US v. 789 CASES
| Decision Date | 20 August 1992 |
| Docket Number | Civ. No. 90-1777 (JP). |
| Citation | 799 F. Supp. 1275 |
| Parties | UNITED STATES of America, Plaintiff, v. 789 CASES, MORE OR LESS, OF LATEX SURGEONS' GLOVES, AN ARTICLE OF DEVICE, etc., Defendant. Claim of Plastic Materials of Puerto Rico, Inc. |
| Court | U.S. District Court — District of Puerto Rico |
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Silvia L. Carreño-Coll, Annamarie Kempic, Asst. U.S. Attys., Hato Rey, P.R., for plaintiff.
Harry Anduze Montaño, Hato Rey, P.R., for claimant.
This is an in rem forfeiture action brought by the plaintiff, United States of America ("plaintiff"), pursuant to the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 301 et seq. The requisite Initial Scheduling Conference and Pretrial Conference were held, and a Non-Jury Trial was conducted on September 3—13, 1991; February 13—14, 1991; March 30— 31, 1991; and April 3, 1992.
Based on the evidence presented by the parties and after due deliberation, this Court now makes the following Findings of Fact and Conclusions of Law.
1. Claimant, Plastic Materials of Puerto Rico, Inc., ("Plastic Materials" or "claimant"), manufactured the seized articles at a building in Loiza, Puerto Rico, (manufacturing facility), and stored certain of the seized articles, device components and accessories as well as finished product, at a warehouse in Luquillo, Puerto Rico. Cox Testimony, day 1, p. 16, 17, 31-44, 65, 104. See also P. González Testimony, day 11, p. 35-36.
2. Plastic Materials' represented that its gloves were to be used as surgeons gloves or as dental examination gloves. Cox Testimony, day 1, p. 21-22; Exhibits1 4, 5; P. González Testimony, day 11, p. 33, day 13, p. 120-121.
3. Plastic Materials' only customer for the seized articles was the United States Department of Defense. Testimony of Harold Gordon Cox (Cox Testimony), day 1 p. 21; Testimony of Peter González Diaz, day 11, p. 33, day 13, p. 120-121; Exhibits Y2, Z2, A3, and T7.
4. The Department of Defense purchased only latex surgeons and dental examination gloves from Plastic Materials. P. González Testimony, day 13, p. 121, Exhibits Y2, Z2, A3, and T7.
5. Plastic Materials is a manufacturer of medical devices. Cox Testimony, day 1, p. 20-21; P. González Testimony, day 11, p. 33, day 13, p. 121.
6. Plastic Materials manufactured the seized latex surgeons gloves and latex examination gloves. Cox Testimony, day 1, p. 21-22, Exhibits 4 and 5 (labeling for surgeons and dental examination gloves); P. González Testimony.
7. The FDA has statutory authority to conduct inspections of device manufacturers pursuant to 21 U.S.C. § 374.
8. Between February 12 and April 12, 1990, FDA conducted an inspection of claimant's manufacturing facility at Loiza, Puerto Rico, and its rented warehouse at Luquillo, Puerto Rico. Cox Testimony, day 1, p. 16, 65; Testimony of Dianiris Ayala Negrón (Ayala Testimony), day 11, p. 11-12; Testimony of Jorge L. Guadalupe (Guadalupe Testimony), day 7, p. 32-33; P. González Testimony, day 12, p. 5-7.
9. Following the FDA inspection, the FDA issued an eleven page, thirty-five item, list of inspection observations, Form 483, to Plastic Materials noting observed deficiencies in the manufacturing operation in the following categories, among others: 1) organization and personnel; 2) building and environmental controls; 3) manufacturing specifications and processes; 4) finished device inspection; and 5) records. Cox Testimony, day 1, p. 108, 109, 111, and Exhibit 42; P. González Testimony, day 12, p. 9.
10. Following the inspection, FDA also issued a three page, five item, list of inspection observations, Form 483, to Plastic Materials noting observed deficiencies in the warehouse at Loiza, Puerto Rico, pertaining to rodent activity and storage conditions for components and finished product. Cox Testimony, day 1, p. 109, and Exhibit 43.
11. Plastic Materials responded with a letter of explanation (Exhibit H3) in which the firm disputed its obligations under the device good manufacturing practice (GMP) regulations and the Act. P. González Testimony, day 123, p. 71-73; Testimony of Z. Frank Twardochleb (Twardochleb Testimony), day 5, p. 71-72, and Exhibit H3.
12. Therefore, Plastic Materials did not use adequate environmental controls in its manufacturing facility and warehouse. Twardochleb Testimony, day 4, p. 41; Testimony of Philip E. Nickerson (Nickerson Testimony), day 5, p. 91, 92, 99; Testimony of Paris Manaford Brickey (Brickey Testimony), day 4, p. 18.
13. Plastic Materials kept the manufacturing facility doors and unscreened windows open during the glove manufacturing process. Cox Testimony, day 1, p. 30; Exhibit 8; P. González Testimony, day 12, p. 58, 63-64.
14. The Luquillo warehouse that Plastic Materials used had gaps between the roof and walls and countless holes and openings in the external walls and doors. Cox Testimony, day 1, p. 67, 72; Exhibits 21 and 22.
15. Open doors and windows and holes and gaps in walls and doors provide easy access for rodents, pests, and airborne contaminants. Brickey Testimony, day 4, p. 15; Twardochleb Testimony, day 4, p. 42; Nickerson Testimony, day 5, p. 92, 107.
16. Plastic Materials did not enclose the area in the manufacturing facility that was used to apply cornstarch to the gloves and the airborne cornstarch spread throughout the manufacturing facility and settled on equipment, including the equipment used to process the liquid latex. Cox Testimony, day 1, p. 31, 35, 38, 39, Exhibits 9, 10, 11, 12, 13.
17. The seized cornstarch, latex, package labels, and packaging material was for use in manufacturing latex surgical and dental examination gloves, Exhibits 4, 5, and 36 (labeling), Testimony of Maria Esther Rosario (Rosario Testimony), day 9, p. 20-23; because Plastic Materials had no other use for those items other than manufacturing such surgical and dental examination gloves. P. González Testimony, day 11, p. 33, 80, day 12, p. 128, day 12, p. 120, 121.
18. Plastic Materials failed to organize its manufacturing facility and warehouse to prevent mix-ups; the lot numbers on an outer carton of gloves was different from the lot number on the inner glove packages, P. González Testimony, day 12, p. 45-46, and Exhibit 44 at p. 18; gloves labeled as sterile were stored in an area supposedly reserved for inspection and packaging, without any indication regarding whether or not they were actually sterilized; Cox Testimony, day 1, p. 43; P. González Testimony, day 12, p. 130; gloves labeled as sterile were stored in the rodent-infested warehouse with supposedly inferior gloves, Cox Testimony, day 1, p. 104. Plastic Materials stored hundreds of gloves in plastic garbage bags which were reused, nor did the firm ensure that the labels would be changed on the reused bags. Cox Testimony at day 1, p. 43, 104; day 2, p. 75-76, day 3, p. 33, 34; Exhibit 44 at p. 18; Rosario Testimony, day 9, p. 31.
19. Plastic Materials used a fan in the manufacturing facility—in the area in which the molds were dipped into the liquid latex—that was covered with a thick coat of the same cornstarch dust that flew throughout the manufacturing facility. Cox Testimony, day 1, p. 47-50 and Exhibit 10.
20. Therefore Plastic Materials did not use effective measures to clean the manufacturing facility. Cox Testimony, day 1, p. 39 and Exhibit 9, 10, 12, and 13.
21. Airborne contamination in a glove manufacturing facility may introduce foreign matter into the finished gloves, causing an inclusion and increasing the likelihood of tears or pinholes. Twardochleb Testimony, day 5, p. 76, 77; Nickerson Testimony, day 5, p. 99.
22. At least sixteen different employees manually performed the dipping and drying procedures. P. González Testimony, day 13, p. 125.
23. Plastic Materials did not establish a standard length of time for the glove molds to be dipped into the latex; each employee determined the dipping time for him or herself. Cox Testimony, day 1, p. 33-34; P. González Testimony, day 13, p. 125.
24. During latex glove manufacturing, the dipping time must be controlled in a uniform, standard, and consistent manner to ensure that the finished glove is safe and effective for its intended use. Twardochleb Testimony, day 4, p. 26, 42; Nickerson Testimony, day 5, p. 90, 96, 97, 108.
25. Plastic Materials permitted each employee to decide independently the speed at which the glove mold was withdrawn from the liquid latex. Cox Testimony, day 1, p. 35; P. González Testimony, day 13, p. 123.
26. During latex glove manufacturing, the speed of withdrawing the latex-coated mold from the liquid latex must be controlled in a consistent and uniform manner to ensure that the finished glove is safe and effective for its intended use. Nickerson Testimony, day 5, p. 90, 94, 97.
27. During latex glove manufacturing, the speed of withdrawing the mold from the liquid latex effects the glove thickness and may cause pinholes. Nickerson Testimony, day 5, p. 93-95; P. González Testimony, day 13, p. 124.
28. Plastic Materials permitted each employee to determine the exact drying time for the latex-coated glove molds. Cox Testimony, day 1, p. 36; P. González Testimony, day 13, p. 126.
29. During latex glove manufacturing, the drying time must be controlled in a uniform, standard, and consistent manner, with a calibrated timing instrument, to ensure that the finished glove is safe and effective for its intended use. Twardochleb Testimony, day 4, p. 26, 42; Nickerson Testimony, day 5, p. 90, 95, 96, 97.
30. Plastic Materials did not have a working thermometer in the heat curing oven. Cox Testimony, day 1, jp. 37; P. González Testimony, day 12, p. 76.
31. During latex glove manufacturing, the heat curing temperature must be controlled at a consistent and uniform level with a thermometer to ensure that the gloves are safe and effective for their intended...
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