U.S. v. Loran Medical Systems, Inc.
| Decision Date | 17 December 1997 |
| Docket Number | No. CV 96-4283 SW (CWx).,CV 96-4283 SW (CWx). |
| Citation | 25 F.Supp.2d 1082 |
| Court | U.S. District Court — Central District of California |
| Parties | UNITED STATES of America, Plaintiff, v. LORAN MEDICAL SYSTEMS, INC., et al., Defendants. |
Nora M. Manella, AUSA, Office of U.S. Attorney, Criminal Div., Los Angeles, CA, Jacqueline H. Eagle, Dept. of Justice, Office of Consumer Litigation, Washington, DC, for U.S.
Bent Formby, Santa Barbara, CA, pro se.
AMENDED ORDER GRANTING PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT
TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
I. Background
On June 20, 1996, this court granted a temporary restraining order enjoining Defendants Loran Medical Systems, Inc., Bent Formby and Ernest Thomas, M.D. ("Defendants") from importing neonatal rabbit and human fetal cells (the "Cell Product") from Russia for use in the treatment of human diabetes. Defendants claim that injection of the Cell Product into diabetic patients can stimulate the body's production of insulin.
On July 1, 1996, the court entered a preliminary injunction against Defendants importation and use of the Cell Product on the grounds that the government had demonstrated a reasonable probability of success on the merits of its claim — that the Cell Product fell within the Food and Drug Administration's ("FDA") regulatory authority pursuant to the federal Public Health Service Act (the "PHS Act"), 42 U.S.C. § 201, et seq. and the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.
Now before the court are the parties cross motions for summary judgment. Plaintiff seeks a permanent injunction against the unregulated use of the Cell Product, while Defendants argue that the Cell Product is outside of the FDA's regulatory authority. For the reasons stated below, the court finds that the FDA has authority over the Cell Product and GRANTS Plaintiff's request for a permanent injunction.
II. Summary Judgment Standard
Summary Judgment is appropriate where there is "no genuine issue as to any material fact and ... the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). In this case, the parties agree that there are no questions of fact. The case thus hinges on a purely legal question, an appropriate use of the summary judgment procedure.
III. Analysis
The gravamen of this case is whether the Cell Product falls within the regulatory ambit of the FDA. The government argues that it does, pointing to regulations defining "biological product," which the FDA regulates pursuant to its authority under the Public Health & Service Act; and regulations involving "drugs" and "new drugs," which the FDA regulates under its Food and Drug Act authority.1
We review the decisions of administrative agencies according to the two-part test established in Chevron v. Natural Resources Defense Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Under Chevron, the first inquiry is whether Congress has directly spoken on the issue before the court. 467 U.S. at 842-43, 104 S.Ct. 2778. The parties agree that there is no statutory authority that directly speaks to the FDA's authority over the cell product. Under the second prong of the Chevron test, the court must determine whether the agency's position is a permissible construction of the relevant statute. Id. The court may only overturn the agency's interpretation if it finds that the interpretation "is not one that Congress would have sanctioned." Id. at 845, 104 S.Ct. 2778 (quoting United States v. Shimer, 367 U.S. 374, 383, 81 S.Ct. 1554, 6 L.Ed.2d 908 (1961)).
A biological product is any "virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure" of human diseases or injuries. 21 C.F.R. § 600.3(h) (emphasis added); see also 42 U.S.C. § 262(a). A product is analogous to a toxin or anti-toxin if, irrespective of its source or origin, it can be used in the treatment of disease through a "specific immune process." 21 C.F.R. § 600.3(h)(5)(iii).
The human immune system will naturally react to the injection of any cellular material, whether obtained from a human or non-human source. Defendants inject the Cell Product into an area of the abdomen selected specifically to evade this response and thus reduce the chance that the cells will be rejected. This procedure purportedly allows the rabbit cells to begin producing insulin immediately while the human fetal cells mature.
The government argues that this attempt at evading the body's natural immune system is a "specific immune process" as required by the FDA's regulations. Defendants read the regulation more narrowly. Defendants rely on the Court of Custom and Patent Appeals opinion in Certified Blood Donor Services Inc. v. United States, 62 C.C.P.A. 66, 511 F.2d 572 (1975), in support of their argument that a substance analogous to a toxin or antitoxin must be used to treat diseases through specific immunization. Defendants' reliance, however, is misplaced. The issue before the court in Certified was whether a serum used for diagnosis rather than treatment fell within the regulatory definition of biological product. 511 F.2d at 575. Moreover, the regulatory language cited, but not relied upon, by the court in Certified is an outdated version of the regulation. The current language was adopted by the FDA in 1973. Accordingly, Certified does not bear on this case.
Defendants also argue that the PHS act only authorizes the FDA to regulate products which immunize against a specific disease, such as polio or smallpox. The court disagrees. As described in greater detail below, Congress conferred upon the FDA the broad statutory authority to regulate products analogous to toxins, antitoxins, vaccines, blood, etc. See 42 U.S.C. § 262(a). The FDA's assertion of authority over immunological agents such as the Cell Product is a reasonable construction of the PHS Act.
Defendants next argue that even if the Cell Product does use a specific immune process, the FDA does not have regulatory authority under the PHS Act because the Cell Product is not analogous to a toxin or antitoxin. Defendants rely on the Fifth Circuit's decision in Blank v. United States, 400 F.2d 302 (1968), which held that blood and plasma were not analogous to therapeutic serums because they were not employed for immunological purposes, they merely replaced blood lost through disease or injury. 400 F.2d at 304. Accordingly, the Blank court held that the FDA did not have regulatory authority over blood and plasma. Id. at 305. Defendants argue that like blood, the Cell Product merely replaces cells that have been lost to disease, in this case diabetes.
Blank rested heavily on the fact that the FDA had not promulgated regulations that could be read to include blood within the definition of a product analogous to a therapeutic serum. 400 F.2d at 303-04. In this case, however, the regulations defining products analogous to toxins and antitoxins appear to encompass the Cell Product. See 21 C.F.R. § 600.3(h)(5)(iii) (). Thus, to the extent the Blank analysis relied on the paucity of regulatory authority, it does not apply in this case.
The Blank court also noted that blood transfusions were unknown to Congress when it enacted the PHS Act in 1902, therefore, it could not have intended blood to be analogous to a therapeutic serum. 400 F.2d at 303. Defendants argue that the Cell Product was similarly unknown to Congress when it last amended the PHS Act. Blank, however, was contrary to the Supreme Court's holding in In re Permian Basin Area Rate Cases, 390 U.S. 747, 88 S.Ct. 1344, 20 L.Ed.2d 312 (1968), that administrative agencies must be able to adapt to changing circumstances. 390 U.S. at 784, 88 S.Ct. 1344; see also Chevron, 467 U.S. at 862, 104 S.Ct. 2778 (). The FDA has construed its mandate under the PHS Act to include a broad spectrum of biological products used in the treatment of disease. The court cannot say that the FDA's construction was unreasonable.
Defendants argue that the Cell Product cannot be a Biological Product under 42 U.S.C. § 262(a) because it is not biologically or genetically altered in any way. Somatic Cell Therapy — medical treatment using biologically altered cells — is regulated under the FDA's authority to regulate biological products. See 58 Fed.Reg. 53250; FDA, Points to Consider in Human Cell Therapy and Gene Therapy 4 (Aug. 27, 1991) (listing examples of somatic cell therapy). But nothing in the regulation requires alteration before a product is to fall under the FDA's purview.2
Accordingly, the court finds that the FDA's conclusion that the Cell Product is a biological product that uses a specific immune process is reasonable, and thus the Cell Product is properly under the FDA's authority.
The FD & C Act defines drugs as, inter alia, "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in [humans]." 21 U.S.C. § 321. The Cell Product was developed for use in the treatment of diabetes. Thus, it meets the statutory definition of a drug.
Defendants argue that the statutory definition is overbroad — that it encompasses a wide variety of items that fall outside the plain meaning of the word "drug." Defendants' argument relies on two cases, both inapposite to the present case. First, Defendants argue that under Juneau v. Interstate Blood Bank of Louisiana, 333 So.2d 354 (La.App...
To continue reading
Request your trial
-
United States v. Regenerative Sciences, LLC
...obviously intended to control the availability of drugs for prescribing by physicians.” Evers, 643 F.2d at 1048;see also Loran Med. Sys., Inc., 25 F.Supp.2d at 1087 (dismissing defendants' “practice of medicine” argument because the court concluded that the cell product was a drug and that ......