Tobacco Documents Online

DEPARTMENT Of HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Office on Smoking and Health Rockville, MD 20857 Background on the Cipollone Case (September 1987) In an ongoing product liability case in which an~ individual' dying of lung cancer has sued three major U.S. cigarette manufacturers (Cipollone v. Liggett Group), the plaintiffs are attempting to introduce the Surgeon General's Reports on the health consequences of smoking as evidence. As a result, the defendants have subpoenaed all preliminary documents related to each Surgeon General's Report on smoking up to and including the 1984 Report. The subpoena covers draft manuscripts; comments by peer reviewers, "senior" reviewers, and Public Health Service agencies; memoranda; etc. The defendants are no doubt looking for areas of disagreement amoung contributors with which they will seek to undermine the credibility ofthe Reports. Our Office, supported by the HHS Office of the General Counsel and the Justice Department, initially refused to hand over the subpoenaed documents, claiming that they were exempt from disclosure as predecisional material. Subsequently, the defendants brought their case to the Maryland District Court, which they won. The Justice Department, on our behalf, appeaied~ the ruling to the Fourth Circuit Court (Richmond, Virginia), which upheld the lower Court decision in Feburary 1987. The Government decided not to appeal the case to the Supreme Court or seek a rehearing en banc for several'reasons, including: (1) the decision: was an "unpublished" one, with somewhat limited value as a precedent; (2) the full Fourth Circuit Court was unlikely to issue a contrary decision; (3) the Supreme Court was unlikely to accept the case since it most often accepts cases with dissimilar outcomes in different Circuits; and (4) a similar decision on appeal or in a rehearing would raise the decision to a higher level of precedent. Consequently, we delivered the subpoenaed: documents for the 1979-1984 Reports (the only ones for which preliminary documents could be found) to the defendants ini June 1987. The documents are covered by a strongly-worded' protective order, which prohibits use of the material outside the specific litigation for which they were subpoenaed. Preliminary documents for the 1985 and 1986 Reports have been requested by the Tobacco Institute under the Freedom of Information Act. We have refused'l these requests, and these refusals have been sustained by the Public Health Service on appeal.

. Page 2 Those who have participated in the production, review, and editing of the 1979- 1984 Surgeon General's Reports, and those who have participated or will participate in subsequent Reports, may be affected by these legal developments. W ith respect to Reports issued after 1984, we are unable, in light of the Cipollone case, to assure confidentiality of preliminary material. However, we can provide assurance that we will continue to treat all documents pertaining to the Reports as conf idential and will resist any attempt to obtain them under any new subpoenas, and that under no circumstances will documents or comments be released unless required by a Court order. In the past, the Surgeon General's Reports have been produced as a collaborative effort between the Public Health Service and outside experts in the smoking-and- health community. The high quality and scientific integrity of these Reports have been universally recognized! We are asking each participant in the 1987 Report and subsequent Reports to strive to maintain this track record. The overall process for producing these Reports will remain as it has been in the past. Please call me if you have any questions pertaining to the above. Ronald M. Davis, M.D. Director Office on Smoking and Health Center for Health Promotion and Educatiom