# Petition for Writ of Certiorari — Bragdon v. Abbott > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386018_1497%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 1999 - **Citation:** 526 U.S. 1131 ## Text ? Supreme Court, U.S FILED No. rr ‘ay Tid ry ft} t : sy VR il Vi piskh as In The SUPREME COURT OF THE UNITED STATES October Term 1998 Randon Bragdon, D.M.D.., Petitioner, V. Sidney Abbott, et al., Respondents. ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIRST CIRCUIT PETITION FOR WRIT OF CERTIORARI JOHN W. McCARTHY, ESQ. Counsel of Record BRENT A. SINGER, ESQ. RUDMAN & WINCHELL, LLC Attorneys for Petitioner P.O. BOX 1401 84 Harlow Street Bangor, Maine 04402-1401 Phone: (207) 947-4501 Q arte ae was? 4 1099 981536 maz 4 a aie QUESTIONS PRESENTED 1. Under the Americans with Disabilities Act (“ADA”), are health care workers required by law to confront greater risks than patients? 2. Under the ADA, are a defendant's private expert's calculations of the statistical likelihood of a fatal injury, relying on data available in September 1994, admissible to raise a genuine issue of fact on whether an objectively reasonable dentist could have deemed a risk significant in September 1994? 3. Are factual and opinion assertions made for the first time on appeal in an amicus brief by a professional Organization admissible evidence justifying summary judgment against a defendant on the issue of direct threat under the ADA? 4. Was it plain and highly prejudicial legal error for the Court of Appeals to maintain that 1987 CDC guidelines inform dentists universal precautions eliminate the need for additional precautions during invasive procedures? 9. Did the Court of Appeals’ method in deciding Dr. Bragdon raises no genuine issue for trial so depart from accepted and usual standards of judicial review, and the prior decision of this Court, that its decision on remand should be vacated and the case remanded for trial? 6. Under Title Ill of the ADA, who has the burden of proof on the issue of direct threat? 7. What level of risk is legally significant under the direct threat provisions of the ADA? il LIST OF PARTIES The parties below were plaintiffs/appellees Sidney Abbott and the Maine Human Rights Commission, and defendant/appellant Randon Bragdon, D.M.D. s i J a | a a 3 iil TABLE OF CONTENTS QUESTIONS PRESENTED .........ccccccssscssvessesees i EA A SIR EPG EAS Was basacscbckavessenisevevostitenuceaiqens il TA COR COU LIN ED Siescinssesss Sevensis cotiveeveeuie ill TABLE OF AUTHORITIES...iis.c..-cccc.cscccccontses. XVi PTR SETAE OF ceaccins iv vivcstludiaceecivevosesesonteis l PRIMING BEDE sicdcdetaivdvisivanteiinctisbvetasctsschcondiness l RELEVANT STATUTES AND REISE EPEAT bats cotdechetelobesadesvecitess sesssvevsecess l STATEMENT OF THE CASE .............::c0cccc000. 2 REASONS FOR GRANTING THE WRIT ....... 5 I. THE COURT SHOULD EXERCISE ITS SUPERVISORY POWER BECAUSE THE APPEALS COURT’S DECISION IS SO PLAINLY FLAWED THAT IT DOES NOTACCOMPLISH THE GOAL SET BY THE COURT OF A FULLY INFORMED DETERMINATION OF THE ISSUE........ 5 A. The 1987 CDC Guidelines Literally Say The Opposite Of What The Appeals Court Says They Say «.......i.c6..c..0.... 5 B. The Appeals Court Inexplicably Ignores Dr. Bragdon’s Expert’s Calculation Of The Risk Based on Objective Information Available in September iV C. The Appeals Court Ignored Evidence That Universal Precautions Have Never Been Shown To Be Effective Against D. The Appeals Court Misstates The Record When It Says The Origins Of The American Dental Association’s 1991 Policy On HIV Are Undisputed, And The Appeals Court Improperly Admitted As Evidence Against Dr. Bragdon Claims Made By The Dental Association For The First Time In Its Amicus Brief On OSGI oeucicivinslccossnccstormahatpraamateiet E. The Court’s Previous Analysis Of The Probative Value Of Seven Possible Occupational Transmissions Of HIV Is Based On A Case of Mistaken BCTAIEY issneispiide taolissheinetehteersilaciaastee F. The Appeals Court Ignored Evidence That Before 1994, Dentists Were Repeatedly Warned The Risk Of HIV Transmission To Them Was Greater Than The Risk To Their Patients ......... G. The Appeals Court’s Decision So Far Departs From The Accepted And Usual Course of Judicial Proceedings That The Court Should Exercise Its SUPCTVISOLY POWELE ......00scccrcisvdassceanceces Oe ONIN ote Ao Lambie Gal hon ein, v Il. THE APPEALS COURT’S DECISION III. IV. CREATES A CONFLICT AMONG THE CIRCUITS, AND AN UNJUSTIFIED DOUBLE-STANDARD IN CONFLICT WITH THE COURT'S DECISION, CONCERNING WHAT LEVEL OF RISK IS LEGALLY SIGNIFICANT .... .... 17 CERTIORARI SHOULD BE GRANTED BECAUSE CASES GENERALLY FAIL TO PROVIDE EMPLOYERS AND PROFESSIONALS ACROSS THE COUNTRY WITH DESERVED GUIDANCE ON WHAT LEVEL OF RISK IS LEGALLY SIGNIFICANT, AND BECAUSE THE APPEALS COURT’S DECISION SO DISTORTS THE MEDICAL AND OBJECTIVE EVIDENCE AVAILABLE TO DENTISTS IN 1994 THAT NO DENTIST OR OTHER PROFESSIONAL TODAY COULD HOPE TO COMPREHEND HOW THE LAW CALCULATES, OR EXPECTS OTHERS TO CALCULATE, THE SIGNIFICANCE CE FR PRESB savsedeccenchorcasad dussexaehscaiadiattgs + obe'gie 19 CERTIORARI SHOULD BE GRANTED BECAUSE THE APPEALS COURT’S DECISION ENCOURAGES HEALTH CARE WORKERS TO PRACTICE BELOW MINIMUM SAFETY Sek PEDERI: cninscscmsassennsecenvacedpibaasitivbeseays 25 vi V. THE APPEALS COURT’S DECISION SHOULD BE REVIEWED BECAUSE IT CONFLICTS WITH ESTABLISHED ) NORMS OF SAFETY IN OTHER F Us ahriceiisvbieseedsopiccowrpih coovedeetookstuapivssnaady sen 26 VI. THE COURT SHOULD ADDRESS THE RECURRING ISSUE OF BURDEN OF PROOF UNDER TITLE III OF THE Ft Reeth BRO te Eko ae EL EEF its Rohs eden pe 27 COUNCIL Iie asvcsceec ss cciicesk sets sicdodastheatdas nr 28 : PETITION APPENDIX . § Abbott v. Bragdon, 163 F.3d 87 (1* Cir. 1998)... 1a-9a Judgment of the United States Court of Appeals for the First Circuit Entered December 29, LODE ooo. cas ii lliG asec Gata eee bali ndadles 10a | Excerpts from Bragdon v. Abbott, 118. S. Ct. 2196 (1998) en ee ethan lla-32a Excerpts from Abbott v. Bragdon, 107 F.2d 934 | C1" Cis: 997 2G oak 33a-52a ‘ Order of Court (1* Cir. Aug. 14, 1998)... 53a-54a : Motion for Remand (Aug. 21, 1998).................. 55a-6la ; Brief of Defendant on Remand......................0+. 62a-169a i Vil Excerpts from Addendum to Brief of Defendant on Remand Docket Doc. 56, Ex. 2 (Def.’s Mot. For S.J. filed 09/19/95), excerpts from CDC, Open Meeting on the Risks of Transmission of Bloodborne Pathogens to Patients During Invasive Procedures (Feb. 20-21, 1991)........ 170a-189a Excerpts from Deposition of John Molinari, Ph.D. (filed 09/19/95) ...............c0000. sie yale iai 190a-19la Excerpts from CDC, Public Health Service Guidelines for the Management of Health- Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis MMWR, vol. 47, no. RR-7 CRI FN cessiicsstodseauaicasenasitecsspscevesiutairsenes 192a-215a Excerpts from Oversight Hearings on OSHA's Proposed Standard to Protect Health Care Workers Against Blood-Borne Pathogens Including the AIDS and Hepatitis B Viruses, vol. 1, Hearings before the Subcommittee on Health and Safety of the Committee on Education and Labor, House of SOCIO sc csivewssnciccescccopevisiacscveseuy exoesees 216a-222a Excerpts from CDC, HIV/AIDS Surveillance Report (U.S. HIV and AIDS cases reported through June, 1994), vol. 6, mo. 1 ..........-...00 223a-225a Do Universal Precautions Reduce Needlestick Injuries?, JAMA, vol. 266, no. 3, pp. 359-360 aly NOOR) Se ek Apert inins 226a-229a Excerpts from OSHA, Safer Needle Devices: Protecting Health Care Workers (Oct. 1997) 230a-240a Vili John Molinari, Ph.D., Infected Health-Care Professionals: Healers or Modern Day Lepers? Part 2 - Approaches and Recommendations, Compend. Contin. Educ. Dent., vol. xiv, no. 8 (Aug. 1993)... 241a-243a Excerpts from Deposition of Deborah Greenspan, BDS, DSc (filed 09/19/95) ......... 244a-249a John Molinari, Ph.D., Infected Health-Care Professionals: Healers or Modern Day Lepers? Part 1 - Issues and Considerations, Compend. Cont. Educ. Dent., vol. xiv, NO: ss nocessusspnribsnssndnahd seobarestec etait aan 250a-254a Docket Doc. 59 (Abbott’s Motion for Summary Judgment), p. 17, filed 09/19/95... 255a Excerpts from deposition of Randon Bragdon, D.M.D. (filed 09/19/95) ........0....0.. 256a-311a Docket Doc. 56 (Bragdon’s Motion for Summary Judgment), Ex. 6, filed 09/19/95... 312a-314a Excerpts from Deborah Greenspan, et al., AIDS and the Mouth (1990).........ccccccccccseseeeee 315a-317a Tokars, et al., Surveillance of HIV Infection and Zidovudine Use Among Healthcare Workers with Occupational Exposure to HIV Infected Blood, Ann. Intern. Med., vol. 118, SiO TZ Cire STS FP isiciaricticenscevesiacknanpenetiactcseser 318a-331a Excerpts from Siew, et al., Percutaneous Injuries in Practicing Dentists, JADA, VOL 126 CRB FIGS Bsisacsicccaoakseadcnsdlanescanccacs 332a-334a ix Docket Doc. 73 (Bragdon’s Opposition to Motion for Summary Judgment) Ex. la, Gooch, et al., Percutaneous Exposures to HIV-Infected Blood Among Dental Workers Enrolled in the CDC Needlestick Study, JADA, vol. 126 (Sept. 1995) ......:ccccceeeeeeeeeees 335a-346a Klein, et al., Low Occupational Risk of [HIV] Infection Among Dental Professionals, New Engla.id J. of Medicine, vol. 318, n. 2 (Jen: A988) csi ciation aecus 347a-356a Docket Doc. 57 (Bragdon Statement of Material Fact), Ex. B, Ciesielski, et al., Transmission of Human Immunodeficiency Virus in a Dental Practice, Annals of Internal Med., vol. 116, no. 10 (May 1992)... 357a-374a CDC, Update: Investigations of Persons Treated by HIV-Infected Health-Care Workers - United States, MMWR, vol. 42, nos 7. Clay: 17, 1998) cncikcpliineiotiriicdiiss 375a-379a Chitwood, et al., HIV Seropositivity of Needles from Shooting Galleries in South Florida, Am. J. of Public Health, vol. 80, nO. DAP eR. 1990) esis hc GRAS: 380a-388a David Ho, M.D., Quantitation of HIV-1 in Vivo, HIV Advances in Research and Therapy, vol. 2, no. 3 (Oct. 1992)..............4 389a-399a Reingold, et al., Failure of Gloves and Other Protective Devices to Prevent Transmission of Hepatitis B Virus to Oral Surgeons, JAMA, vol. 259, no. 17, pp. 2558-2560 (GY 198) 3. ccscc dine alee 400a-408a xX Enid Neidle, But the Horse Has Left the Stable, Quintessence Int’l, vol. 25, no. 3 (999A) oo iiccnicccircinrlastecacni mas ee 409a-413a Letters from Kenneth Burrell, D.D.S.., Secretary of Council on Dental Therapeutics, American Dental Association, to Dr. E. J. Neiburger, dated 05/25/90 and 07/17/90........ 414a-417a Noble, et al., Hepatitis B and HIV infections in dental professionals: Effectiveness of infection control procedures, J. Can. Dent. Assoc., vol. 57, no. 1 (Jan. 1991)..........5....... 418a-429a American Dental Association, Cost of OSHA Compliance Gets Mixed Response, vol. 25, no: 18 (Oct S; 1994) ..3..c8ee Aan 430a-434a Excerpts from Comment no. 863 (April 23, 1991) in ADA Comment Book # 1 for Public Inspection, Justice Dept., Disability Rights Division, 1425 New York Ave., NW, Washington, D.C. (Letter from American Association of Orthodontists dated 04/23/91 to John Wodatch, U. S. Dept. of Justice)....... 435a-438a Excerpts from CDC, HIV/AIDS Surveillance Report (U.S. HIV and AIDS cases reported and or diagnosed through June, 1995) vol. 7, 7 THO. Tso. ccsssisdeivaseligavenounceceseuss haubetiesebbstln ieeiase 439a Excerpts from Karon, et al., Prevalence of HIV Infection in the United States, 1984 to 1992, JAMA, vol. 276, no. 2. (1996)............. 440a-448a Excerpts from United Nations and WHO, Report on the Global HIV/AIDS Epidemic (TGC SITY aisaccvcicscinliudeeskaniistumccntentatcaaiie 449a-450a xl Page 8 of Abbott’s brief as Appellee (1996). 451a-452a CDC, Recommendations for Prevention of HIV Transmission in Health-Care Settings, MMWR, vol. 36, no. 2S (1987)...............00006 453a-461a.13 Excerpts from CDC Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings, MMWR, vol. 37, 377-382, 387,388 (1988)... 462a-467a Excerpts from CDC, Public Health Service Statement on Management of Occupational Exposure to Human Immunodeficiency Virus, Including Considerations Regarding Zidovudine Postexposure Use, MMWR, vol. 39, nd: RR-T C1990) nk ke 468a-472a Excerpts from ADA and OSHA, A Guide to Dental Employer Obligations, Post-Exposure Evaluation and Follow-Up Requirements under OSHA’s Standard for Occupational Exposure to Bloodborne Pathogens (1997)... 473a-478a Weber & Wulc, The Use of a Contained Breathing Apparatus to Isolate the Operator and Assistant for Aerosolizing Procedures Including Dermabrasion and Laser Surgery, Annals of Plastic Surgery, vol. 29, 6. 2 (1992 oc ea BR, aaa 479a-483a Excerpts from Abbott’s answers to RPILRION IOS cs secsevnssacivoiidigeseceiunnsvatersceueesin 484a-488a i ae xil Excerpts from O’Brien and Bartlett, 7B Plus HIV, American Journal of Nursing CNG TSG ZK oa ciincsenot tices at colatarnecsvecbacts 489a-492a Copies of brief covers (4) of amici curiae..... 493a-500a Excerpts from Mark Mascolini, Interview with David Ho., MD, How Far Can You Knock Down HIV? TAPAC 1.......cccccccscecseeeeeee 501la-503a USA Today, Scientists solve mystery of Jupiter's rings, (Sept. 16, 1998) ...........00000.. 504a-505a Copies of letters to and from the American Dental Association regarding Dr. Bragdon’s requests for information concerning the Association’s 1991 Policy Statement ............ 506a-514a Excerpts from Ehrlich, et al., Essentials of Dental Assisting O992) cscs thins whciicnGns. 515a-517a Excerpts from Ehrlich, et al., Essentials of Dental Assisting, (1996) sccisticathieiudiitonn 518a-523a Excerpts from Appendix to Brief of Dr. Bragdon on Appeal (July 1996) Excerpts from Declaration of Deborah Greenspan dated 9/17/95 ...........cccccssssecseeseees 524a-526a CDC, Recommended Infection-Control Practices for Dentistry, 1993, 41 Morbidity & Mortality Weekly Report, No. RR-8 (May 28, 1993) c..ccccccisecsicceeescssseveee 527a-547a Xill Robert & Bell, HIV Transmission in the Health-Care Setting, Infectious Disease Clinics of North America, vol. 8, yaw TD go) Sandee BR tsircee) Caen 7 aaa 548a-566a John Molinari, Ph.D., H/V, Health Care Workers and Patients: How to Ensure Safety in the Dental Office, JADA, MOL TAs O. Fe CAMeh BIA) sais tanccocncessmncnnceeiee 567a-57la Excerpts from Declaration of Sanford F. Kuvin, M.S., M.D., D.T.M. & H. dated 9/14/95 with Report of Sanford F. Kuvin nea kn Re ea en ORE EEE MS ey SE OT §72a-575a Affidavit of Randon Bragdon, D.M.D., dated gy PRESERNSSE TRIN Sane HABE ET Artes bake oor Ce Gee Re 576a-578a Excerpts from Abbott’s Answers to Defendant Randon Bragdon, D.M.D.’s, PRDORT OB IONI OE ccc ccccenesskiie Siebel nthe 579a Excerpts from Deposition of Donald Marianos, DDS, taken on 8/10/95 ................. 580a-583a Abbott’s Patient Registration and Health IE FGI aia cscinciccharcieiscc nsdn tapes 584a-585a Excerpts from Deposition of Sanford F. Kuvin, M.D., dated July 20, 1995................. 586a-589a Excerpts from the American Dental Association Policy on AIDS, HIV Infection and the Practice of Dentistry .......... 590a-59la Affidavit of Arleen Richman dated 9/29/95 .. 592a-596a XiV Excerpts from Food and Drug Adminis- tration Notice to All Registered Blood Establishments dated 4/23/92 ..0...........::00cc000 Second Declaration of Sanford Kuvin, NLD. Gated 10/4/95 a Bee Ce a Declaration of William Halteman Ph.D. ....... Excerpts from Declaration of Donald Wayne Marianos, D.D.S. dated 10/18/95...... Excerpts from Second Affidavit of Randon Bragdon, D.M.D. dated 10/18/95 .................. Letter to Senator Daniel Moynihan from David Satcher, M.D., Director of CDC GRO LOFT ID iis ccetnandeinsetihccislinss elbpcbcicntainced Wong, et al., Are Universal Precautions Effective in Reducing the Number of Occupational Exposures Among Health Care Workers? A Prospective Study of Physicians on a Medical Service, JAMA Vol. 265, No. 9, p. 1126 (1991)... Fahey, et al., Frequency of Non- parenteral Occupational Exposures to Blood and Body Fluids Before and After Universal Precautions Training, Am. J. of Medicine, Vol. 90 (Feb. 1991) ..........0...0... Johnson & Robinson, Human Jmmuno- deficiency Virus-1 (HIV-]) in the Vapors of Surgical Power Instruments, J. of Medical Virology, Vol. 33 (1191)................. 597a-601la 602a-610a 6lla-614a 615a-617a 618a-620a 621a-622a 623a-636a 637a-653a 654a-660a SENSES Se pa Rebbe Ti els NE Ra ati a a oth ee ae oa es Pa Re Seg at sed te AIR a IS AIM II bias XV Case-Control Study of HIV Serocon- version in Health-Care Workers After Percutaneous Exposure to HIV-Infected Blood — France, United Kingdom, and United States, January 1988 — August 1994,Morbidity and Mortality Weekly Report, Vol. 44, No. 50 (12/22/95)...........000: 661a-665a Declaration of Leon Kelleher, D.D.S. Bate SIP DIGG ss vaiiskcceikscteecteetaatadbininlsscitiasast 666a-669a Dr. Bragdon’s Response to Abbott’s Brief on Remand with attached Exhibit A....................00. 670a-674a Dr. Bragdon’s Renewed Motion for Remand CRIT IIS isnt sss scissacecsbaccntiirdeniccessnsses vocadeibactataiceel 675a-68la Excerpts from Transcript of 11/12/98 Proceedings before the U. S. Civil Rights CORAIIIGBIGI iii scccsinscccncnntccceslaes dee inetiidonts 682a-683a Order of Court (1* Cir. Oct. 21, 1998) ..........2... 684a-685a XV1 TABLE OF AUTHORITIES CASES PAGES American Dental Ass’n v. Martin 984 F.2d 823 (7™ Cir.), cert. denied, 510 US. BSF CaP) cvcriincicnibicsmslsattisaesasdadigetins 10 Bradley v. University of Tex. M.D. Anderson Cancer Ctr. 3 F.3d 922 (5" Cir. 1993), cert. denied, | 114 S42: 1071 90s) cs 17 Burroughs v. City of Springfield 163 F.36 505 (6* Cir. 1998) 5c 24 Daugherty v. City of El Paso 56 F.3d 695 (5" Cir. 1995), cert. denied, 111 S. Ct. 1263 (1996). vsciccsckesectvccblsetd esta Marie 23 Dipol v. New York City Transit Auth. 999 F. Supp. 309 (E.D.N.Y. 1998)................... 23 Doe v. Dekalb County Sch. Dist. 145: F368 TOOT CLSOG) see ui is cesteiesecapeecenes 23 Doe v. University of Md. Medical Sys. Corp. 50 F.3d 1261 44% Cit: A995) SSeS ics 17 Doe v. Washington Univ. 780 F. Supp. 628 (E.D. Mo. 1991)... 17 E.E.0.C. v. Amego Inc. £10 F.3d 139 €1" Ci: 9997) 6 che ee 23,28 E.E.0.C. v. Exxon Corp. 1 F. Supp.2d 635 (N.D. Tex. 1998) ..........5c50: 21,28 XVil E.E.O.C. v. Union Pacific R.R. 6 F. Supp.2d 1135 (D. Idaho 1998).................. 21,24,28 Estate of Mauro v. Borgess Med. Ctr, 137 ee we SO vissiinsiccnrscprnssiasnntecsooannen 17 Industrial Union Dep’t, AFL-CIO v. American Petroleum Institute GAS U.S: GOT G9GO) (iron conssscsensccreecnssscocssoesssoenss Nw Nm International Union U.A.W. v. General Dynamics Land Systs. Div. 615 264570 (DC. Cis, 1987)......00...0.......0065- 26 LaChance v. Duffy's Draft House, Inc. 146 F.3d 832 (11™ Cir. 1998) .....ceeeeeeeeeeeeees 24 Leckelt v. Board of Comm'rs of Hosp. Dist. No. 1 S00 P94 890 (5" Cr. 1990. cascades tii 17 Montalvo v. Radcliffe F.3d , 1999 WL 65624 (4" Cir. Nunes v. Wai-Mart Stores, Inc. F.3d , 1999 WL 33703 (9" Cir. Onishea v. Hopper 126 F.3d 1323 (11" Cir. 1997), vacated for en banc review, 133 F.3d 1377 (11" Cir. Scoles v. Mercy Health Corp. of S.E. Pa. 887 F. Supp. 765 (E.D. Pa. 1994)............: 17 XVill Turco v. Hoechst Celanese Corp. 101 F.3d 1090 (5™ Cir. 1996) .0....ccccccceeceeeeeeees 24 STATUTES 26 USC ac l 29 US C4 CO kek SS 26 AS UES OTE neces cineca 2 REGULATORY AUTHORITIES 28 CPR. § SC LOC) vicinsceciosincnsiscissncintbade de 21 2P CBE. © IGG icaccckincsntacoconapentethenssadactugsin 21 SG POSTE, OE GG issn s eats bari skccsenenespcnondaunns 12,13,22 56 Fed. Reg: at G6U26....... niin ein 8 MISCELLANEOUS Beekmann & Henderson, Managing Occupational Risks in the Dental Office, 125 J. Am. Dental Assn. 847 (July 1994)........... 15 _ CDC, HIV/AIDS Surveillance Report, vol. 6, no. 1, p. 15, tbl. 11 (Mid-year ed. June 1994).... 14 CDC, Recommendations for Prevention of HIV Transmission in Health-Care Settings, 36 Morbidity & Mortality Weekly Report, INO. Bid CF DG TD dnceseinckccttevesccaceiepiatectinttedertalenns 4.6 CDC, Recommended Infection Control Practices for Dentistry, 41 Morbidity & Mortality Weekly Report, No. RR-8 (ESS ZO UPI os esnttcnrtecccicdcecdnasieanabersbacdionibiciens 25 Comment, Federal Statutes and Regulations: The Americans with Disabilities Act 112 Harv. L. Rev. 283 (No. 1998).................... 18,1924 X1X Gooch, et. al., Percutaneous Exposures to HIV-infected Blood Among Dental Workers Enrolled in the CDC Needlestick Study, 126 J. Am. Dental Assn 1237 (1995) ...........-.-++. 14 Noble, et al., Hepatitis B and HIV Infections in Dental Professionals: Effectiveness of Infection Control Procedures, J. Can. Dent. Po Ra Pe Me Gg) aps aby een EOE 9 Reingold, et al., Failure of Gloves and Other Protective Devices to Prevent Transmission of Hepatitis B Virus to Oral Surgeons, JAMA, vol. 259, no. 17 38) * | SRS 9 Stern, et. al., Supreme Court Practice Sek get © Pa Lc) Maperersrgconamies | ePas eee Mer 29 YS OPINIONS BELOW Abbott v. Bragdon, 163 F.3d 87 (1" Cir. 1998) (affirming summary judgment) (1a-9a); Bragdon v. Abbott, __ ~iU~LS. ~___, 118 S. Ct. 2196 (1998) (vacating and remanding) (11a-32a); Abbott v. Bragdon, 107 F.2d 934 (1* Cir. 1997) (affirming summary judgment) (35a-52a); Abbott v. Bragdon, 912 F. Supp. 580 (D. Me. 1995) (summary judgment in favor of plaintiff). JURISDICTION The judgment of the United States Court of Appeals for the First Circuit (the “Appeals Court”) was entered on December 29, 1998 (10a). This Court has jurisdiction pursuant to 28 U.S.C. § 1254(1). RELEVANT STATUTES AND REGULATIONS 42 U.S.C. § 12182(b)(3): “Specific Construction. Nothing in this subchapter [title Ill of the ADA] shall require an entity to permit an individual to participate in or benefit from the goods, services, facilities, privileges, advantages and accommodations of such entity where such individual poses a direct threat to the health or safety of others. The term ‘direct threat’ means a significant risk to the health or safety of others that cannot be eliminated by a modification of policies, practices, or procedures or by the provision of auxiliary aids or services.” 28 C.F.R. §36.208(c): “In determining whether an individual poses a direct threat to the health or safety of others, a public accommodation must make an individualized assessment, based on reasonable judgment that relies on current medical knowledge or on the best available objective evidence, to ascertain: the nature, duration, and severity of the risk; the probability that the potential injury will actually occur; and whether reasonable modifications of policies, practices, or procedures will mitigate the risk.” a ee STATEMENT OF THE CASE On September 16, 1994, Sidney Abbott visited Randon Bragdon, D.M.D., at the urging of the Executive Director of the Eastern Maine AIDS Network (485a, 487a). Ms. Abbott informed Dr. Bragdon she had been HIV positive for approximately eight years (259a). Dr. Bragdon performed a non-invasive dental examination on her in his office. He found a cavity near the gum line on a back lower tooth that needed filling (256a-259a). Filling the cavity required invasive procedures (577a-578a), which were defined in 1987 by Centers for Disease Control and Prevention (“CDC”) as the manipulation or cutting of “oral or perioral tissues, including tooth structure, during which bleeding occurs or the potential for bleeding exists” (459a). According to the 1987 CDC guidelines, universal blood and body-fluid precautions “should be the minimum precautions for all such invasive procedures” (emphasis in original) (459a). Based on this information and other evidence available in September 1994 (e.g., studies of the efficacy of universal precautions (226a, 400a, 414a, 418a, 466a, 623a, 637a), reported rates of accidental sharps injuries among dentists (316a, 372a), published seroconversion rates. after percutaneous HIV exposure (318a, 557a), OSHA analyses (e.g., 56 Fed. Reg. at 64092), and other CDC guidelines and reports of actual and possible HIV transmissions (224a, 549a-550a), Dr. Bragdon believed performing the invasive procedures necessary to fill Ms. Abbott’s cavity posed a direct threat of accidental HIV transmission to himself and his staff, meaning, a significant risk that could not be eliminated by universal precautions, by other reasonable modifications of policies, practices, or procedures, or by the provision of auxiliary aids or services. See 42 U.S.C. § 12182(b)(3) (definition of direct threat). Dr. Bragdon believed the best way to minimize the HIV risk consistent with the highest standard of care for Ms. Abbott, was to perform the invasive procedure using «2 state-of-the-art infection control in the most aseptic environment available. He therefore offered to fill the cavity in what he thought would be a local hospital, less than 1.5 miles from where Ms. Abbott lived and worked, and where he believed dental facilities were maintained and he would be permitted to perform the procedure “without any problem” (261a, 265a, 584a). Ms. Abbott said she would consider it (579a), but instead she sued him under Title Ill of the ADA. The District Court had jurisdiction under 28 U.S.C. § 1331. The District Court granted summary judgment against Dr. Bragdon based on affidavits of a public health official that were not available until after September 1994. Abbott, 912 F. Supp. at 589. The Appeals Court, and later this Court, agreed the affidavits could not be used against Dr. Bragdon in determining whether Dr. Bragdon’s risk assessment was objectively reasonable from the standpoint of medical and objective evidence available in September 1994 (22a). The Appeals Court nonetheless affirmed summary judgment against Dr. Bragdon based on its reading of 1993 CDC Dentistry Guidelines (the “1993 Guidelines”) and a 1991 American Dental Association Policy Statement on HIV (the “1991 Dental Association Policy”) (44a-45a). The Court granted certiorari. By opinions issued June 25, 1998, four members of the Court agreed “it is clear ... that [Dr. Bragdon] presented more than enough evidence to avoid summary judgment on the ‘direct threat question” (Part Il of Rehnquist, C.J., concurring and dissenting in part, joined by O'Connor, J., Scalia, J. and Thomas, J.) (30a, 32a). Three members of the Court were uncertain (Kennedy, J., Souter, J., and Ginsburg, J.). They believed CDC, or other public health authority guidance available in September 1994, should be given special weight in understanding what would be an objectively reasonable tisk assessment at the time, and that the existence of a significant risk must be determined from the standpoint of wake objectively reasonable dentists. However, because the 1993 Guidelines “do not assess the level of risk,” they doubted the 1993 Guidelines justified summary judgment against Dr. Bragdon (21a-23a). The same members of the Court questioned the Appeals Court’s reliance on the 1991 Dental Association Policy. They pointed out the American Dental Association is not a public health authority, and that the ADA calls for a “scientific assessment of the risk,” which is a question of “statistical likelihood, not professional responsibility.” They thought the record did not disclose a scientific or statistical basis for the 1991 Dental Association Policy. The Policy was some evidence the medical community had assessed the risk, but it did not prove there was no direct threat, or that no reasonable dentist could have thought there was a direct threat based on other medical or objective evidence (23a-24a). Furthermore, although Dr. Bragdon and Ms. Abbott presented affidavit testimony from expert witnesses, the affidavits did not disclose whether the opinions were based on information available in September 1994 (24a). They therefore favored vacating the judgment and remanding to “permit a full exploration of the issue” - (26a). Justice Ginsburg emphasized it was best to err, if at all, “on the side of caution,” and her stated goal was to “ensure a fully informed determination” (28a). Justices Stevens and Breyer thought summary judgment should be affirmed. However, to make a majority of five, they joined Justices Kennedy, Souter, and Ginsburg in favoring a remand to the Appeals Court (27a). The effect was to block a remand for trial, even though of the six justices who expressed an opinion on the issue, four thought Dr. Bragdon clearly raised genuine issues for trial. The Appeals Court’s decision on remand, see 5a-6a, relies on CDC’s 1987 Recommendations for Prevention of HIV Transmission in Health-Care Settings, 36 MMWR No. 2S (Aug. 21, 1987) (the “1987 Guidelines”) (453a-461a.13), instead of CDC’s 1993 Guidelines (527a-547a). Such REPEL: SEER NO WN «i. reliance is so literally misplaced it is hard to imagine what the Appeals Court was thinking. The decision also applies a legally unjustified double standard, inexplicably ignores Dr. Bragdon’s expert's statistical calculations, and wrongly treats as undisputed certain factual and opinion assertions made by the American Dental Association for the first time on remand in an amicus brief. The Appeals Court’s opinion is so deeply fiawed that it cannot be said to have accomplished the tasks set by the Court of a full exploration of the scientific evidence and a fully informed determination. The opinion, at best, carries forth sub silentio a policy determination that regardless of the scientific and statistical evidence available to dentists in September 1994, and regardless of what CDC publications actually say, the case should not go to trial. REASONS FOR GRANTING THE WRIT |. - 20 COURT SHOULD EXERCISE ITS SUPERVISORY POWER BECAUSE THE APPEALS COURT’S DECISION IS SO PLAINLY FLAWED THAT IT DOES NOT ACCOMPLISH THE GOAL SET BY THE COURT OF A_- FULLY INFORMED DETERMINATION OF THE ISSUE. A. The 1987 CDC Guidelines Literally Say The Opposite Of What The Appeals Court Says They Say. The Court properly doubted the 1993 Guidelines support summary judgment on the level of risk (23a). Thus, on remand, the Appeals Court relied on the 1987 Guidelines, instead of the 1993 Guidelines. The Appeals Court says the 1987 Guidelines “explain{] that the use of the universal precautions eliminates the need for additional precautions that CDC formerly had advocated” (6a). This information from the 1987 Guidelines, according to the Appeals Court, fills the implicit gap in the 1993 Guidelines, thereby informing objectively reasonable dentists there is no significant risk, thereby proving Dr. Bragdon acted irrationally. ae Under a bold heading “Precautions for Invasive Procedures,” the 1987 Guidelines define an “invasive procedure” as, inter alia, “the manipulation ... of any oral or perioral tissues, including tooth structure, during which bleeding occurs or the potential for bleeding exists” (459a). Filling a cavity near the gum line is a quintessential example of an invasive procedure (577a-578a). The 1987 Guidelines then say: The universal blood and _ body-fluid precautions listed above, combined with the precautions listed below, should be the minimum precautions for all such invasive procedures. (459a) The “universal blood and body-fluid precautions listed above,” to which the 1987 Guidelines refer, are routine precautions for non-invasive procedures. They take the place of formerly recommended CDC isolation precautions in non-invasive settings (459a). The “precautions listed below,” to which the 1987 Guidelines refer, are special precautions for invasive procedures, for dentistry, and for other specialized services (459a). The 1987 Guidelines say the precautions listed above and below combined should be the minimum precautions for all invasive procedures. The Appeals Court says the 1987 Guidelines say the opposite, namely, universal precautions “eliminate the need for additional precautions.” On that basis, and really only on that basis, the Appeals Court rules that Dr. Bragdon is a civil rights violator who does not deserve a trial, and who should be exposed for liability under the ADA for Ms. Abbott's attorneys’ and experts’ fees in excess of $300,000. What is going on? The reasonable thing to conclude from the 1987 Guidelines, since it is what they say, is that universal precautions, plus all the other precautions described in the Guidelines, are not the maximum prudent precautions when filling cavities near the gum line, but the minimum ee camaro Pye precautions. This clearly expresses the view that even with universal precautions, there is a residual risk of significance, and therefore it is wise to take additional precautions, and in fact dentists are told they “should” take additional precautions. Yet the Appeals Court says the opposite, and based on that, affirms summary judgment against Dr. Bragdon again. With this kind of topsy-turvy, up-is-down logic, what could Dr. Bragdon possibly have said to convince the Appeals Court that published CDC guidelines do not support Ms. Abbott and there is a genuine issue for trial? What could he have said? What's more, Dr. Bragdon specifically pointed out in his response brief that the 1987 Guidelines support him, not Ms. Abbott, on this very point (670a-673a). The Appeals Court accepted the brief for filing (684a). in addition, how are conscientious professionals in the future supposed to understand what the law requires, when the law as it now stands is that CDC guidelines mean the opposite of what they actually say? It just does not get any more Orwellian than this. There is no way the highest court in any country should let this stand as a fully informed determination of an issue. To do so would insult the integrity of the judicial process and trivialize in the extreme the Court's previous decision to vacate and remand. B. The Appeals Court Inexplicably Ignores Dr. Bragdon’s Expert’s Calculation Of The Risk Based On Objective Information Available In September 1994. Throughout the case, and on remand, Dr. Bragdon argued that his expert witness, Sanford Kuvin, M.S., M.D., D.T.M.&H., calculated the risk, by accepted scientific methodology, of contracting HIV by accidental needlestick when giving intra-oral injections to HIV-positive patients. The risk is 1 in 67,000 per intra-oral injection, or 1 in 10, over 30 years of practice, if a dentist gives one such injection each working day (606a). A 1 in 67,000 risk is i. greater than the risk of a fatal accident while skydiving, which is approximately 1 in 100,000 (592a, 596a).’ On remand, Dr. Bragdon further emphasized how, according to the Court, the “question under the [ADA] is one of statistical likelihood, not professional responsibility” (24a, 83a-86a). Dr. Bragdon explained in careful detail in his brief, see 91a-119a, 147a-151a, why Dr. Kuvin’s calculations of the risk are reliable and admissible, how they are based on published data available in 1994, why Dr. Kuvin’s results comport with CDC estimates of the risk to patients (106a-112a), why his results comport with the number of documented and possible occupational transmissions of HIV as reported by CDC’s “passive surveillance” system (147a-151a), and why his results raise a genuine issue for trial (116a-119a). The Appeals Court ignored Dr. Kuvin’s analyses with no explanation at all. There is no hint as to whether the Appeals Court thought Dr. Kuvin’s analyses were inadmissible, or if admissible, not on point, or if on point, insufficient to raise a genuine issue of the statistical likelihood of the risk, or if sufficient to raise that issue, insufficient to raise a genuine issue that that level of risk is legally significant. In sharp contrast, the Appeals Court states Ms. Abbott “proffered the opinions of several prominent experts” (7a). These are the same, non-public health authority, private expert opinions referred to by this Court, when it noted that it could not tell if such opinions were based on information available in September 1994 (24a). To correct this deficiency, Dr. Bragdon moved on remand for a further, limited remand, to give experts a chance to clarify through affidavits the extent to which their opinions are based on ' OSHA assesses the significance of a risk based on an assumed 45 years of exposure during an entire working lifetime. See 56 Fed. Reg. at 64028. Dr. Kuvin’s calculation based on 30 years of exposure is therefore conservative by accepted OSHA standards. ee 46% information that was available in September 1994 (55a). Dr. Bragdon was particularly concerned because previously the Appeals Court in a footnote ostensibly discounted Dr. Kuvin’s analyses because the Appeals Court was uncertain that Dr. Kuvin relied on information available in September 1994 (45a-46a). Dr. Bragdon wanted to make sure the record is clear that Dr. Kuvin’s calculations and opinions rely on data that was available to knowledgeable dentists in September 1994. The Appeals Court denied Dr. Bragdon’s motion which would have given the experts a chance to clarify whether their opinions were based on information available in September 1994 (684a). The Appeals Court then applied a double standard whereby it ignored the expert opinion of Dr. Kuvin (e.g, 573a-574a, 606a), but cited Ms. Abbott's experts’ opinions as further evidence against Dr. Bragdon, with nothing more to rely on than what the Court rejected as too uncertain to rely on (7a). The rule at summary judgment is that courts must view the record in the light most favorable to the non-movant. What the Appeals Court did by nullifying Dr. Kuvin without comment, while citing Ms. Abbott's private experts, is totally contrary to the rule of law. This further illustrates how unspoken policy judgments are controlling this case, rather than the law or any objective evidence available to dentists in September 1994. C. The Appeals Court Ignored Evidence That Universal Precautions Have Never Been Shown To Be Effective Against HIV. Dr. Bragdon explained in detail, see 120a-127a, why no knowledgeable dentist in 1994 could have concluded universal precautions have any significant impact on the risk of contracting HIV in the dental office. See also, e.g., 226a; Reingold, et al., Failure of Gloves and Other Protective Devices to Prevent Transmission of Hepatitis B Virus to Oral Surgeons, JAMA, vol. 259, no. 17 (1988) (400a); Noble, et al., Hepatitis B and HIV infections in -10- dental professionals: Effectiveness of infection control procedures, J. Can. Dent. Assoc., vol. 57, no. 1 (1991) (418a). A corollary is that no knowledgeable dentist in 1994 would have concluded universal precautions are the best way to combat the risk of HIV transmission when working on a person known to carry HIV (see 127a-130a). This evidence was also ignored by the Appeals Court. The real effect of universal barrier precautions is to provide some extra safety at the statistical margins against the transmission of many diseases including HIV, while at the same time placating irrational public fears about HIV. In truth, the statistical risk of HIV transmission during invasive medical procedures is /ess than many irrational people probably think, but much more than CDC leads people to think, probably on account of policy-guided fears that admission by authorities of any non-trivial risk will fuel irrational patient behavior, which will ‘ead to more people dying due to not going to doctors for fear of HIV, than would die by accidental HIV transmission. For policy purposes, public health officials rationalize the view that the HIV risk to dentists is acceptably low, since, in their minds, no practical alternative eliminates the known risk of percutaneous injuries, short of not performing the procedures at all, which is unacceptable. Likewise, CDC scientists know there is no scientific evidence that universal precautions significantly reduce the risk of HIV transmission. So do American Dental Association scientists (414a-417a). That is why the Dental Association opposed OSHA’s 1991 bloodborne pathogen regulations, which require dental employers at costs in excess of $20,000 a year to maintain universal precautions for employees (431a). See American Dental Ass'n v. Martin, 984 F.2d 823 (7" Cir.), cert. denied, 510 U.S. 859 (1993)). Only if “universal precautions” are defined to include the hepatitis B vaccine (which they do under OSHA regulations and which legally justified the regulations), have “universal precautions” been shown to reduce any the genesis of the Policy, and he pointed out logical holes in the Dental Association’s so-called “science.” He tried repeatedly to remand for discovery to expose the true origins of the Policy. Yet the Appeals Court said the scientific basis of the 1991 Policy was “undisputed.” But even if the Dental Association’s factual claims about the process were undisputed, which they are not, the Appeals Court still confuses scientific method with committee process (6a-7a). What this Court thought important was not the ipse dixit of the Dental Association, but any statistical or scientific basis for the Policy. The Dental Association’s factual claim that the Policy was formulated by a group of experts (6a-7a) is not scientific proof of its validity, but merely the claim that the Policy is based on science. The question is, what science? The Dental Association in fact offered no new scientific evidence or calculation of the risk. It also omitted crucial details. For example, it said its 1991 Policy was largely based on the 1987 Guidelines, but it did not explain how the 1987 Guidelines say universal precautions should be the minimum precautions for all invasive procedures. The Dental Association also vaguely described the testing of dentists for HIV at annual dental conventions, but provided no analysis of whether a statistically significant inference may be drawn. Dr. Bragdon has now learned from persons familiar with the process that the testing was voluntary, and each year a significant group of dentists chose (i.e., self- selected) not to be tested. Thus, whereas Dr. Bragdon and OSHA rely on, for example, the scientifically acceptable Klein study, see 56 Fed. Reg. at 64092, which suggests to unbiased readers a significant incidence of occupationally acquired HIV among dentists, the Dental Association relies on what OSHA calls confusing contentions not supported by the data, id. Nevertheless, the Appeals Court credits the factual and opinion statements of the Dental Association in an amicus brief, says they are undisputed when they are disputed, ne Yee and says they also justify summary judgment against Dr. Bragdon. This is not science or law, and it does not accomplish the goals set by this Court on remand. E. The Court’s Previous Analysis Of The Probative Value Of Seven Possible Occupational Transmissions Of HIV Is Based On A Case Of Mistaken Identity. Dr. Bragdon explained to the Appeals Court that this Court, in its original decision, confused the seven reported possible transmissions of HIV to dental workers reported by CDC in June 1994* with seven other dental workers reported by Gooch, et al.° (see 144a-147a). Gooch reported in 1995 that a total of seven dental workers who were enrolled in a CDC neediestick study did not report back for HIV testing to see if they seroconverted after percutaneous HIV exposure at work (see 339a (Gooch explaining that six dental workers did not return for follow- up testing after establishing baseline seronegativity, and a seventh was never tested)). The Court’s original decision confuses these seven dental workers with the seven dental workers reported in the June 1994 CDC surveillance report (see 25a-26a). The CDC surveillance report describes dental workers who already contracted HIV. The seven individuals described by Gooch failed to return for follow-up testing to see if they contracted HIV. By confusing the two groups, the Court ends up by doubting the probative value for Dr. Bragdon of the seven cases described by Gooch (see 26a). Instead, the correct question is how would reasonable dentists have understood the seven cases reported by CDC in its June 1994 surveillance report, reproduced at 224a. * CDC, HIV/AIDS Surveillance Report, vol. 6, no. 1, p. 15, tbl. 11 (Mid-year ed. June 1994), reproduced at 224a. ° Gooch et al., Percutaneous Exposures to HIV-infected Blood Among Dental Workers Enrolled in the CDC Needlestick Study, 126 J. Am. Dental Assn. 1237, 1239 (1995), reproduced at 335a, 339a. a rea eee es ee -15- From the standpoint of dentists in September 1994, the seven dental-worker cases reported in the CDC table at 224a were described in the Journal of the American Dental Association in July 1994 to dentists as cases in which occupational transmission cannot be proven, but is strongly suspected. These cases involve health care workers who are ... found to be HIV infected, and who have provided histories of occupational HIV-related exposures. Susan Beekmann & David Henderson, Managing Occupational Risks in the Dental Office, 125 J. Am. Dental Assn. 847, 848 (July 1994). Likewise, during recent hearings before the United States Civil Rights Commission, CDC’s Deputy Director of the National Center for HIV, STD & TB Prevention, Dr. Ronald Valdiserri, explained that after “extensive investigation by CDC,” these HIV-infected health care workers were found not to have another risk behavior, and that is why the cases are “probable,” but not “definite” (emphasis added) (682a-683a). Published CDC reports in 1994 did not use the word “extensive” to describe the investigation conducted by CDC, but simply said the workers “have been investigated” (224a). However, exactly like OSHA and other experts in the field, see 142a-144a, Dr. Bragdon reasonably treated the cases as probable (i.e., more likely than not) occupational HIV transmissions to dental workers, regardless of the label applied by CDC. CDC’s own published, official position in 1988 was that “possible” transmissions of HIV to dental workers (and there were only two, not seven, at that time) -16- indicated a real threat to dentists, see 466a.* F. The Appeals Court Ignored Evidence That Before 1994, Dentists Were Repeatedly Warned The Risk Of HIV Transmission To Them Was Greater Than The Risk To Their Patients. This Court held that the existence of a direct threat must be determined from the standpoint of the practicing professional (21a). Dr. Bragdon therefore pointed out on remand, as he has all along, that experts on both sides agree the risk to an uninfected dentist working on an HIV- infected patient is greater than the risk to an uninfected patient from an infected dentist (87a, 191a, 246a, 570a, 581a). Dr. Bragdon also pointed out this assessment of the relative risks was repeatedly made known to dentists, in professional publications meant for dentists, on or before September 1994 (191a (referring to 1991 first edition of Practical Infection Control in Dentistry), 570a, 253a). The Appeals Court ignored this, too, in its supposed determination of what an objectively reasonable dentist could think in 1994. G. The Appeals Court’s Decision So Far Departs From The Accepted And Usual Course Of Judicial Proceedings That The Court Should Exercise Its Supervisory Powers. To summarize, whatever evidence Dr. Bragdon produced, the Appeals Court ignored. The evidence the Appeals Court took seriously are inadmissible assertions by the Dental Association in an amicus brief and Ms. Abbott’s experts’ affidavits, the evidentiary bases of which this Court thought were too unclear to justify summary judgment. The public health authority evidence the Appeals Court took most seriously is language in the * After Dr. Bragdon called the Appeals Court's attention to Dr. Valdiserri’s testimony, Dr. Valdiserri notified the Appeals Court that he wants to recant his live testimony, and on reflection he really meant to say “possible” not “probable.” Eppur si muove (and yet it moves). MEG hones 1 er nS «P But see, Onishea v. Hopper, 126 F.3d 1323, 1334 (11" Cir. 1997) (remanding for the “quantitative analysis necessary to find a significant risk,” but giving no indication how to perform the analysis or what level of quantitative risk is legally significant), vacated for en banc review, 133 F.3d 1377 (11" Cir. 1998); E.E.0.C. v. Union Pacific R.R., 6 F. Supp.2d 1135, 1139 (D. Idaho 1998) (stating defendant should have cited “studies or other literature on the subject of the ability of monocular-sighted person to drive safely,” but giving no indication what level of risk is significant); E.E.0.C. v. Exxon Corp, 1 F. Supp.2d 635, 645 (N.D. Tex. 1998) (stating defendant must show there is a “direct threat,” but giving no indication what level of risk is significant or how to show it). -22- which is many times greater than the level of risk deemed legally significant by OSHA, 56 Fed. Reg. at 64092. This is overwhelming evidence of a direct threat from the standpoint of dentists in 1994. The point deserves emphasis. OSHA has established what is an unacceptable lifetime risk for HIV exposure. That risk is 0.1% or 1 in a 1000. Thus, OSHA has established that a single HIV needilestick exposure in a lifetime of practice is unacceptable! So how can Ms. Abbott seriously maintain that HIV needlestick injuries are not significant risks? How could an objectively reasonable dentist in 1994 not think there was a significant risk when working on HIV-infected patients, when just one slip during an entire lifetime of practice would put him at between three to five times what OSHA sets as an unacceptable lifetime hazard? This point was also made clear to the Appeals Court (96a-98a). Based on its decision, however, health care workers again have no way of knowing whether this fact has any relevance to how they are expected to recognize a direct threat. Is OSHA’s 1 in a 1000 standard for a “clearly significant risk,” which was derived from dicta in /ndustrial Union Dep't, AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 655 (1980), not applicable to a direct threat analysis under the ADA? Or does the ADA expect health care professionals to never have an accidental needlestick during an entire lifetime of practice? Other reasons why the Court should exercise its supervisory power is that the Appeals Court’s opinion is another example of conflicting opinions and a chronic lack of meaningful guidance from courts on the direct threat issue. For example, the district court in Nunes v. Wal-Mart Stores, Inc., __ F.3d ___, 1999 WL 33703 (9" Cir. 1999), granted summary judgment to defendant on a direct threat analysis based on the possibility that a cashier might drop a heavy object on a customer during a fainting spell. The «93 227 a achieve an apparent reduction in needlestick rates simply by delegating a greater proportion of needle procedures to nursing staff. There is a growing body of evidence indicating that UPs alone are not sufficient to reduce the risk of needlestick injuries.*” We are concermed that prolonging the reliance on UPs to prevent needlestick injuries will only further delay the transition to safer needle designs, a delay that will be measured by the number of health care workers contracting fatal, preventable disease. Janine Jagger, MPH, Ph.D “ Richard D. Pearson, MD University of Virginia School of Medicine Charlottesville 1. Wong ES Stotka JL, Chinchilli VM, Williams DS, Stuart GC, Markowitz SM. Are universal precautions effective in reducing the number of occupational exposures among health care workers? JAMA. 1991;265:1123-1128. 2. Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD. Rates of needle-stick injury caused by various devices in a university hospital. N Engl J Med. 1988;319:284.288 3. Ribner BS. Landry MN, Gholson GL, Linden LA. Impact of a rigid, puncture resistant container system upon needlestick injuries. Infect Control. 1987;8:63-66. 4.Krasinski K, LaCouture R, Holzman R.S. Effect of changing needle disposal systems on needle puncture injuries. /nfect Control. 1987-:8:59-62. 5. Linneman CL, Cannon C, DeRonde M. Lanphear B. Effect of educational programs, rigid sharps containers, and universal precautions on reported needlestick injuries in health care workers. Infect Control Hosp Epidemiol. 1991; 12-214-219. In Reply. -- We believe our choice of patient-care months as the denominator for occupational exposures is neither inappropriate nor misleading. In our study, we were interested in the difference in the frequency of occupational exposures before and after implementation of UPs and, specifically, with regard to needlestick injuries, the percent reduction as a result of UPs (ie, the rate of injuries after implementation divided by 228 a the rate of injuries before implementation). For this calculation, it is clear that the choice of denominators is irrelevant since they cancel out. We contend that the risk of needlestick injuries is procedure-dependent and the number of patients cared for on the study wards is the most important determinant of the number of procedures performed. Since we observed no variations in the month-to-month patient census or any changes in ward practices during the study period, we attributed the reduction in the frequency of exposures to the effect of UPs. Thus, while it is possible that physicians could have actually reduced their risk of needlestick injuries by delegating procedures to nurses after implementation of UPs, we have no reason to believe that this occurred and, in fact, this was not observed. ' Regarding our interpretation of needlestick data, we documented a 62% reduction in the frequency of needlestick injuries after the implementation of UPs. Although this was not statistically significant, we believe the observed reduction in injuries among our physicians reflects a real trend that would be statistically significant had our study period been extended. Studies on the epidemiology of needlestick injuries _ Suggest that placement of puncture-resistant needle disposal units at the site of use can prevent certain types of needlestick injuries, namely those due to recapping, transport of uncapped needles, and improper disposal.*° These types of preventable injuries represent approximately 20% of all needlestick injuries reported by hospital employees. However, studies also suggest that among house-staff physicians, the percentage of preventable needlestick injuries may be much higher than among nonphysician health care workers, eg, nurses.** In our recent study,’ the proportion of injury among house-staff physicians due to recapping was 54% and due to improper disposal, 3%. Thus, the placement of needle disposal units in treatment areas may have a greater effect on physicians than on other health care workers, which may explain why our study, which observed physicians only, demonstrated a 229 a benefit, while other studies, which have included all groups of health care workers, did not. As studies by Jagger and others have shown, the problem of needlestick injuries is complex. The solution, by necessity, will also be complex and involve multiple approaches, including education, better needle disposal systems, and improved design of needles and related equipment. Jagger and Pearson misinterpret our study in that we are not suggesting that UPs, with improved access to needle disposal, will by themselves solve the needlestick injury problem. Our results do suggest that UPs are helpful and, as such, should be included in any prevention program. Edward S. Wong, MD Sheldon M. Markowitz, MD Hunter Holmes McGuire Veterans A ffairs Medical Center Richmond, VA |. Stotka JL, Wong ES, Stuart CG, William DS, Duma RJ, Markowitz SM. Epidemiology of exposures to blood and body fluid sustained by health care workers. Presented at the Third International Conference on Nosocomial Infections; July 31-August 3, 1990; Atlanta, GA. 2. Ribner BS, Landry MN, Gholson GL, Linden LA. Impact of a rigid, puncture resistant container system upon needlestick injuries, /nfect Control. 1987;8:63-66. 3. Becker MH, Janz NK, Band J. Bartley J, Snyder MB, Gaynes RP. Noncompliance with universal precautions policy: why do physicians and nurses recap needles? Am J Infect Control. 1990-:18-:232-239. 4. McGeer A, Simor AE, Low DE. Epidemiology of needlestick injuries in house officers. J Infect Dis. 1990; 162:961-964 5. Mangione CM Gerberding JL, Cummings SR. Occupational exposure to HIV: frequency and rates of underreporting of percutaneous and mucocutaneous exposures by medical housestaff. 4m J Med 1991;90:85- 90. (partial letter captioned “Medical Malpractice Suits and Autopsies” omitted] 360 JAMA, July 17, 1991--Vol 266, No. 3 Letters 230a |Add. 49] Safer Needle Devices: Protecting Health Care Workers http://www.osha-sic.gov/SLTC/needle. . .ces/saferneedledevices.ntm] #orohiv Department of Labor United States of America Safer Needle Devices: Protecting Health Care Workers Prepared by the Occupational Safety and health Administration Directorate of Technical Support Office of Occupational Health Nursing October 1997 Acknowledgment: This document was developed by the Office of Occupational Health Nursing, with significant contributions from Susan Elliott, ARNP, MSN. MPH, OSHA Nurse Intern, and Digna Walker, RN, B.S.N., OSHA Nurse Intern. Contents Acron reviati [Add. 50] Safer Needle Devices: Protecting Health Care Workers http://www.osha-slc.gov/SLTC/needle. ..ces/saferneedledevices.ntm! #orohiv 23la (Source: Ippolito, 1997) Q How serious is the occupational risk of needlestick injuries to health care workers? A One of the most critical contro] components of health care worker protection against bloodborne pathogens must be the reduction of sharps-related incidents. The statistics cited below provide a picture of the seriousness of the problem. Hospital-based healthcare workers experience some 800,000 needlestick injuries each year in the United States (Jagger, 1990). About 2% or approximately 16,000 of these are likely to be comtaminated by HIV (American Hospital Association, 1991). Needlestick injuries account for up to 80% of all accidental exposures to blood (Jagger, 1988). Based on various studies, researchers have documented that needlestick injuries are under reported by health care workers and the number of exposures could potentially be much higher (Hamory, 1983). Chiarello (1992) cites several studies that found rates of under-reporting between 40.4% and 53% for nurses and 92% for laboratory personnel. Physicians under reported needlestick injuries by 70% to 95%. In well-documented Studies, injuries from contaminated needles and other sharp devices used in the health care setting have been associated with transmission of bloodborne pathogens to health care workers. In fact, more than 20 pathogens have been transmitted through sharps or needlestick injuries (Chiarello, 1992). Of these, HIV, HBV and HCV pose the greatest risk to the health care worker (Ippolito et al., 1997). The risk of transmission of HBV and HCV through percutaneous injury is much higher than for HIV (CDC, 1991). Understanding the prevalence of these bloodborne diseases in the patient population gives a better picture of the risk health care workers face: ® A study of the Johns Hopkins Hospital emergency room determined the prevalence of the HCV, HBV and HIV in blood samples from 2523 patients. Of these patients: 232a ® 18% were seropositive for HCV e@ 5% were seropositive for HBV © 6% were seropositive for HIV (Kalen et al, 1997). © An estimated 1.25 million people in the U.S. are chronically infected with HBV and 6,000 die each year as a result of HBV-related liver disease (Moyer & Hodgson, 1996). © In 1989, the CDC studied the prevalence of HIV in three inner city hospitals and three suburban hospitals. In the three inner city hospitals, seroprevalence of HIV ranged from 4.1 to 8.0 per 100 patients. The suburban hospitals’ seroprevalence rates ranged from 0.2 to 6.1 per 100 patients (Marcus et al., 1989) © In 1997, the National Institutes of Health estimated that nearly 4 million people in the U.S. are infected with Hepatitis C (NIH, 1997). Of these, 85% develop chronic HCV infection and the potential for transmission of HCV to others (CDC, 1997). Q What occupational risk does Hepatitis B pose to the health care worker? A For more than 50 years, HBV infection, a well-documented and recognized occupational hazard, has been and continues to be one of the most common bloodborne pathogens among health care workers. Studies conducted prior to implementation of recommendations to prevent bloodborne pathogen 5 of 18 7/22/98 3:49 PM [Add. 51] 233 a Studies conducted prior to implementation of recommendations to prevent bloodborne pathogen transmission (1976-1 985) show that health care workers had a prevalence of HBV infection three to five times higher than the general U.S. population (Moyer & Hodgson, 1996), * Hepatitis B is much more transmissible than HIV. Health care workers at greatest risk work in areas where they are directly exposed to blood ( in emergency rooms, clinical laboratories, operating rooms, hemodialysis units, etc.) (CDC, 1991). ¢ The risk of a health care worker contracting HBV from needlestick injuries ranges from 6% to 30% (CDC, 1991). ¢ In 1994, 1000 health care workers developed HBV infection, and each year 100 to 200 health care workers die from this disease (CDC, 1997). The Centers for Disease Control] and prevention (CDC) estimates that the annual number of new HBV infections in health care workers has steadily declined from 12,000 in 1985, due in part to the widespread adoption of universal precautions, vaccination against hepatitis B and the implementation of OSHA’s Bloodborne Pathogens Standard’ (Moyer & Hodgson, 1996). Q What occupational risk does Hepatitis C pose to the health care worker? A Hepatitis C virus infection is a major cause of chronic liver disease in the United States and worldwide. The virus, because of its similarity to HBV, presents an occupational risk to persons whose work activities involve handling human blood and body fluids (CDC, 1997). * Needlestick injuries are the most common cause of occupational HCV exposure (Hibberd, 1995). * In 1995, an estimated 560 to 1,120 cases of HCV infection occurred among health care workers who were occupationally exposed to blood (Alter, 1993). * No vaccine is available for hepatitis C and no effective post- exposure prophylaxis is known at this time (CDC, 1997). 234a e Screening tests for hepatitis C antibodies are commercially available, but interpretation of the results, especially in a post- exposure situation, is limited by several factors. e A positive result does not distinguish between acute, chronic, or past infection, and a negative result does not indicate the absence of acute infection, only the absence of antibodies to HCV. e False positives are common in populations with a low prevalence of HCV. e The tests do not detect HCV antibodies in approximately 5% of people (CDC, 1997). e As many as 85% of all HCV-infected persons develop chronic infection. Persons with chronic hepatitis are at increased risk for cirrhosis and primary hepatocellular carcinoma. Hepatitis C is now the leading reason for liver transplantation in the United States (NIH, 1997). Q What occupational risk does HIV pose for the health care worker? A HIV infection has been reported after occupational exposures to HIV-infected blood through needlesticks or cuts; splashes in the eyes, nose, or mouth; and skin contact. e Exposures from needlesticks or cuts cause most infections. The average risk of HIV infection after a needlestick exposure to HIV-infected blood is 0.3% or 1 in 300. Even though the risk of seroconversion after needlestick is relatively rare, injured health care workers may suffer disabling physical side effects from post-exposure anti-viral medication as well as severe emotional trauma as they await their test results (CDC, 1991). e The risk after exposure of the eye, nose, or mouth to HIV- infected blood is estimated to be, on the average, 0.1% or 1 in 1,000 (CDC, 1987). e The risk after exposure of the skin to HIV-infected blood is estimated to be less than 0.1%. The 8 7/22/98 3:49 PM EEE 235a [Add. 52] Safer Needle Devices: Protecting Health Care Workers http: //www.osha-sic.gov/SLTC/needle. ..ces/saferneediedevices.ntm] #orohiv The risk after exposure of the skin to HIV-infected blood is estimated to be less than 0.1%. The risk may be higher if the skin is broken or if the contact involves a large area of skin or is prolonged (CDC, 1987). * As of July, 1996, CDC had received reports of 52 documented cases and 11] “possible” cases (1.€., documentation was unclear) of occupationally acquired HIV among health care workers in the United States. Of the 52 documented cases of occupationally acquired HIV infection, 45 resulted from needle sticks or cuts (CDC HIV/AIDS Surveillance Report, 1996) (Table 2). The number of occupationally acquired HIV infections in health care workers is increasing each year (Figure 3). (Table 2 and Figure 3 omitted] [Add, 53] Safer Needle Devices: Protecting Health Care Workers http://www.osha-sic, gov/SLTC/needle.. -ces/saferneedledevices.ntm!#orohiv [balance of Figure 3 omitted] Note: The CDC did not publish statistics on occupationally acquired HIV in health care workers in the years 1989, 1990, and 1991. The CDC began publishing statistics on health care workers with possible occupationally acquired HIV in 1992 Q Why are universal precautions and personal protective equipment not adequate to protect the health care worker against needlestick injuries? A Using universal precautions, along with personal protective equipment, engineering controls and other work practice controls, reduces employee exposure to bloodborne pathogens. Personal 236 a protective equipment provides a barrier to protect skin and mucous membranes from contact with blood and other potentially infectious material (OPIM), but most personal protective equipment is easily penetrated by needles. Needlestick injuries are caused by unsafe needle devices rather than careless use by health care workers. (Jagger, 1988). Safer needle devices have been shown to significantly reduce the incidence of accidental needlesticks and exposure to potentially fatal bloodborne illnesses (CDC, 1997). Q What is a safer needle device? A A safer needle device incorporates engineering controls to prevent needlestick injuries before, during, or after use through built-in safety features. The term, “safer needle device,” is broad and includes many different types of devices from those that have a protective shield over the needle to those that do not use needles at all. The common feature of effective safer needle devices is that they reduce the risk of needlestick injuries for health care workers. Q Can safer needle devices prevent needlestick injuries? A All needlestick injuries are not preventable, but research has shown that almost 83% of injuries from 18 7/22/98 3:45 PM {Add. 54] Safer Needle Devices: Protecting Health Care Workers http://www.osha-slc.gov/SLTC/needle. . .ces/saferneediedevices.ntm | #orohiv A hollowbore needles can be prevented (Ippolito et al, 1997). Many of these needlesticks can be prevented by using devices that have needles with safety features or eliminate the use of needles altogether (e.g., needleless IV connectors, self re-sheathing needles, and blunted surgical needles). 237 a Most current research is hospital based and studies have indicated that a significant portion of needlestick injuries occur when manipulating IV lines or administering IV and IM injections (Jagger, 1988). In 1992 the FDA published a safety alert warning of the risk of needlestick injuries from the use of hypodermic needles as a connection between two pieces of IV equipment. This alert was based on research that demonstrated that secondary IV tubing with connector needles was associated with the highest risk of needlestick injury. The use of needleless IV systems or systems with recessed needles to connect adjoining equipment was strongly encouraged in this alert (See Appendix A). Two new studies indicate that the use of safer needle designs can reduce the risk of needlestick injuries among health care workers. The National Center for Infectious Diseases (NCID) Hospital ~~ Infections Program conducted the studies in collaboration with eight hospitals in three U.S. cities. The results appear in the January 17, 1997 issue of MMWR. (See References) The first study describes the use of blunt suture needles during gynecologic surgery, and indicates that blunt suture needles may reduce the likelihood of a needlestick during surgery by as much as 86%. The second study examined the use of safer needles for drawing blood and found that safer needles for drawing blood may reduce needlesticks to health care workers by 27% to 76%. The investigations also found that the use of safer needles did not lessen the quality of patient care. Further, the safer needles were generally accepted by health care workers. Some devices have not been well-accepted in the clinical setting nor associated with a significant decease in injury rate. These results may be explained by lack of training or lack of support for change in the clinical setting (Chiarello, 1992). Although all major medical device manufacturers market devices with safety features, no standard criteria exist for evaluating the safety claims of these features. Employers implementing needlestick prevention programs should evaluate the effectiveness of various devices in their specific settings. 238 a Q What are the design features of a safer needle device? A The Food and Drug Administration (FDA, 1992, 1995) has suggested that a safety feature designed to protect health care workers should: e Provide a barrier between the hands and the needle after use; e The safety feature should allow or require the worker’s hands to remain behind the needle at all times; e Bean integral part of the device and not an accessory, ° Bein effect before disassembly and remain in effect after disposal to protect downstream workers; and e Be simple and self evident to operate and require little or no training to use effectively. Features designed to protect the health care workers should not “have a negative impact on the delivery of patient care. As an example, there are a few reports of increased bloodstream infections with the use of needleless IV systems” (Chiarello, 1997). Q What are some of the types of safety features used in safer needle devices? A The types of safety features used in safer needle devices can be categorized according to certain of 18 7/22/98 3:45 PM [Add. 55] Safer Needle Devices: Protecting Health Care Workers http://www.osha-slc gov/SLTC/needle.. _ces/saferneedledevices.ntm | #orohiv A The types of safety features used in safer needle devices can be categorized according to certain aspects of the safety feature, 1.¢., whether the feature is active or passive and whether the engineering control is part of the device (Chiarello, 1995). 239 a * Passive safety features remain in effect before, during and after use; health care workers do not have to activate them. Passive features enhance the safety design and are more likely to have a greater impact on prevention. ¢ Active devices require the health care worker to activate the safety mechanism. Failure to do so leaves the worker unprotected. Proper use by health care workers is the primary factor in the effectiveness of these devices. * An integrated safety design means that the safety feature is built in as an integral part of the device and cannot be removed. This design feature is preferred. * An accessory safety device is a safety feature that is external to the device and must be carried to or temporarily or permanently fixed to the point of use. This design also is dependent on employee compliance and according to some researchers, is not desirable. (See Appendix B for examples of ways these engineering features can be designed into needle devices.) Q How can health care employers evaluate and select safer needle devices? A OSHA’s Bloodborne Pathogens Standard requires that “Each employer having an employee(s) with occupational exposure ... shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure” [29 CFR 1910.1080)(c)(1)(iMB)}. A variety of safer needle devices is now widely available. Manufacturers have responded to the need for safer devices and as a result, a wave of safer medical products have flooded the marketplace. One thousand U.S. patents for safer medical devices have been issued since 1984 (Ippolito, 1997). Employers are faced with the tremendous task of selecting and evaluating products from the vast array of devices available. Although OSHA does not require employers to institute the most sophisticated engineering controls, it does require the employer to evaluate the effectiveness of existing controls and to review the feasibility of instituting more advanced engineering controls (CPL 240 a 2-2.44C). OSHA staff should encourage an employer to implement a needlestick prevention program. Research to date has shown that no single safer needle device will work equally well in every facility so employers must develop their own programs to select the most appropriate devices. The goal is to choose devices that are: e Clinically effective, e Acceptable to user, and e Most effective in reducing needlestick injuries in that particular setting (Chiarello, 1995). To evaluate and select appropriate safer needle devices, health care employers should review available needlestick injury data including the personnel involved, the devices used, and the circumstances and frequency of needlestick events. This information can assist the employer in determining how employees can maximally benefit from a product change to a safer needle devices. Although not required by OSHA, collection and evaluation of complete needlestick injury data by hospitals are key to identifying injury patterns and then implementing an effective abatement plan (Chiarello, 1995). Q What are the steps a health care employer should consider in developing a comprehensive needlestick prevention program and implementing safer needle devices? A Chiarello (1995) describes a framework to aid health care employers in establishing a comprehensive program to select and evaluate safer medical devices in a systematic manner. The of 18 7/22/98 3:45 PM [Add. 56] 24la (Compend Contin Educ Dent, Vol. XIV, No. 8, p. 966 (Aug. 1993)] Dental Infection Control Forum By John A. Molinari, PhD Infected Health-Care Professionals: Healers or Modern Day Lepers? Part 2--Approaches and Recommendations In the first part of this two-part series, basic concerns were discussed regarding the potentially volatile issue of health-care workers infected with the human immunodeficiency virus (HIV). These concerns included health-care workers’ occupational risks for HIV, patient risks during treatment by HIV-infected health-care workers, and possible ramifications of proposed legislation designed to identify infected health-care workers and require informed consent before rendering patient care. This follow-up article will focus on approaches and recommendations that attempt to address the problem by using science-based knowledge as a foundation. One theme that should always be considered when modification of public-health policy is contemplated includes ‘wo components: 1) health-care risks must first be demonstrated; and 2) proposed solutions must be deliberated in light of their own expected benefits and risks. Most people would agree that issues Surrounding HIV infection and the acquired immunodeficiency syndrome (AIDS) are more emotionally charged than any other recently encountered infectious disease. Additional concern was exhibited by the public in 1990, when the first of a total of six HIV-infected patients in a Florida dental practice were determined to have been infected by a dentist who carried the same HIV strain. Perceived patient risks of HIV transmission continue to provide segments of the media with opportunities to make 242 a undocumented claims. It is difficult to change perceptions, especially where safety and risk issues are concerned. One can only respond by offering data from ongoing look-back and epidemiological investigations. These indicate that more than 19,000 patients of HIV-infected health-care workers have been tested, and none were found to have been infected by health- care workers.' In light of the perception-vs-data debate, what can be done, then, to protect the high standards of patient care, give reasonable assurances to patients, and, at the same time, acknowledge the nghts of health-care workers? In 1991, two states, New York and Michigan, drafted and approved guidelines for HIV-infected health-care workers, which were later modified to include workers infected with the hepatitis B virus (HBV).*° Both documents were subsequently reviewed by the Centers for Disease Control and Prevention (CDC) and deemed to be equivalent to the CDC “Recommendations for Preventing Transmission of the Human Immunodeficiency Virus and the Hepatitis B Virus During Exposure-Prone Invasive Procedures. Table 1 lists the specific recommendations included in the Michigan guidelines. These guidelines were based on ongoing studies that indicate an extremely low risk for HIV transmission and a low risk of HBV cross-infection from infected health-care workers to patients. A fundamental principle for provision of patient care is strict adherence to the application of universal precautions to prevent transmission of blood-borne infections. When the data and historical success of appropriate infection- control procedures are considered, mandatory HIV testing of all health-care workers and limiting the practice of HIV- or HBV-infected health-care workers are simply not justified. Can we guarantee zero risk for both the health-care workers and patients? No--however, in acting responsibly toward fulfilling our professional role as oral-care providers, it is incumbent on each health-care worker to invest time, effort, and active participation in those educational aspects of disease prevention that can provide the greatest measure of personal 243 a protection to the health-care worker and to the patient population. Reduction of risk factors in both professional and personal arenas remains the cornerstone in conscientious and responsible actions designed to guarantee absolute minimal risk of infection. The time, effort, and even dollars invested toward the pursuit of minimal risk is the most responsible option available to the health-care worker to provide both personal and patient confidence in establishing minimal disease risk. 966 Compend Contin Educ Dent, Vol XIV, No. 8 (Aug. 1993) [Add. 57] 244 a IN THE UNITED STATES DISTRICT COURT DISTRICT OF MAINE mma Moone SIDNEY ABBOTT, ) Plaintiff ) ) CIVIL ACTION No. ) 97-0273-B ) ) ) VS. RANDON BRAGDON, DMD Defendant Deposition of DEBORAH GREENSPAN Tuesday, July 25, 1995 Reported by: MARLENE LEE, CSR No. 4623 [Pages 2 and 3 omitted] [Page 4] DEBORAH GREENSPAN, having been duly sworn, testified as follows: EXAMINATION BY MR. McCARTHY MR. McCARTHY: Q. Would you state your full name for the record. A. Deborah Greenspan. Q. And your age? A. Fifty-five. Q. Present occupation? A. Clinical professor of oral medicine in the Department of Stomatology, School of Dentistry, University of California. 245 a Q. Is that your full-time employment? A. Yes, it is. Q. Do you treat patients in that capacity? A. Yes, I do. Q. To what extent? A. I see patients in the Stomatology Clinical Center several days a week. Q. Would you say you spend most of your time seeing patients? A. I would say approximately 50 percent of my time is spent seeing patients. Q. Are you those patients’ primary dental [Add. 58] * KK [page 17 omitted] A. No. Q. Is there a greater risk of transmission of HIV from patient to health care provider than from health care provider to patient, in your opinion? MS. PERLEY: What type of health care provider are you talking about? THE WITNESS: Could you repeat the question so I’m clear? 246 a MR. McCARTHY: Q. Sure. Is there a greater risk of the transmission of HIV from patient to health care provider than from health care provider to patient? A. There is a difference. Q. What is the difference? A. There are no documented cases of patients acquiring HIV infection from the health care provider. Q. But what is the answer to my question? A. If you repeat the question. I think I’d answered it. Q. Is there a greater risk of transmission of HIV from healu: care provider to patient than there is from patient to health care provider? A. There is no risk -- there is no [Page 19] documented risk reported of a patient acquiring HIV infection from a health care provider. There are a number of cases that have been documented of HIV being acquired by a health care worker as a result of exposure. Q. And so what is the answer to my question? A. That there is a difference in risk between the two. A. And which risk do you see as greater? A. The risk is greater of acquiring -- the risk is very small, but nevertheless it is greater to acquire HIV infection from a patient to a health care provider than the other way around. But it is very small. 247 a Q. You made reference to the term “documented.” Do you think it’s possible to believe transmissions have taken place of HIV, whether they be from health care provider to patient or vice- versa, without the transmission being documented? A. Not that I would use to make any judgments from. [ would only use documented evidence. Q. And when you say “documented,” in terms [page 20 omitted] [Add. 59] [pages 21, 22, 23 and 34 omitted] [Add. 60] * ee [pages 153, 154, 155, and part of page 156 omitted] [Page 156] Q. On Pages 100 and 182 of your book. “Aids and the Mouth,” you state that the general dentist gives an average of 177 local injections a month, and that the rate of needle-stick injuries was 1.5 per 100 injections. A. That was based, as far as I remember, on a survey that had been done. Q. Was that a reliable survey? A. Based upon the reliability of self-report, then I would say that the reporting was reliable. But it’s always based on -- if it’s based 248 a [Add. 61] [Page 157] on self-report, it’s based on the ability of people to recall. But the survey, I trust -- but there was limitations to such surveys. Q. Do you think that the figure of 1.5 needle-stick injuries per 100 injections is a reliable statistic for scientists to utilize in considering HIV issues? A. I’m not sure how it pertains to HIV issues. But in answer directly to your question, I think that there is one survey and gives us some idea of how, in the context of that survey, that was what was reported And therefore I believe it was reliable. Q. Do you think it’s fair for one who is trying to estimate the rate of needle-stick injuries to rely on this calculation of 1.5 per 100 injections that you have referred to in your book? A. I think that this was one survey that was done and gives one an idea of the number that were reported in this instance. Q. But do you have any reason to discount the survey? A. I have no reason to discount the survey. Merely that it must be taken in context of [Page 158] subsequent surveys that are done. Q. Have you heard of subsequent surveys that would cause you to believe the estimate of sticks per injection should be different than 1.5 per 100? 249 a A. There has been a subsequent Survey after this book was published where the numbers are slightly different. Q. How? A I don’t recall what they were, but | would comment that they are slightly different, as often heppens in many surveys. Q. When you say “slightly different,” they might be |.6? You don’t mean they might be 5.5 per injection? A. I believe they are within the same, if I may use the term, ball park. Q. How do you define “injection” in the sense you utilized it in the sentence we just read? A. Can you remind me of what we said? Sorry. Q. I think you said, “General dentists give an average of 177 local anesthetic injections per month, and the rate of needle- stick injuries is 1.5 per 100 injections.” [Page 159] A. “Injection” merely follows the term “local anesthetic.” It’s part of the same process. The local anesthetic is what you put in. Injection is the way you deliver it. [rest of page 159 and page 160 omitted] [Add. 62] 250 a [Compend Contin Educ Dent, Vol XIV, No. 6, p. 706] Dental Infection Control Forum By John A. Molinari, PhD Infected Health-Care Professionals: Healers or Modern Day Lepers? Part I-Issues and Considerations The working environments of health-care providers changed dramatically on July 27, 1990. It was on this date that the Centers for Disease Control and Prevention (CDC) reported the first instance of possible transmission of the human immunodeficiency virus (HIV) to a patient from an HIV-infected health-care worker. The public and many others in the health professions were stunned, and soon the case of the “Florida dentist” was being discussed and debated in many forums. Subsequent information linking five additional patients to the dentist’s HIV strain added to the turmoil and emerging public concern. Unfortunately, the exact mode of viral transmission has not been delineated to date, and probably never will be elucidated. As a result of extensive media attention and the absence of important epidemiologic information, many health professionals, and the public, have drawn conclusions that are based more on frustration, fear, and anger than on scientific data. It is not my purpose to review the known details of this case in this article. No matter what happened, the results have already been tragic to those infected, their families, and to society in general. Instead, in the first part of this two-part series, I will offer my views on some important issues that have the potential to polarize treatment providers from their patients. These issues are: occupational HIV risks for health-care workers, mandatory HIV testing, and notification of HIV status to patients. The following discussion will briefly outline known health- care worker occupational risks, policy dilemmas, and possible ramifications of proposed legislation aimed at practice limitations for infected health-care workers. Part 2 of this article will discuss the specific approaches and recommendations that have been generated by groups of health professionals, their organizations, and a number of state health departments. 25la There is one question that has been on the minds of health- care workers since the earliest reports of patients with acquired immunodeficiency syndrome (AIDS) were published in 198]. That question is: how much of an occupational risk do we have when treating patients with AIDS? Subsequent isolation and characterization of HIV provided opportunities to use serological assays to investigate suspected cross-infection cases. Numerous studies have been reported and continue to be performed to examine possible incidents of HIV transmission in a variety of clinical settings. Despite thousands of reported accidental exposures, 31 occupational HIV transmissions were documented by the CDC, as of July 1992, with 65 additional cases still under investigation (Table 1).' A few important trends become apparent while reviewing these data: (1) while not zero, the risk to health-care workers appears to be very small; (2) no documented HIV transmission to dental workers has yet been reported; and (3) 23 out of 31 documented transmissions and 22 out of 65 possible transmissions have occurred in either nurses or in clinical laboratory workers. Both of these groups commonly work with needles and draw blood specimens from patients. It is also well documented that blood is the most common body fluid present in occupational transmission. and most reported health-care injuries involve needlesticks or other sharps accidents. With specific reference to dental professionals, six have been investigated and are without identifiable behavioral or transfusion risks. In each instance, percutaneous or mucocutaneous Occupational exposures to blood or other body fluids containing HIV was reported, but HIV seroconversion was not documented. Even though these figures Suggest a very smal] HIV risk for dental-care providers, we should not interpret them as indicating no risk. Our routine aseptic, barrier, sterilization. and disinfection infection-control precautions have gone a long way in establishing a high standard of practice safety for both health-care workers and those receiving care. These should not be compromise, be- 706 Compend Contin Educ Dent. Vol. XIV, No. 6 [Add. 63] 252 a [advertisement omitted] cause HIV does not seem to be a major occupational infection for dental workers. My thoughts on the questions surrounding mandatory HIV testing for health-care workers and notification of infection status to patients are based on guidelines that I was pleased to help develop for the Michigan State Department of Public Health.’ The original recommendations of our task force, which were published in 1991, specifically addressed HIV; however, the scope was expanded in 1992 to include hepatitis B-virus-infected health-care workers. Central to the debate of HIV-infected health-care workers is: What is considered an acceptable level of risk of HIV transmission? The CDC has periodically updated retrospective studies of patients of HIV-infected health-care workers. At present, HIV test results obtained from more than 18,000 of the patients of 32 HIV-infected health-care workers demonstrate no HIV infections that could be attributed to medical or dental care, except for the dental patients in Florida. To place these risks in better perspective, they should be compared to other risks patients face as they enter the health-care system. For example: / out of every 10,000 persons undergoing general anesthesia dies; / to 2 out of every 100,000 persons treated with penicillin have an adverse _ (anaphylactic) reaction resulting in death.’ Some elected officials would like to pass legislation mandating HIV testing for health-care workers, with those found to be infected being required to disclose their HIV status to patients. Many of us who work in the area of infectious diseases see substantial problems Table 1--Health-Care Workers with HIV Infection and/or AIDS, With Documented and Possible Occupationally Acquired HIV Infection, by Occupation, Reported Through June 1992' Occupation Documented _— Possible Occupational Occupational Transmission Transmission Number Number Dental workers, including dentist 0 6 Embalmer/morgue technician 0 3 Emergency medical technician/pararnedic 0 7 253 a Health aide/attendaat l 5 Housekeeper/maintenance worker l 5 Laboratory technician, clinical ll 10 Laboratory technician, nonclinical I I Nurse 12 12 Physician, nonsurgical 4 7 Physician, surgical 0 2 Respiratory therapist l l Surgical technician 0 l Technician/therapist, other 0 3 Other health-care occupations 0 2 TOTAL 31 65 708 Compend Contin Educ Dent, Vol XIV, No. 6 [Add. 64] with this line of thinking. Many health-care workers who know they have personal risk factors for HIV infection would be tested anonymously, or would avoid testing altogether. Thus, the Because the risk of HIV transmission from patient to health-care worker is much higher than the risk of transmission from health-care worker to patient, mandatory testing of health-care routine testing of patients. Because of the window period for development of positive serological reactions following HIV infection, retesting of subjects to determine their infection Status would have to be done on a regular basis. In effect, many millions of scarce health-care dollars would have to be diverted from effective HIV prevention Strategies to finance such testing. It is also unfortunate that the intent of proposed mandatory testing and disclosure policies appears to be aimed at automatically limiting the practice of HIV -infected health-care workers. | believe that, in addition to the factors mentioned above, other negative consequences of such policies would occur. These include: (1) the loss of services of noninfected health-care workers who choose to modify their practice or change careers based on fears of occupational seroconversion and its consequences: (2) the loss of 254 a employment of HIV-infected health-care workers including their valuable services to society; (3) the probable reduction in services for HIV-infected patients, including denial of care by health-care workers who fear seroconversion; and (4) the negative (social, psychological, and financial) impact of false-positive tests resulting from widespread testing in populations with a low incidence of disease. Some argue that patients have the right to know whether or not their health-care workers are HIV-infected. Patients have the right to any information that might be reasonably expected to affect their health status. In general, however, the HIV infection status of health-care workers does not meet this criterion because of the extremely low risk of HIV transmission from the infected health- care worker, and the standard of infection control routinely practiced during patient treatment. What reasonable and scientific actions do we take, then, instead of mandatory testing and patient notification? Stay tuned. [References omitted] [ Advertisement omitted] [Add 65] 255a (Ms. Abbott’s Motion for Summary Judgment page 17] te On November 7, 1994, after Sidney Abbott had filed a complaint against Dr. Bragdon with the Maine Human Rights Commission, Dr, Bragdon -- for the first time -- applied for hospital privileges at Down East Community Hospital (“Down East”) in Machias, Maine. See R.A., Ex. R.” Down East twice requested additional information from Dr. Bragdon. R.A., Ex. T. Dr. Bragdon did not provide the requested information. Dr. Bragdon does not today have privileges at Down East or any other hospital. [Notes 20 and 21 omitted] * Machias is approximately a two hour drive from Bangor. In addition, the cost of the hospital operatory at Down East is five dollars per minute. See transcript of deposition of David Kennedy, Account Officer at Down East, R.A., Ex. §: 5. Assuming even a thirty minute procedure, this would increase the cost of filing a cavity from $35 to $45 to $185 to $195. The cost of the operatory could be greater if the head nurse who is in charge of billing determined that the hospital should bill for the time it takes Dr. Bragdon to set up his equipment and supplies. R.A., Ex. §:10. [Add. 66] 256 a Abbott v. Bragdon Deponent Randon Bragdon, D.D.S. [Page 269] A. We use single gloves when we do examinations. Q Okay. Did Judith Bragdon ask you anything else? A. No. Q Did you have any conversations with anyone else in your office on September 16th, 1994, about Sidney Abbott prior to meeting Sidney Abbott? A. No. Q. Tell me what happened when Sidney Abbott entered your treatment room. What was the first thing you said to her? A. I can’t remember. Probably small talk. Usually I comment on the weather or something like that, but I can’t remember. Q. Prior to Sidney Abbott’s entering your treatment room, had you determined in your own mind whether you would provide dental treatment to her or not? A. I didn’t know what she wanted done. Q. Prior to Sidney Abbott’s entering your treatment room -- well, by dental treatment, how do you define dental treatment? A. I don’t understand the question. Q. Okay. Let me step back and rephrase that. Prior to entering -- Sidney Abbott entering your treatment room, had you made any determination about whether you would provide a service to her 257 a [Page 270] QO. such as filling a cavity? Not specific to her, no. Okay. Prior to meeting Sidney Abbott, did her HIV Status - - her HIV-positive status -- had you made any decision about what you would and wouldn’t provide to her on September 16th, 1994, on the basis of her HIV-positive status? MR. GILBERT: Are you focusing the witness’s attention on the approximately one-minute time frame that he talked about earlier between when he reviewed the form and when he showed the patient into the office, in that one minute? Q. 0 MR. KLEIN: _ Right. Prior to meeting Sidney Abbott. No. Okay. Describe to me everything you can remember about what Sidney Abbott said to you and what you said to her. I think I already have. Okay. Is there anything else? Not that I can recollect right now. Okay. What -- did you take -- tel] me what type of dental] €xamination or procedures you performed [Page 271] on Sidney Abbott? ‘a A. Q. PB PLO Fe REF ee 258 a She said -- I examined the lesion which she was inquiring about, and then I did a general exam. Okay. And what does that consist of specifically? Basically, it’s a general look at the soft tissue and a general look at the other teeth to see if there is any major problems. Okay. What instrument -- With the mirror and explorer. I’m sorry? A mirror and an explorer. Tell me exactly what you did with a mirror and explore? What do you mean? How did you use them to perform the dental exam? Took the mirror in my left hand and the explorer in my right hand and examined the teeth. I may have used the mirror to retract her cheek, too. I sometimes do during an exam. And you noticed on the health registration form that Ms. Abbott indicated that she had a toothache? Yes. And did you take any steps to determine whether [Page 272] Ms. Abbott’s toothache was indicative of something other than a cavity such as the -- such as the dental conditions which you described earlier that can be -- that a toothache would be indicative of? 259 a A. No, because I did ask her if it was bothering her, and she said no. She said that she had been recently examined by another dentist. MR. KLEIN: .Can we have this as the next exhibit? (Bragdon Exhibit #14 marked.) BY MR. KLEIN: Q. Can you identify Exhibit 14? A. Yes. This is the record of Sidney Abbott with the front and back page. Q. Can you please read into the record all of the notations that you placed on that record? A “9/16/94, buckle decay, number 18. HIV diagnosed eight years ago. Wants to know cost. 35 to 45 dollars. Would have to do in hospital outpatient because of infectious disease policy. Will think about and get back to us.” And it’s noted under the charges, no charge. If Sidney Abbott had not indicated on the Patient Registration and Health Record that she is HIV [Add. 67} [Page 281] QO Q, Describe to me the circumstances under which you would have filled Sidney Abbott’s Cavity. If she had indicated that she wanted to have it done, I would have made arrangements, if possible to do it ina hospital setting. What hospital? 260 a A. I’m not sure. Q. Why aren’t you sure? A. Because I’ve never had to take and make arrangements for such a thing. Q. What hospital would have attempted to treat Sidney Abbott in? A. Probably Downeast Memorial Hospital. Q. Where is that? A. In Machias. Did I say Downeast Community Hospital? Q. That’s in Machias? A. Yes. Q. How many miles is Machias from Bangor? A. I’m not sure. Q. Do you have an estimate? A. Probably 60 miles or thereabouts. Q. Are there any other hospitals aside from Machias that you would have considered treating Sidney Abbott in? [Page 282] A. I would have considered Eastern Maine or St. Joseph's Hospital. Q. Any others? A. No. Q Q. 26la Where is St. Joseph’s Hospital located? In Bangor. As of September 16th, 1994, you didn’t have privileges at - ~ to use the facilities of any hospital, is that correct? That is correct. And prior to September 16th, 1944. had you ever inquired about obtaining privileges at any hospital? No. And had you ever even inquired about the process for obtaining privileges at any hospital prior to September 16th, 1994? No. Okay. At some time subsequent to September 16th. 1994, did you have any communication with the Eastern Maine Medical Center? No. Okay. At some time subsequent to September 16th, 1994 -- strike that. On September 16th, 1994. if Ms. Abbott had wanted you to fill her cavity, was [Page 283] Eastern Maine Medical Center the first place that you would have inquired into with respect to using a hospital operatory? Yes. 262 a Q. All right. And at some time after September 16th, 1994, did you learn anything about Eastern Maine Medical Center that would affect your ability to obtain privileges there to use a dental operatory? A. Yes. QO. What did you learn? A. I learned that you were planning to depose Dr. Paul LaMarche. Q. When did you learn that? A. From my counsel, John McCarthy. Q. When did you learn that? A. I can’t remember for sure. Q. Continue. A And that flagged us that there must be some problem at Eastern Maine which you planned to amplify on. So with that I called Dr. Chris Maller. Q. Can you spell the last name? A. M-A-L-L-E-R. Q. Okay. Was that prior to LaMarche’s deposition? [Page 284] A. Yes. Q. And who is Dr. Maller? A. He is a general dentist in Bar Harbor who also has an office up here. 263 a 0 In Bangor? > Yes. I knew he did some hospital dentistry, and at the time I thought he was in the Eastern Maine facility. So I was going to inquire about their facilities and application and whatnot. He advised me that the head of dental services at Eastern Maine was also the head of dental services at St. Joseph’s Hospital. It was a problem in that he was against general dentists working in a hospital setting. 6) Who is the head of dental services at Eastern Maine Medical Center that you are referring to? A Dr. Daniel McCarthy. Q What else did Dr. Maller tell you? He told me that as a result he couldn’t make any headway with getting hospital privileges at Eastern Maine. and he understood that they had allowed the dental facility to deteriorate. Did he tell you specifically how they -- did he tell you specifically or -- did he tell you specifically what kind of dental facility they [Add. 68] Do you know what kind of dental facility they had there? No 264 a Q. Do you know what he meant by they had allowed the dental facility to deteriorate? A. He indicated he didn’t think you could do general regular dentistry there anymore. Q. Okay. And he indicated that he was doing his hospital dentistry at the Bar Harbor hospital on administrative privileges permission. Q. Okay. Did you have any further conversation with Dr. Maller about hospital privileges? A. No, I didn’t. Q. After your conversation with Dr. Maller, you didn’t have any communications with Eastern Maine Medical Center? A. No. Q. At any time have you had any communications with the St. Joseph’s Hospital about obtaining privileges? A. No. Q. Okay. You have never even -- have you ever [Page 286] inquired about the process for obtaining privileges at St. Joseph’s Hospital? A. No. Q. Are there any other hospitals in the Bangor area at which you would have applied for privileges to treat Sidney Abbott? Q. Q. 265 a No. Okay. Did you ask Dr. Maller what you should do to obtain hospital privileges somewhere? In the sense of specific steps, no. I asked him -- he indicated that Dr. McCarthy was just implacable, and he didn’t think that anything could be done with him at either hospital from his personal experience; and since we was in litigation, I wasn’t too anxious to take and get into an adversarial situation. With whom? With Dr. McCarthy. Okay. Your understanding was that the hospital, Eastern Maine Medical Center, did not have the dental facilities you needed, is that right? He indicated that, too. My understanding at the time that Sidney Abbott came in was that they maintained them and general dentistry could be [Page 287] Q. done at that facility without any problem. Okay. Because that had been the state of affairs in previous years. And you’ve since learned that that was not correct, is that right? That’s right. All right. That as of September 16th, 1994, Eastern Maine Medical Center had not maintained its dental facilities. is that right? 266 a A. That was my understanding. Q. Do you know what facilities St. Joseph’s Hospital ever had for dental treatment? A. No. Q. Okay. Did you ever inquire whether St. Joseph’s Hospital ever had the kind of dental equipment you would need to treat Sidney Abbott? A. No. Q. Have you ever applied for privileges to use a hospital surgical operatory or any other aspect of a hospital to provide dental services to a patient? A. Besides BMHI, which we have already discussed, and I have also applied to Downeast Community Hospital in Machias. {Page 288] MR. KLEIN: __Let’s go off the record for a second. (Off the record colloquy.) BY MR. KLEIN: Q. When did you apply for privileges to Downeast Hospital in Machias? A. I can’t remember the exact date. It’s dated on the letter. It’s on the cover. It’s November something. Q. You think it was in November of 1994? A. I think so. Q A. A . Q 267 a Prior to submitting the application to Machias, did you have any written or verbal c Machias? Yes. ommunications with anyone at Who did you speak with or what was the mode of communication? Telephone. Who did you call? Did you Yes. Who? I called Dr. Charles Dorr. D-O-R-R. Who is he? call someone? Can you spell the last name? [Add. 69] (Page 289] A A He is a general dentist -- Okay. -- who is head of dental services down there. How did you get Dr. Dorr’s I knew him. I knew he was there. name? doing hospital dentistry down 268 a All right. How did you know that? Previous conversations. What was your conversation with Dr. Dorr? Pe eS ie I asked him about getting courtesy privileges, and his response was: Do you have an HIV patient that you want to treat? And I said I may have. And he indicated he didn’t think there would be any problem with getting privileges and sent the form out the next day. Q. Okay. Did you first tell Dr. Dorr that you may have an HIV-positive patient? A. No. He asked me. Q. Okay. So you didn’t mention -- he asked you whether you wanted to treat prior to your mentioning anything about having an HIV-positive patient, is that nght? A. Let’s back up a bit. I asked him about the hospital privileges, and that was his response [Page 290] because he is aware of my infectious disease policy. Q. All right. Was Dr. Dorr at the time that you called him aware of the litigation in the case known as John Doe versus Randon Bragdon? A. Yes, he was. Q. How was he aware of that; do you know? A. From the mailings. Q. What mailings? ET NS at LS Re Tae eT eS I 7 A. That I had mailed out to the members of the dental society in 91. Q. Did those mailings reference the lawsuit brought by John Doe? A. Yes. Q. Had you prior to this conversation had any -- A. Let me think here a minute. It referenced the proceedings of the Maine Dental Society. It may not have been the lawsuit itself. I believe there had been an article or two in the paper, or three. Q Prior to your conversation with Dr. Dorr about obtaining privileges at Machias, had you ever had a discussion with him about your infectious disease policy? A. No. [Page 291] Q Okay. Had you ever had a discussion with him about the previous lawsuit against you brought by John Doe? A. No. Q What else did you discuss with Dr. Dorr in this conversation? A. That was it. That wasn’t it. I asked him what they had for a facility there, if we would be able to do general dentistry, and he said yes. Q Tell me everything you know about the facilities for dentistry at Machias. A. He said that they had a chair, delivery unit and a hospital 269 a Operatory for it. 270 a Q. If that everything you would need? A. It was the best I could find at the time. Q. Well, is it everything you would need? A. It’s not everything I desire. It’s the best we could do. That’s why we have worked hard to get three state-of-the- art facilities here in the state because we recognize that what we need isn’t available. Q. What is your understanding of the infection control capabilities of the hospital operatory at Machias? A. I haven’t been down there to actually see it, so [Page 292] I would have to inspect it, but my understanding is that, one, we would be able to wash it down completely after use. I would be able to set up so that virtually everything that couldn’t be autoclaved could be disposable. Q. Anything else? A. And they had a filtered-air system. Q. What do you mean by a filtered-air system? A. That the air would be filtered for airborne pathogens. Q. Okay. Is that everything? A. That’s all I’m sure of or I feel sure of. Q. Have you ever been to Machias to inspect their facilities? A. No. 271 a Q. Did you ever make any inquiry about the nature of the infection control capabilities of the facilities at Machias other than this conversation you are relating with Dr. Dorr? A. No. Q. If you had privileges to use the facilities at Machias on September 16th, 1994, would you have treated Sidney Abbott in that facility? A. Yes. MR. GILBERT: You’re assuming for [Add. 70] [Page 333] A That I am writing for my expert position. Is there more of your expert position coming to us in the future? No. As documentation for what the position is. Q Pardon me? A It will be a footnoted documentation of my position. Q Okay. So you will be supplementing your expert position with additional information? A. No. MR. McCARTHY: That comes from counsel. MR. KLEIN: Well, what is the story? MR. McCARTHY: There is no story. He is referring {0 materials between counsel and -- Ee | 272 a MR. KLEIN: Between him and you? MR. McCARTHY: Yes. MR. KLEIN: Weare getting that, too? MR. McCARTHY: No. (Recess taken from 3:04 to 3:19.) MR. KLEIN: The parties have agreed that Dr. Bragdon’s deposition will be resumed on Tuesday, June 13th, and Wednesday, June 14th. The parties will agree that Dr. Bragdon’s deposition will be continued on the days of June 13th and June 14th from the hours of 9:00 to 6:00 [Page 334] with an hour for lunch and reasonable breaks and, that with respect to the documents, that the plaintiff is seeking to compel from Dr. Bragdon -- Dr. Bragdon’s counsel agrees -- that we are not prejudiced with respect to seeking a further resumption of Dr. Bragdon’s deposition if the judge or magistrate judge orders it along with our motion to compel. MR. McCARTHY: That’s correct. MR. KLEIN: Anything else? MS. PERLEY: The United States and the Maine Human Rights Commission will be asking questions on the 13th, and counsel for Sidney Abbott will be asking questions on the 14th. MR. McCARTHY: And Dr. Bragdon doesn’t concede that the United States has the mght to ask questions, and it’s understood that we are not waiving that right by allowing you to ask questions on the 13th. BY MR. KLEIN: Te a wR a ee ae 273 a Dr. Bragdon, you just went through a number of different changes which you are using to support your expert position that universal precautions are not adequate. Is that correct? That’s correct. [Page 335] Q. Q Are there any other examples that you care to provide in response to that answer other than what you have just given? No. Calling your attention again to your expert report which is Exhibit 7, at page two you have listed a number of considerations that you think are necessary for treatment of an HIV-positive patient in a hospital operatory, is that correct? Yes. Yes. Air filtration filters the air in the operatory which minimizes airborne pathogens both rising from the Procedure and also from the ambient. For example, immunocompromised patients are quite sensitive to aspergillus, aspergiliosis (sic). Can you spell that? [Page 336] 274a A-S-P-I-R-G-I-L-L-I-O-S-I-S (sic). What is that? It’s an infection. It’s a fungus-type infection HIV patients get quite easily, and it’s also a threat to other immune- compromised patients. It doesn’t take much to expose the environment to it. For example, lifting out a tile to repair a light or something can put it into the air, and it’s part of standard hospital infection control if they are anticipating remodeling to move patients from there to put hepa filters in at the very least. They usually try to put barriers in, too. Is this something that you are concerned about HIV- positive patients contracting or that you are concerned by HIV-positive patients transmitting to -- Contracting. -- staff? Contracting. Ultraviolet lights. They are another extra measure in killing pathogens. Negative pressure operating room provides protection from airborne pathogens leaving the operatory area. I’m sorry, I just didn’t hear that. (Add. 71] [Page 337] A. It minimizes the chance of airborne pathogens leaving the operatory area to get into other areas outside the operatory. These are used quite commonly even for patient rooms that there 1s either a known or potential problem with respiratory disease, airborne disease. Respirators, these provide a higher level filtration than the standard ear-loop surgeon’s masks we use. Sterile water supply should be QO. Q. Q. 275 a used with three-way syringe and the high-speed hand piece. And the primary pathogens that are threats of that are pseudomonas and legionella bacteria. If I could just ask one question. What is pseudomonas? And how do you spell that? P-S-E-U-D-O-M-O-N-A-S. And what is it? If I remember correctly, it’s antero bacteria. It’s a what? If I remember correctly, which I may not, it’s a gram negative antero bacteria; A-N-T-E-R-O bacteria. And what is its significance with respe*t to this case? It causes disease. And what about legionella? It causes Legionaire’s Disease. And I’m sorry, continue on with respect to the sterile water supply. That’s it. Is your concern about the sterile water supply -- what is your purpose in using sterile water supply? It’s to protect the patient. From pseudomonas and legionella? oO 276 a A. There is other pathogens, but those are two primary ones. Q. What other pathogens are you trying to protect from the patient? A. I’m not sure it’s well documented, but it is documented that in many dental delivery systems that the water has high levels of bacteria; and as you know, even bacteria that normally don’t produce disease can in an immune- compromised patient. Q. Okay. A. I had another thought that slipped my mind. There has been one case of an orthodontist that they believe died as a result of Legionaire infection from a dental unit. [Page 339] Q. Okay. If you can continue with each of the areas. A. Okay. Hair coverings should be worn to prevent contamination of hair by droplets and splashes. oh 3 And if I can just -- as we are going through each one of these, since the list is long, my question is how each one provides an advantage over your dental operatory. A. With the standard precautions we take, we don’t cover our hair. Q. Okay. A. A face shield should be worn to protect skin areas not protected by the masks; safety glasses, from droplets and ] splashes: Double gloving. 4 Q. How does that provide an advantage over your dental operatory? TS Tee ae a ee ee oF o rN SURF TD ee ea ee A. It doesn’t in itself, but this should be done. I’m not saying that every one of these things couldn’t be done in the operatory, but I am saying the presentation was to give indication of what types of things should be done. Okay. Double gloving should be used to minimize penetration of skin -- to skin. Gloves should be changed every 30 minutes for extended procedures [Page 340] to minimize leaks and hands washed before regloving. Treatment should be carefully planned so that in as far as possible, all dental materials and items to be used are transferred to disposable containers in appropriate amounts to eliminate contamination of kits. Disposables should be used as much as possible. Shoes should be covered. In all probability hospital scrubs should be worn. These should be changed as procedures have been completed, placed in appropriate container hamper. Second assistant should be present to minimize cross contamination. In as far as possible, direct passing of instruments from dentist to assistants should be eliminated. Hoses and cords should be covered. There is also advantage in the hospital setting in case of medica] emergency. Standard hospital post- operative cleanup protocols are adequate. They wash down the floors between procedures and things like that which normally wouldn’t be done in a dental operatory. As far as possible, instruments should be cleansed and sterilized at the hospital. Equipment which cannot be heat sterilized . should be thoroughly clean disinfected. Use of such equipment should [Add. 72} [Page 341] be avoided whenever possible. That concludes it. 278 a Q. Okay. Dr. Bragdon, are you able to quantify the risk of HIV transmission in a private dental operatory? A. Yes. Q. What is that? The risk of transmission in the dental operatory if you have a percutaneous injury is approximately .5 percent. Q. what is the risk of HIV transmission in -- are you able to quantify the risk of HIV transmission in a hospital surgical operatory? A. Yes. Q. What is that? A. If you have a percutaneous injury, it’s .5 percent. MR. KLEIN: Let’s go off the record. (Off the record colloquy.) BY MR. KLEIN: Q. Dr. Bragdon, what is the -- is the risk of obtaining or sustaining a percutaneous injury in a hospital operatory the same as or different than the risk of sustaining a percutaneous injury in a private dental operatory? {Page 342] A. It would be less. Q. And why is that? A. Because you take different protocols than what you ordinarily take. ae 279 a Q. What protocols do you take? A. What protocols? Q With respect to -- which make a lesser risk of Sustaining a percutaneous injury in a hospital setting? 4 One, you would have the second assistant so that your chairside assistant could concentrate more on what she was doing, not to have those distractions. Two. we would do what we could to minimize passes between; certainly minimize them as much as possible so that you minimize injuries in making passes. The double gloving will provide some but not a whole lot of protection. Q. Is that everything? A. That takes care of the percutaneous-injury aspect. Q. Are you able to double glove in your private dental operatory? A Yes. Q. Okay. A. But I have explained before that it is not [Page 343] practical on a regular basis. Q Are you able to utilize a second assistant in your private dental operatory? A. No. Q. And why is that? A. There is not room. Q. O Q. Q. 280 a Okay. In your view, what is the -- are you able to quantify the risk of HIV transmission in a dental operatory from a nonpercutaneous event? No. Are you able to quantify the risk of HIV transmission in a hospital surgical operatory from a nonpercutaneous event? No. Do you believe that there is any risk of HIV transmission in a dental operatory from a [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386018_1497%3A1. Public record. Not legal advice.