DOCKET for NICOPURE LABS, LLC v. FDA et al, Jun 23-26, 2016

June 26, 2016 7:28 pm by Gene Borio

EXCERPT:

06/24/2016 MINUTE ORDER. The parties have submitted a proposed schedule that agrees to “consolidation,” presumably pursuant to Federal Rule of Civil Procedure 42(a)(2), but it does not include further steps that would achieve the benefit of the efficiency that consolidation can provide. The Court is inclined to order that Nicopure and Right to be Smoke-Free file a single consolidated amended complaint followed by a single motion for summary judgment, or that, at the very least, they file a consolidated summary judgment pleading for all of the identical claims, with Right to be Smoke-Free filing its own motion and subsequent pleadings only with respect to the claims that are unique. The Court will hear the parties’ views on this issue during a telephone conference that will be scheduled for a date and time to be determined. In the meantime, the briefing schedule in the Nicopure matter is hereby VACATED, and plaintiffs’ summary judgment pleadings will be due no earlier than July 8, 2016. SO ORDERED. Signed by Judge Amy Berman Jackson on 6/24/2016.(lcabj3) (Entered: 06/24/2016)

06/26/2016 Set/Reset Hearings: The Telephone Conference call in these cases is set for Tuesday, June 28, 2016, at 11:15 AM before Judge Amy Berman Jackson. The Deputy Clerk will provide the parties with the dial-in telephone number and pass code by e-mail on Monday, June 27, 2016. (jth) (Entered: 06/26/2016)

END EXCERPT

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CIVIL DOCKET FOR PHILIP MORRIS USA INC. et al v. FDA, Jun 20, 2016

June 23, 2016 5:09 pm by Gene Borio

EXCERPT:

06/20/2016 42 TRANSCRIPT OF MOTION HEARING PROCEEDINGS before Judge Amit P. Mehta held on June 9, 2016; Page Numbers: 1-94. Date of Issuance: June 20, 2016. Court Reporter/Transcriber: William Zaremba; Telephone number: (202) 354-3249. Transcripts may be ordered by submitting the Transcript Order Form.

END EXCERPT

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DOCKET for NICOPURE LABS, LLC v. FDA et al, Jun 21-23, 2016

June 23, 2016 5:03 pm by Gene Borio

EXCERPT:

MINUTE ORDER. Two cases filed in this Court, Right to be Smoke-Free Coalition v. FDA, No. 16-cv-1210, and Nicopure Labs, LLC v. FDA, No. 16-cv-878, challenge the FDA’s final rule “Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products,” No. FDA-2014-N-0189, 81 Fed. Reg. 28,973 (May 10, 2016). While Right to Be Smoke-Free brings some new claims, both cases allege that the Deeming Rule is arbitrary and capricious in violation of the Administrative Procedure Act, 5 U.S.C. § 500 et. seq., and both claim that the regulation unlawfully infringes upon plaintiffs’ First Amendment rights. In light of the common questions of law and fact in these two cases, the Court believes that Federal Rule of Civil Procedure 42(a) is applicable. Any party who objects to consolidation under Rule 42(a)(2) or any other form of joint treatment under Rule 42(a)(1) must notify the Court by June 22, 2016, and provide the reasons for its objection. If any party wishes to propose a procedure or revised schedule for the Court’s consideration, the proposal must be submitted by the same date. SO ORDERED. Signed by Judge Amy Berman Jackson on 6/21/2016. (lcabj3) (Entered: 06/21/2016)

END EXCERPT

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DOJ APPEAL: CLERK’S ORDER filed scheduling oral argument, June 8, 2016

June 9, 2016 1:07 am by Gene Borio

The PDF is Here

EXCERPT:

It is ORDERED, on the court’s own motion, that this case be scheduled for oral argument on September 13, 2016, at 9:30 A.M. The composition of the argument panel willusually be revealed thirty days prior to the date of oral argument on the court’s web site atwww.cadc.uscourts.gov.

The time and date of oral argument will not change absent further order of the Court.

END EXCERPT

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NICOPURE v FDA: PROTECTIVE ORDER, Jun 8, 2016

June 9, 2016 12:37 am by Gene Borio

The PDF is Here

EXCERPT:

This Order shall govern the disclosure, handling, and use of the following documents and other information in the administrative record for this case, which are hereinafter referred to as “Protected Information”:

. . .

All information that is derived from Protected Information, even if incorporated into another document or compilation or referred to in testimony, shall be treated as Protected Information

END EXCERPT

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DOCKET for NICOPURE LABS, LLC v. FDA et al, Jun 8, 2016

June 9, 2016 12:25 am by Gene Borio

EXCERPT:

06/08/2016 15 SCHEDULING ORDER. Plaintiff’s motion for summary judgment shall be filed by June 24, 2016. Defendants’ opposition to plaintiff’s motion, combined with any cross-motion, which shall be supported by a single memorandum of points and authorities, shall be filed by July 19, 2016. Plaintiff’s reply in support of its motion, and opposition to defendants’ cross-motion, supported by a single memorandum of points and authorities, shall be filed by July 29, 2016. Defendants’ reply in support of its cross motion shall be filed by August 8, 2016. The Court will hold a hearing on the motions on September 8, 2016 at 10:00 a.m. in Courtroom 3. Defendants’ obligation to answer the complaint shall be held in abeyance pending the resolution of the cross-motions. See Order for complete details. Signed by Judge Amy Berman Jackson on 6/8/2016. (lcabj3) (Entered: 06/08/2016)

06/08/2016 16 PROTECTIVE ORDER (see the order for complete details) Signed by Judge Amy Berman Jackson on 06/08/2016. (jth) (Entered: 06/08/2016)

END EXCERPT

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PHILIP MORRIS v FDA: PLAINTIFFS’ NOTICE OF SUPPLEMENTAL AUTHORITY, Jun 7, 2016

June 7, 2016 4:49 pm by Gene Borio

The PDF is Here

EXCERPT:

Plaintiffs respectfully submit this Notice regarding U.S. Army Corps of Engineers v. Hawkes Co., No. 15-290, 578 U.S. __ (May 31, 2016) . . .

In Hawkes, the U.S. Supreme Court held that a jurisdictional determination by the U.S. Army Corps of Engineers that property contains “waters of the United States”—and is therefore subject to the Clean Water Act—constitutes reviewable “final agency action” under the Administrative Procedure Act (“APA”). . .

So too, here, where the Second SE Directive warns manufacturers that they must undergo premarket review before implementing label changes that, in FDA’s view, render a product “distinct” or changing the quantity in which the product is marketed. If a manufacturer implements such changes without premarket review, it faces significant criminal and civil penalties for marketing misbranded and adulterated products. Hawkes thoroughly refutes FDA’s position that, as an alternative to review of the Second SE Directive, Plaintiffs could simply implement a label or product-quantity change without premarket review and then wait for FDA either to initiate an enforcement action or exercise its prosecutorial discretion not to bring such an action. The Court in Hawkes emphasized that regulated entities “need not assume” the risk of criminal and civil penalties “while waiting for [the agency] to ‘drop the hammer’ in order to have their day in court.” FDA, however, would require tobacco product manufacturers either to incur the risks of an enforcement action, or comply with the unlawful regulatory requirements and endure a prior restraint of speech imposed by the Second SE Directive by delaying their label and product-quantity changes at least 90 days (and indefinitely for non-provisional products) while the agency conducts premarket review. The APA does not impose such an untenable choice on regulated parties.

END EXCERPT

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PHILIP MORRIS v FDA: DOCKET 6/6-6/7/16

June 7, 2016 4:18 pm by Gene Borio

06/06/2016 MINUTE ORDER: Pursuant to Local Civil Rule 7(n), the parties should have filed a jointly prepared appendix of the administrative record in this case. It appears from the docket that they have not done so. Accordingly, a joint appendix shall be filed on or before June 8, 2016, at 12:00 p.m. Signed by Judge Amit P. Mehta on 06/06/2016. (lcapm1) (Entered: 06/06/2016)

06/06/2016 Set/Reset Deadlines/Hearings: Joint appendix due by 6/8/2016. (cdw) (Entered: 06/07/2016)

06/07/2016 40 NOTICE OF SUPPLEMENTAL AUTHORITY by AMERICAN SNUFF COMPANY, LLC, ITG BRANDS, LLC, PHILIP MORRIS USA INC., R.J. REYNOLDS TOBACCO COMPANY, SANTA FE NATURAL TOBACCO COMPANY, INC., U.S. SMOKELESS TOBACCO COMPANY LLC (Attachments: # 1 Exhibit A)(Estrada, Miguel) (Entered: 06/07/2016)

06/07/2016 41 JOINT APPENDIX by AMERICAN SNUFF COMPANY, LLC, ITG BRANDS, LLC, PHILIP MORRIS USA INC., R.J. REYNOLDS TOBACCO COMPANY, SANTA FE NATURAL TOBACCO COMPANY, INC., U.S. SMOKELESS TOBACCO COMPANY LLC. (Estrada, Miguel) (Entered: 06/07/2016)

Nicopure v FDA: [PROPOSED] PROTECTIVE ORDER, Jun 6, 2016

June 7, 2016 4:13 pm by Gene Borio

The PDF is Here

EXCERPT:

5. Protected Information may be used only for the purposes of litigating this civil action and any appeals thereof. Except as provided in Paragraph 6, no person who obtains access to Protected Information pursuant to this Order shall disclose those documents or that information without either the prior, express, written consent of the producing party or its counsel, or further order of the Court.

6. Counsel for the parties may disclose Protected Information only to (a) the Court and its staff, including court reporters; (b) the attorneys of record for the parties; (c) associates and staff of the attorneys of record for the parties, but only to the extent necessary to perform their duties; (d) Defendants and their employees; (e) Plaintiff; (f) outside experts or consultants retained by any party, including their associates and staff, but only to the extent necessary to provide their services; and (g) third-party contractors engaged in copying, organizing, filing, coding, converting, storing, or retrieving data or information, including as part of a litigation support system, but only to the extent necessary to render such services.

7. Before Plaintiff’s counsel discloses Protected Information to any person listed in Paragraph 6(e)-(g), that person must be provided with a copy of this Order, and must sign a copy of the Acknowledgment and Consent form attached hereto (Exhibit A). Plaintiff’s counsel shall retain copies of the signed Acknowledgment and Consent forms in their litigation files and shall make them available to Defendants’ counsel upon request.

8. If Protected Information is disclosed to any person not listed in Paragraph 6, upon learning of such disclosure Plaintiff’s counsel must promptly (a) inform Defendants of the disclosure, including the surrounding facts and circumstances; and (b) request the return or destruction of the Protected Information and seek to minimize any further unauthorized disclosure.

END EXCERPT

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NICOPURE v. FDA: JOINT MOTION FOR ENTRY OF PROTECTIVE ORDER, Jun 6, 2016

June 7, 2016 4:05 pm by Gene Borio

The PDF is Here

EXCERPT:

3. The administrative record contains over 135,000 comments. FDA estimates that more than 10,000 of those are web-based comments from individual consumers, many of which contain personally identifying information, such as names and e-mail addresses, in the “submitter information” field. Although this identifying information is not disclosed online, it appears in the administrative record and cannot be redacted without a page-by-page review of all 135,000 comments. In addition, at least one commenter specifically designated its comment as confidential.

4. This information is private in nature, may be confidential, and may be protected from disclosure under the Privacy Act absent a court order. The entry of an order addressing the disclosure, handling, and use of this information would facilitate the production of the administrative record and promote an efficient resolution of this action.

5. Accordingly, the parties jointly request that the Court enter the attached Protective Order.

END EXCERPT

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