AMERICAN FRAUD and The Tylenol Murders

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J&J Scandal
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JOHNSON & JOHNSON WHISTLEBLOWERS
 


 

 

 
 
J&J ORTHO-BIOTECH PROCRIT WHISTLEBLOWERS

 

On October 13, 2009, less than two months after winning the following landmark verdict, Mark Duxbury died at the age of 49, an unsung hero. Kathleen Sharp's book, Blood Feud, tells Duxbury's story.

 

Drug Rep in $3B Procrit Case: "80% of My Sales Were Medicare Fraud"

 

Aug 17, 2009

 

The whistleblowers in the Procrit qui tam case claim that their careers at Johnson & Johnson’s Ortho Biotech unit were based mostly on lies. Mark Duxbury and Dean McClennan, both former sales reps at J&J, claim that the bulk of their business selling Procrit to hospitals and clinics was conducting Medicare fraud.

 

Duxbury claims he sold $13 million of Procrit between 1992 through 1998, and that approximately 80 percent of those sales were “false or fraudulent claims for Medicare reimbursement.”

 

McClennan sold more than $65 million of Procrit, and about 50 percent of his sales were fraudulent Medicare claims, he alleges.

 

The case — which J&J denies — was revived by a Massachussetts federal appeals court last week. It contains the usual complaints: marketing the spread between the price reimbursed by Medicare and the lower price the company sold it at, and off-label marketing.

 

But it also names names. Dozens of them: Doctors, hospitals, and clinics. In each case it describes how the doctor or institution took advantage of J&J’s schemes to lower the price it sold Procrit to doctors at, while asking the government to reimburse at the higher “average wholesale price.”

 

The whistleblowers’ lawyer says Medicare was defrauded of $3 billion.

 

Broadly, the complaint states (download here), J&J is accused of:

… giving providers unreported unlawful front end and back end payments in the form of “off-invoice” discounts, rebates, account credits, and other cash or cash equivalent payments such as phony “grants”, “advisory board honoraria”, and “donations” directly tied to the providers’ purchase of Procrit.

The complaint alleges that J&J did this by making presentations to hospitals demonstrating the savings they could make by overbilling Medicare.

 

The pair also carried "free patient trial cards" worth at least $400,000 in free Procrit, which they could hand out to customers who would then bill Medicare for the full retail price of the drug:

Defendant routinely referred to free Procrit as “cash.” Defendant employees Thomas Amick, William Pearson, Robert Ashe, George Mooney, William Ball, John Woodhouse, Keith Wood, Michael Barton and Robert Nelson instructed Relator Duxbury to treat free Procrit as a “cash” equivalent incentive to Providers.

 

Defendant employees which include numerous managers during this time period, including but not limited to Dwayne Marlowe, James Scelfo, Robert Ashe instructed Relator McClellan to treat free Procrit as a “cash” equivalent incentive to Providers.

J&J, in its motion to dismiss (download here), does not contend that the allegations of Medicare fraud are false, but that the complaint is deficient because Relators are not the "first to file."

 

Because Mark Duxbury and Dean McClellan objected to J&J's illegal and dangerous marketing practices, they were fired.

 

 

Federal appeals court revives multibillion-dollar Medicare fraud case brought by whistleblowers

 

August 13, 2009

 
A federal appeals court has issued a major reversal in a case charging a Johnson & Johnson subsidiary with a multi-billion-dollar Medicare fraud. The decision revives claims of former pharmaceutical sales representatives who alleged a kickback scheme to illegally market a powerful drug used with deadly side-effects and defraud the United States government.

 
The 1st U.S. Circuit Court of Appeals in Boston reinstated part of the whistleblower lawsuit brought by former Johnson & Johnson sales representatives Mark Duxbury and Dean McClellan. The appeals court sent that part of the case, dealing with doctor kickbacks, back to the original court that had dismissed the case, the U.S. District Court in Boston.

The whistleblowers charged Johnson & Johnson and its subsidiary, Ortho, of boosting profits at the expense of the taxpayers and endangering the lives of hundreds of thousands of patients.

They say Ortho illegally marketed Procrit, an anti-anemia drug, and engaged in a scheme to provide kickbacks to providers who prescribed and over-utilized the drug in ways it was not approved for at the time by the Food and Drug Administration.

Procrit was among the world’s best-selling drugs. It was used by cancer patients who had undergone chemotherapy and suffered from anemia as a result.
 
Attorney Jan Schlichtmann was the lead counsel for the plaintiffs, former sales representatives Mark Duxbury and Dean McClellan.

“After almost six years of denials, it is time for Johnson & Johnson to own up to the charges of illegal marketing, kickbacks to providers and attempts to plunder the U.S. Treasury,” said Schlichtmann. “It is time the United States Department of Justice intervenes in this case, which charges the largest-ever defrauding of Medicare.”
 
 
 

 
 
ZOMAX WHISTLEBLOWERS
 
Dr. James A. Dale, former J&J assistant director of medical research, and Edward F. Lemanowicz, a senior scientist who served as liaison with the Food and Drug Administration, alleged that company officials sought to mislead the public, the FDA and the medical profession about potentially dangerous side effects.
 
Because Dr. James Dale and Sr. Scientist Edward Lemanowicz put the public's safety over Johnson & Johnson's profits, they were fired.
 
Zomax was on the market for 28 months before McNeil suddenly recalled it.  But by that time, so many physicians had been gulled into believing the painkiller to be both safe and useful that they had prescribed it for nearly 15 million people.  By the Food and Drug Administration's accounting, the drug had contributed to at least 14 deaths.  These deaths followed anaphylactoid reactions, allergic or hypersensitive responses that commonly lead to a drop in blood pressure, difficulty in breathing, facial swelling, rashing, and itching.  In addition to the 14 who died, more than 2,200 other Zomax users suffered allergic reactions, including 403 for whom the reactions were life-threatening. (It is conventional scientific wisdom that adverse drug reactions are grossly underreported.)
 
The FDA from the start considered Zomax, the first nonsteroidal anti-inflammatory drug it approved, to be the only drug of its kind to pose a possible cancer risk to humans.  Based on an independent review of an animal study, Dr. M. Adrian Gross, a former FDA toxicologist, rated the cancer risk of Zomax "highly significant."
 
By the time McNeil ceased sales in the United States, it had sold $100 million worth of Zomax here, although the company admitted it knew of five Zomax-related deaths and of 1,100 reports of allergic reactions.  Still, J&J was not going to give up its millions so easily.  After the recall, McNeil sought FDA approval to remarket the drug with a strict new package insert, saying it was approved only for chronic pain, and even then as a last resort. And it continued to sell the drug abroad - another stumbling block before the blind - well into the following year.

J&J CEO, James Burke, told the The Washington Post he was proud of his company's handling of Zomax, rejecting suggestions that J&J should have withdrawn the drug immediately after the February meetings in Pennsylvania.  Once the company decided to recall the drug, he said, "I think we did a good thing - I don't see how you could do it any faster."

Dr. Dale wasn't quite so proud. The deaths "were avoidable," he told the Post.  "They were avoidable side effects. . . . I feel guilty. . . . We met and had the opportunity to take action. . . . We could have done something sooner."

Despite his devastating perspective on J&J's marketing of Zomax, Dale has never testified in a Zomax lawsuit.  In the several cases in which his testimony was sought - testimony in which he would reveal the advice of McNeil's three top physicians at the February 1983 meetings - J&J did what it has done in numerous embarrassing law suits:  It settled, on condition that the court files be sealed forever.
 
Source:  Drug Fiends
 
 
 
LIFESCAN WHISTLEBLOWERS
 
On Tuesday, March 31, 1998, thirty to forty federal agents raided  the headquarters of J&J subsidiary, LifeScan. They cordoned off the building and served a search warrant.
 
The raid came after two whistleblowers filed a claim with the government alleging that LifeScan was knowingly manufacturing and selling to the general public a faulty blood glucose monitoring system consisting of the SureStep meter and test strips.  They identified two problems with the system: (1) that the system erred by sometimes giving extremely low readings when the test strip had not been fully inserted into the meter; and (2) that the system improperly displayed an “error” message when the user’s blood glucose level was abnormally high, rather than indicating that the level was high.  The whistleblowers also alleged that the labeling was false in that it failed to identify these problems in what was, in actuality, a defective medical device.  The LifeScan whistleblowers further alleged that LifeScan had sought to conceal these problems from the FDA.

Johnson and Johnson executives ignored the whistlblower employees who told executives about the serious problems with the device. J&J executives ignored the whistleblowers when they asked J&J to alert the FDA and consumers about the defects.
''Mistakes were made in the LifeScan situation,'' said CEO, Ralph Larsen. ''There were errors in judgment. We did too little, too late.''
 
The whistleblowers filed a lawsuit agaist J&J in October 1997.  After a three year investigation, in December 2000, the government intervened in the case and reached a settlement that required LifeScan to plead guilty to criminal violations and to pay $60 million in fines and civil penalties.
 
LifeScan acknowledged that they introduced an adulterated and misbranded medical device, failed to provide appropriate notifications and information to the FDA, and submitted false and/or misleading reports to the FDA. The company also admitted that the Surestep labeling was deficient, that it did not properly notify the government of those deficiencies and that it was slow to remedy them completely.
 
Because these J&J employees put the public's safety over Johnson & Johnson's profits, they was fired.
 
 
 
 
 
RISPERDAL WHISTLEBLOWER
 
In July 2002 Allen Jones, an investigator at the Pennsylvania Office of the Inspector General (OIG), was appointed lead investigator when he uncovered evidence of payments into an off-the-books account. The account, earmarked for "educational grants" was funded in large part by Pfizer and J&J subsidiary, Janssen Pharmaceutica. Payments were made from the account to state employees who developed formulary guidelines recommending expensive new drugs over older, cheaper drugs with proved track records.
 
Jones attempted to expose evidence of the pharmaceutical companies wrongdoings, which included influencing state officials with trips, perks, lavish meals, and transportation to and first-class accommodations in major cities. Some state employees were paid honorariums of up to $2,000 for speaking in their official capacities at drug-company sponsored events.  Jones met stiff resistance by OIG officials.  He was told that pharmaceutical companies are major political contributors and that he should not continue his probe. Jones stated that he was effectively threatened with loss of job, career and reputation if he continued to investigate the pharmaceutical companies.  He was removed from the drug investigation, forbidden to inquire further, and assigned to menial duties.
 
Jones was escorted out of his workplace on 28 April and told "not to appear on OIG property" after OIG officials accused him of talking to the press.
 
In 2004 Jones initaited a Qui Tam lawsuit alleging that J&J's Janssen Pharmaceutica unit caused the government to overspend on Risperdal.  The complaint alleges that J&J used deceptive marketing techniques to promote specific guidelines for prescribing antipsychotics that favored the use of Risperdal over older and much cheaper medications.  The result was a huge increased in sales of Risperdal, a drastic increase in costs to Medicaid, and endangering patients.
 
In  December 2006, Texas Attorney General, Greg Abbott, joined Allen Jones' Qui Tam lawsuit accusing Johnson & Johnson and five of the their subsidiaries--including Janssen Pharmaceutical, the manufacturer of Risperdal, for bilking the state Medicaid / Medicare budget.  Since then numerous additional States have joined the lawsuit and are seeking hundreds of millions of dollars in damages.
 
 
Because Alan Jones put the public's safety over Johnson & Johnson's profits, he was fired.
 
 
CHEIF MEDICAL OFFICER WHISTLEBLOWER
 
Johnson & Johnson fired its chief medical officer, Joel Lippman, because of his insistence that unsafe medical products be recalled. J&J repeatedly released or refused to recall dangerous products to which he objected, including the Ortho-Evra birth control patch and Intergel. -- http://www.yourlawyer.com/articles/read/12377
 
Because Dr. Joel Lippman put the public's safety over Johnson & Johnson's profits, he was fired.
 
Ortho Evra: A study was released that confirmed previous studies showing an increased risk of blood clots associated with the use of Ortho Evra versus oral contraceptives. The study found that women using Ortho Evra were twice as likely to develop blood clots as those using oral contraceptive pills. Blood clots can lead to heart attacks and strokes.
 
J&J Ethicon's Cardiac device: Lippman claims the case that led directly to his illegal firing involved three complaints he received that an Ethicon arterial cannula called DFK24, a life-sustaining device used in heart bypass surgery, lost its tip during surgery, and had to be retrieved from the patient’s aorta.
 
J&J Ethicon - Intergel: Lippman says that he demanded, for more than a year, that Intergel be recalled, and that after "a decision to recall the product was made," he was summoned to the office of Michael Dormer, "Chairman of Medical Devices and Diagnostics for J&J in New York City," where Dormer and four attorneys attacked him "for the decision to recall Intergel".
 
Michael Dormer resigned in 2007, after he admitted the company used bribes to secure overseas foreign business.
 
 
ORTHO McNEIL WHISTLEBLOWER - Bribes and illegal kickbacks 
 
Ed West was fired from his job at J&J subsidiary Ortho-McNeil after he refused to participate in illegal kickback schemes or to pay bribes to hospital officials.
 

Subsequently, West filed a Qui Tam lawsuit claiming that Ortho-McNeil Pharmaceutical and its parent corporation, Johnson & Johnson, pursued a marketing strategy that gave kickbacks and unlawful remuneration to hospitals. The case is currently active and the following allegations are contested by Johnson & Johnson.

 

In 1999, the introduction of the newer, cheaper competitor drug Tequin by Bristol-Myers Squibb threatened to encroach upon Levaquin’s market share. Prompted to pursue more aggressive marketing tactics, Ortho-McNeil resorted to illegal kickback schemes

designed to gain and maintain a competitive edge.

 

When West was employed as an Ortho-McNeil sales representative, his manager instructed him to make a $5,000 payment to Holy Cross Hospital in Chicago. He was told that four other Ortho-McNeil employees would make equivalent payments, for a combined total of $25,000.

 

In fact, his supervisor told him that a regional manager had, with the permission of the Ortho-McNeil home office, executed a

similar payment to a different Chicago hospital for the same purpose of inducing the hospital to retain Levaquin on its formulary.

 

According to West, cash bribes were not the only fraudulent marketing practice implemented by Ortho-McNeil. Ortho-McNeil sales representatives also offered conditional price discounts; that is, purchasers would receive a discount only if they agreed to drop competitor drugs from their formulary. Specifically, West alleges that, in 2002, an Ortho-McNeil sales representative offered a price discount on Levaquin to Holy Cross Hospital on the “condition that the hospital ‘no longer stock Cipro,’” even though, according to West, Cipro was approved for treatment of several illnesses for which Levaquin was not.

 

West also alleges that Ortho-McNeil cut rebate checks running into “the tens of thousands of dollars” payable to hospitals that purchased Levaquin. When Ortho- McNeil sales representatives delivered these checks to the hospitals, they were instructed to tell the hospitals that hospitals could easily hide these rebates from Medicare and Medicaid – and thus make a “hidden profit” on Levaquin.

 

According to Relator, Ortho-McNeil also marketed another “hidden profit” mechanism to hospitals by encouraging them to divide and re-use single use premix bags of Levaquin in order to create a secret discount and increase hospital profits and Levaquin sales.

 

Finally, West alleges that Ortho-McNeil created other kickbacks under the guise of “speaker fees,” “research grants,” and other gifts to particular doctors who regularly prescribed Levaquin. West was fired by Ortho-McNeil in July 2000. According to West, he was fired after he refused to participate in providing Holy Cross Hospital with cash payments as part of the scheme described above.

 

Because Ed West objected to J&J's illegal marketing practices, and refused to pay kickbacks he was fired.

 

J&J Loses Bid to Dismiss Whistleblower Lawsuit

 

 

 

 

 

 

 

Sean Dix, The American Dream, And Justice (Floss At Your Own Risk)

 

Part I

By Mary Sparrowdancer

© Copyright, July 2008

7-17-08

In 1993, a gifted young inventor in Manhattan named Sean Dix created and then patented a new dental flossing device called FlossRings. His next patented invention was sterilized dental floss in five-inch segments that would be inserted into the FlossRings. These were revolutionary advancements in dental health care, but Sean did not realize how revolutionary they were at the time. He would not discover until 1995, that his would be the only sterilized and sterilely packaged floss in the industry. Like most of us, Sean assumed that all dental floss was sterile. The unfortunate truth is that it is not.  

The FlossRings were sterling, stainless steel, or plastic red, blue or clear ring-like devices that fit over the two index fingers, holding five inches of floss between them. They make flossing easier, even for people with dexterity problems, and an Indiana University study ten years ago reported that the FlossRings and sterile segments removed 23.8% more plaque than Johnson&Johnson (J&J) waxed floss alone. While this paper was being written in 2008, however, it was discovered that the actual percentage number was not 23.8 percent. It was an astounding 31 percent. An "x" and a "y" in the equation had been reversed by someone working in the study. This would be but one of numerous unexplained "oddities" to be encountered by the man who invented sterilized dental floss.

At the time of his inventions, Johnson&Johnson had been enjoying its position as a leader in the flossing industry for almost 100 years. In 1994, J&J began showing interest in the Dix FlossRings and invited Sean to a meeting with their worldwide acquisitions leader, Brian Bootel. Also in the meeting were the J&J marketing director, and the head of research and development. Sean met with them one afternoon in May of 1994, showed them his goods, and showed them how sterile floss segments could be sterilized and packaged sterilely like Band-Aids. As the marketing director began to show visible excitement over what Sean was showing them, Sean states that Mr. Bootel extended his right foot under the conference table and kicked her.

Sean had no idea that on this spring day in 1994 the only person in that room (and the only person in the U.S.) who knew how to make and package sterile dental floss was Sean Dix. He was the dreamer who, despite having no college training, had easily solved the one problem that the old spooled dental floss industry had been unable or unwilling to solve for one century. He knew that the way to keep dental floss sterile for each use was to package it in segments instead of winding it by the yard around spools.

No one said a word, however. No one in the J&J conference room told Sean that he was showing them the only feasible way of putting sterile floss on the market.

It was strangely synchronistic that while this meeting was taking place in 1994, Johnson&Johnson was going through another "un- sterile" situation that was also being kept quiet. This was another sterilization matter that J&J felt the public need not hear about. Most of us, including Sean, would not hear about Johnson& Johnson's Ethicon Vicryl sutures until 1999. The Vicryl sutures were being distributed for use in surgical procedures in 1994, despite the fact that Ethicon's sterilization equipment had stopped functioning in their plant in Texas.

Sean Dix did not accept the agreement offered to him by J&J in June of 1994. He sensed that something was not quite right and that the personnel were behaving oddly, although he still had no idea what their secret might have been. He instructed his attorney to issue a letter terminating his relationship with J&J, which was carried out via telecopier on June 28, 1994. Ignoring that letter, and with Sean Dix still on their minds, in August, Mr. Bootel, again contacted Sean and offered a better agreement. This time Sean signed it, entering a brief "evaluation confidentiality agreement" with J&J. During this time, J&J would conduct tests, and Sean was to maintain silence about his products.

The J&J personnel continued their own silence regarding the revolutionary sterile flossing concept, and they conducted an evaluation using only five sets of FlossRings provided by Sean.

Oddly, after the evaluation J&J decided they did not wish to pursue things further, stating they had "other internal strategic objectives" to pursue. According to Sean, they also refused to honor Item 10 of their own agreement, in which J&J had promised to share the results of their study. Sean moved on, leaving J&J behind and he began focusing on his manufacturing plans.

It was in the spring of the following year, 1995, that Sean learned the truth about conventional, spooled dental floss while he prepared for the manufacturing phase of his own products.

In a matter-of-fact manner, an industry expert broke the news to Sean about his planned sterile floss.

"You realize you are going to be the only one who has sterilized floss in the industry," the expert said to Sean.

"My jaw dropped," Sean stated to me as he remembered that life- changing moment.  

Stunned, Sean states he then asked the man, "You mean floss isn't sterilized?" To which the man replied: "None."

Worse, Sean learned that the non-sterilized floss spools were assembled and packaged by hand. Sean wondered how many others also assumed in error that the floss they were inserting deep into gum tissue was sterile. He placed an ad in the Village Voice, asking for volunteers to take a poll in exchange for some free FlossRings. Question #2 of the poll asked the following:

"2.) Did you know that all dental floss currently on the market is Not Sterilized and is packaged by hand A) Yes___ B) No___"  

Of the 41 people who responded, all 41 checked B, "No." One hundred percent of those answering this poll and every other poll he conducted assumed in error that their floss was sterile. No one knew it was being handled by people providing cheap factory labor in various countries throughout the world, including China.

In November of 1995, Sean contacted Robert Morrissey, the author of a 624-page book written about the importance of sterilization titled, "Sterilization Technology." Sean had read the book, and wanted to have a chat with Mr. Morrissey about the importance of sterilized dental floss. It was not difficult to locate Mr. Morrissey because Mr. Morrissey also happened to work for Johnson&Johnson. Sean wished to make certain that the top experts at J&J were aware that their company was declining a technique that would have given Johnson&Johnson the honor of bringing sterilized floss into the marketplace.  

Further documenting this phone conversation, Sean then wrote a letter to Morrissey, stating, "The consumers believe that floss is sterile and given the choice, 100 out of 100 as polled would opt for the sterile floss." He mentioned again that he had offered Johnson&Johnson the opportunity of bringing sterilized floss to the marketplace, and that he would now do this, himself. "Above and beyond the confines of boardroom politics," Sean wrote, "we have the duty to make progress in the area of sterilization."

Morrissey did not reply. Sean felt the phone call and correspondence were gestures of good will to make certain that top experts at a company he highly respected were aware that they were declining a revolutionary idea. But this gesture also did something else. It put Johnson&Johnson on notice that Sean had finally realized the enormity of what he had invented. He finally knew he would bring the only sterile dental floss to the market.

Sean never dreamed how seriously his innovations had rattled the century-old spooled floss industry. He thought fair business competition was part of the American Dream and there would be fair play among the competitors. He assumed that competition meant healthier, safer products for the public. But the future was to hold an unimaginable nightmare for the solitary man about to bring on a dental revolution.  

In the ensuing months, favorable reviews of Sean's inventions poured in. Among the first to give positive reviews were Forbes FYI, the Boston Globe, and Bloomberg News. His products were praised as "revolutionary" and helping to modernize dental care. In June of 1996, his products would be placed on permanent exhibit in The National Museum of Dentistry in Baltimore, a museum that is affiliated with the Smithsonian.

By 1996, Sean's FlossRings were available in CVS drugstores nationwide, with other stores also placing orders. Easily affordable at $1.99, the first in-store orders were selling out.

Dix planned to sell the soon-to-be-manufactured sterile floss segments for $1.99 per package, as well. Investors were lined up, and Mr. Bootel, years later, estimated that the market potential for Sean's products was approximately $50 to $100 million yearly.

This represented a hefty percentage of the yearly US floss market that was being enjoyed by industry spooling giants, including Johnson&Johnson, but it made sense. Most people would choose sterile floss over that which is not sterile, the same as they would sensibly choose sterile Band-Aids over non-sterile wound dressings. And, there would be only one sterile dental floss available: the floss created by Sean Dix.

Sean sent a video of his Hammacher Schlemmer proposal for notable inventions to Bloomberg News, CNN and others. While Sean was receiving nationwide orders, favorable media attention and his first products were selling well, while investors were lined up, while the prototypes of the sterile segments had been created and were on the verge of major manufacturing and just a week prior to being honored by the Smithsonian's affiliate museum, Sean was contacted by media giant CNN. They also wanted to do a news feature on his inventions. He was thrilled and felt that being on CNN news would surely launch his emerging revolution.  

Questions that some might be asking at this point are: why have we never heard about any of this, and why in 2008 are we still flossing with non-sterile dental floss that is spooled and hand- packaged by factory workers? Where are the Sean Dix FlossRings shown to remove significantly more plaque than Johnson& Johnson's waxed floss alone? Where are the Sean Dix sterile floss segments, proudly and sterilely made in the USA? Who took our product choices away from us? Who removed the new competition from the old- fashioned spooled dental floss market?

These are questions that the public might wish to direct toward Ted Turner, CNN, and Johnson&Johnson.  

The CNN crew filmed Sean first at a Drug Guild meeting, and then the crew of Jeanne Moos filmed him at CVS and his apartment. They filmed him stating he had invested approximately $60,000 into his products. He explained again that his products were about to be honored in the National Museum of Dentistry, talked again about the sterility issue and why his superior floss would be an exciting new competitor in the floss market. They already knew all about this, however, long before they ever contacted Sean as they had seen and heard all of this in their copy of the Hammacher Schlemmer video.

As Moos prepared to leave, Sean states she paused to comment on the enormous aftereffects of being on a CNN news segment. "You realize that a piece like this can either make you or break you," she said. Sean found this statement curious. Since his products had received good reviews, he dismissed the warning.

The news clip was scheduled to be run on June 12, 1996. Sean, his investors, his potential investors, his national sales team, his family and his friends were all waiting to watch the clip, and Sean phoned CNN to find out when, exactly, it would be aired so they would not miss it. He was told that it would be aired right after Larry King Live, and he thanked the reporter. "Don't thank me yet," she said, "you might not like it."

As everyone watched, CNN aired the clip, and stunned silence filled Sean's mother's apartment as it unfolded on national TV. The clip was an insulting mockery of Sean Dix and his inventions. In addition, it contained inaccurate scenes invented by Moos and the crews. Removed entirely from the film footage was any and all mention that Sean Dix was about to offer people the only sterile dental floss on the market. In fact, the word, "sterile" was carefully omitted from all dialogue. The sterile floss segments were instead referred to by Moos as "pre-tipped floss segments." There was no mention of the fact that conventional floss is not sterile, which might have truly come as "news" to the millions of viewers watching. There was no mention that Sean's sterile product would have forced the old-fashioned dental spooling giants into an expensive modernization of their equipment in order to compete with one young man by the name of Sean Patrick Dix.  

No mention was made about his products being placed on permanent exhibit at the Smithsonian's affiliate museum. Instead, the "news" clip created by Moos was filled with sarcastic ridicule in which she equated his inventions to the sort of junk one finds in a box of Cracker Jack. Her clip began and ended as she poured a cheap, noisy sound-card playing the "Mission Impossible" theme from a box of Kellogg's Corn Pops. The clip never mentioned that Sean had turned down J&J's first agreement. It showed only the later letter from J&J stating they had changed their minds. Two dentists fumbled with the rings and gave disparaging ratings. Sean would later be told that one of the dentists involved was the personal dentist of Moos. Moos ended this clip stating of Sean, "He's a man with a mission - -" and then loudly playing the Mission Impossible theme song again. Above this din she stated, "Try playing that on your FlossRings."

The "American Dream" of a young inventor dissolved overnight into a surrealistic nightmare as Ted Turner's CNN news comedians played their destructive Mission Impossible Corn Pops clip, not once, not two or three times, but repeatedly. Sean need not have worried about "missing" this airing, because the Turner outfit aired it continuously throughout the night and the next day on numerous programs, as well as continuously on "Headline News" until there was complete national saturation. It is not known how many days CNN repeatedly played this destructive clip, because Sean Dix stopped watching CNN on June 13th as his business collapsed around him.  

The warning that Jeanne Moos had given Sean about CNN's ability to "make or break" a person, became a reality. When CNN was finished with its false advertising campaign, Sean Dix was completely broken. The investors and national sales teams fled in the aftershock and embarrassment. The empire of Ted Turner destroyed Sean's business, scattered his investors and successfully eliminated the only competition to the spooled dental floss market, overnight. But Sean points out that he was not the only one harmed by this act. The American consumers were harmed as well. We lost our chance to finally have a superior, sterile dental floss, and we lost a chance to have an improved way of flossing that specifically out-flossed Johnson&Johnson's waxed floss, alone.

Some at CNN defended this clip as merely being "humorous," but there is truly nothing humorous about a media giant using its full broadcasting capabilities to air an incomplete and inaccurate clip for the purpose of nationally destroying a worthy new competitor who stood poised to become the new leader in the dental floss industry.

This hatchet job was especially egregious considering the fact that Johnson & Johnson has a heavy presence on Turner Broadcasting. CNN regularly features Johnson & Johnson's products and services on their website as though they were "news," thus blurring the distinction between news and product advertising. Press releases have stated that CNN "collaborates" with J&J. In a press release for "Safe Kids," Turner Broadcasting is referred to as "Johnson & Johnson's partner." Turner has also installed former top Johnson&Johnson personnel into top management within the massive Turner industry, a fact that is worthy of consideration because most shareholders would ostensibly want to protect their shareholder investments. In addition, Johnson&Johnson is among the top ten largest advertisers on earth, another important business consideration especially when comparing J&J's potential advertising revenue to that of one single man, Sean Dix. It was the solitary man who stood to have become a serious competitor with the industry giant, should he have been allowed to move forward.

Because of close ties to the floss-giant, J&J, CNN could have ethically refused to review the products of the new floss competitor who was threatening J&J's grip on the floss market.

They could have claimed a "conflict of interests," but they chose to eliminate the competition, instead. Ironically, in the State Science and Technology Institute magazine dated June 14, 1996, two days after Sean Dix's revolutionary products had been destroyed on national television by CNN, Johnson & Johnson was listed as having been named by President Clinton to receive a National Medal of Technology, the nation's highest technology honor, for "contributions to the present state of knowledge," and for "technological innovation and advancement of U.S. global competitiveness."  

Overnight, the one man who dared to compete with the Goliath of the spooled-floss industry lost everything. In fact, Sean had been so powerfully wiped out and undone, he could not even afford to sue the giant "partners" for what they had done to him. The entire outdated spooled floss industry was then left to carry on "as is," with no need for an expensive machinery upgrade in order to compete with Sean Dix.

Sean quickly discovered that the two dentists shown fumbling with the FlossRings on the Moos news clip had not been allowed to read the package instructions prior to using them, nor had they been made aware that the floss segments were a superior, sterilized product.  

After realizing that CNN had manipulated them, one of the dentists wrote a letter to Sean stating, "I feel it only fair to write you with regard to the manner in which I was first exposed to your product" The dentist, George D. Reskakis, D.D.S., and his staff stated that the CNN film crew simply handed the FlossRings to the dentists and asked them to demonstrate and rate them. One dentist was asked to use 18 inches of floss, instead of the five inches as directed on the package. Dr. Reskakis wrote: "Since that initial time I have carefully reviewed all of the information and documentation . . . Upon further review, and with the addition of the sterile pre-knotted floss, I now feel this is a viable and potentially valuable product for my patients." But what the dentist might have desired for his patients was apparently of no concern to anyone at CNN. Sean began immediately sending this information to CNN, including copies of the Reskakis letter, but his letters and his phone calls were completely ignored. There would be no retraction, no correction, no apology and CNN felt that the matter was closed.

Throughout 1996 and into 1997, Sean dedicated himself to politely attempting to correct CNN, to no avail. His FlossRings would eventually be seen on many news sources, including the New York Times, Prevention Magazine, the Saturday Evening Post, Glamour Magazine and numerous others, but his investors never returned after the massive, national cable campaign that had been carried out by CNN.

Peter Lusk, a potential investor wrote, "I have known Sean Dix since 1995 and am familiar with his 'Floss Rings' product.

Before the [Jeanne Moos] CNN article, I was willing to invest approximately $100,000 personally, and attempt to raise an additional $1,000,000 for the 'Floss Rings' product. Due to the embarrassingly negative and trivializing tone of the CNN article, I found it very difficult to approach my contacts and my family's contacts for potential investment. These contacts include, but are not limited to, Peter Lusk Sr., Tony Forstmann, Theodore Forstmann, Joel Leff, William F. Harnish, Lionel Pincus, Whale Securities and other accredited investors."

In April of 1997, as the legal, corporate, and human rights of Sean Dix continued to be trampled, Johnson&Johnson took out a full page dental floss ad in Prevention Magazine to appear opposite the magazine's dental news feature called "Your Healthy Smile."

The ad announced J&J's new line of improved floss. Incredibly, appearing in the J&J ad were two clear ring-like devices magnifying the J&J floss. On the opposite page were unauthorized photos of a smiling model happily using a pair of Sean's blue FlossRings to floss her teeth, but nowhere in the Prevention article were the FlossRings identified as Dix FlossRings. There was no mention anywhere of Sean Dix. This violation of his property rights has never been adequately explained, but when Prevention Magazine learned of the problem, it featured the Dix FlossRings in a later issue.

Meanwhile, Sean continued to send faxes, Fed-Ex packages, and make phone calls to CNN, pleading for them to listen to him but for reasons he did not understand, they all ignored him. In 1998, he was finally told to send another package and Ted Turner would examine it personally. He did this, only to have CNN tell him they lost it. He then went to the expense of Fed-Exing another package to Ted Turner containing the letter from the dentist, and was told on the phone by Blaine Sergew that they could not locate this package, either. She then she asked him to hold as she transferred his call. He assumed she was looking for someone to help locate the Fed Ex package.

It was at this point, in July of 1998, that Sean states he was transferred for the first time to Thomas McCormick of CNN security. McCormick said to Sean, "You don't get it do you? We don't care." The reality of the matter then suddenly became clear. CNN had been ignoring and misleading Sean Dix because they had no intention of "correcting" their devastating clip of his products. The clip had apparently accomplished exactly what it was intended to accomplish: the destruction of a competitor. Sean then realized the only way to be heard was to somehow bring this into court. Having no money now, he decided the only answer was to be arrested by CNN. Sean then sent 6,000 faxes to CNN consisting primarily of the dentist's letter about the unethical clip.

Several weeks later, in another phone call, Sean explained to McCormick he wanted CNN to arrest him so he could take the matter to court. Sean was then threatened by McCormick. McCormick threatened that Sean would wind up "lost" in the Atlanta prison system. "People get lost in there sometimes and sometimes they just never come to trial," he stated. McCormick told Sean that he, McCormick, was not a part of the jail system, but "sometimes I feed it." McCormick would later testify in court that the CNN staff had been instructed not to engage in conversation with Sean, and to ignore him.

Sean pressed on, announcing on his website that he was going to hold a protest against CNN and J&J at the CNN building in New York on October 6, 1999. Three days before the protest, a man identifying himself as "Peter Kislewski" paid a visit to Sean's uncle's bakery, and had a meeting with Sean and the uncle, in which he offered "worldly advice" for Sean to cancel the protest and leave Johnson&Johnson alone. Sean, however, was determined to bring the matter to court, and he held his protest.  

At the protest, Sean states he was physically assaulted, head- butted in the chest by a maintenance man, pushed backwards down a staircase, and then thrown through the revolving doors. ("But I wasn't hurt," he said.) He was arrested out in front of the building on CNN charges that he "broke the doors" he had been thrown through. Most of Sean's interactions with CNN and J&J have been recorded, and most of the above interaction was recorded on video. The doors are clearly shown to be working, and not "broken." People in the video are shown passing through the revolving doors while Sean was being arrested. The charges were later dismissed and the case sealed after CNN failed to show up for the court hearing three times.

A telephone conversation then took place with Peter Kislewski, and this time Kislewski warned that Sean should not try to seek justice from J&J, stating that Johnson&Johnson could easily have him "whacked" and make it look like a suicide. Kislewski told him that CNN's threat of making him "lost" in the prison system was quite real, and that it amounted to a death threat as well.

Kislewski warned Sean Dix to leave the Johnson&Johnson matter behind him and move on.  

"They are a huge company and they can do anything and keep it quiet," Kislewski said about Johnson&Johnson. "Look at the Ethicon sutures. Look at how many people died and they kept that quiet."

Sean had not heard anything about "Ethicon sutures" before this moment. That evening, searching online, he found the San Francisco Examiner articles (dated 1999), revealing that in May of 1994 while Sean was sitting in the Johnson&Johnson offices offering them his sterile floss, J&J's Ethicon company was distributing surgical Vicryl sutures after their sterilization machinery stopped functioning. The massive, mysterious infections resulted in additional surgeries for some, loss of life for others, amputations, pain, and disfigurement. Law suits were claiming contaminated sutures. Doctors and surgeons were not notified and were mystified about the strange infections. Some remain unaware, today. The Examiner stated the hushed recall resulted in only a fraction of the sutures being removed from hospitals and doctors offices. According to The Examiner, Johnson&Johnson's Ethicon "sought to keep secret information about both the sterilization failure at the Texas factory and the infection outbreak that had been linked to the sutures in lawsuits and FDA records."  

In a statement given to me, Sean said he was so stunned to learn about this cover-up that it marked another important life-changing moment.

"I grew up using Johnson&Johnson products," Sean stated, "and I thought they were a company to be completely trusted or I would have never offered my products to them. I had offered my sterile floss idea to them, now I was seeing evidence suggesting that I was nothing more than another one of their victims. I was naïve and I never saw the car coming. On behalf of all of their victims, I was not going to keep silent about this. I was not going to just let it 'go away' as they were hoping."  

Kislewski would take things one step beyond his current warnings.

He revisited Sean's uncle's bakery and issued a strongly worded warning to the uncle, while grasping him by the wrist. The warning so unnerved the uncle, he never told Sean about it until almost a year after Sean's eventual trial.

Sean resumed sending faxes to CNN in February of 2000, and CNN continued to ignore them. On April 6, 2000, Sean sent a letter to David Jordan, Assistant Chief, Health Care Task Force, U.S. Department of Justice, Antitrust Division, stating that CNN and J&J had conspired to restrain trade. Mr. Jordan responded that same afternoon, writing, "The purpose of the antitrust laws is to foster and maintain competition in the nation's economy for the benefit of consumers." Mr. Jordan wrote that while Sean had reported something that was a theoretical possibility, "you provide nothing to explain CNN's motivation for entering into such a conspiracy" Sean wrote again on April 8th, only to be told again there was not sufficient evidence to open an investigation.  

On April 10th, NYPD Detective Jeremiah Everett visited Sean to tell him that CNN might take legal action against him if he continued to send correspondence to them. Sean invited the detective up into his apartment, showed him the CNN tape and explained what CNN had done to him, and said that he, Sean, wanted CNN to arrest him so he could have his day in court. Sean explained he had been trying to be arrested since 1998 when he realized this was an antitrust case that the government had so far refused to act upon, and that Sean finally thought, "What do I have to do, threaten to kill someone?" On this day, April 10th, he announced to Det. Everett that he was threatening to "kill Ted Turner" if only Ted were there in his apartment. The detective apparently knew this was not a true threat, because he did not arrest Sean.

On April 12th, 2000, Sean wrote another desperate letter to the U.S. Department of Justice, Antitrust Division, this time to Joel Klein. This letter received no response from the government, at all.  

On April 18, 2000, having exhausted all other ways of enticing CNN

to have him arrested, and frustrated with the government's failure to act, Sean decided to try the tactics already used by CNN and Johnson&Johnson. He wrote a fax stating he would "attempt" to kill Ted Turner, and signed it, hoping this would get him finally into court. He wrote "If you press charges I will have my day in court . . . Let us let a federal court observe the conditions that have led us to this impass." Fearing they would ignore this fax as well, he sent copies to numerous local television stations, the Associated Press, WGBH, and he sent thirteen copies to eleven different fax numbers at CNN.

Of the 22 copies of this fax sent out, only WGBH bothered to contact CNN to ask if they had received a copy of the alleged "threat." Eric Brass of WGBH's legal department phoned CNN's legal department and asked if they wanted a copy. Mr. Brass was asked to send it to fax number 404-827-1995, and he did so at 4:42 P.M. CNN could only produce four copies of the "threat" in court, and only one of those produced was actually sent by Dix, the others were duplicates. CNN could only produce one because presumably everyone else was following longstanding instructions to "ignore" Sean Dix and his meaningless faxes. It was acted on quickly, however, by someone in the office of David Kohler, the head of the CNN legal department. Someone using his fax machine faxed a copy to Midtown South Detective Squad in New York at 2:50 P.M., that afternoon.  

Sean remained free, however, until finally arrested on April 19th.

Following his arrest, he spent the first 30 days being shuffled from various holding cells, including a prison barge, without any indictment against him at all. Then, he spent nine months "lost" in the Atlanta prison system while he awaited his trial.

Sean's alleged threat was referred to as "Grand Larceny," and his indictment from the Grand Jury identified him as "Jason P. Lance."

On October 20, 2000, Pilar Keagy Johnson, a CNN Senior Legal Counsel, and Sarah Smith Flynn, CNN Executive Assistant, gave statements to the Federal Bureau of Investigation (FBI), claiming that they remembered well the last fax Sarah Flynn received from Sean Dix. The FBI-302 report which was a part of discovery states that when Flynn returned from lunch on April 18, 2000 at approximately 2:00 P.M., she noticed a one-page fax on her fax machine in her office, a fax machine specifically identified by its fax number as 404-827-1995. This, the report states, was the fax sent by Sean Dix. The FBI report states that as Flynn read the fax, she felt "very frightened" and felt "cold and ashen."

She brought this fax to Ms. Pilar Johnson. According to the FBI report, "Johnson and Flynn took the threatening fax from Sean Dix very seriously and acted quickly to notify security."  

Later in court, under oath, Flynn again stated that she had received this fax in her fax machine at approximately 2:00 P.M. and that she then started a security scramble, stating she was emotionally "very distracted" and "bothered tremendously" for the remainder of the day.

The only problem with the statements recorded by the FBI, is that Sean Dix never faxed anything to Sarah Flynn at 404-827-1995 on April 18, 2000.

According to his itemized telephone bill, available to prosecution and defense during the trial, there were no faxes made to 404-827-1995 on April 18, 2000. The itemized bill reveals that Dix did send 13 faxes to CNN, (including to David Kohler's fax, 404-827-0843), but according to the documentation, no faxes were sent from Sean Dix to Sarah Flynn at 404-827-1995 on April 18, 2000.  

Sean would eventually be incarcerated in federal prison for approximately two years for his mocked threat to Ted Turner, which a judge acknowledged on the record was done only in an to attempt to tell in a court what CNN had done to him. The hoped-for court hearing never happened. No one from CNN or Johnson & Johnson has ever been brought to justice for anything they threatened to do to Sean Dix, or anything they actually physically and monetarily carried out against Sean Dix.

At this time, Jeanne Moos is still at it, and continues to draw the ire of watchdog group, Media Matters. Karl Frisch, the organization's communications director, stated, "Funny or not, when Jeanne Moos does these types of fluff pieces, she is advancing these attacks, doing real damage. This is CNN, not Comedy Central."  

In a 1999 article carried by CNN, Jean Kilbourne wrote, "Today, Time Warner, Sony, Viacom, Disney, Bertelsmann, and News Corporation together control most publishing, music, television, film, and theme-park entertainment throughout the developed world. It is estimated that by the end of the millennium these companies will own 90 percent of the world's information, from newspapers to computer software to film to television to popular music. We may be able to change the channel, but we won't be able to change the message." In 1996, Time Warner acquired Turner Broadcasting.

Several phone calls to Johnson&Johnson's "Reach" Division Consumer Product Helpline were made during the writing of this paper to check on their sterile floss status. The "specialists" were asked if J&J floss was sterilized. Their answers varied and were confusing. We were told first, "There is no sterile floss today;" and then by another, "All Floss is 100% sterile," followed by "Some of our floss may be sterile," but this person did not know which ones. A medical specialist later phoned Sean and shouted that questions about sterilized floss were "trivial!" Finally a supervisor stated that none of their flosses are sterilized. Similar phone calls to other floss suppliers resulted in the same confusion. Many, including personnel working for dental floss suppliers still assume that dental floss must be a sterile product.

No one answering the Helplines knew that the man making the phone calls remains today the only person in the United States with a simple patented method of providing us with a superior, sterile flossing technique: the man who was ruined by CNN.  

"I think people are going to want to help you, Sean," I said to him as we brought to a close one month of intense study of the court transcripts, the records, and his personal description of some of what has been done to him (he refuses to discuss parts of his ordeal). "What do you want me to ask for on your behalf? Do you want me to ask for donations to help with legal expenses?"

"No, I don't want any donations," he said.

"What do you want," I asked again.

"Justice," he said. "I want justice. I want the government to do its job and see that justice is finally served.

I'm not asking only for myself because this whole case is not only about me. It's about the American people and the American Dream.

We've all been harmed by what's happened in this situation. We have to ask for justice so that this does not happen again to the next Sean Dix who tries to make people's lives a little better only to be cut down by industry giants."

It seems that justice and sterile dental floss are both long overdue. If you agree, please send one email with a link to this article to the Department of Justice. Ask them where the justice is for Sean Dix and the American Dream.

antitrust.atr@usdoj.gov I also invite everyone so inclined to freely link to this article, and to list it on your blogs and websites and to email links to as many people as possible. This situation was not just about a solitary man named Sean Patrick Dix. It was and is about all of us.

* * * * * * * * *

Mary Sparrowdancer is an independent journalist and the author of a bestselling book about the Messiah, called "The Love Song."

www.sparrowdancer.com Stay tuned for Part II of Sean's saga, detailing perjury, and Sean's subsequent two years in federal prison. Sean was released from prison in November of 2004. He remains a "convicted felon" based in part on perjury. Sean can be reached here: dixppi@worldnet.att.net and by phone at his place of business: 212-254-7563.

* * * * * * * * *

References used throughout this paper include copies of documents provided by Sean Dix, personal correspondence, one telephone conversation, videos, DVDs, CDs, as well as references linked below.

Sean Dix's FlossRings.

http://www.flossrings.com/

http://www.flossrings.com/study.htm

 

 

 

 
JANSSEN PHARMACEUTICA WHISTLEBLOWER - Illegal Off-label marketing and Retaliation
 

 

Fisk MC, Voreacos D.



According to sworn statements in a retaliation lawsuit filed in Trenton, NJ, Johnson & Johnson’s Janssen Pharmaceutica unit pushed sales representatives to promote its antipsychotic drug Risperdal for uses not approved by the FDA.

Three sales representatives allege they were directed to grow share in off-label populations. Lynn Powell, one of the former salespeople, claims J&J fired her in 2004 for complaining about such practices, violating a law shielding workers from retaliation. 

The declarations, which are exhibits in Powell’s suit against the company, contradict the company’s statement in a court filing that any so-called off-label promotion “was and is strictly prohibited by Janssen.” 

Pushing Boundaries 

Almong the almost 1,000 pages of documents in the Powell case are salespeoples descriptions of marketing pitches, articles provided to them on studies of off-label uses, and details on the hiring of medical leaders to talk to other physicians about the drug’s benefits in conditions for which Risperdal was not indicated.

Powell’s lawyers argued in court papers that Janssen “observed, encouraged, documented and praised Lynn and her peers for following management’s direction to promote Risperdal off- label.”
 
Because Lynn Powell would not keep quiet about J&J's illegal marketing practices, she was fired. 


J&J on Firing 

Powell was fired because of repeated violations of company policy barring the practice, the company said in a Nov. 7 filing seeking dismissal of the case. 

Powell argued otherwise. “Lynn’s career ended not because she broke a company rule against off-label promotion, but because she challenged sales direction that ignored that rule,” her lawyers said in a Dec. 5 filing. 


Sales Calls 

Powell was a sales representative in Raleigh, North Carolina, from 2000 until February 2004. She sold from $1.5 million to $2 million worth of Risperdal in 2003, according to pretrial testimony of Michael Walsman, the drug’s former national sales director.  

Like her colleagues, she documented her sales calls on doctors and hospitals in computer notes and helped set up promotional speaker programs by physicians, court records show. 

In 2003, she wrote an “action plan” outlining her goals, according to court records. She said she would ask one doctor to try Risperdal for depression symptoms and another to add it for a bipolar patient taking Zyprexa. She said she would push doctors’ assistants to look at such symptoms and encourage physicians to add Risperdal to depression drug therapy. 

Thompson praised Powell’s plan in an e-mail. 

“Take a look at Lynn’s action plan,” he wrote to her colleagues. “She did an outstanding job of focusing on the ‘common’ things. This year, if we are going to succeed, we have to do the common things uncommonly well!” 

Her relationship with the company soured after she communicated about off-label marketing with a doctor outside the company for whom she was arranging a talk with other physicians. 

In the litigation, J&J has emphasized that sales representatives were warned in writing that they could be fired for off-label promotions. 

In no way did upper management ever tell us to be in accordance with this,” Powell said in her deposition. “They actually told us the opposite and stressed and pushed us to sell off label.” 

Thompson sent his staff a Janssen “backgrounder” in preparation for a 2003 sales meeting that said Risperdal “continues to be a leader as its realm of use expands into mood and anxiety symptoms.” 

Risperdal is not approved for the treatment of anxiety or mood disorders.

Sixty percent of growth in the so-called atypical- antipsychotic market was “driven by the mood and anxiety segment, with primary care physicians (PCPs) accounting for one third of that growth,” according to the document in the court files. 

 
 

 
 
 
 
The CREDO: Johnson & Johnson's "Moral Compass"
 
 
James Burke, J&J CEO from 1976 to 1989, confirmed that during the Tylenol Crisis "the guidance of the credo played the most important role" in the company’s decision making.
 
Ralph Larsen, CEO from 1989 to 2002, described the CREDO as "the Heart of Johnson & Johnson."
 
William Weldon, CEO from 2002 to present, says "the CREDO is the moral compass which provides Johnson & Johnson direction."
 
 
 
THE FUTURE