Pharmaceutical Research and Manufacturers of America et al v. Sandoval et al

Filing 28

ORDER. IT IS HEREBY ORDERED, ADJUDGED, and DECREED that 26 plaintiffs' motion for a temporary restraining order be, and the same hereby is, DENIED. IT IS FURTHER ORDERED that the briefing schedule regarding 27 plaintiffs' motion fo r preliminary injunction shall proceed as follows: defendants must file their reply to plaintiffs' motion on or before 9/27/2017. Plaintiffs will thereafter have fourteen (14) days to file a reply. IT IS FURTHER ORDERED that a preliminary injunction hearing is set for 10/17/2017, at 11:00 a.m. in courtroom 6A. Signed by Judge Kent J. Dawson on 9/14/17. (Copies have been distributed pursuant to the NEF - MR)

1
2
3
4

UNITED STATES DISTRICT COURT

5

DISTRICT OF NEVADA

6

***

7
8

PHARMACEUTICAL RESEARCH AND
MANUFACTURERS OF AMERICA, et al.,

ORDER
Plaintiff(s),

9
v.

10
11

Case No. 2:17-CV-2315 JCM (CWH)

BRIAN SANDOVAL, et al.,
Defendant(s).

12
13

Presently before the court is plaintiffs Pharmaceutical Research and Manufacturers of

14
15
16
17
18
19
20
21
22
23
24
25
26

America (“PRMA”) and Biotechnology Innovation Organization’s (“BIO”) motion for a
temporary restraining order.1 (ECF No. 26). Plaintiffs request that this court require defendants
Brian Sandoval (in his official capacity as Governor of Nevada) and Richard Whitley (in his
official capacity as Director of the Nevada Department of Health and Human Services, or
“NDHHS”) “to immediately cease and desist all action implementing or enforcing Sections 3.6–
4, 4.3, 6, 7, 8, 9, and all related sections or subsections of Nevada Senate Bill No. 539.” (ECF No.
26 at 2).
I.

Facts
On June 5, 2017, The Nevada Senate and State Assembly both passed SB 539 (“SB 539”).

As relevant to this case, the bill creates a reporting scheme for information related to diabetes
drugs. The bill requires NDDHS to promulgate a list of prescription drugs essential for the
treatment of diabetes by February 1 of each year. Thereafter, the manufacturers of drugs on the

27
28
1

James C. Mahan
U.S. District Judge

Plaintiffs have also filed a motion for preliminary injunction. (ECF No. 27).

1

list must provide NDHHS with a report by April 1 of each year.2 The report must contain cost,

2

pricing, profit, coupon, rebate, and related metrics for the manufacturer’s drug, along with any

3

other “information prescribed by regulation . . . for the purpose of analyzing the cost of

4

prescription drugs . . . on the list.”3 SB 539 § 3.8. On or before June 1 of each year, NDHHS shall

5

compile a report summarizing certain manufacturer disclosures. SB 539 § 4.3. Pursuant to Section

6

28, subsection 3,

7

Sections 1 to 6.5, inclusive, 7.5, 8, 9, and 26.6 of this act become effective upon
passage and approval for the purpose of adopting regulations and performing any
other administrative tasks that are necessary to carry out the provisions of this act
and on October 1, 2017, for all other purposes.

8
9

SB 539 § 28.
10
Section 26.9 of the bill alters the report deadlines for the first reporting period. SB 539 §
11
26.9. On or before November 1, 2017, NDHHS shall place on its website the initial list of drugs
12

essential to the treatment of diabetes.4 Id. On or before July 1, 2018, the manufacturers shall

13
submit their first reports pursuant to section 3.6. Id. On or before September 1, 2018, NDHHS
14
shall compile its first report pursuant to section 4.3. Id.
15
II.

Legal Standard

16
Under Federal Rule of Civil Procedure 65, a court may issue a temporary restraining order
17
when the moving party provides specific facts showing that immediate and irreparable injury, loss,
18
19

or damage will result before the adverse party’s opposition to a motion for preliminary injunction
can be heard. Fed. R. Civ. P. 65. “Injunctive relief is an extraordinary remedy and it will not be

20
granted absent a showing of probable success on the merits and the possibility of irreparable injury
21

should it not be granted.” Shelton v. Nat’l Collegiate Athletic Assoc., 539 F.2d 1197, 1199 (9th

22
Cir. 1976).
23
24
25
2

26

Other provisions of the bill impose reporting requirements on certain pharmaceutical sales
representatives, non-profit organizations, and other entities. See, e.g., SB 539 §§ 4.6, 4.9.

27

3

28

4

James C. Mahan
U.S. District Judge

The bill specifically exempts this information from trade secret protection. SB 539 § 9.

Plaintiffs represent that NDHHS plans to publish its initial list on October 15, 2017. (ECF
No. 26 at 11). NDHHS has already published a draft list. (ECF No. 26-4).
-2-

1

III.

Discussion

2

Plaintiffs assert that the disclosure of information required by section 3.6 of the act, and its

3

subsequent publication as required by section 4.3, impermissibly infringes upon plaintiffs’ patent

4

and trade secret protections, constitutes a taking of property without just compensation, and

5

violates the dormant commerce clause. Plaintiffs’ motion states that not only must a TRO issue

6

as soon as possible, but also that plaintiffs would like to be heard on their motion for preliminary

7

injunction prior to October 1, 2017. Plaintiffs claim “[t]he challenged provisions of SB 539

8

become effective on October 1, 2017, and officially strip affected manufacturers of trade-secret

9

protection for their confidential data as soon as the department publishes its list of ‘essential’

10

diabetes drugs . . . .” (ECF No. 26 at 31). Plaintiffs further state that their members must

11

“immediately reassess the risks and returns of their investments in diabetes therapies.” Id.

12

Plaintiffs’ motion for a TRO does not satisfy the requirements of Federal Rule of Civil

13

Procedure 65(b)(1). Plaintiffs have not shown that “immediate and irreparable injury, loss or

14

damage will result . . . before the adverse party can be heard in opposition.” F.R.C.P. 65(b)(1)(A).

15

The bill became effective for purposes of promulgating regulations on June 15, 2017 (the date it

16

was signed), SB 539 § 28, and the department has already published a proposed list of essential

17

diabetes drugs. (ECF No. 26-4). Further, plaintiffs first round of disclosures to NDHHS are not

18

due until July 1, 2018. SB 539 § 26.9. Plaintiffs have not demonstrated that any additional or

19

irreparable harm will accrue on either October 1, 2017, or on October 15, 2017. Per Federal Rule

20

of Civil Procedure 65, defendants must be afforded time to respond to plaintiffs’ motion. See

21

F.R.C.P 65(a) & (b)(1)(A).

22

IV.

Conclusion

23

Plaintiffs have not shown this court that ex parte relief is warranted on these facts. The

24

court will therefore deny plaintiffs’ motion for a temporary restraining order (ECF No. 26), and

25

will set a schedule for consideration of plaintiffs’ motion for preliminary injunction (ECF No. 27).

26

...

27

...

28

...

James C. Mahan
U.S. District Judge

-3-

1

Accordingly,

2

IT IS HEREBY ORDERED, ADJUDGED, and DECREED that plaintiffs’ motion for a

3

temporary restraining order (ECF No. 26) be, and the same hereby is, DENIED.

4

IT IS FURTHER ORDERED that the briefing schedule regarding plaintiffs’ motion for

5

preliminary injunction (ECF No. 27) shall proceed as follows: defendants must file their reply to

6

plaintiffs’ motion on or before September 27, 2017. Plaintiffs will thereafter have fourteen (14)

7

days to file a reply.

8

IT IS FURTHER ORDERED that a preliminary injunction hearing is set for October 17,

9

2017, at 11:00 a.m. in courtroom 6A.

10

DATED September 14, 2017.

11
12
13

__________________________________________
UNITED STATES DISTRICT JUDGE

14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
James C. Mahan
U.S. District Judge

-4-