On appeal from Superior Court of New Jersey, Law Division, Hudson County.
Petrella, Baime and Villanueva. The opinion of the court was delivered by Villanueva, J.A.D.
Intervenor Public Citizen, Inc. appeals from a trial court order which granted intervenor access to certain materials, but held that most documents identified by defendant drug company would remain under seal and subject to a prior protective order entered in the underlying action which had been concluded. We remand for further findings of fact regarding the basis for keeping the various documents under seal.
In the underlying action, plaintiffs*fn1 sought to recover damages for injuries resulting from Thelma Hammock's ingestion of Accutane. Defendant Hoffmann-LaRoche, Inc. ("Roche") manufactures and distributes Accutane for use, pursuant to the direction of a licensed physician only, for the treatment of severe recalcitrant
cystic acne. In May 1986, a Board-certified dermatologist, Dr. Jose Fishman, prescribed Accutane to Thelma Hammock. At that time, the package insert for the drug contained a "black box" warning regarding its potential teratogenicity.
As a result of Thelma Hammock's ingestion of Accutane during her pregnancy, her son Marvin was born severely deformed and brain damaged. Plaintiffs alleged that Roche had withheld information about the health risks of Accutane from the Food and Drug Administration (FDA) and prescribing physicians. Plaintiffs also alleged that Dr. Fishman was negligent in prescribing Accutane during Thelma Hammock's pregnancy, but they settled with Dr. Fishman after Roche was granted summary judgment and prior to our opinion on plaintiffs' appeal.
Pursuant to R. 4:10-3, Roche file a motion for a protective order covering the documents requested by plaintiffs in discovery. This motion was supported by detailed affidavits of Dr. George S. Vadnai and Donald Hollander. Roche contends that the documents, for which it sought and continues to seek protection, contain information essential to the filing of an Investigational New Drug ("IND") or New Drug Application ("NDA") for Accutane. IND's and NDA's are the vehicles by which a pharmaceutical company receives approval to market prescription drugs. FDA regulations provide that data contained in an IND or NDA file can be proprietary, trade secret materials not subject to public disclosure. See 21 C.F.R. § 20.111(d).
Roche claims a proprietary interest in keeping secret the material within the Accutane IND and NDA files. The affidavits of Dr. Vadnai and Mr. Hollander also explained that the IND and NDA files contain detailed information on the nature of the research efforts undertaken by Roche in connection with its development of Accutane. Roche argued that there was "good cause" for the entry of a protective order because it would be grossly unfair to make Roche's information and expertise about Accutane freely available to competing pharmaceutical companies. Such release, Roche explained, would permit those companies to investigate and
market dermatologic products without incurring the substantial expenses that Roche had incurred in developing Accutane.
On May 18, 1989, the Judge determined that Roche had demonstrated "good cause" for the entry of an order ("May 18 Order") governing the dissemination of Roche documents.*fn2 The Judge stated that good cause existed because "such documents may*fn3 contain trade secrets, confidential and proprietary information and material protected by the physician-patient privilege of persons who are not parties to this action." The May 18 Order provides in part: (i) all documents produced by Roche shall be used only in conjunction with this lawsuit; (ii) a party objecting to the designation of Roche documents as confidential, had to do so within sixty days of receipt of such documents; and (iii) Roche had the burden of demonstrating that a challenged document contains trade secrets or other proprietary and confidential information.
On June 23, 1989, after another hearing, the Judge directed Roche to make available to plaintiffs certain transcripts from the other suits against Roche, but prohibited plaintiffs' counsel from conferring with other attorneys in other jurisdictions concerning Accutane litigation and disseminating any information obtained in the present litigation.
Throughout this case, Roche reminded plaintiffs that the documents it produced which were attached to or referenced in plaintiffs' briefs were subject to the terms of the May 18 Order and could not be disseminated. Plaintiffs never objected to Roche's
position regarding the applicability of the May 18 Order to the documents referenced and ...