CHERYL R. ZWART, Magistrate Judge.
Plaintiff's motion to compel, (
Plaintiff 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.
Defendants 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"). (
Plaintiff, 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. (
Therefore, 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."
To 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. (
For the following reasons, Plaintiff's motion to compel will be granted in part, and denied in part.
Generally 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' needs.
Relevancy
Defendants argue against production, claiming the requested documents are not "newly acquired information" and are thereby irrelevant, unduly burdensome, and disproportionate to the needs of the case.
Whether Defendants possessed "newly acquired information," as defined by federal regulation, is an integral substantive issue in this case. The parties have conflicting views as to whether "documents that concern any Complaint Investigation Process," as targeted by Request No. 36, meet that regulatory definition. However, the court need not here resolve this substantive dispute to determine this information's relevancy.
"Information within [the] scope of discovery need not be admissible in evidence to be discoverable." Fed. R. Civ. P. 26(b)(1). Discovery is sufficiently relevant if it "appears reasonably calculated to lead to the discovery of admissible evidence."
The correct inquiry is not whether the information sought is
Defendants indicate that the files sought by Request No. 36 are "created in the process of investigating product complaints" and "[t]here may be circumstances where information found in complaint investigation files might support a change in the manufacturing process." (
Labelling provides information which Plaintiff may review when deciding whether to use ParaGuard as a contraceptive, with Defendants required to maintain and update that labeling with new safety information as it becomes available. (
Based on the foregoing, the court determines that for the period of November 9, 2005 through January 11, 2010, as to all lot numbers, Request No. 36 meets the relevancy threshold required by the federal rules.
The party resisting discovery may defeat a motion to compel information— even information that is demonstrably relevant—if that party establishes that production would constitute an undue burden or an unreasonable hardship, and are thus disproportionate to the needs of the case. The parties' obligations are not satisfied by overly generalized or conclusory arguments. Instead, the parties must state—with some particularity—the bases for their assertions.
"The parties and the court have a collective responsibility to consider the proportionality of all discovery and consider it in resolving discovery disputes."
The court is sympathetic to the time and expense production of these documents may require. But "[t]he fact that production of documents would be burdensome and expensive and would hamper a party's business operation is not a reason for refusing to order production of relevant documents."
In terms of access to the information, and the importance to the case, Plaintiff's arguments are availing. Defendants have exclusive access to these documents. Moreover, these documents are reasonably calculated to lead to information that could preclude Defendants' federal preemption defense, an issue of paramount importance to the substance of this dispute. In carefully weighing the information regarding Defendants' anticipated burden and expense, and the other factors of proportionality, the court finds the hardships are not undue or unreasonable and the requested information is not disproportionate to the needs of the case.
As a result, the undersigned will allow discovery of responsive documents for a four-year period preceding Plaintiff's procedure to insert her ParaGard device. Thus, Defendants will be compelled to produce documents responsive to Request No. 36,
Accordingly,
IT IS ORDERED that Defendant's Motion to Compel, (