Hammock Ex Rel. Hammock v. Hoffmann-LaRoche, Inc.

662 A.2d 546, 142 N.J. 356, 23 Media L. Rep. (BNA) 2345, 1995 N.J. LEXIS 535
CourtSupreme Court of New Jersey
DecidedAugust 2, 1995
StatusPublished
Cited by83 cases

This text of 662 A.2d 546 (Hammock Ex Rel. Hammock v. Hoffmann-LaRoche, Inc.) is published on Counsel Stack Legal Research, covering Supreme Court of New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hammock Ex Rel. Hammock v. Hoffmann-LaRoche, Inc., 662 A.2d 546, 142 N.J. 356, 23 Media L. Rep. (BNA) 2345, 1995 N.J. LEXIS 535 (N.J. 1995).

Opinion

The opinion of the Court was delivered by

COLEMAN, J.

This case requires us to decide whether the public has a right of access to judicial records and materials filed with the court in civil *361 litigation. Public Citizen Group, Inc. (Public Citizen), a non-profit organization that advocates safe, affordable and effective drugs, sought access to documents filed with the trial court under a protective order in a pharmaceutical manufacturer products-liability case. After the products-liability case was dismissed on summary judgment, the trial court denied Public Citizen access to the documents and materials filed with the court with respect to predisposition-nondiseovery motions. The Appellate Division remanded the matter to the trial court for redetermination. 269 N.J.Super. 289, 635 A.2d 533 (1993). On remand, the trial court did not unseal the records and the Appellate Division affirmed in an unpublished opinion.

We granted certification, 139 N.J. 288, 654 A.2d 469 (1994), to establish a standard for deciding when the public should have access to judicial records in the form of documents, transcripts and legal memoranda with attachments filed with a trial court in support of, or in opposition to, motions in civil litigation. We reverse and remand for redetermination in accordance with the standard established today.

I.

A

This case has a protracted procedural history spanning seven years. It began when Thelma Hammock filed a medical malpractice claim against her attending physician, Dr. Jose Fishman, a dermatologist, and a products-liability claim against HoffmanLaRoche (Roche). Roche manufactured and distributed the drug Accutane after it received Food and Drug Administration (FDA) approval in May 1982. Plaintiffs attending physician prescribed Accutane in May 1986 for the treatment of her severe recalcitrant cystic acne. During her use of the drug, plaintiff became pregnant, and gave birth to a child with severe physical deformities and brain damage.

*362 Plaintiffs theory of products liability was alleged inadequacy of warning to prescribing physicians such as Dr. Fishman. The warning was allegedly inadequate because it did not advise prescribing physicians to obtain blood-pregnancy tests. The medical-malpractice claim against Dr. Fishman was based on negligence in prescribing Accutane during plaintiffs pregnancy.

Plaintiff sought discovery of more than 1,000 documents from Roche pursuant to Rule 4:10-1 and -2. Roche resisted, contending that many of the documents sought contained trade secrets and confidential and proprietary information, or were protected from disclosure by the physician-patient privilege.

Roche filed a motion for a protective order pursuant to Rule 4:10-3. It submitted affidavits of Doctor George S. Vadnai and Donald Hollander who explained that some of the information sought was essential to the filing with the FDA of an Investigational New Drug (IND) or New Drug Application (NDA) for Accutane. INDs and NDAs are the documents required by the FDA for a pharmaceutical company to obtain approval to market a prescription drug. FDA regulations provide that data contained in an IND or NDA file is not subject to public disclosure. See 21 C.F.R. § 20.111(d).

On May 18, 1989, the trial court concluded that “good cause” existed under Rule 4:10-3(g) justifying the entry of a protective order sealing the documents. The finding of good cause was based on the court’s conclusion that many of the documents “may 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 protective order controlled the dissemination of Roche documents by providing:

(2) Plaintiffs, their attorneys, or any experts or consultants retained by them, are prohibited from disseminating, in any fashion, manner or method, copies of the documents thereof, to any other person, firm or organization, not directly associated with plaintiffs or upon further written order of this court; * * * (5) All information in whatever form, discovered from examination of said documents shall be used only in connection with this action; * * * (11) If a party objects to the designation by Roche of any documents as containing trade secrets, proprietary or confidential information, the party shall (within 60 days of receipt of such docu *363 ments) identify each document it wishes to remove from the provisions of this Order ... Roche shall have the burden of proving that such documents contain trade secrets or other confidential and proprietary information.

Within a month after entry of the May 18 order, the trial court directed Roche to make available to plaintiffs counsel certain transcripts from other lawsuits filed against Roche. The protective order was amended to prohibit plaintiffs counsel from conferring with attorneys in other jurisdictions with respect to Accutane litigation and from disseminating any information obtained in the present litigation.

It is undisputed that counsel for plaintiff and Roche used many of the documents in connection with various motions and briefs filed with the trial court. It was always understood by counsel for the parties that documents attached to motions or references to them in the briefs were subject to the May 18, 1989, protective order as amended.

B

Roche filed two motions for summary judgment, and counsel for the parties utilized documents placed under seal in support of, and in opposition to, those motions. The trial court denied one motion on June 29,1990, and thereafter also denied a motion for reconsideration. On February 29, 1991, a different judge granted partial summary judgment to Roche.

After full discovery, Roche again moved for summary judgment seeking dismissal of the products-liability claim on October 25, 1991. By that time, a different trial judge was presiding over the matter. To support its renewed application, Roche relied on testimony of plaintiffs expert and Dr. Fishman, as well as the prescribing information available for Accutane in May 1986. In opposition to the motion, plaintiff submitted hundreds of pages of Roche's documents and deposition transcripts, some of which were referred to in the briefs. Those voluminous submissions included transcripts, confidential marketing information, proprietary business materials and privileged medical information about other *364 birth defect cases in which Accutane had been ingested during pregnancy.

The trial court conducted oral argument on May 14, 1992. Roche convinced the trial court that in May 1986 its warning informed Dr. Fishman, and other physicians prescribing Accutane, of the drug’s potential to cause birth defects through Roche’s “Black Box” warning specifically approved by the FDA. The trial court granted summary judgment dismissing the products-liability case based on the learned-intermediary rule codified by N.J.S.A. 2A:58C — 4. See Niemiera by Niemiera v. Schneider, 114

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662 A.2d 546, 142 N.J. 356, 23 Media L. Rep. (BNA) 2345, 1995 N.J. LEXIS 535, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hammock-ex-rel-hammock-v-hoffmann-laroche-inc-nj-1995.