The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Relentless and Tragic Marketing: Psychiatric Drugs from Before the Cradle to the Grave

by John Breeding, PhD and Amy Philo

Working with others, we strive to alleviate distress and to support and enhance the personal growth, transformation, individuation, self-determination, and clear and expanded awareness of individuals. Necessity dictates that we also spend a lot of time challenging aspects of the mental health profession that do the opposite—creating more distress, suppressing growth and transformation, violating self-determination, and dulling and blinding awareness. We call it psychiatric oppression, the systematic, institutionalized mistreatment of those judged as “mentally ill.” This essay focuses especially on the ever expanding encroachment of psychiatric oppression to more and more of the population, and to individuals who are less and less in need of actual help. This encroachment takes the form of mass marketing for psychiatry and the pharmaceutical industry. One key aspect of oppression theory is the claim to virtue. For psychiatric oppression that claim is the notion that mentally ill people need their treatment; its growing extension is the concept of prevention, that potentially mentally ill people need treatment as well!

The Regressive Progression: Treatment to Prevention

“An ounce of prevention is a pound of cure.” Like all great aphorisms, this one, often associated with Ben Franklin, holds wisdom and is partly true, based on assumption. In this case, one must assume the role of victim of unnecessary malady that necessitates a cure…and that there is a felt connection or empathic relatedness to the one who suffers malady. Where these assumptions are not met, the aphorism is false. To wit, for the giant corporation of Halliburton and its government and military operations group, or for the mercenary army of Blackwater, going to war is worth a great deal more than diplomacy.

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Filed under: "prevention", 'ADHD', adverse drug reactions, Amy Philo, anitdepressants and pregnancy, antidepressant side effects, antidepressants, antidepressants during pregnancy, antidepressants during pregnancy studies, antipsychotics, baby, Baby Matthew, big brother, big pharma, bigpharmavictim, Birth Defects, birth defects caused by antidepressant, child endangerment, choking, Christian Delahunty, Christiane Schultz, Collusion, congenital heart defects, Congress, Coon Rapids, courts, dead babies, drugging children, Drugging Vets, ECT, Effexor, Effexor in pregnancy, Elderly, electroshock, eugenics, FDA, FDA Warnings, forced 'treatment', Freedom Commission on Mental Health, heart defects, Indiana, Isaac Philo, Melanie Stokes, Mercy Hospital, mothers act, paxil birth defects, Paxil in pregnancy, pharmacology, Postpartum Support International, PPD, Pregnancy, psychiatric hospital, schizophrenia, screening, SSRI, suicide, Supreme Court, The Future of The United States, toxicity deaths, Zoloft, , , , , , , , , , , , , ,

Vaccination Profiteers Gang Up on Hannah Bruesewitz in Supreme Court

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.

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Filed under: 2010, autism, Preemption, Supreme Court, thimerosal, vaccines

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.

Filed under: 2009, autism, CDC, flu, front groups, Offit, Supreme Court, thimerosal, vaccines, WHO

FDA and Big Pharma Gang Up On Joe Citizen

Evelyn Pringle November 6, 2006

The botched safety processes at the FDA have had an extremely negative impact on the nation’s public health and tens of thousands of people have died as a result of its negligent handling of the Vioxx debacle alone.

Americans today can no more trust what’s in their medicine cabinets than could the pioneers in the 1800s who filled their medicine chests when the snake oil salesmen came to town.

The FDA is now apparently claiming infallibility by telling consumers that if it says a drug is safe and the warnings on a drug’s label are sufficient, no consumer can bring a lawsuit against a drug’s maker in a state court for injuries caused by a drug, even if it is shown that the drug company actively concealed information about known injuries associated with the drug not only from consumers, but from the FDA as well.

Throughout the FDA’s 100 year history, state consumer protection laws have played an important role in protecting Americans from unsafe pharmaceutical products, and consumer protection advocates are rightfully questioning whether the FDA can or will provide the same protection.

Its no secret that the Bush-sanctioned FDA is bent on protecting drug company profits and doesn’t care enough about protecting consumers from unsafe drugs. A March 2006 report to Congress issued by the Government Accountability Office, after an investigation of the FDA ability to monitor drug safety, said the FDA’s performance was undermined by infighting between drug evaluation administrators whose allegiance is with industry and the Office of Drug Safety.

According to Attorney, Jim Gottstein, who recently scored a major victory in the Alaska Supreme Court protecting patients in state institutions from forced drugging with psychiatric medications, “the fact that current leaders of the FDA have taken the extraordinary step of interjecting the FDA into cases to argue pre-emption, leaves no doubt that it has abdicated its duty to protect the public from unsafe drugs in favor of protecting pharmaceutical profits.”

State lawmakers are also crying foul over the FDA’s arrogant undermining of state consumer protection laws because under Executive Order 13132, the FDA is required to consult with state authorities about the effects of regulations it issues on states. In the original proposed rule, the FDA specifically said that the regulation would not preempt state laws so state officials had no chance to object to the preemption rule.

According to the National Conference of State Legislatures, the preemption language in the preamble to the Final Rule is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called the FDA’s action an abuse of agency process and a complete disregard for our dual system of government.

According to Baum Hedlund attorney, Karen Barth Menzies, “the FDA’s statement is nothing more than the policy position of appointed officials with an agenda unrelated to public safety.”

“As such,” she says, “it should have zero preemptive effect.”

When Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938, it specifically rejected a proposal to include a private right of action for damages caused by products regulated by the FDA, on the grounds that a right of action already existed under state common law.

The new FDA preemption rule provides no exceptions even in cases like Vioxx where the FDA asked the company to change the warning label based on reports of serious adverse effects, and a drug maker like Merck refuses to change the label for more than 18 months while many more patients are killed and injured.

In addition, the FDA contends that the agency’s approval of the drug label preempts not only claims related to label warnings but also claims related to false advertising.

Given the on-going heated debate over the FDA’s ability to police the pharmaceutical industry as a whole, critics say it is a particularly inappropriate time to eliminate the role that private citizen lawsuits in state courts play.

But then again, what can we expect when the agency’s top attorney, Daniel Troy, is recruited directly from Pfizer’s stable of lawyers. Troy began the administration’s preemption war against Joe Citizen to protect Big Pharma profits as soon as he set up shop at the FDA, by filing amicus briefs on behalf of drug companies, including Pfizer.

Even though Pfizer had been one of his clients and Troy’s firm was paid over $350,000 for work he performed in the year before he was appointed chief counsel, Troy agreed to file a brief in support of Pfizer on behalf of the FDA, arguing, unsuccessfully, that state tort claims should be preempted.

He later justified writing the brief by claiming that he did not become involved in the case until after the 1-year period in which government employees may not participate in cases involving former clients. In hindsight, the 1-year grace period reportedly expired less than a month before Troy agreed to go to bat for his former client.

In stark contrast to Troy’s pro drug company stance, in a 1996 speech, the Clinton appointed FDA chief counsel, Margaret Jane Porter, said the FDA had a “longstanding presumption against preemption” and that “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”

When simply filing amicus briefs did not work because no judge accepted the FDA’s at best feeble and at worst ridiculous arguments, in January 2006, the FDA added the preamble to the new drug labeling rules stating that the Food, Drug and Cosmetic Act “pre-empts conflicting or contrary state law.”

Judges are having mixed reactions to the FDA’s preemption position. In a stinging rebuke, New Jersey judge, Carol Higbee, during a June 6, 2006 hearing involving Vioxx lawsuits, called the Final Rule’s preamble “a political statement by the FDA.”

As for the claim that state lawsuits should be preempted, she said, “It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption.”

“In addition to being contrary to the law of the land,” she stated, “it is also contrary to the Constitution of the United States.”

She ended her comments by telling Merck’s Vioxx attorneys, “And I am not going to allow you to use it.”

On June 2, 2006, the Associated Press reported that a federal judge had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on behalf of the parents of an 11-year-old boy who committed suicide after taking the antidepressants Zoloft and Effexor.

The judge rejected the preemption argument stating: “Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability.”

“Defendant’s pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling,” the court said.

“In the absence of Congress’s express statement,” the judge stated, “defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so.”

In what can only be viewed as a rare ruling, In Bextra and Celebrex, on August 16, 2006, the US District Court for the Northern District of California dismissed the state law failure-to-warn claims saying they conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act.

The court attempted to justify the FDA’s “180-degree reversal of its prior position” on preemption, by noting that an agency’s view may change over time and especially with a change in administration.

But in New Jersey on September 29, 2006, a federal district court in McNellis v Pfizer Inc, refused to allow the preemption defense and based on the fact that the text of FDA regulations had remained unchanged for years, ruled that the regulations did not conflict with New Jersey’s failure-to-warn laws.

The court also said that FDA regulations allow increased warnings when new risks emerge and that the Food, Drug and Cosmetic Act does not contain a preemption clause.

Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker’s preemption motion in Perry v Novartis Pharma Corp, noting concerns about the effectiveness of the FDA’s monitoring of recently approved drugs, making the availability of state tort suits an “important backstop to the federal regulatory scheme.”

On October 5, 2006, the 2nd Circuit Court of Appeals was also critical of the FDA’s preemptive reach stating, “[W]hatever deference would be owed to an agency’s view … an agency cannot supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,” in Desiano v Warner-Lambert et al.

Three weeks later, on October 28, 2006, the Associated Press reported another state court victory against preemption in a case where Wyeth was ordered to pay nearly $6.8 million to a Vermont women after the Vermont Supreme Court upheld a lower court’s ruling.

The court’s decision said federal labeling requirements “create a floor, not a ceiling” for state regulation, noting that the FDA regulations allow drug companies to go beyond required warnings.

“When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability,” the court wrote.

Peter Lurie, deputy director of the health research group at Public Citizen, told the Associated Press that the case appeared to mark a push-back against efforts by the industry, the administration and the FDA to preempt state regulation of prescription drugs.

“If you have a wide enough berth that you can strengthen the label,” he said, “you can’t use the FDA-approved label as an automatic protection against lawsuits.”

Since May 2006, all eyes in the legal field have been on the appeal in the case of Colacicco v Apotex, Inc, – F Supp 2d -, 2006 WL 1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the lower court ruled against a man whose wife committed suicide after taking Paxil.

Joseph Colacicco filed a lawsuit against both drug makers alleging that his wife committed suicide in October 2003, just 21 days after she began taking Paxil for mild depression with claims of wrongful death, negligence and a failure to warn her doctor of a link between Paxil and an increased risk of suicide.

In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil generic maker, Apotex, relied on the FDA’s position that state failure-to-warn claims are preempted.

The judge ruled that the defendants were entitled to a dismissal of all claims because the FDA controls the content of warnings and requires generic drug makers to use the same labeling as approved for the drug’s original maker.

In this case, the judge on his own initiative, asked the FDA to submit an amicus brief. And in response, on the tax payer’s dime, the FDA wrote a brief asking the court to rule against the American citizen and dismiss the lawsuit against the drug companies.

In fact the FDA was the strongest supporter of preemption in this case because according to the attorneys handling the case, Glaxo itself barely addressed the preemption issue during oral arguments on the motion.

In a decision that experts predict may end up before the US Supreme Court, the judge ended up dismissing the claims without ever considering whether the FDA regulations pose a conflict to the plaintiff’s state tort claims.

Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the Conshohocken, Pennsylvania firm of Pogust & Braslow are representing the plaintiff in the case.

Attorney, Harris Pogust, says the judge’s ruling “could potentially do away with all failure-to-warn pharmaceutical cases”

The FDA action he notes, “does not seem to be a public health concern as much as a political concern.”

According to Mr Braslow, “the Judge readily admits that he did not analyze whether there is or was a conflict between state law and federal law and surmises that he probably would not find a conflict if he actually did the analysis.”

“But, the Judge explained,” he said, “that it doesn’t matter – if the FDA says there is preemption, then there must be preemption. Far be it for a Judge to interpret the law.”

“The Bush-era FDA,” Mr Braslow notes, “in a complete reversal of the position it took in its 2000 rule proposal, has now officially cemented its role as a pawn for the pharmaceutical industry.”

“It was not that long ago,” Mr Braslow points out, “that the FDA came forward with amicus briefs on behalf of the consumer in prescription drug litigation.”

“Now,” Mr Braslow says, “an argument first put forward in a couple Zoloft suicide cases, has become the primary argument in every prescription drug case, and could,” he warns, “potentially, mean the end for anyone seeking recourse from injuries resulting from prescription drugs, no matter how fraudulent the drug company’s conduct.”

“Make no mistake,” he states, “the position taken by the Bush-era FDA is an attempt by the current administration to achieve tort reform for the benefit of big pharma and at the expense of the injured consumer, without the consent of Congress.”

“The Bush-era FDA takes this position,” he warns, “unconcerned by the reality that preemption would allow drug companies to peddle their drugs with impunity and avoid being justifiably called into court for deceiving the public about the safety and effectiveness of those drugs.”

“Notwithstanding the FDA’s position on preemption,” Mr Braslow says, “courts examining this issue, if they take any time to actually look at the FDA regulations in question, would realize that there is no conflict between federal drug regulations and state tort claims.”

“Federal drug regulations specifically mandate drug companies to strengthen their drug’s label,” he explains, “as soon as there is reasonable evidence of an association of a serious hazard with their drug.”

“A state tort claim,” Mr Braslow points out, “does not force a drug company to take any action that is not already permitted by federal regulations.”

“Because federal regulations for prescription drugs are minimum standards,” he notes, “federal regulations can never conflict with a state common law claim.”

“The District Court erred,” he states, “in abdicating to FDA legal opinion, as opposed to interpreting the law.”

“What the Colacicco court did,” he says, “was improperly abdicate to the FDA’s legal opinion.”

Critics say it’s time for the FDA to get back to protecting consumers from dangerous products, rather than protecting the profits of the pharmaceutical industry.

According to career scientist, Dr David Graham, in a 2005 interview with Jeanne Lenzer in the journal Public Library of Science, “The pharma-FDA complex has to be dismantled and the American people have to insist on that, otherwise we’re going to have disasters like Vioxx that happen in the future.”

Filed under: 2006, Baum, Braslow, Colacicco, FDA, Preemption, Supreme Court, Troy

Supremes Say Strip Search of Student Uncalled For

Evelyn Pringle June 30, 2009

The constitutional rights of 13-year-old Savana Redding were violated when school officials in Arizona conducted a strip-search based on a suspicion that she might be hiding drugs in her underwear, the Supreme Court ruled on June 25, 2009, in an 8 to 1 decision.

The suspect drugs that led to the search in this case were “prescription-strength ibuprofen and over-the-counter naproxen, common pain relievers equivalent to two Advil, or one Aleve,” the court noted in the opinion.

The search failed to uncover any pills.

“The issue here is whether a 13-year-old student’s Fourth Amendment right was violated when she was subjected to a search of her bra and underpants by school officials acting on reasonable suspicion that she had brought forbidden prescription and over-the-counter drugs to school,” the opinion states.

“Because there were no reasons to suspect the drugs presented a danger or were concealed in her underwear, we hold that the search did violate the Constitution,” the court wrote.

“Savana’s subjective expectation of privacy against such a search is inherent in her account of it as embarrassing, frightening, and humiliating,” the court said. “The reasonableness of her expectation (required by the Fourth Amendment standard) is indicated by the consistent experiences of other young people similarly searched, whose adolescent vulnerability intensifies the patent intrusiveness of the exposure.”

“Changing for gym is getting ready for play; exposing for a search is responding to an accusation reserved for suspected wrongdoers and fairly understood as so degrading
that a number of communities have decided that strip searches in schools are never reasonable and have banned them no matter what the facts may be,” the court pointed out.

“In sum, what was missing from the suspected facts that pointed to Savana was any indication of danger to the students from the power of the drugs or their quantity,
and any reason to suppose that Savana was carrying pills in her underwear,” the court said. “We think that the combination of these deficiencies was fatal to finding the search reasonable.”

As the lone voter against the ruling, Justice Clarence Thomas, wrote: “Redding would not have been the first person to conceal pills in her undergarments,” in his dissenting opinion.

“Nor will she be the last after today’s decision, which announces the safest place to secrete contraband in school,” he said

Apparently to substantiate that Savana “would not have been the first person to conceal pills in her undergarments,” Thomas cited five stories from the media involving drug busts where persons hid drugs in their underwear, none of which were at a school, or concerned minors. And, the drugs identified in the media reports were Oxycontin, Hydrocodone, and Ecstasy.

The ruling came in a case titled, Safford Unified School District v Redding, and the American Civil Liberties Union represented the plaintiff, April Redding, Savana’s mother.

“Neither the Constitution nor common sense permits school officials to treat a strip search the same as a locker or backpack search,” said Steven Shapiro, the ACLU’s national Legal Director, in a June 25, 2009 statement. “Today’s ruling eliminates any confusion that school officials may have had about this seemingly obvious point.”

The ACLU and ACLU of Arizona were joined in the case by Bruce Macdonald, with the law firm McNamara, Goldsmith, Jackson & Macdonald, and Andrew Petersen, with the firm Humphrey & Petersen.

Adolescent health experts and privacy rights advocates also filed amicus briefs in support of Redding, including the National Education Association, National Association of Social Workers (NASW), CATO Institute, Rutherford Institute, Goldwater Institute and Urban Justice Center, and others.

The Supreme Court decision is available online at: http://www.aclu.org/drugpolicy/search/40031lgl20090625.html

Filed under: 2009, Supreme Court

Implant For-Profit Industry Not Deserving of Preemption Protection – Part I

Evelyn Pringle July 9, 2007

In addition to the question of how many soldiers will be dead or injured by the time self-proclaimed “war President” George Bush leaves office, Americans need to ask themselves how many citizens will be dead or injured as a result of an FDA controlled by the industry most credited with funding his move to the White House.

Last year, the FDA announced that the agency’s approval of a pharmaceutical product preempts product liability lawsuits against the industry giants in state courts, even when a company actively conceals information that shows serious injury and death are known to be associated with a product.

With the solid backing of the FDA, preemption is now being used as an argument to dismiss lawsuits filed by injured citizens in state courts against medical device makers.

Critics point out that many risks associated with a new product will not be known at the time of FDA approval and that additional safety information often surfaces only after a device is widely used on the market.

Furthermore, FDA regulations allow device makers to add stronger warnings when a risk becomes known, without requiring FDA approval. However, all too often, company documents which surface as a result of litigation show that the device maker was aware of safety risks long before the product was approved and that they actively concealed the information from the FDA.

Legal experts say the legal remedies available under state laws are set up to give additional protection to consumers over and above the minimal protection provided by the FDA approval process, and especially at times like this, when the FDA is run by appointed industry insiders who refuse to police the medical device industry.

The Medical Device Amendments to the Federal Food, Drug and Cosmetic Act establish a federal statutory and regulatory scheme governing the sale of devices in the U.S., but the MDA provides no private cause of action against device makers and therefore, the preemption of state law claims would eliminate most, if not all, legal remedies for persons injured by defective products.

Whether or not the administration has succeeded in immunizing device makers will likely be known in 2008, because on June 25, 2007, the U.S. Supreme Court agreed to hear an appeal in Riegel v Medtronic, involving a case against Medtronic which could determine whether patients will have the right to file lawsuits against device makers under consumer protection laws enacted by the individual states.

The Public Citizen Litigation Group is representing Charles Reigel, who was injured in 1996 when a balloon catheter burst while he was undergoing an angioplasty, a procedure used to open clogged arteries.

After the Second Circuit Court found the lawsuit was preempted based on FDA approval, Public Citizen attorneys Allison Zieve, Wayne Smith and Brian Wolfman, filed a petition asking the Supreme Court to consider whether the Food, Drug, and Cosmetic Act expressly preempts state-law actions brought by patients who have been injured by devices that received pre-market approval, and to issue a ruling due to the inconsistent rulings on the preemption issue in cases filed in the lower courts.

The petition argues that the FDA has switched positions on whether pre-market approval preempts state law claims since the government’s views were solicited by the Court in 1997, when the FDA supported the right to pursue state law claims.

The Supreme Court asked the Solicitor General to offer the government’s views and, of course, the FDA used tax dollars collected in large part from the injured plaintiffs who might have cause to file claims in state courts, to send up a brief that backed Medtronic 1000% in it use of preemption to prevent Americans from suing the device giant.

In direct harmony with Medtronic, the FDA brief tells the Court not to bother with the conflict in preemption rulings in the lower courts because there are now more rulings on one side of issue than the other.

“Also like Medtronic,” Public Citizen responds in a reply brief, “the government asks the Court to overlook the undisputed conflict because it might simply go away.”

“What has changed since 1997,” Public Citizen notes, “is the government’s view on the merits of the question presented.”

“The government’s inconsistency on this question of statutory meaning only underscores the need for this Court to resolve the question presented,” the brief states.

Legal experts say the ruling in this case has the potential to affect thousands upon thousands of lawsuits currently filed in state courts against the makers of medical devices, including defective products implanted in patients with heart disease, such as defibrillators, pacemakers and drug-eluding stents, and devices used during spinal surgery.

A favorable ruling for Medtronic could literally save Boston Scientific from the poor house because, at last count, the company was facing over 75 class actions and 1,100 individual lawsuits involving defective defibrillators and pacemakers manufactured by the recently-acquired Guidant Corp, according to Boston’s SEC filing.

Also, the number of litigants against Boston is rising by the month. On June 15, 2007, the Brown & Crouppen law firm of St Louis filed a 39-count product liability lawsuit in St Clair County on behalf of 14 plaintiffs against Guidant, Boston and Cardiac Pacemakers, alleging the defibrillators/pacemakers were defective and required them to be hospitalized.

These latest lawsuits claim the devices were defective in design, did not conform to federal requirements and subjected users to risks of heart attacks, death and other illnesses that exceeded the benefits of the devices. Other safer products were available, and the makers actively concealed the product defects in order to prevent adverse publicity.

According to the June 29, 2007, Madison St Clair Record, this is at least the third complaint filed by Brown & Crouppen against these same companies.

Spinal surgery represents another division of the implant for-profit industry. A study in the November 2006 Spine journal, conducted at Dartmouth Medical School, analyzed data on lower back (lumbar) surgery among Medicare recipients aged 65 and older nationwide and found that surgery rates in 2002-2003 were almost 8 times higher than in 1992 in some areas of the U.S., and in 2003, Medicare spent over $1 billion on spine surgery.

On August 5, 2006, the LA Times reported that spinal surgery has become a very lucrative business, “with at least $3.2 billion spent last year in the U.S. on spinal fusion.”

In October 2004, Johnson & Johnson obtained FDA approval for the Charite artificial spinal disc as an alternative to spinal fusion surgery, but experts contend that the superiority of the two procedures is limited to the cost. Charite replacement can run as high as $50,000, while spinal fusion surgery costs less than half that, at roughly $23,000.

A favorable ruling on preemption would be great news for Johnson & Johnson, considering that SEC filings reveal that there were 100 lawsuits pending against the company at the end of 2006 related to the Charite artificial spinal disc, alleging that the company knew the disc was defective and boosted profits by implanting the device for uses not approved by the FDA and in patients who would not benefit from the device.

Between the time the disc was approved in October 2004 and July 2006, the FDA had already received over 130 reports of serious adverse events in patients implanted with the device and, in most cases, the disc was implanted in patients who did not meet the criteria for disc replacement as specified by the FDA.

Although a favorable Supreme Court ruling would be beneficial to the device makers in dealing with lawsuits filed by private plaintiffs in state courts, it will do nothing to stop the on-going investigations into the marketing of devices to determine whether device makers are funneling money to doctors and hospitals to increase the use of their products.

Anti-kickback statutes make it illegal for doctors or medical facilities to receive financial incentives to increase the use of devices, which in turn increase the number of implant procedures, in patients covered by public health care programs.

In the end, it was the greed, evidenced by drastic rise in the use of not only defibrillators and pacemakers, but all medical devices with Medicare patients over the past few years that drew the attention of lawmakers and law enforcement officials to the implant for profit industry.

On September 26, 2006, the New York Times reported that overall, Medicare payments to hospitals for implant procedures grew from $10 billion to $14 billion, an increase of about 40%, in just 2 years.

As of today, every major device maker is under investigation for working with doctors and hospitals to increase profits by billing public health care programs for implant procedures performed on patients who, in many cases, did not need the devices.

The FBI, the U.S. Department of Justice and the Department of Health and Human Services have set up a Medicare Fraud Strike Force, and the Strike Force is predicting that as much as $2.5 billion can be saved by cracking down on the device makers, doctors and hospitals involved in the implant industry.

The investigations of J&J and its DePuy Division are not limited to the Charite disc. In June 2006, the company was served a subpoena by the Antitrust Division of the DOJ, requesting documents related to the manufacture and sale of the company’s orthopedic devices, and search warrants were executed in connection with the investigation, according to documents filed by J&J with the SEC on August 8, 2006.

SEC filings also show that Medtronic is responding to a subpoena from the Office of the U.S. Attorney for the District of Massachusetts, issued under the Health Insurance Portability & Accountability Act of 1996, requesting documents relating to pacemakers and defibrillators; monitoring equipment and services; benefits to persons in a position to recommend purchases of such devices; and the company’s training and compliance materials relating to the fraud and abuse and federal Anti-Kickback statutes.

Investigations are also underway into over-use of the new drug-eluting stents (DES), marketed by Boston and Johnson & Johnson, with the average cost to Medicare ranging from $11,184 to $14,287, according to the Centers for Medicare and Medicaid Services.

The first DES was approved in 2003, and on December 4, 2006, Bloomberg reported that, in 2005, the new stents accounted for 43% of total sales for Boston and 52% for Johnson & Johnson. By the end of 2006, the new stent was a top-selling device for Boston, bringing in about $2 billion.

On March 1, 2007, the House Oversight and Government Reform Committee, which conducts oversight of Medicare spending, ordered Johnson & Johnson and Boston to turn over documents, related the marketing of drug-eluting stents.

In May 2007, the Strike Force reported that one Maryland cardiologist had implanted 25 unnecessary stents in 2006, with most patients covered by Medicare.

The salary for the cardiologists who benefit from stent procedures is roughly half-a-million dollars a year, according to an article in Slate Magazine on May 8, 2007.

Legal analysts are predicting that the lawsuits filed by patients injured as a result of the massive over-use of medical devices will involve all the co-conspirators in the medical profession who helped turn the implant business into a billion-dollar industry overnight.

Filed under: 2007, Boston Scientific, Charite, DePuy, Guidant, Johnson and Johnson, MEDICAID, medical devices, MEDICARE, Medtronic, Preemption, Riegel, stents, Supreme Court

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