Paul Simmerly is another lawyer turned activist that has been busy investigating pharmaceutical companies and what he has found and proven is horrifying.
Sharyl Attkisson from Full Measure is also hot on their tail
Anyway I would like to share with you his press release and the documentation he has provided.
LADIES AND GENTLEMEN:
I am going to be a guest on Katherine Hines’ radio show tomorrow, Tuesday, May 10th from 11:30 AM to 1:00 PM Eastern Time. The following email I sent to Katherine summarizes the Procrit Scandal. Please forward this to your representatives in Congress, government regulators, journalists and any activists you can think of. Here’s a Bar Exam question for you: Count the instances of misconduct involved here.
Here’s a link to the show page for Bedlam in America: www.wljaradio.net/bedlam-in-america.html
I am glad you are interested in the Johnson & Johnson/Procrit/Mark Duxbury story. It is an incredible, multi-faceted and absolutely true story, but the details remain largely hidden from the public.
Along with lead attorney Jan Schlichtmann (played by John Travolta in the movie “A Civil Action”), I represented Mark Duxbury in a False Claims Act (aka the Qui Tam law) case, 31 U.S.C. Sec. 3729 et seq., alleging Medicare Fraud on the part of Johnson & Johnson (“J&J”) in the marketing, promotion and sale of its blockbuster drug, Procrit. The federal False Claims Act, also known as the Qui Tam law, is a 150 year old law passed by Congress during the Civil War to assist overworked prosecutors by allowing whistleblowers to act as private Attorneys General to sue for fraud committed against the United States (U.S. taxpayers). A simple example: A cannonball manufacturer has a contract with the Union Army and supplies 10,000 cannonballs, but bills the government for 15,000. A clerk in the billing department blows the whistle on this fraud against the government, files suit and gets a percentage of the recovery. The government can join the lawsuit at any time. Today, the False Claims Act is the primary way the United States recovers damages for fraud committed against it.
Procrit is an anti-anenia/anti-fatigue prescription drug that was invented, patented and manufactured by Amgen and sold by Johnson & Johnson pursuant to a Product License Agreement with Amgen for all uses except dialysis treatment. Its technical name is Epoetin Alfa (aka as EPO) and Amgen sells it under the brand name Epogen or EPO and J&J sells it under the brand name Procrit. At its peak, Procrit accounted for revenues to J&J of approximately $3 billion per year. For several years it was the most reimbursed Medicare drug.
In short, the Medicare Fraud occurred when J&J induced health care providers to submit false, full price claims for Medicare reimbursement for free and discounted drug and encouraged “off-label promotion” of the drug for uses and dosages that were not approved (the more profitable, unapproved dosage of 40,000 IU once per week was represented as being better than the approved 10,000 IU three times per week).
This Medicare Fraud scam was the same scam that was used by Amgen to sell Epogen and the same scam used by J&J to sell Risperdal, as well as literally hundreds of other Medicare Frauds perpetrated by other “Big Pharma” companies. The only difference in these pervasive scams is the name of the Big Pharma company and the name of the drug. From 1991 through 2012, there have been at least 303 Medicare Fraud settlements involving almost $30 billion in fraud damages against the U.S. taxpayers. See attached Public Citizen News article. J&J alone has settled 14 of these Medicare Fraud cases. That total does not include the 2013 Risperdal settlement for $2.2 billion with J&J over its marketing, promotion and sale of that drug, described in the attached DOJ Press Release. In each of these cases, the DOJ imposes what is called a “Corporate Integrity Agreement” in which the Big Pharma company pledges to not engage in similar conduct in the future. Obviously, these Agreements are ignored and not enforced. This is quite possibly the biggest scandal in the law today.
DOJ attorneys, charged with enforcing our Medicare Fraud laws, complain that these cases are complicated and time-consuming. However, that is the whole purpose behind the False Claims Act – to allow private attorneys to do the heavy lifting. Considering that these cases are all virtually identical and that they are all settled long before trial, that complaint rings very hollow.
Our client, Mark Duxbury, a Procrit salesman for Johnson & Johnson, testified truthfully in a deposition, pursuant to a subpoena he was served by Amgen in a lawsuit brought by Amgen against another company for illegally re-selling Procrit. Duxbury naively and innocently turned over documents that showed Amgen that he was selling Procrit in violation of its Product License Agreement with J&J. In short, Amgen sued J&J in a private arbitration under the auspices of a private mediation and arbitration company run by retired judges, Judicial Arbitration and Arbitration Services (“JAMS”) and fired Duxbury. I sued J&J for wrongful termination. After a couple hundred thousand dollars worth of work, we lost (I had it on a contingent fee and was never paid a dime and even advanced $3,000 in costs). The Court felt that getting his company involved in one of the biggest lawsuits in history ($30 billion potentially involved) was not sufficient reason to justify our argument of retaliation against Duxbury for being a whistleblower. I consider Mark Duxbury to be the Jeffrey Weigand (see Tobacco Litigation) of the pharmaceutical industry. Moral of the story – do not testify against your employer in a private arbitration unless they force you by court action and you respond with demands for retaliation protection and fees for an attorney.
In the wrongful termination lawsuit in King County Superior Court (we appealed to the Court of Appeals and Washington State Supreme Court as well), J&J’s attorneys were able to successfully argue that a protective order was appropriate to keep certain documents confidential even though it was in violation of long-standing, well-settled Washington State law. Of course, J&J could release anything it wanted, including defamatory material about our client Duxbury, but Duxbury was prevented from defending himself by using the secret documents and information contained therein. Of course, if the formula for Epoiten Alfa (Procrit or Epogen) had been a proprietary secret, or if how it was marketed and sold was some kind of trade secret, a Court Protective Order might have made sense, but the formula and how the drug is marketed and sold are in no way secrets. You can look up the formula on the Internet (see Wikipedia article) and get it in about .02 microseconds. If you want to sell the drug you could invest several hundred million dollars in manufacturing it and a several thousand person sales force to sell it and then watch as dozens of J&J and Amgen attorneys descend upon you to sue for damages which would bankrupt you.
In this private JAMS arbitration, the main issue, if not only issue, was how J&J and Amgen sold Procrit. Amgen makes it (and sells it under the name Epogen or EPO) and entered into a Product License Agreement for J&J to sell it for all uses except dialysis treatment. During years of depositions and six months of testimony during the final hearing, all witnesses testified that both companies violated criminal Medicare Fraud laws in their promotion, marketing and sales of the drug. All proceedings were secret. Virtually all witnesses for J&J committed perjury, which they were allowed to do with impugnity. Since all proceedings were secret, they faced no threat of prosecution. See attached arguments from J&J attorney.
At each day of the six month long final hearing of the secret arbitration, over one hundred attorneys attended the proceedings. The testimony covered how Amgen and J&J committed ongoing criminal Medicare Fraud. Ongoing criminal activity is not covered by attorney client privilege. In many states, an attorney has a duty to come forward and report his client’s ongoing criminal activity. Further, these attorneys were advising their clients on how to violate the Medicare laws and were therefore participants in the ongoing criminal activity. It was literally like two Mafia families getting together for a secret trial on how to divide the proceeds of their ongoing criminal activity. None of this is of any concern to the DOJ.
Procrit and Epogen were frequently prescribed for fatigue in cancer patients being treated with chemotherapy. Several years after Duxbury’s termination from J&J, the FDA issued a “black-box warning” banning the use of Procrit and Epogen for cancer patients because it caused cancer. It is believed that more than 500,000 people have died from the use of Procrit and Epogen.
We had a big problem in the False Claims lawsuit. United States Attorney General Eric Holder used to work for the law firm representing J&J, Covington Burling, before being appointed Attorney General. Many pages of the Covington Burling website trumpet how well they are connected with government and how many of their lawyers used to work for the government. The Department of Justice (DOJ) and Attorney General Holder went after Amgen, J&J’s direct competitor, and got them for Medicare Fraud in what was at that time the largest Medicare Fraud settlement in history. See the attached DOJ Press Release. Duxbury disclosed the secret JAMS Arbitration to the Department of Justice before the Amgen case was even filed. The DOJ used the evidence produced in the Amgen v. J&J Arbitration to achieve the Amgen settlement. But the DOJ elected to not intervene in the Duxbury case and go after J&J, Holder’s former client. I believe most DOJ attorneys wanted to go after J&J. Holder probably even worked on the Duxbury False Claims Act case since he specialized in Big Pharma defense while in private practice. This was a major conflict of interest. In a previous DOJ prosecution of Pfizer Corporation, Holder had recused himself from any involvement in the case because he had previously represented Pfizer and therefore had a conflict of interest. Holder’s failure to intervene in the Duxbury case cost the U.S. taxpayers more than $3 billion, depending upon how damages and penalties were assessed.
From the Wikpedia article on Eric Holder:
Return to private practice[edit]
In July 2015, Holder rejoined Covington & Burling, the law firm at which he worked before becoming Attorney General. The law firm’s clients have included many of the large banks Holder declined to prosecute for their alleged role in the financial crisis. Matt Taibbi of Rolling Stone opined about the move, “I think this is probably the single biggest example of the revolving door that we’ve ever had.”[158][159]
I made formal complaints to the Inspector General’s Office in the Department of Justice and to the Criminal Investigations Department at the FDA about the conduct of AG Holder and his attorneys which were wholly ignored.
Procrit and Epogen/EPO, being anti-fatigue medications, have frequently been used illegally by Lance Armstrong and other bicycle racers to win races, sometimes with fatal results. See attached articles. Ironically, while writing this I watched CBS’ 60 Minutes tonight and one of the segments was about a former member of the Russian track team who was banned from the Olympics for taking this drug and who blew the whistle on the entire Russian track team which is currently banned from this summer’s Olympics. Incredibly, Amgen is still the name sponsor of the Tour of California bicycle race.
Attorney General Holder recently charged Senator Robert Menendez of New Jersey for interfering in the Medicare Fraud investigation of a Menendez friend and contributor, the same conduct Holder is guilty of. I have contacted Judge William Walls, who is handling the Menendez case, and informed him about all of this. I will not allow someone to be prosecuted for the same conduct committed by his prosecutors.
Then, we have the JAMS conduct in the Erin Brockovich case (see attached). The JAMS Arbitrators in that case got gifts from the lawyers. This raises the profound question for attorneys of whether you should consider bribery, apparently a legal and authorized way to practice law, as a way to win your case in a private arbitration. Did you just see that the late Supreme Court Justice Scalia was the Supreme Court’s most frequent traveler, to spots around the globe, on trips paid for by private sponsors? According to The Seattle Times of February 27, 2016, when Scalia died, he was staying, again for free, at an incredibly exclusive West Texas hunting lodge owned by a businessman whose company had recently had a matter before the Supreme Court. This was in addition to the 258 subsidized trips that Scalia took between 2004 and 2014. Scalia went on at least 23 privately funded trips in 2014 alone (that’s two a month!). I guess given this Scalia conduct that it’s no wonder about the conduct of the Arbitrators from JAMS. Ironically, this Brockovich article by Kathleen Sharp is how I got in touch with her about the Procrit case. She then wrote a book and a screenplay was written, but production of the movie has been held up by threats of legal retaliation from J&J, of course. Ms. Sharp is definitely someone you should interview as well. At least one other person is writing an alternative script and I am doing the same.
The Duxbury case was in litigation almost ten years. The case was dismissed once by federal Judge Rya Zobel on the motion of J&J. She took 18 months to make her decision. Her ruling was reversed on appeal and J&J petitioned the Supreme Court for a writ of certiorari which was denied. Unfortunately, Mark Duxbury died of a lethal combination of prescription drugs and alcohol before we could finish the case. Upon remand, Judge Zobel dismissed the case again and that dismissal was upheld on appeal. Duxbury’s death was fatal to our case procedurally. If the DOJ had intervened in our case, I believe we would have won. Every previous case in which the DOJ has intervened has resulted in a settlement because a corporation losing a False Claims Act case carries the death penalty – a permanent injunction against ever again doing business with the United States.
The facts that I have alleged have never been denied by anyone. I have source documents, available upon request, to prove everything.
I am going to keep after this matter for as long as I live.
PAUL E. SIMMERLY
Duxbury – 9-1-15 letter to Judge Walls re Menendez with attachments
Duxbury – Armstrong NYT OpEd Duxbury – Blood Feud Prologue – How a cancer patient taking Procrit dies
Duxbury – DOJ vs. Amgen Settlement Press Release
Duxbury – DOJ vs. JJ Risperdal Press Release
Duxbury – J J Brief excerpt in JAMS Arbitration admitting perjury of all of its executives – excerpt Duxbury – Kathleen Sharp article for Cycling News re Amgen settlement
Duxbury – Public Citizen News – Holding Big Pharma’s Feet to the Fire
