We were recently asked if we had anything on the blog about taking depositions of active FDA personnel – active as opposed to former (many of whom are available to be hired as litigation “experts”). It turns out we hadn’t, so we thought we’d take a shot.
We know this is pretty hard to do because the FDA doesn’t want its resources dissipated and its personnel distracted by being forced to testify in private product liability litigation. Generally, government employees are immune from discovery in private litigation under rules first set out in United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1952). In Touhy, a convict tried to subpoena an FBI agent in the course of his habeas corpuspetition. The agent refused to comply, and was held in contempt.
The Supreme Court reversed, holding that a subordinate of a government employee may refuse to comply with a subpoena relating to his work “on the ground that the subordinate is prohibited from making such submission by his superior.” Id. at 467. A governmental agency can validly issue regulations restricting the availability of its personnel to participate (voluntarily or involuntarily) in private litigation. Id. at 468. Such discovery, the Court held, could easily become unduly burdensome to government operations. The “variety of information” that government employees possess” and “the possibilities of harm from unrestricted disclosure in court,” warrant “centralizing determination” concerning compliance with civil process. Id.
We’ll dispose of a secondary (to what we are discussing here, anyway) issue quickly. As for documents (which is what Touhywas primarily about), the FDA’s longstanding practice is to require private litigants to use the Freedom of Information Act (FOIA), which was enacted long after Touhy was decided. See 21 C.F.R. §20.2. We’re not getting into that, as FOIA requests are a cottage industry in their own right.
That’s the basic framework. In the case of the FDA, the Commissioner has authority to promulgate Touhy regulations. 21 U.S.C. §371(a); FDA Staff Manual Guides §1410.10(1)(A)(1) (2005). The FDA’s regulation is one which ordinarily tells private litigants, in effect, to pound sand:
(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health and Human Services, except as authorized by the Commissioner of Food and Drugs pursuant to this section or in the discharge of his official duties under the laws administered by the Food and Drug Administration, shall give any testimony before any tribunal pertaining to any function of the Food and Drug Administration or with respect to any information acquired in the discharge of his official duties.
(b) Whenever a subpoena, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the giving of any testimony, such officer or employee shall, unless otherwise authorized by the Commissioner, appear in response thereto and respectfully decline to testify on the grounds that it is prohibited by this section.
21 C.F.R. §20.1(a-b) (emphasis added). A private litigant can ask the FDA in writing for an exception, but has to state the reasons “under oath.” Id. at §20.1(c). If, from the FDA’s perspective, the testimony being sought is in the “public interest and will promote the objectives of the act and the agency” then the FDA can allow it. Id.
The scope of review of FDA decisions under §20.1 is open to some question. Most decisions specifically in the FDA context have applied the extremely deferential “arbitrary and capricious” standard. E.g., Frank v. FDA, ___ F. Supp.2d ___, 2014 WL 718476, at *7 (E.D. Mich. Feb. 26, 2014); Moran v. Pfizer, Inc., 2000 WL 1099884, at *2 & n.1 (S.D.N.Y. Aug. 4, 2000),reconsideration denied, 160 F. Supp.2d 508 (S.D.N.Y. 2001);Cleary, Gottlieb, Steen & Hamilton v. Dep’t of HHS, 844 F. Supp. 770, 786 (D.D.C. 1993); In re Vioxx Products Liability Litigation, 235 F.R.D. 334, 344 (E.D. La. 2006). However, as discussed inVioxx, there is a split of authority in non-FDA cases between application of this administrative standard and of the civil litigation standard under Fed. R. Civ. P. 45.
As one might expect, particularly since the Agency has been criticized as lacking sufficient resources to do its job, e.g., Wyeth v. Levine, 555 U.S. 555, 578 n.11 (2009) (FDA “has limited resources,” which “are inadequate to permit the discharge of its existing responsibilities”), the FDA is not known to be free with exceptions to its Touhy regulation. Ironically, although plaintiffs are quick to harp on the Agency’s limitations, they seem to be more likely than defendants (although both sides do it) to try to exacerbate those limitations by demanding depositions that would distract the FDA’s employees from their regular jobs.
The leading FDA case is Giza v. Sec’y of HEW, 628 F.2d 748 (1st Cir. 1980), in which a private product liability litigation plaintiff sought documents and the depositions of three current employees of FDA (then part of the Department of Health, Education & Welfare). Id. at 750. The FDA refused, the trial court sided with the FDA, the document request was resolved, and the First Circuit affirmed as to the refusal of FDA employees to testify. The district court was “plainly correct.” Id. at 751. First, the FOIA request had nothing to do with testimony. Id. (“a district court simply has no authority under the FOIA to compel an agency to generate explanatory material”). Second, there was no ground for a mandamus action against the FDA. FDA employees “owed [plaintiffs] no duty to submit to a deposition.” Id. at 752. Third, the Agency could not be compelled to make its employees available for deposition on grounds of “comity”:
[A]lthough comity is an important aspect of the relationship between federal and state courts, the Gizas could muster no authority for a district court's enforcement of a state court subpoena as a matter of comity.
Id. Fourth, and finally, there was no constitutional right to take a deposition of a relevant federal agency under the constitution’s Full Faith & Credit Clause, and a federal statute, 28 U.S.C. §1738, enforcing it. Neither had ever been construed “interpreting this statute so as to place an affirmative obligation on, and vest jurisdiction in, a federal court to enforce a state court subpoena.” Giza, 628 F.3d at 752.
To see what else was out there we mainly shepardized the FDA’s regulation. The most recent interesting case was earlier this year,Frank, 2014 WL 718476, in which another plaintiff sought an FDA deposition, and return of the product, after sending the product to the FDA for inspection and “not get[iting] the answer they wanted.” Id. at *6. Section 20.1 was held to be a proper exercise of the FDA’s general “housekeeping” authority. Touhyregulations do not improperly withhold information from the public.
[I]t is well-established that valid agency regulations promulgated pursuant to Touhy prevent a federal employee from being compelled to obey a subpoena contrary to his federal employer’s instructions. [Plaintiffs] mistakenly identify such regulations as non-binding. However, Touhy regulations promulgated by various agencies with similar wording to the one at bar have been upheld as binding.
Id. at *5 (citations omitted). It was also “disingenuous” to suggest that the FDA had involved itself in litigation, when the plaintiff initiated the request for an examination. Id. at *6. Further, a state-law plaintiff has no power to make the FDA do anything:
The doctrine of sovereign immunity precludes the state court to compel FDA employees contrary to FDA instructions and to allow otherwise would be a violation of the Supremacy Clause.
Id. Finally, if a litigant submits a product to the FDA for an investigation, hoping for a favorable answer, and does not get it – the litigant isn’t entitled (at that late date) to ask for the product back:
[T]he FDA’s decision to retain the [product] was not arbitrary or capricious. [Plaintiffs] admit that they gave [it] to the FDA and the receipt they were given indicates that [the product] was “provided at no charge” rather than “borrowed (to be returned).” Nothing in the record shows that [plaintiffs] were entitled to have the [product] returned to them.
Id. at *7.
Several courts have held that product liability plaintiffs are not entitled to depose an FDA witness in a state-law action to cast doubt on the agency’s administrative decisions:
Assuming that the FDA Witnesses would, if called, express doubts concerning the safety or effectiveness of [the product], those reservations would be the personal opinions of the FDA Witnesses. By attempting to call the FDA Witnesses to express these opinions, plaintiff is apparently attempting to cloak the personal opinion of an individual physician with the aura of authority that results from the physician’s employment with the FDA. This is misleading because it tends to create the misimpression that the individual physician's opinion somehow has greater weight by virtue of his employment with the FDA.
Moran, 2000 WL 1099884, at *2 (footnote omitted); see id. at *3 (parties cannot use FDA witnesses as “a free source of expert testimony”); accord Miller v. Boston Scientific Corp., 380 F. Supp. 2d 443, 453 n.1 (D.N.J. 2005) (plaintiff not permitted to call FDA employees in support of claim “that Defendant fraudulently obtained [FDA] approval”); O’Neill v. Novartis Consumer Health, Inc., 55 Cal. Rptr. 3d 551, 561 (Cal. App 2007) (plaintiffs “precluded from obtaining the testimony of any officer or employee of the FDA”). Under the standard set by §20.1(c), a deposition sought to undercut the FDA's regulatory decisions are unlikely to be viewed by the Agency as “promot[ing] the objectives of the act and the agency.”
In Cleary, Gottleib, defendants in an MDL demanded that FDA employees be deposed after they had testified before Congress that medical causation was problematic, and that the substance in question was “generally recognized as safe.” 844 F. Supp. at 785-86. There was no “compelling reason” for the testimony because defendants could hire their own causation experts. Id. at 786. Congressional testimony was not the same as – and much more limited than − testifying in private litigation:
This policy had been established to protect the public health by ensuring that FDA employees spend their time pursuing their official duties and not serving as witnesses in private lawsuits. [The FDA’s] policy is also intended to avoid creating the impression that FDA or one of its employees is taking a partisan position in litigation to which the Agency is not a party.
Id. The FDA was allowed to determine “that public health would be furthered more by allowing his researchers to do their work than by disrupting their research so they could allow a private litigant” to prepare for private litigation. Id. at 787. Nor did the FDA have to accept a party's assurances that “repetitive” discovery would not occur, particularly when the number of plaintiffs was large and the requestor had no ability to control the other side's counsel. Id.
Another interesting case is Vioxx, which demonstrates that it is possible for private litigants – particularly in MDLs – successfully to compel the testimony of an FDA employee over the Agency’s objections. The court in Vioxx held that the FDA acted arbitrarily and capriciously in refusing the deposition because it had already allowed the same individual to take the time to make numerous other public statements of relevance to the litigation:
[The FDA employee] has already testified before Congress, appeared on television shows, been interviewed by numerous magazines and newspapers, and has spoken at professional meetings about the FDA’s interplay with [the product]. How can it be that the FDA and [its employee] had enough resources and time for him to appear in all these varied venues yet neither can afford to have him appear for a federal court subpoenaed deposition at the time and place of their choosing? The FDA has not offered any reasons. The Court suspects that there are none, except for arbitrariness and caprice.
Vioxx, 235 F.R.D. at 345. Also of interest in Vioxx is the court’s discussion of other instances where the FDA “voluntarily” provided employees to be deposed in MDLs:
]T]he FDA has voluntarily produced medical officers in connection with other pharmaceutical MDLs. . . . [T]he FDA’s refusal letter does not address the specifics surrounding [plaintiffs’] particular request for [the employee’s] deposition. Instead, despite the fact that the PSC specifically pointed out that the FDA has voluntarily produced medical officers in other MDLs, the FDA only offered a two page standardized refusal letter.
Id.; see also In re Orthopedic Bone Screw Products Liability Litigation, 1995 WL 925670, at *1 (E.D. Pa. Aug. 10, 1995) (ordering FDA depositions in MDL). At least where an FDA employee has already been active outside the scope of his employment, there is precedent for getting that FDA employee’s deposition notwithstanding an Agency objection in those unusual factual circumstances. Further, as indicated in the Vioxx opinion, to get the deposition, the MDL plaintiffs essentially gave up all control over the timing of the event. Vioxx, 235 F.R.D. at 345 (plaintiffs “willing to depose [the employee] at any place and any time, such as in the evening or on the weekends, convenient with his schedule”). Further, if other FDA employees, not so actively involved in outside activities, were subpoenaed, the court could address legitimate Agency “concerns” “on a case-by-case basis.” Id.
Finally, parties in actions arising under federal law have had more success than state-court plaintiffs in demanding that current FDA employees testify. “In examining the issue of whether a litigant may compel discovery from a non-party federal government agency, courts have distinguished between cases in which the underlying action arises in federal court and cases in which the underlying action arises in state court.” Connaught Laboratories, Inc. v. SmithKline Beecham P.L.C., 7 F. Supp.2d 477, 479 (D. Del. 1998), appeal quashed, 165 F.3d 1368 (Fed. Cir. 1999). This dichotomy is particularly pronounced where the FDA has cooperated with the prosecutors in a particular investigation. SeeSEC v. Selden, 484 F. Supp. 2d 105, 108-09 (D.D.C. 2007) (FDA could not block depositions of current employees sought by defendant in federal criminal action); In re U.S. Bioscience Securities Litigation, 150 F.R.D. 80, 82 (E.D. Pa. 1993); Metrex Research Corp. v. United States, 151 F.R.D. 122, 124 (D. Colo. 1993) (“§20.1 is a regulation promulgated by FDA for its own benefit. It does not supersede the Federal Rules of Civil Procedure”); United States v. Kitmanyen, 2011 WL 5557420, at *10 (Army Crim. App. Oct. 31, 2011) (While FDA legitimately precluded FDA employee from being subpoenaed to travel to Germany to testify at trial; prior discovery deposition was proper);but see SEC v. Biopure Corp., 2006 WL 2789002, at *4 (D.D.C. Jan. 20, 2006) (subpoena to FDA quashed where party had not gone through proper administrative channels); Kaplan v. Rose, 1992 WL 57936, at *1 (D.D.C. Mar. 2, 1992) (following Touhy in securities case).
There. We have not tried to structure this as an argument that FDA employees, as a rule, should or should not be subject to deposition by private litigants. It's not categorical. Rather, we see this as a case-specific issue, properly subject to at least some Agency discretion.