Christison v. Biogen Idec et al
Filing
146
MEMORANDUM DECISION denying 136 Motion to Exclude Expert Report of Eugene Major and to Disqualify Eugene as Expert Witness. Signed by Magistrate Judge Dustin B. Pead on 3/30/15 (alt)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF UTAH, CENTRAL DIVISION
KENNETH CHRISTISON, individually and as
surviving spouse of Annalee Christison,
deceased, and as personal representative of the
estate of Annalee Christison, deceased,
Plaintiff,
MEMORANDUM DECISION
Case No. 2:11-cv-01140-DN-DBP
District Judge David Nuffer
v.
BIOGEN IDEC,
Magistrate Judge Dustin B. Pead
ELAN PHARMACEUTICALS, LLC,
Defendants.
I.
INTRODUCTION
This matter was referred to the Court under 28 U.S.C. § 636(b)(1)(A). (Docket No. 117.)
On February 23, 2015, Defendants filed a joint motion to exclude Dr. Eugene Major’s expert
report and to disqualify Dr. Major as an expert on the basis of federal regulations. (Dkt. No.
136.) For the reasons set forth below, the Court DENIES Defendants’ motion.
II.
BACKGROUND
Plaintiff alleges that Defendants negligently developed and marketed Tysabri, a multiple
sclerosis medication. (See Dkt. No. 96 at 14–24.) Plaintiff further alleges that Defendants failed
to test Tysabri sufficiently and failed to warn patients who took Tysabri that the medication
increased their risk for developing a brain disease called Progressive Multifocal
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Leukoencephalopathy (“PML”). (Id.) Due to Defendants’ alleged negligence, Plaintiff’s wife,
who took Tysabri for multiple sclerosis, developed and died from PML. (Id.)
III.
DEFENDANTS’ MOTION TO STRIKE DR. MAJOR’S REPORT AND
EXCLUDE TESTIMONY.
Defendants argue that Dr. Major should not be allowed to testify because he formerly worked
for the National Institute of Health (“NIH”) and, in that capacity, received confidential and
sensitive information regarding Defendants. (Dkt. 136.) Defendants cite United States
Department of Health and Human Services (“DHHS”) regulations to support their position:
No employee or former employee of the DHHS may provide testimony or
produce documents . . . concerning information acquired in the course of
performing official duties . . . unless authorized by the Agency head . . . .
Id. (quoting 45 C.F.R. § 2.3).
Plaintiff argues that 45 C.F.R. § 2.3 is merely a statement of policy rather than a substantive
provision of law and that it does not establish blanket governmental privilege that would bar Dr.
Major’s testimony. (Dkt. 139.) Plaintiff further argues that DHHS is the proper entity to enforce
the regulations invoked and that, even if DHHS was inclined in intervene, it likely could not
strike Dr. Major’s report or completely prohibit him from testifying.
a. Defendants do not cite any authority that requires the Court to strike Dr.
Major’s report or preclude him from testifying.
The regulation cited is not a rule of evidence, nor does it augment the Federal Rules of Civil
Procedure. The Touhy case, which is often cited as upholding regulations such as 45 C.F.R. §
2.3, 1 is substantially narrower than Defendants suggest. Touhy dealt only with a discrete issue:
whether the head of an executive agency can prohibit an employee from divulging internal
agency records even when those documents are the subject of a valid subpoena. U.S. ex rel.
1
Such regulations are commonly referred to as Touhy regulations.
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Touhy v. Ragen, 340 U.S. 462, 468 (1951). The Supreme Court held that the agency could
prohibit such disclosure as a matter of internal policy because “the usefulness, indeed the
necessity, of centralizing determination as to whether subpoenas duces tecum will be willingly
obeyed or challenged is obvious.” Id. The Touhy case involved a current–not former–employee
and it did not consider exclusion of a witness based on the regulation. Further, the Supreme
Court expressly declined to rule on the propriety of the agency withholding the information.
Rather than creating a rule of exclusion, Touhy merely upheld a regulatory scheme that allows
the head of an agency to determine the timing and scope of agency disclosures.
Also, the cited regulation is promulgated pursuant to 5 U.S.C. § 301, which provides:
The head of an Executive department . . . may prescribe regulations for the
government of his department, the conduct of its employees, the distribution and
performance of its business, and the custody, use, and preservation of its records,
papers, and property. This section does not authorize withholding information
from the public or limiting the availability of records to the public.
5 U.S.C. § 301. The Supreme Court has interpreted this statute as merely a “housekeeping
statute,” without substantive effect. Chrysler Corp. v. Brown, 441 U.S. 281, 310 (1979)
(“Nothing in the legislative history of [§ 301] shows that Congress intended this statute to be a
grant of authority to the heads of the executive departments to withhold information from the
public or to limit the availability of records to the public.”). Thus, Section 2.3 merely creates an
internal system for DHHS to control the flow of information out of its offices. The regulation
does not create an evidentiary privilege or augment the Federal Rules of Civil Procedure.
b. The Court declines to strike the report or exclude Dr. Major’s testimony
under Rule 26.
Although the regulations do not themselves mandate exclusion, the Court has discretion to
enter appropriate discovery orders. See Fed. R. Civ. P. 26(b)(2). Defendants cite several cases in
favor of exclusion, but none of them convince the Court that exclusion is warranted here.
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Defendants cite Boca Raton Community Hospital, Inc. v. Tenet Healthcare Corp. to
demonstrate that former employees can be prohibited from testifying. See 2006 U.S. Dist. LEXIS
38560. That case is readily distinguishable. In Boca Raton, the United States appeared as amicus
and moved for a protective order to exclude a former DHHS employee’s declaration and prohibit
his deposition. See id. at *2–3. Further, the proposed relief was limited. The United States sought
only to prohibit the deposition until such time as the former employing agency made its decision
about whether the employee could testify about certain matters. Id. at 5.
Here, the United States has not made any attempt to appear in this case. Likewise, the Court
has not been made aware an attempt by the United States or NIH to prevent Dr. Major’s
testimony. While Plaintiff may be taking a risk by utilizing Dr. Major’s testimony without
authorization (Defendants suggest such authorization is both necessary and lacking), Defendants
have not convinced the Court that Plaintiff should be prohibited from taking that risk.
Likewise, Defendants cite U.S. ex rel. Pogue v. Diabetes Treatment Centers of America, but
it was the United States that sought to prohibit testimony in Pogue, not a private litigant. 474 F.
Supp. 2d 75, 79 (D.D.C. 2007). Further as the Pogue court recognized, “there is no authority
indicating that HHS can block all testimony by a former employee as to that individual's
personal opinions and observations, absent the assertion of a specific privilege.” Id. at 80.
Defendants do not cite to discrete pieces of information that Dr. Major received and should not
discuss. Instead, they attempt to exclude his testimony altogether by arguing that Dr. Major is
indelibly tainted by his past work. Even under the authority on which they rely, Defendants’
proposed relief is extreme.
Finally, the policy rationale underlying the regulations is best served through enforcement by
the United States, rather than private litigants. The United States can best determine whether
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proposed testimony falls within the scope of 45 C.F.R. § 2.3 and when enforcement is necessary
to preserve the institutional candor of regulated entities. Private litigants, though well intended,
may take these regulations too far, attempting to exclude information to gain a litigation
advantage, rather than to serve the public interest. Accordingly, the Court declines to strike the
report or prohibit Dr. Major from testifying.
IV.
ORDER
For the reasons analyzed above, the Court DENIES Defendants’ joint motion to disqualify
and to strike. (Dkt. 136.)
Dated this 30th day of March, 2015.
By the Court:
Dustin B. Pead
United States Magistrate Judge
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