Evelyn Pringle
The American Academy of Pediatrics announced the submission of an amicus brief to the US Supreme Court on July 30, 2010, “joined by 21 partnering health organizations,” in the vaccine injury case of Bruesewitz v Wyeth, to support the powerful vaccine maker against a lone family.
Oral arguments in the case took place on October 12, 2010, but a final decision won’t be known for months. The most recent drug injury preemption case decided by the Court was also against Wyeth and the ruling came down in favor of plaintiff, Diane Levine.
The Court took the Bruesewitz case to determine whether 18-year-old Hannah, disabled by injuries she received from Wyeth’s diphtheria, tetanus and pertussis (DPT) vaccine at 6-months-old in 1992, has the right to bring a lawsuit against Wyeth after the Vaccine Court, set up by the 1986 National Childhood Vaccine Injury Act, refused compensation even though she will require life-long care and her vaccine was traced to a lot that had 65 adverse reactions including two deaths, 39 emergency room visits, and 6 hospitalizations.
After compensation was denied, the family filed suit against Wyeth in Pennsylvania and argued that the vaccine Hannah received was defectively designed and had a known safer vaccine been used her injuries could have been avoided.
Wyeth filed for summary judgment and the lower court dismissed the case holding that the 1986 vaccine law preempted all design defect claims. In March 2009, the Third Circuit Court of Appeals affirmed the ruling and the family filed a petition for review in the Supreme Court.
“Amici—all of whom support the routine vaccination of children against a host of vaccine-preventable infectious diseases—urge this Court to affirm the judgment of the Third Circuit below,” the brief filed by the 22 groups states.
The term “host” inadequately describes the number of “routine” shots kids get today, along with the increased risk of injury. Before 1986, children’s vaccines included diphtheria, tetanus, pertussis, measles, mumps, rubella and inactivated poliovirus. Since the Vaccine Injury Act was passed, nine new vaccines have been added, including hepatitis B, rotavirus, haemophilus influenzae type b, pneumococcal, influenza, varicella, hepatitis A, meningococcal, human papillomavirus (for girls), or an additional 46 doses for girls and 43 for boys, the CDC’s 2009 Recommended Immunization Schedule shows.
Amici Anything But Impartial
JB Handley, co-founder of Generation Rescue, as well as co-founder and contributor to Age of Autism, says whenever he meets pediatricians he asks what percentage of their revenue comes from vaccine administration. “The number always astounds me,” he said on Age of Autism. “The answers I get are that anywhere from 50-80% of their revenue comes from giving vaccines.”
In addition to their individual income from giving shots, Wyeth is now owned by Pfizer and over the past few years, the grant reports of the two companies show millions of dollars pouring into the American Academy of Pediatrics and many of the “partnering health organizations” that signed off on the brief.
For instance, Pfizer 2009 report lists two grants to the Academy totaling $56,000 and Wyeth donated $630,000 to benefit the group in 2009. Wyeth also gave the Academy $345,919 in 2008. The group received $524,080 from Pfizer in the first two quarters of 2010 alone.
In 2009, the Academy presented the “President’s Certificate for Outstanding Service” award to Dr Paul Offit, whose least offensive nickname, of many, is “Dr Proffit.”
Offit was also called the “poster child” for the term “biostitute,” by Robert Kennedy Jr at a green vaccine rally in Washington in 2008, for making himself the spokesperson for the vaccine industry and pretending to be an independent scientist without disclosing his ties to and the millions of dollars he’s made off the vaccine industry.
“The AAP is honoring Dr. Offit in recognition of his ongoing commitment to promote immunization,” the Academy’s October 16, 2009 announcement stated, without mentioning the financial windfalls he received due to his “commitment to promote immunization.”
On December 9, 2009, a report on Offit was published on Age of Autism with the headline, “Counting Offit’s Millions: More on How Merck’s Rotateq Vaccine Made Paul Offit Wealthy,” by Dan Olmsted and Mark Blaxill, authors of the new book, “Age of Autism: Mercury Medicine and A Manmade Epidemic.”
The report points out that Paul Offit, “vaccine entrepreneur and public health spokesperson, has earned approximately $10 million in income from Rotateq® royalties through 2009 and stands to earn a total of between $13-35 million over the life of his rotavirus vaccine patents.”
The analysis by Blaxill and Olmsted found that Offit’s future royalty income is tied to the vaccine’s future sales in the US and international markets, which gives him a strong financial stake in both the specific success of the rotavirus vaccine category and the global reputation of vaccines in general.
The American Academy of Family Physicians also signed off on the amicus brief. This group, along with its state chapters and Foundation, received a combined total of more than $5 million from Pfizer in 2009, and another $856,772 from Wyeth. In the first half of 2010, Pfizer gave the Family Physician groups $1,334,165.
Another signer, the American Medical Association, received grants worth $751,500 from Pfizer and a $5,000 grant from Wyeth in 2009. The Association received $447,400 from Pfizer in the first two quarters of 2010.
Several other members of the group that ganged up on Hannah in the brief also received plenty from the vaccine makers. Pfizer gave $55,000 to the National Foundation for Infectious Diseases in 2009, and Wyeth gave $45,000. In 2008, the Foundation received $2,153,500 Wyeth, and Pfizer gave it $58,500 in the first half of 2010.
In 2009, the Infectious Diseases Society of America received $15,000 from Wyeth and $65,000 in 2008.
The American Public Health Association received three grants totaling $200,000 from Pfizer in 2009.
The March of Dimes and its Foundation combined got $4,500 from Wyeth in both 2008 and 2009. Pfizer gave the groups $14,500 in the first half of 2010.
In 2009, Wyeth gave the National Association of Pediatric Nurse Practitioners Foundation four grants totaling $175,150 and three worth $70,000 in 2008.
Parents of Kids with Infectious Diseases received $75,000 from Wyeth in 2009.
The Immunization Action Coalition was paid $95,000 by Wyeth in 2009 and $136,743 in 2008.
Every Child By Two received nearly a million dollars, or $950,000, from Wyeth in 2009, and $350,000 in 2008.
In the August 4, 2008 report, “Every Child By Two: A Front Group for Wyeth,” JB Handley points out that Craig Engesser, an employee of Wyeth with a title of Senior Director, Professional Affairs, was on the Board of Every Child By Two for as far back as he could track. In fact, Engesser had even served as the group’s treasurer.
Handley also noted that Paul Offit had recently joined the group’s Board.
For the year 2006, Handley found IRS filings showed Wyeth gave Every Child By Two $350,769 and page 23 of the filing read: “Wyeth Vaccine: Ensure all children from birth to Age 2 are fully immunized.”
The National Healthy Mothers, Healthy Babies Coalition received $200,000 from Pfizer in 2009, and Wyeth gave the Georgia chapter $500 in 2008. Other corporate sponsors listed on the group’s website in 2009 included Merck, GlaxoSmithKline, Johnson & Johnson and Sanofi-Pasteur.
Amici for Hannah
Amicus briefs were also submitted in support of the Bruesewitz family in September 2009 and June 2010, by attorneys from the state of New York, Mary Holland and Robert Krakow, on behalf of the National Vaccine Information Center and its cofounders, parent advocates who helped draft the 1986 legislation, the New Jersey Coalition for Vaccine Choice, No Mercury, Truth About Gardasil, Age of Autism, National Autism Association, Autism One, SafeMinds, Autism United, US Autism and Asperger Association, Talk About Curing Autism, Generation Rescue, and the Elizabeth Birt Center for Autism Law and Advocacy.
It would require too much space to list every organization, but all together more than 25 signed off on the briefs - none of which receive money from vaccine makers. Basically the question to be answered by the Supreme Court is: Does § 22(b)(1) preclude all vaccine design-defect claims even if the vaccine’s side effects were avoidable?
“The legislative history suggests that all the stakeholders – Congress, parents, manufacturers and physicians – understood that victims preserved the right to take design defect claims to court,” the June brief says. “Respondent and its amici appear to be trying to achieve through the judiciary what they failed to obtain through Congress.”
In fact, the brief includes several statements made at the time the Act was passed that suggest that Congress recognized that victims, who duly filed for compensation in the Vaccine Program, could take design defect claims to court under Section 22(b).
For instance, when presenting the Act to the full House of Representatives for a vote, Rep Henry Waxman, the chief sponsor of the Act, stated that civil claims for “inadequately researched” vaccines would be preserved under Section 22. Waxman’s description of this claim, that a vaccine’s design did not take adequate account of avoidable safety risks, would likely be a design defect, the brief notes.
“Furthermore, the Committee explicitly rejected the opportunity to create a broad exemption for all design defect claims when it considered the Act,” it says. “Proposals were considered by the Committee that would have explicitly preempted all design defect claims, but the final version did not contain those provisions.”
“By rejecting language that would have barred all design defect claims,” the attorneys wrote, “Congress showed its intent to permit courts to decide on a case-by-case which side effects were genuinely ‘unavoidable.’”
“The Act and its legislative history simply do not make sense without the understanding that the tort system remains an available alternative for such cases,” the brief says. “And Congress’ intent to keep the courthouse doors open is even more important today than it was in 1986.”
“The significance of the Bruesewitz case relates to all vaccine injury – it goes to the heart of whether Vaccine Court is fulfilling the role Congress set for it, and whether it is possible to challenge the design safety of a vaccine in any court in the United States,” Holland explained in a March 10, 2010 commentary on Age of Autism.
“For the autism community, the case could not be more central,” she says, “it will determine whether the 5,000 petitioners in the Omnibus Autism Proceeding can continue their claims in state and federal courts if Vaccine Court ultimately dismisses their claims.”
Right about now, paranoia in the vaccine industry is no doubt running at an all time high since the announcement of the first award in a vaccine-autism case in September 2010 for another girl named Hannah, with $1.5 million to start and $500,000 a year for life to pay for her care. “Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime,” CBS News reported on September 10, 2010.
Hannah was “described as normal, happy and precocious in her first 18 months,” until “she was vaccinated against nine diseases in one doctor's visit,” in July 2000, CBS said.
A government study titled, “The Prevalence of Parent-Reported Diagnosis of Autism Spectrum Disorder among Children in the United States, 2007,” evaluated the number of children in the US who currently had an Autism Spectrum Disorder diagnosis in 2007, based on data from a national Survey of Children's Health, and found that 1 in 91 children between the ages of 3 and 17 carried an ASD diagnosis.
”Even more alarming, for the subset of children between ages 6 and 14 immunized during the 1990's the prevalence is actually 1 in 71 children with an autism diagnosis,” Age of Autism reported.
”This age group represents children in the U.S. with the highest exposure to thimerosal, the mercury preservative routinely used until CDC, AAP and industry recommended its removal “as soon as possible” from all childhood vaccines,” AoA explained.
It’s obvious that parents no longer trust claims by the government and drug companies about harmless vaccines. On October 17, 2010, in the Huffington Post, Kim Stagliano, managing editor of AoA and author of the new book, “All I Can Handle I’m No Mother Teresa,” reported that a new study from CS Mott Children’s Hospital found 89% of parents think vaccine safety is the most important topic in medical research today.
“That makes sense, since the American pediatric vaccine schedule now includes 48 vaccinations before the age of six,” Stagliano says. “Parents are facing vaccination choice issues at every pediatric visit.”
Fictional Fear Factors
In the brief filed by the groups with all the money from Wyeth and Pfizer, when warning that vaccine makers might flee the market if they have to face the threat of lawsuits and unpredictable litigation costs, they argue that the number of vaccine makers has not greatly increased since 1986 and refer to the “precarious state of the vaccine industry.”
“The preemption of all design defect claims is critical to Congress’s objective of stabilizing the vaccine market and safeguarding the Nation’s vaccine supply,” they claim.
First of all, the vaccine industry is not in dire financial straights, in fact far from it. On June 11, 2009, Kalorama Information issued a press release for the vaccine sales forecast in a market analysis report with the headline, “New Report Forecasts More Than Doubling of Vaccine Sales by 2013.”
“Few areas of pharmaceuticals have seen the fast-moving developments in the marketplace that the vaccine market has,” Kalorama noted. The press release described 2008 as another “stellar year for the world vaccine market,” in which sales “grew 21.5% since 2007 to reach $19.2 billion.”
A year earlier, Kalorama reported that stronger than anticipated revenues for flu vaccines and the “surprising commercial success” of Merck's Gardasil had led to $16.3 billion in vaccine sales in 2007, “an increase of 38% over 2006 sales of $11.7 billion.”
However: “Vaccine manufacturers face many challenges in bringing new vaccines to market,” the amicus brief points out, with a note to: “See Paul A. Offit, Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?, 24 Health Affairs 622, 623-629 (2005).”
The brief goes on to complain about how much the cost of developing vaccines has increased. “Between 1991 and 2003, for instance, costs for research and development, post licensure clinical studies, and production process improvements grew from $231 million to $802 million,” it said, citing Stanley A Plotkin, et al, Vaccines 38 (5th ed 2008). Plotkin was a co-inventor with Offit on the Rotateq vaccine.
But in any event, the high prices charged for vaccines today wipe out those costs in record time. For instance, Rotateq runs close to $200 for a 3 dose series and when you multiply that by the CDC’s calculation of more than 4 million babies born each year in the US, annual sales come to over $800 million in this country alone. Wyeth’s pneumococcal vaccine “makes $2 billion a year in sales,” according to a July 25, 2008 report by CBS News.
About a year ago, Dr Proffit was shilling for vaccine makers in the October 18, 2009 “Wall Street Journal,” by claiming infants should get 2 regular flu and 2 swine flu vaccines, without mentioning that all 4 contained the mercury-based preservative, thimerosal. “Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart,” Offit said.
With the headline, “Most flu shots contain mercury, but few know it,” on November 13, 2007, the Milwaukee Journal Sentinel reported that when using the standards set for methyl mercury consumption, a 22-pound baby getting the flu shot “would get more than 25 times the amount of mercury considered safe.”
In the WSJ article, Offit was identified only as “chief of infectious disease” at the Children's Hospital of Philadelphia, when in fact he holds a “$1.5 million dollar research chair at Children's Hospital, funded by Merck,” according to CBS News.
That bit of advice from Offit in the WSJ could potentially drum up over 4,000,000 new customers every year for shot givers and vaccine makers in the US for flu vaccines alone. Last year, the September 14, 2009 Los Angeles Times reported that physician offices usually “charge about $25 to $75 for the seasonal shot, including administration fees.”
“If you are immunizing a child for the first time, the child may need two shots,” the Times said. “Ask the healthcare professional giving the shot if you will have to pay two fees.”
For the sake of simplicity, let’s say doctors threw in both seasonal flu shots for one fee of $75. The total amount made from vaccinating 4,000,000 babies would be $300 million.
The Times said the H1N1 shot would be free, although doctor's offices and clinics may charge an administrative fee. But the swine flu shots were in no way free. Tax payers paid vaccine makers a fortune as a result of the pig flu hoax. However, for the sake of non-argument, let’s say the shot givers only charged $10 per infant to give each of the two swine flu vaccines. They would still make $80 million.
Will Health Care Workers Revolt?
The fact that health care workers have an aversion to flu vaccines is likely the best testament to the lack of benefits and potential harms associated with vaccines including the inability to sue for compensation if injured. It only stands to reason that if vaccines worked so great this group would be the first in line to get them.
But a new policy statement by the American Academy of Pediatrics, in a paper in the October, 2010 issue of their official journal, “Pediatrics,” gives notice of plan to force health care workers to get flu vaccines with the heading, “Recommendation for Mandatory Influenza Immunization of All Health Care Personnel.”
The Academy claims that “despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low.”
Mandatory influenza immunization for all health care personnel is “ethically justified, necessary and long overdue to ensure patient safety,” the group said in a statement.
“The influenza vaccine is safe, effective, and cost-effective, so health care organizations must work to assuage common fears and misconceptions about the influenza virus and the vaccine,” the Academy claims.
Their paper reports that in January 2010, the CDC estimated the percentage of health care personnel who received vaccines was only 61.9% for seasonal flu, 37.1% for swine flu, and only 37.1% received both the seasonal and swine flu vaccines.
However, it’s not like the industry is suffering from a lack of flu shot customers even when health care workers refuse to get them. In 2009 alone, multi-national corporations took home profits of $2.8 billion in influenza vaccine sales, according to an October 2010 report by Barbara Loe Fisher, co-founder of the National Vaccine Information Center.
By comparison, since the Vaccine Injury Act was passed roughly 25 years ago, the vaccine court has paid out less than $2 billion. Of the more than 13,550 petitions filed covering all vaccines, compensation for injuries was only awarded in about 2,500 cases.
Of course the estimates in the paper, if true at all, would have come from the same CDC that was run for years by Julie Gerberding and has put out the trumped up claim year after year that 36,000 people in the US die of the flu annually, with the death number never changing even when vaccination rates greatly increase.
In a December 21, 2009 Pharmalot Blog, Ed Silverman reported that Gerberding, “who until this year was the director of the US Center for Disease Control and Prevention, was named president of Merck’s vaccine division.”
As the former “top dog” at the CDC, she “has plenty of experience overseeing the selection of recommended immunizations,” FiercePharma noted on December 22, 2009.
“Autism activists, particularly those who believe vaccines are a primary cause of regressive autism, are often derided for conspiratorial comments about the CDC and Big Pharma,” JB Handley pointed out on the Pharmalot blog.
“This one is making us look more sane every day,” he said.
On October 7, 2010, Barbara Loe Fisher reported that doctors at Children’s Hospital of Philadelphia (Dr Proffit’s Kingdom), are ordering all employees to get a flu shot every year or be sent home for two weeks without pay to “think about it.”
“Anyone, who still refuses to get a flu shot after that, is fired,” she wrote. And that goes for not just doctors and nurses, she says, but every person who has anything to do with the health care facility, including students, volunteers, and contract workers.
“An exception could be made if the doctors in charge approve a “medical exemption” to vaccination, which, today,” Fisher warns, “is about as hard to get as a job.”
(Evelyn Pringle is a columnist for Scoop International and an investigative journalist and researcher focused on exposing corruption in government and corporate America)
Showing posts with label Supreme Court. Show all posts
Showing posts with label Supreme Court. Show all posts
Saturday, November 6, 2010
Monday, August 2, 2010
Profit Driven Swine Flu Propaganda - Pump Up the Volume - Part Five
Evelyn Pringle October 2009
In the video commentary titled, Mild Swine Flu & Over-Hyped Vaccine, on the website for the National Vaccine Information Center, the group's co-founder and president, Barbara Loe Fisher, reports:
"We are witnessing a roll-out of the largest, most expensive mass vaccination campaign in the history of our nation. A rollout that is bigger than even the polio vaccine campaigns of the 1950's."
"If you or your child are injured from getting a flu swine flu shot, you are on your own," Fisher warns.
"Because Congress shielded the vaccine manufacturers and any person giving swine flu shots from lawsuits if people get hurt," she says. "There is no funded government vaccine injury compensation program for swine flu vaccine."
"Doctors are telling some children under 10 years old to get 3 to 4 flu shots this year - 2 shots for seasonal flu and one or two more for swine flu," Fisher points out.
"We have never given young children 3 to 4 flu shots in a single year and there is no information about how safe it is to do that," she advises.
On October 18, 2009, the Wall Street Journal advised that: "Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart," citing Paul Offit, chief of infectious disease at the Children's Hospital of Philadelphia, as the source, without letting readers know how rich he has become profiting off the vaccine industry.
Eight months ago, on February 16, 2009, "Age of Autism" published a report titled, "Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market," by Dan Olmsted and Mark Blaxil, for an investigation that found:
"Dr. Paul Offit of the Children's Hospital of Philadelphia (CHOP) took home a fortune of at least $29 million as part of a $182 million sale by CHOP of its worldwide royalty interest in the Merck Rotateq vaccine to Royalty Pharma in April of last year."
"Based on an analysis of current CHOP administrative policies, the amount of income distributed to Offit could be as high as $46 million," the report noted.
"In a Moody's report dated June 2008, CHOP reported net proceeds from the Rotateq transaction of $153 million, a deal basis that would put the value of Offit's 30% share at $45.9 million," the authors wrote.
"Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP)," the AoA report states. "In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months.
"For example, after ACIP approved the addition of Merck's (and Offit's) Rotateq vaccine to the childhood vaccination schedule, Merck's Rotateq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008," the authors explain.
"When one multiplies a price of close to $200 per three dose series of Rotateq by a mandated market of four million children per year, it's not hard to see the commercial value to Merck of favorable ACIP votes," the authors point out.
From 1998 to 2003, Offit served as a member of ACIP. As a member of the ACIP, Offit "voted to include the rotavirus vaccine in the Vaccines for Children program, which ultimately made his Rotateq product worth hundreds of millions of dollars to Merck," the National Autism Association reports.
Offit also holds a "$1.5 million dollar research chair at Children's Hospital, funded by Merck," according to a July 25, 2008 report by CBS News titled, "How Independent Are Vaccine Defenders?"
Calling them "the most trusted voices in the defense of vaccine safety," CBS reports that the American Academy of Pediatrics, Every Child By Two, and pediatrician Dr Paul Offit, have something else in common - "strong financial ties to the industry whose products they promote and defend."
"The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters," CBS found. Totals were secret, but documents cited by CBS reveal the following:
A $342,000 payment from Wyeth, maker of the pneumococcal vaccine - which makes $2 billion a year in sales.
$433,000 from Merck, the same year the academy endorsed Merck's Gardasil vaccine - which made $1.5 billion a year in sales.
Another top donor was Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot added to the childhood vaccine schedule in June 2008, CBS said.
"Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too - but wouldn't tell us how much," CBS investigative correspondent Sharyl Attkisson reports.
In April 2009, the AAP even filed a friend of the court brief (amicus) with the US Supreme Court in support of a petition for a writ of certiorari from vaccine makers Wyeth and GlaxoSmithKline to overturn a unanimous ruling by the Georgia Supreme Court that decided a civil lawsuit filed by Marcelo and Carolyn Ferrari on behalf of their autistic son was not barred by the National Childhood Vaccine Injury Compensation Act.
The Georgia decision noted that recognizing presumptive preemption would "have the perverse effect of granting complete tort immunity from design defect liability to an entire industry."
The Farrari family alleges that the vaccine makers could have manufactured safer childhood vaccines without the mercury-based, thimerosal, that caused their son's autism. The Georgia court's ruling would allow a jury to decide the case.
On September 9, 2009, the National Autism Association issued a press release with a headline: "Offit's Failure to Disclose Jeopardizes Swine Flu Vaccine Program," referring to his recent appearance on a segment of NBC's Dateline.
"As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, the integrity of all vaccine developers has been called into question by the financial relationship of a leading vaccine advocate and a pharmaceutical manufacturer," NAA advised.
"If people are to have confidence in the integrity of the Swine Flu vaccination program this fall then we need full disclosure of all financial relationships between proponents and manufacturers on every vaccine on the market," said Jim Moody, attorney for the NAA, in the press release.
"Who has an objective opinion about a company that has made them rich?" he said.
"Offit has zero credibility in matters of vaccine safety," says Wendy Fournier, president of the NAA. "Not only does he advance the absurd suggestion that children could safety get 100,000 vaccines at a time, he opposes any studies of the comparative health of unvaccinated children that could shed light on the extent and nature of vaccine-caused injuries, leading to their prevention."
Beyond Offit's financial conflicts, autism advocates are also dismayed about his credibility on speaking about autism in general, as he does not treat patients with autism.
"It's a mystery how such an inexperienced and financially conflicted man has become the go-to guy for information on autism," Ms Fournier says. "Here's a man with no real knowledge about autism that again and again appears in media coverage."
"Not only is he completely unqualified to address autism from a medical standpoint, his financial conflicts of interest disqualify him as a credible source for vaccine safety commentary as well," she points out.
Too many shots
"Today's immunization schedule now calls for kids to get 55 doses of vaccines by age 6," according to the CBS News report.
The four flu shots recommended this year will be in addition to all the other vaccines children receive in complying with the mandatory childhood vaccine schedule.
On the "Age of Autism" website, Mary Podlesak warns that the flu vaccines still contain mercury. "I was reading the package inserts for the H1N1 vaccines from Novartis, Sanofi Pasteur and CSL last night," she said. "All three state the vaccine contains 25mcg of mercury -- not 25mcg of thimerosal -- 25mcg of mercury."
"When I checked the package inserts for the seasonal flu vaccine, they read the same as the H1N1 description," Podlesak wrote.
The package insert states: "The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury."
Smaller amounts of thimerosal also remain in some other vaccines, even those marketed as "preservative-free," according to Age of Autism.
The H1N1 vaccine insert also states: "Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A"
"(H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed. "
Back on May 20, 2003, after a three year investigation of pediatric vaccine safety, initiated in the US House Committee on Government Reform, the "Mercury in Medicine Report," was placed in the Congressional record.
"Thimerosal used as a preservative in vaccines in likely related to the autism epidemic," the report concluded.
"This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding the lack of safety data regarding injected thimerosal and the sharp rise of infant exposure to this known neurotoxin," the Committee advised.
"The FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule," the report pointed out.
"At the same time that the incidence of autism was growing," the Committee said, "the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold."
Vaccine makers and conflicted public health officials are always claiming that studies show vaccines did not cause the autism epidemic. In a February 24, 2009 Huffington Post article, Robert F Kennedy, Jr, pointed out "that for sixty years the tobacco industry successfully defended a product that was killing one out of every five of its customers against thousands of legal actions brought by its victims and their families."
"Big tobacco prevailed for six decades," he said, "even without the help of supportive government agencies deliberately suppressing real science and research."
"In that sense vaccine victims must leap a much higher hurdle," he added.
In the video commentary titled, Mild Swine Flu & Over-Hyped Vaccine, on the website for the National Vaccine Information Center, the group's co-founder and president, Barbara Loe Fisher, reports:
"We are witnessing a roll-out of the largest, most expensive mass vaccination campaign in the history of our nation. A rollout that is bigger than even the polio vaccine campaigns of the 1950's."
"If you or your child are injured from getting a flu swine flu shot, you are on your own," Fisher warns.
"Because Congress shielded the vaccine manufacturers and any person giving swine flu shots from lawsuits if people get hurt," she says. "There is no funded government vaccine injury compensation program for swine flu vaccine."
"Doctors are telling some children under 10 years old to get 3 to 4 flu shots this year - 2 shots for seasonal flu and one or two more for swine flu," Fisher points out.
"We have never given young children 3 to 4 flu shots in a single year and there is no information about how safe it is to do that," she advises.
On October 18, 2009, the Wall Street Journal advised that: "Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart," citing Paul Offit, chief of infectious disease at the Children's Hospital of Philadelphia, as the source, without letting readers know how rich he has become profiting off the vaccine industry.
Eight months ago, on February 16, 2009, "Age of Autism" published a report titled, "Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market," by Dan Olmsted and Mark Blaxil, for an investigation that found:
"Dr. Paul Offit of the Children's Hospital of Philadelphia (CHOP) took home a fortune of at least $29 million as part of a $182 million sale by CHOP of its worldwide royalty interest in the Merck Rotateq vaccine to Royalty Pharma in April of last year."
"Based on an analysis of current CHOP administrative policies, the amount of income distributed to Offit could be as high as $46 million," the report noted.
"In a Moody's report dated June 2008, CHOP reported net proceeds from the Rotateq transaction of $153 million, a deal basis that would put the value of Offit's 30% share at $45.9 million," the authors wrote.
"Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP)," the AoA report states. "In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months.
"For example, after ACIP approved the addition of Merck's (and Offit's) Rotateq vaccine to the childhood vaccination schedule, Merck's Rotateq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008," the authors explain.
"When one multiplies a price of close to $200 per three dose series of Rotateq by a mandated market of four million children per year, it's not hard to see the commercial value to Merck of favorable ACIP votes," the authors point out.
From 1998 to 2003, Offit served as a member of ACIP. As a member of the ACIP, Offit "voted to include the rotavirus vaccine in the Vaccines for Children program, which ultimately made his Rotateq product worth hundreds of millions of dollars to Merck," the National Autism Association reports.
Offit also holds a "$1.5 million dollar research chair at Children's Hospital, funded by Merck," according to a July 25, 2008 report by CBS News titled, "How Independent Are Vaccine Defenders?"
Calling them "the most trusted voices in the defense of vaccine safety," CBS reports that the American Academy of Pediatrics, Every Child By Two, and pediatrician Dr Paul Offit, have something else in common - "strong financial ties to the industry whose products they promote and defend."
"The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters," CBS found. Totals were secret, but documents cited by CBS reveal the following:
A $342,000 payment from Wyeth, maker of the pneumococcal vaccine - which makes $2 billion a year in sales.
$433,000 from Merck, the same year the academy endorsed Merck's Gardasil vaccine - which made $1.5 billion a year in sales.
Another top donor was Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot added to the childhood vaccine schedule in June 2008, CBS said.
"Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too - but wouldn't tell us how much," CBS investigative correspondent Sharyl Attkisson reports.
In April 2009, the AAP even filed a friend of the court brief (amicus) with the US Supreme Court in support of a petition for a writ of certiorari from vaccine makers Wyeth and GlaxoSmithKline to overturn a unanimous ruling by the Georgia Supreme Court that decided a civil lawsuit filed by Marcelo and Carolyn Ferrari on behalf of their autistic son was not barred by the National Childhood Vaccine Injury Compensation Act.
The Georgia decision noted that recognizing presumptive preemption would "have the perverse effect of granting complete tort immunity from design defect liability to an entire industry."
The Farrari family alleges that the vaccine makers could have manufactured safer childhood vaccines without the mercury-based, thimerosal, that caused their son's autism. The Georgia court's ruling would allow a jury to decide the case.
On September 9, 2009, the National Autism Association issued a press release with a headline: "Offit's Failure to Disclose Jeopardizes Swine Flu Vaccine Program," referring to his recent appearance on a segment of NBC's Dateline.
"As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, the integrity of all vaccine developers has been called into question by the financial relationship of a leading vaccine advocate and a pharmaceutical manufacturer," NAA advised.
"If people are to have confidence in the integrity of the Swine Flu vaccination program this fall then we need full disclosure of all financial relationships between proponents and manufacturers on every vaccine on the market," said Jim Moody, attorney for the NAA, in the press release.
"Who has an objective opinion about a company that has made them rich?" he said.
"Offit has zero credibility in matters of vaccine safety," says Wendy Fournier, president of the NAA. "Not only does he advance the absurd suggestion that children could safety get 100,000 vaccines at a time, he opposes any studies of the comparative health of unvaccinated children that could shed light on the extent and nature of vaccine-caused injuries, leading to their prevention."
Beyond Offit's financial conflicts, autism advocates are also dismayed about his credibility on speaking about autism in general, as he does not treat patients with autism.
"It's a mystery how such an inexperienced and financially conflicted man has become the go-to guy for information on autism," Ms Fournier says. "Here's a man with no real knowledge about autism that again and again appears in media coverage."
"Not only is he completely unqualified to address autism from a medical standpoint, his financial conflicts of interest disqualify him as a credible source for vaccine safety commentary as well," she points out.
Too many shots
"Today's immunization schedule now calls for kids to get 55 doses of vaccines by age 6," according to the CBS News report.
The four flu shots recommended this year will be in addition to all the other vaccines children receive in complying with the mandatory childhood vaccine schedule.
On the "Age of Autism" website, Mary Podlesak warns that the flu vaccines still contain mercury. "I was reading the package inserts for the H1N1 vaccines from Novartis, Sanofi Pasteur and CSL last night," she said. "All three state the vaccine contains 25mcg of mercury -- not 25mcg of thimerosal -- 25mcg of mercury."
"When I checked the package inserts for the seasonal flu vaccine, they read the same as the H1N1 description," Podlesak wrote.
The package insert states: "The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury."
Smaller amounts of thimerosal also remain in some other vaccines, even those marketed as "preservative-free," according to Age of Autism.
The H1N1 vaccine insert also states: "Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A"
"(H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed. "
Back on May 20, 2003, after a three year investigation of pediatric vaccine safety, initiated in the US House Committee on Government Reform, the "Mercury in Medicine Report," was placed in the Congressional record.
"Thimerosal used as a preservative in vaccines in likely related to the autism epidemic," the report concluded.
"This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding the lack of safety data regarding injected thimerosal and the sharp rise of infant exposure to this known neurotoxin," the Committee advised.
"The FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule," the report pointed out.
"At the same time that the incidence of autism was growing," the Committee said, "the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold."
Vaccine makers and conflicted public health officials are always claiming that studies show vaccines did not cause the autism epidemic. In a February 24, 2009 Huffington Post article, Robert F Kennedy, Jr, pointed out "that for sixty years the tobacco industry successfully defended a product that was killing one out of every five of its customers against thousands of legal actions brought by its victims and their families."
"Big tobacco prevailed for six decades," he said, "even without the help of supportive government agencies deliberately suppressing real science and research."
"In that sense vaccine victims must leap a much higher hurdle," he added.
Daniel Troy - Bush Administration's Preemption Gang - Part I
Evelyn Pringle February 2008
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
Daniel Troy - Bush Administration's Preemption Gang - Part II
Evelyn Pringle February 2008
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
Ted Olson - Bush Administration Preemption Gang - Part I
Evelyn Pringle March 2008
The line up of attorneys supporting preemption for the device maker, Medtronic, in the US Supreme Court recently, demonstrates that no conflict of interest rules apply to attorneys who serve in the Bush Administration.
The former Solicitor General, Ted Olson, represented Medtronic and other attorneys who filed amicus briefs or participated in oral arguments urging a favorable ruling for the device giant included the former Assistant to the Solicitor General, Carter Phillips, and the former Chief Counsel of the FDA, Daniel Troy.
Mr Olson is the former boss of Edwin Kneedler, the Deputy Solicitor General who represented the Bush Administration in asking the Court to throw out the case, during oral arguments on December 4, 2007.
The case involved one lone citizen, Donna Riegel, whose husband died as a result of a faulty device, and the question for review was whether the preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, preempts state-law claims against Medtronic for injuries caused by medical devices that received premarket approval from the FDA.
The Bush Administration filed a brief at the petition stage and told the Court not to review the lower court’s decision to dismiss the case at all. The list of current Administration attorneys on the briefs filed supporting Medtronic include the General Counsel of the Department of Health and Human Services, the Solicitor General, the Deputy Solicitor General, the Assistant Attorney General, the Assistant to the Solicitor General and two attorneys with no official title listed.
Most of these attorneys would have worked with Mr Olson, Mr Carter and Mr Troy, on briefs filed in cases before the Supreme Court when they were members of the Bush Administration.
As expected, the Court ruled against the private citizen and threw the case out. On February 21, 2008, the New York Times called it “a victory for the Bush administration.”
However, that victory may be short and sweet, because the Times also quoted Senator Edward Kennedy (D-MA), who sponsored the device legislation in 1976, as saying Congress never intended for FDA approval to give device makers blanket immunity from liability for injuries caused by faulty devices. “Congress obviously needs to correct the court’s decision,” he stated.
In addition, Representative Henry Waxman (D-Cal), chairman of the House Committee on Oversight and Government Reform, who was on the House panel that approved the Amendments, was also quoted in the Times as saying: “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
The starting point for any preemption analysis is Congressional intent. What did Congress intend the words of a statute to mean when it was enacted. During oral arguments, Mr Olson professed to know what Congress "intended" when enacting the 1976 legislation.
However, he has never served in Congress where laws are made and his "public service" over the past 20 years has been limited to racing back and forth through the back door of the White House to do the dirty work for Republican Administrations in hopes of earning a position in the White House the next time a Republican President took office.
His success in helping George Bush Jr steal the 2000 election by representing him before the Supreme Court in Bush v Gore, which resulted in a 5-4 decision to halt the recount of votes in Florida, ordered by the Florida Supreme Court, no doubt earned him the appointment of Solicitor General.
Going back in time, from 1981 to 1984, Mr Olson was the Assistant Attorney General for the Office of Legal Counsel under President Ronald Reagan and Vice President, George Bush, Sr, and he later represented President Reagan during the Iran Contra scandal.
Prior to joining the Reagan Administration Mr Olson was a member of the Gibson Dunn & Crutcher law firm. The senior partner in the firm, William French Smith, was the personal attorney for President Reagan when he was governor of California.
After Mr Reagan became President, he made Mr Smith attorney general and Mr Smith brought two attorneys from his firm to Washington. He brought Ken Starr, another great patriot, to serve as his chief of staff and Mr Olson to serve as assistant attorney general in the Office of Legal Counsel.
Mr Olson’s history of dirty dealings while serving in the Reagan Administration and his prominent role in the plot to oust President Bill Clinton from office during the 1990s, came back to haunt him and almost derailed his confirmation as Solicitor General in the current Bush Administration.
As a starting point in considering whether Mr Olson was an appropriate candidate to serve as Solicitor General, at a May 17, 2001 hearing, Senator Patrick Leahy (D-Vt) described what a person in this high position should be by stating:
"The Solicitor General fills a unique position in our Government. The Solicitor General has great responsibility for the integrity of our laws. The Solicitor General is not merely another legal advocate whose mission is to advance the narrow interests of a client, or merely another advocate of his President’s policies. The Solicitor General is much more than that.
“The Solicitor General must use his or her legal skills and judgment to higher purposes on behalf of the law and the rights of all the people of the United States."
Senator Leahy further stated that the Solicitor General is the only government official who must be, according to the statute, "learned in the law."
"The Solicitor General," he pointed out, "must argue with intellectual honesty before the Supreme Court and represent the interests of the Government and the American people for the long term, and not just with an eye to short-term political gain."
At one hearing Mr Olson described what he believed a Solicitor General should be, but he certainly was not describing himself when stating:
"The Solicitor General holds a unique position in our Government in that he has important responsibilities to all three branches of our Government. . . . And he is considered an officer of the Supreme Court in that he regularly and with scrupulous honesty must present to the Court arguments that are carefully considered and mindful of the Court’s role, duty, and limited resources.
"As the most consistent advocate before the Supreme Court, the Solicitor General and the lawyers in that office have a special obligation to inform the Court honestly and openly. The Solicitor General must be an advocate, but he must take special care that the positions he advances before the Court are fairly presented.
“As Professor Drew Days said to this committee during his confirmation hearing 8 years ago, the Solicitor General has a duty towards the Supreme Court of ‘absolute candor and fair dealing.’"
On May 11, 2001, the Washington Post pointed out that Mr Olson had been accused of providing misleading testimony when he worked in the Reagan Justice Department. The story behind this assertion is that Mr Olson was the subject of an independent counsel investigation himself in the mid-1980s, after a finding by the House Judiciary Committee that he lied to Congress to cover up the Reagan Administration's political use of a “Superfund,” set up to fund the clean-up of hazardous waste sites, in doling out sweetheart deals to favored companies through the Environmental Protection Agency.
During the investigation, the Administration asserted executive privilege to withhold documents that had been subpoenaed by a two House Committees. An October 25, 1982 memo to President Reagan authored by Mr Olson, stated that the documents withheld contained no evidence of wrongdoing by Administration officials, a condition for asserting executive privilege, and "The Administrator [Anne Gorsuch Burford] concurs in this recommendation", This memo later became the lightening rod in the investigation.
First of all, the EPA Administrator, Ms Burford, had not agreed that the Administration should claim executive privilege and refuse to turn over the documents, and second, the documents withheld did contain evidence of wrongdoing by Rita Lavelle, the EPA Assistant Administrator, who was later convicted of perjury and obstruction of justice.
Pursuant to a directive signed by President Reagan, Ms Burford asserted executive privilege in response to both subpoenas in December 1982, and both committees cited her for contempt of Congress. From there, the investigation snowballed and Mr Olson hung Ms Burford out to dry and left her with no choice but to resign on March 9, 1983.
On March 10, 1983, Mr Olson was called to testify before the Judiciary Committee about the advice given by the Justice Department that led to the withholding the documents. The October 25, 1982 memo had still not been provided to the committee, yet when asked whether the Justice Department had turned over all the documents pertaining to the advice given to President Reagan, Mr Olson stated:.
"Well, Mr. Chairman, we tried to provide everything that we have that pertains to the advice that we have given. Most of those documents are published. I don't include handwritten notes of my own. I make Xerox copies of cases and make notes in the margin. There are scraps of paper probably everywhere. I'm not sure that we've included everything. We've included everything that we think is relevant to the questions that you've asked and to the advice that we've given."
In a February 1983 letter, the committee chairman had asked the Justice Department to "supply all documents prepared by or in the possession of the Department in any way relating to the withholding of documents that Congressional committees have subpoenaed from the EPA."
Mr Olson left the Justice Department and returned to Gibson Dunn & Crutcher, in the spring of 1984, and in the end, the Judiciary Committee obtained access to virtually all the documents sought. But the battle with the Justice Department to obtain the information turned out to be more exasperating than dealing with the EPA controversy itself. In its final December 1985 report, the Committee concluded that:
"[T]he Department of Justice, through many of the same senior officials
who were most involved in the EPA controversy, consciously prevented
the Judiciary Committee from obtaining information in the Department's
possession that was essential to the Committee's inquiry into the
Department's role in that controversy.
"Most notably, the Department deliberately, and without advising the Committee, withheld a massive volume of vital handwritten notes and chronologies for over one year.
"These materials, which the Department knew came within the
Committee's February 1983 document request, contained the bulk of the
relevant documentary information about the Department's activities
outlined in this report and provided a basis for many of the Committee's
"findings."
Among the other abuses cited in the report were the withholding of other documents until the committee had independently learned of their existence, as well as materially "false and misleading" testimony by the Office of Legal Counsel. "Theodore Olson gave false and misleading testimony at a Judiciary Subcommittee hearing on March 10, 1983," the report stated.
The Reagan Administration was compelled to appoint an independent counsel by the Judiciary Committee in 1986, to determine whether charges should be filed against Mr Olson for his part in covering up the EPA scandal.
Mr Olson filed a legal challenge to the constitutionality of the independent counsel provisions of the Ethics in Government Act of 1978, which was appealed all the way to the US Supreme Court, and resulted in an 1987 decision upholding the constitutionality of the Act, with the lone dissenting vote being cast by Justice Anthony Scalia.
In 2001, Ms Burford published the book, "Are You Tough Enough? An Insider's View of Washington Politics," and wrote:
"The people at Justice behind the push for executive privilege were all presidential appointees who, to be blunt, shared several characteristics: (1) they didn't have enough to do; (2) they weren't very good lawyers; and (3) they had tremendous egos. They wanted to make a name for themselves in Washington, and one way to do that while they were at Justice was to have their names on a Supreme Court case."
When President Reagan left office, Mr Olson was his attorney during the Iran-Contra scandal, in dealing with the Independent Counsel's office and directing President Reagan's now famous, “I don’t recall” testimony, in the legal proceeding and trials of other Reagan Administration officials and White House aides.
Jumping ahead to a more recent lawyering endeavor by Mr Olson on behalf of the Bush Administration, on May 16, 2007, Amy Kotz reported in "The American Lawyer," that a report by a special committee of the World Bank Group, questioned Gibson, Dunn & Crutcher's review of World Bank president Paul Wolfowitz's transfer of his girlfriend, Shaha Riza, to a high-paying job at the US Department of State.
Ms Kotz noted that documents released by the bank showed that Wolfowitz asked Gibson to review the deal in the summer of 2005 and a Gibson Dunn team, including Theodore Olson and Eugene Scalia, concluded that the contract was "a reasonable resolution of the perceived underlying conflict of interest."
Gibson landed the assignment because of its "ability to present a strong team within 24 hours," according to a memo from a Wolfowitz aide that was released by the board. This team included former Solicitor General, Theodore Olson, and employment partner, Eugene Scalia, Ms Kotz reports.
That would be the son of Supreme Court Justice Antonin Scalia, the Justice who wrote the opinion in Medtronic.
The line up of attorneys supporting preemption for the device maker, Medtronic, in the US Supreme Court recently, demonstrates that no conflict of interest rules apply to attorneys who serve in the Bush Administration.
The former Solicitor General, Ted Olson, represented Medtronic and other attorneys who filed amicus briefs or participated in oral arguments urging a favorable ruling for the device giant included the former Assistant to the Solicitor General, Carter Phillips, and the former Chief Counsel of the FDA, Daniel Troy.
Mr Olson is the former boss of Edwin Kneedler, the Deputy Solicitor General who represented the Bush Administration in asking the Court to throw out the case, during oral arguments on December 4, 2007.
The case involved one lone citizen, Donna Riegel, whose husband died as a result of a faulty device, and the question for review was whether the preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, preempts state-law claims against Medtronic for injuries caused by medical devices that received premarket approval from the FDA.
The Bush Administration filed a brief at the petition stage and told the Court not to review the lower court’s decision to dismiss the case at all. The list of current Administration attorneys on the briefs filed supporting Medtronic include the General Counsel of the Department of Health and Human Services, the Solicitor General, the Deputy Solicitor General, the Assistant Attorney General, the Assistant to the Solicitor General and two attorneys with no official title listed.
Most of these attorneys would have worked with Mr Olson, Mr Carter and Mr Troy, on briefs filed in cases before the Supreme Court when they were members of the Bush Administration.
As expected, the Court ruled against the private citizen and threw the case out. On February 21, 2008, the New York Times called it “a victory for the Bush administration.”
However, that victory may be short and sweet, because the Times also quoted Senator Edward Kennedy (D-MA), who sponsored the device legislation in 1976, as saying Congress never intended for FDA approval to give device makers blanket immunity from liability for injuries caused by faulty devices. “Congress obviously needs to correct the court’s decision,” he stated.
In addition, Representative Henry Waxman (D-Cal), chairman of the House Committee on Oversight and Government Reform, who was on the House panel that approved the Amendments, was also quoted in the Times as saying: “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
The starting point for any preemption analysis is Congressional intent. What did Congress intend the words of a statute to mean when it was enacted. During oral arguments, Mr Olson professed to know what Congress "intended" when enacting the 1976 legislation.
However, he has never served in Congress where laws are made and his "public service" over the past 20 years has been limited to racing back and forth through the back door of the White House to do the dirty work for Republican Administrations in hopes of earning a position in the White House the next time a Republican President took office.
His success in helping George Bush Jr steal the 2000 election by representing him before the Supreme Court in Bush v Gore, which resulted in a 5-4 decision to halt the recount of votes in Florida, ordered by the Florida Supreme Court, no doubt earned him the appointment of Solicitor General.
Going back in time, from 1981 to 1984, Mr Olson was the Assistant Attorney General for the Office of Legal Counsel under President Ronald Reagan and Vice President, George Bush, Sr, and he later represented President Reagan during the Iran Contra scandal.
Prior to joining the Reagan Administration Mr Olson was a member of the Gibson Dunn & Crutcher law firm. The senior partner in the firm, William French Smith, was the personal attorney for President Reagan when he was governor of California.
After Mr Reagan became President, he made Mr Smith attorney general and Mr Smith brought two attorneys from his firm to Washington. He brought Ken Starr, another great patriot, to serve as his chief of staff and Mr Olson to serve as assistant attorney general in the Office of Legal Counsel.
Mr Olson’s history of dirty dealings while serving in the Reagan Administration and his prominent role in the plot to oust President Bill Clinton from office during the 1990s, came back to haunt him and almost derailed his confirmation as Solicitor General in the current Bush Administration.
As a starting point in considering whether Mr Olson was an appropriate candidate to serve as Solicitor General, at a May 17, 2001 hearing, Senator Patrick Leahy (D-Vt) described what a person in this high position should be by stating:
"The Solicitor General fills a unique position in our Government. The Solicitor General has great responsibility for the integrity of our laws. The Solicitor General is not merely another legal advocate whose mission is to advance the narrow interests of a client, or merely another advocate of his President’s policies. The Solicitor General is much more than that.
“The Solicitor General must use his or her legal skills and judgment to higher purposes on behalf of the law and the rights of all the people of the United States."
Senator Leahy further stated that the Solicitor General is the only government official who must be, according to the statute, "learned in the law."
"The Solicitor General," he pointed out, "must argue with intellectual honesty before the Supreme Court and represent the interests of the Government and the American people for the long term, and not just with an eye to short-term political gain."
At one hearing Mr Olson described what he believed a Solicitor General should be, but he certainly was not describing himself when stating:
"The Solicitor General holds a unique position in our Government in that he has important responsibilities to all three branches of our Government. . . . And he is considered an officer of the Supreme Court in that he regularly and with scrupulous honesty must present to the Court arguments that are carefully considered and mindful of the Court’s role, duty, and limited resources.
"As the most consistent advocate before the Supreme Court, the Solicitor General and the lawyers in that office have a special obligation to inform the Court honestly and openly. The Solicitor General must be an advocate, but he must take special care that the positions he advances before the Court are fairly presented.
“As Professor Drew Days said to this committee during his confirmation hearing 8 years ago, the Solicitor General has a duty towards the Supreme Court of ‘absolute candor and fair dealing.’"
On May 11, 2001, the Washington Post pointed out that Mr Olson had been accused of providing misleading testimony when he worked in the Reagan Justice Department. The story behind this assertion is that Mr Olson was the subject of an independent counsel investigation himself in the mid-1980s, after a finding by the House Judiciary Committee that he lied to Congress to cover up the Reagan Administration's political use of a “Superfund,” set up to fund the clean-up of hazardous waste sites, in doling out sweetheart deals to favored companies through the Environmental Protection Agency.
During the investigation, the Administration asserted executive privilege to withhold documents that had been subpoenaed by a two House Committees. An October 25, 1982 memo to President Reagan authored by Mr Olson, stated that the documents withheld contained no evidence of wrongdoing by Administration officials, a condition for asserting executive privilege, and "The Administrator [Anne Gorsuch Burford] concurs in this recommendation", This memo later became the lightening rod in the investigation.
First of all, the EPA Administrator, Ms Burford, had not agreed that the Administration should claim executive privilege and refuse to turn over the documents, and second, the documents withheld did contain evidence of wrongdoing by Rita Lavelle, the EPA Assistant Administrator, who was later convicted of perjury and obstruction of justice.
Pursuant to a directive signed by President Reagan, Ms Burford asserted executive privilege in response to both subpoenas in December 1982, and both committees cited her for contempt of Congress. From there, the investigation snowballed and Mr Olson hung Ms Burford out to dry and left her with no choice but to resign on March 9, 1983.
On March 10, 1983, Mr Olson was called to testify before the Judiciary Committee about the advice given by the Justice Department that led to the withholding the documents. The October 25, 1982 memo had still not been provided to the committee, yet when asked whether the Justice Department had turned over all the documents pertaining to the advice given to President Reagan, Mr Olson stated:.
"Well, Mr. Chairman, we tried to provide everything that we have that pertains to the advice that we have given. Most of those documents are published. I don't include handwritten notes of my own. I make Xerox copies of cases and make notes in the margin. There are scraps of paper probably everywhere. I'm not sure that we've included everything. We've included everything that we think is relevant to the questions that you've asked and to the advice that we've given."
In a February 1983 letter, the committee chairman had asked the Justice Department to "supply all documents prepared by or in the possession of the Department in any way relating to the withholding of documents that Congressional committees have subpoenaed from the EPA."
Mr Olson left the Justice Department and returned to Gibson Dunn & Crutcher, in the spring of 1984, and in the end, the Judiciary Committee obtained access to virtually all the documents sought. But the battle with the Justice Department to obtain the information turned out to be more exasperating than dealing with the EPA controversy itself. In its final December 1985 report, the Committee concluded that:
"[T]he Department of Justice, through many of the same senior officials
who were most involved in the EPA controversy, consciously prevented
the Judiciary Committee from obtaining information in the Department's
possession that was essential to the Committee's inquiry into the
Department's role in that controversy.
"Most notably, the Department deliberately, and without advising the Committee, withheld a massive volume of vital handwritten notes and chronologies for over one year.
"These materials, which the Department knew came within the
Committee's February 1983 document request, contained the bulk of the
relevant documentary information about the Department's activities
outlined in this report and provided a basis for many of the Committee's
"findings."
Among the other abuses cited in the report were the withholding of other documents until the committee had independently learned of their existence, as well as materially "false and misleading" testimony by the Office of Legal Counsel. "Theodore Olson gave false and misleading testimony at a Judiciary Subcommittee hearing on March 10, 1983," the report stated.
The Reagan Administration was compelled to appoint an independent counsel by the Judiciary Committee in 1986, to determine whether charges should be filed against Mr Olson for his part in covering up the EPA scandal.
Mr Olson filed a legal challenge to the constitutionality of the independent counsel provisions of the Ethics in Government Act of 1978, which was appealed all the way to the US Supreme Court, and resulted in an 1987 decision upholding the constitutionality of the Act, with the lone dissenting vote being cast by Justice Anthony Scalia.
In 2001, Ms Burford published the book, "Are You Tough Enough? An Insider's View of Washington Politics," and wrote:
"The people at Justice behind the push for executive privilege were all presidential appointees who, to be blunt, shared several characteristics: (1) they didn't have enough to do; (2) they weren't very good lawyers; and (3) they had tremendous egos. They wanted to make a name for themselves in Washington, and one way to do that while they were at Justice was to have their names on a Supreme Court case."
When President Reagan left office, Mr Olson was his attorney during the Iran-Contra scandal, in dealing with the Independent Counsel's office and directing President Reagan's now famous, “I don’t recall” testimony, in the legal proceeding and trials of other Reagan Administration officials and White House aides.
Jumping ahead to a more recent lawyering endeavor by Mr Olson on behalf of the Bush Administration, on May 16, 2007, Amy Kotz reported in "The American Lawyer," that a report by a special committee of the World Bank Group, questioned Gibson, Dunn & Crutcher's review of World Bank president Paul Wolfowitz's transfer of his girlfriend, Shaha Riza, to a high-paying job at the US Department of State.
Ms Kotz noted that documents released by the bank showed that Wolfowitz asked Gibson to review the deal in the summer of 2005 and a Gibson Dunn team, including Theodore Olson and Eugene Scalia, concluded that the contract was "a reasonable resolution of the perceived underlying conflict of interest."
Gibson landed the assignment because of its "ability to present a strong team within 24 hours," according to a memo from a Wolfowitz aide that was released by the board. This team included former Solicitor General, Theodore Olson, and employment partner, Eugene Scalia, Ms Kotz reports.
That would be the son of Supreme Court Justice Antonin Scalia, the Justice who wrote the opinion in Medtronic.
Ted Olson - Bush Administration Preemption Gang - Part II
Evelyn Pringle March 2008
Theodore Olson was one of the masterminds behind the Arkansas Project, which operated between 1993 and 1997, with the single-minded goal of trying to dig up, or in the alternative manufacture, enough dirt to get rid of the twice elected President, Bill Clinton.
His lies to Congress about his role in this sordid affair nearly derailed his confirmation as Solicitor General in the current Bush Administration.
The Arkansas Project was funded by more than $2 million from Pittsburgh billionaire Richard Mellon Scaife and funneled through the American Spectator magazine. While testifying before Congress at his confirmation hearings, Mr Olson lied through his teeth about his role in this plot.
At May 17, 2001 hearing, Senator Patrick Leahy (D-Vt), noted that his concern from the outset about Mr Olson serving as Solicitor General was whether Mr Olson's "sharp partisanship over the last several years might not be something that he could leave behind."
Through the course of the hearing and written questions, he stated, "Mr. Olson has not shown a willingness or ability to be sufficiently candid and forthcoming with the Senate so that I would have confidence in his abilities to carry out the responsibilities of the Solicitor General and be the voice of the United States before the United States Supreme Court. In addition, I am concerned about other matters in his background."
Specifically, Senator Leahy said, questions persisted about Mr Olson’s involvement with the American Spectator Magazine and the Arkansas Project.
He pointed out that Mr Olson had implied that his role was extremely limited as a member of the Board of Directors of the American Spectator Educational Foundation and that he was involved only after the fact, when the Board conducted a financial audit and terminated the Arkansas Project activities in 1998.
However, he noted that Mr Olson had subsequently modified his answers over time, and his recollection had changed, and he conceded additional knowledge and involvement. "His initial minimizing of his role," the Senator said, "appears not to be consistent with the whole story."
He recounted that in April, 2001, Mr Olson's testimony was that he was not involved, except as a Member of the Board but that over several weeks and several rounds of questions, Mr Olson had expanded his initial response to admit that he and his firm provided legal services in connection with the matter, that he had discussions in "social" settings with those working on ‘Arkansas Project’ matters, and that he himself authored articles for the magazine paid for out of Scaife’s special ‘Arkansas Project’ fund.
On April 5, 2001, in response to a question by Senator Leahy of whether he was "involved in the so-called ‘Arkansas Project’ at any time," Mr Olson responded by saying:
"As a member of the board of directors of the American Spectator, I became aware of that. It has been alleged that I was somehow involved in that so-called project. I was not involved in the project in its origin or its management."
According to Senator Leahy, after some additional correspondence, Mr Olson changed his answer stating: "My only involvement in what has been characterized as the ‘Arkansas Project’ was in connection with my service to the Foundation as a lawyer and member of its Board of Directors."
When first asked about a vicious article he coauthored that was published anonymously under the pseudonym "Solitary, Poor, Nasty, Brutish and Short" in the Spectator, Mr Olson did not acknowledge that the magazine had hired his firm to prepare such materials or to perform legal research on the theoretical criminal exposure of the President and First Lady based on press accounts of their conduct.
Mr Olson testified that the article contained "statements of a private citizen." However, he failed to explain why, as a private citizen, he chose to make his public attacks on the Clintons anonymously.
Senator Leahy later quoted Mr Olson's law partner, Doug Cox, as telling the Washington Post that he and Mr Olson worked on legal matters for the American Spectator, which included legal research that was incorporated into an article published in 1994, under a fictitious name and claimed that the President might be facing up to 178 years in prison and the First Lady 47 years in prison.
Senator Leahy noted that Mr Olson and Mr Cox “have now acknowledged-- that Mr. Olson co-authored a number of articles for the American Spectator for which he or his firm were paid with Scaife funds and that Mr. Olson provided legal advice in connection with other efforts funded with Scaife funds in connection with the ‘Arkansas Project’.”
In a May 14, 2001, letter to Senator Orin Hatch, Mr Olson wrote that he and his law firm participated in the researching and writing of, "informational material which the magazine chose to publish under the pseudonym ‘Solitary, Poor, Nasty, Brutish and Short'."
Mr Olson then incorporated a portion of the retainer letter between the American Spectator and his firm and indicated, "my firm was paid our normal billing rates."
Senator Leahy pointed out that Mr Olson had previously written to him on this point and stated: "I received payments for articles authored or co-authored by me. The fees ranged from $500 to $1,000 per article, as I recall."
The Senator then stated, “I find it hard to imagine that Mr. Olson’s normal billing rates and those charged by his firm would yield only $500 to $1,000 per article.”
He also objected to the fact that he was unable to get Mr Olson or the magazine to provide billing records to clear up the matter once and for all.
However, Senator Leahy quoted the May 10, 2001, article in the Washington Post that said over $14,000 had been paid to Mr Olson’s law firm and specifically attributed by the American Spectator Magazine to the Arkansas Project.
At the time of the hearing and his answer to all the question, Senator Leahy said, “Mr. Olson was well aware of what the ‘Arkansas Project’ run by the organization for which he acted as lawyer, author and contributor, Board Member and officers had involved.”
“He had been presented with an audit and played a pivotal role in reviewing the examination of its management, methods and results,” he pointed out.
David Brock, a former reporter for the American Spectator and the author of some of the most vicious Clinton articles published, came forward and told the Judiciary Committee staff that Mr Olson attended several meetings at the home of R Emmett Tyrrell Jr, the editor of magazine when ideas for editorials were discussed by the Arkansas Project.
Mr Brock reported that Mr Olson was also not truthful about his role in ghostwriting smear-Clinton articles in Spectator magazine. For instance, he said, Mr Olson encouraged the publication of a story with speculation about Vince Foster being murdered, even though Mr Olson himself believed Mr Foster had committed suicide, to keep the heat on the Clinton Administration until another scandal was shaken loose.
In response to questions about the Vince Foster article, Mr Olson did not deny Mr Brock’s account of the events, he simply wrote that he told Mr Brock that the article did not appear to be libelous or to raise any legal issues that would preclude its publication, and that he was not going to tell the editor-in-chief what should appear in the magazine.
In the May 21, 2002, New York Observer, Joe Conason reported that the financial records of the American Spectator Educational Foundation showed several payments in 1994 to Mr Olson's law firm, that were "listed explicitly as Arkansas Project "expenses."
Mr Conason says another attendee at the meetings that Mr Brock referred to was David Henderson, a Spectator foundation director who served as an overseer of the project. He also reports that Mr Brock's assertion was corroborated by a letter in which the Spectator's publisher named persons who regularly attended the meetings at his home, and the first name on the list, which included Mr Brock and Mr Henderson, was "Ted Olson."
In 1998, a series of articles in Salon magazine by Murray Waas provided an inside look at the shenanigans going on behind the scenes in the midst of Ken Starr’s Whitewater Investigation.
According to Mr Waas, Mr Olson was providing advice to the Arkansas Project, dating back to its inception in late 1993 or early 1994 and in fact, "one of the initial meetings to set up the Arkansas Project was held at Olson's downtown Washington, D.C., office at Gibson, Dunn & Crutcher."
Yet, at an April 2001 hearing, Senator Leahy asked Mr Olson whether there had been any meetings of the Arkansas Project in his office and he responded: "No, there were none."
In follow-up written questions, Senator Leahy asked in particular about the time frame of 1993 and 1994, and Mr Olson answered that he was, "not aware of any meeting organizing, planning or implementing the ‘Arkansas Project’ in my law firm in 1993 or 1994."
Senator Leahy then followed up by drawing his attention to a passage out of the book, “The Hunting of the President,” in which the authors wrote that a meeting did take place at his office in November 1993, with David Henderson, Steve Boynton, John Mintz, Ronald Burr and Michael Horowitz, at which the topic was using Scaife funds and the American Spectator to, "mount a series of probes into the Clintons and their alleged crimes in Arkansas."
In response, Mr Olson did not deny that a meeting took place but disputed the description of the topic of the meeting and noted that he did, "not recall the meeting described."
During the confirmation proceedings, Mr Olson also lied through his teeth about how he ended up representing David Hale, a corrupt municipal judge in Arkansas facing a multitude of criminal charges who served as the "star" witness in the Whitewater fiasco claiming that President Clinton had pressured him to make a fraudulent $300,000 loan to Susan McDougal.
Mr Hale himself is a real piece of work. He ran the investment firm, Capital Management Services, and received matching funds from the Small Business Administration to administer loans to disadvantaged companies. However, a federal investigation showed that although Capital financed over 50 companies, Mr Hale secretly owned 13.
In 1994, Mr Hale pleaded guilty to fraud and conspiracy, but with more than a little help from his friends in high place, the low-life crook was able to avoid being sentenced for two more years.
When Senator Leahy asked Mr Olson at an April 5, 2001 hearing, how he came to represent this crook, he replied, "[t]wo of [Hale’s] then lawyers contacted me and asked ..."
A few seconds later he stated, "[o]ne of his lawyers contacted me– I can’t recall the man’s name– and asked whether I would be available to represent Mr. Hale in connection with that subpoena here in Washington, D.C. They felt that they needed Washington counsel with some experience dealing with a congressional investigation. I did agree to do that. Mr. Hale and I met together."
A little over a month later, in a May 9, 2001, letter, Mr Olson wrote, I "cannot recall when [he] was first contacted about the possibility of representing Mr. Hale."
He further states that he believes, "that [he] was contacted by a person or persons whose identities [he] cannot presently recall sometime before then regarding whether I might be willing to represent Mr. Hale if he needed representation in Washington.”
“As I recall,” Mr Olson wrote, “I indicated at the time that I might be able to do so, but only in connection with a potential congressional subpoena, not with respect to legal matters pending in Arkansas. . . .”
“I believe that this meeting was inconclusive because Mr. Hale did not at that time need representation in Washington," he stated.
One of the names that Mr Olson could not remember, even though he apparently wracked his brain for over a month, was David Henderson, the director of the Arkansas Project.
On May 11, 2001, the Washington Post may have helped jog Mr Olson’s memory when it reported that Mr Henderson said he had made the introduction when Mr Hale came to Washington to find a lawyer who could help him deal with a subpoena from the Senate Whitewater committee, and Mr Henderson sat in on a meeting.
During a May 17, 2007 hearing, Senator Leahy stated in regard to the wanna-be Solicitor General: “It now strikes me as strange that a man as capable as Mr. Olson with his vast abilities of recall could not remember the name of David Henderson.”
“It leads one to wonder,” he continued, “whether Mr. Olson’s failure to recall the name David Henderson had something to do with his not wanting to indicate the connection to such a central figure in the ‘Arkansas Project’.”
He also pointed out that a January 1996, letter written by Mr Olson to accept membership on the board of directors of the American Spectator was addressed to the publisher of the magazine and was copied to Mr Henderson.
When the Senate Whitewater Committee hearings got underway, not surprisingly, the Democrats were eager to call Mr Hale to testify because he was supposed to be the star witness in the Whitewater witch-hunt and the only person who had made any direct allegations of wrongdoing against President Clinton.
However, whenever efforts were made to bring in Mr Hale to testify, Mr Starr would claim that his appearance might hinder or impede his investigation, although Mr Hale continued to make his allegations against the President through the media where they of course were impossible to refute. As the minority, the Democrats were hamstrung, because they had no power to issue a subpoena to Mr Hale to compel his testimony.
When the pressure mounted to bring Mr Hale to Washington, Mr Olson jumped in to save the day by saying his busy schedule would not permit him to represent Mr Hale at the moment because he was preparing for 2 cases before the US Supreme Court in early 1996, and so the Committee would have to wait until he disposed of those cases.
Six month later on June 6, 1996, the Senate committee received a letter from Mr Hale’s attorneys, stating in part: "Mr. Hale will claim the protection of his Constitutional privilege under the Fifth Amendment to the Constitution of the United States and respectfully decline to testify ... if he is compelled to appear in response to the subpoenas."
John Mintz, a former general counsel for the FBI, also represented Mr Hale, and the question that has never been answered, is where would a bankrupt municipal judge get the money to hire a former assistant attorney general and high-ranking attorney in the FBI.
A report released in May 2001, stated that Mr Olson provided "approximately $140,000 in legal representation for which Hale has not paid and which has been written off by Olson's law firm as uncollectible."
The report also stated: "There is certainly reason to believe that Olson took on Hale as a 'paying' client with no real expectation that he would ever be paid."
The Senate Whitewater Committee ended its investigation without ever hearing from the man lauded as the star witness in the case against President Clinton.
However, Mr Hale was the star witness in the 1996 trial against Arkansas Governor Jim Guy Tucker and James and Susan McDougal. At the trial, Mr Hale testified that he had found Mr Olson through Randy Coleman, a Little Rock criminal defense attorney who represented him at the time, and that he was also assisted in the effort to find the Washington attorney by a "Senator Hollingsworth."
Had Mr Hale told the jury about the role of Stephen Boynton and David Henderson in helping him find Mr Olson, it would have certainly led to revelations about the Arkansas Project, including the money paid to Mr Hale as the key source for the demented plot.
In March 1998, Murray Waas and Jonathon Broder revealed in Salon Magazine that Mr Hale had received cash payments from the Arkansas Project regularly from 1994 to 1996. They quoted eyewitnesses Caryn Mann and her son who reported that after Mr Hale became a federal witness in the Mr Starr's investigation, he received payments from as little as $40 to as much as $500.
Sources told Salon that Mr Scaife funded the Project through tax-exempt foundations. “Under the scheme,” they wrote, “two of Scaife's charitable foundations transferred as much as $600,000 a year to a third charitable foundation, which owns the conservative American Spectator magazine“.
Most of the money was then transferred to Stephen Boynton, described in Salon, as an attorney and conservative political activist with long-standing ties to Scaife.
The article explains that a portion of the funds went to a Parker Dozhier, a sportsman and fur trapper in Hot Springs, Arkansas, who then made the payments to Mr Hale, and quotes Caryn Mann, Mr Dozhier's former live-in girlfriend, and her son Joshua Rand.
They told Salon that they witnessed the payments while Mr Hale was staying at Mr Dozhier's fishing cabin complex between 1994 and 1996. Ms Mann stated that Mr Dozhier was well compensated for his role in the scheme and that she kept the books and kept track of the incoming checks from Mr Boynton and his associate, David Henderson.
She told Salon that checks began arriving sporadically in 1994, but by 1995, $1,000 checks arrived monthly and that Mr Boynton and Mr Henderson showed up often to speak to Mr Hale and Mr Dozhier, and after they left, there was "always an abundance of cash."
"Sometime it was only $40, $60 or $80 at a time, but other times it was $120 or $240 or $500," Mr Rand explained in the article.
"If Hale needed to pay a $200 bill, Parker would give him the money, plus an extra $100 or $120 for his pocket,” he said.
Speaking on the condition of anonymity, 2 former executives of the American Spectator, corroborated the story that funds from the Project went to Mr Hale. One executive stated: "Henderson told me that David Hale's family needed to be taken care of, and they had a way of doing that," and the second verified that account, according to the Salon report.
On April 13, 1998, Time Magazine reported that the attorney general, Janet Reno, wanted to examine the payments made to Mr Hale, but she still had not decided how.
The article notes that if she referred the matter to Ken Starr, “that means he would be investigating both his chief witness, Hale, and his own likely future benefactor, Scaife, who is partially funding two Pepperdine University deanships that Starr is supposed to settle into after Whitewater.”
In a series of reports for Salon in August 1998, Murray Waas reported that:
“In addition to his involvement with the American Spectator, Olson has served on the advisory boards of four separate Washington, D.C., conservative organizations that have received substantial funding from Scaife, according to a Gibson, Dunn & Crutcher biography of Olson and financial disclosure statements of the four political groups.”
Mr Waas also noted that Mr Olson's wife, Barbara, was a founder and member of the advisory board of the Independent Women's Forum, which he said had “received at least $350,000 in funding from Scaife over the last several years.”
The American Spectator served as a launching pad for the whole Paul Jones fiasco which started with what came to be called the, "Troopergate" article, authored by David Brock, alleging that Arkansas state troopers had helped procured women for then Governor Clinton and claiming that a woman named, "Paula," had told a state trooper that she would be willing to be the Governor’s girlfriend.
In April 1998, the Chicago Sun-Times reported that two of the troopers who were sources for the article, Larry Patterson and Roger Perry, were paid by Peter Smith, a Chicago investment banker, described as a large GOP contributor, “who spent about $80,000 over 18 months to get tales about Clinton's personal life into print,” in Time Magazine on April 13, 1998.
Mr Brock has since publicly apologized to the Clintons for his reporting in the Spectator and acknowledged that the troopers who claimed they procured women for then Governor Clinton had received money.
Behind the scenes, the Olsons were working hand and glove with the Jones attorneys. In 1994, Mrs Olson's Women's Forum considered filing an amicus brief in support of Paula Jones and the attorney with whom the group discussed the brief was none other than Ken Starr.
When it came time to argue whether a President could postpone litigation until he leaves office, before the Supreme Court, in early 1997, Mr Olson, and the rejected Supreme Court Justice of the Reagan Administration, Robert Bork, held a moot court to allow the Jones attorneys to practice their arguments before the hearing.
For her part, Barbara Olson, now deceased, devoted much of her time as wife of the bush Administration’s future Solicitor General, writing the book, "Hell to Pay," and literally trashed Hillary Clinton, the First Lady of the United States.
Theodore Olson was one of the masterminds behind the Arkansas Project, which operated between 1993 and 1997, with the single-minded goal of trying to dig up, or in the alternative manufacture, enough dirt to get rid of the twice elected President, Bill Clinton.
His lies to Congress about his role in this sordid affair nearly derailed his confirmation as Solicitor General in the current Bush Administration.
The Arkansas Project was funded by more than $2 million from Pittsburgh billionaire Richard Mellon Scaife and funneled through the American Spectator magazine. While testifying before Congress at his confirmation hearings, Mr Olson lied through his teeth about his role in this plot.
At May 17, 2001 hearing, Senator Patrick Leahy (D-Vt), noted that his concern from the outset about Mr Olson serving as Solicitor General was whether Mr Olson's "sharp partisanship over the last several years might not be something that he could leave behind."
Through the course of the hearing and written questions, he stated, "Mr. Olson has not shown a willingness or ability to be sufficiently candid and forthcoming with the Senate so that I would have confidence in his abilities to carry out the responsibilities of the Solicitor General and be the voice of the United States before the United States Supreme Court. In addition, I am concerned about other matters in his background."
Specifically, Senator Leahy said, questions persisted about Mr Olson’s involvement with the American Spectator Magazine and the Arkansas Project.
He pointed out that Mr Olson had implied that his role was extremely limited as a member of the Board of Directors of the American Spectator Educational Foundation and that he was involved only after the fact, when the Board conducted a financial audit and terminated the Arkansas Project activities in 1998.
However, he noted that Mr Olson had subsequently modified his answers over time, and his recollection had changed, and he conceded additional knowledge and involvement. "His initial minimizing of his role," the Senator said, "appears not to be consistent with the whole story."
He recounted that in April, 2001, Mr Olson's testimony was that he was not involved, except as a Member of the Board but that over several weeks and several rounds of questions, Mr Olson had expanded his initial response to admit that he and his firm provided legal services in connection with the matter, that he had discussions in "social" settings with those working on ‘Arkansas Project’ matters, and that he himself authored articles for the magazine paid for out of Scaife’s special ‘Arkansas Project’ fund.
On April 5, 2001, in response to a question by Senator Leahy of whether he was "involved in the so-called ‘Arkansas Project’ at any time," Mr Olson responded by saying:
"As a member of the board of directors of the American Spectator, I became aware of that. It has been alleged that I was somehow involved in that so-called project. I was not involved in the project in its origin or its management."
According to Senator Leahy, after some additional correspondence, Mr Olson changed his answer stating: "My only involvement in what has been characterized as the ‘Arkansas Project’ was in connection with my service to the Foundation as a lawyer and member of its Board of Directors."
When first asked about a vicious article he coauthored that was published anonymously under the pseudonym "Solitary, Poor, Nasty, Brutish and Short" in the Spectator, Mr Olson did not acknowledge that the magazine had hired his firm to prepare such materials or to perform legal research on the theoretical criminal exposure of the President and First Lady based on press accounts of their conduct.
Mr Olson testified that the article contained "statements of a private citizen." However, he failed to explain why, as a private citizen, he chose to make his public attacks on the Clintons anonymously.
Senator Leahy later quoted Mr Olson's law partner, Doug Cox, as telling the Washington Post that he and Mr Olson worked on legal matters for the American Spectator, which included legal research that was incorporated into an article published in 1994, under a fictitious name and claimed that the President might be facing up to 178 years in prison and the First Lady 47 years in prison.
Senator Leahy noted that Mr Olson and Mr Cox “have now acknowledged-- that Mr. Olson co-authored a number of articles for the American Spectator for which he or his firm were paid with Scaife funds and that Mr. Olson provided legal advice in connection with other efforts funded with Scaife funds in connection with the ‘Arkansas Project’.”
In a May 14, 2001, letter to Senator Orin Hatch, Mr Olson wrote that he and his law firm participated in the researching and writing of, "informational material which the magazine chose to publish under the pseudonym ‘Solitary, Poor, Nasty, Brutish and Short'."
Mr Olson then incorporated a portion of the retainer letter between the American Spectator and his firm and indicated, "my firm was paid our normal billing rates."
Senator Leahy pointed out that Mr Olson had previously written to him on this point and stated: "I received payments for articles authored or co-authored by me. The fees ranged from $500 to $1,000 per article, as I recall."
The Senator then stated, “I find it hard to imagine that Mr. Olson’s normal billing rates and those charged by his firm would yield only $500 to $1,000 per article.”
He also objected to the fact that he was unable to get Mr Olson or the magazine to provide billing records to clear up the matter once and for all.
However, Senator Leahy quoted the May 10, 2001, article in the Washington Post that said over $14,000 had been paid to Mr Olson’s law firm and specifically attributed by the American Spectator Magazine to the Arkansas Project.
At the time of the hearing and his answer to all the question, Senator Leahy said, “Mr. Olson was well aware of what the ‘Arkansas Project’ run by the organization for which he acted as lawyer, author and contributor, Board Member and officers had involved.”
“He had been presented with an audit and played a pivotal role in reviewing the examination of its management, methods and results,” he pointed out.
David Brock, a former reporter for the American Spectator and the author of some of the most vicious Clinton articles published, came forward and told the Judiciary Committee staff that Mr Olson attended several meetings at the home of R Emmett Tyrrell Jr, the editor of magazine when ideas for editorials were discussed by the Arkansas Project.
Mr Brock reported that Mr Olson was also not truthful about his role in ghostwriting smear-Clinton articles in Spectator magazine. For instance, he said, Mr Olson encouraged the publication of a story with speculation about Vince Foster being murdered, even though Mr Olson himself believed Mr Foster had committed suicide, to keep the heat on the Clinton Administration until another scandal was shaken loose.
In response to questions about the Vince Foster article, Mr Olson did not deny Mr Brock’s account of the events, he simply wrote that he told Mr Brock that the article did not appear to be libelous or to raise any legal issues that would preclude its publication, and that he was not going to tell the editor-in-chief what should appear in the magazine.
In the May 21, 2002, New York Observer, Joe Conason reported that the financial records of the American Spectator Educational Foundation showed several payments in 1994 to Mr Olson's law firm, that were "listed explicitly as Arkansas Project "expenses."
Mr Conason says another attendee at the meetings that Mr Brock referred to was David Henderson, a Spectator foundation director who served as an overseer of the project. He also reports that Mr Brock's assertion was corroborated by a letter in which the Spectator's publisher named persons who regularly attended the meetings at his home, and the first name on the list, which included Mr Brock and Mr Henderson, was "Ted Olson."
In 1998, a series of articles in Salon magazine by Murray Waas provided an inside look at the shenanigans going on behind the scenes in the midst of Ken Starr’s Whitewater Investigation.
According to Mr Waas, Mr Olson was providing advice to the Arkansas Project, dating back to its inception in late 1993 or early 1994 and in fact, "one of the initial meetings to set up the Arkansas Project was held at Olson's downtown Washington, D.C., office at Gibson, Dunn & Crutcher."
Yet, at an April 2001 hearing, Senator Leahy asked Mr Olson whether there had been any meetings of the Arkansas Project in his office and he responded: "No, there were none."
In follow-up written questions, Senator Leahy asked in particular about the time frame of 1993 and 1994, and Mr Olson answered that he was, "not aware of any meeting organizing, planning or implementing the ‘Arkansas Project’ in my law firm in 1993 or 1994."
Senator Leahy then followed up by drawing his attention to a passage out of the book, “The Hunting of the President,” in which the authors wrote that a meeting did take place at his office in November 1993, with David Henderson, Steve Boynton, John Mintz, Ronald Burr and Michael Horowitz, at which the topic was using Scaife funds and the American Spectator to, "mount a series of probes into the Clintons and their alleged crimes in Arkansas."
In response, Mr Olson did not deny that a meeting took place but disputed the description of the topic of the meeting and noted that he did, "not recall the meeting described."
During the confirmation proceedings, Mr Olson also lied through his teeth about how he ended up representing David Hale, a corrupt municipal judge in Arkansas facing a multitude of criminal charges who served as the "star" witness in the Whitewater fiasco claiming that President Clinton had pressured him to make a fraudulent $300,000 loan to Susan McDougal.
Mr Hale himself is a real piece of work. He ran the investment firm, Capital Management Services, and received matching funds from the Small Business Administration to administer loans to disadvantaged companies. However, a federal investigation showed that although Capital financed over 50 companies, Mr Hale secretly owned 13.
In 1994, Mr Hale pleaded guilty to fraud and conspiracy, but with more than a little help from his friends in high place, the low-life crook was able to avoid being sentenced for two more years.
When Senator Leahy asked Mr Olson at an April 5, 2001 hearing, how he came to represent this crook, he replied, "[t]wo of [Hale’s] then lawyers contacted me and asked ..."
A few seconds later he stated, "[o]ne of his lawyers contacted me– I can’t recall the man’s name– and asked whether I would be available to represent Mr. Hale in connection with that subpoena here in Washington, D.C. They felt that they needed Washington counsel with some experience dealing with a congressional investigation. I did agree to do that. Mr. Hale and I met together."
A little over a month later, in a May 9, 2001, letter, Mr Olson wrote, I "cannot recall when [he] was first contacted about the possibility of representing Mr. Hale."
He further states that he believes, "that [he] was contacted by a person or persons whose identities [he] cannot presently recall sometime before then regarding whether I might be willing to represent Mr. Hale if he needed representation in Washington.”
“As I recall,” Mr Olson wrote, “I indicated at the time that I might be able to do so, but only in connection with a potential congressional subpoena, not with respect to legal matters pending in Arkansas. . . .”
“I believe that this meeting was inconclusive because Mr. Hale did not at that time need representation in Washington," he stated.
One of the names that Mr Olson could not remember, even though he apparently wracked his brain for over a month, was David Henderson, the director of the Arkansas Project.
On May 11, 2001, the Washington Post may have helped jog Mr Olson’s memory when it reported that Mr Henderson said he had made the introduction when Mr Hale came to Washington to find a lawyer who could help him deal with a subpoena from the Senate Whitewater committee, and Mr Henderson sat in on a meeting.
During a May 17, 2007 hearing, Senator Leahy stated in regard to the wanna-be Solicitor General: “It now strikes me as strange that a man as capable as Mr. Olson with his vast abilities of recall could not remember the name of David Henderson.”
“It leads one to wonder,” he continued, “whether Mr. Olson’s failure to recall the name David Henderson had something to do with his not wanting to indicate the connection to such a central figure in the ‘Arkansas Project’.”
He also pointed out that a January 1996, letter written by Mr Olson to accept membership on the board of directors of the American Spectator was addressed to the publisher of the magazine and was copied to Mr Henderson.
When the Senate Whitewater Committee hearings got underway, not surprisingly, the Democrats were eager to call Mr Hale to testify because he was supposed to be the star witness in the Whitewater witch-hunt and the only person who had made any direct allegations of wrongdoing against President Clinton.
However, whenever efforts were made to bring in Mr Hale to testify, Mr Starr would claim that his appearance might hinder or impede his investigation, although Mr Hale continued to make his allegations against the President through the media where they of course were impossible to refute. As the minority, the Democrats were hamstrung, because they had no power to issue a subpoena to Mr Hale to compel his testimony.
When the pressure mounted to bring Mr Hale to Washington, Mr Olson jumped in to save the day by saying his busy schedule would not permit him to represent Mr Hale at the moment because he was preparing for 2 cases before the US Supreme Court in early 1996, and so the Committee would have to wait until he disposed of those cases.
Six month later on June 6, 1996, the Senate committee received a letter from Mr Hale’s attorneys, stating in part: "Mr. Hale will claim the protection of his Constitutional privilege under the Fifth Amendment to the Constitution of the United States and respectfully decline to testify ... if he is compelled to appear in response to the subpoenas."
John Mintz, a former general counsel for the FBI, also represented Mr Hale, and the question that has never been answered, is where would a bankrupt municipal judge get the money to hire a former assistant attorney general and high-ranking attorney in the FBI.
A report released in May 2001, stated that Mr Olson provided "approximately $140,000 in legal representation for which Hale has not paid and which has been written off by Olson's law firm as uncollectible."
The report also stated: "There is certainly reason to believe that Olson took on Hale as a 'paying' client with no real expectation that he would ever be paid."
The Senate Whitewater Committee ended its investigation without ever hearing from the man lauded as the star witness in the case against President Clinton.
However, Mr Hale was the star witness in the 1996 trial against Arkansas Governor Jim Guy Tucker and James and Susan McDougal. At the trial, Mr Hale testified that he had found Mr Olson through Randy Coleman, a Little Rock criminal defense attorney who represented him at the time, and that he was also assisted in the effort to find the Washington attorney by a "Senator Hollingsworth."
Had Mr Hale told the jury about the role of Stephen Boynton and David Henderson in helping him find Mr Olson, it would have certainly led to revelations about the Arkansas Project, including the money paid to Mr Hale as the key source for the demented plot.
In March 1998, Murray Waas and Jonathon Broder revealed in Salon Magazine that Mr Hale had received cash payments from the Arkansas Project regularly from 1994 to 1996. They quoted eyewitnesses Caryn Mann and her son who reported that after Mr Hale became a federal witness in the Mr Starr's investigation, he received payments from as little as $40 to as much as $500.
Sources told Salon that Mr Scaife funded the Project through tax-exempt foundations. “Under the scheme,” they wrote, “two of Scaife's charitable foundations transferred as much as $600,000 a year to a third charitable foundation, which owns the conservative American Spectator magazine“.
Most of the money was then transferred to Stephen Boynton, described in Salon, as an attorney and conservative political activist with long-standing ties to Scaife.
The article explains that a portion of the funds went to a Parker Dozhier, a sportsman and fur trapper in Hot Springs, Arkansas, who then made the payments to Mr Hale, and quotes Caryn Mann, Mr Dozhier's former live-in girlfriend, and her son Joshua Rand.
They told Salon that they witnessed the payments while Mr Hale was staying at Mr Dozhier's fishing cabin complex between 1994 and 1996. Ms Mann stated that Mr Dozhier was well compensated for his role in the scheme and that she kept the books and kept track of the incoming checks from Mr Boynton and his associate, David Henderson.
She told Salon that checks began arriving sporadically in 1994, but by 1995, $1,000 checks arrived monthly and that Mr Boynton and Mr Henderson showed up often to speak to Mr Hale and Mr Dozhier, and after they left, there was "always an abundance of cash."
"Sometime it was only $40, $60 or $80 at a time, but other times it was $120 or $240 or $500," Mr Rand explained in the article.
"If Hale needed to pay a $200 bill, Parker would give him the money, plus an extra $100 or $120 for his pocket,” he said.
Speaking on the condition of anonymity, 2 former executives of the American Spectator, corroborated the story that funds from the Project went to Mr Hale. One executive stated: "Henderson told me that David Hale's family needed to be taken care of, and they had a way of doing that," and the second verified that account, according to the Salon report.
On April 13, 1998, Time Magazine reported that the attorney general, Janet Reno, wanted to examine the payments made to Mr Hale, but she still had not decided how.
The article notes that if she referred the matter to Ken Starr, “that means he would be investigating both his chief witness, Hale, and his own likely future benefactor, Scaife, who is partially funding two Pepperdine University deanships that Starr is supposed to settle into after Whitewater.”
In a series of reports for Salon in August 1998, Murray Waas reported that:
“In addition to his involvement with the American Spectator, Olson has served on the advisory boards of four separate Washington, D.C., conservative organizations that have received substantial funding from Scaife, according to a Gibson, Dunn & Crutcher biography of Olson and financial disclosure statements of the four political groups.”
Mr Waas also noted that Mr Olson's wife, Barbara, was a founder and member of the advisory board of the Independent Women's Forum, which he said had “received at least $350,000 in funding from Scaife over the last several years.”
The American Spectator served as a launching pad for the whole Paul Jones fiasco which started with what came to be called the, "Troopergate" article, authored by David Brock, alleging that Arkansas state troopers had helped procured women for then Governor Clinton and claiming that a woman named, "Paula," had told a state trooper that she would be willing to be the Governor’s girlfriend.
In April 1998, the Chicago Sun-Times reported that two of the troopers who were sources for the article, Larry Patterson and Roger Perry, were paid by Peter Smith, a Chicago investment banker, described as a large GOP contributor, “who spent about $80,000 over 18 months to get tales about Clinton's personal life into print,” in Time Magazine on April 13, 1998.
Mr Brock has since publicly apologized to the Clintons for his reporting in the Spectator and acknowledged that the troopers who claimed they procured women for then Governor Clinton had received money.
Behind the scenes, the Olsons were working hand and glove with the Jones attorneys. In 1994, Mrs Olson's Women's Forum considered filing an amicus brief in support of Paula Jones and the attorney with whom the group discussed the brief was none other than Ken Starr.
When it came time to argue whether a President could postpone litigation until he leaves office, before the Supreme Court, in early 1997, Mr Olson, and the rejected Supreme Court Justice of the Reagan Administration, Robert Bork, held a moot court to allow the Jones attorneys to practice their arguments before the hearing.
For her part, Barbara Olson, now deceased, devoted much of her time as wife of the bush Administration’s future Solicitor General, writing the book, "Hell to Pay," and literally trashed Hillary Clinton, the First Lady of the United States.
Subscribe to:
Comments (Atom)