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4. As more fully explained in this and the accompany- i'ng,affidavi'ts," the subpoenae (,Exs. 1 and 2)., should be quashed because:. (a) The material sought - data collected!by an academic medical researcher - is absolutely privileged under New.York lav.. (At the very least i~t enjoys a quali':fied pri- vilege.) (b) To allow enforcement of'the subpoenae would, have a devastating adverse effect on medical and scientific research generally and on Mount Sinai and the Cancer Society in, particular. To require an academic with no connection with a litigation to produce the fruits of his:investigation will deter researchers from imaginative and vital scientific research. Scientists will be toldthat if they conduct research in certain f'ields:they will be spending their time gathering data to respond to subpoenae instead of pursuing acad'emic research. Enforcement of the,subpoenae wil.l mean that exploration into controversial problems will be discouraged, potential research subjects will be reluctant to participate in essential scientific studies., and the initiative of scientists to aggressively seek cures too diseases afflicting our society will be undermined!.. u " Because of their bulk, the exhibits accompanying,abl of the III affidavits are being submitted in a separately bound volume. I! v a N ~ A V. V. 3

SUPREME COURT OF THE STATE OF NEW YORK' COUNTY OF NEW YORK ----------------------------------------x In the Matter of The Application of' R.J. Reynolds Index No. 10276/86 Tobacco Company for an Order to Tak:e the Deposition Upon Oral Questions of Mount,Sinai School of:Medicine.in AFFIDAVIT IN SUPPORT a Certain Action entitled Carrie Page . OF MOTION'TO QUASH v. Lincoln Electri~c Company, et al.,. SUBPOENAE'! No. 257046, Pending in the Superior Court, County of Contra Costa, State of California ----------------------------------------x In the Matter of The Application of R.J. Reynolds Tobacco Company for an Order to Take the Deposition Upon Oral Questions of The American Cancer Society in a Certain Action entitled' Carrie Page v. Lincoln Electric Comoany, et a1., No. 257'046, Pendiing im.the Superior Court, County of Contra Costa., State of California ---------------------------------------- x. STATE OF NEW YORK COUNTY OF NEW YORK ss.. MICHAEL A. CARDOZO, being duly sworn, deposes and says: 1. I am a member of Proskauer Rose Goetz & Mendelsohn, attorneys for the Mount Sinai, School of Medicine ("Mount S'inai"), and the American Cancer Society ("Cancer Society"). I submit ,o N a ~ A W W I~i

-both the articles and in the accompanying affidavit~of' Dr. Selikoff'. Dr.. Selikoff explains that for each of the three studies a group of people who had been exposed to asbestos wass selected, and their medical history was then prospectively traced. Dates of birth, dates o£ exposure to asbestos, smoking history, and many other physicali and medical characteristics were obtained from union reco.rds, physical examinations, ques- tionnaires,. correspondence and telephone calls. 12. The cause of death of people who died during the study period was identified.. Cause of death information was obtained from death certificates, autopsy reports, hospital and physician records, histologic specimens (slides) and x-rays. The resulting information was transferred to computer tapes and statistical analyses them run. The frequency of'death by lung cancer of people who were exposed to asbestos and who smoked was compared t6 comparable male populations generally and to smokers in particular. The results, which suggested a synergis- tic effect between smok:ng and asbestos exposure, were then published. 13'. However, although.the subpoenae seek.productiom of all dasa collected during the course of. the studies, the pubSished!artirles did not report on all the data that had been collected at that time. instead the articles discussed only the relationship of,exposure to asbestos and'smoking. Moreover,. N ~ N 8 ~ A Oa N

affidavit and was scheduled to give nis final appro.val to the affidavit, and to sign and swear to it, on Monday June 9. Unfortunately, Dr.. Se:likoff became seriously il1 over the week- end, was hospitalized, andiis scheduled to undergo major surgery this.week. The Selikoff affidavit is therefore submitted to this Court unsigned, an6is incorporated hereiin as an exhibi~t to my affidavit. I represent to this Court that based upon my meetings with Dr. Selikoff, the affidavit, to the best of' my knowledge, is correct, and Dr. Selikoff, but.for his sudden illness, woulid have signed it.. The Studies Whose Raw Data Are The Subject of the Subpoenae 10. The subpoenae demand production of all "documentar tion, data,collection or data bases (the "raw data") that formed the basis for" three studies conducted by Dr. Selikoff (a 71 year old Professor of Community Medicine at Mount Sinai),. and colleagues at the Cancer Society. Articles about those studies, which studies are continui~ng today, were published by Dr. Selikoff in 1968, 1979 'and 1980.. Those articles concluded that the combined effect of exposure to asbestos and smoking i~ncreases the risk of lung cancer by a multip3icative., rather than add!i- t.ive, factor. 11. The methodology folliowed in arriving at the con- c3usions expressed in the articles is.explained in detail in

in the,form in which they were used when the articlbs wer.e pub- lished.. Those tapes are continually brought up to date as addi- tional iinformation on the.subjects of the on-going,studies have been gathered. The Threat to Scientific Research Posed by the Subpoenae 16. The Reynolds subpoenae reflect an assault on the. integrity of academic research. The life's work of one of the. world's leading epidemiologists has been subpoenaed in a case with which he has absolutely no connection. 17. The chilling effect.onthe academic and scientific community reflected by these subpoenae is attested to in.the accompanying affidavits of' Leon E. Rosenberg (the Dean of the Yale University School of Medic:ine),. Dr. Arthur C. Upton (a Professor of' Environmental Medicine at NYU Medical Center), and Paul H.L., Walter (the President of the American Association of University Professors, an organization that rep:,esents over 50,000 faculty members and research scholars), and in a letter (Ex. 17) from Mr. Frank Yores (Executive Director of the Asso- ciated.Medical Schools of New York, representing 13 medical schools in this State). The concerns of these institutions are reiterated in the accompanying affidavits of' Dr.. Selikoff and Mr. Seidman, and Dr,. Nathan Kase, the Dean of the Mount Sinai School.of Medicine. ~~

(',c) The burden of complying with ttie subpoenae would be enormous. Because of the physician-patient privilege, and the confidentiality conditions under which the material was obtained, no production of the subpoenaed material could occur (andleven then only upon a gross violation of the privacy of. the individuals involved) until every piece of paper iin the 97 file cabinets and 250 bound volumes had been redacted of all identifying data,. Such a process is estimated to take 7,0:00 man hours and would totally disrupt.files relating to on-going medical research. To require production would seriously inter- fere with, ilf not destroy, the professional life of Dr. Selikoff. Since only Dr. Selikoff is totally familiar with.the,material, rnd since hi's personal handwritten notes concerning 4,000 indi- viduals would have to be redacted, he would have to actively participate in the redaction process.. -(d): Reynolds has no need for the subpoenaed data. For over twenty years it has had more than adequate oppor- tunity to eoLlect data similar to that sought by the subpoenae,, and'to analyze the data itself. Indeed, numerous studies simi- lar to Dr. Selikoff's have been conducted by others.. Reynolds shouldinot be alilowedt to~ collect and then analyze the data col- lected'Dy,someone else. Ln any event, the validity of the con- clusions set forth in Dr. Selikoff's articles cannot be."'checked" by analysis of the subpoenaed',material. Much of'the data (such as x-raysand slides) on which the published conclusions are 4

subsequen2 to the publication of each article the studies,con- tinued. Additional data on the subjects of' these studies.vas gathered,. physical examinations of the subjects were conducted and causes of death of subjects who died after the articles were published, were collected.. The results of this latter information, although subpoenaed, have never been published. 14. Between the time of the commencement of the,stud- ies and today,. confidential medical data on approximately 1®,500 individuals has been collected. Physical examinations of'ap- proximately 4,000 people have been personally performed, approxi- mately 8,000 0 people,have answered questionnaires and additional information has been collected by correspondence and telephone. calls. All of the information has been collected with assurances that it would remain confidential. 15. The material that has been collected by these three studies is, as Dr. Selikoff explains in.his affidavit, of astronomical proportions. In addition, a great deal of the information collected has been transferred to.computer tapes. The data in the Cancer Society's present possession are set. forth in the accompanying affidavit of Mr. Harbert Seidman, a Vice President of the Cancer Society and another author of the articles.Mr.. Seidman also explains that the computer tapes maintained by the Cancer Society, to whi~ch informatiom collectedl in the course of the studies has been tzansferred, do,not exist .o N 9 A n7 ~ A Op W

18. These affidavits make three essentiaL points: (a) Scientists will be deterred from conducting vital medical research if'f they know that the results of thei.r research, even if not analyzed nor published, will be subject to subpoena. It is essential for scholars to be able to freel'~y hypothesize and collect data without,fear that every piece of information.gatheredl, or note made, may be subject to a subpoena. To rule otherwise will be to war,n scientists that if they inves tigate controversial areas -- such,as toxic waste or environmental pollution -- which may be the subjects of litigation, they may be spending their time gathering documents to comply with~a subpoena instead of pursuing essential scientific research. There will be a substantial chill imposed on research into areas where large companies, such as those i~n the tobacco industry,, may have a monetary incentiv.e for academics not to pry too far. . (b) Human subjects of scienti~fic studies will qui~ckly decline to become involved in such studies if their highlg personal and confidential medical histories will be por- trayed!in a courtroom. Whether or not identifying data about an individual is redacted, the fact remains that individuals will not want to be subjects of vital medical research if' their. physical and~emotional symptoms will be introduced in a court- room, and'.their rights of privacy thereby invaded even if thei.r names are not publicly linked to the symptoms. 11 N a N A. Ja Go. Cn

of EnvironmentaL and Occupational Medicine, there is explained in detail why production of' the subpoenaed material will be of no use to Reynolds. Specifically, those affidavits demonstrate that: (a) Dr. Selikoff's studies were subject to four di~fferent peer. reviews before publication. It is those peer reviews, where the proposed work of a scientist is carefully evaluated for adequacy by his peers, that serves as the appropri- ate check on whether research is being conducted in accordance with accepted medical.and scientific practice. It is not scien- ti.fically acceptable to seek to verify scientific conclusions by reviewing, many years after the fact., the underlying data. (b) The physical condition of the 4,000 persons whom Dr. Selikof.f physically examined cannot be verified. Wholly apart from the fact that the physician-patient privilege would preclude such examinations is the fact that many people examined are dead and the physical condition of the rest has obviously changed over time. Therefore, whether the data on which,the published'conclusions were based!were accurately recorded cannot now be determined. _ (c) Muchof the data on which the conclusions in the published articles were based are no longer in Mount Sinai~'s possession. The responses to questionnaires were dis- carded after the information was transferred t.o a¢omputer tape. ,a 13 + N a A OP v

issuance of the subpoenae,. In the affidavit submitted by Reynolds to this Court in support of that motion (Ex. 5),, Reynolds represented that "the studies and conclusions drawn from.these [subpoenaed.] documents will be relied upon by plai~n- tiff's expert witness to support plaintiff's theory that dece- dent's alleged lung cancer was proximately caused1by Reynolds' cigarettes." What Reynolds failed to tell this Court is that, as a letter to us (Ex. 6+ from plaintiff's counsel iin _he Page case states, no experts have as yet been designated by plaintiff in the Page litigation. 8. The original return date for the challenged sub- poenae was adjourned by Reynolds to June 12, 1986. My efforts to persuade Reynolds, and all the tobacco companies (many of whom have said that they too plan to issue subpoenae for the same material in cases in which they are defendants) to with- draw the subpoenae for the reasons set forth in these moviing papers, has proven unavailing.* 9. One of the affidavits submitted on this motion is that of Dr. Selikoff. He had,carefully reviewed drafts of the * As these papers were being finalized we were advised that Ligggtt Group, Inc.,'another tobacco manufacturer, asked the California court in another litigation - Quontametteo v. Lincoln Electric Co. - to issue a commission for issuance of subpoenae duces tecum to Mount Sinai and the Cancer Society. The subpoenae whose authorization is requested is virtually identical to those challenged:on.this motion. 6

'this affidavit in support ofltheirf motion, made pursuant to CPL,R 55 2304 and 3103, to quash subpoenae duces tecum that have been served upon them by R.J'. Reynolds Tobacco Company ("Reynolds")~. 2'.., The subpoenae challenged on this moti'on seek pro- duction of extraordinarily confidential medical data relating to the physical condition and,personal habits of approximately 18,500 persons. The data, collected over a 22 year period, is located in 97 file cabinet drawers,(which in turn are in 19 file cabinets), 250 bound volumes and assorted computer tapes. The material subpoened measures 324 linear feet. 3:., The data issought.for use in a litigation pending agai'nst Reynolids in CaDifornia with which neither: Mount Sinai nor the Cancer Society have any. connection eithe.r as a party or as a w,itness. According to Reynolds, pliai'ntiff's expert in that liltigation (,who~has not yet even been designated), willi rely upon certain articles, published in 1968', 1978 and 1979, authored by Dr. Irving J. Selikoff and others, that were based on an analysis of some - but by no means all - of the data sub- poenaed. Those articles concluded that someone exposed to asbes- tos was-far more likely to contract cancer if he smoked cigar- ettes than if he did not smoke. -4 N ~ ~! + p V .u a 2 ~~

-based have long ago been returned by Dr. Selikoff to third par- ties who supplied the informatiom. Information derived from other data has been transferred to computer tapes and then de- stroyed (the computer tapes no longer exist in the form,in which, they existed,when the articles were published). Still other data consists of clinical notes based on physical examinations of more than 3,000 individuals, all of'whom are either now dead or in a different physical condition. Procedural Backgroundi 5. Presently pending iin a California state court is an action entitled Page v. Li~ncoln Electric Company et al. The complaint in that action, to which.Reynolds is also~a party de- fendant, alleges, inter alia, that plaint,if'f's decedent.incurred lung cancer as a result of both exposure to asbestos and cigar- ette smok,ingi., 6. Reynolids asked the Court in the.Califbrni~a action to issue a commission to this Court that would'autAorize the issuance of subpoenae to Mount Sinai and the Cancer Society.Copies of'two affidavits submitted to the California.Court by Reynolds in suppor.t of its motion for issuance of a commission are annexed! as Exhibits 3. and d'. 7. After the commission was issued by the California Court, Reynolds,made an ex Parte application to this Court for 5

(c) The incentive to researchers to~work aggires- sively to be the first to solve medical.issues wi1L be under- mined'if the unpublished results of their research wi~l be made public before they have an.opportunity to check their research, and publish the results themselves. 19. It is for these reasons that under. New York law the fruits of academic or scientific research.-- which is what is subpoenaed here -- are absolutely privileged. (Under federal law such research is quali~fiedly privileged.). The Burden 20., Simply to reciite w:.at is involved in producing the subpoenaed material should establish~its burden. Annexed to Dr. Selikoff's affidavit (Ex. 8) are photographs of the 324 linear feet of material that is the subject off the subpoenae. The burden of .redact,in%identifying material from data in 97 file cabinet drawers would,be enormous. The disruption to the vital on-going research by Dr. Selikoff, who is 71 years oDd and who would have.t.; personally supervise the redaction pro- cess, wouldiresuli.in the destruction of the remainder of his professional Life. The Lacic ofNeed 21..In the accompanying affidavits of both Dr. Selikoff and Dr.Philip Landrigan, the Director of Mount Sinai's Division 1.2 ro a A1 ~ ? 0e O%

Slides, x-rays and other data on which cause of death concl'u- I sions were based were returned to providers of the information. Therefore, whether correct conclusions were drawn from data existing,at the time cannot be checked because the data no longer exists in anywhere near its original form. (d) Reynolds' purported.need for. the subpoenaed material certainly cannot extend to data gathered but never publ'icly discLosed. Obviously no exper.t will rely on that material in offering testimony against Reynolds. Yet much of the information subpoenaed is of this unpublished nature. (e) Finally there is no reason why Rey,nolds could not, have conducted its own studies of the effect. of cigar- ette smok,ing.and,asbestos.. Indeed, as Drs. Landrigan andi Selikoff explain in their affidavits, and as Reynolds itself has conceded', there are. many studies that have beeniconductedd similar to those conducted!by Dr. Selikoff.. It is those studies, rather than Dr. Selikoff's raw data,, that should be used,by Reynolds to try, to show that Dr. Selikoff's published conclu-' sions were erroneous. 22.. In this Latflerr connecti'on, the Court shouldi be aware of an affidavit filed by Reynolds in a Aawaiian federal court (Ex. 7) in another case brought by someone who had alleg- edly incurred lung cancer as a result of exposure to asbestos and cigarette smoking. In that affidavit Reynolds told the, 14

Court.tha2 there were at least 1$ other studies ccncerning the effect of' cigarette smoking and asbestos. Assuming this to be. true.. Reynolidssurely does not need Dr. Selikoff'"s materials too challienge the validity of his published conclusions; it can rely instead on the 18 studies which it claims show the invali- dity of Dr. Sel.ikoff's conclusions. Conclusion 23. There is simply no basis for the present subpoenae.. The material sought is privileged, the burden of production would be overwhelming and need for the material is non-existent. The motion to quash the subpoenae should be granted. . i. . Michael A. Car' oto Sworn to before.me this /('' day of'June, 1986. Notary Public. K1nEVK°`1ES TORIELLO. N0TARY C, Ir' IC. SK.rc' tve. Vek. Nba3-Al09C1? Obd FchmcndCc. Ca.n 6kd m N..Y.ri Co~-. Co-nmss-a~ E.,,ec.JMe.eh i~. c 15