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RJR v. FDA: Judge Leon’s Memorandum Opinion (Nov. 7, 2011) 

CONCLUSION

This case poses a constitutional challenge to a bold new tact by the Congress, and the FDA, in their obvious and continuing efforts to minimize, if not eradicate, tobacco use in the United States. Notwithstanding the potential legal and financial ramifications of this challenge, the Government, for reasons known only to itself, is unwilling to voluntarily stay the effective date of this Rule until the Judicial Branch can appropriately review the constitutionality of the Government's novel -- and costly -- approach to regulating tobacco packaging and advertising. Thus, this Court must -- and will -- act to preserve the status quo until it can evaluate, on the merits (and without incurring irreparable harm to those companies genuinely affected), the constitutionality of the commercial speech that these graphic images compel. Therefore, for all the foregoing reasons, this Court concludes that the plaintiffs have demonstrated: (1) a substantial likelihood of success on the merits; (2) that they will suffer irreparable harm absent injunctive relief; (3) that neither the Government, nor the public, will suffer any comparable injury as a result of the relief sought; and (4) that the public's interest in the protection of its First Amendment rights against unconstitutionally compelled speech will be, in fact, furthered. Accordingly, the plaintiffs' Motion for Preliminary Injunction [Dkt. #11] is GRANTED. An order consistent with this decision is attached herewith.

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On Petitions for a Writ of Certiorari to the Florida First District Court of Appeal (PDF) 

The Campbell and Martin cases, which involve an even more extreme departure from traditional judicial procedures than did Scott, provide the Court with a more focused opportunity to consider the extent to which the Due Process Clause limits the authority of States to significantly alter those procedures in the name of increased judicial efficiency. Given the increasing frequency with which state courts have been willing to jettison traditional procedural rules in the name of litigation efficiency in the class action context, review of the decisions below is particularly warranted.

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DOCKET FOR RJR, et. al. v. FDA Jan. 1-Jan. 31, 2012 

01/13/2012 NOTICE of Oral Argument on 10 35 MOTIONS for Summary Judgment. Oral Argument is set for 2/1/2012 at 11:00 AM in Courtroom 18 before Judge Richard J. Leon. (jth) (Entered: 01/13/2012)

01/13/2012 50 AMICUS BRIEF by AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN LEGACY FOUNDATION, AMERICAN LUNG ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, AMERICAN PUBLIC HEALTH ASSOCIATION, CAMPAIGN FOR TOBACCO FREE KIDS, PUBLIC CITIZEN. (znmw, ) (Entered: 01/17/2012)

01/13/2012 51 AMICUS BRIEF by WASHINGTON LEGAL FOUNDATION. (znmw, ) (Entered: 01/17/2012)

01/13/2012 52 AMICUS BRIEF by AMERICAN ADVERTISING FEDERATION, ASSOCIATION OF NATIONAL ADVERTISERS. (znmw, ) (Entered: 01/17/2012)

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• 2012-01-26 MEMORANDUM OPINION on deferring a decision on corrective statements (PDF) 

The Court has concluded, for the following reasons, that there will be no deferral of decision-making regarding the corrective action statements.

1. It is perfectly clear from Defendants’ Response that the litigation challenging the Regulations promulgated by the Food and Drug Administration (“FDA”) . . . will not end (if ever) for an extremely long period of time. The case now pending before our Court of Appeals will, unquestionably, take at least one or more years to get resolved and an additional one to two years if the Supreme Court decides to grant certiorari which the loser before our Court of Appeals will undoubtedly request. In short, the period of any such deferral of decision-making would be both lengthy and indefinite. . . .

the public interest in obtaining such a remedy far outweighs any concern about judicial economy.

4. The issues to be addressed on remand here are very different substantively from and are governed by different statutory standards than those raised in R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration . . .

6. Finally, the Tobacco Control Act specifically stated in very clear language that “[n]othing in this Act . . . shall be construed to . . . affect any action pending in Federal, State or tribal court, or any agreement, consent decree, or contract of any kind.”

For all these reasons, the Court will not defer a decision on the corrective action statements pending the outcome of R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration.

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ORDER #28-REMAND: CONSENT ORDER BETWEEN USA, INTERVENORS, AND LORILLARD re: DOCUMENT DISCLOSURE OBLIGATIONS (Dec. 27, 2011) 

Upon consideration of the Joint Motion for Consent Order Between the United States, the Public Health Intervenors (hereafter "Plaintiffs"), and Lorillard Tobacco Company (hereafter "Lorillard") Concerning Document Disclosure Obligations Under Order #1015, and the entire record herein, it is hereby ORDERED that:

A. Lorillard will deposit, on or before the dates indicated below, the amounts indicated below with the Registry of the Court:

Friday, January 13, 2012 $217,000

Monday, December 31, 2012 $217,000

Tuesday, December 31, 2013 $216,000

Total: $650,000

B. The Registry of the Court will, upon receipt of each of these installments, disburse the funds to the University of California, San Francisco (hereafter "UCSF").

C. Lorillard will make these payments primarily in lieu of its prior obligations under Order #1015 to code the person mentioned, organization mentioned, and brand mentioned fields and as part of a resolution of the scope of Lorillard's coding obligations for documents posted on its public document websites as a result of production in court or administrative actions in the United States concerning smoking and health, marketing, addiction, low-tar or low-nicotine cigarettes, or less hazardous cigarette research both prior to November 15, 2011, and on or after that date. . . .

A. This Consent Order is without prejudice to Lorillard's argument that Order #1015 does not apply retrospectively, and no party will cite this Consent Order as a basis for arguing that any other part of Order #1015 applies retrospectively.

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DOCKET FOR USA v. PHILIP MORRIS USA, et al Dec. 23-Dec. 29, 2011. 

12/23/2011 5960 NOTICE by R.J. REYNOLDS TOBACCO COMPANY (Francisco, Noel) (Entered: 12/23/2011)

12/23/2011 DEPOSIT of Funds into registry of the Court on December 23, 2011, in the amount of $200,000.00. Receipt Number 4616044746 by RJ REYNOLDS TOBACCO CO. (dr) (Entered: 12/27/2011)

12/27/2011 5961 Consent ORDER 5958 Between the United States, the Public Health Intervenors, and Lorillard Tobacco Company Concerning Document Disclosure Obligations Under Order #1015. Signed by Judge Gladys Kessler on 12/23/11. (alp) (Entered: 12/27/2011)

12/29/2011 5962 ORDER #29-Remand: No Defendant shall remove any document from the population available to the public at the [Minnesota] Depository until further Order of the Court (see Order for details). Signed by Judge Gladys Kessler on 12/19/11. (CL, ) (Entered: 12/29/2011)

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RJR Notice of Deposit of $200,000 (PDF) 

NOTICE

Defendant R.J. Reynolds Tobacco Company hereby gives notice that it has deposited its payment of $200,000 due by December 31, 2011 pursuant to Order #27-Remand into the Registry of the Court.

Dated: December 22, 2011

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• DELAWARE COUNTY LICENSED BEVERAGE ASSOCIATION, AMERICAN LEGION POST 19, AMERICAN LEGION POST 167, AMERICAN LEGION POST 446, AMVETS POST 12, and LOW BOB'S TOBACCO V. DELAWARE COUNTY (PDF) 

In reviewing an ordinance passed by a governmental body, such as the County Commissioners, a judge cannot substitute her own judgment on whether the ordinance is wise or fair to all concerned. The judge cannot strike down an ordinance just because it results in undue economic hardship on certain businesses. The judge cannot balance the interests of the public who want to visit smoke-free establishments versus those who want the freedom to use tobacco products in bars and private clubs.

I

This Court will decline to find the ordinance at issue unconstitutional, for the reasons outlined below. But the Court hopes Plaintiffs will seek review by a higher court. The appellate courts in Indiana have not addressed this issue. These courts may see the issue in a different light from the trial court.

The way this trial court sees the issue, balancing various interests, weighing economic impacts, and determining public policy issues belongs solely to the Delaware County Commissioners. Ultimately, Plaintiffs have presented a political issue. The Court is not referring to political as in "Democrat," "Republican," or "Independent." The Court is referring to the political process where voters elect people to offices to make these decisions, and if people are not satisfied with the decisions made, they use the political process to replace the officials who made the decision.

The court is obviously not advocating that the voters remove any of the three Delaware County Commissioners from office because they passed the Ordinance. The Court is saying that if any plaintiff does not agree with the Ordinance, he or she has a remedy: using the political process to change or repeal the Ordinance.

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(Proposed) ORDER #___-REMAND: CONSENT ORDER BETWEEN USA AND LORILLARD re: DOCUMENT DISCLOSURE OBLIGATIONS UNDER ORDER #1015  

Upon consideration of the Joint Motion for Consent Order Between the United States, the Public Health Intervenors (hereafter “Plaintiffs”), and Lorillard Tobacco Company (hereafter “Lorillard”) Concerning Document Disclosure Obligations Under Order #1015, and the entire record herein, it is hereby ORDERED that: . . .

II. Monetary Terms

A. Lorillard will deposit, on or before the dates indicated below, the amounts indicated below with the Registry of the Court:

Friday, January 13, 2012 $217,000

Monday, December 31, 2012 $217,000

Tuesday, December 31, 2013 $216,000

Total: $650,000

B. The Registry of the Court will, upon receipt of each of these installments, disburse the funds to the University of California, San Francisco (hereafter “UCSF”).

C. Lorillard will make these payments primarily in lieu of its prior obligations under Order #1015 to code the person mentioned, organization mentioned, and brand mentioned fields and as part of a resolution of the scope of Lorillard’s coding obligations for documents posted on its public document websites as a result of production in court or administrative actions in the United States concerning smoking and health, marketing, addiction, low-tar or low-nicotine cigarettes, or less hazardous cigarette research both prior to November 15, 2011, and on or after that date. . . .

A. This Consent Order is without prejudice to Lorillard’s argument that Order #1015 does not apply retrospectively, and no party will cite this Consent Order as a basis for arguing that any other part of Order #1015 applies retrospectively.

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DEFENDANTS’ RESPONSE TO ORDER OF NOVEMBER 17, 2011 on Correctives 

Defendants respectfully submit this response to this Court’s Order of November 17, 2011, which directed the parties “to submit their views on the following questions: (1) should this Court defer consideration of the issue of corrective action statements (as well as the issue of retail store advertising placement), (2) if so, for how long should such consideration be deferred?” D.E. 5950 at 2 (Nov. 17, 2011). In Defendants’ view, this Court should defer its resolution of the pending corrective-statement and point-of-sale issues until the conclusion of the ongoing appellate proceedings in the D.C. Circuit, and any subsequent proceedings in the U.S. Supreme Court, in R.J. Reynolds Tobacco Co. v. United States FDA, _ F. Supp. 2d _, 2011 WL 5307391 (D.D.C. Nov. 7, 2011), appeal pending No. 11-5332 (D.C. Cir.). That appeal from Judge Leon’s order preliminarily enjoining the FDA’s graphic-warnings rule raises several issues that overlap with those before this Court, and is currently proceeding on an expedited briefing schedule. In the interests of judicial economy, this Court should therefore await the resolution of that appeal before deciding the pending corrective-statement and point-of-sale issues.

In R.J. Reynolds, Judge Leon issued a preliminary injunction against the implementation of an FDA rule that requires cigarette manufacturers to display a series of nine rotating graphic- warning labels on the top 50% of the front and back of every cigarette package and the top 20% of advertisements. . . .

Deferring resolution of the corrective-statement and point-of-sale issues until the D.C. Circuit rules is unlikely to generate significant delay. After noticing an appeal on November 29, 2011, the Government filed an Unopposed Motion to Set Expedited Briefing Schedule. Pursuant to that request, the D.C. Circuit expedited briefing of the appeal: The Government has already filed its opening brief and all briefing in the appeal will be completed by February 13, 2012; oral argument is scheduled for April 10, 2012. It is therefore possible that the D.C. Circuit will be in a position to issue an opinion in the spring of 2012. See also 28 U.S.C. § 1657(a) (requiring “each court of the United States” to “expedite the consideration of . . . any action for temporary or preliminary injunctive relief”).

Deferring resolution of the pending corrective-statement and point-of-sale issues would therefore constitute a sound case-management decision that is likely to conserve this Court’s resources without engendering significant delay.

CONCLUSION

This Court should defer resolution of the pending corrective-statement and point-of-sale issues until the conclusion of appellate proceedings in the D.C. Circuit, and any subsequent proceedings in the U.S. Supreme Court, in R.J. Reynolds Tobacco Co. v. United States FDA.

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USA re Correctives, Dec. 20, 2011 

UNITED STATES’ RESPONSE TO ORDER SEEKING VIEWS ON DEFERRING CONSIDERATION OF RECOMMENDED CORRECTIVE STATEMENTS

On November 17, 2011, the Court directed the parties to submit their views on whether the Court should defer considering the issue of corrective statements and point-of-sale placement of the corrective statements within retail stores; and if so, for how long. The United States urges the Court to continue to move forward on this remedy expeditiously. The time that the Court originally contemplated for the Defendants to make the required corrective statements has long since passed. Waiting for further events in other cases is unnecessary, as future appellate decisions will not assist the Court in resolving the issues before it here, and delay is not in the public interest. What is more, the Court has already addressed—and explicitly rejected—the arguments that Defendants are most likely to muster in favor of further waiting.

ARGUMENT

1. POSTPONING DECISION ON CORRECTIVE STATEMENTS WILL NOT CONSERVE JUDICIAL RESOURCES, BUT WILL GIVE DEFENDANTS INDIRECTLY WHAT THE COURT REFUSED TO GIVE THEM DIRECTLY . . .

2. POSTPONING DECISION ON THE CORRECTIVE STATEMENTS WOULD BE CONTRARY TO THE PUBLIC INTEREST, AS THIS COURT HAS PREVIOUSLY FOUND . . .

When denying Defendants’ vacatur motion in this case nearly six months ago, the Court observed that “[i]t has been well over eleven years since this case was filed and nearly five years since this Court found that Defendants ‘knowingly and intentionally engaged in a scheme to defraud smokers and potential smokers, for purposes of financial gain, by making false and fraudulent statements, representations, and promises.’ ” US v. PM Vacatur Decision, 787 F. Supp. 2d at 82 (internal citation omitted). It is now more than twelve years since this case was filed, and over five years since the Court found Defendants liable and ordered a corrective- statement remedy. The corrective-statement remedy should be implemented now.3

CONCLUSION

For the reasons stated above, the United States respectfully urges the Court not to defer its consideration of this important remedy.

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PUBLIC HEALTH INTERVENORS’ RESPONSE TO THE COURT’S NOVEMBER 17, 2011 ORDER ON CORRECTIVES  

The Court has already correctly determined that the remedies imposed in this case remain necessary and appropriate irrespective of the Family Smoking Prevention Act. See United States v. Philip Morris USA, Inc., 787 F. Supp. 2d 68 (D.D.C. 2011) (denying Defendants’ motion for vacatur). This is particularly true with regard to the corrective statements remedy, which the Court of Appeals explained will “prevent and restrain [Defendants] from making fraudulent public statements on smoking and health matters in the future.” In short, while litigation over the Family Smoking Prevention Act is likely to continue for years, corrective statements are needed now to prevent and restrain Defendants from their continuing misconduct, which the Court has already found – and the Court of Appeals affirmed – is likely to continue. 566 F.3d at 1134 (the record “amply support[s]” the “conclusion that Defendants ‘continue to make false and misleading statements . . . .”) (other citations omitted); see also, e.g., United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 910 (D.D.C. 2006) (“As Defendants’ senior executives took the witness stand at trial, one after another, it became increasingly clear that these Defendants have not, as they claim, ceased their wrongdoing or, as they argued throughout the trial, undertaken fundamental or permanent institutional change”). . . .

Finally, the mere fact that First Amendment arguments are being raised against both this Court’s corrective statement remedy and the FDA Act certainly does not counsel in favor of delaying resolution of corrective statements until such matters have been completely resolved (including on appeal) in the other case pending in this Circuit. Should any future decisions regarding that case – such as, for example, a ruling in the Court of Appeals – become relevant to any issues remaining before this Court, they can be taken into account at that time, just as the ultimate resolution of the issues this Court is considering regarding the corrective statement remedy may inform the resolution of the challenge to the FDA Act (which has not yet even been heard on summary judgment). Accordingly, the mere fact that both cases involve the First Amendment issues is not a reason to delay the corrective statements remedy in this case.

Conclusion

For the foregoing reasons, the Court should not delay resolution of the corrective statements remedy in light of the ongoing litigation under the FDA Act and its implementing regulations or for any other reason. Rather, to prevent and restrain further misconduct, the Court should order Defendants to issue corrective statements without delay.

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Philip Morris Notice of $200,000 payment (PDF) for Documents  

NOTICE

Defendants Altria Group, Inc. and Philip Morris USA Inc. hereby give notice that they have deposited their payment of $200,000 due by December 31, 2011 pursuant to Order #27- Remand into the Registry of the Court.

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• ORDER #27-REMAND: CONSENT ORDER CONCERNING DOCUMENT DISCLOSURE OBLIGATIONS UNDER ORDER #1015 

it is hereby

ORDERED that:

Defendants' document disclosure obligations under Order #1015 (DN 5733, Aug. 17. 2006), published as United States v. Philip Morris USA Inc., 449 F. Supp. 2d 1, 940-44 (D.D.C. 2006), aff'd in part & vacated in part, 566 F.3d 1095 (D.C. Cir. 2009) (per curiam), cert. denied, 561 U.S._, 130 S. Ct. 3 501 (2010), are MODIFIED as set forth below. . . .

II. Monetary Terms

A. Philip Morris USA Inc. and Altria Group, Inc. (collectively, hereafter "PM") and R.J. Reynolds Tobacco Company (hereafter "RJR"') will each deposit, on or before the dates indicated below, the amounts indicated below with the Registry of the Court:

Friday, December 30, 2011 $200,000

Wednesday, February 15, 2012 $750,000

Friday, February 15, 2013 $750,000

Friday, February 14, 2014 $750,000

Monday, February 16, 2015 $675,000

Total (PM and RJR each): $3.125 million

Total (combined): $6.25 million

B. The Registry of the Court will, upon receipt of each of these installments, disburse the funds to the University of California, San Francisco (hereafter "UCSF").

C. PM and RJR will make these payments in lieu of their prior obligations under Order #1015 to code person mentioned, organization mentioned, and brand mentioned fields, and as part of a resolution of the scope of their coding obligations for documents posted on their public document websites as a result of production in court or administrative actions . . .

III. Monetary Conditions and Technical Meetings with UCSF

A. The funds deposited with the Registry of the Court will be used by UCSF to improve access to and functionality of the Legacy Tobacco Documents Library, e.g., through coding documents and providing enhanced search capabilities (with the understanding that the university may assess some percentage for indirect costs). UCSF will not use these funds for any other purpose.

B. As a condition for receipt of the payments provided in Paragraph A above, UCSF will file through the ECF system, by December 31 of each year (beginning in 2012) and up to and including the final year in which these funds are used, a certification confirming that these funds have been used only for the purposes described in the preceding paragraph and not for any other purpose.

C. If UCSF uses any of these funds in a manner inconsistent with Paragraph B, any such funds will be refunded to the Registry of the Court. In that event, the parties will have thirty (30) days to apply to the Court requesting that the funds either be refunded to Defendants, or used in some other manner related to document coding and/or document websites. . . .

c. The technical requirements for documents posted to Defendants' Internet Document Websites are as follows:

i. Posting Requirements for Hardcopy and Electronic Documents

A. For scanned hard-copy documents, Defendants will post to their websites searchable PDFs of the documents, with Optical Character Recognition (OCR) search capability, and will include OCR text in a separate text file.

B. For electronic-source documents (both email and non-email), Defendants will post to their websites searchable PDFs of the documents, with OCR search capability, and will provide the extracted electronic text in a separate text file, unless those documents are redacted, in which case OCR text will be provided.

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DOCKET FOR USA v. PHILIP MORRIS USA, et al Dec. 13-Dec. 21, 2011. 

12/15/2011 5953 ORDER #27-REMAND: Consent Order Between the United States, the Public Health Intervenors, Philip Morris USA Inc., Altria Group, Inc., and R.J. Reyonlds Tobacco Company Concerning Document Disclosure Obligations Under Order #1015. Signed by Judge Gladys Kessler on 12/14/2011. (tth) (Entered: 12/15/2011)

12/20/2011 5954 RESPONSE TO ORDER OF THE COURT re 5950 Order, filed by ALTRIA GROUP, INC., LORILLARD TOBACCO COMPANY, PHILIP MORRIS USA INC., R.J. REYNOLDS TOBACCO COMPANY. . . .

12/20/2011 5956 MEMORANDUM by TOBACCO-FREE KIDS ACTION FUND. . . .

12/20/2011 5957 NOTICE by ALTRIA GROUP, INC. . . .

12/20/2011 DEPOSIT of Funds into registry of the Court in the amount of $ 200,000.00

12/20/2011 5955 RESPONSE TO ORDER OF THE COURT re 5950 Order, Seeking Views on Deferring Consideration of Recommended Corrective Statements filed by UNITED STATES OF AMERICA. . . .

12/21/2011 5958 Joint MOTION for Order Concerning Document Disclosure Obligations under Order #1015 by AMERICAN CANCER SOCIETY, AMERICAN HEART ASSOCIATION . . .

12/21/2011 5959 NOTICE OF AGREEING TO BE SUBJECT TO CONSENT ORDER by REGENTS OF THE UNIVERSITY OF CALIFORNIA re 5958 Joint MOTION for Order Concerning Document Disclosure Obligations under Order #1015 (Leff, Peter)

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