((quoting General Electric v. Joiner, 522 U.S. 136, 146 (1997)).

[16]  FDA, “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance for Industry” at 8 (2005) (emphasis added).

[17]  Id. at 9.

[18]  Id.

[19]  Id. at 11 (emphasis added).

[20]  EUDRAVigilance Expert Working Group, European Medicines Agency, “Guideline on the Use of Statistical Signal Detection Methods in the EUDRAVigilance Data Analysis System,” at 3 (2006) (emphasis added).

[21]  Gerald J. Dal Pan, Marie Lindquist & Kate Gelperin, “Postmarketing Spontaneous Pharmacovigilance Reporting Systems,” in Brian L. Strom & Stephen E. Kimmel and Sean Hennessy, Pharmacoepidemiology at 185 (6^th ed. 2020) (emphasis added).

[22]  Id. at 187.

[23]  Id. See also Andrew Bate, Gianluca Trifirò, Paul Avillach & Stephen J.W. Evans, “Data Mining and Other Informatics Approaches to Pharmacoepidemiology,” chap. 27, in Brian L. Strom & Stephen E. Kimmel and Sean Hennessy, Pharmacoepidemiology at 685-88 (6^th ed. 2020) (acknowledging the importance of DPAs for detecting signals that must then be tested with analytical epidemiology) (authors from industry, Pfizer, and academia, including NYU School of Medicine, Harvard Medical School, and London School of Hygiene and Tropical Medicine).

[24]  See, e.g., Patrick Waller & Mira Harrison-Woolrych, An Introduction to Pharmacovigilance 61 (2^nd ed. 2017) (“[A]lthough the numbers are calculated in a similar way to relative risks, they do not represent a meaningful calculation of risk.” *** “Indicators of disproportionality are measures of association and even quite extreme results may not be causal.”); Ronald D. Mann & Elizabeth B. Andrews, Pharmacovigilance 240 (2d ed. 2007) (“Importantly, data mining cannot prove or refute causal associations between drugs and events. Data mining simply identifies disproportionality of drugevent reporting patterns in databases. The absence of a signal does not rule out a safety problem. Similarly, the presence of a signal is not a proof of a causal relationship between a drug and an adverse event.”); Patrick Waller, An Introduction to Pharmacovigilance 49 (2010) (“[A]lthough the numbers are calculated in a similar way to relative risks, they do not represent a meaningful calculation of risk. Whilst it is true that the greater the degree of disproportionality, the more reason there is to look further, the only real utility of the numbers is to decide whether or not there are more cases than might reasonably have been expected. Indicators of disproportionality are measures of association and even quite extreme results may not be causal.”); Sidney N. Kahn, “You’ve found a safety signal–now what?  Regulatory implications of industry signal detection activities,” 30 Drug Safety 615 (2007).

The right-wing of American politics, with its religious enthusiams, has long shown a willingness to ignore and subvert science to advance its policy agendas. The left wing of American politics, however, is not immune from ignoring evidence-based scientific conclusions in its policy agenda. When it comes to World-Trade Center (WTC) attack, the hostility to evidence-based conclusions appears to be bipartisan.

The attack on the WTC by evil Muslim religious extremists was deplorable, and the September 11th rescue workers deserve our respect and gratitude. They may even deserve compensation for fortuitous, un-related chronic diseases experienced a decade or so later. Dressing up our gratitude in the language of causality and victimhood, however, undermines basic respect for scientific evidence and leads to specious claiming.

The New York Times, no slouch when it comes to specious claiming on scientific issues, provided a great example with its editorial this morning, advocating for increased federal funding for the WTC compensation fund. Editorial Board, “Give Sept. 11 Survivors the Help They Deserve: A fund to aid the thousands sickened from the toxic dust of the World Trade Center attack is running out of money,” N.Y. Times (Feb. 28, 2019). The Times’ editors pictured a retired federal worker as one “who suffers from illnesses like leukemia related to recovery work at ground zero.” The editorial tells us that this man, in 2015, “was told he had leukemia linked to his work there, “like many who had been at the site.” The editors went on to bemoan how this man, and others like him, might receive much less than what had been promised by the federal WTC compensation fund.

The passive voice can be very revealing for the deception and misrepresentations it hides. Who told this man such a thing, about a “link,” whatever that is? And on what evidence was the “link” supposedly established?

Of course, there were toxic materials disseminated by the Muslim terrorist attack, and scientists have studied health outcomes among both the rescue workers and responders, as well as among civilians who joined the effort to look for survivors and victims. One study that was published shortly after the 10-year anniversary of the WTC attack, failed to show any “link” between respiratory or physical exposure to WTC dusts and materials and leukemia.¹ In the authors’ words, “”Using within-cohort comparisons, the intensity of World Trade Center exposure was not significantly associated with cancer of the lung, prostate, thyroid, non-Hodgkin lymphoma, or hematological cancer in either group.”

Table 3 of their paper reported specifically on leukemia, using standardized incidence ratios (SIR), in two time windows:

Early Period (with enrollment through 2006, n = 21,218.

SIR 0.73 (95% C.I., 0.20 to 1.87)

and

Later Period (enrollment 2007-2008, n = 20,991)

SIR = 1.25 (95% C.I., 0.46 to 2.72)

A later paper by many of the same authors updated the cohort through 2011. Again, the results overall were equivocal in terms of standardized incidence ratios, but quite “null” for leukemia:

“RESULTS: All-cancer SIR was 1.11 (95% confidence interval (CI) 1.03-1.20) in RRWs, and 1.08 (95% CI 1.02-1.15) in non-RRWs. Prostate cancer and skin melanoma were significantly elevated in both populations. Thyroid cancer was significantly elevated only in RRWs [rescue workers] while breast cancer and non-Hodgkin’s lymphoma were significantly elevated only in non-RRWs. There was a significant exposure dose-response for bladder cancer among RRWs, and for skin melanoma among non-RRWs [civilians].”²

Table II of this later report provides the evidence that the New York Times’ anonymous “linker” was mostly likely full of soup:

Rescue/recovery workers (RRW) (N=24,863)

Leukemia: 16 observed; 17 expected

SIR = 0.95 (95% C.I., 0.54 – 1.54)

Enrollees not involved in rescue and recovery (non-RRW) (N = 35,476)

Leukemia: 18 observed, 22 expected

SIR = 0.81 (95% C.I., 0.48 – 1.29)

An article reporting on the results of multiple cohorts in the American Journal of Industrial Medicine (“red journal”) makes clear that causal conclusions or “linking” is not appropriate on the available evidence:

“Conclusions. The presence of three cohorts strengthens the effort of identifying and quantifying the cancer risk; the heterogeneity in design might increase sensitivity to the identification of cancers potentially associated with exposure. The presence and magnitude of an increased cancer risk remains to be fully elucidated. Continued long-term follow up with minimal longitudinal dropout is crucial to achieve this goal.”³

These authors’ point about continued, long-term follow up is of course true, but immaterial to the validity of the present compensation schemes. The evidence for the relevant time window has been collected and analyzed. Whether compensation for longer latency period manifestations of chronic disease is appropriate is a separate issue. There is just no link in the New York Times’ linking. Evidence-based policy needs evidence, not editorial opinion.

1Jiehui Li, James E. Cone, Amy R. Kahn, Robert M. Brackbill, Mark R. Farfel, Carolyn M. Greene, James L. Hadler,Leslie T. Stayner, and Steven D. Stellman, “Association between World Trade Center exposure and excess cancer risk,” 308 J. Am. Med. Ass’n 2479 (2012).

2Mark R. Farfel, James L. Hadler, Amy R. Kahn, Kevin J. Konty, Leslie T. Stayner, and Steven D. Stellman, “Ten-year cancer incidence in rescue/recovery workers and civilians exposed to the September 11, 2001 terrorist attacks on the World Trade Center,” 59 Am. J. Indus. Med. 709 (2016).

3Paolo Boffetta, Rachel Zeig-Owens, Sylvan Wallenstein, Jiehui Li, Robert Brackbill, James Cone, Mark Farfel, William Holden, Roberto Lucchini, Mayris P. Webber, David Prezant, and Steven D. Stellman, “Cancer in World Trade Center responders: Findings from multiple cohorts and options for future study,” 59 Am. J. Indus. Med. 96, 96 (2016) (emphasis added).

It Was a Dark and Stormy Night

All around the country, first year law students are staring at the prospect of their final examination in contracts, one of the required courses in the law school curriculum in the United States. So here is a practice question.

A lawyer for David Dennison drafts a memorandum of agreement between Mr Dennison and Stephanie Clifford. The memorandum calls for Ms Clifford to remain silent about a sexual liaison between Mr Dennison and her, in return for payment of $130,000, in “hush money.”

Mr Dennison never signed the putative contract, and he never provided the consideration for Ms Clifford’s silence. The lawyer for Mr Dennison, however, wired Ms Clifford the money, although he apparently was never given the money by his client, or reimbursed for the payment, later¹.

Mr Dennison’s lawyer also represents the President of the United States (POTUS). POTUS may well be Mr Dennison, but he has never acknowledged that Dennison was a name he used. Mr Dennison’s lawyer has publicly acknowledged that he provided the money to Ms. Clifford, and that his client Mr Dennison or whoever Mr Dennison is, did not reimburse him².

The putative contract calls for arbitration and penalties. A company, EC, LLC, obtained a temporary restraining order (TRO) from the designated alternative dispute resolution company. EC, LLC v Peterson, ADR Services TRO (Feb. 27, 2018)³. A week later, Stephanie Clifford sued POTUS (a.k.a. David Dennison) for declaratory relief, in California Superior Court, Los Angeles County, after the TRO was entered. Clifford v. Trump, Calif. Super. Ct., Los Angeles Cty. Complaint (Mar. 06, 2018)⁴.

Prepare a bench memorandum for the trial court judge who has been assigned the declaratory judgment action. Make sure you address all issues of contract formation and enforcement, affirmative defenses such as the statute of frauds⁵, as well as professional ethics of the lawyers involved. Address the ethical propriety of POTUS’s lawyer’s paying consideration for a hush contract out of his own pocket and then claiming the benefit of the bargain for his client, as well as the legal consequences of his public disclosure on the enforceability of the putative contract. If you come up with a negotiation strategy for the wife of POTUS to vitiate her pre-nuptial agreements with POTUS, you will receive extra credit.

Watch the upcoming issues of the New York Times for the answer to this practice question.