Dreger v. KLS Martin, LP

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF OHIO

EASTERN DIVISION

ALISSA DREGER,

Plaintiff,

Case No. 2:20-cv-3814

Judge Michael H. Watson

v. Magistrate Judge Elizabeth P. Deavers

KLS MARTIN, LP,

Defendant.

OPINION AND ORDER

This matter is before the Court to consider the Motion for a Protective Order filed by

Defendant KLS Martin, L.P., (ECF No. 58), and the corresponding Motion to Compel filed by

Plaintiff Alissa Dreger, (ECF No. 65). Plaintiff also has filed a motion for leave to amend her

motion to compel, citing a need to correct clerical errors. (ECF No. 71.) This latter motion

(ECF No.71) is unopposed and, therefore, is GRANTED. Accordingly, for purposes of this

Opinion and Order, the Court will consider ECF No. 65 as amended by ECF No. 71-1. Thus, the

competing discovery motions have been fully briefed. (See also ECF Nos. 70, 72.) For the

following reasons, the motions are GRANTED, in part, and DENIED, in part. Because the

Court is able to resolve these matters on the basis of the parties’ briefing, Defendant’s request for

oral argument is DENIED.

I.

Federal Rule of Civil Procedure 37 permits a party to file a motion for an order

compelling discovery if another party fails to respond to discovery requests, provided that the

motion to compel includes a certification that the movant has, in good faith, conferred or

attempted to confer with the party failing to respond to the requests. Fed. R. Civ. P. 37(a)(1).

Here, the Court is satisfied that this prerequisite has been satisfied.

Determining the scope of discovery is within the Court's discretion. Bush v. Dictaphone

Corp., 161 F.3d 363, 367 (6th Cir. 1998). Unless the court orders otherwise, the scope of

discovery is that “[p]arties may obtain discovery regarding 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). The Court can, and indeed must, limit the frequency or extent of discovery “if it

determines that: (i) the discovery sought is unreasonably cumulative or duplicative, or can be

obtained from some other source that is more convenient, less burdensome, or less expensive; (ii)

the party seeking discovery has had ample opportunity to obtain the information by discovery in

the action; or (iii) the proposed discovery is outside the scope permitted by Rule 26(b)(1).”

Planned Parenthood Sw. Ohio Region v. Hodges, No. 1:15-CV-00568, 2019 WL 13044827, at

*2 (S.D. Ohio Mar. 31, 2019) (citing Fed. R. Civ. P. 26(b)(2)(C)). The Court also has discretion

to limit the scope of discovery by issuing protective orders, for good cause shown, forbidding the

requested discovery “to protect a party or person from annoyance, embarrassment, oppression, or

undue burden or expense.” Fed. R. Civ. P. 26(c).

The Federal Rules of Civil Procedure grant parties the right to “obtain discovery

regarding any nonprivileged matter that is relevant to any party's claim or defense.” Fed. R. Civ.

P. 26(b)(1); see also Siriano v. Goodman Mfg. Co., L.P., No. 2:14-CV-1131, 2015 WL 8259548,

at *5 (S.D. Ohio Dec. 9, 2015). “Relevance is construed very broadly for discovery purposes.”

Doe v. Ohio State Univ., No. 2:16-CV-171, 2018 WL 1373868, at *2 (S.D. Ohio Mar. 19, 2018)

(emphasis in original) (citation omitted). Despite being construed broadly, the concept of

relevance is not unlimited. Averett v. Honda of Am. Mfg., Inc., No. 2:07-cv-1167, 2009 WL

799638, at *2 (S.D. Ohio March 24, 2009). Indeed, “[t]o satisfy the discoverability standard, the

information sought must have more than minimal relevance to the claims or defenses.” Doe,

2018 WL 1373868 at *2 (citations omitted). Furthermore, when information is “negligibly

relevant [or] minimally important in resolving the issues” this will not satisfy the standard. Id.

(citation omitted).

“[T]he Federal Rules of Civil Procedure instruct district courts to limit discovery where

its ‘burden or expense. . . outweighs its likely benefit, taking into account the needs of the case,

the amount in controversy, the parties’ resources, the importance of the issues at stake in the

litigation, and the importance of the proposed discovery in resolving the issues.’” Surles ex rel.

Johnson v. Greyhound Lines, Inc., 474 F.3d 288, 305 (6th Cir. 2007) (quoting former Fed. R.

Civ. P. 26(b)(2)(C)(iii)). This Court has previously held that “[t]hese factors are retained in

revised Fed. R. Civ. P. 26(b)(1), reflecting ‘their original place in defining the scope of

discovery’ ” because “ ‘restoring proportionality’ is the touchstone of revised Rule 26(b)(1)’s

scope of discovery provisions.” Siriano, 2015 WL 8259548, at *5 (citing Fed. R. Civ. P.

26(b)(1)). In analyzing the extent of the burden on the producing party, the Court of Appeals for

the Sixth Circuit “has held that limiting the scope of discovery is appropriate when compliance

‘would prove unduly burdensome,’ not merely expensive or time-consuming.” Id. (citing Surles,

575 F.3d at 305) (emphasis in original).

II.

This products liability action, filed on July 29, 2020, asserts claims for, inter alia,

manufacturing defect, design defect, failure to warn, and failure to conform to representation.

(Complaint, ECF No. 1.) These claims arise from two surgical procedures in which a rib plate

and associated screws sold by Defendant were implanted into and explanted from Plaintiff.

Despite Defendant’s characterization of this case as a “straightforward” and “simple” products

liability action, this is not the first combative discovery dispute the parties have called upon the

Court to resolve.

The current dispute centers largely on discovery related to other similar incidents. In the

context of this dispute, Defendant accuses Plaintiff of blowing the scope of discovery out of

proportion while Plaintiff counters that Defendant is withholding information considered

fundamental in products liability cases. The particular documents at issue here include Medical

Device Reports (“MDRs”) and documents other than MDRs, including complaint files, product

complaints, and documentation of CAPA-related activities as reflected in Requests for

Productions Nos. 1, 2 and 3 in Plaintiff’s Second Set of Requests for Production and

Interrogatory No. 1 in Plaintiff’s Second Set of Interrogatories. These requests appear to be

addressed to documents and information relating specifically to the “Rib Plate” (Model Number

24-015-22-71), i.e., the same model number implanted into and explanted from Plaintiff’s body,

and more broadly to what Plaintiff has deemed the “KLS Martin Thoracic Plating System,” i.e.,

similar thoracic plates (“Other Plate Models”). (For purposes of the current dispute, Plaintiff

confirms that she seeks documents or information relating only to other plates and not any

associated “rib screws” or instruments. See ECF No. 65 at 5 n. 4.) Also at issue are

Defendant’s obligation to produce a privilege log and to produce certain documents belonging to

KLM.

Defendant’s view, simply stated, is that Plaintiff is entitled only to a copy of MDRs

relating to the “Subject Rib Plate” (the specific device implanted into and later explanted from

Plaintiff’s body), a properly redacted copy of which it already has provided to Plaintiff. (ECF

No. 58 at 6 n. 4.) Consistent with its view that Plaintiff is not entitled to any information related

to similar incidents, Defendant has objected to the discovery requests on numerous grounds. In

large part, Defendant asserts that certain statutes and regulations governing the adverse event

reporting program administered by the United States Food and Drug Administration (“FDA”)

control here and prohibit the requested discovery. Beyond this, Defendant argues that the

requests incorporate overly broad definitions; cover a seventeen-year time period; are not limited

to documents in its possession; seek privileged information or information subject to work

product protection; seek irrelevant documents; are not proportional to the needs of the case; and

generally are overbroad and unduly burdensome. Defendant seeks a protective order addressed

not only to these specific requests but also to “any substantially similar discovery requests”

Plaintiff may issue in the future.

Defendant, however, explains that the FDA maintains a free Manufacturer & User

Facility Device Experience (“MAUDE”) Database that provides publicly-available and

appropriately disclosable versions of MDRs it has received and suggests that Plaintiff’s referral

to this Database is a reasonable resolution here. (ECF No. 58 at 13.) Thus, in sum, Defendant

objects to any discovery directed to both the “Rib Plate” (Model Number 24-015-22-71), i.e., the

same model implanted into and explanted from Plaintiff’s body, and to what Plaintiff has

described as “similar thoracic plates that comprise the KLS Martin Thoracic Plating System”

(“Other Plate Models”).1 Defendant also has declined to provide a privilege log, arguing that

one is not required because any withheld documents are not “otherwise discoverable” as

contemplated by Fed.R.Civ.P. 26(b)(5). Finally, Defendant contends that it has no obligation or

1 Plaintiff confirms that, with respect to this “System,” she is not seeking documents for “rib

screws” or instruments, only plates. (ECF No. 65 at 5.)

ability to produce documents belonging to KLM because it does not possess or control such

documents.

For her part, Plaintiff argues that she is entitled to discover evidence of similar incidents,

including MDRs and other documents, because such evidence is relevant to causation,

Defendant’s knowledge of any alleged defect and potential harm, and Defendant’s failure to

warn. With respect to the MDRs, Plaintiff confirms that she already has accessed the MAUDE

Database and obtained any publicly-available MDRs. (ECF No. 65 at 12.). Thus, she is seeking

only MDRs that are not available in that Database. (Id.) Further, she confirms that she has

agreed to redactions as appropriate to protect the identities of the patients, reporters, etc.

associated with other incidents. (ECF No. 65 at 5.) As for discovery related to Other Plate

Models more specifically, Plaintiff argues that the information she seeks is relevant because

these “other models are made of the same material, are used for the same purpose, function in the

same manner, and feature the same design (particularly those that are rib plates).” (ECF No. 65

at 14.) Plaintiff also contends that Defendant and KLM are under common ownership and

because Defendant is KLM’s agent for purposes of medical device reporting in the United States,

Defendant must be considered to have control over documents in KLM’s possession.

Additionally, Plaintiff asserts that Defendant cannot claim privilege and then fail to provide a

privilege log to enable Plaintiff ‘s evaluation of those privilege claims. Finally, Plaintiff argues

that Defendant is required to maintain a CAPA system – designed to provide notice of dangers –

and that Defendant must disclose documents relating to this system. (ECF No. 65 at 6.) Based

on all of the above, Plaintiff has for an award of sanctions against Defendant under Fed.R.Civ.P.

37.

III.

Plaintiff’s Complaint alleges, in part, that the KLS rib plate was defective and that

Defendant had actual prior knowledge of a risk its rib plates would break during the chest

expansion and contraction of ordinary breathing and failed to provide a warning, all in violation

of Ohio Revised Code §§ 2307.74 – 2307.77. Accordingly, the starting point for the Court’s

analysis is whether any of the requested discovery at issue addressed to similar incidents is

relevant to any of these claims or whether, consistent with Defendant’s view, relevant

information is limited to only that relating to the Subject Rib Plate.

A. Relevance

This Court and other courts considering the relevancy of inquiries similar to those made

by Plaintiff here have concluded that generally, “discovery relating to ‘similar, if not identical

[product] models’” is permissible.” Kroft v. Broan-Nutone, LLC, No. 2:11-CV-388, 2012 WL

13026969, at *2 (S.D. Ohio Apr. 5, 2012) (citing Tolstih v. L.G. Electronics, No. 2:07-CV-582,

2009 WL 439564, at *5 (S.D. Ohio Feb. 20, 2009) (quoting Holfer v. Mack Trucks, Inc., 981

F.2d 377, 380–81 (8th Cir. 1992)); see also Reising v. Toro Co., No. 1:17-CV-00431, 2018 WL

5489568, at *4 (S.D. Ohio Oct. 29, 2018); Hennigan v. G.E. Co., No. 09-11912, 2010 WL

4189033, at *5 (E.D. Mich. Aug. 3, 2010)). Of course, “[p]rior accidents or incidents must be

‘substantially similar’ to the one at issue before they will be admitted into evidence.” In re

Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prod. Liab. Litig., 505 F. Supp. 3d 770,

781–82 (S.D. Ohio 2020) (Sargus, J.) (quoting Rye v. Black & Decker Mfg. Co., 889 F.2d 100,

102 (6th Cir. 1989)). “Typically, this requires ‘that the accidents must have occurred under

similar circumstances or share the same cause.’” Id. Indeed, “[p]ermitting discovery of models

that are not substantially similar is truly the equivalent of comparing apples and oranges where

there are differences between the other models and the model at issue.” Reising, supra, at *4

(quoting Tolstih, supra, at *5 (citation and internal quotation omitted)). “Evidence of prior

incidents may demonstrate that a defendant was on notice or had knowledge of the risks giving

rise to the incident.” Davol, 505 F. Supp. 3d at 781-782 (citing Koloda v. Gen. Motors Parts

Div., Gen. Motors Corp., 716 F.2d 373, 375–76 (6th Cir. 1983)). Neither “great specificity nor

perfectly identical circumstances, are required to show substantial similarity. Id. at 782.

Accordingly, putting issues of FDA statutes and regulations and the breadth or undue

burden of Plaintiff’s requests as framed aside for the moment, discovery relating to the “Rib

Plate” (Model Number 24-015-22-71) is relevant.2 Stated another way, “’[i]t would be difficult,

if not impossible, for a plaintiff to make a showing that other incidents are substantially similar,

if they are precluded from discovery of that information in the first place.’” Kroft, 2012 WL

13026969 at *4 (quoting Hennigan, 2010 WL 4189033 at *5). Thus, the motion for a protective

order is DENIED to the extent that it relies on a relevance challenge to prohibit any discovery

relating to the Rib Plate. Instead, the parameters of the permissible discovery will be addressed

more specifically below.

With respect to other models, Plaintiff acknowledges that the discoverability of

information relating to different models turns on whether those models “‘share with the accident-

causing model those characteristics pertinent to the legal issues raised in the litigation.’” Tolstih,

2009 WL 439564 at *5 (quoting Fine v. Facet Aerospace Products Co., 133 F.R.D. 439, 441

(S.D.N.Y. 1990)).3 In determining whether discovery of a different model is permissible under

2 Presumably, although the parties’ briefing does not make this clear, this Model Number can be

further described as a “20 hole, 1.5 mm thick X-shape rib fixation plate.” (Quigley Affidavit, ECF

No. 70-1 at ⁋ 18).

3 The Court noted in Davol that, when introduced to demonstrate notice or knowledge, a lesser

degree of similarity may be required if the incident would have alerted the defendant. 505 F.

Supp. 3d at 781–82. As set forth above, Plaintiff argues in terms of substantial similarity and

makes no claim-dependent distinction.

Rule 26, courts should undertake a “fact specific inquiry . . . to determine the extent of the

similarities or dissimilarities between models.” Reising, 2018 WL 5489568, at *4. Further, it is

Plaintiff’s burden to identify these “pertinent characteristics.” See, e.g., Menendez v. Wal-Mart

Sores East L.P., No. 1:10-CV-00053, 2010 WL 3088440, at *2 (N.D. Ind. Aug. 4, 2010)

(declining to compel discovery on additional models unless the plaintiffs “produce[d] an expert

opinion identifying certain ‘pertinent characteristics’ that would be relevant in determining

‘substantially similar’ [models]”); Tolstih, 2009 WL 439564 at *7 (implicitly acknowledging that

the plaintiff has the burden to “demonstrate that [the] different models were substantially similar

and therefore relevant”); Lohr v. Stanley-Bostich, Inc., 135 F.R.D. 162, 164 (W.D. Mich. 1991)

(plaintiff, through his expert, identified the product features that caused or contributed to his

injury, prompting the court to permit discovery into other products containing the identified

features).

Consistent with the above authority, Plaintiff relies on the Declaration of Dr. David

Paulus, its retained expert. (ECF No. 65-1.) According to Dr. Paulus, he has been retained in the

past to review two other plates from the KLS Martin Thoracic Plating System line. Of those two

plates, one was a sternum locking plate and the other was a similar rib plate. (Id. at ⁋ 7.) In his

professional opinion, these devices share the following common features: they are fashioned

from commercially pure titanium; the different rib plate models share a design commonality

featuring a series of connected and alternating counter-sunk bone screw holes, while the sternum

plate similarly features counter-sunk holes which are in one line instead of alternating; these

thoracic plating systems likely share a common manufacturing process; these thoracic plating

systems are all attached directly to broken bones by means of bone screws; and the rib plates are

intended to hold the broken bone ends together until healing occurs. (Id. at ⁋ 8.) In his

professional opinion, the three thoracic plating systems he has studied more likely than not failed

in the same manner when affected by the movement of the chest during respiration and this

design defect, for the same reasons, more likely than not affects other models in the KLS family

of thoracic plating systems. (Id. at ⁋⁋ 9, 10.)

For its part, Defendant impugns the validity of Dr. Paulus’s Declaration, noting his lack

of detail and its speculative assertions, and submits the Affidavit of Carson Quigley, a

Biomedical Engineer and its Product Manager for sternal and rib products, including rigid fixation

plating products comprised of plates and screws for application to the bones in the human sternal

thoracic cavity. (ECF No. 70-1 at ⁋ 2.) In short, Ms. Quigley explains in detail that “the three

KLS plates Dr. Paulus has reviewed are of different types and thicknesses, were designed for

different purposes, were manufactured using different methods, and were applied to three completely

different parts of the bodies of three different patients who had three different surgical procedures to

address three different medical issues.” (Id. at ⁋ 21.)

The matter of discovery into incidents involving other product models does not warrant

significant discussion. On the current record, Plaintiff has failed to demonstrate that the Other Plate

Models possess characteristics pertinent to the legal issues raised in this litigation. As Defendant

points out, Dr Paulus’s Declaration is comprised of speculation and a very limited review of

Defendant’s products. These shortcomings are particularly stark when contrasted with the

detailed explanations of certain other products set forth in Ms. Quigley’s Affidavit. Accordingly,

the motion for a protective order is GRANTED as to Request for Production No. 2 on grounds

of relevance and Plaintiff’s motion to compel in this regard is DENIED.

B. MDRs

As noted, Plaintiff confirms in her briefing that with respect to MDRs, she seeks only

those that are not available in the MAUDE Database. (ECF No. 65 at 12.) In response to this

confirmed limitation, Defendant represents that it has no such MDRs. (ECF No. 70 at 10-11.)

Ordinarily, the representation of a party's attorney that no documents exist is sufficient to defeat

a motion to compel absent credible evidence that the representation is inaccurate. Brown v.

Tellermate Holdings Ltd., No. 2:11-CV-1122, 2013 WL 1363738, at *6 (S.D. Ohio Apr. 3,

2013). Consequently, if Plaintiff “’do[es] not provide any evidence demonstrating that

responsive documents do, in fact, exist and are being unlawfully withheld, [her] motion to

compel must fail.’” Id. (quoting Alexander v. F.B.I., 194 F.R.D. 299, 301 (D.D.C. 2000). Here,

she has not done so. Of course, trial counsel have an affirmative obligation to insure that what

their clients tell them is accurate. The Court presumes that they have discharged their duties in

this case. Id. (citing Bratka v. Anheuser–Busch Co., Inc., 164 F.R.D. 448 (S.D. Ohio 1995)).

Accordingly, Defendant’s motion for a protective order is GRANTED as to any MDRs not

available in the MAUDE Database and Plaintiff’s motion to compel is DENIED.

C. CAPA System

Plaintiff contends that Defendant is required to maintain a “CAPA System” in accordance

with 21 C.F.R. § 820.100. According to Plaintiff, the notice of dangers, or lack thereof, these

CAPA policies and procedures provide is relevant to her claims here. Defendant explains,

however, that it is not required to maintain such a system and that the current dispute over

CAPA-related activities results from Plaintiff’s misunderstanding of the applicable FDA

regulations. The Court agrees.

As the Court understands it, Plaintiff believes that, because Defendant is a manufacturer

for purposes of 21 C.F.R. § 803, it also is a manufacturer for purposes of 21 C.F.R. § 820.3.

This belief, however, is misplaced because the two sets of regulations have distinct definitions of

“manufacturer.” For example, 21 C.F.R. § 803 addresses Medical Device Reports. Defendant

explains that, for purposes of medical device reporting, it falls within the definition of

manufacturer because it is the initial distributor of a foreign entity. See 21 C.F.R. § 803.3(l)(4).

(ECF No. 70 at 22-23.) The regulations set forth in 21 C.F.R. § 820, however, relate to Quality

System Regulation. For purposes of those regulations, “manufacturer” is defined as follows:

(o) Manufacturer means any person who designs, manufactures, fabricates,

assembles, or processes a finished device. Manufacturer includes but is not limited

to those who perform the functions of contract sterilization, installation, relabeling,

remanufacturing, repacking, or specification development, and initial distributors

of foreign entities performing these functions.

21 C.F.R. § 820.3. Subpart J contains the regulations applicable to “Corrective and Preventative

Action.” 21 C.F.R. § 820.100. Defendant explains that, for purposes of 21 C.F.R. § 820, it is a

repackager/relabeler and, as such, it maintains a QMS system designed to address packaging and

labeling issues. Defendant further asserts that its QMS system would only generate a CAPA

document if a repackaging/relabeling issue arose but it never has with respect to rib fixation

products. As a result, it has no documents responsive to Plaintiff’s CAPA-related request. (ECF

No. 70 at 25.) Defendant’s explanation appears consistent with the scope of the relevant

regulations. See 21 C.F.R. § 820.1. (“This part establishes basic requirements applicable to

manufacturers of finished medical devices. If a manufacturer engages in only some operations

subject to the requirements in this part, and not in others, that manufacturer need only comply

with those requirements applicable to the operations in which it is engaged.”) Plaintiff sets forth

no meaningful authority to the contrary, instead relying on her own interpretations of the various

regulations. Accordingly, the motion for a protective order is GRANTED and the motion to

compel is DENIED as to any documents “evidencing its CAPA System.”

D. Complaint files, product complaints and remaining issues

The current discovery dispute has evolved as reflected in the parties’ briefing and, in light

of the conclusions reached above, such that the crux of the debate is the discoverability of

complaint files and product complaints relating to the “Rib Plate” (Model Number 24-015-22-

71) (“20 hole, 1.5 mm thick X-shape rib fixation plate”). The resolution of this issue also will

impact any obligation Defendant may have to produce a privilege log or to obtain documents

from KLM. The Court will address each of these issues, as necessary, in turn.

Turning first to the matter of the discoverability of Defendant’s complaint files and

product complaints, Defendant explains that these items are protected from discovery under

applicable statutes and regulations governing FDA reporting, specifically 21 U.S.C. § 360i(b)(3)

and 21 C.F.R. 20.63(a) and (f). The statutory provision, 21 U.S.C. § 360i(b)(3), pertains to

“User Reports” and provides, as relevant, that:

(3) No report made under paragraph (1) by--

(A) a device user facility,

(B) an individual who is employed by or otherwise formally affiliated with such a

facility, or

(C) a physician who is not required to make such a report,

shall be admissible into evidence or otherwise used in any civil action involving

private parties unless the facility, individual, or physician who made the report had

knowledge of the falsity of the information contained in the report.

21 U.S.C. § 360i(b)(3). The relevant regulations set forth in 20 C.F.R. § 20.63 provide as

follows:

(a) The names or other information which would identify patients or research

subjects in any medical or similar report, test, study, or other research project

shall be deleted before the record is made available for public disclosure.

…

(f) The names and any information that would identify the voluntary reporter or any

other person associated with an adverse event involving a human drug, biologic,

or medical device product shall not be disclosed by the Food and Drug

Administration or by a manufacturer in possession of such reports in response

to a request, demand, or order. Information that would identify the voluntary

reporter or persons identified in the report includes, but is not limited to, the

name, address, institution, or any other information that would lead to the

identities of the reporter or persons identified in a report. This provision does

not affect disclosure of the identities of reporters required by a Federal statute

or regulation to make adverse event reports. Disclosure of the identities of such

reporters is governed by the applicable Federal statutes and regulations.

21 C.F.R. § 20.63.

As previously discussed, Defendant is a “manufacturer” for purposes of medical device

reporting. (ECF No. ECF No. 70 at 22 “… just because KLS qualifies as a ‘manufacturer’ for

the limited purpose of medical device reporting….”). Consistent with the express applicability

of § 360i(b)(3) to “User Reports,” courts have recognized that manufacturer reports are not

addressed by § 360i(b). In re Davol, 505 F. Supp. 3d at 780. Instead, manufacturer reports are

addressed by § 360i(a). Id. Accordingly, courts have held that § 360i(b)(3) does not apply to

manufacturer reports. Id. (“Though no binding precedent is on point, the vast majority of courts

to consider this question or similar ones have reached the same interpretation of § 360i(b)(3).”)

(citing Coolidge v. United States, No. 10-CV-363S, 2018 WL 5919088, at *2 (W.D.N.Y. Nov.

13, 2018) (citing cases); Kubicki ex rel. Kubicki v. Medtronic, 307 F.R.D. 291, 298 (D.D.C.

2014) (considering discoverability rather than admissibility); In re Ethicon, Inc. Pelvic Repair

Sys. Prods. Liab. Litig., Nos. 2:12-MD-02327, 2:12-cv-4301, 2014 WL 505234, at *5 (W. Va.

Feb. 5, 2014) (citing Chism v. Ethicon Endo-Surgery, Inc., No. 4:08CV00341-WRW, 2009 WL

3066679, at *1 (E.D. Ark. Sept. 23, 2009)). Defendant attempts to claim the protection of 21

U.S.C. § 360i(b)(3) by explaining that the complaints it receives only come “from protected

mandatory device user facilities, voluntary healthcare providers or patient reporters.” (ECF No.

70 at 8.)4 The Court is not persuaded.

Indeed, other courts also have rejected the interpretation Defendant urges here. Thus,

despite Defendant’s insistence that 21 U.S.C. § 360i(b)(3) bars the discovery of its complaint

files, some courts have concluded that complaint files and related documents are subject to

discovery. See, e.g., Ascenzo v. Medtronic Minimed, Inc., No. 05CIV3610SCRMDF, 2007 WL

9817973, at *1 (S.D.N.Y. May 31, 2007) (finding defendant's “complaint files or database”

subject to discovery and rejecting defendant’s argument that its complaint records were protected

by 21 U.S.C.§ 360i(b)(3)); Contratto v. Ethicon, Inc., 225 F.R.D. 593, 598 n.10 (N.D. Cal. 2004)

(“Section 360i(b)(3) by its own terms does not apply to a manufacturer's complaint files.”

Unlike here, the defendant conceded that the statute did not cover its complaint files but similar

to here, had contended that because the initial complaint fell within the statute, then all

documents generated by the complaint should likewise be protected ); see also Adcox v.

Medtronic, Inc., 131 F. Supp. 2d 1070, 1074 (E.D. Ark. 1999) (finding complaints made by

patients or their legal representatives to be discoverable, but only after redaction of reporter and

patient identifying information). The Court finds the reasoning of the above authority persuasive

and applies it here. In so doing, the Court notes, as other courts have, that the type of

information Plaintiff seeks here routinely would be discoverable in a products liability suit in the

absence of § 360i(b)(3). See Ascenzo, at *3. Thus, the Court concludes that Defendant’s

complaint files and product complaints relating to the “Rib Plate” (Model Number 24-015-22-

71) (“20 hole, 1.5 mm thick X-shape rib fixation plate”) are not protected from discovery under §

4 Beyond this, Defendant asserts by footnote that Davol, “is premised upon an incorrect

understanding of the regulatory framework, and inaccurate conclusions regarding relevant case

law.” (ECF No. 70 at 9 n.13.)

360i(b)(3). To this extent, the motion for a protective order is DENIED and the motion to

compel is GRANTED. Defendant is DIRECTED to produce these documents to Plaintiff

within FOURTEEN DAYS OF THE DATE OF THIS OPINION AND ORDER. As

discussed above, Plaintiff has agreed to redactions as appropriate. (ECF No 65 at 5 n.5.)

Because Defendant’s overbreadth and undue burden arguments are both undeveloped and

likely impacted by the limitations the Court has imposed on discovery herein, the Court will not

consider these concerns as any further basis for a protective order. To the extent Defendant cites

a discovery period of “nearly two decades” as overbroad and burdensome on its face, this

conclusory allegation is not persuasive. Indeed, the Court notes that a discovery period of

seventeen years, standing alone, is not necessarily subject to limitation. See, e.g., Reising, 2018

WL 5489568, at *5 (allowing Plaintiff to obtain 15 years' worth of information on residential

lawn mowers). Further, as to the matter of a privilege log, Defendant has represented that, in the

event the Court finds any information to be discoverable, it will provide one that is compliant

with the Federal Rules of Civil Procedure. Thus, to the extent that Defendant believes that any

information found to be discoverable here is subject to some privilege protection, it shall produce

any such privilege log within FOURTEEN DAYS OF THE DATE OF THIS ORDER.

This brings the Court to the matter of Defendant’s obligation to obtain relevant

documents in KLM’s possession. Although the specific documents sought are not well-defined

in the parties’ briefing, consistent with this Opinion and Order and as reflected in the discovery

requests at issue, the Court concludes that these documents include the internal complaint files

maintained by KLM for the “Rib Plate” (Model Number 24-015-22-71) (further described as a

“20 hole, 1.5 mm thick X-shape rib fixation plate).5

As noted above, Defendant argues that it is an entity distinct from KLM and, therefore, it

does not possess or control KLM’s documents and otherwise has no right to access or obtain them.

In support of its position, Defendant has submitted the Affidavit of William Ticoras, its President.

(ECF No. 58-12.) According to Mr. Ticoras, Defendant is an operational entity which sells and

distributes various craniomaxillofacial and sternal thoracic products and services in the United States,

including but not limited to, products manufactured by KLM. (Id. at § 4.) Further, Mr. Ticoras

attests that KLM has no financial interest in this action; KLM owns no interest directly or indirectly

in Defendant and Defendant owns no interest directly in KLM; Defendant has no contractual or other

right to compel KLM’s documents; Defendant is not typically provided with copies of KLM

documents relating to design, manufacturing, or testing; it does not have actual possession of any

documents prepared and maintained by KLM other than those provided in the ordinary course of

their business relationship; and if Defendant asks KLM for documents, it is strictly up to KLM as to

whether to honor the request. (Id. at §§ 9-10, 13-16.)

For her part, Plaintiff argues that Defendant may have engaged in “deceptive conduct” in the

course of the briefing cycle on these motions by removing language from its website indicating that it

was a subsidiary of KLM and including language indicating that it is a U.S. importer and distributor.

Plaintiff suggests that this change was undertaken to intentionally deprive her of relevant evidence.

Initially, the Court finds no merit to Plaintiff’s argument here. Certainly, a subsidiary may be

deemed to have control over a parent corporation’s documents under certain circumstances. See

Robert Bosch LLC v. Snap-On Inc., No. 12-11503, 2013 WL 823330, at *2 (E.D. Mich. Mar. 6,

5There is some indication in the briefing that Plaintiff also seeks information relating to KLM’s

CAPA-reporting. To the extent this is so, for the same reasons discussed, Defendant has neither a

legal right nor the practical ability to obtain them from KLM.

2013). However, Mr, Ticaro’s affidavit explaining the relationship between Defendant and

KLM does not describe it in terms of a parent/subsidiary relationship. Significantly, it is dated

August 10, 2022. This date precedes by more than a month the date highlighted by Plaintiff as

the date it cited to Defendant’s website representations in its filings in this litigation. So, beyond

the dubiousness of Plaintiff’s expectation that the Court would find the evidentiary value of

website representations to exceed that of a sworn affidavit, the timeline does not comport with

Plaintiff’s theory.

On a more substantive note, “[t]he Sixth Circuit has held that “documents are deemed to

be within the ‘possession, custody, or control’ for purposes of Rule 34 if the party has actual

possession, custody or control, or has the legal right to obtain the documents on demand.” St.

Clair Cnty. Employees' Ret. Sys. v. Acadia Healthcare Co., Inc., No. 3:18-CV-00988, 2022 WL

4095387, at *9 (M.D. Tenn. Sept. 7, 2022) (quoting In re Bankers Tr. Co., 61 F.3d 465, 469 (6th

Cir. 1995) (emphasis in original)). Applying this precedent, some courts have construed the

“legal right” standard narrowly while other courts have found that control includes the practical

ability to produce documents from a third party. Id. On the current record, Plaintiff’s contention

that Defendant has a right to KLM’s documents fails under either test.

As for a legal right to the documents, Mr. Ticora’s sworn statements confirm that

Defendant has no such right to documents in KLM’s possession. However, whether a party has a

sufficient degree of control over requested documents to constitute a practical ability to obtain

the documents is a question of fact. St. Clair Cnty., 2022 WL 4095387, at *10 (citing 8B

Charles Alan Wright & Arthur R. Miller, Fed. Prac. & Proc. Civ. § 2210 (3d ed.) (“The concept

of ‘control’ is very important in applying [Rule 34], but the application of this concept is often

highly fact-specific.”). “’Particular concerns can arise when a corporate party is related to

another corporation, and this nonparty corporation actually possesses the materials in question.’”

Id. In this circumstance, “[r]ather than adopting an overarching rule . . . courts have tended to

focus on the facts shown in a particular case.” Id. Important factors to be considered include “the

existence of cooperative agreements . . . between the responding party and the non-party, the

extent to which the non-party has any stake in the outcome of the litigation, and the non-party's

history of cooperating with document requests.” Gross v. Lunduski, 304 F.R.D. 136, 142

(W.D.N.Y. 2014) (quoting Alexander Interactive, Inc., 2014 WL 61472, at *3 (citing cases)).

Mr. Ticora’s Affidavit confirms that there are no cooperative agreements between

Defendant and KLM; that KLM has no financial stake in this litigation; and that any decision to

provide documents to Defendant is completely within KLM’s control and discretion. Plaintiff

has presented no meaningful evidence to the contrary. Thus, on this record, the Court cannot

conclude that Defendant has the practical ability to obtain access to KLM’s documents.

Accordingly, the motion for a protective order is GRANTED as to any relevant documents in

KLM’ possession and the motion to compel is DENIED.

Finally, given the resolution of the cross-motions, the Court cannot conclude, as urged by

Plaintiff, that Defendant’s discovery conduct warrants an award of sanctions. Similarly, the

Court declines to issue a pre-emptive prohibition on any future discovery requests as suggested

by Defendant’s motion.

IV.

For the foregoing reasons, Defendant’s Motion for a Protective Order (ECF No. 58) is

GRANTED, in part and DENIED, in part. Defendant’s request for oral argument is DENIED.

Plaintiff’s Motion to Compel (ECF No.65, as amended by ECF No. 71) is GRANTED, in part

and DENIED, in part. Plaintiff’s motion for leave (ECF No.71) is GRANTED as unopposed.

Plaintiff’s request for sanctions is DENIED. Defendant is DIRECTED to produce a privilege

log and appropriately redacted documents as described above to Plaintiff within FOURTEEN

DAYS OF THE DATE OF THIS OPINION AND ORDER.

IT IS SO ORDERED.

Date: January 27, 2023 /s/ Elizabeth A. Preston Deavers_______

ELIZABETH A. PRESTON DEAVERS

UNITED STATES MAGISTRATE JUDGE