Carr v. C.R. Bard, Inc.

297 F.R.D. 328, 2014 WL 463447, 2014 U.S. Dist. LEXIS 15873
CourtDistrict Court, N.D. Ohio
DecidedFebruary 5, 2014
DocketNo. 3:13 CV 824
StatusPublished
Cited by2 cases

This text of 297 F.R.D. 328 (Carr v. C.R. Bard, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Carr v. C.R. Bard, Inc., 297 F.R.D. 328, 2014 WL 463447, 2014 U.S. Dist. LEXIS 15873 (N.D. Ohio 2014).

Opinion

MEMORANDUM OPINION AND ORDER

JACK ZOUHARY, District Judge.

Introduction

Pending before this Court is Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s (collectively “Bard”) Motion for Protective Order (Doc. 33), which Plaintiff Cathy Carr (“Carr”) opposed (Doc. 34). On February 3, 2014, this Court heard oral argument on the Motion.

This dispute centers on a report, prepared by Dr. John Lehmann, in December 2004 (“the Lehmann Report”). Bard asks this Court to enter a protective order “requiring Plaintiff to destroy the [Lehmann Report] and precluding Plaintiff from using the content of the [Lehmann] Report in the prosecution of her case” (Doc. 33 at 1). Bard asserts the Lehmann Report is work product, and not subject to disclosure in this case.

[330]*330Two other courts — a California state court (“the Giordano Court”) and a Nevada federal court (“the Phillips Court”) — have addressed substantially similar issues as are presented in the pending Motion; each court reached a different conclusion.

Background

Carr filed this action in April 2013, alleging that a Bard medical device — the G2 Filter— which was implanted as a “prophylactic” measure following a car accident, had fractured and became partially “lodged in the space between [her] inferior vena cava and [her] aorta” (Doc. 1 at 1). The G2 Filter is a successor device to the Recovery Filter. And both devices, as agreed at oral argument, differ from an earlier Bard product, the Simon-Nitinol Filter, in that the Recovery and G2 Filters are removable, not permanent (Doc. 35-4 at 9) (explaining, in deposition testimony of a Bard medical director, that the Recovery Filter “could [be] place[d] into a person for short-term needs” as opposed to a “permanent filter” which is “put in for a lifetime of a patient”); (Doc. 21 at 7) (admitting, in Bard’s Answer, that the Food & Drug Administration (“FDA”) approved the G2 Filter “for optional use as a retrievable inferior vena cava filter”).

Bard obtained FDA clearance for the G2 Filter under the “premarket notification process” (Doe. 21 at 7) (admitting, in Bard’s Answer, that the G2 Filter obtained premarket clearance), which required a demonstration that the G2 Filter was “substantially equivalent” to some FDA-approved predicate device. See 21 U.S.C. § 360c(i) (defining “substantial equivalence” for premarket approval purposes). To win FDA approval of the G2 Filter, Bard identified the Recovery Filter as its predicate device (Doc. 34 at 4; see also Hearing Transcript).

Under FDA regulations, Bard must maintain “good manufacturing practice requirements” (“GMPR”), which include a requirement that “medical device manufacturer[ ] establish and maintain procedures for investigating causes of device failure and methods for correcting those problems” (id.). See also 21 C.F.R. § 820.100(a) (describing a manufacturer’s obligation to “establish and maintain procedures for implementing corrective and preventive action”). Bard established procedures for monitoring device failures, including the preparation of a “Remedial Action Plan” (“RAP”), which, in general terms, analyzes the problems posed by a particular Bard device (Doc. 34 at 4.); (see also Doc. 35-2) (describing Bard’s RAP framework). Each RAP includes, in turn, a Health Hazard Evaluation (“HHE”), or a “risk/benefit analysis to determine whether ... Bard should withdraw [a] product [as to which failures may have occurred] from the market” (Doc. 34 at 5); (see also Doc. 35-2 at 4) (noting “the assigned Medical Directoras]” responsibility for “providing medical consultation” in developing the plan and “documenting a health hazard evaluation to be included in the Division’s proposed action plan”).

Bard received its first claim related to alleged Recovery Filter failures in February 2004 (Doc. 33 at 10). See also Phillips v. C.R. Bard, Inc., 290 F.R.D. 615, 671 (D.Nev. 2013). In early November 2004, Bard hired a former Bard Medical Director, Dr. Lehmann (Doc. 34 at 5), to produce a report analyzing Recovery Filter failures, and comparing Recovery Filter failures to competitor devices (Doc. 33-1 at 2-3).

In an affidavit attached to Defendants’ Motion, Donna Passero, Assistant General Counsel for Bard, states Dr. Lehmann’s engagement was “for the purpose of conducting an independent investigation and [to] draft[ ] a report concerning Bard’s Recovery[] Filter, which I — in conjunction with Bard’s Law Department — requested for the purpose of providing Bard with legal advice” concerning that Filter “and to prepare for and assist with anticipated and ongoing litigation” (id. at 2-3). Passero reminded Dr. Lehmann about the litigation-related nature of his report during the engagement (id. at 3). The Lehmann Report itself is branded as “Attorney work product” (see Doc. 33-2 at 4-5).

There is some dispute as to who received copies of the Lehmann Report, or of reports that discussed or cited to the Lehmann Report, after Dr. Lehmann’s December 2004 submission to the Law Department. Eventually though, the Lehmann Report was in-[331]*331eluded in a January 2005 RAP “distributed to certain employees at the Bard subdivision” where the Recovery Filter was manufactured, all of whom, Defendants assert, “were senior or high-ranking” Bard employees (Doc. 33 at 3-4); (see also Doc. 35-1 at 4-5) (reflecting, on the January 2005 RAP’s initial pages, the signatures of a Bard president and four vice presidents, who reviewed the RAP).

In addition, Bard’s then-Medical Director, Dr. Ciavarella, testified that he was allowed to use the Lehmann Report at his “discretion” in preparing the January 2005 RAP’s HHE (Doc. 34 at 7-8). He testified no Bard employee told him he had to keep the Lehmann Report “secret” because it was prepared in anticipation of litigation (Doc. 35-6 at 6). But later in the same deposition, Dr. Ciavarella partially contradicts that statement-he acknowledged that he knew the Lehmann Report was “confidential” when he received it, and that the Bard Law Department was responsible for retaining Dr. Lehmann for purposes of generating the Lehmann Report (Doe. 33-2 at 3-5). He also testified that he “did [not] know that Dr. Lehmann’s Report was going to be utilized in conjunction with the preparation of an HHE on the Recovery [F]ilter” (Doe. 33-2 at 4). Moreover, Dr. Lehmann’s legal-consulting engagement continued throughout Spring 2005, when he handled “follow-up items related to and which arose out of the report he submitted” (Doc. 33-1 at 4).

In December 2012, Bard “inadvertently” produced the Lehmann Report in Giordano (Doc. 33-3 at 1-5). Bard raised a “clawback request” with respect to the Lehmann Report (id.), which counsel in Giordano — the same counsel who represent Carr — opposed via motion with the California court. Around the same time, Bard sought, and obtained, a ruling in the Phillips Court that the Lehmann Report was work product. See Phillips v. C.R. Bard, Inc., 290 F.R.D. 615, 670-71 (D.Nev.2013). Five days later, the Giordano Court rejected Bard’s clawback request in a decision that reads, in relevant part and without further explanation: “After consideration of all arguments and evidence, the Court rules that Defendant’s clawback request is denied” (Doc. 34-2 at 2).

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297 F.R.D. 328, 2014 WL 463447, 2014 U.S. Dist. LEXIS 15873, Counsel Stack Legal Research, https://law.counselstack.com/opinion/carr-v-cr-bard-inc-ohnd-2014.