U.S. v. Abbott Laboratories
| Citation | 505 F.2d 565 |
| Decision Date | 24 March 1975 |
| Docket Number | No. 74-1230,74-1230 |
| Parties | UNITED STATES of America, Appellant, v. ABBOTT LABORATORIES, a corporation, et al., Appellees. |
| Court | United States Courts of Appeals. United States Court of Appeals (4th Circuit) |
Howard E. Shapiro, Atty., U.S. Dept. of Justice (Thomas E. Kauper, Asst. Atty. Gen., and Roger B. Andewelt, Atty., U.S. Dept. of Justice on brief), for appellant.
George M. Burditt, Chicago, Ill., for Abbott Laboratories and Thomas F. Ellis, Raleigh, N.C., for Herbert M. Gross (James R. Phelps and Burditt & Calkins, Chicago, Ill., and James C. Little and Hatch, Little, Bunn, Jones, Few & Berry, Raleigh, N.C., on brief), for appellee Abbott Laboratories; (Maupin, Taylor & Ellis, Raleigh, N.C., on brief), for appellee Herbert M. Gross.
Lucas, Rand, Rose, Meyer, Jones & Orcutt and Louis B. Meyer, Wilson, N.C., on brief for appellee Clarence J. Endicott.
Lindsay C. Warren, Jr., John H. Kerr, III, and Taylor, Allen, Warren & Kerr, Goldsboro, N.C., on brief for appellee Robert T. O'Donnell.
C. Kitchin Josey and Josey & Vaughan, Scotland Neck, N.C., on brief for appellee Robert H. Otto.
John R. Jolly, Jr., and Spruill, Trotter & Lane, Rocky Mount, N.C., on brief for appellee Harry Howell.
Before WINTER, BUTZNER and WIDENER, Circuit Judges.
The government appeals from the district court's dismissal of a sixty-count indictment charging Abbott Laboratories (Abbott) and five of its current or former employees with causing the introduction into interstate commerce of adulterated and misbranded intravenous solution drugs in violation of 21 U.S.C. 331(a). The district court dismissed the indictment (1) because of prejudicial pretrial publicity released by the special prosecutor in answer to an inquiry by a newspaper reporter, prejudicial publicity contained in a press release originating from the Department of Justice, and prejudicial publicity contained in another press release originating from the Food and Drug Administration (FDA), and (2) because the grand jury which returned the indictment, at the instance of Department of Justice attorneys, considered 'prejudicial and inflammatory' information not relevant to its inquiry, which caused it to be biased in derogation of the constitutional rights of the defendants. We think that under the facts of the case, dismissal of the indictment was too drastic a remedy for what misconduct on the part of the government occurred and that the challenged evidence considered by the grand jury was relevant to its investigation and proper to be considered by it. We reverse and remand the case for further proceedings.
In December, 1970, the Center for Disease Control (CDC) of the United States Public Health Service investigated an increase in the incidence of blood poisoning among hospital patients. CDC concluded that between October, 1970, and March 1, 1971, one hundred fifty cases of blood poisoning and nine deaths had occurred in eight hospitals among patients who had received intravenous fluid therapy employing intravenous fluids and intravenous fluid systems manufactured by Abbott. CDC investigators found bacterial contamination of the cap liner in unopened Abbott bottles of intravenous solutions, and they postulated that 'the organisms can enter the fluid from the plastic cap liners when the caps are opened and replaced while the bottle is held for later use.' The report of these findings received national media coverage describing the illnesses and deaths and isolation of the 'guilty germ' in the cap liner of Abbott bottles. On March 22, 1971, Abbott issued a nationwide recall of its intravenous solutions.
FDA recommended to the Department of Justice that Abbott and those of its employees 'responsible' for distribution of the allegedly contaminated intravenous solutions be prosecuted. The matter was presented to a grand jury in a district in which Abbott manufactures intravenous solutions, and the indictment was returned on May 29, 1973.
As soon as the indictment was returned, the United States Attorney for the Eastern District of North Carolina notified the news media that he had a press release concerning the indictment. The news department of a Raleigh television station requested an interview with him. The request was granted and the interview held at about 2:00 p.m. in his office. Two special prosecutors from the Justice Department and an attorney from FDA were also present. The interview was conducted in three stages by a television newswoman from the local station. There was first an off-camera interrogation of the government attorneys by the correspondent. Then there was a taped interview of the U.S. Attorney, at which he answered questions that had been submitted in advance. After the taping session, the correspondent continued to interrogate the attorneys for a time.
During the pretaping interrogation, the correspondent asked whether any deaths or illnesses were attributed to the misbranded drugs. One of the special prosecutors replied that 'the Center for Disease Control in Atlanta previously reported that nine deaths occurred in 1971.' During the subsequent taping session, the correspondent asked the same question of the U.S. Attorney. Not expecting this question to be asked, he replied that the indictment had nothing to do with any deaths. Following the taped interview, the correspondent continued to ask questions concerning deaths attributable to Abbott's intravenous solution. The answers, in substance, provided the same information as the answer quoted above.
On the six o'clock news that day, the Raleigh TV station broadcast a news report concerning the indictment, which contained the following statements:
Nine deaths and four hundred illnesses have been attributed to contaminated drugs made by a North Carolina company.
. . . . an
. . . the drugs were manufactured by the Abbott Laboratories Hospital Products Division of Rocky Mount.
The taped interview was also broadcast on this program, but the U.S. Attorney's statement that the indictment had nothing to do with any deaths was omitted.
On the same day, United Press International (UPI) ran a story citing sources in the Justice Department in Washington, containing the following statement:
A federal grand jury has returned criminal indictments against Abbott Laboratories, Inc. and five of its present or former employees on charges involving allegedly contaminated intravenous fluid linked to nine deaths and hundreds of injuries, the Justice Department announced Tuesday.
The circumstances make it clear that the remarks of those present at the interview in the U.S. Attorney's office in Raleigh were not the source of this news release. Nothing further is apparently known about the actual source of this release than that which appears on its face. This UPI release received the wide publication that could be expected in the case of a wire service of this type.
On May 29, 1973, some hours after the indictment was handed down, the FDA issued a press release in Washington, D.C., containing the following statements:
Five present or former officials of the company also were named in the indictment for interstate shipment of intravenous drugs that were unsterile and dangerous to public health.
. . . .t o
The Center for Disease Control, at Atlanta, Georgia, reported fifty deaths from four hundred and twelve patient episodes during late 1970 and early 1971 from septicemias (blood poisonings) which CDC determined to be associated with the use of contaminated Abbott intravenous solutions.
. . . .ott
These individuals held positions of responsibility with respect to the adulteration and misbranding for the intravenous drugs named in the indictment.
Both the UPI 'nine deaths' release and the FDA 'fifty deaths' release received wide coverage throughout the nation in the television, radio and printed media at the time of the indictment. The 'nine deaths' story arising out of the interview with the U.S. Attorney reached the viewers of WRAL-TV of Raleigh, North Carolina, who are spread throughout many of the counties of the Eastern District of North Carolina.
The proof shows that the death or possible death of persons who had received Abbott's intravenous solutions was mentioned before the grand jury in three separate instances. The first was during the examination of preliminary witnesses, and the last was during the prosecutor's discussion of the recommended indictment. No transcript for these instances is in the record or available, and further details cannot be stated.
The second instance was during the interrogation of Robert O'Donnell, Abbott's Director of Quality Assurance, who was named as a defendant in the indictment subsequently returned. Mr. O'Donnell was questioned about an investigation conducted by Abbott in a Detroit hospital which purportedly exculpated Abbott or seriously questioned the findings of CDC. He was asked if that hospital had 'had a couple of dead bodies . . . from Abbott I. V. solutions,' and O'Donnell said that he could not recall. He was then questioned about certain Detroit newspaper accounts concerning hospital deaths resulting from tainted bottle caps, in an effort to refresh his recollection. Finally, he was asked if his investigator had said that the Detroit newspaper was 'crazy as bedbugs' when it reported deaths in Detroit from the use of Abbott solutions. Mr. O'Donnell denied the statement by the investigator.
Defendants sought dismissal of the indictment by two motions. On July 13, 1973, they moved to dismiss the indictment on the grounds that the prejudicial publicity engendered by the 'nine deaths' story arising out of the WRAL-TV interview with the prosecutor and, independently, out of the UPI release in Washington, and by the FDA's 'fifty deaths' release...
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