Bracco Diagnostics, Inc, v. Shalala, 963 F. Supp. 20 (DC District April 21, 1997)

Briefed by: A. Longwell, Esq., 1999


The US Supreme Court denied cert. for this case, in which a Federal District Judge determined that FDAs treatment of one ultrasound contrast agent as a device, and three others as drugs, was “arbitrary and capricious agency action, and a violation of the APA”(Administrative Procedures Act).


Bracco Diagnostics, DuPont Merck with its partner ImaRx, SONUS, and Molecular Biosystems, Inc. (MBI) all manufacture ultrasound contrast media which contains fluorinated gas (perflouropropane) encapsulated in microbubbles and administered by iv injection. The bubbles improve the quality of ultrasound images. The bubbles eventually dissolve and the patient exhales the gas. Bracco’s product is called BR-1, ImaRx’s DMP 115, SONUS’ is EchoGen, MBI’s is FS069. In 1995, CDRH had approved MBIs Albunex as a class III device after a 4 year PMA review. This product was a precursor to FS069. Instead of having encapsulated microbubbles, Albunex utilized sonicated air produced by special equipment just before injection.

In October 1992, SONUS filed a request for designation, asking that EchoGen be reviewed as a drug. Ombudsman Amanda Peterson concurred. Bracco (aware of the EchoGen determination) submitted an IND for BR-1 to FDA in 1994. ImaRx submitted an IND in 1995. SONUS filed an NDA for EchoGen in 96. Meanwhile MBI had been talking to CDRH about its new product and had written the CDRH ombudsman in 1996 to ask that the product continue to be regulated as a device. CDRH agreed, and proceeded to review a PMA for FS069. In the summer of 96, Bracco, DuPont Merck and SONUS began discussions with FDA to urge them to employ common standards for all ultrasound contrast media. Each filed Citizens Petitions, Bracco first. At the time of the trial, none had received a response. DuPont Merck asked for expedited review of its request and did not get it. These companies (the Ps) knew that approval of FS069 was imminent, so they went to court to enjoin FDA from proceeding with the review of FS069 as a device.


The Court determined that emergency injunctive relief was appropriate. The plaintiffs had a very good case on the merits. “Bracco, DuPont Merck, SONUS and MBI products are identical in all material respects, and FDA has not provided a legitimate reason for failing to regulate these products the same way. No common treatment plus no rational explanation equals “arbitrary and capricious”. The judge also held that there was a danger of irreparable harm, and that there were good public policy reasons for granting the injunction.

All four products likely met both the definition of drug and the definition of a device, so FDA has discretion in determining how to treat them. However, FDA has no discretion to treat them disparately, forcing some products to adhere to a demonstrably higher standard than others. The drug route had caused the sponsors of the drug products to engage in more difficult, more time-consuming and more expensive testing than the sponsor of the device product. (Much evidence in case) This was injurious to the Ps. Additionally, the earlier approval of the MBI product, if allowed, would enable MBI to be first on the market and that would cause additional harm.

Granting the injunction would cause MBI serious harm, since it relied in good faith on the FDA decision, given to them in writing. Additionally, the product is a useful one and would be beneficial to public health. However, the public interest in preventing FDA from acting unlawfully is greater.

That Ps have not exhausted all administrative remedies before going to court does not prevent granting an injunction. FDA admitted that their response to the Bracco petition (Due under law by June 1997, but not yet received by April 1997) might only consist of a letter advising the petitioner that the agency needed more time to consider. Additionally the approval of the MBI product was imminent. Because of these circumstances, exhaustion of administrative remedies is not required.


The injunction was granted. FDA was forbidden to approve MBIs PMA, OR any of the Ps NDAs, until such time as FDA could either 1) treat all these products the same, or 2) come up with a rational explanation of why they should not do so. In their response to the Bracco Citizen’s petition. (July 25, 1997) FDA declared that henceforward, all ultrasound contrast agents would be treated as drugs and would be reviewed by CDER. MBIs review was shifted to CDER, MBI paid the user fee, the panel recommending approval was a Device Panel, NDA approval was obtained, in Dec 1997-the Bracco product was approved in Oct. 1998.


FDA can’t treat similar products differently when deciding whether they are to be considered as drugs or as devices. However, note -MBI still got approval first with much less data than did competitors. . Moral: Always start with CDRH-even if you get in trouble, you may still come out ahead.