Opinion
CIVIL ACTION NO. 2:12-cv-05201
04-03-2014
JO HUSKEY, et al., Plaintiffs, v. ETHICON, INC., et al., Defendants.
MEMORANDUM OPINION AND ORDER
Before the court is the plaintiffs' Motion for Clarification of the Application of the Court's Prior Orders Excluding FDA 510(k) Evidence to Plaintiffs' Trial, and to Strike FDA Regulatory Opinions of Dr. Schultz and Mr. Ulatowski [Docket 114]. For the reasons stated below, the motion is DENIED and expert discovery related to the FDA's 510(k) process is STAYED.
Under Local Rule of Civil Procedure 7.1, motions for clarification must be accompanied by a separately filed supporting memorandum. The plaintiffs are reminded to follow this rule in the future.
I. Motion for Clarification
The plaintiffs seek several forms of relief. First, the plaintiffs seek to exclude "any evidence or testimony relating to the FDA's 510(k) clearance of the TVT-O product, or the lack of FDA enforcement action relative to the TVT-O product." (Pls.' Mot. [Docket 114], at 2). In support, the plaintiffs point to my past rulings where I determined that the 510(k) process does not relate to the safety and efficacy of products. See In re C. R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL 2187, 2013 WL 3282926, at *2 (S.D. W. Va. June 27, 2013) and Lewis v. Johnson & Johnson, — F. Supp. 2d —, 2:12-cv-04301, 2014 WL 152374, at *4-6 (S.D. W. Va. Jan. 15, 2014). The plaintiffs ask for "clarification" that the court's orders in In re C. R. Bard, Inc. and Lewis will apply in this case, thus precluding Ethicon from making any reference at trial to the FDA's 510(k) process. (Pls.' Mot. [Docket 114], at 3). The plaintiffs want to avoid "having to take expert discovery on these FDA regulatory issues—and prevent unnecessary Daubert briefing from being submitted to the court." (Id.).
The plaintiffs essentially seek a protective order limiting the scope of discovery. The court may, for good cause, enter an order "forbidding inquiry into certain matters, or limiting the scope of disclosure or discovery to certain matters." Fed. R. Civ. P. 26(c)(1)(D). Here, the plaintiffs argue that it would be unnecessary to engage in discovery on the 510(k) process because they believe that this issue will ultimately be excluded from trial.
I have repeatedly and thoroughly considered the admissibility of the FDA's 510(k) process, and I have consistently found that the 510(k) process does not relate to safety or efficacy. Nonetheless, I have not reviewed the admissibility of the 510(k) process in relation to Illinois law, and it has not been fully briefed here. It is conceivable—although difficult to imagine—that my ruling on this issue could differ in this case. Therefore, the parties are invited to move in limine for a determination of the admissibility of the 510(k) process as soon as possible. The court will rule on such motions expeditiously. Accordingly, the plaintiffs' motion for clarification is DENIED.
Regarding expert discovery related to the 510(k) process, such discovery is STAYED until the court has an opportunity to rule on the admissibility of the 510(k) process.
II. Motion to Strike
Second, the plaintiffs move to strike the expert reports of Daniel Schultz, M.D. and Timothy A. Ulatowski, M.S. Federal Rule of Civil Procedure 12(f) gives courts the power to strike items from the record. The rule provides that the "court may strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter." Fed. R. Civ. P. 12(f). As the rule clearly states, the court's power is limited to striking pleadings. Pleadings are complaints; third-party complaints; answers to complaints, third-party complaints, crossclaims, and counterclaims; and replies to answers. See Fed. R. Civ. P. 7(a). Expert reports are not pleadings and therefore are not subject to motions to strike. See Rindfleisch v. Gentiva Health Servs., 962 F. Supp. 2d 1310, 1316 (N.D. Ga. 2013) (refusing to strike expert report because it was not a pleading and therefore not "subject to a motion to strike"); MJ Harbor Hotel, LLC v. McCormick & Schmick Rest., 599 F. Supp. 2d 612, 623 (D. Md. 2009) ("Because [the expert's] report and testimony are not pleadings, they are not subject to [Rule 12(f)]."); cf. Hrivnak v. NCO Portfolio Mgmt., Inc., 723 F. Supp. 2d 1020, 1029 (N.D. Ohio 2010) (refusing to strike an "offer of judgment" because it was not a pleading), aff'd, 719 F.3d 564 (6th Cir. 2013). Therefore, the plaintiffs' motion to strike is DENIED.
III. Motion for a Jury Instruction
Finally, the plaintiffs request an "instruction at the outset of trial that the manufacturer is responsible for safety and efficacy." (Pls.' Mot. [Docket 114], at 3). I will not entertain requests for jury instructions this far in advance of trial. The plaintiffs should submit their proposed jury instructions on all relevant issues on June 6, 2014, as directed by Pretrial Order #109 [Docket 88]. Accordingly, the plaintiffs' motion for a jury instruction is DENIED.
IV. Conclusion
For the reasons stated above, the plaintiffs' motion [Docket 114] is DENIED and expert discovery related to the 510(k) process is STAYED. The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any unrepresented party.
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JOSEPH R. GOODWIN
UNITED STATES DISTRICT JUDGE