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89.7317 A['6 4 ~9 IN TFI~ (go rt of FOR THE SECOND CIRCUIT ~N THE MATTER OF THE APPLICATION OP THE AMERICAN TOBACCO COMPANY, R.J, I~'gNOLDS TOBACCO COM- PANY, and PHILIP MORRIS, INC., Appellees, MOUNT SINAI SCHOOL OF MEDICINE and THE AMERICAN CANCER SOCIETY, Appellants. ON AppEAL FROM THE UNITED STATES DISTklCT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK No. M~-8~ PETITION FOR REHEARING WITH A SUGGESTION FOR REHEARING EN BANC PROSKAUER ROSE GOETZ & MENDELSOHN Attorneys for Petitioners-Appellanls Mount Sinai School of Medicine and The Americun Cancer Society 300 park Avenue New York, New York 10022 (212) 909-7000 Of Counsel: ~4V~ICI-D~EL A. CARDOZO C!-!ARLES S. SIMS SALIANN SCARPULLA

T ELE OF NTENT TABLE OF AUTHORITIES ................... i PRELIMINARy STATEMENT .................. 1 POINT I: THE pANEL IMPROPERLY REFUSED TO QUASH THE SUBPOENAS UNDER RES JUDICATA . POINT II: THE PANEL DISREGARDED TEE POLICIES UNDERLYING NEW YORK'S ABSOLUTE EXPERTS' PRIVILEGE AND THE NEED, IF THERE WAS DOUBT ABOUT THE PRIVILEGE'S EXTENT, TO CERTIFY THE ISSUE TO THE NEW YORK COURT OF APPEALS ...... , ..... POINT III: THE PANEL'S QUALIFIED PRIVILEGE RULING WAS IN ERROR .............. POINT IV: THE PANEL ERRED IN APPROVING A PROTECTIVE ORDER THAT FAILS TO ENSURE AGAINST THE EXPOSURE OF pARTICIPANTS' IDENTITIES TO EMPLOYERS AND OTHERS .... . ..... 13 CONCLUSION ...................... 15

TABLE OF AUTHORITIES Alemite Mf~. CorD. V. Staff, 42 P.2d 832 (2d Cir. 1930) . . 14 Baker v. F&F Inv't, 470 F.2d 778 (2d Cir. 1972), cert. denied, 411 U.S. 968 (1973) ................ 12 Cunninuham and Kaminu, P.C.v. Nadiari, 53 A.D.2d 520 (ist Dep't 1976) (mem.) .................. 5 Deitchman v. E.R. squibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1982) ...................... 12 Parnsworth v. Procter & Gamble Co., i01 Y.R.D. 355 (N.D. Ga. 1984), aff'd, 758 F.2d 1545 (llth Cir. 1985). . . 12 Gilly v. City of New York, 69 N.Y.2d 509 (1987) ...... 7 Gowan v. Tully. 45 N.Y.2d 32 (1978) ............ 5 Gray v. Board of HiGher Educ. of New York. 692 F.2d 901 (2d Cir. 1982) ..................... i0 In re American Tobacco Co., NO. 1317, Slip op. 4623 (2d Cir. July 21, 1989) ................ passim In re Pennzoil Co.. 108 A.D.2d 666 (ist Dep't 1985) ........................... 12 In re R.J. Revnolds Tobacco Co°r 136 Misc. 2d 282 (Sup. Ct. N°Y. Co. 1987) .................. 3 Kidney v. Kolmar Laboratories. Inc., 808 F.2d 955 (2d Cir. 1987) ................. ...... 8 O'Brien v. City of Syracuse, 54 N.Y.2d 353 (1981) ..... 4 O'Neill v. Oakurove Constr. Inc., 71 N.Y.2d 521 (1988) Plummer v. R.H. Macv & CO., 69 A.D.2d 765 (Ist Dep't 1979) ............................ 7 Salin~er v~ Random House. Inc., 811 F.2d 90 (2d Cir.), cert. deniedg 108 S.Ct. 213 (1987) ............. 15 Silkwood v~ Kerr-McGee CORD.. 563 F.2d 433 (18th Cir. 1977) ...................... 9 United States v. Burke, 700 F.2d 70 (2d Cir.), cer~t, denied, 464 U.S. 816 (1983) ............. 12 i

winters v. Lavine, 574 F.2d 46 STATUTES 28 U.S.C. §1738 ......... (2d Cir. 1978). 5 ii

UNITED STATES COURT OF A~PEALS FOR TH~ SECOND CIRCUIT In the Matter of the Application of The A/serican Tobacco Company, R~J. Reynolds Tobacco Company, and Philip Morris, Inc., Appellees, Mount Sinai School of Medicine and the American Cancer Society, Appellants. Docket NO. 89-7317 PETITION FOR REHEARING WITH A SUCGESTION FOR REHEARING EN BANC PRELIMINARY STATEMENT This case presents the question whether biomedical researchers must produce, in product liability actions to which they are total strangers, their unpublished and in substantial part unreported-on confidential data involving the medical histories of thousands of participants in long-term prospective health and mortality studies. In affirming Judge Duffey's order requiring production of a computer tape from which participants' identities can be derived, without safeguards restricting its use to the underlying litigation or precluding its dissemination to the world at large, the panel erred, we respectfully suggest, in four separate respects: By refusing to quash the subpoenas under res ~, even though state court subpoenas seeking precisely the same computer tape had previously been quashed by the 1

state courts after extensive litigation upon consideration of the same issues presented here; By disregarding the policies underlying New York's absolute experts' privilege which squarely applies here, and declining to certify what at least is an unsettled but clearly dispositive and important issue to the New York Court of Appeals; By affirming the district court's decision on the improper ground that it was not an abuse of discretion with respect to the application of the qualified privilege, when the district court expressly held that there was n~ such privilege and refused to consider the interests in avoiding harm to confidentiality and biomedical research whose weighing the privilege requires; and By affirming enforcement of the subpoenas even though release of the data will allow the employers of the research participants both to identify them and to provide the data to persons unrelated to the underlying litigations. Appellants Mount Sinai School of Medicine and The American Cancer Society ("Mount Sinai") respectfully petition, pursuant to Rules 35 and 40 of the Federal Rules of Appellate Procedure, for a rehearing of the opinion of this Court dated July 21, 1989. In light of the exceptional importance of this case to the vital enterprise of biomedical research and the research institutions at which it is conducted, appellants respectfully suggest that this is an

appropriate matter to be considered by the entire Court of Appeals. This is a proceeding to quash the latest ten of a string of more than 30 third party subpoenas, served by defen- dants in distant product liability actions, seeking computer tapes containing biomedical research data conducted by Dr. Irving Selikoff. The research data at issue, which concerns more than 18,000 persons,1 relates to the relationship between asbestos exposure, cigarette smoking, and cancer. Mount Sinai and its researcher, Dr. Selikoff, are not parties to, and will not be witnesses at, the underlying litigations. Subpoenas seeking that same computer tape, and secondarily the files from which the computerized data was drawn, were previously issued by the New York Supreme Court, and quashed after extensive litigation, on the ground that they were subject to a qualified privilege. The state court expressly held that quite apart from the other information secondarily sought in the state court subpoenas, the minimal need for the computer tape was outweighed by the burdens on scholarship and on the continued vitality of the research enterprise. In re R.J. Reynolds Tobacco Co.. 176 Misc. 2d 282 (Sup. Ct. N.Y. Co. 1987). 1 3,500 (not 500 as the panel decision states, In Re American Tobacco Co., No. 1317, Slip op. 4623, 4626 (2d cir. July 21, 1989)) of those persons were physically examined by the Mount Sinai researcher (A209, 213, 945- 46, 950). 3

The tobacco companies strategically declined to perfect their state court appeals and instead issued new subpoenas for the pending federal cases in which they were defendants. These new subpoenas seek the same computer tape which had been their principal goal in the state court, hut this time they deleted the request for certain additional data previously sought. Mount Sinai's motion to quash before Judge Dully was denied. The District Court also largely rejected Mount Sinai's motian for a protective order, refusing to permit redaction or collapsing of identifying information (including union local and dates of birth and death) that the district court recognized would permit identification of research subjects. ~OINT I THE PANEL IMPROPERLY REFUSED TO QUASH ~ SUBPOENAS UNDER RES JUDICATA The panel's decision misapplies New York's re s iudicata law and exposes both scholarly researchers and state and federal courts to wasteful, unnecessary, and unjust relitigation. Under New York law, which the panel conceded is appli- cable, claims "arising out of the same transaction or series of transactions are barred, even if based on different theor- ies or seeking a ~ ~ " O'Brien v. City of S ra~, 54 N.Y.2d 353, 357 (1981) (emphasis added). The panel nonetheless held that even though the tobacco companies' 4

state court subpoenas for the computer tape (for use in fung- ible litigation against asbestos and tobacco companies) had previously been quashed, see Re n~, 136 Misc.2d at 282, the state court's resolution of Mount Sinai's privilege claims was not re s judicata. The panel held that New York law does not give preclusive effect to such decisions when a second subpoena is "clearly narrower or more specific." Slip op. at 4637. The only authority cited for that proposition, Cunnin~ham and Kaminq, P.C.v. Nadjari , 53 A.D.2d 520 (ist Dep't 1976) (mem.), has no application to re s "u~icata. There is no New York state case that provides any basis for concluding, as the panel did, that a fully litigated decision quashing a subpoena for a computer tape with i0 fields of data on 18,000 persons would not preclude subsequent subpoenas in identical cases seeking the sa~e information on only i0,000 persons, or subpoenas seeking nine fields of that data on the same 18,000 persons. The panel's decision also ignores the strong policies, previously emphasized by both this Court and the New York courts, precluding relitigation which "would destroy a right adjudicated [previously] .... " Gowan v. Tully, 45 N.Y.2d 32, 36 (1978); ~ Winters v. Lavine, 574 F.2d 46, 56 (2d Cir. 1978). Here, Mount Sinai's right to maintain the tapes in confidence, adjudicated by the state court, has been

destroyed by the decisions of the district court and the panel. In the state court Reynolds represented to Justice Danzig that "[t3he data we basically need is, . . . contained on the computer tapes, not the 97 file cabinets of documents .... ,, (AI04). By affirming an order directing production of the very material the state court declined to order produced, the panel's decision severely damages the policies of finality, comity and fundamental fairness that underlie rest. In product liability and mass toxic tort contexts, where numerous cases are frequently brought in both state and federal courts, the decision guarantees successive opportunities in both forums for defendants to litigate claims for third party experts' materials, so long as the requests submitted in each successive forum are marginally narrower than those which they had previously lost. The panel advanced no policy to support that result, and its wasteful and unfair rule ensures that even a total victory in hard fought and expensive litigation will be only temporary. Where, as here, the parties and the court in a first litigation specifically address precisely the data sought in the second, relitigation of these claims is irreconcilable with the policies underlying 28 U.S.C. §1738 and New York's law of res iudicata.

POINT II THE PI~r~L DISREGARDED ~ POLICIES L~NDERLYING NEW YORK'S ABSOLUTE EXPERTS' PRIVILEGE AND THE ~rEED, IF THERE WAS DOUBT ABOUT THE PRIVILEGE'S EXTENT, TO CERTIFY THE ISSLrE TO THE NEW YORK COURT OF APFEALS The panel's refusal to apply New York's absolute third-party experts' privilege to biomedical research files disregards the policies the privilege is intended to further. Contrary to the decision's misstatement, New York's absolute privilege is not limited to protecting experts from being "compelled to give . . . opinions." Slip. op. at 4638. Indeed, it affords no particular protection for opinion at all, but rather, as recently and unanimously held in city of New York. 69 N.Y.2d 509, 512 (1987), protects experts from "being drawn into litigation on limitless occasions because of their distinctions and attainments." New York's absolute experts' privilege applies to an expert's documents as well as his opinion. Plummer v. R.H. Macv & Co., 69 A.D.2d 765 (ist Dep't 1979). compelling Dr. Selikoff to produce to the tobacco and asbestos companies data which he has devoted his career to amassing and analyzing damages the interests underlying the privilege in the same way, and at least as severely, as would his forced testimony in court. The need to protect the absolute confidentiality which Dr. Selikoff promised study participants has already consumed substantial time that would otherwise be devoted to research. Different or further 7

requests from the tobacco and asbestos companies and other parties will inevitably increase the time spent on defending the confidentiality rights of the research participants. The burden on Dr. Selikoff's time will further increase when he is forced to respond as the tobacco companies' "experts" (the antithesis of disinterested scholars) manipulate and massage his data and seek to discredit his previously published conclusions in court and in the press. The intrusion will have precisely the adverse effects on scholarly and professional work that the New York privilege was designed to prevent, and the failure to apply the privilege is therefore irreconcilable with ~. At a minimum, if it were unable to conclude with reasonable certainty that the Gillv privilege applies to the facts of this case, the panel should have accepted Mount Sinai's request to certify this issue to the New York Court of Appeals. See Kidney v. Kolmar Laboratories. Inc., 808 F.2d 955 (2d Cir. 1987). The question is dispositive, important, and certain to reoccur; and so long as the panel's decision stands, researchers, if subpoenaed in the New York federal courts, will be deprived of the protection an absolute privilege would afford them. In the meantime, if this Court.s ruling is nob the one the New York Court ~f Appeals would have reached, incalculable damage will have been done. 8

THE PANEL'S QUALIFIED PRIVILEGE RULING WAS IN ERROR The panel's consideration of Mount Sinai's contention that a qualified researcher's privilege must at a minimum be applied under both New York and Federal law was flawed in multiple respects, and amounts to a ~ se rule in which the privilege will necessarily fail in every case where arguably relevant confidential biomedical research data bearing on product liability or mass toxic tort cases is subpoenaed. The panel erred most glaringly when, after assuming that New York would apply at least a qualified privilege, it affirmed, under an abuse of discretion standard, "the district court's application of . . . a balancing test.', Slip op. at 4641. Since the district court expressly held that "there is no qualified privilege under the circumstances . . .,,,2 and therefore never undertook the balancing which the qualified privilege envisions, it failed to exercise its discretion, and there is no valid basis for upholding its ruling under that standard.3 2 The district court did not, as the opinion wrongly suggests, "assume that there is a qualified privilege." slip. op. 4641 with A793. The comment quoted (A789) was a hypothetical addressed to counsel for Mount Sinai (not the tobacco companies as stated by the panel) and formed no part of the court's ruling. 3 See Silkwood v. Kerr-McGee CORD., 563 F.2d 433, 438 (10th Cir. 1977) (even where abuse of discretion standard applies, failure to weigh proper factors is (continued...) 9

Moreover, while the panel,s decision assumed the applicability of a qualified privilege, it overlooked the fact that the state court had already conducted the balancing required by that privilege. In Reynolds, the state court held, contrary to the subsequent ruling of Judge Duffy, that ongoing scientific research would be discouraged by production of the data for which the tobacco companies had shown minimal need. ~, 136 Misc.2d at 286-288. The panel therefore erred in not giving these state court findings collateral estoppel effect. Nor can the panel's decision be upheld as a correct weighing of the relevant interests under the state law qualified privilege. Mount Sinai's interests were shortcounted in the panel's mistaken belief that "the tobacco companies have narrowed their subpoenas to request only data that was relied upon by Dra Selikoff in preparing articles that were published some years ago." Slip. op. at 4642. The record was undisputed that, as was true in the state court, the subpoenas demanded, the tape contains, and the order directed production of, all the information that had been gathered by 1979 or 1980 for the long-term studies on which 3(...continued) reversible error). In fact, in Gray v. Board of HiGher Educ. of New York, 692 F.2d 901, 904 (2d cir. 1982), this Court reversed a district court's privilege ruling even without finding an abuse, merely because it "[struck] the balance . . . differently." 10

Dr. Selikoff preliminarily reported in his 1979 and 1980 articles, not just the narrow portion of the data actually reported on in those articles.4 Indeed, a principal goal o~ the tobacco companies is to use that as-yet unreported on data to attempt to demonstrate (albeit in a manner which the record shows would be scientifically invalid) spurious statistical relationships and thereby cast doubt on the relationships which the study was designed to test for, and found.5 As the discussion of such procedural inventions as "a central repository of such data to which current and future suitors could have access" demonstrates, sllp. op. at 4644,6 the panel's "qualified privilege" is essentially no privilege at all. While the panel expressed concern over the 40 pending subpoenas referred to at oral argument, it ignored the 30 previous subpoenas served by appellees on Mount Sinai, and the tobacco Companies. documented history of harassment of medical researchers and covering up of unfavorable results of medical research they had conducted, some of it in areas comparable to Dr. Selikoff's. 4 5 6 See A~03, 209-10, 214, 338, 345, 1097-1101. ~_~ AI027-I035. It is not at all clear that such a "central" repository is feasible where, as here, half the cases are pending in state, not federal, caurts, and the material found redactable in one case might be deemed relevant in the next. 11

The qualified privilege that New York courts have applied in similar contexts,7 and which has been applied by federal courts as well,8 is not satisfied by the weighing performed by the panel. Controlling cases require a carefully defined determination of whether the party seeking to overcome the privilege has made a "clear and specific showing" that the information is "[a] highly material or relevant, [b] necessary or critical to the maintenance of the claim, and [c] not obtainable from other available sources." United States v. ~, 700 F.2d 70, 77 (2d Cir.), cert. denied, 464 U.S. 816 (1983); ~, 71 N.Y.2d at 527. For the scholars whose work is jeopardized in this case, and for others whose jeo- pardy is yet to come, it is essential that this rigorous analysis (already conducted by the state court) be undertaken in careful recognition of the dangers involved, so that society's compelling interest in human participant-based biomedical research is protected. 7 8 See O'Neill v. Oakurove Constr. Inc., 71 N.Y.2d 521, 527-29 (1988); In nnzoil co., 108 A.D.2d 666 (ist Dep't 1985). See Baker v. F&F Inv't, 470 F.2d 778 (Sd cir. 1972), ceF~. denied, 411 U.S. 966 (1973); Farnsworth v. Procter & Gamble Co., 1Ol F.R°D. 355 (N.D. Ga. 1984), aff'd, 758 F.Sd 1545 (llth Cir. 1985) ; Deitchman v. E.R. S~uibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1982). 12

POINT I_VV TI~ P.~IEL ERRED IN APPROVING A PROTECtiVE ORDER THAT FAILS TO ENSURE AGAINST THE EX~OSUP, E OF p.~ARTICIPAI~'~I IDEI~IITI~S ~ EMPLOYERS AND OTHERS The panel's decision, upholding the district court's limited protective order, sanctions unprecedented burdens on the confidentiality o£ biomedical research participants and the scholarly interests of researchers. The panel recocj1~ized, as had the district court, that nit might be possible for the tobacco companies to determine the identities of some of the research participants from the information remaining on the computer tapes after the redaction ordered by th~ district court." Slip. op. at 4645° Nmo other reported dec£sion in the United States has ordered productionof information that allowed for the possibility of such identification, even under an appropriate protective order. Telling the research participants here, or would-be partlcipants in AIDs research, that data from which their identities may be determined might have to be produced to their employers, but those employers will be in contempt if they try to identify them, is surely a major disincentive to becoming a subject of such research° In addition, the panel f~iled to recognize the inadequacies of the protective order's provisions. Thus, it failed to recognize that the order (Ai097-Ii01) contains: 13

limits on the extent of dissemination of the data that the more than 40 parties to the litigations in question can make, or that their disseminees can make in turn; no restrictions on the data's use beyond the underlying or similar litigations; no provisions precluding publication of the database in tobacco or asbestos industry newsletters or its inclusion in computer bulletin boards; no :requirement (contrary to the statement in the panel's opinion, slip op. at 464S) that the Acknowledgement Form be signed prior to access to the data (indeed the Form provides exactly to the contrary) (All01); and no provisions (contrary to the panel's assumption, slip op. at 4645) which could lawfully subject many of those who will receive access to the data to the jurisdiction of the court or the requirements of the protective order.9 Furthermore, the order contravenes the policies underlying Rule 45 by requiring Mount Sinai (and presumably third party researchers subpoenaed in analogous cases) to li- tigate in distant courts - not the Southern District - its opposition to access by persons who seek the data through legal process, but who refuse to sign the Acknowledgment For~. Permitting dissemination with no restriction on use beyond the underlying litigation also directly impairs the right of first publication (or non-publication) which this Court has recently zealously protected in an analogous 9 See Alemite Mfa. CorD. V. Staff, 42 F.2d 832 (2d Cir. 1930) (L. Hand~ J.). 14

context.I0 The panel's decision permits researchers funded by the tobacco and asbestos companies to obtain Dr. Selikoff's entire database (without compensating him for it), to publish it or even to place it on-line, to publish studies and articles based on it, and to impede his ongoing work, by forcing him to respond to highly interested misuses of his data, funded by large corporations whose economic interests the data unwittingly jeopardizes. A greater disincentive to engaging in vital research in controversial areas could hardly be devised. The panel's panel, or fdl banc, CONCLUSION judgment should be reconsidered by the and on such reconsideration, reversed. Respectfully submitted, PROSKAUER ROSE GOETZ & MENDELSOHN f / . L 11 , / IJ - Attorneys for Petitioners- Appellants Mount Sinai School of Medicine and The American cancer society 300 Park Avenue New York, New York 10022 (212) 909-7000 Of Counsel: Michael A. Cardozo Charles S. Sims Saliann Scarpulla August 4, 1989 i0 See Salinaer v. Random Rouse. Inc., 811 F.2d 90 (2d Cir.), cert. denied, 108 S.Ct. 213 (1987), 15

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