Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-4_18-cv-06972/USCOURTS-cand-4_18-cv-06972-10/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

ADRIAN HOLLEY, et al.,

Plaintiffs,

v.

GILEAD SCIENCES, INC.,

Defendant.

Case No. 18-cv-06972-JST (JSC)

ORDER RE: DISCOVERY DISPUTES

Re: Dkt. Nos. 194, 221, 224, 232

Plaintiffs in this pharmaceutical mass action “have taken one or more of Gilead’s drugs 

containing tenofovir disoproxil fumarate (TDF)” and “have suffered unnecessary kidney and bone 

damage resulting from Gilead’s failure to provide adequate warnings and its decision to develop 

drugs containing TDF rather than the safer compound tenofovir alafenamide fumarate 

(TAF).” (Dkt. No. 75.) The district court has assigned discovery disputes to the undersigned 

magistrate judge. Now pending before the Court are four joint letters regarding various discovery 

disputes. (Dkt. Nos. 194, 221, 224, 232.) The Court held oral argument on April 23, 2020.

I. Gilead Fact Sheets (Dkt. No. 221)

Plaintiffs and Gilead have agreed to produce “fact sheets.” The parties presently dispute 

what information Gilead should be required to provide in their fact sheets concerning Gilead’s 

contacts/communications with each plaintiff’s physicians. Gilead agrees to provide the requested 

information to the extent it is available in its G360 database as follows:

1) Call Notes—Contemporaneous information inputted by sales representatives 

and medical scientists concerning their in-person contacts with healthcare 

providers (HCPs).

2) Email Records—Records of emails sent from sales representatives to HCPs 

using G360.

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3) Medical Information Requests (“MIRs”)—Requests made by HCPs for 

scientific information relating for a TDF and/or TAF medication and Gilead’s 

responses thereto.

4) Dear Doctor Letters (“DDLs”)—Letters sent by Gilead to HCPs regarding 

safety updates about TDF and/or TAF medications, and responses thereto.

5) Consulting Relationships—Identification of relationships with HCPs, the dates 

consulted, and the nature of the relationship.

6) Speaker Presentations—Name and date of event where an HCP spoke for 

Gilead.

7) Clinical Trial Information—Identification of each clinical trial in which an HCP 

was a Principal Clinical Investigator.

The database is not complete: it begins in January 2013 and thus does not cover much of the 

relevant time period in this lawsuit. For responsive information prior to that date, however, Gilead 

would have to review unstructured data to compile the information Plaintiffs seek as to each 

plaintiff’s prescribing and treating physicians. At present there are over 900 plaintiffs in these 

consolidated actions, each with several physicians. The Court understands that Gilead is not 

withholding discovery prior to 2013: it has produced promotional material, letter and email 

templates, and speaker presentation PowerPoints—all of which are evidence of what Gilead was 

communicating to physicians. It has not, however, for example searched for particular emails that 

may have been sent to specific physicians prior to 2013 as it contends there is no centralized way 

to do so.

The Court declines to order Gilead to do more at this time. Plaintiffs fail to show that the 

discovery they seek is proportional to the needs of the case as its relevance, at least at this stage, is 

minimal. They contend that requiring Gilead to search non-centralized records for thousands of 

physicians “aids assessment of any individual claim, especially when Plaintiffs’ physicians are 

likely to be witnesses in this case and all these issues speak to potential bias.” (Dkt. No. 221-3 at 

2.) The Court agrees that if a treating/prescribing physician actually gives testimony in this case, 

Plaintiffs are entitled to know that physician’s relationship with Gilead. But there is no indication 

at this stage in the litigation that all of the thousands of physicians potentially at issue will give 

testimony. The more burdensome searches can wait until the pool of potential witnesses (and 

bellwether plaintiffs) is narrowed.

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Plaintiffs’ insistence that such information as to each and every treating and prescribing 

physician is needed now to even begin to select bellwether cases is not persuasive given the nature 

of the claims at issue in this particular case. There is no allegation that Gilead paid or otherwise 

improperly induced physicians to use TDF drugs rather than TAF drugs—the allegation is that 

Gilead delayed development of the TAF drugs. And, as described by the district court, the failure 

to warn claims are premised on Gilead providing only the weakest, inadequate warnings to doctors 

and patients about “the need for frequent monitoring of all patients for TDF-associated kidney and 

bone damage –preventing doctors from detecting early signs of TDF toxicity.” (Dkt. No. 75 at 2-

3.) In their joint letter brief Plaintiffs contend that they allege that there were alternative drugs 

available and thus they need to know whether Gilead incentivized physicians to prescribe Gilead’s 

TDF drugs over other drugs. But they make this contention without citation to their pleadings, and 

it does not appear in the district court’s description of their claims. In any event, as a start 

Plaintiffs will get the information available from January 2013 forward. 

Given the minimal showing as to relevance, the Court declines to order Gilead to 

“recommission” its Tango database which it used for call records prior to 2013. Gilead represents 

it would cost over $100,000 to restore the database and make it searchable. At oral argument the 

Court asked Plaintiffs if they would be willing to bear that cost, and they demurred.

The Court agrees with Plaintiffs, however, that Gilead should search for Plaintiffs 

prescribing physicians and a certain number of treating physicians. Plaintiffs say up to four 

additional treating physicians and Gilead says none. Since the search is limited to the central 

database, Gilead has not explained how searching for additional names is overly burdensome. If 

Gilead had relationships/communications with these physicians, and that information is in the 

central database, then the information should be disclosed. 

However, the Court declines to order Gilead to disclose the prescribing practices of 

each and every plaintiff’s prescribing physician. Plaintiffs contend that monitoring “the 

prescribing practices of Plaintiffs’ physicians as it relates to antiretroviral medications” is 

needed for Plaintiffs “to understand whether their own physicians were targeted based on 

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this analysis.” But Plaintiffs do not explain how such evidence would tend to prove their 

design defect or failure to warn claims.

As for renumeration to Plaintiff’s treating physicians, it is unclear if Gilead is 

refusing to produce information that it has in a structured database or only that which is not 

centralized. Even if from 2013 forward such information is available on a government 

website, Gilead should produce the information it has in its own possession, custody and 

control. Given that it provides the information to the government, the Court assumes that it 

can access it back to a certain date from a structured data source.

There are other issues that appear in one party’s part of the statement, but not the other 

party’s. For example, Gilead’s portion of the joint letter brief addresses TDF/TAF Medications 

(Dkt. No. 221-4 at 9-10), but the Court cannot discern where that issue is addressed in Plaintiffs’ 

portion. This presentation is not helpful. Going forward the parties shall structure their statements 

so that they address the same issues in a coherent format. The moving party should provide their 

portion of the statement to the resisting party, the resisting party then responds, then the moving 

party can add a reply (within the page limits) to come after the resisting party’s response in the 

letter.

The parties’ joint motion to file portions of the letter brief and exhibits thereto under seal 

because they reference and/or describe Gilead’s highly confidential and proprietary brand plans 

and information data systems is GRANTED. (Dkt. Nos. 221, 228.) However, to the extent that 

the parties file future administrative motions to seal, they must comply with Civil Local Rule 79-

5(d)(1)(D)’s requirement that “[t]he unredacted version must indicate, by highlighting or other 

clear method, the portions of the document that have been omitted from the redacted version” and 

they shall ensure that there is no redacted text in the unredacted version of the submission.

II. ESI Protocol (Dkt. No. 232)

 The parties have agreed to use the ESI Protocol adopted for the California state 

court cases, except that Plaintiffs in these federal cases want an adjustment in the type of 

metadata they (but not Gilead) have to produce. Plaintiffs’ ESI is potentially relevant to 

statute of limitations and damages. The Court is unable to understand the parties’ arguments 

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in the letter brief without concrete examples. Accordingly, Gilead is ordered to identify one 

plaintiff for whom Plaintiffs shall produce the required ESI in Plaintiffs’ preferred 

format. The parties shall then meet and confer as to why what is produced is or is not 

sufficient. While the meet and confer cannot occur in person, it must at least take place by 

video (as must all meet and confers before an issue is brought to the Court’s attention). It 

may be for some particular plaintiffs what Plaintiffs propose to produce is sufficient; for 

others it may not be. A rational approach might be for the parties to agree that for those 

initial productions in which, upon review, Gilead believes it needs more fulsome metadata, 

Plaintiffs would retain a vendor to retrieve that data for that particular plaintiff upon a 

particular showing. This approach avoids unnecessary costs for those plaintiffs who do not 

have many responsive documents or whose produced metadata already tells Gilead 

everything it reasonably needs to know. It is essentially the same approach that Gilead has 

advocated with respect to some of its own productions.

 Nonetheless, if the parties cannot reach an agreement, then any further dispute on the 

ESI Protocol shall be submitted to the Court for resolution by May 29, 2020. Any such 

submission shall include as exhibits examples of the format as actually produced for a 

particular plaintiff and examples of what Gilead contends it needs.

III. Requests for Production (Dkt. No. 224)

 Gilead shall produce responsive documents for the three additional Gilead scientists for 

the period October 2004 through January 1, 2009. It has already agreed to produce documents 

from these custodians pre-October 2006 and has not persuasively articulated why including the 

search through 2009 would be unduly burdensome. To the extent Plaintiffs’ proposed search terms 

result in too many unresponsive documents, then Gilead shall meet and confer with Plaintiffs to 

hone the search terms for these custodians to target potentially responsive documents.

 Gilead shall search for responsive documents regarding its TAF decision-making 

through January 2016, when Gilead sought approval to market Vemlidy. Gilead’s position that 

there will not be any relevant documents can again be tested through honing the search terms 

during that period. The parties are expected to work collaboratively to mitigate the gathering of 

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unresponsive documents. If the initial searches uncover troves of non-responsive documents, then 

Plaintiffs must work with Gilead to narrow the terms.

 Gilead shall search Apollo for the relevant documents through October 2019 (rather than 

its proposed 2015 cut-off), but only in relation to those drugs that were approved after 2015. For 

example, as Genvoya was approved in 2015, there is no good reason to require Gilead to search 

for documents related to the development of Genvoya after that date. But since Descovy was not 

approved until December 2019, Gilead should search Apollo for documents related to the 

development of Descovy up to that date. Accordingly, the search terms will be narrowed for the 

period after 2015. 

IV. Board of Director Documents (Dkt. No. 194)

Gilead agrees to produce responsive Board of Directors documents through December 31, 

2016 provided that it may redact irrelevant information given the commercially sensitive nature of 

matters discussed at Board meetings. The Court agrees. Plaintiffs’ concern that Gilead will redact 

prejudicial relevant information is not well-taken; if counsel was going to violate their ethical 

obligations they would just withhold the document all together rather than produce it in redacted 

form. On other hand, the default in discovery is disclosure without redaction. The Court expects 

that if information is not commercially or scientifically sensitive it should not be 

redacted. Finally, to the extent Plaintiffs cannot understand a document because of redactions, 

they should confer with Gilead. That is a matter that the parties should easily and informally 

resolve.

Although it is not clear from the letter if there is a dispute as to what Gilead is 

producing through December 31, 2016, the Court is not ordering production of documents 

relevant to drugs not at issue in this litigation or discovery on the active ingredients 

contained in TAF or TDF drugs unrelated to the drugs at issue. Viread is a drug at issue in 

this litigation, even if it is being discussed in connection with Hepatitis B.

As for the post-December 31, 2016 documents, Gilead shall produce Board of 

Directors documents, if any, related to the development of a TAF PrEP drug through 

October 2019—the date the FDA approved Descovy for PrEP. Gilead has not articulated 

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any burden with respect to searching Board documents on this limited topic. The Court is 

not persuaded, however, that Board of Directors documents are the proper place to search for 

documents reflecting Gilead’s efforts to convince physicians of the safety benefits of TAF 

drugs over TDF documents. The relevant discovery is what Gilead told physicians;

discovery that is being produced.

Plaintiffs’ request for Gilead to search compensation committee minutes is denied.

This Order resolves Docket Nos. 194, 221, 224, 232, 238.

IT IS SO ORDERED.

Dated: May 1, 2020

JACQUELINE SCOTT CORLEY

United States Magistrate Judge

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