In Re: Medtronic Inc v. ( 1999 )

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
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No. 98-3804
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In re: Medtronic, Inc., * On Application for a Writ
* of Mandamus.
Petitioner. *
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Submitted: November 16, 1998
Filed: July 26, 1999
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Before BEAM, LOKEN, and MORRIS S. ARNOLD, Circuit Judges.
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BEAM, Circuit Judge.
Petitioner seeks a writ of mandamus or, in the alternative, a writ of prohibition
soliciting relief from two discovery orders entered in a products liability case pending
in the federal District Court for the Eastern District of Arkansas. The underlying
action, Doris Adcox v. Medtronic, Inc., No. LR-C-96-333, invokes the diversity
jurisdiction of the court. We earlier stayed the disputed orders and now grant a writ
of mandamus.
I. BACKGROUND
Adcox, a recipient of a Medtronic heart pacemaker with an allegedly defective
"lead,"1 seeks discovery of the names of patients, physicians and facilities involved
with other allegedly defective Medtronic pacemakers and, especially, the names of
physicians who reported to Medtronic incidents similar to those experienced by Adcox.
Medtronic apparently maintains a document repository that includes copies of
Medical Device Reports (MDRs) generated under regulations adopted by the federal
Food and Drug Administration (FDA). The Medical Device Amendments to the Food,
Drug, and Cosmetics Act (FDCA), in part, provide:
Every person who is a manufacturer or importer of a device intended for
human use shall establish and maintain such records, make such reports,
and provide such information, as the Secretary may by regulation
reasonably require to assure that such device is not adulterated or
misbranded and to otherwise assure its safety and effectiveness.
21 U.S.C. § 360i(a) (emphasis added).
The statute also states that, "The Secretary may by order require a manufacturer
to adopt a method of tracking a Class II or Class III device," if the device could fail
under circumstances similar to those experienced by Adcox. See id. at § 360i(e). A
pacemaker lead is , as we understand it, a Class III medical device. See Medtronic,
Inc. v. Lohr, 518 U.S. 470, 477 (1996). In addition to this specific rulemaking and
order authority, the FDCA also provides the FDA with general rulemaking power
pursuant to 21 U.S.C. § 371(a) (authority vested in secretary to promulgate regulations
for enforcement of the FDCA).
1
A lead is an electrical cable used to carry information between the heart and the
generator portion of the pacemaker.
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Based upon this statutory authority, and to further congressional policy adopted
by the Act, the FDA has established a voluntary system of medical device reporting by
healthcare professionals, and, in conjunction with this system, has promulgated 21
C.F.R. § 20.63(f) which provides:
(f) The names and any information that would identify the
voluntary reporter or any other person associated with an adverse event
involving a human drug, biologic, or medical device product shall not be
disclosed by the Food and Drug Administration or by a manufacturer in
possession of such reports in response to a request, demand, or order.
Information that would identify the voluntary reporter or persons
identified in the report includes, but is not limited to, the name, address,
institution, or any other information that would lead to the identities of the
reporter or persons identified in a report. This provision does not affect
disclosure of the identities of reporters required by a Federal statute or
regulation to make adverse event reports. Disclosure of the identities of
such reporters is governed by the applicable Federal statutes and
regulations.
(1) Exceptions. (i) Identities may be disclosed if both the voluntary
reporter and the person identified in an adverse event report or that
person's legal representative consent in writing to disclosure, but neither
FDA nor any manufacturer in possession of such reports shall be required
to seek consent for disclosure from the voluntary reporter or the person
identified in the adverse event report or that person's legal representative;
or
(ii) Identities of the voluntary reporter and the person who
experienced the reported adverse event may be disclosed pursuant to a
court order in the course of medical malpractice litigation involving both
parties; or (iii) The report, excluding the identities of any other
individuals, shall be disclosed to the person who is the subject of the
report upon request.
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(2) Preemption. No State or local governing entity shall establish
or continue in effect any law, rule, regulation, or other requirement that
permits or requires disclosure of the identities of the voluntary reporter or
other person identified in an adverse event report except as provided in
this section.
The validity of this regulation constitutes the fighting issue in this discovery
dispute. This is because the district court has ordered Medtronic "to contact the 4000
or so lead recipients for whom [Medtronic] apparently filed a Medical Device Report
(MDR) with the Food and Drug Administration." Adcox v. Medtronic, Inc., No. LR-C-
96-333 (E.D. Ark. Oct. 28, 1998) (order granting discovery). As noted by the district
court, the contact, in the form of a proposed letter prepared by Adcox's lawyers and
apparently approved by the court, gives the (4000 or so) lead recipients an opportunity
to waive their physician/patient privilege. Adcox contends that the purpose of this
letter is to gather evidence to help her prove the liability of Medtronic. Medtronic, on
the other hand, contends that the purpose of the letter is to allow Adcox's lawyers to
identify and solicit additional plaintiffs for the underlying lawsuit since the district court
has denied class action status. The record, including Medtronic's stipulations
concerning the lead's faulty condition, tends to support the idea that plaintiff
identification is a primary purpose, if not the primary purpose, of the letter.
Because the orders of the district court require Medtronic to violate the federal
regulation, 21 C.F.R. 20.63(f), we asked the government to file a response if it wished
to do so. It has now responded in support of Medtronic, urging this court to grant the
requested writ.
II. DISCUSSION
We almost never issue a writ of mandamus in a district court discovery dispute
because, as noted by respondent Adcox, such an order may issue only "in those
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exceptional circumstances amounting to a judicial usurpation of power." In re Ford
Motor Co., 751 F.2d 274, 275 (8th Cir. 1984). "The remedy of mandamus is a drastic
one, to be invoked only in extraordinary situations." Allied Chem. Corp. v. Daiflon,
Inc., 449 U.S. 33, 34 (1980). Petitioner Medtronic, respondent Adcox and the
government all concede that in this circuit we are controlled by the five guidelines
outlined in In re Bieter Co., 16 F.3d 929 (8th Cir. 1994).2 Here, we think the
requirements of Bieter have been met because all guidelines, except guideline four,
have been established.
Medtronic, Adcox and the government argue at length about the policies behind
the regulatory scheme, and the meaning, force and applicability of the various statutes
and FDA regulations. However, we need not discuss these matters in detail because
the district court held, and properly so, that "the clear language of [21 C.F.R. §
20.63(f) and] FDA's rationale for this rule, . . . demonstrate[] that FDA does seek to
prevent [the] court-ordered contact by the manufacturer with an adverse event reporter
or with the party identified in such report." Adcox, Order of October 28, 1998, at 2.
But, despite the "plain meaning and clear intent of this regulation," the district court
ordered that the contact be made. Id. at 3. This order was based upon a finding that
"the regulation conflicts with Federal Rule of Evidence 501, which takes precedence
over the regulation with respect to determining the limits of possible evidentiary
privileges." Id. Under the facts of this case, this conclusion is clearly erroneous as a
matter of law. See Bieter, 16 F.3d at 932.
2
The five guidelines are: (1) the party seeking the writ has no other adequate
means, such as direct appeal, to attain the relief desired; (2) the petitioner will be
damaged or prejudiced in a way not correctable on appeal; (3) the district court's order
is clearly erroneous as a matter of law; (4) the district court's order is an oft-repeated
error, or manifests a persistent disregard of the federal rules; and (5) the district court's
order raises new and important problems or issues of first impression. See In re Bieter,
16 F.3d 929, 932 (8th Cir. 1994).
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To begin with, Federal Rule of Evidence 501 (Rule 501) does not support the
weight placed upon it by the district court. Indeed, we think that Rule 501 is involved,
at most, only peripherally in this dispute. The district court order refers only to the first
sentence of the rule which states:
Except as otherwise required by the Constitution of the United States or
provided by Act of Congress or in rules prescribed by the Supreme Court
pursuant to statutory authority, the privilege of a witness, person,
government, State, or political subdivision thereof shall be governed by
the principles of the common law as they may be interpreted by the courts
of the United States in the light of reason and experience.
Based upon this language, the district court concluded that "only Congress or the
United States Supreme Court [and not federal executive agencies] can enact laws or
rules limiting common law privileges." Adcox, Order of October 28, 1998, at 3.
Actually, however, this being a diversity case, the second sentence is the
operative portion of Rule 501. It says
However, in civil actions and proceedings, with respect to an element of
a claim or defense as to which State law supplies the rule of decision, the
privilege of a witness, person, government, State, or political subdivision
thereof shall be determined in accordance with State law.
Thus, in this case, Arkansas law dictates the scope of the physician-patient privilege
that may apply. See Ark. R. of Evid. 503. Neither the district court nor any of the
parties point to any authority for the proposition that federal executive rulemaking is
subordinated to evidentiary rules established by state lawmakers, and we have found
no precedent for such an interesting theory.
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Beyond this, we do not see how the physician-patient privilege is adversely
impacted at all in this situation. Arkansas Rule of Evidence 503 protects medical
records and confidential communications made for the purpose of diagnosis or
treatment of a patient's physical condition by a physician. The patient, here the
pacemaker recipient, controls the disclosure of this information. So, if a physician files
an MDR with the permission of the patient, the privilege is waived. If, on the other
hand, the voluntary report is filed without the patient's knowledge, section 20.63(f)
works to protect the patient's privilege while still advancing the substantial healthcare
purposes carefully and accurately outlined by the government in its amicus brief to the
court. This well-crafted approach does not in any way, as we see it, purport to create
a new physician-patient privilege that modifies or overrules Arkansas Rule 503 or, for
that matter, Federal Rule 501. In other words, Adcox's claim, as set forth in her
opening brief to the court, that the FDA, through section 20.63(f) has created "a new
federal FDA/Manufacturer/Physician/Patient privilege which would conflict with
Federal Rule of Evidence 501 and Congress' stated intent to defer the rules of privilege
to the States" is, at best, hyperbole and, at worst, misguided analysis.
Any conflicting state evidentiary rules are nullified to the extent that they directly
conflict with federal statute. See Hillsborough County v. Automated Med. Labs., Inc.,
471 U.S. 707, 713 (1985). Federal regulations have no less preemptive effect than
federal statutes where Congress has authorized an administrator to exercise his or her
discretion. See Capitol Cities Cable, Inc. v. Crisp, 467 U.S. 691, 699 (1984). And,
we believe that the FDA rulemaking has, in this instance, functioned well within
congressional authorization. Thus, any conflict between Arkansas Rule 503, as made
applicable by the second sentence of Federal Rule of Evidence 501, and section
20.63(f), must be resolved in favor of the FDA rule. However, as earlier explained, we
see no substantial conflict in the application of both rules in this litigation.
Finally, 21 U.S.C. § 360i(b)(3), brought to our attention by the government,
specifically provides that certain device user facility reports, as defined in the statute
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"shall [not] be admissible into evidence or otherwise used in any civil action involving
private parties unless the facility, individual, or physician who made the report had
knowledge of the falsity of the information contained in the report." 21 U.S.C. §
360i(b)(3). Since there is no evidence of false information, the government contends
that this statute directly precludes the discovery and use of the information in these
facility reports, some of which, according to the government, will almost certainly be
contained within the Medtronic document repository referred to above. We agree with
the government's analysis of this legislation, and to the extent that compliance with any
discovery order by the district court requires divulgence of the contents of reports
within the scope of 21 U.S.C. § 360i(b)(3), the orders are invalid.
III. CONCLUSION
For the reasons stated above, we grant the petition for writ of mandamus. We
direct the district court to vacate its discovery orders dated September 29, 1998, and
October 28, 1998, and all oral modifications thereof, if any, insofar as such orders
require divulgence of any information contained in or gleaned from voluntarily
submitted MDRs as such documents are defined in applicable statutes and regulations.
We also direct that discovery be disallowed to the extent that such discovery requires
reliance upon information contained in or gleaned from device user reports within the
scope of 21 U.S.C. § 360i(b)(3).
A true copy.
Attest:
CLERK, U.S. COURT OF APPEALS, EIGHTH CIRCUIT.
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