US Attorneys > USAM > Title 4 > Civil Resource Manual
prev | next

111.

Sample Medical Device Indictment

THE GRAND JURY CHARGES:
COUNT 1
Conspiracy

A. Introduction

At times material to this Indictment:

1. The United States Food and Drug Administration ("FDA") was the federal agency responsible for protecting the health and safety of the American public by ensuring, among other things, that devices designed for use in the treatment of humans were safe and effective for their intended uses. Toward this end, FDA regulated and monitored the manufacture, processing, packing, and shipment in interstate commerce of devices.
2. Under the Federal Food, Drug, and Cosmetic Act ("FDC Act"), a "device" was defined, in relevant part, as "an . . . implement . . . or other similar or related article which is . . . intended for use in the . . . cure, mitigation, treatment, or prevention of disease, in man . . . and which does not achieve its primary intended purposes through chemical action within or on the body of man . . . and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. § 321(h).
3. Under the FDC Act, agents of FDA were authorized by law to inspect any establishment in which devices were manufactured, processed, or packed or from which devices were shipped in interstate commerce. The authority to inspect extended to all records, files, papers, and facilities bearing on the manufacture, processing, packaging, and shipment of devices. 21 U.S.C. § 374.
4. Cover Up Products ("CUP") [NOTE: names and places changed from original] did business at 1234 Madeup Highway 111, Hooville, Georgia. CUP was engaged in the manufacture, processing, packaging, and interstate distribution of devices -- to wit, surgical equipment covers labeled as and otherwise represented to be "sterile," and marketed under the name "Cover Ups." CUP distributed the "Cover Ups" to health-care facilities, and designed and promoted them to be used to cover surgical equipment during surgical procedures, thereby allowing the physician to maintain a sterile field around the patient undergoing the surgical procedure.
5. Defendant XXXXX X. XXXXXXX, JR., was the plant and operations manager of CUP, and was responsible for the manufacture, processing, packaging, sterilization, and shipment of the "Cover Ups."
6. XXXXXX X. XXXXXX was an owner of CUP, and was primarily involved in the promotion and sales of the "Cover Ups."
B. The Conspiracy

Beginning in or about April 1992 until in or about June 1992, within the Northern District of Georgia and elsewhere, the defendant,

XXXXXX X. XXXXXXX, JR.,

together with persons known and unknown to the Grand Jury, did knowingly, willfully, and unlawfully combine, conspire, confederate, and agree to commit offenses against the United States, more particularly:

1. to violate the FDC Act, Title 21, United States Code, Sections 331(a) and 333(a)(2), by introducing, and delivering for introduction, into interstate commerce, with the intent to defraud and mislead, devices that were adulterated within the meaning of Title 21, United States Code, Section 351(c), in that their purity and quality fell below that which they purported, and were represented, to possess, because the devices were labeled as sterile when they had not been sterilized and were not sterile; and
2. to violate the FDC Act, Title 21, United States Code, Sections 331(a) and 333(a)(2), by introducing, and delivering for introduction, into interstate commerce, with the intent to defraud and mislead, devices that were misbranded within the meaning of Title 21, United States Code, Section 352(a), in that their labeling was false and misleading because such labeling represented that the devices were sterile when in fact the devices had not been sterilized and were not sterile.
C. Means and Manner

1. XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX promoted CUP's "Cover Ups" to health-care facilities as "a STERILE EQUIPMENT COVER designed for covering your equipment during procedures." According to promotional materials disseminated by CUP, "COVER UPS are an easily applied, single equipment cover that maintains the sterility of field."
2. However, in order to maximize CUP's profits and their own compensation, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX intentionally shipped unsterilized and non-sterile "Cover Ups" to numerous health-care facilities that were customers of CUP.
D. Overt Acts

In furtherance of the conspiracy and to effect the objects thereof, in the Northern District of Georgia and elsewhere, the defendant and his co-conspirators committed the following overt acts, among others:

1. On or about April 10, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Mobile, Alabama, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
2. On or about April 10, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Joliet, Illinois, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
3. On or about April 13, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Clearwater, Florida, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
4. On or about April 21, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Mobile, Alabama, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
5. On or about April 21, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Houston, Texas, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
6. On or about April 27, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Dothan, Alabama, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
7. On or about April 30, 1992, XXXXXX X. XXXXXXX, JR., and XXXXXXX X. XXXXXX caused CUP to send to a health-care facility in Hartford, Connecticut, a shipment of "Cover Ups" labeled as sterile that had not been sterilized and were not sterile.
8. On or about June 9, 1992, during the course of an FDA inspection of CUP, XXXXXX X. XXXXXXX, JR., falsely told an FDA investigator, and falsely asserted in a sworn affidavit, that CUP first began making sales of "Cover Ups" on or about May 20, 1992.
In violation of Title 18, United States Code, Section 371.

COUNTS 2-9

Interstate Shipment of Adulterated Devices

1. Those parts of Count 1 described as Part A, Introduction, paragraphs 1 through 6 are incorporated herein and are realleged as if set forth in full in these Counts.

2. On or about the dates listed below, within the Northern District of Georgia, the defendant,

XXXXXX X. XXXXXXX, JR.,

with the intent to defraud and mislead, caused to be introduced, and delivered for introduction, into interstate commerce, from Hooville, Georgia, to the destinations listed below, devices that were adulterated within the meaning of Title 21, United States Code, Section 351(c), in that their purity and quality fell below that which they purported, and were represented, to possess, because the devices were labeled as sterile when they had not been sterilized and were not sterile, each such instance described below being a separate and additional Count of this Indictment.

Count Date Destination

2 04/10/92 Mobile, Alabama

3 04/10/92 Joliet, Illinois

4 04/13/92 Clearwater, Florida

5 04/21/92 Mobile, Alabama

6 04/21/92 Houston, Texas

7 04/27/92 Dothan, Alabama

8 04/30/92 Hartford, Connecticut

9 01/28/93 Texas City, Texas

All in violation of Title 21, United States Code, Sections 331(a) and 333(a)(2), and Title 18, United States Code, Section 2.

COUNTS 10 - 17

Interstate Shipment of Misbranded Devices

1. Those parts of Count 1 described as Part A, Introduction, paragraphs 1 through 6 are incorporated herein and are realleged as if set forth in full in these Counts.

2. On or about the dates listed below, within the Northern District of Georgia, the defendant,

XXXXXX X. XXXXXXX, JR.,

with the intent to defraud and mislead, caused to be introduced, and delivered for introduction, into interstate commerce, from Hooville, Georgia, to the destinations listed below, devices that were misbranded within the meaning of Title 21, United States Code, Section 352(a), in that their labeling was false and misleading because such labeling represented that the devices were sterile when in fact the devices had not been sterilized and were not sterile, each such instance described below being a separate and additional Count of this Indictment.

Count Date Destination

10 04/10/92 Mobile, Alabama

11 04/10/92 Joliet, Illinois

12 04/13/92 Clearwater, Florida

13 04/21/92 Mobile, Alabama

14 04/21/92 Houston, Texas

15 04/27/92 Dothan, Alabama

16 04/30/92 Hartford, Connecticut

17 01/28/93 Texas City, Texas

All in violation of Title 21, United States Code, Sections 331(a) and 333(a)(2), and Title 18, United States Code, Section 2.

COUNT 18

False Statement

1. Those parts of Count 1 described as Part A, Introduction, paragraphs 1 through 6 are incorporated herein and are realleged as if set forth in full in this Count.

2. On or about June 9, 1992, within the Northern District of Georgia, in a matter within the jurisdiction of FDA, an agency of the United States, the defendant,

XXXXXX X. XXXXXXX, JR.,

knowingly and willfully made a material false statement and representation to an FDA official: that is, during an FDA inspection of CUP, XXXXXX X. XXXXXXX stated to an FDA investigator that CUP first began selling "Cover Ups" on or about May 20, 1992, when in fact, as XXXXXX X. XXXXXXX well knew, CUP had been selling and shipping non-sterile "Cover Ups," falsely labeled as sterile, since in or about April 1992.

All in violation of Title 18, United States Code, Section 1001.

A TRUE BILL
______________________________ FOREPERSON

KENT B. ALEXANDER
United States Attorney

______________________________
JAY I. BRATT
Attorney
U.S. Department of Justice
Office of Consumer Litigation

[cited in USAM 4-8.255; Civil Resource Manual 109]