DOCKET for FORSYTH v MPAA

July 15, 2016 9:01 pm by Gene Borio

Date Filed: 02/25/2016
Jury Demand: Plaintiff
Nature of Suit: 370 Other Fraud
Jurisdiction: Diversity

Date Filed # Docket Text

07/15/2016 44 RESPONSE (re 31 MOTION to Strike 1 Complaint, Defendants’ Notice of Motions and 1 Special Motion to Strike Pursuant to California Anti-SLAPP Statute, Cal. Civ. Proc. Code Section 425.16 et seq., or, in the alternative, 2 Motion to Dismiss Pursuant, 33 MOTION to Strike Complaint ) filed byTimothy Forsyth. (Attachments: # 1 Declaration Declaration of David Schachman)(Schachman, David) (Filed on 7/15/2016) (Entered: 07/15/2016)

07/15/2016 45 Request for Judicial Notice re 44 Opposition/Response to Motion, filed byTimothy Forsyth. (Related document(s) 44 ) (Schachman, David) (Filed on 7/15/2016) (Entered: 07/15/2016)

NICOPURE v FDA: MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF NICOPURE LABS, LLC’S MOTION FOR SUMMARY JUDGMENT, July 8, 2016

July 11, 2016 6:03 pm by Gene Borio

The PDF is Here

EXCERPT:

In the Deeming Rule, FDA has purported to regulate products outside the scope of its statutory authority. It has purported to subject Nicopure and the rest of the vaping industry to crushing regulation in the interest of the public health while conceding that there may not be any public health interest in the regulation. FDA compounded this improper approach by ignoring reasonable, more flexible alternatives to the “all-or-nothing” approach taken with respect to vaping products. The agency also abdicated its obligation to conduct a reasoned cost-benefit analysis. And it has violated Nicopure’s First Amendment rights. This Court should set aside the Deeming Rule’s regulation of vaping devices and e-liquids.

END EXCERPT

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NICOPURE v. FDA: DECLARATION OF JEFF STAMLER, July 8, 2016

July 11, 2016 5:46 pm by Gene Borio

The PDF is Here

EXCERPT:

1. I am the CEO and co-founder of Nicopure Labs, LLC (“Nicopure”). I began working for Nicopure on October 22, 2009. I have personal knowledge of, and am competent to testify regarding, the following.

. . .

13. In total, Nicopure produces over 2,400 types of stock keeping units (“SKUs”), with approximately 40% of those consisting of e-liquid. The remaining 60% of Nicopure’s SKUs are for vaporizers and related parts such as batteries, replacement tanks, empty cartridges, heating coils, wall chargers and adapters, mouthpieces, and USB chargers, none of which contains or is derived from tobacco, and none of which is intended for human consumption. For example, SKU #XG6XPASS- MANU-BLCK is a rechargeable battery, which is not made or derived from tobacco, and which is not intended for human consumption.

14. Of Nicopure’s approximately 950 e-liquid SKUs, 83% contain nicotine.

. . .

21. In contrast to the uncertainty of approval, the immense cost of filing a PMTA for a single product (let alone a product portfolio) is definite. FDA itself estimates that the average cost per e-liquid PMTA will be $131,643, and that the average cost of a vaporizer PMTA will be $440,725.

. . .

32. In other words, as of August 8, 2016, Nicopure cannot continue to bring innovative new products to market without (i) investing the substantial time and money required to prepare a PMTA, and (ii) waiting for FDA to adjudicate the PMTA. That process is likely to take years to complete

. . .

33. But for the Deeming Rule, Nicopure would continue to work to improve the variety, quality, and performance of its e-liquids and vaping devices by researching, developing, and introducing new products.

. . .

44. The Deeming Rule will also restrict Nicopure’s ability to make truthful, nonmisleading statements to consumers. Beginning on the Rule’s effective date, Nicopure will not be able to inform consumers that its products are free of, or contain reduced levels of, any substance, without an order of approval from FDA. These restrictions cover, among other things, truthful, nonmisleading statements that Nicopure’s products are free of smoke, ash, tar, and certain chemicals.

END EXCERPT

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NICOPURE v. FDA: NICOPURE LABS, LLC’s MOTION FOR SUMMARY JUDGMENT, July 8, 2016

July 11, 2016 5:39 pm by Gene Borio

The PDF is Here

EXCERPT:

The Court should enter summary judgment in Nicopure’s favor; declare that the Deeming Rule exceeds FDA’s statutory authority, is arbitrary, capricious, or an abuse of discretion, was promulgated with an unlawful cost-benefit analysis, and is contrary to the First Amendment; and vacate and set aside the Deeming Rule.

END EXCERPT

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DOCKET for NICOPURE LABS, LLC v. FDA et al, Jun 23-28, 2016

June 26, 2016 7:28 pm by Gene Borio

EXCERPT:

All further filings with this Court shall be filed only in Nicopure Labs v. FDA, Civil Action No. 16-878. Nicopure Labs’ motion for summary judgment shall be filed by July 8, 2016. The Right to Be Smoke-Free motion for summary judgment, which must be focused on the claims unique to those plaintiffs, shall be filed on July 25, 2016. Defendants’ opposition to both motions and cross-motion for summary judgment, which shall be supported by a single memorandum of points and authorities, shall be filed by August 16, 2016. Nicopure and Right to Be Smoke-Free shall file a consolidated reply in support of their motions for summary judgment, and in opposition to defendants’ cross-motion for summary judgment, by August 26, 2016. Defendants’ reply in support of their cross-motion shall be filed by September 9, 2016. The hearing on the motions currently set for September 8, 2016 is hereby vacated, and a motions hearing will be held on October 19, 2016 at 10:00 a.m. in Courtroom 3. Defendants’ obligation to answer the complaints in both cases shall be held in abeyance pending the resolution of the parties’ cross-motions for summary judgment. See Order for complete details. SO ORDERED. Signed by Judge Amy Berman Jackson on 6/28/2016. (lcabj3) (Entered: 06/28/2016)

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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