Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-5_17-cv-06580/USCOURTS-cand-5_17-cv-06580-5/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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United States District Court

Northern District of California

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

SAN JOSE DIVISION

MARLESSA KNOLES,

Plaintiff,

v.

TEVA PHARMACEUTICALS USA, INC.

and TEVA BRANDED 

PHARMACEUTICALS PRODUCTS R&D, 

INC.,

Defendants.

Case No. 17-cv-06580-BLF 

ORDER VACATING HEARING ON 

PLAINTIFF’S MOTION TO 

SUBSTITUTE TRUE NAME FOR 

FICTITIOUSLY NAMED 

DEFENDANT; GRANTING MOTION; 

AND SETTING DEADLINE FOR 

PLAINTIFF TO FILE AMENDED 

COMPLAINT

[Re: ECF 66]

Plaintiff Marlessa Knoles filed the complaint in this action – erroneously titled as a “First 

Amended Complaint” – on November 14, 2017, asserting that Defendants Teva Pharmaceuticals 

USA, Inc. (“Teva USA”) and Teva Branded Pharmaceuticals Products R&D, Inc. (“Teva 

Branded”) are liable for injuries she suffered due to implantation and removal of a Paragard 

Intrauterine Device (“IUD”). Compl., ECF 2. Specifically, Plaintiff alleges that when her doctor 

attempted to remove the IUD, it broke into several pieces, some of which could not be retrieved. 

Compl. ¶¶ 17-18. Defendants answered and filed a motion for judgment on the pleadings (“JOP”), 

which was granted with leave to amend. Answers, ECF 24, 26; Order Granting Motion for JOP, 

ECF 62. Leave to amend was expressly limited to the claims asserted against Defendants Teva 

USA and Teva Branded, and Plaintiff was directed not to add new claims or parties without prior 

leave of the Court. Order Granting Motion for JOP, ECF 62. 

On February 22, 2019, the date upon which Plaintiff’s amended pleading was due, Plaintiff 

filed a Motion to Substitute True Name for Fictitiously Named Defendant, seeking to add a new 

defendant identified as “Paragard.” Motion to Substitute at 2, ECF 66. Plaintiff also filed an 

Application for Extension of the deadline to amend the complaint pending resolution of her 

Motion to Substitute. Application for Extension, ECF 65. Defendants Teva USA and Teva 

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United States District Court

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Branded filed a single opposition brief addressing both the Motion to Substitute and the 

Application for Extension. Opposition, ECF 67. The Court granted Plaintiff’s Application for 

Extension, finding that the Motion to Substitute should be resolved prior to any amendment. 

Order Granting Plaintiff’s Application for Extension, ECF 68. Having reviewed the briefing on 

the Motion to Substitute, the Court concludes that the motion is appropriate for disposition without 

oral argument and it therefore VACATES the hearing set for May 23, 2019.

Plaintiff incorrectly asserts that her Motion to Substitute is governed by the liberal 

standards set forth in Federal Rule of Civil Procedure 15(a), under which “[t]he court should freely 

give leave when justice so requires.” Fed. R. Civ. P. 15(a)(2). Plaintiff ignores the fact that she is 

seeking to add a new defendant after expiration of the deadline to add parties set forth in the Case 

Management Order issued July 19, 2018. Case Management Order, ECF 49. Once the Court has 

filed a pretrial scheduling order establishing a deadline for amending the pleadings, Federal Rule 

of Civil Procedure 16 controls. See Johnson v. Mammoth Recreations, Inc., 975 F.2d 604, 607-08 

(9th Cir. 1992). Under Rule 16, Plaintiff must show “good cause” for adding a new defendant

after expiration of the deadline to add parties. See Fed. R. Civ. P. 16(b)(4) (“A schedule may be 

modified only for good cause and with the judge’s consent.”). If Plaintiff is able to show good 

cause under Rule 16, she then must demonstrate that amendment also is appropriate under Rule 

15. See Rodarte v. Alameda Cty., No. 14-CV-00468, 2015 WL 5440788, at *2 (N.D. Cal. Sept. 

15, 2015) (“If, however, the moving party has shown good cause under Rule 16(b), it must then 

demonstrate that its motion is also proper under Rule 15.”).

“Rule 16(b)’s ‘good cause’ standard primarily considers the diligence of the party seeking 

the amendment.” Johnson, 975 F.2d at 609. Plaintiff’s counsel explains that Plaintiff’s chart 

indicated that her physician, Dr. Zeidberg, reported the broken IUD to “the ParaGard 

pharmaceutical company, Teva pharmaceuticals, reference #147055” in May 2015; and that the 

portion of the IUD retrieved from Plaintiff was sent to “Teva pharmaceuticals” for evaluation. 

Motion at 3 & Exh. 2, ECF 66. Plaintiff’s file contained two letters from Teva entities to Dr. 

Zeidberg, both dated May 29, 2015. One letter, indicating that it was from a “Quality Systems 

Coordinator” at “Teva Woman’s Health,” gave directions on how to mail the IUD fragments for 

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evaluation. Motion, Exh. 3, ECF 66. The other letter, indicating that it was from “Teva 

Pharmaceuticals,” stated that information regarding removal of an embedded IUD was enclosed 

and provided contact information in the event further assistance was required. Id. Plaintiff’s 

counsel explains that, based on those communications, counsel believed that the defendant Teva 

entities were the proper defendants. Motion at 3. Based on this explanation, as supported by the 

documentation from Dr. Zeidberg, the Court finds that Plaintiff has shown good cause as required 

under Rule 16.

Defendants Teva USA and Teva Branded argue that amendment should not be permitted 

because Plaintiff has not established that “Paragard” is a legal entity. Defendants correctly point 

out that Plaintiff has not used a designator such as “Inc.,” “Corp.,” or “LLC,” and that it is unclear 

from Plaintiff’s papers whether “Paragard” in fact is an entity capable of suit. Consistent with 

Federal Rule of Civil Procedure 11, it is Plaintiff’s responsibility to ensure that “Paragard” has 

legal capacity to be sued, and Plaintiff must effect service of process on “Paragard” within 90 days 

after filing an amended pleading, as required under Federal Rule of Civil Procedure 4(m). The 

Court expects and requires Plaintiff to comply with these obligations.

Defendants Teva USA and Teva Branded also argue that amendment should not be 

permitted because Plaintiff previously sued “Paragard/Ortho-McNeil/Teva” in the Monterey 

County Superior Court based on the circumstances surrounding her IUD removal. See Opp. Exh. 

A, ECF 67-1. The Court grants Defendants’ request for judicial notice of the state court complaint

and other documents filed in the Monterey case. See Reyn’s Pasta Bella, LLC v. Visa USA, Inc., 

442 F.3d 741, 746 n.6 (9th Cir. 2006) (“We may take judicial notice of court filings and other 

matters of public record.”). To the extent that Defendants are arguing that Plaintiff knew of 

Paragard’s existence prior to filing the present action, it appears that the state court complaint was 

filed by Plaintiff pro se, and that she obtained counsel only shortly before the state court dismissed 

the case for failure to appear at a Case Management Conference. See Opp. Exh. A, ECF 67-1. As 

discussed above, counsel has explained that counsel believed the Teva entities were the proper 

defendants and so filed the present action only against Teva USA and Teva Branded. The Court 

therefore is not persuaded that the prior lawsuit precludes a finding of good cause here.

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Having determined that amendment is permissible under Rule 16, the Court must 

determine whether amendment is warranted under Rule 15. The record does not suggest any bad 

faith or undue delay on the part of Plaintiff, Defendants have not established that any prejudice to 

them would result from amendment, it is not clear that amendment would be futile, and Plaintiff 

has not previously amended her pleading. See In re W. States Wholesale Nat. Gas Antitrust Litig., 

715 F.3d 716, 738 (9th Cir. 2013) (listing factors to be considered when deciding whether to grant 

leave to amend). Accordingly, Plaintiff’s Motion to Substitute is GRANTED.

The Court notes that while Plaintiff’s Motion to Substitute identifies the proposed new 

party as “Paragard,” the proposed Second Amended Complaint attached as an exhibit to her 

motion identifies the new party as “Paragard IUD.” Motion to Substitute at 2 & Exh. 4, ECF 66. 

The Court cautions Plaintiff to be more precise in future filings, and to ensure that the new 

defendant is correctly identified in the amended pleading.

ORDER

(1) Plaintiff’s Motion to Substitute to add a new defendant is GRANTED;

(2) Plaintiff shall file an amended complaint on or before May 17, 2019;

(3) The amended complaint shall add the appropriate Paragard entity as a defendant 

and shall cure the deficiencies identified in the Court’s prior Order Granting 

Motion for JOP; and

(4) Plaintiff may not add any other new parties or claims without express leave of the 

Court.

Dated: May 14, 2019 ______________________________________

BETH LABSON FREEMAN

United States District Judge

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