HON. ALFREDO R.A. BENGZON, IN HIS CAPACITY AS SECRETARY OF HEALTH, HON. CATALINA C. SANCHEZ, IN HER CAPACITY AS THE DIRECTOR OF FOOD AND DRUGS OF THE NATIONAL DRUG COMMITTEE OF …

Bengzon versus Boie-Takeda Chemicals

The Case

This is a petition for certiorari and prohibition brought by the Secretary of Health and the Director of the Bureau of Food and Drugs against Boie-Takeda Chemicals, Incorporated. The petitioners ask the Supreme Court to annul a writ of preliminary injunction issued by the Court of Appeals, which restrained them from enforcing a regulation banning the sale of the drug Danzen. The case matters because it fixes the standard for reviewing a preliminary injunction on certiorari, and because it teaches that the writ exists to preserve the status quo, the last actual peaceable uncontested status that preceded the controversy, while the principal case is still pending.

Procedural History

Boie-Takeda filed in the Court of Appeals a petition for certiorari and prohibition with preliminary injunction against the Department of Health and its officials, alleging that the cancellation of the registration of its product was done without due process of law. The Court of Appeals issued a temporary restraining order, set the application for hearing, and after oral arguments and the submission of memoranda, granted the writ of preliminary injunction. The Secretary of Health then elevated the matter to the Supreme Court on a petition for certiorari and prohibition with preliminary injunction, alleging grave abuse of discretion. The Supreme Court treated the respondent's motion to dismiss and opposition as its comment, and resolved the merits of the petition.

Facts

Boie-Takeda is a Philippine corporation engaged in the manufacture, distribution, and sale of drugs. Among its products is Danzen, a tablet containing serrapeptase, which it had been licensed to manufacture and sell in the Philippines since 1970. The drug is also sold in other countries, such as Japan and the Federal Republic of Germany, but not in the United States.

Based on a decision of the United States Food and Drug Commissioner, affirmed by the United States Court of Appeals, which determined that oral anti-inflammatory proteolytic enzymes had not been shown to be effective for their labeled uses, the Director of the Bureau of Food and Drugs, with the approval of the Secretary of Health, issued a regulation ordering the recall of the registration of all pharmaceutical preparations containing anti-inflammatory proteolytic enzymes. A week later, an addendum regulation expressly included Danzen in the list of banned preparations.

Boie-Takeda sought reconsideration, submitting data on the safety and efficacy of serrapeptase. After a brief hearing before the Technical Advisory Committee on Registration of Products, the Director denied the request. Boie-Takeda appealed to the Secretary of Health, who referred the appeal to the National Drug Committee. That committee granted a short hearing, but the Secretary eventually confirmed the recall and cancellation of the registration of Danzen and directed the company to discontinue marketing it. Alleging denial of due process, Boie-Takeda went to the Court of Appeals, which issued the writ of preliminary injunction now challenged before the Supreme Court.

Issues

• Whether or not the Court of Appeals committed grave abuse of discretion in issuing the writ of preliminary injunction restraining the enforcement of the regulation banning Danzen.
• Whether or not the question of whether Boie-Takeda was denied due process of law in the administrative proceedings may be resolved in this petition.

Applicable Provisions

Section 2 of Republic Act Number 3720, as amended by Executive Order Number 175, defines the policy and powers of the Department of Health, and provides:

To implement this policy, the Government shall: (a) Establish standards and quality measures for foods, drugs and devices and cosmetics. (b) Adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious and good quality drugs and devices in the country. (c) Adopt measures to ensure the rational use of drugs and devices, such as, but not limited to, banning, recalling or withdrawing from the market drugs and devices which are not registered, unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National Drug Formulary, and the use of generic names in the labelling of drugs. (d) Strengthen the Bureau of Food and Drugs.

This provision supplies the authority invoked by the petitioners for the recall and withdrawal order, and frames the substantive dispute that the Court of Appeals will decide on the merits.

Ruling

On the first issue, the Court held that the Court of Appeals did not commit grave abuse of discretion. The issuance of a writ of preliminary injunction is an exercise of sound discretion, and the Supreme Court generally refrains from interfering with it on certiorari except in cases of manifest abuse. The Court explained the office of the remedy:

A writ or preliminary injunction, as an ancillary or preventive remedy may only be resorted to by litigant for the preservation or protection of his rights or interests, and for no other purpose, during the pendency of the principal action.

The writ here was issued to protect and preserve Boie-Takeda's right or license to market Danzen, which it had done since 1970. Its object was to preserve the status quo, which the Court described as the last actual peaceable uncontested status that preceded the pending controversy, namely, the status before the withdrawal order was issued. The Court also stressed that the writ was granted only after a hearing where both parties presented their arguments, which negated any suggestion of grave abuse of discretion.

On the second issue, the Court held that the question of whether Boie-Takeda was denied due process in the proceedings before the Secretary of Health, the Bureau of Food and Drugs, the National Drug Committee, and the Technical Advisory Committee on Registration of Products was not for the Supreme Court to determine, because it was still pending adjudication in the principal case before the Court of Appeals.

Doctrine

A writ of preliminary injunction is an ancillary and preventive remedy available only to preserve or protect a right or interest during the pendency of the principal action, and for no other purpose. Its object is to preserve the status quo, meaning the last actual peaceable uncontested status that preceded the pending controversy. The grant of the writ rests on the sound discretion of the court, and on certiorari the Supreme Court will not interfere except upon a showing of manifest or grave abuse of discretion. The fact that the writ was issued after a hearing, where both parties were heard, negates grave abuse of discretion. Finally, the merits of the principal controversy, such as a claim of denial of due process in administrative proceedings, are left to the court hearing the principal action and are not resolved in the incidental review of the injunction.

Disposition

The petition for certiorari and prohibition was denied, and the writ of preliminary injunction issued by the Court of Appeals was sustained.

Remember This

Memorize the line that a preliminary injunction preserves the status quo, the last actual peaceable uncontested status that preceded the controversy, and that its issuance is discretionary and reviewable only for grave abuse. Examiners use this case to test the nature and purpose of the writ, and the rule that the Supreme Court will not decide the merits of the principal case in a petition directed only at the injunction.