United States v. Gonsalves

435 F.3d 64, 2006 U.S. App. LEXIS 1371, 2006 WL 146605
CourtCourt of Appeals for the First Circuit
DecidedJanuary 20, 2006
Docket04-2316
StatusPublished
Cited by36 cases

This text of 435 F.3d 64 (United States v. Gonsalves) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Gonsalves, 435 F.3d 64, 2006 U.S. App. LEXIS 1371, 2006 WL 146605 (1st Cir. 2006).

Opinion

BOUDIN, Chief Judge.

Wallace Gonsalves, Jr., an osteopathic doctor, conducted a solo medical practice in Cranston, Rhode Island. In 1971, he was certified as a “civil surgeon” with the former Immigration and Naturalization Service (“INS”), performing blood tests and administering immunizations to immigrants seeking permanent residence in the United States. Gonsalves, like most doctors, kept drugs in his office premises, including vaccines needed for immunizations.

In June 2002, Catherine Cordy, Chief of the Board of Pharmacy of the Rhode Island Department of Health (“DOH”), received an anonymous complaint about Gon-salves’ medical practice, later determined to have come from Kelly Walsh. Walsh, a former employee, reported that Gonsalves was engaged in workers’ compensation fraud and was illegally selling drug samples to a local pharmacist. Cordy referred this complaint to the Attorney General and the DOH’s Board of Medical Licensure, and Walsh was interviewed on July 8, 2002.

Walsh told investigators that Gonsalves had instructed employees to immunize immigrant patients with diluted vaccines and to administer to those patients only a half-dose of the already-diluted vaccines. She also reported that Gonsalves was falsely certifying to the INS that patients had been tested for various diseases when no such tests had been performed and requiring payments of $150-$300 in cash (which he did not record in his books) for the INS examination, even though the examinations were covered by the patients’ insurance.

On August 16, 2002, the Rhode Island Attorney General’s office executed a search warrant in Gonsalves’ office for general patient and business records, the DOH executed an administrative subpoena for twelve specific patient records, and Cordy, relying on her statutory authority to inspect without a warrant locations where drugs are held, R.I. Gen. Laws § 21-31-21 (2004), conducted an inspection for misbranded or adulterated drugs. Cordy seized various drugs as misbranded or adulterated — evaluations later confirmed in testing by the Food and Drug Administration.

In due course, Gonsalves was indicted in federal court for drug adulteration and tampering, 18 U.S.C. § 1365(a) (2000) and 21 U.S.C. §§ 33100, 333(a)(2) (2000), making false statements to the government, 18 U.S.C. § 1001 (2000), and tax violations, 26 U.S.C. §§ 7201, 7206(1) (2000). At trial, the government’s evidence permitted a jury to conclude that Gonsalves was criminally responsible for, among other things, the dilution and improper storage of vaccines, false certifications to the INS that patients had been tested for HIV and syphilis, falsely reporting that patients had been properly immunized, and the failure to report over $400,000 in income. The jury convicted Gonsalves on all submitted counts.

For these offenses, the district court sentenced Gonsalves to ten years in prison and fined him heavily. In the appeal now before us, Gonsalves does not dispute the adequacy of the evidence (save in one limited respect discussed below) but contests the refusal of the district court to suppress evidence against him, certain of the jury instructions, and alleged errors in his sentencing. The principal assault is on Cor-dy’s search of Gonsalves’ office and her *67 seizure of vaccine samples, which provided much of the evidence against Gonsalves.

Prior to trial, Gonsalves moved to suppress the drugs thus seized on the basis that Cordy had conducted the search and seizure without a warrant. The district court denied the motion on the ground that the search and seizure fell within the “administrative exception” to the warrant requirement. Such an exception to the normal requirement — a warrant based on probable cause — applies where certain conditions are met. New York v. Burger, 482 U.S. 691, 702-03, 107 S.Ct. 2636, 96 L.Ed.2d 601 (1987). See also United States v. Biswell, 406 U.S. 311, 317, 92 S.Ct. 1593, 32 L.Ed.2d 87 (1972); Colonnade Catering Corp. v. United States, 397 U.S. 72, 76-77, 90 S.Ct. 774, 25 L.Ed.2d 60 (1970).

Ordinarily, administrative searches are permitted in highly regulated industries where authorized by a statutory scheme and where, in addition, the scheme furthers a substantial government interest, warrantless inspections are necessary to further this interest, and the scheme provides a constitutionally adequate substitute for a warrant in terms of notice to those regulated and restrictions on the administrator’s discretion. Burger, 482 U.S. at 702-03, 107 S.Ct. 2636. In simplest terms, a pharmaceutical factory need not be treated as if it were someone’s home.

Gonsalves’ first objection to Cor-dy’s administrative search of his office is that the medical profession should not be treated as a highly regulated enterprise. Whatever the status of the profession in the abstract, the statute in this case permits administrative searches of “establishments” where drugs are manufactured or stored, R.I. Gen. Laws § 21-31-21, and the seizure at issue is solely of drugs reasonably believed to have been misbranded or adulterated. Our focus, therefore, is on the regulation of drugs — not the practice of medicine in general.

In Rhode Island, as under federal law and in other states, drugs are heavily regulated in storage and dispensation and have been for many years. Mann v. Cannon, 731 F.2d 54, 59-60 (1st Cir.1984); see also United States ex rel. Terraciano v. Montanye, 493 F.2d 682 (2d Cir.) (Friendly, J.), cert, denied, 419 U.S. 875, 95 S.Ct. 137, 42 L.Ed.2d 114 (1974) (pharmacy operations in New York). Rhode Island’s Food, Drugs, and Cosmetics Act has been in effect for a half-century, 1956 R.I. Pub. Laws ch. 56 § 1 (codified at R.I. Gen. Laws §§ 21-31-1 to -23), and the pertinent provisions are numerous, longstanding and pervasive. 1 The scheme readily passes the “closely regulated” test of Burger. 482 U.S. at 701, 107 S.Ct. 2636.

Whether the practice of medicine in general meets this test is a different question that we need not decide. Compare Tucson Woman’s Clinic v. Eden, 379 F.3d 531, 549-51 (9th Cir.2004). Nor are we concerned on this appeal with patient records; Cordy’s search and seizure was solely directed to misbranded and adulterated drugs held at large in Gonsalves’ office.

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Bluebook (online)
435 F.3d 64, 2006 U.S. App. LEXIS 1371, 2006 WL 146605, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-gonsalves-ca1-2006.