Automated Medical Laboratories, Inc. v. Hillsborough County, 83-3014

Decision Date16 January 1984
Docket NumberNo. 83-3014,83-3014
Citation722 F.2d 1526
PartiesAUTOMATED MEDICAL LABORATORIES, INC., Plaintiff-Appellant, v. HILLSBOROUGH COUNTY, Florida, and Hillsborough County Health Department, Defendants-Appellees.
CourtU.S. Court of Appeals — Eleventh Circuit

Larry A. Stumpf, Miami, Fla., for plaintiff-appellant.

Richard Landfield, Washington, D.C., for amicus Blood Resources Assoc. & FL Assoc. of Plasmapheresis Establishments.

Deolores D. Menendez and Emeline L. Acton, Tampa, Fla., for defendants-appellees.

Appeal from the United States District Court for the Middle District of Florida.

Before FAY and HENDERSON, Circuit Judges, and TUTTLE, Senior Circuit Judge.

TUTTLE, Senior Circuit Judge:

Appellant Automated Medical Laboratories, Inc. ("Automated") filed a civil action against appellees Hillsborough County, Florida (the "County") and Hillsborough County Health Department (the "Department") in the United States District Court for the Middle District of Florida. Appellant challenged the constitutionality of County Ordinances 80-11 and 80-12 ("County Ordinances") and the rules and regulations promulgated thereunder. Following a nonjury trial, United States District Court Judge William J. Castagna rejected all of Automated's constitutional attacks on the local legislation, including its federal pre-emption attack, except for the claim that Sec. 7 of Ordinance 80-12 and Sec. 4 of the rules and regulations imposed an impermissible burden on interstate commerce. This Court finds that the County Ordinances are pre-empted by federal regulation. Therefore, the district court holding that Sec. 7 of Ordinance 80-12 and Sec. 4 of the rules and regulations are invalid is affirmed, and the holding that the remainder of the County Ordinances are valid is reversed.

I. BACKGROUND

Automated is a Florida corporation that operates, through subsidiary corporations, eight blood plasma centers in the United States. One of the centers, Tampa Plasma Corporation ("TPC"), is located in Tampa, Hillsborough County, Florida. Automated's plasma centers collect blood plasma from paid donors by plasmapheresis. Plasmapheresis is a process whereby, during a single procedure, blood is removed from a human donor, the plasma is removed from the whole blood, and the red blood cells are returned to the donor. Automated sells the plasma to pharmaceutical concerns, which use it in the manufacture of pharmaceutical products such as tetanus vaccine, albumin, and anti-hemophilic factor.

Prior to the enactment of the County Ordinances, the Food and Drug Administration of the United States Department of Health and Human Services ("FDA") had issued regulations, which are contained in 21 C.F.R. Secs. 600.3-680.26 (1983) (the "federal regulations"), that established standards and procedures for plasmapheresis operations. The federal regulations provide for FDA inspection of plasmapheresis facilities, establish standards for personnel and physical plants, necessitate licenses for plasmapheresis products and facilities, and establish human blood product standards, including the means to select suitable plasmapheresis donors.

In conformance with the federal regulations, TPC selects plasma donors on the basis of medical history, tests, and physical examinations. On each potential donor's initial visit, and at four-month intervals thereafter, TPC's staff physician reviews the candidate's medical history, performs a physical examination, and decides whether to reject or accept the candidate. If the candidate is accepted, the physician explains the plasmapheresis procedure as well as its associated risks and obtains the candidate's written informed consent to having the plasmapheresis procedure performed. In addition to the regularly scheduled staff physician's review and examination, nonmedical employees of TPC, who are trained and supervised by the staff physician, review the candidate's medical history prior to each donation of plasma. Nonmedical employees also determine, prior to each donation of plasma, that the candidate's weight, body temperature, blood pressure, pulse rate, serum protein, and hematocrit value are within the limits established by the federal regulations.

In conformance with the federal regulations, TPC has established procedures for eliminating from its donor population persons whose plasma could contain hepatitis virus. The staff physician rejects any candidate who has a history of viral hepatitis, a history of addiction to self-injected narcotics, or who has, within the preceding six months, had close contact with anyone having viral hepatitis, undergone major surgery, received whole blood or any human blood derivative known to be a possible source of viral hepatitis, or been tattooed. In addition, TPC sends a sample of each donation of plasma it collects to an outside laboratory operated by another wholly owned subsidiary of Automated to be tested for hepatitis contamination. If a sample is found to be contaminated, TPC destroys the unit of plasma from which the sample was taken and permanently rejects the donor from whom that unit was collected.

TPC has also established procedures for eliminating candidates who have exceeded the volume and frequency limits for plasma donations established in the federal regulations. To monitor the frequency with which a person donates plasma, TPC has established a donor identification system. At the time of a donor's first visit, TPC requires two forms of identification to establish the donor's identity. To identify the donor on subsequent visits, TPC provides the donor with an identification card, to which is affixed the donor's photograph. In addition, TPC establishes for each donor a permanent donor record file, which contains the donor's photograph and signature, as well as descriptive identifying information (address, telephone number, birthdate, sex, height, eye and hair color, race, and blood type), written reports of the donor's physical examinations, signed consent forms, and written records documenting every plasma donation made. For each donation, TPC documents the date of donation, the bleed number, the donor's medical history and laboratory test results, and the volume of whole blood and red blood cells returned. By means of a permanent donor record file, TPC can deter any attempted donation which would result in a potential donor subjecting his or her health to risks by exceeding the amount and frequency limits set forth in the federal regulations.

TPC is not required by the federal regulations to coordinate its donor identification system with that of other plasma centers in the County. If, however, circumstances warrant the checking of a potential donor's identity with another plasmapheresis center, TPC's phlebotomists examine both arms of the potential donor for signs of recent needle marks. Any potential donor who evidences recent needle marks that cannot be attributed to previous donations reflected in his or her permanent donor record file is referred to the staff physician for further evaluation.

The federal regulations provide for the inspection of TPC by an FDA official at least once every two years. The FDA inspection covers all aspects of the condition of TPC's facility, equipment, and records, as well as the methods used by TPC in collecting, processing, testing, storing, and shipping the plasma it collects. During the four years preceding the trial of this action, TPC was inspected approximately six times by the FDA. Those inspections apparently failed to reveal any deficiency in TPC's plasmapheresis operation other than a noisy fan or air conditioner in the staff physician's office, which allegedly made it difficult for one physician to communicate well with potential donors, forms that needed to be reprinted to make them clearly legible, and the observation, contested by TPC at the time of the inspection, that the staff physician had once "checked off" certain parts of a potential donor's physical examination form before actually performing them.

On November 26, 1980, the County adopted Ordinances 80-11 and 80-12. Ordinance 80-11 imposes a license tax and conditions the issuance of a license on, among other things, agreement by the blood plasma donor center to "reasonable and continuing access" by Department personnel for inspections, a public hearing, and continuously updated information regarding the owners, employees, equipment, and facilities.

The stated purpose of Ordinance 80-12 is "to provide a system for the registration and identification of and the gathering of medical data applicable to Commercial Blood Plasma Vendors as being in the common interest of the health of the people of Hillsborough County." On March 5, 1981, the Department issued rules and regulations pursuant to Ordinance 80-12. Ordinance 80-12 requires that a potential donor must undergo a medical examination and obtain a "certificate of good health" before participating in the plasmapheresis process within the County. The regulations require that a potential donor present that certificate, together with his or her own sworn affidavit stating that he or she has not been detained or treated for acute or chronic alcoholism during the preceding twelve months, to the Department. The Department then issues its own identification card to the potential donor. This identification card permits the potential donor to undergo plasmapheresis for a period of six months only at a single specified plasmapheresis facility located within the County.

Ordinance 80-12 also requires that TPC submit to the Department on a daily basis information as to each plasmapheresis procedure performed, including the following: the date of the procedure; the name, address, age, weight, height, sex, identification number, and current hematocrit value of the donor; the results of the donor's breath analysis; the amount of whole blood removed and the proportion of red cells returned; and the results of testing...

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    ...require the application of the preemption doctrine. As the 11th Circuit Court of Appeals states in Automated Medical Laboratories, Inc. v. Hillsborough County, 722 F.2d 1526 (11th Cir.1984): The rationale underlying the pre-emption doctrine is that the Supremacy Clause invalidates state law......
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