FDA has posted 2 updates on its website, the first was the FDA background on the suit (<click here), and the second update, the FDA guidelines addendum (<click here), yesterday evening regarding the Preliminary Injunction that RxUSA we obtained.  Both of those postings are attached for your edification. As you can see, the FDA has taken the position that, as long as the Preliminary Injunction remains in force (assumedly for the duration of the lawsuit), it will honor the Preliminary Injunction nationwide and require pedigree information only back to the last authorized distributor (and will not require lot numbers and the like on pedigree documentation). RxUSA with Counsel Michael Levine's guidance is now moving into the next phase of the litigation where we will be conducting discovery and preparing the RxUSA et al  case for trial

FEDERAL JUDGE JOHANNA SEYBERT, US District Court, Eastern District of New York, on 12/5/2006, issued an injunction, in CV 06-5086 (JS) (AKT), blocking the Department of Health and Human Services and the U.S. (FDA) Food and Drug Administration from implementing regulations which, in our opinion would have virtually destroyed all Secondary Pharmaceutical Wholesale Distributors in the United States, and at the same time gutted the intent of Congress's institution of Pedigree, nationwide, to protect the nations drug supply. Please read carefully the entire order of Judge Seybert, in a courageous stand to expand the protection of the nations drug supply, and preserve the Constitution rights of The plaintiffs. See the complete final order by  <clicking here>

RxUSA and other Plaintiffs, prevailed in the action seeking injunctive relief, filed in Federal Court, Eastern District of New York CV 06-5086 (JS) (AKT). The Court, in the Magistrates opinion, is recommending the issuance an injunction . See the Report and Recommendation of Federal Magistrate A. Kathleen Tomlinson by (clicking here)

RxUSA and other Plaintiffs, on 11/22/2006,  filed an Order To Show Cause in the action against the Department of Health and Human Services and the U.S. (FDA) Food and Drug Administration. Please (click>)OTSC 11-22-2007 to review the filed documents in their entirety.

RxUSA Wholesale Inc., and other Plaintiffs announce the filing of an action for a declaratory judgement against the DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION ,  (<CLICK HERE)  on 9/20/2006 seeking a determination that the FDA’s rule (effective December 1, 2006) interpreting a section of the Prescription Drug Marketing Act which exempts Authorized distributors from providing pedigree information for pharmaceutical products (while requiring all others in the chain of distribution to provide such information) is unconstitutional.  The purpose of the action is to protect the Integrity, Safety and Security of the Nation’s Drug supply by requiring 100% National Pedigree Compliance by all US Drug Wholesalers, without  exception. The action has been filed in the Federal Court of the Eastern District of New York, Docket # 06 CV 5086.  

RxUSA files suit against McKesson Corporation 9/18/2006 (click here for complete details from the summons) filed 7/20/2006 in Supreme Court,  Nassau County, State of New York, Index Number  011564 seeking $54,160,257.88 in damages  McKESSON has made a motion to remove the RxUSA litigation to Federal Court. The Complaint, Docket No. 06 CV  4343(DRH)  in that action, having been removed to the Federal Court in the Eastern District of New York,  having been Amended by RxUSA in a filing made this day, September 19, 2006

Press Release 7/14/2006: RxUSA Wholesale Inc. (www.rxusawholesale.com) announced the filing, on 7/14/2006, in the Eastern District of New York, of a Complaint, DOCKET # 06 CV 3447, seeking  recovery of damages in the amount of $586,733,225.00, and in addition, the recovery of three-fold  damages ($1,760,199,675.00), together with reasonable attorneys' fees incurred by Plaintiff, and the costs and taxable disbursements of this action.  The complaint  alleges violations of various provisions of the United States Anti-trust laws, New York State Donnelly law violations, restraint of trade, illegal boycott, and (against some of the defendants) violations of the Federal RICO statutes and Federal Securities' laws and regulations.  The complaint alleges, among other things, that a concerted effort is underway to eliminate competition in the pharmaceutical industry by destroying the “secondary wholesale” class of trade and, thereby, keeping pharmaceutical prices artificially high for consumers, and exposing the public to a substantially weakened integrity and security of the Nation’s Drug supply. 

Anti-Trust Complaint filed 7/14/2006 (click here).  RxUSA Wholesale Inc. (www.rxusawholesale.com) announced the filing, on 7/14/2006, in the Eastern District of New York, of a Complaint, DOCKET # 06 CV 3447, seeking  recovery of damages in the amount of $586,733,225.00, and in addition, the recovery of three-fold  damages ($1,760,199,675.00), together with reasonable attorneys' fees incurred by Plaintiff, and the costs and taxable disbursements of this action.  The complaint  alleges violations of various provisions of the United States Anti-trust laws, New York State Donnelly law violations, restraint of trade, illegal boycott, and (against some of the defendants) violations of the Federal RICO statutes and Federal Securities' laws and regulations.  The complaint alleges, among other things, that a concerted effort is underway to eliminate competition in the pharmaceutical industry by destroying the “secondary wholesale” class of trade and, thereby, keeping pharmaceutical prices artificially high for consumers, and exposing the public to a substantially weakened integrity and security of the Nation’s Drug supply. 

SCHERING-PLOUGH IN DEAL SETTLING CRIMINAL AND CIVIL CLAIMS FOR $435 MILLION (<CLICK) (From Yahoo News 8/28/2006)- Schering-Plough Corp. said Tuesday it has agreed to pay $435 million and will plead guilty to conspiracy to settle a federal investigation into its drug sales and marketing practices and its clinical trial programs. Kenilworth, N.J.-based Schering-Plough said it will pay $255 million to resolve civil aspects of the previously disclosed investigation. A subsidiary, Schering Sales Corp., will pay a criminal fine of $180 million and plead guilty to one count of conspiracy under the agreement, which is subject to court approval.

FEDERAL TRADE COMMISSION OPINION "IN THE MATTER OF RAMBUS, Inc. DOCKET # 9302- (<CLICK) In this current Major opinion regarding future AntiTrust matters the Commissioner Pamela Jones Harbour, issued a unanimous opinion, covering the way the FTC will standardize application of their review policy affecting the following:  1-Standards of Review applying "The Preponderance of Evidence Standard as the FTC standard for adjudications; 2-Exclusionary Conduct and Course of Conduct standards;  3-Possesaion of Monopoly Power; 4-Causation; and 5-Spoliation  and FTC Remedies.

FEDERAL TRADE COMMISSION  VS. CARDINAL HEALTH INC and BERGEN-BRUNSWIG CORP; and FEDERAL TRADE COMMISSION  VS. MCKESSON CORP and AMERISOURCE HEALTH CORP (<CLICK)

Bristol-Myers Squibb agrees to record Securities Litigation Settlement  (<CLICK)

FTC RULES THAT CONSUMMATED MERGER IS ANTICOMPETITVE- (<CLICK)  PERHAPS THE FTC WILL DECIDE TO RECONSIDER THE RUSHED McKESSON/DK MERGER IN LIGHT OF CURRENT ALLEGED ANTI TRUST AND MONOPOLY CHARGED FILED IN THE RXUSA SUIT ABOVE?????

IN RE BRAND NAME PRESCRIPTION DRUGS ANTITRUST LITIGATION, 288F.3RD-BRAND NAME ANTI TRUST ACTION  2002 (<CLICK)

THE PUBLIC, CONGRESS AND THE ATTORNEY GENERALS OF EACH AND EVERY STATE IN THESE UNITED STATES OF AMERICA,  ARE RESPECTFULLY REQUESTED TO JOIN THIS FIGHT TO PROTECT THE AMERICAN PUBLIC'S RIGHT TO THE BEST SECURITY AND SAFETY FOR THE DRUG SUPPLY AND TO KEEP DRUG PRICES AS LOW AS POSSIBLE:  We realize that the big drug companies have enormous political and financial power and will probably try to crush us, but we feel we have a civic duty to our customers and the citizens of the United States to make sure that competition remains alive in the pharmaceutical industry to keep consumer prices more  affordable.  We view this as a fight to protect all of us.   Just as we have  donated a substantial portion of our profits to charity, we feel that we have to take up this gauntlet, regardless of the personal expense and harm to us, for the good of the public and our friends in our industry. Please join with us in this effort. We can be reached at our E-mail address: litigation@rxusa.com

Request for Secondary Pharmaceutical Wholesalers to join coming class action (click here)

PDMA ACT DISCUSSION AND OPINION ABOUT PEDIGREE REQUIREMENTS AND THE IMPACT TO THE DRUG INDUSTRY: PLEASE READ THE ATTACHMENT TO GAIN A DEEPER UNDERSTANDING OF THE ISSUES AFFECTING THE SECONDARY WHOLESALER AND PROTECTING THE SAFETY AND INTEGRITY OF THE DRUG SUPPLY IN THE USA.

PDMA PROFILE OF THE WHOLESALE INDUSTRY FINAL REPORT- ORIGINAL 'FINAL' REPORT FOR VIEWING

PDMA ACT- ATTACHMENT G-INDUSTRY PROFILE- FOR YOUR REVIEW