United States District Court, D. Nebraska
MEMORANDUM AND ORDER
R. ZWART UNITED STATES MAGISTRATE JUDGE
motion to compel, (Filing No. 69), is pending and fully
submitted. For the reasons discussed below, the motion will
be granted in part, and denied in part.
Stephanie Ideus (“Plaintiff”) filed a lawsuit
against Defendants Teva Pharmaceuticals USA, Inc. and Teva
Women's Health, Inc. (“Defendants”), alleging
she experienced complications during and after removal of
ParaGard T-380 (“ ParaGuard”), an intrauterine
copper contraceptive device manufactured by Defendants. As
Plaintiff's physician removed the device in 2014, a piece
broke off and became embedded in the myometrium of her
uterine wall, necessitating a surgical extraction procedure.
At present, Plaintiff's sole remaining claim alleges
Defendants failed to warn of the possible breakage and
embedment risks associated with the removal of Paragard.
have raised a federal preemption defense to Plaintiff's
failure to warn claim. Defendants argue-and this the court
previously agreed-that federal regulations restrict a drug
manufacturer's ability to change the drug labelling
approved by the Food and Drug Administration
(“FDA”). (Filing No. 56) (granting
Defendants' motion for judgment on the pleadings on the
basis of federal preemption but allowing Plaintiff a chance
to amend her complaint). Thus, Defendants claim any state law
warning and labelling requirements-as here proffered by
Plaintiff-are preempted by federal law. (Filing No. 61).
in turn, argues that the FDA's “changes being
effected” regulation allows for labelling changes when
a drug manufacturer comes into possession of “newly
acquired information” subsequent to a label's FDA
approval. (Filing Nos. 64 and 69). And when evaluating
Defendants' renewed motion for judgment on the pleadings,
this court agreed, (Filing No. 66), finding Plaintiff had
pleaded the existence of newly acquired information so as to
overcome Defendants' preemption defense at the
pleading stage) (emphasis added).
as this litigation enters the discovery phase, a central
dispute is the existence, sufficiency and character of
“newly acquired information” that Defendants may
possess. Plaintiff's motion to compel requests an order
compelling a response to Request No. 36, which seeks
“all documents that concern any Complaint Investigation
Process regarding Paragard T-380 A Copper
IUD.” (Filing No. 69 at CM/ECF p. 1). Despite
the broad wording, Plaintiff concedes that Request No. 36
seeks only documents concerning “breakage and
embedment” of ParaGard. (Id. at CM/ECF p. 2).
date, in response to Request No. 36, Defendants have produced
only documents specifically related to the manufacturing
“lot” in which Plaintiff's ParaGard device
was produced. (Id). Plaintiff contends Defendants
should be required to produce breakage and embedment
information for all manufacturing lots of ParaGard
spanning November 9, 2005 to present-not just for the lot
specific to Plaintiff's device. (Id.).
following reasons, Plaintiff's motion to compel will be
granted in part, and denied in part.
speaking, the Federal Rules of Civil Procedure allow for
discovery of “any nonprivileged matter that is relevant
to any party's claim or defense and proportional to the
needs of the case.” Fed.R.Civ.P. 26(b)(1). Thus, the
proper scope of discovery embraces information that is not
only relevant but also proportionate to the litigants'
Relevancy, for the purposes of
discovery, includes “any matter that bears on, or that
reasonably could lead to other matters that could bear on,
any issue that is or may be in the case.”
Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351
(1978). The proportionality analysis then requires the court
to weigh “the importance of the issues at stake in the
action, the amount in controversy, the parties' relative
access to relevant information, the parties' resources,
the importance of the discovery in resolving the issues, and
whether the burden or expense of the proposed discovery
outweighs its likely benefit.” Fed.R.Civ.P. 26(b)(1).
argue against production, claiming the requested documents
are not “newly acquired information” and are
thereby irrelevant, unduly ...