MO v. FDA: DEFENDANTS’ REPLY IN SUPPORT OF THEIR MOTION TO DISMISS, OR IN THE ALTERNATIVE, FOR SUMMARY JUDGMENT, Feb 10, 2016

February 12, 2016 10:36 am by Gene Borio

The PDF is Here

EXCERPT:

Plaintiffs’ pre-enforcement, facial challenges to a guidance document issued by the United States Food and Drug Administration (FDA) are not ripe because the guidance document does not represent final agency action and Plaintiffs have not shown that they will suffer significant hardship if review is withheld. Even if Plaintiffs’ claims are ripe for review, the Court should grant summary judgment to Defendants. The guidance document sets forth reasonable interpretations of the Family Smoking Prevention and Tobacco Control Act (“TCA”), which harmonize the TCA’s structure and text and further its core purposes. Because the guidance does no more than advise the public of the agency’s interpretation of the statute it administers, it is not a substantive rule, and Plaintiffs’ procedural challenges to it are meritless. Finally, Plaintiffs’ constitutional challenges to the FDA’s interpretation of the TCA regarding label changes that render a product distinct should be rejected because the agency’s interpretation of the statute does not violate the First or Fifth Amendment. For all of these reasons, the government’s Motion to Dismiss, or in the Alternative, For Summary Judgment should be granted.

. . .

Finally, the government previously explained that FDA has not pursued a single civil or criminal enforcement action related to distribution of a new tobacco product without premarket review, has not issued a Warning Letter to any of the Plaintiffs related to any issue addressed in the Guidance, and, under the agency’s regulatory enforcement policy, ordinarily gives firms the opportunity to correct violations voluntarily “prior to the initiation of enforcement action.” Plaintiffs respond only that the fact that FDA “may choose to exercise its discretion to give manufacturers a chance to correct violations does not mean that FDA will always do so or that the threat of enforcement is any less real.” But Plaintiffs have offered no basis for presuming, on a facial challenge, that FDA will depart from its ordinary practices and policies.

CONCLUSION

For the reasons set forth above and in our opening brief, Defendants’ Motion to Dismiss, or in the Alternative, for Summary Judgment should be granted, and Plaintiffs’ Motion for Summary Judgment should be denied.

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SANTA FE: ORDER GRANTING STAY OF PROCEEDINGS PENDING A RULING BY THE JUDICIAL PANEL ON MULTIDISTRICT LITIGATION, FEB 5, 2016

February 8, 2016 5:45 pm by Gene Borio

The PDF is Here

EXCERPT:

ORDERED AND ADJUDGED, on this 5TH day of Feb., 2016, that:

1. All proceedings in this action are hereby stayed pending resolution of the Motion for Transfer of Actions to the District of New Mexico for Consolidation of All Pretrial Proceedings Pursuant to 28 U.S.C. § 1407 [MDL No. 2695] pending before the Judicial Panel on Multidistrict Litigation (the “MDL Motion”), or further order of this Court.

2. The Parties are directed to notify the Court within five (5) business days after the MDL Judicial Panel rules on the pending MDL Motion.

END EXCERPT

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6184 ORDER #62-Remand Re: Corrective Statements

February 8, 2016 4:35 pm by Gene Borio

The PDF is Here

EXCERPT:

ORDERED, that the Parties shall be governed by the corrective statements set forth on pages 4-6 of the accompanying Memorandum Opinion; and it is further

ORDERED, that the Parties shall determine what minor changes are needed to implement the Consent Order; and it is further

ORDERED, that the Parties shall file their proposed changes no later than April 1, 2016.

END EXCERPT

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MEMORANDUM OPINION to Order #62-Remand, Feb 8, 2016

February 8, 2016 4:21 pm by Gene Borio

The PDF is Here

EXCERPT:

Despite the fact that the Court of Appeals accepted the five topics that the Court had chosen to include and had rejected one sentence in the preamble designed to introduce the beginning of each of those topics, Defendants submitted a 40 page opening brief in opposition to the opening briefs of the Government and the Public Health Intervenors. In that brief, Defendants rewrote much of the five statements already approved by the Court of Appeals. Thus, when all is said and done, Defendants would now have this Court return to the drawing board and start the process all over again.

That is ridiculous — a waste of precious time, energy, and money for all concerned — and a loss of information for the public. The Court has no intention of following that path, although it is obvious that Defendants are, once again, attempting to stall any final outcome to this long-standing litigation. . . .

this Court adopts the corrective statements submitted by the Government and contained on pages 4-6 herein.

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DOCKET for USA v. PHILIP MORRIS USA, et al Feb 3-8, 2016

February 8, 2016 4:00 pm by Gene Borio

Date Filed # Docket Text

02/03/2016 6183 NOTICE OF WITHDRAWAL OF APPEARANCE as to COUNCIL FOR TOBACCO RESEARCH-USA, INCORPORATED. Attorney Steven S. Michaels terminated. (Johnson, Ada) (Entered: 02/03/2016)

02/08/2016 6184 ORDERED, in accordance with the per curiam Order of the Court of Appeals on August 5, 2015, that the Parties shall be governed by the corrective statements set forth on pages 4-6 of the accompanying Memorandum Opinion; the Parties shall determine what minor changes are needed to implement the Consent Order; and the Parties shall file their proposed changes no later than April 1, 2016. Signed by Judge Gladys Kessler on 2/8/16. (CL) (Entered: 02/08/2016)

02/08/2016 6185 MEMORANDUM OPINION to Order #62-Remand. Signed by Judge Gladys Kessler on 2/8/16. (CL) (Entered: 02/08/2016)

02/08/2016 Set/Reset Deadlines: Proposed changes needed to implement the Consent Order due by 4/1/2016. (CL) (Entered: 02/08/2016)

SANTA FE: DOCKET for Rothman v. Santa Fe Natural Tobacco Company, Jan 21-Feb 5, 2016

February 8, 2016 3:56 pm by Gene Borio

01/21/2016 18 NOTICE OF APPEARANCE by Michael Fraser Stoer on behalf of Reynolds American, Inc., Santa Fe Natural Tobacco Company, Inc.. (Stoer, Michael) (Entered: 01/21/2016)

02/02/2016 19 ORDER FOR ADMISSION PRO HAC VICE granting 17 Motion for Peter J. Biersteker to Appear Pro Hac Vice. ENDORSEMENT: The Clerk of the Court is requested to terminate the motion (doc. 17). SO ORDERED. (Signed by Judge Nelson Stephen Roman on 2/2/2016) (mml) (Entered: 02/02/2016)

02/02/2016 20 ORDER FOR ADMISSION PRO HAC VICE granting 16 Motion for Noel J. Francisco to Appear Pro Hac Vice. ENDORSMENT: The Clerk of the Court is requested to terminate the motion (doc. 16). SO ORDERED. (Signed by Judge Nelson Stephen Roman on 2/2/2016) (mml) (Entered: 02/02/2016)

02/05/2016 21 ORDER GRANTING STAY OF PROCEEDINGS PENDING A RULING BY THE JUDICIAL PANEL ON MULTIDISTRICT LITIGATION: All proceedings in this action are hereby stayed pending resolution of the Motion for Transfer of Actions to the District of New Mexico for Consolidation of All Pretrial Proceedings Pursuant to 28 U.S.C. § 1407 [MDL No. 2695] pending before the Judicial Panel on Multidistrict Litigation (the “MDL Motion”), or further order of this Court. The Parties are directed to notify the Court within five (5) business days after the MDL Judicial Panel rules on the pending MDL Motion. ENDORSEMENT: The Parties are also directed to notify, via written submission, the Court on or before April 7, 2016 of the status of the JPML hearing on March 31, 2016, and to seek further extension of the stay if appropriate. Failure to notify the Court as directed will result in the case being calendared. SO ORDERED. (Signed by Judge Nelson Stephen Roman on 2/5/2016) (mml) (Entered: 02/08/2016)

COTNER NOTICE OF FRAUD / REQUEST TO RE OPEN

February 1, 2016 5:21 pm by Gene Borio

The PDF is Here

EXCERPT:

[HANDWRITTEN:]

IN THE U.S. FEDERAL CLAIMS COURT, IN WASHINGTON, D.C., IS COTNER AND THE UNITED STATES -V- STATE OF OKLA. NO. 15-1236, UNCONTESTED.

THE STATE OF OKLA FALSIFIED EVIDENCE, DOCUMENTS AND APPLICATIONS IN THIS COURT, IN THIS CASE, TO DEFRAUD THE UNITED STATES GOVERNMENT OUT OF A MINIMUM OF ONE BILLION DOLLARS, NOW PROVABLE BY OVER 200,000 CLASS PLAINTIFFS IN OKLA. THAT THE STATE OF OKLA. STOLE THEIR SETTLEMENT MONEY FROM . . .

PETITIONER MOVES THAT COURT TO RE OPEN THIS CASE, ORDER AN AUDIT OF EACH STATUE, WITH SPECIAL ATTENTION TO OKLA., AND TO DO SO WITHOUT DELAY [illegible] SEEK REFUND. . .

RESPECTFULLY,

ROBERT COTNER, #93280

(FOR THE UNITED STATES)

[HANDWRITTEN:]

Leave to file granted–Judge Kessler–

1/28/16

END EXCERPT

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DOCKET for USA v. PHILIP MORRIS USA, et al Jan 29, 2016

February 1, 2016 5:15 pm by Gene Borio

Date Filed # Docket Text

01/28/2016 6181 NOTICE of fraud by ROBERT COTNER; (”Leave to file granted” by Judge Kessler) (td) (Entered: 01/29/2016)

01/29/2016 6182 MOTION to reopen by ROBERT COTNER; (See docket entry no. 6181 to view document.) (td) (Entered: 01/29/2016)

MO v. FDA: DOCKET, Jan 28, 2016

January 27, 2016 4:24 pm by Gene Borio

Date Filed # Docket Text

01/27/2016 37 Unopposed MOTION for Extension of Time to File Response/Reply as to 29 MOTION to Dismiss or, in the Alternative, Motion for Summary Judgment MOTION for Summary Judgment by SYLVIA M. BURWELL, STEPHEN OSTROFF, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Proposed Order)(Nelson, James) (Entered: 01/27/2016)

01/28/2016 MINUTE ORDER granting 37 Motion for Extension of Time to File Reply. It is further ordered that Defendants’ Reply in Support of Defendants’ Motion to Dismiss, or in the Alternative, for Summary Judgment, is due on or before February 10, 2016. Signed by Judge Amit P. Mehta on 01/28/2016. (lcapm1) (Entered: 01/28/2016)

MO v. FDA: PLAINTIFFS’ CONSOLIDATED MEMORANDUM OF LAW IN OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS, OR IN THE ALTERNATIVE, FOR SUMMARY JUDGMENT, AND REPLY IN SUPPORT OF PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT, Jan 15, 2016

January 23, 2016 12:47 pm by Gene Borio

The PDF is Here

EXCERPT:

In the Second SE Directive, however, FDA disregards the clear statutory distinction between the regulation of tobacco products and the regulation of tobacco product labels, and seeks to use a supposedly nonreviewable “guidance” document to impose a premarket review requirement on tobacco product labels. FDA’s defense of that extra-statutory power grab disregards settled precedent on the reviewability of final agency action, upends the structure of the Tobacco Control Act, and rewrites the plain statutory language. . . .

FDA makes virtually no attempt to establish that, as a matter of plain meaning, a tobacco product with a modified label but the identical physical characteristics constitutes a “new tobacco product” that “was not commercially marketed in the United States as of February 15, 2007.” . . .

FDA seeks to use the Second SE Directive to manufacture a third exception, arrogating to itself pre-approval authority that Congress expressly and deliberately withheld. . . .

the Court should enter summary judgment for Plaintiffs, declare the Second SE Directive to be unlawful, vacate it, and enjoin its enforcement.

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