Court Opinion

ID: 9672468
Source: CourtListenerOpinion
Date Created: 2023-08-24 03:55:35.854925+00
Date Added: 2024-06-11T18:16:16.450657
License: Public Domain

*161DOGGETT, Justice,
dissenting.
Once again the majority has intervened in an ongoing trial court proceeding to rewrite Texas law. This time the special treatment accorded in creating a previously unknown discovery privilege threatens the public health and safety by posing formidable obstacles to the search for truth in pharmaceutical and medical device litigation. I dissent.
I.
The events leading to this particular case began with the suicide of Michael Hays Biffle, six days after beginning his prescription of Prozac, an anti-depressant manufactured by Eli Lilly. Alleging that the drug was responsible for the death, his family sought production of premarketing documents, including all reports Lilly forwarded to the FDA containing descriptions by health care providers of their patients’ adverse reactions to Prozac.
Lilly objected to discovery of this “confidential information,” which included alleged trade secrets and the identities of patients who had experienced adverse reactions, as well as their reporting physicians. Alternatively, the company sought a protective order preventing any disclosure of this information to other litigants or the public. On October 17, 1991, Judge John McClellan Marshall held a hearing on both the Biffles’ request for production and Lilly’s motion for a protective order; arguments centered on trade secrets and the need to prohibit discovery of the identities of reporters of adverse reactions. On October 23 Marshall granted the plaintiffs’ request in part and issued a limited protective order entitling Lilly to withhold from discovery technical materials concerning the manufacture of Prozac and to redact from adverse reaction reports the names of patients, but not reporters. This order did not limit public disclosure of the documents.
On December 2, 1991, Lilly sought mandamus relief to prevent public disclosure, and the majority immediately granted an emergency stay. See Eli Lilly & Co. v. Marshall, 829 S.W.2d 156 (Tex.1991) (Doggett, J., dissenting to order granting leave to file petition for writ of mandamus). This court later ordered that Lilly’s trade secret claim be considered in a hearing on sealing under Tex.R.Civ.P. 76a. See Eli Lilly & Co. v. Marshall, 829 S.W.2d 157, 158 (Tex.1992, orig. proceeding).
Although expressing concern in this court only with the question of public disclosure, Lilly continued its efforts in the trial court to prohibit any discovery of adverse reaction reporters’ identities. Under the October 23 order, Lilly had represented that all documents ordered produced would be made available at its headquarters in Indianapolis. When the Biffles’ counsel arrived at the scheduled time, however, Lilly refused to provide many of the documents and redacted reporters’ names from those which were produced. Following a hearing, the trial court in January 1992“re-quired Lilly to pay the Biffles’ future costs in obtaining those materials as sanctions for defiance of the prior order.
On January 22, Lilly returned to Austin, this time complaining of the trial court’s abuse of discretion in ordering the discovery of reporters’ identities. This second mandamus request came despite Lilly’s earlier representation to this court that its only complaint as to the October 23 order was “on the dissemination question.” Motion for Temporary Relief, Petition for Writ of Mandamus, and Brief in Support at 9. The following day John Luke Hill, the former Chief Justice of this court and now counsel for Eli Lilly & Co., filed here a letter of concern he had just personally received from an employee of the Food and Drug Administration (FDA). Within a few hours, the majority granted emergency relief. When after another hearing in which the FDA participated, the trial court for the third time rejected the reporter confidentiality arguments, the majority granted leave to file this second petition for writ of mandamus, described by Lilly’s counsel at oral argument as a “pure [federal] preemption ease.”
Lilly’s claim that FDA rules prevent a state court from authorizing access to reporter identities conflicts with the explicit *162language of an applicable regulation never cited by Lilly in any of its briefing:
Records of the Food and Drug Administration which the Commissioner has determined are not available for public disclosure ... shall nevertheless be made available for public disclosure in compliance with a final court order requiring such disclosure.
21 C.F.R. § 20.83(a) (1991). The FDA clearly anticipated production of adverse reaction reports pursuant to ah order like that issued by Judge Marshall.1 Understandably, no published appellate court opinion anywhere has ever agreed with the type of preemption argument advanced by Lilly.
Reluctantly accepting the reality that preemption does not apply here, the majority nonetheless pontificates about this subject0 at length without noting that
[consideration of [preemption] ... starts with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress.
Cipollone v. Liggett Group, Inc., 505 U.S. -, -, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407, 422 (1992) (citations omitted). This presumption against preemption is even more difficult to overcome in the specific context of administrative regulations:
[B]ecause agencies normally address problems in a detailed manner and can speak through a variety of means, including regulations, preambles, interpretive statements, and responses to comments, we can expect that they will make their intentions clear if they intend for their regulations to be exclusive.
Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 718, 105 S.Ct. 2371, 2377, 85 L.Ed.2d 714 (1985); see also California Coastal Comm’n v. Granite Rock Co., 480 U.S. 572, 583, 107 S.Ct. 1419, 1426, 94 L.Ed.2d 577 (1987) (“it is appropriate to expect an administrative regulation to declare any intention to preempt state law with some specificity”). Hence, given the FDA’s express disavowal in 21 C.F.R. § 20.83 of the preemptive effect for confidentiality regulations in court proceedings, the majority was left with the task of finding some other basis for its preconceived result.2
II.
To meet that challenge, the majority simply creates a new exception to discoverability nowhere previously recognized in our state rules or statutes. Were there a true public need for such absolute reporter confidentiality, the FDA could initiate rule-making to address it or certainly the drug manufacturers could voice their concerns to Congress or the Legislature. Rushing to legislate its own new basis for secrecy, the majority, however, pursues a course long ago abandoned by most courts by creating an entirely new common law privilege from discovery. As one eminent scholar has noted, “[t]he development of judge-made privileges halted a century ago.” Charles McCormick, The Scope of Privilege in the Law of Evidence 16 Tex. L.Rev. 447, 469 (1938). Unlike the majority, which appears determined to reverse this longstanding trend, most jurisdictions exercise judicial restraint by interpreting statutes rather than enacting new privileges.3
*163Nor does this record show a sufficiently compelling basis to justify special treatment for Lilly. The sole evidence cited in support of this new privilege is the conclu-sory statement of a single individual, not even subject to cross-examination, that if reporters’ identities were made public, “health care professionals and others would be much more reluctant to report adverse events for fear of involving themselves ... in litigation.” Majority opinion at 158 n. 7 (citing affidavit of Joyce Johnson at 4.) This statement in turn relies on a single study, which, in fact, concluded that only 11 percent of reporters of adverse reactions expressed concerns regarding the legal implications of their reports. See id. at 5; Julie Milstein, Gerald Faich, et al., Factors Affecting Physician Reporting of Adverse Drug Reactions, 20 Drug. Info. J. 157, 162 (1986).
Subsequent studies by one of the same authors, moreover, found that only 10 percent of all adverse reaction reports are sent directly to the FDA rather than to the drug manufacturer. Gerald Faich, et ah, National Adverse Drug Reaction Surveillance, 257 J.Am.Med.Ass’n 2068 (1987). Since the FDA’s confidentiality regulations do not prevent the drug maker from revealing the identity of reporters, the fact that 90 percent of the reports are sent to manufacturers indicates that health care providers are not particularly concerned that their identities be kept confidential. Additionally, almost half of the physicians surveyed were not even aware that the FDA has a system for reporting such reactions. Audrey Rogers, Gerald Faich, et ah, Physician Knowledge, Attitudes, and Behavior Related to Reporting Adverse Drug Events, 148 Arch.Internal Med. 1596, 1599 (1988). Allowing discovery cannot deter reports from doctors unaware of the existence of the reporting system. Many health care providers are, however, keenly aware of the need to protect their patients’ health — perhaps the real fear here is that some physicians will follow their ethical obligation to “make relevant information available to patients, colleagues, and the public_” American Medical Association, Principles of Medical Ethics, reprinted in Law and Ethics in the Medical Office 126 (Marcia Lewis, ed., 1983).
As the majority acknowledges in rejecting the preemption argument, the FDA regulations do not themselves provide any “compelling public interest” justification, 850 S.W.2d at 160, for this newly established common law privilege. The FDA has never considered reporter confidentiality absolute. As the FDA Commissioner summarized public comment from health care providers, drug manufacturers, and others when the confidentiality rules were first proposed:
Comments pointed out that the Food and Drug Administration cannot guarantee confidentiality for any record, since a court may conclude that the information is subject to public disclosure.
39 Fed.Reg. 44,619 (1974). In adopting what is now 21 C.F.R. § 20.83, the FDA reflected a public policy determination that any need for reporter confidentiality can be superseded by the public interest in seeking truth during the litigation process.
III.
This court’s once strong commitment to open discovery4 is quickly being replaced with a new double standard of justice that promotes secrecy. In the past, this court had emphasized that discovery represents
*164the linchpin of the search for truth, as it makes a trial less of a game of blind man’s bluff and more a fair contest with the issues and facts disclosed to the fullest practicable extent. In recent years, we have sought to secure this objective through both revision of the Texas Rules of Civil Procedure and our opinions discouraging gamesmanship and secrecy.
State v. Lowry, 802 S.W.2d 669, 671 (Tex.1991, orig. proceeding) (citations omitted). The unwarranted invention of a new discovery privilege here serves only to loosen the linchpin, and cast greater doubt into the search for truth.
In the past, the party with something to hide bore the burden of justifying a restriction on discovery. See Barnes v. Whittington, 751 S.W.2d 493, 494 (Tex.1988, orig. proceeding) (“a privilege must be established to justify an exception to the general rule favoring discovery”); Peeples v. Honorable Fourth Supreme Judicial Dist., 701 S.W.2d 635, 637 (Tex.1985, orig. proceeding) (party seeking to exclude matters from discovery must affirmatively plead and prove a particular privilege); Tex.R.Civ.P. 166b(3)(e) (exempting from discovery matters protected by existing privileges). But here, the majority cites no applicable statutory provision, or evidentia-ry or procedural rule that entitles Lilly to resist production of the identities of reporters of adverse drug reactions. In the past, the party seeking a protective order was required to show a “particular, articulated and demonstrable injury,” see Masinga v. Whittington, 792 S.W.2d 940, 940-41 (Tex.1990, orig. proceeding); Garcia v. Peeples, 734 S.W.2d 343, 345 (Tex.1987, orig. proceeding). But for at least one drug maker, the majority alters all of that well-established law. Despite our prior refusal to shield discovery based on “conclusory allegations” of harm, see Masinga, 792 S.W.2d at 941; Garcia, 734 S.W.2d at 345, this manufacturer’s unsubstantiated global claims are accepted without question. The burden of proof is then reversed by requiring the Biffles to show “particularized relevance and need” for the reporters’ identities. 850 S.W.2d at 160.
While reciting the requirement that mandamus will issue “only to correct a clear abuse of discretion,” 850 S.W.2d at 157, in the course of staying four trial court orders and twice issuing the “extraordinary” remedy of mandamus in a single lawsuit, the majority has effectively eliminated any exercise of discretion regarding the proper scope of discovery. Despite having conducted three separate hearings addressing the majority’s concerns, Judge Marshall has been accorded no reasonable latitude to assess the validity of Lilly’s claims.
The public interest in health and safety— the purported basis for the majority’s action — has in fact been jeopardized by its writing. Manufacturers of drugs and medical devices are now presumptively free to conceal the identities of those who complain of the potential life-threatening qualities of their products.
GAMMAGE, J., joins in this opinion.

. Despite its unambiguous language, counsel for Lilly responded at oral argument that this regulation "has nothing to do with the issues before this court.”

. Despite my vigorous disagreement with this creation of a new privilege, I certainly do join in the majority’s strong reaffirmation of "the doctrine of shared discovery" as recognized in Garcia v. Peeples, 734 S.W.2d 343, 347 (Tex.1987) and the right of the Biffles "to share [any] discovery with their expert witnesses and litigants in other cases.” 850 S.W.2d at 160.

.See State ex. rel. Chandra v. Sprinkle, 678 S.W.2d 804, 807 (Mo.1984) (in bank); Sherman v. District Court, 637 P.2d 378, 384 (Colo.1981) (en banc); Davison v. St. Paul Fire & Marine Ins. Co., 75 Wis.2d 190, 248 N.W.2d 433, 441 (1977); Valley Bank of Nev. v. Superior Court of San Joaquin City, 15 Cal.3d 652, 125 Cal.Rptr. 553, 554-55, 542 P.2d 977, 978-79 (1975) (in bank); Nazareth Literary & Benevolent Inst. v. Stephenson, 503 S.W.2d 177, 178-79 (Ky.1973); Southern Bell Tel. & Tel. Co. v. Beard, 597 So.2d 873, 876 n. 4 (Fla.Ct.App.1992); Matter of Parkway Manor Healthcare Center, 448 N.W.2d 116, 120-*16321 (Minn.Ct.App.1989); Scroggins v. Uniden Corp. of America, 506 N.E.2d 83, 85 (Ind.Ct.App.1987).

. See Axelson v. McIlhany, 798 S.W.2d 550, 553 (Tex.1990, orig. proceeding) (abuse of discretion to deny discovery of potentially relevant documents without reviewing them in camera); Garcia v. Peeples, 734 S.W.2d 343, 347-48 (Tex.1987, orig. proceeding) (abuse of discretion to grant a blanket protective order against sharing discovery with other litigants); Peeples v. Hon. Fourth Supreme Judicial Dist., 701 S.W.2d 635, 637 (Tex.1985, orig. proceeding) (burden is on party asserting a privilege from discovery to produce evidence concerning its applicability); Jampole v. Touchy, 673 S.W.2d 569, 573 (Tex.1984, orig. proceeding) (abuse of discretion to deny discovery of alternative designs of product). But see National Tank Co. v. Brotherton, 851 S.W.2d 193 (Tex.1993, orig. proceeding) (restricting access to post-accident investigations).