US v. Baxter Healthcare Corp.

• Decision Date: 16 May 1989
• Docket Number: No. 88 C 3636.,88 C 3636.
• Citation: 712 F. Supp. 1352
• Parties: UNITED STATES of America, Plaintiff, v. BAXTER HEALTHCARE CORP., a corporation, Defendant, and Glaxo Specialties Inc., a corporation, Intervenor-Defendant.
• Court: U.S. District Court — Northern District of Illinois

712 F. Supp. 1352

UNITED STATES of America, Plaintiff, v. BAXTER HEALTHCARE CORP., a corporation, Defendant, and Glaxo Specialties Inc., a corporation, Intervenor-Defendant.

No. 88 C 3636.

United States District Court, N.D. Illinois, E.D.

May 16, 1989.

Anton R. Valukas, U.S. Atty., and Frederick H. Branding, Asst. U.S. Atty., Chicago, Ill., for plaintiff.

George M. Burditt and Steven M. Kowal, Burditt, Bowles, Radzius & Ruberry, Ltd., Thomas P. Sullivan and William A. Von-Hoene, Jr., Jenner & Block, Chicago, Ill., and Paul M. Hyman, Hyman, Phelps & McNamara, P.C., Washington, D.C., for defendants.

MEMORANDUM OPINION¹

BRIAN BARNETT DUFF, District Judge.

The federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. §§ 321 et seq. (1982), has one overriding purpose: protecting the public health. See United States v. Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726 (1969). To that end, Congress has enacted laws and the federal Food and Drug Administration ("FDA") regulations to guarantee the safety and efficacy of the drugs Americans use. By their nature, written rules are not fluid. Events and technologies can outdistance them, which lead some to argue that rules—instead of bettering the lot of citizens—become downright unhelpful. Critics level probably more of these charges against the food and drug laws than they do against any other body of regulations.

In our constitutional system the courts should not be the makers of public policy. Our chief task is to apply the law as given or intended to have been given. When it comes to the Food, Drug and Cosmetic Act and its regulations, our touchstone is not what is "best" for patients or physicians, in the ultimate sense of "best," but rather what the law deems necessary to protect the public health. If a federal law or regulation enacted to protect the public health fails to serve the public's interest, it is up to the public, working through the Congress and the FDA, to change it. In the interim the sole task of the courts is to apply the law, and leave policy differences to the critics. It is better for this court to uphold the public's legislated concern for its protection from poor drugs than to risk that protection for what the court feels is best for the country.

This said, this case is a simple matter, although it requires an extensive look at the Food, Drug and Cosmetic Act and its regulations. Based on the affidavits filed to date, these are the undisputed facts: Baxter Healthcare Corporation has operated two plants known as "Travenol Regional Compounding Centers" or "TRCs" since the mid-1980s. At one time, these plants manufactured as many as 35 different products containing 17 different active ingredients. Twenty of these products are antibiotic in nature, and are used to prevent infections.² The other 15 products were used in chemotherapy.³

Pursuant to two separate but similar sets of statutes and regulations,⁴ the FDA has approved each of the 17 active ingredients used by Baxter as raw materials in its TRCs for use in patients under a physician's supervision. These active ingredients come in either powder or liquid form, and have FDA-approved labels that describe how they should be handled and employed. For all but three of these compounds,⁵ a nurse, technician, or doctor must reconstitute the powder or dilute the liquid with an appropriate solvent prior to giving the drug to a patient. In some hospitals and clinics, this process is done in a central mixing facility. The labels of some of the FDA-approved compounds contemplate this, and describe how to prepare these compounds in bulk and store them for later use.⁶

Superficially, the role of the TRCs in this process as anticipated by Baxter is simple: rather than have a physician or hospital solvate or dilute the compound, Baxter does it itself via the TRCs. The TRCs reconstitute or dilute the drug, and package the resulting solution in single-dosage units. Baxter then relabels and freezes the reconstituted or diluted antibiotic compounds, while only relabeling and refrigerating the reconstituted drug compounds. The new labels bear expiration dates that differ from those indicated on the labels of the original approved compounds, but Baxter has performed its own stability studies to support the new dates. With three drugs that did not require reconstitution or dilution prior to administration, Baxter would remove the compounds from their original FDA-approved containers, transfer them to larger FDA-approved Viaflex® bags, and relabel the products.⁷ Baxter would then sell its single-dose "multipacks" and its pooling bags to physicians and hospitals. The administering individual would then need only obtain a pre-packaged dose or withdraw a single dose from a pooling bag, then introduce it into the patient. No reconstitution or dilution was necessary.

Because it believes that the TRCs are doing exactly what a doctor or hospital would do with FDA-approved ingredients, Baxter argues that the FDA has authorized the TRC products. The FDA argues in contrast that the TRCs are making new drugs, ones which the FDA has not approved. According to the FDA, Baxter's TRCs are violating the law, and thus the FDA has moved for a preliminary injunction halting further TRC operations. Baxter vigorously opposes the government's request for an injunction.

This court's authority to restrain violations of the Food, Drug and Cosmetic Act stems from 21 U.S.C. § 332(a). In order to obtain an injunction, the government must establish that Baxter has violated the Act and that there exists "some cognizable danger of recurrent violation...." United States v. W.T. Grant Co., 345 U.S. 629, 633, 73 S.Ct. 894, 898, 97 L.Ed. 1303 (1953); see also SEC v. Holschuh, 694 F.2d 130, 144 (7th Cir.1982) (restraining violations of Securities Act of 1933, 15 U.S.C. §§ 77a et seq. (1982)); Commodity Futures Trading Com'n v. Hunt, 591 F.2d 1211, 1220 (7th Cir.1979) (restraining violation of Commodity Exchange Act, 7 U.S.C. §§ 1 et seq. (1982)). The grant of authority to issue an injunction is not the same as a mandate that an injunction issue whenever the government proves a violation and cognizable danger of recurrence. The court must employ its sound discretion in imposing all equitable remedies, including those which Congress has authorized. See W.T. Grant, 345 U.S. at 633, 73 S.Ct. at 897; Hecht Co. v. Bowles, 321 U.S. 321, 328-30, 64 S.Ct. 587, 591-92, 88 L.Ed. 754 (1944). But Baxter intends to go ahead with its TRC program unless enjoined, and the company has not suggested other remedies for the harms which the TRC products could cause (although the FDA has not demonstrated there are any) prior to a full trial. The government's motion thus turns on whether Baxter has violated the Act, as an injunction is the only means of preventing TRC products from reaching the American market.

The FDA contends that Baxter has violated three provisions of the Act:⁸ § 331(a), which prohibits "the introduction ... into interstate commerce of any ... drug ... that is adulterated or misbranded;" § 331(d), which prohibits "the introduction ... into interstate commerce of any article in violation of section ... 355 of this title;" and § 331(k), which prohibits

the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a ... drug ..., if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.

Even though the government claims three separate violations of the Act, one issue is central to the government's arguments on each: whether Baxter is making "new drugs" or unapproved antibiotic drugs at its TRCs. Unless this is the case, the TRC products are not adulterated drugs, nor has Baxter introduced them in violation of 21 U.S.C. §§ 355 and 357. Additionally, as Baxter uses or encloses the same labels on its TRC products that the FDA approved for the active components themselves, if the TRC products are the same as the active components, then Baxter has not misbranded or altered the products' labels in violation of the law.

Section 355 of the Act states: "No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug." The Act defines "new drug" as

(1) Any drug ... the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof ...; or

(2) Any drug ... the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

21 U.S.C. § 321(p). When examining a product to determine whether it is a drug, new or otherwise, the court must look at the product as a whole, "complete with active and inactive ingredients." United States v. Generix Drug Corp., 460 U.S. 453, 459, 103 S.Ct. 1298, 1301-02, 75 L.Ed. 2d 198 (1983). See also Premo Pharmaceutical Laboratories, Inc. v. U.S., 629 F.2d 795, 799 (2d Cir.1980).

The government has submitted the affidavits of several experts who state that Baxter's TRC products are not generally recognized among qualified experts as safe and effective for use under the conditions recommended in their labels. The experts also claim that the TRC products have not been used to a material extent or for a material time. Baxter does not dispute these...