Picone v. Shire U.S. Inc. (Indirect Purchaser Antitrust Class Action)

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

*

*

*

In re INTUNIV ANTITRUST * Civil Action No. 16-cv-12396-ADB (Indirect)

LITIGATION *

*

*

*

MEMORANDUM AND ORDER

BURROUGHS, D.J.

This case involves allegations that the Defendants settled patent litigation over the

ADHD drug Intniv on anticompetitive terms. The Indirect Purchaser Plaintiffs (“IPPs”) are

parents and caretakers who purchased Intuniv or generic Intuniv for a child’s or ward’s medical

needs.1 The IPPs claim that the Defendants engaged in sham patent litigation over Intuniv, and

then settled that litigation on terms that delayed competition for both brand Intuniv,

manufactured by Shire, and generic Intuniv, manufactured by Actavis.

Before the Court are the IPPs’ motion for a protective order and to quash discovery of

their children’s and wards’ (“Minors”) medical records and Defendants Shire and Actavis’ joint

motion to compel discovery of the Minors’ medical records. [ECF Nos. 114, 116]. The IPPs

1 The IPPs have moved for certification of a “Nationwide Consumer Class” comprised of, “For

the period beginning November 15, 2012, to the present: (A) all persons who purchased brand or

generic Intuniv in the United States for personal or household use, and who paid the purchase

price themselves; and (B) all persons covered by commercial health insurance who purchased

brand Intuniv in the United States for personal or household use, and who paid some of the

purchase price pursuant to a co-payment or co-insurance provision,” with certain exclusions.

See [ECF No. 146 at 1–2].

also request fees and costs. [ECF No. 114-1 at 17–18]. For the reasons explained below the

motions are DENIED in part and GRANTED in part.

I. DISCUSSION

The Defendants have been attempting to obtain discovery since November 2017 as to the

factors that influenced the IPPs’ selection of Intuniv, including potential alternative treatments

and price. The IPPs have resisted discovery into the Minors’ medical, pharmaceutical, and

health insurance records (collectively “medical records”) on grounds of irrelevance, undue

burden, and privilege. The IPPs produced heavily redacted pharmacy records to demonstrate

that they purchased branded or generic Intuniv but declined to make additional productions,

provide complete responses to interrogatories, or authorize non-parties to produce medical

records.

The IPPs request that the Court quash a third-party subpoena served on Dr. Steven J.

Auster, a medical service provider in this district, issue a protective order prohibiting the

Defendants from further prosecution of non-party subpoenas issued to the Minors’ healthcare

providers, and order the Defendants to pay their fees and costs. Conversely, the Defendants

request an order requiring the IPPs to: (i) produce executed authorizations pursuant to Actavis’

Demand for Authorizations (“DFA”) to allow the Defendants to obtain the IPPs’ medical

records, see [ECF No. 118-5]; (ii) provide full responses to Shire’s Interrogatories Nos. 1–3, 9,

and 10, see [ECF No. 118-3]; (iii) produce documents responsive to Shire’s Requests for

Production (“RFP”) Nos. 1–4, see [ECF No. 118-4]; and (iv) produce complete and unredacted

versions of the prescription records that the IPPs have produced to date. [ECF No. 116 at 2–3].

DFA No. 12 and Shire’s RFP No. 23 could lead to the production of communications between the

Minors and their therapists, while the other requests are more narrowly tailored and will not

result in the production of such communications. See [ECF Nos. 118-2, 118-3, 118-4, 118-5].

The legal issues are whether the Minors’ medical records are relevant to the claims in this

case, whether the Defendants’ requests impose a burden that is disproportionate to the needs of

the case, and whether the requested materials are privileged.

a. Relevance

“Parties 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).

Discovery “is designed to help define and clarify the issues.” In re New England Compounding

Pharmacy, Inc. Prods. Liab. Litig., MDL 13-2419-FDS, 2013 WL 6058483, at *3 (D. Mass. Nov.

13, 2013) (quoting Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351 (1978)).

The IPPs claim standing to sue and damages because they paid higher co-pays for Intuniv

than they would have paid absent the Defendants’ conduct, which the IPPs argue unreasonably

2 DFA No. 1 seeks authorization to obtain “complete medical records relating to the Minors from

each health care provider who has previously consulted, treated, or examined any of the Minors

for any of the conditions and/or symptoms for which the Minors, at some point, were prescribed

Intuniv or generic Intuniv” and related to “the condition(s) and/or symptom(s) for which the

Minors were at some point prescribed Intuniv or generic Intuniv.” [ECF No. 118-5 at 1]. The

Defendants narrowed this request to the time period from the date the Minors were diagnosed

with ADHD to July 31, 2015. [ECF No. 118-10 at 2].

3 Shire’s RFP No. 2 requests: “All documents concerning Your healthcare providers’ decision(s)

to prescribe Intuniv, Generic Intuniv, and/or any other drug or non-drug-based treatment for the

same health condition for which You, at some point, were prescribed Intuniv or Generic

Intuniv, including, for each healthcare provider contact or communication related to that health

condition: (i) all documents related to every complaint, symptom, adverse reaction, or

other injury, (ii) all medical reports and related documents (including all healthcare

provider records, scans, lab reports, etc.), (iii) all documents concerning the treatment

and/opinions of healthcare providers, and (iv) all medical claims, bills, payments, and related

documents.” [ECF No. 118-4 at 6–7].

restrained trade in a “relevant product market” comprised of “Intuniv and its generic

equivalents.” [ECF No. 39 ¶¶ 112, 117–32, 157]. The Defendants argue that the Minors’

medical records may show that alternative treatments to brand or generic Intuniv were available,

and that the availability of alternative treatments will inform the contours of the relevant product

market and may provide evidence that the IPPs did not pay a higher price as a result of the

challenged conduct. [ECF No. 117 at 2–3, 15].

“Determining the scope of a product market begins with examining the universe of

products that are considered ‘reasonably interchangeable by consumers for the same purposes.’”

Flovac, Inc. v. Airvac, Inc., 817 F.3d 849, 854 (1st Cir. 2016) (quoting United States v. E.I. du

Pont de Nemours & Co., 351 U.S. 377, 395 (1956)). The Minors’ medical records are therefore

relevant to extent they contain information on alternative treatments. See Eastman Kodak Co. v.

Image Tech. Servs., Inc., 504 U.S. 451, 481 (1992) (“The proper market definition in this case

can be determined only after a factual inquiry into the ‘commercial realities’ faced by

consumers.” (quoting United States v. Grinnell Corp., 384 U.S. 563, 572 (1966))); In re Loestrin

24 Fe Antitrust Litig., No. 1:13-md-2472-S-PAS, 2017 WL 1491911, at *6 (D.R.I. Mar. 15,

2017) (“[D]ocuments related to the parties’ competing versions of the relevant product market

are relevant.”). Additionally, because the IPPs claim they were damaged through their insurance

co-pays, the IPPs’ insurance records and the Minors’ pharmaceutical records are relevant to the

issue of damages. See [ECF No 39 ¶¶ 117–32].

b. Burden and Privilege

The IPPs’ undue burden and privilege objections are based primarily on the argument

that the Defendants’ requests may lead to the production of privileged psychotherapist-patient

communications that could be used to annoy or embarrass the IPPs and the Minors. A party is

entitled to nonprivileged, relevant information if its requests are “proportional to the needs of the

case, considering the importance of the issues at stake in the action, the amount in controversy,

the parties’ relative access to relevant information, the parties’ resources, the importance of the

discovery in resolving the issues, and whether the burden or expense of the proposed discovery

outweighs its likely benefit.” Fed. R. Civ. P. 26(b)(1). A Court may, “for good cause, issue an

order to protect a party or person from annoyance, embarrassment, oppression, or undue burden

or expense.” Fed. R. Civ. P. 26(c)(1).

The laws of the five states on which the IPPs’ claims are based, along with federal

common law, recognize a psychotherapist-patient privilege. The Supreme Court has stated that

the psychotherapist-patient privilege “covers confidential communications made to licensed

psychiatrists and psychologists.” Jaffee v. Redmond, 518 U.S. 1, 15 (1996).4 The privilege is

“rooted in the imperative need for confidence and trust” and is intended to promote “frank and

complete disclosure of facts, emotions, memories, and fears.” Id. at 10. It covers

communications that are made (1) confidentially, (2) between a psychotherapist or another

covered person and the patient, and (3) in the course of diagnosis or treatment. Silvestri v.

Smith, No. 14-13137-FDS, 2016 WL 778358, at *2 (D. Mass. Feb. 26, 2016) (citing In re Grand

Jury Proceedings (Violette), 183 F.3d 71, 73 (1st Cir. 1999)). The privilege protects “‘only the

substance of communications’ between the patient and his treatment provider” and “does not

apply to ‘facts regarding the occurrence of psychotherapy, such as the name of the

4 The Defendants have not argued that the federal common law psychotherapist-patient privilege

does not apply, although the claims here arise from state law causes of action. See Fed. R. Evid.

501 (“[I]n a civil case, state law governs privilege regarding a claim or defense for which state

law supplies the rule of decision”); Shea v. McGovern, No. 1:08-12148-MLW, 2011 WL

322652, at *5 (D. Mass. Jan. 31, 2011) (“Questions of privilege in federal question cases are

governed by federal law.”) (citing Fed. R. Evid. 501).

psychotherapist or dates and costs of treatment,” or “other non-communicative information such

as the nature of any diagnosis or treatment for a mental health condition.” Silvestri, 2016 WL

778358, at *2 (quoting Howe v. Town of N. Andover, 784 F. Supp. 2d 24, 34 (D. Mass. 2011);

citing In re Adoption of Saul, 804 N.E.2d 359, 363-65 (Mass. App. Ct. 2004)). The IPPs claim

that the Minors’ medical records are also privileged under the laws of Florida, Massachusetts,

Missouri, New York, and Wisconsin. See Fed. R. Evid. 501 (“[I]n a civil case, state law governs

privilege regarding a claim or defense for which state law supplies the rule of decision.”).5 The

IPPs agree, however, that the “general analysis that courts employ with these laws [is] similar to

the test federal courts employ with respect to the federal psychotherapist-patient privilege.”

[ECF No. 114-1 at 16].

Most of the requests at issue will not lead to the discovery of psychotherapist-patient

privileged communications because they request documents that will not contain

communications between the Minors and their therapists.6 RFPs Nos. 1,3, and 4 relate to the

IPPs’ purchase of Intuniv, medications prescribed in lieu of Intuniv, and insurance benefits.

[ECF No. 118-4 at 7–8]. Similarly, Shire’s Interrogatories Nos. 1, 2, 3, 9, and 10 relate to the

IPPs’ purchase of Intuniv, medications prescribed in lieu of Intuniv, insurance claims, and

damages. [ECF No. 118-3 at 5–10]. Those requests seek relevant information that does not fall

within the psychotherapist-patient privilege, and the Court will grant the Defendants’ motion to

5 See Fla. Stat. § 90.503; Mass. Gen. Laws ch. 233 § 20B; Mo. Rev. Stat. § 337.055; N.Y.

C.P.L.R. § 4507; Wis. Stat. §§ 146.82, 905.04.

6 To the extent that the IPPs have asserted broader protections for health records, the IPPs cannot

maintain those protections because they have placed the Minors’ treatment for ADHD, the

availability of alternative treatments, their insurance policies, and the economics of their

pharmaceutical purchasing practices at issue in this case. See In re New England Compounding

Pharm., 2013 WL 6058483, at *13 (“In most cases, when a patient puts his health at issue in

litigation, the privilege is waived.” (citing In re Asbestos Prods. Liab. Litig., 256 F.R.D. 151, 155

n. 10 (E.D. Pa. 2009))).

compel with respect to those requests. See Silvestri, 2016 WL 778358, at *2 (holding that facts

regarding the occurrence of psychotherapy and the names of treatments were not privileged).

Although the Defendants expressly disclaim any interest in “sensitive communications

between the Minors and their therapists,” [ECF No. 117 at 11], DFA No. 1 and RFP No. 2 could

lead to the production of privileged communications. See supra notes 2–3. The Minors’ medical

records are relevant and must be produced, but the Court will allow the IPPs to collect the

medical records and redact privileged communications that do not relate to alternative treatments

or the cost of Intuniv. Further, the scope of the production is limited to records from the year in

which the minor at issue was diagnosed with ADHD through 2015. The Court will therefore

quash the subpoena issued to Dr. Auster and order that the parties work collaboratively towards

the production of medical records with appropriate redactions and limited to the post-diagnosis

timeframe.7

The Court will also restrict the scope of DFAs Nos. 4 and 5, which seek authorizations to

obtain “complete pharmacy or drug store records with respect to any drugs prescribed for each of

the Minors” and “complete health insurance records” for the previous 10 years. [ECF No. 118-5

at 3]. Given that the IPPs damages are based upon co-pays that varied by drug, and that a myriad

7 DFAs Nos. 2 and 3 request “hospital records relating to the Minors (including diagnostic tests

such as MRIs, CAT scans, EKGs, EEGs, x-rays, and technicians’ reports of such diagnostic

tests) from each hospital, clinic, or other health care facility at which any of the Minors were

treated” and “medical records for any laboratory testing related to any of the conditions and/or

symptoms for which the Minors, at some point, were prescribed Intuniv or generic Intuniv.”

[ECF No. 118-5 at 3]. As with DFA No. 1, DFAs Nos. 2 and 3 are “directed at records for

consultation, treatment, or examination for the condition(s) and/or symptom(s) for which the

Minors were at some point prescribed Intuniv or generic Intuniv, regardless of whether that

particular consultation, treatment, or examination resulted in an Intuniv or generic Intuniv

prescription.” [ECF No. 118-5 at 3]. The parties must work collaboratively towards the

production of relevant medical records from healthcare providers and hospitals, including any

relevant laboratory testing, but Plaintiffs need not solicit such laboratory records that are not in

the possession of care providers or hospitals.

of factors could affect the amount of the IPPs’ co-pays and the availability of alternative

treatments, the Court will grant Defendants motion to compel authorizations for the

pharmaceutical and health insurance records. The Court will, however, limit the date range for

pharmacy and health insurance records to the year in which the minor was diagnosed with

ADHD through 2015.

II. CONCLUSION

For the reasons stated, ECF Nos. 114 and 116 are resolved as follows:

1. The IPPs shall provide authorizations allowing Defendants to obtain complete pharmacy

and health insurance records as requested by DFAs Nos. 4 and 5 from the year in which

the minor was diagnosed with ADHD through 2015 within fourteen (14) days of this

order.

2. The IPPs shall provide responses to Shire’s Interrogatories Nos. 1, 2, 3, 9, and 10 within

fourteen (14) days of this Order.8

3. The IPPs shall produce any documents in their possession or custody that are responsive

to Shire’s RFPs Nos. 1, 3, and 4 within fourteen (14) days of this order.

4. The IPPs shall obtain and produce all records responsive to Shire RFP No. 2 or which

could be collected pursuant to an authorization responsive to DFA Nos. 1 or 2 with

appropriate redactions. Any relevant medical records presently in the possession or

custody or the IPPs must be produced within fourteen (14) days of this order. The IPPs

must request relevant documents from the Minors’ healthcare providers within seven (7)

days of this order and then undertake a prompt review and production of responsive

documents.

5. The IPPs shall produce complete, unredacted versions of the pharmaceutical records that

the IPPs have previously produced within seven (7) days of this Order.

6. The IPPs’ request for fees and costs is denied.

7. All medical records shall be treated as “confidential outside counsel only” information

under the protective order. [ECF No. 98].

8 In responding to interrogatory 9(i), which demands “a quantification of any money damages

You allege that You suffered,” it is sufficient for the IPPs to respond that they believe they

overpaid for Intuniv, if they cannot provide a more precise amount. [ECF 118-3 at 9].

SO ORDERED.

December 14, 2018 /s/ Allison D. Burroughs

ALLISON D. BURROUGHS

U.S. DISTRICT JUDGE