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BRACCO DIAGNOSTICS, INC. v. SHALALA

April 21, 1997

BRACCO DIAGNOSTICS, INC., Plaintiff,
v.
DONNA SHALALA, Secretary, United States Department of Health and Human Services, MICHAEL FRIEDMAN, M.D., Lead Deputy Commissioner, Food and Drug Administration, and FOOD AND DRUG ADMINISTRATION, Defendants. THE DUPONT MERCK PHARMACEUTICAL COMPANY and IMARX PHARMACEUTICAL CORP., Plaintiffs, v. DONNA SHALALA, Secretary, United States Department of Health and Human Services, and MICHAEL FRIEDMAN, M.D., Deputy Commissioner for Operations, Food and Drug Administration, Defendants. SONUS PHARMACEUTICALS, INC., Plaintiff, v. FOOD AND DRUG ADMINISTRATION, DONNA SHALALA, Secretary, United States Department of Health and Human Services, and MICHAEL FRIEDMAN, M.D., Lead Deputy Commissioner, Food and Drug Administration, Defendants.



The opinion of the court was delivered by: FRIEDMAN

 This matter is before the Court on plaintiffs' motions for preliminary injunction. Their motions are opposed by the Food and Drug Administration and the other defendants, as well as by their competitor, Molecular Biosystems, Inc., whom the Court has permitted to enter the case as a defendant-intervenor. The defendants have also moved to dismiss the complaints for lack of subject matter jurisdiction and for failure to state a claim. The Court heard extensive oral argument on April 18, 1997, and, upon consideration of the briefs filed by the parties and the arguments presented, it grants plaintiffs' motions for preliminary injunction.

 I. BACKGROUND

 The plaintiffs in these three consolidated cases are manufacturers of injectable contrast imaging agents for use with diagnostic ultrasound equipment in the diagnosis of cardiac dysfunction. Bracco's product is named BR-1; the DuPont Merck and ImaRx product is named DMP 115; and the SONUS product is named EchoGen. Each product contains fluorinated gas (perfluoropropane) encapsulated in a microsphere membrane or microbubble. Each is administered by intravenous injection into a patient's body in order to better reflect the sound waves used in ultrasound diagnostics, which in turn helps to improve the quality of the ultrasound images. After injection, the microbubbles eventually dissolve and the patient exhales the gas. See Bracco Mot. for Prelim. Inj., Declaration of Frank Didato at P 2; DuPont Merck Mot. for Prelim. Inj., Declaration of Dr. Alan P. Carpenter at PP 12-16; SONUS Mot. for Prelim. Inj., Declaration of Dr. Steven Quay at PP 4-5. Plaintiffs' products are at various stages of review by the FDA, but none presently is approved for marketing.

 Plaintiffs argue that the only difference between their products and FSO69 is that the microbubbles in FSO69 are suspended in human albumin while the microbubbles in plaintiffs' products are suspended in a synthetic medium, a matter they say is of no significance. The declarations they have filed and an exhibit they submitted at oral argument (Exhibit 1), which is appended to this Opinion, demonstrate to the Court's satisfaction that the characteristics of all three of the plaintiffs' products and those of FSO69 are identical in all material respects. Indeed, on this point, the FDA has offered no counter-declarations or argument in response. The few differences noted in Dr. Dittrich's declaration submitted by MBI do not persuade the Court that all four products at issue are not virtually identical in their important characteristics.

 Despite the similarity of the products, the FDA has chosen to regulate plaintiffs' products as new drugs and MBI's product as a device. *fn1" Under the Federal Food, Drug and Cosmetic Act ("FFDCA"), there are separate provisions governing the regulation of drugs and devices, and the review provisions applicable to each differ in several respects. Compare 21 U.S.C. § 355 (regulating review and approval of new drugs) with 21 U.S.C. §§ 351(f), 360c, 360d, 360e (regulating classification, review and approval of devices). In addition, the FDA has established two distinct operating units or "Centers" to exercise the FDA's regulatory responsibilities: the Center for Drug Evaluation and Review ("CDER") is responsible for drugs; the Center for Devices and Radiological Health ("CDRH") is responsible for medical devices. 21 C.F.R. §§ 5.100, 5.32, 5.33, 5.59, 5.71, 5.72. Each has authority to approve products within its jurisdiction, but each Center is subject to direction by the Office of the Commissioner of the FDA.

 The FDA has decided to treat MBI's product as a device and is treating plaintiffs' products as drugs; thus, both the CDER and the CDRH are regulating ultrasound contrast agents. The two Centers, however, apparently are applying very different standards to assess the safety and effectiveness of essentially identical products. Plaintiffs maintain, without contradiction, that they have been required to produce much more exhaustive scientific data demonstrating the safety and effectiveness of their ultrasound agents while MBI, in response to requests from the CDRH, has been required to submit much less rigorous information and testing results. *fn2"

 In January of 1982, the FDA issued a proposed rule relating to the classification of all radiological devices pursuant to the 1976 Medical Device Amendments to the FFDCA. 47 Fed. Reg. 4406 (Jan. 20, 1982). In its preamble, which constitutes an advisory opinion binding on the agency unless repudiated by the agency, see 21 C.F.R. § 1085(d)(1)(e), the FDA stated: "The agency has determined that all radiologic contrast media, including barium enema kits, are to be regulated by FDA as drugs under section 201(g) of the act (21 U.S.C. 321(g)(1)) and not as devices." 47 Fed. Reg. 4406, 4412. Plaintiffs argue that the FDA's review of MBI's precursor to FSO69, Albunex, and of FSO69 itself as devices rather than as drugs is directly contrary to this advisory opinion and, thus, unless fully and rationally explained, is arbitrary and capricious agency action in violation of the Administrative Procedure Act. Defendants and MBI respond that the advisory opinion had nothing whatsoever to do with products like plaintiffs' or MBI's and thus is of no moment in this litigation. *fn3"

 In October 1992, SONUS recommended to the FDA that its product, EchoGen, be regulated as a drug, and the FDA product jurisdiction officer concurred by designating the CDER as the unit with primary review over EchoGen. See SONUS Mot. for Prelim. Inj., Ex. C, Letter from Amanda Pederson to Charles H. Davis (Dec. 17, 1992); Declaration of Dr. Steven C. Quay at P 6. Bracco, allegedly relying on the FDA's policy of regulating ultrasound contrasting agents as drugs, see supra at 7 & n.3, and its designation of EchoGen as a new drug, submitted an Investigational New Drug application ("IND") to the CDER for its product BR-1 on December 24, 1994. *fn5" ImaRx submitted an IND for DMP 115 to the CDER on August 8, 1995. On September 15, 1996, SONUS filed a New Drug Application ("NDA") for EchoGen.

 Meanwhile, unbeknownst to plaintiffs, the FDA had been engaging in discussions with MBI about whether review responsibility for its products should be transferred from the CDRH to the CDER -- in other words, whether the FDA should begin to treat MBI's products as drugs rather than as devices. MBI Mem. in Opp'n, Declaration of Howard C. Dittrich, M.D. at P 3. MBI urged the FDA "to maintain in all respects the status quo," and "to insure that MBI's products continued to be regulated as medical devices assigned to CDRH." MBI Mem. in Opp'n, Ex. 5, Letter from Steven H. Unger, Deputy, Office of the Chief Mediator and Ombudsman, FDA to Kenneth C. Widder at 1 (March 29, 1996). The FDA ultimately agreed that "the principal review responsibility for Albunex and MBI's other microsphere contrast agents should remain in CDRH," and MBI was advised that both Albunex and FSO69 would "remain subject to review and regulation as medical devices." Id. at 2. Plaintiffs were unaware of the existence of this letter or of the decision that had been made until after the instant lawsuits had been filed.

 By February 24, 1997, however, plaintiffs were aware that MBI had submitted its application for approval of FSO69 as a device and that the FDA had indicated it was satisfied with the studies performed by MBI to demonstrate the safety and efficacy of FSO69. Plaintiffs also were aware of the fact that the CDRH was the entity reviewing the Pre-Market Approval application for FSO69, submitted in October of 1996, although they were not aware that a final determination had been made that FSO69 would be reviewed as a device and approved, if at all, as a device. *fn6"

 Beginning in the summer of 1996, Bracco, DuPont Merck and SONUS began discussions with the FDA in an effort to persuade the FDA to regulate ultrasound agents under uniform standards, be they as devices or as drugs. When the informal discussions were unsuccessful, each of the plaintiffs filed a Citizen Petition pursuant to FDA regulations. See 21 C.F.R. § 10.25. Bracco was the first to file its petition on December 27, 1996. Because the FDA has 180 days to respond to citizen petitions, see 21 C.F.R. § 10.30(e)(2), neither Bracco nor the other plaintiffs, who filed their petitions later, have yet received responses.

 In their petitions, plaintiffs requested the FDA to act promptly to eliminate the disparity in the regulation of ultrasound contrast agents and what they viewed as the "unjustified preferential treatment" given to MBI to the disadvantage of those whose products were being treated as drugs. See Bracco Mot. for Prelim. Inj., Exs. 3-5; DuPont Merck Mot. for Prelim. Inj., Ex. 1; SONUS Mot. for Prelim. Inj., Ex. G. They pointed out that the CDRH applies significantly different standards than the CDER to assess the safety and effectiveness of the agents even though the products are essentially identical. Id. Plaintiffs requested that the FDA determine that all ultrasound contrast agents be regulated under uniform standards and procedures either as new drugs or as medical devices. DuPont Merck asked for expedited consideration of its request, presumably because it knew that MBI's product was on track for approval by mid-April 1997. See DuPont Merck Mot. for Prelim. Inj., Ex. 1 at 1. DuPont Merck did not get expedited review, and all of the petitions remain pending. *fn7"

 II. DISCUSSION

 A. Standards for Granting Emergency Injunctive Relief

 In deciding whether to grant emergency injunctive relief, the Court must consider (1) whether there is a substantial likelihood that plaintiffs will succeed on the merits of the case, (2) whether plaintiffs will suffer irreparable injury absent an injunction, (3) the harm to defendants or other interested parties, and (4) whether an injunction would be in the public interest or at least not be adverse to the public interest. Sea Containers Ltd. v. Stena AB, 281 U.S. App. D.C. 400, 890 F.2d 1205, 1208 (D.C. Cir. 1989); see Washington Metro. Area Transit Comm'n v. Holiday Tours, Inc., 182 U.S. App. D.C. 220, 559 F.2d 841, 843 (D.C. Cir. 1977).

 Plaintiff is not required to prevail on each of these factors. Rather, under Holiday Tours, the factors must be viewed as a continuum, with more of one factor compensating for less of another. "If the arguments for one factor are particularly strong, an injunction may issue even if the arguments in other areas are rather weak." CityFed Fin. Corp. v. Office of Thrift Supervision, 313 U.S. App. D.C. 178, 58 F.3d 738, 747 (D.C. Cir. 1995). An injunction may be justified "where there is a particularly strong likelihood of success on the merits even if there is a relatively slight showing of irreparable injury." Id. Conversely, when the other three factors strongly favor interim relief, a court may grant injunctive relief when the moving party has merely made out a "substantial" case on the merits. The necessary level or degree of likelihood of success that must be shown will vary according to the Court's assessment of the other factors. Washington Metro. Area Transit Comm'n v. Holiday ...


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