*1 On July 23, 2021, Plaintiffs Edwards Lifesciences Corporation and Edwards Lifesciences LLC (“Edwards”) filed a renewed motion for sanctions against Defendants Meril Life Sciences Pvt. Ltd. and Meril, Inc. (“Meril”) for failure to comply with Federal Rule of Civil Procedure 37.

On October 28, 2021, the Court held a hearing, and after careful consideration of the parties' arguments, briefing, and the applicable legal authority, GRANTS IN PART AND DENIES IN PART Plaintiffs' motion for sanctions.

On March 31, 2021, Edwards filed a motion for sanctions. While the undersigned denied the motion, the Court found that Edwards was entitled to anonymized raw data from the 30-person and 100-person Myval-1 clinical studies that took place in India, as well as documents responsive to other requests for production of documents. (5/20/21 Order, Dkt. No. 170 at 1-2.) This included the patient medical records and other source documents from the studies. See ids.

On July 23, 2021, Plaintiffs filed a renewed motion for sanctions on the grounds that Meril was withholding the underlying medical records from the Myval-1 clinical studies and documents responsive to Requests for Production Nos. 161-179 and 184-191. (Pls.' Mot., Dkt. No. 177.) On August 6, 2021, Defendants filed an opposition. (Defs.' Opp'n, Dkt. No. 186.) On August 13, 2021, Plaintiffs filed a reply. (Pls.' Reply, Dkt. No. 191.)

On October 28, 2021, the Court held a hearing, and ordered the parties to submit supplemental briefing. On November 4, 2021, Plaintiffs filed a supplemental brief. (Pls.' Suppl. Br., Dkt. No. 273[1].) On November 12, 2021, Defendants filed a supplemental brief. (Defs.' Suppl. Br., Dkt. No. 281[2].)

Federal Rule of Civil Procedure 37 allows the court to sanction a party that fails to obey a discovery order by:

Fed. R. Civ. P. 37(b)(2)(A).

A district court “has great latitude in imposing sanctions for discovery abuse.” Dahl v. City of Huntington Beach, 84 F.3d 363, 367 (9th Cir. 1996); Sloan v. Oakland Police Dep't, 2005 WL 8156878, at *3 (N.D. Cal. July 26, 2005) (“As indicated by the clear language of Rule 37, the above-listed orders are not intended to constitute an exhaustive list of the orders a judge may issue as sanctions.”). However, any such sanction must be “just” in light of the particular circumstances of the case. Ins. Corp. of Ireland v. Compagnie des Bauxites, 456 U.S. 694, 707 (1982).

*2 When choosing among possible sanctions, the Court should consider a sanction designed to: (1) penalize those whose conduct may be deemed to warrant such a sanction; (2) deter parties from engaging in the sanctioned conduct; (3) place the risk of an erroneous judgment on the party who wrongfully created the risk; and (4) restore a prejudiced party to the same position he or she would have been in absent the wrongdoing. See Nat'l Hockey League v. Metro. Hockey Club, Inc., 427 U.S. 639, 643 (1976); Wyle v. R.J. Reynolds Indus., Inc., 709 F.2d 585, 589 (9th Cir. 1983).

Rule 37 mandates the imposition of monetary sanctions on a party that fails to obey a discovery order, by requiring that the offending party “pay the reasonable expenses, including attorney's fees, caused by the failure, unless the failure was substantially justified or other circumstances make an award of expenses unjust.” Fed. R. Civ. P. 37(b)(2)(C); Leon v. IDX Sys. Corp., 464 F.3d 951, 958 (9th Cir. 2006) (citation and internal quotation marks omitted). “Willfulness, fault, or bad faith is not required for the imposition of monetary sanctions under Rule 37(b)(2).” In re NCAA Student-Athlete Name & Likeness Licensing Litig., 2012 WL 5372477, at *6 (N.D. Cal. Oct. 30, 2012).

Edwards is seeking sanctions against Meril for failing to comply with prior court orders that compelled Meril to produce anonymized patient data, the underlying patient medical records, and source documents. (Pls.' Mot. at 5.)

A. Whether documents have been improperly withheld

In sum, Edwards argues that Meril has withheld the documents ordered produced, and that, despite Meril's protestations to the contrary, Meril “owns” all of the data and records collected. (Pls.' Mot. at 9.) In opposition, Meril argues that it has produced all data in its possession, custody and control. (Defs.' Opp'n at 11.) Specifically, Meril contends that the only raw data, including patient medical records, collected pursuant to study protocol are the data entered by the physicians in the electronic case report form (“eCRF”) database, which has been produced. (Defs.' Opp'n at 11.) Meril provides that they did not retain any echocardiographic images from presentations by investigators, and that this information was provided by the physician, rather than Meril. Id. Meril's contention that they are not required to produce the documents, because they do not have “direct access” is unavailing, as it runs afoul of the case law. (See Defs.' Suppl. Br. at 4.)

“Control is defined as the legal right to obtain documents upon demand.” United States v. International Union of Petroleum & Indus. Workers, 870 F.2d 1450, 1452 (9th Cir.1989). In support of its position, Edwards cites to documents that confirm that Meril owns the raw data, but that it also has access to the individual patient medical records. (See Pls.' Mot. at 9-10, 14.) In opposition, Meril contends that the Myval-1 clinical studies were sponsored by Meril, but they were conducted by physicians (“Investigators”) at participating hospitals (“Institutions”), and the source documents remain in the possession of the Investigator and Institution, not the Sponsor. (Defs.' Opp'n at 5-6.) Thus, Meril claims that the only data it owns is the data entered into the eCRF database. Id. at 10.

All evidence, however, points to the contrary. On March 10, 2021, Meril represented to the Court that it possessed the individual patient records when it informed the undersigned that it had sought permission from the Drugs Controller General of India (“DCGI”) “to produce the individual patient medical records in this litigation under the terms of the protective order.” (Dkt. No. 118 at 1.) Even if the “individual patient records” described were the eCRF database, as Meril contends, actual patient records are within Meril's custody or control under the terms of the Clinical Trials Agreements with the participating Institutions and the MyVal-1 Clinical Study Protocol, which permits Meril to access and copy the [redacted] Additionally, Edwards cites to the testimony of Dr. Daggubati, Meril's physician expert, in which he stated that he believed echocardiograms had been viewed by [redacted]. (Pls.' Suppl. Br. at 3, Ex. C.)

*3 3 The exhibit has been sealed, and may only be accessed at Dkt. No. 185-6.

At the hearing, it became evident to the undersigned that Meril has not engaged in the discovery process in good faith based on their indefensible position that documents retained by the participating hospitals were not in their legal custody.

Edwards also explained that they had reason to believe that the raw data produced from the eCRF database was not accurate, because its experts tried to use Meril's data, and the calculations did not add up. Meril argued that the information was entered into the database after viewing the echocardiogram image, and that, after entry, Meril does not have the ability to alter the data. Meril further contends that Edwards should be denied supplemental discovery because Plaintiffs are pursuing a “new liability theory.” (See Defs.' Suppl. Br. at 4.) To the contrary, the documents sought are responsive to discovery that was timely propounded and that the undersigned has already ordered produced. The fact that Edwards now posits that the eCRF data was falsified does not change the fact that Meril did not comply with the prior court orders.

Given the relatively broad definition of “possession, custody or control,” and the documents provided, the underlying medical records and documents at issue in this motion are in Meril's legal possession. As a result, Meril's withholding the echocardiograms and other responsive documents is a violation of the prior court orders, and the conduct is sanctionable under Rule 37.

B. Relief Requested

Since Meril violated the court orders, sanctions are appropriate under Rule 37. Edwards requests six different forms of relief in connection with the renewed motion for sanctions:

(Pls.' Mot. at 16.) Given the rapidly approaching trial date, the problem with the relief requested is that it will not ameliorate the prejudice experienced by Edwards absent a continuance of the trial date. However, in light of the current suspension of jury trials in this district due to the omicron variant, a continuance is likely.

*4 Thus, the undersigned orders Meril to produce the relief requested in #1, supra, within 7 days of this order. Meril is reminded that this includes all responsive documents in the possession of Institutions, including patient records and echos, as those documents are in Meril's legal custody. If the documents still exist, Meril must produce them, even if it requires coordinating with the Institutions to obtain copies of the records, which is permitted under the Clinical Trial Agreement. If the documents have been destroyed pursuant to the Clinical Trial Agreement, or otherwise not “retained,” then sanctions may be imposed for spoliation, but that issue is more appropriately addressed by the presiding judge. Meril is not required to produce any documents that have been previously produced. While the undersigned understands that the eCRF database is hosted on a secure, third-party server, Meril will arrange with the third-party to give Plaintiffs access to database itself. (See Defs.' Opp'n at 1.) Since Meril cannot alter the data, Plaintiffs should not be able to either, which will make the access “read-only.”

Edwards' second and third requests for relief fall within the purview of the presiding judge, because they require permission to deviate from the existing case deadlines.

At this time, the Court declines to impose the fourth request for relief, which is to issue an order to show cause to Defendants why they should not be held in contempt.

Fifth, Edwards' request that Meril be ordered to pay coercive sanctions is denied, as Plaintiffs provide no legal authority in support thereof.

Sixth, while the undersigned believes that an award of reasonable attorneys' fees and costs is appropriate, Edwards did not provide any basis for a fee award. Civil Local Rule 37-4(b)(3) requires that, any request for attorneys' fees and costs sought in connection with a motion for sanctions filed under Rule 37 be accompanied by a supporting declaration that “itemize[s] with particularity the otherwise unnecessary expenses, including attorney fees, directly caused by the alleged violation or breach, and set forth an appropriate justification for any attorney-fee hourly rate claimed.” Edwards' failure to comply with the civil local rules prevents the court from determining the appropriate sanctions award at this juncture. Therefore, Edwards is ordered to submit a supporting declaration that fully complies with Civil Local Rule 37-4(b)(3) by no later than January 21, 2022. The supporting declaration shall also comply with the requirements of Civil Local Rule 54-5(b)(2),(3), and Edwards shall provide the relevant billing records. Any opposition to the supporting declaration shall be filed by Meril no later than January 28, 2022.

In the supplemental brief, Edwards requests that the Court convene an evidentiary hearing to address whether there was spoliation of approximately 500 echocardiograms. (Pls.' Suppl. Br. at 5.) Meril represents that they placed a litigation hold on all of their records at the beginning of this case, but the duty to preserve also extends to the trial-related documents maintained by the Institutions. (See Defs.' Suppl. Br. at 5.) Whether or not Meril engaged in spoliation must be addressed by the presiding judge. This lawsuit was filed on October 14, 2019, and served on October 22, 2019, which triggered Meril's duty to preserve all potentially relevant documents to the Myval product, including patient medical records. See United States v. Kitsap Physicians Serv., 314 F.3d 995, 1001 (9th Cir. 2002).[4] [redacted], the echos should have been in the Institution's possession at the time the case was filed, and they should have been retained. (See Protocol at MERIL 00023732.) Regardless, even in the absence of a finding of spoliation, the existence of the discrepancies between the numbers in the Myval-1 database and the numbers presented to the public can be presented at trial and be considered by the jury.

*5 For the reasons set forth above, the Court GRANTS IN PART AND DENIES IN PART Edwards' motion for sanctions.

IT IS SO ORDERED.

Citations will be to the sealed version, available at Dkt. No. 272-4.

Citations will be to the sealed version, available at Dkt. No. 280-4.

That said, the duty to preserve may arise before litigation commences. See, e.g., World Courier v. Barone, No. C 06–3072 TEH, 2007 WL 1119196, at *1 (N.D.Cal. Apr. 16, 2007).