We Lost Bruesewitz v. Wyeth, But We Gained Sotomayor and Ginsburg
By Kent Heckenlively, Esq.
I will confess my deep disappointment over the outcome in Bruesewitz v. Wyeth. The case was well-presented by the attorneys and I thought it might be one of those rare instances where there could be a convergence of conservative suspicion of big government and a liberal suspicion of big business.
I was wrong. The conservatives did not hold true to their principles. The liberals did.
And yet in the 6-2 decision I must also note a crack in the defenses. You'll forgive me if I sound a little like Atticus Finch in To Kill a Mockingbird, who noted hope in a small-town southern jury who argued long and hard before convicting an obviously innocent black man of attempted rape.
To put it bluntly, the republican males of the court folded and the democratic women, Sotomayor and Ginsburg stood firm and identified the true issues in the case. Sotomayor's blistering dissent set the stage for future public debates. Here is the preview she gave of her 28 page dissent:
"Vaccine manufacturers have long been subject to a legal duty, rooted in basic principles of products liability law, to improve the design of their vaccines in light of advances in science and technology. Until today, that duty was enforceable through a traditional state-law tort action for defective design. In holding that section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act), 42 U.S.C. section 300aa-22(b)(1), preempts all design defect claims for injuries stemming from vaccines covered under the Act, the Court imposes its own bare policy preference over the considered judgment of Congress. In doing so, the Court excises 13 words from the statutory text, misconstrues the Act's legislative history, and disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market. Its decision leaves a regulatory vacum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products. Because nothing in the text, structure, or legislative history of the Vaccine Act remotely suggests that Congress intended such a result, (bold is mine) I dissent."
This dissent sets the stage for all future conversations.
We lost all of the Vaccine Court cases. In the Supreme Court we lost 6-2. But a different dynamic now begins.
If one might say the republicans of the Supreme Court favored the pharmaceutical companies, it's now the job of the media which is overwhelmingly democratic to sell this decision. But the media darlings of the Supreme Court aren't Roberts and Scalia. It's Sotomayor, if it's anybody.
And now the media is in the uncomfortable position of saying their favorite Justice, that "wise Latina", somehow went off the tracks, and lost her mind on this case. How else can they explain her vigorous dissent? They can't say it's because she's a former Playboy bunny. She's not some angry mom looking for somebody to blame because her child is disabled. She hasn't been tried and found guilty in some bizarre kangaroo medical court. She is a woman of exceptional intelligence and ability who is often touted as a future Chief Justice of the Supreme Court.
Sotomayor represents the best of principled liberal ideals wedded to a classic American story of overcoming great odds. I have often wondered where autism might find a home among our political parties. The answer is clear to me now.
Democratic women. That's not to say there aren't wonderful republicans in this fight, but we must fight on the battlefield which is most advantageous to us at this time.
No women on this court found in favor of the pharmaceutical companies. To me that's the take-home message of this decision and the way I think it will play across the country. (I know, if Elena Kagan had participated in this decision she probably would have found in favor of the pharmaceutical companies, but she didn't.)
How many mothers will be comforted by the fact that all the men on the court ended up on one side of this issue and all the women on the other? Does it make them more likely to follow the CDC recommended schedule? I don't believe it does.
Yes, we lost an important battle in the Supreme Court. But we also gained a valuable ally and some amazing intellectual firepower. For the first time in the history of this debate an unassailable figure in American life has stood up and said that the way the Vaccine Court is operating is wrong.
Sotomayor wrote that "nothing in the text, structure, or legislative history of the Vaccine Act remotely suggests that Congress intended such a result." The words have been written and published for all to see. Yes, we are still a minority, but this dissent says we have a right to be heard and a reasonable point of view.
The fight goes on.
Kent Heckenlively is Legal Editor of Age of Autism
RIP Justice Ginsburg
Posted by: Autism Investigated | September 19, 2020 at 01:09 PM
Hey Twyla,
It's kind of weird. There's a ton of detail on "failure to warn," but I can't find the preemption of manufacturing defects described in any greater detail than "unavoidable even though the vaccine was properly prepared."
So maybe you're right. Maybe the Bruesewitz family can still bring a civil suit in State court, alleging that Hannah's particular vaccine lot was not "properly prepared."
In a State court, I would assume that the petitioner would have the right to a real discovery process; the only problem is that Wyeth (now Pfizer) probably shredded any files related to those vaccine lots many years ago.
(One previous employer of mine instructed all of us during orientation to shred/electronically destroy any paperwork that had been around more than six months, unless it was related to ongoing business. Since Wyeth removed this particular vaccine from the market, and since no civil suits were pending against the company, thanks to the 1986 Act, I'm sure any files relating to Hannah's vaccine lot are long, long gone.)
Posted by: Theresa O | February 26, 2011 at 07:51 AM
Twyla,
I think the "failure to warn" defect (the second one you list) is preempted in the sections copied at the bottom of this comment (from p. 46 ff of the authorizing legislation, the 1986 Act).
You'll note that the manufacturer *doesn't actually have to warn* the person receiving the vaccine. It's actually written into the 1986 Act that "failure to warn" defects are preempted, even though the manufacturer is not required to warn. Bizarre, right?
There are three circumstances under which a manufacturer may be considered to be liable under "failure to warn" (and I think this answers my earlier question about when a petitioner may bring a civil suit in State court after losing in "vaccine court"): (1) committing fraud during the FDA licensing process, (2) withholding information obtained during post-licensure surveillance, or (3) committing some unspecified criminal activity relating to the vaccine.
One might argue that the second point is a bit vague: withholding the information from whom? How quickly is the manufacturer asked to report on the adverse events reported? For instance, no injuries have been added to the Table for Gardasil, although there have been severe injuries and deaths logged in VAERS. Have potential Gardasil recipients been warned? I'm willing to bet that the government considers the very existence of VAERS (about which very few parents know) to be adequate disclosure.
Anyway, here's the legal language for "failure to warn." (I believe the "manufacturing defect" language is also in there, and is similarly dismissive.)
Sec. 300aa-22. Standards of responsibility
...
(2)
For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows -
(A)
that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa-23(d)(2) of this title,or
(B)
by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
(c)
Direct warnings
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
(d)
Construction
The standards of responsibility prescribed by this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death.
(e)
Preemption
No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this part.
...
Sec. 300aa-23. Trial
...
(d)
Punitive damages
(1)
If sought by the plaintiff, the third stage of such an action shall be held to determine the amount of punitive damages a vaccine manufacturer found to be liable under section 300aa-22 of this title shall be required to pay.
(2)
If in such an action the manufacturer shows that it complied,in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this chapter applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in -
(A)
fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 262 of this title,
(B)
intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or
(C)
other criminal or illegal activity relating to the safety and effectiveness of vaccines,
which activity related to the vaccine-related injury or death for
which the civil action was brought.
Posted by: Theresa O | February 26, 2011 at 07:33 AM
"Section 22(b)(1)provides:
"No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." §300aa–22(b)(1)."
Why do the male justices feel so sure that "properly prepared" only means free of manufacturing defects, and does not also encompass being free of design defects? If something is poorly designed (e.g. contains mercury) how can it be considered to be "properly prepared"? If side effects have been ignored, denied, and swept under the rug instead of studied, how can continuing to have the same side effects be considered "unavoidable"?
Posted by: Twyla | February 26, 2011 at 01:42 AM
I have a question, Kent. I'm reading that:
"Products-liability law establishes a classic and well known triumvirate of grounds for liability:
- defective manufacture,
- inadequate directions or warnings, and
- defective design."
Apparently this Supreme Court decision knocked out the "defective design" grounds, saying that this does not apply to vaccines. But apparently the other two grounds are still alive and well? I seem to recall that the vaccine received by Hannah Bruesewitz was from a lot that was recalled due to a high rate of adverse reactions? So couldn't they make the argument that the vaccine was not manufacturesd right? Whether they would win or lose, whether they have evidence for this, I don't know -- but wouldn't they have a right to make this arguement in court, before a jury?
And couldn't a family still make the argument that there were inadequate directions and warnings, such as assurances that vaccines don't cause autism, and no taking into account red flags such as prior vaccine reactions or a family history of autoimmunity or immunodeficiency?
Posted by: Twyla | February 26, 2011 at 12:59 AM
I felt the same way, Kent. I was so happy that Justice Sotomayer had spoken sense, and that Justice Ginsburg had agreed with her.
I was hoping that the decision would be in favor of the Bruesewitz family, but I knew that a lot of the justices are supporters of corporate interests -- for example Chief Justice Roberts, who disposed of his Pfizer shares so that he could participate in this decision.
I'm wondering, what does Nina Totenberg think of this? And President Obama, you nominated Justice Sotomayer and apparently you have tremendous respect for her. Are you listening to what she said?
Thank you, Justice Sotomayer, for daring to be in a monority of 2, when you are so new to the Supreme Court. Thank you for your backbone and intellect!
Posted by: Twyla | February 25, 2011 at 11:53 PM
I have read all of this and all the comments. There are a lot of people that know a lot of law here.
And a lot of people that are confussed which I think is why law was invented in the first place - to confuse.
Are our children damaged by vaccine: Yes or No? Well - hell yes their damaged!
I --for my own family no longer care what the stupid vaccine courts do.
You all are going to find that you may not even be able to get SSI or their stupid medicare or medicad that is shitty anyway!
I cannot even get my son any type of "affordable" health insurance! So much for the big Congressian health bill what ever. It is all words, words, words and not a speck of justice.
When I as a mother takes a 6 inch thick binder complete with a short history, insiting references of proof along with the tons of the actually proof from educational institues, psych evaluations, psychirists, medical doctors, developmental instiutions and and on and on -and it means nothing! - but the lawyers and the judge tells me to get to work and reshuffle it all again- redo!
So I redo and redo the information on a year by year/month by month basis of only the educational instiutions, and all the psych stuff beginning from age 3 till 24 years old - whew! But please they tell me to exclude the doctor's records about epilepsy and muscle pains,and immune problems - after all--- all they wanted to know if he could chew gum as he stuffs paper into boxes - well really just stuff paper into boxes and they won't make him chew gum. How so very kind!
Like I said I can't even get stuipid medicad, or SSI so now what about a vaccine injury court?
Posted by: Benedetta | February 25, 2011 at 07:50 PM
Thanks, Kent. I agree that Justice Sotomayor's dissent is now a major contribution to this debate. And don't forget Dr. Bernadine Healy, former director of the National Institutes of Health. She too has spoken eloquently of the need for more science and for the value of transparent judicial process. We have champions, and perhaps more than we know.
Posted by: Mary Holland | February 25, 2011 at 06:50 PM
I fear we are going to experience more of this, now that they have little to fear from the courts or anyone else: Forced "Vaccinations: Musings on what the road to Hell is paved with" http://www.vaccinationnews.com/Scandals/Jun_17_10/Scandal96.htm
What about threatening to bring charges of assault and battery if force is attempted? Anyone???
Posted by: Sandy Gottstein | February 25, 2011 at 01:34 PM
Theresa O, Don't you know they can just say anything and it's okay? And we can provide reams of data and it is ignored?
Of course you are right. I recently even did a piece on epilepsy and vaccination: http://www.vaccinationnews.com/20110119VaccinationandEpilepsyGottsteinS
For what it's worth.
Posted by: Sandy Gottstein | February 25, 2011 at 01:07 PM
NUMBER ONE reason to vote for a second term of President Obama, the retirement (or worse) of Ruth Bader Ginsberg.
From Wikipedia -
"Illness
Ginsburg was diagnosed with colon cancer in 1999 and underwent surgery followed by chemotherapy and radiation therapy. During the process, she did not miss a day on the bench.[27] On February 5, 2009, she again underwent surgery related to pancreatic cancer.[28] Ginsburg's tumor was discovered at an early stage.[28] Ginsburg was released from a New York hospital, eight days after the surgery and heard oral arguments again four days later. On September 24, 2009, Ginsburg was hospitalized for lightheadedness following an outpatient treatment for iron deficiency and was released the following day.[29]
Future plans
With the retirement of John Paul Stevens in 2010, Ginsburg became, at 77 years of age, the eldest justice on the Court.[30] Despite rumors she would retire as a result of old age, poor health, and the death of her husband,[31][32] she denied she was planning to step down. In an August 2010 interview, Ginsburg stated that the Court's work was helping her cope with the death of her husband and suggested she would serve until at least 2012 when a painting that used to hang in her office is due to be returned to her.[30] She also expressed a wish to emulate Justice Louis Brandeis, who retired at 82,[30] an age that Ginsburg would attain in 2015."
Posted by: Henderson | February 25, 2011 at 12:46 PM
@ fanofthefew - “Since the vaccines are now being called "unavoidably unsafe", aren't there any smart lawyers out there making a case for parents not wanting to be forced to put their kids in unavoidably unsafe predicaments. How can they force us to be unavoidably unsafe? Surely there is a civil right there.”
I’m wondering exactly the same thing that you are. How is “unavoidably unsafe” any different from a “clear and present danger” or an “imminent risk of harm” under 14th or 5th Amendment Equal Protection? I wish the lawyers amongst us, would jump in here and comment.
Posted by: patrons99 | February 25, 2011 at 12:22 PM
Marc, it's under "Subpart B - Additional Remedies," and it's on page 42.
It explicitly says that the petitioner may, *after* receiving a no-compensation decision from the "vaccine court," file a claim *for damages.*
Posted by: Theresa O | February 25, 2011 at 11:52 AM
Thanks for the post, One thing I take issure with. If you think the media is "overwhelmingly democratic" and they will now feel some pressure to support our cause, I think you are sadly mistaken. I think the media is owned by big business, big pharma being one of the biggest, and the only real outlet we have is the internet. Soon they may be able to control and restrict even the internet. I suspect they have many paid stooges allready creating blogs and contributing to Wikipedia.
Posted by: Maureen Fischer | February 25, 2011 at 11:50 AM
Hi Theresa:
Thanks for the response. I'm not exactly sure which section you're quoting (it's a 64 page bill, and there are tons of subpart As in that PDF:)), so let me recommend Cornell Law School's US Code site: http://www.law.cornell.edu/uscode/html/uscode42/usc_sec_42_00000300--aa011-.html. You'll see from this that petitioners are prohibited from asking any court other than the vaccine court for judgment and instructs lower courts to toss cases that ask for compensation.
I think (not positive--I couldn't find the exact section you were referring to in my couple of minutes I had to investigate, so happy to look again) that what you were referring to was a clause that you could appeal a judgment in state or federal courts in the sense that you believe you didn't get a fair shot under the vaccine court. Think of it as an option for appeal if you feel there was a procedural issue that caused a judgement against you. Once again, this does not allow for compensation, which is what Bruesewitz was asking.
I hope this makes more sense for you.
Posted by: Marc | February 25, 2011 at 11:13 AM
Sarah,
You are right. My comment about reporting vaccine pushers and child killers to the DHS was sarcastic. I know very well that we can’t expect any justice from anybody in the government, because they all serve the corporate golden calf. We must protect our children from abuse by the corporate-government. The problem is that the government is depriving our children of basic human rights to public education, for which we are paying with our taxes.
Posted by: Zofie | February 25, 2011 at 09:27 AM
How many remember the final episode of M*A*S*H?
Goodbye, farewell, and Amen?
When Hawkeye angrily admonished the woman, he had told her to keep not a chicken quiet, but rather her baby. Unable to keep the baby from crying, the woman smothered her own child to silence it and protect the lives of the people on the bus.
This highly watched episode is certainly embedded in the social sub-conscience. Pure fiction used to brain-wash the general population for the sole purpose of relaying a message that survival requires human sacrifice.
"We are in the midst of an international epidemic. Those responsible for investigating and dealing with this epidemic have failed. Among the reasons for this failure is the fact that they are faced with the prospect that they themselves may be responsible for the epidemic. Therefore, in their efforts to exonerate themselves they are an impediment to progress. I believe that public health officials know there is a problem; they are, however, willing to deny the problem and accept the loss of an unknown number of children on the basis that the success of public health policy - mandatory vaccination - by necessity involves sacrifice. Neither I, nor my colleagues subscribe to the belief that any child is expendable. History has encountered and dealt with such beliefs. You, the parent's and children, are the source of the inspiration and strength for our endeavours; our quest for truth through science - a science that is compassionate, uncompromising and uncompromised. I do not mean to stir you to mutiny, but be assured that armed with this science it is in your power to force this issue, in your pediatricians office, in Congress, in the Law Courts. Keep faith with your instincts - they have served you well." - Andy Wakefield April 22, 2002
Posted by: Media Scholar | February 25, 2011 at 06:48 AM
I have no legal background, and this raises so many vague questions. I'm trying to put some into words here:
Doesn't this make it easier for petitioners to sue HHS on the constitutionality of the program? Wouldn't this force them to have to demonstrate that the NVICP does not deny constitutional rights, that it is actually "no fault," with a "lower burden of proof," etc., as is supposedly legislated--something I don't believe could be shown to be the case?
Fundamentally, doesn't the very non-existence of any true control group in vaccine "safety studies" mean that there is no scientific basis for the NVICP to reject the claims of any injury following a vaccine, so how can they claim to not be adversarial, acting on a "lower burden" standard, now that they have required petitioners with autism to propose the mechanisms of injury resulting in autism from an experimental vaccine schedule and then back it up with data on their own dime while government agencies are hiding pertinent data, etc?
Posted by: JenB | February 25, 2011 at 12:57 AM
Marc, I get what you're saying, but the original legislation (found here: http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf ) explicitly states that the petitioner *may* choose not to accept the decision of the Court of Federal Claims, and may instead choose to pursue a tort ("file a civil action") against the vaccine manufacturer in state court:
"(a) Election
After judgment has been entered by the United States Court of Federal Claims or, if an appeal is taken under section 300aa-12(f)of this title, after the appellate court's mandate is issued, the petitioner who filed the petition under section 300aa-11 of this title shall file with the clerk of the United States Court of Federal Claims -
(1) if the judgment awarded compensation, an election in writing to receive the compensation or to file a civil action for damages for such injury or death, or
(2) if the judgment did not award compensation, an election in writing to accept the judgment or to file a civil action for damages for such injury or death." (p. 42 of 64)
My question is, does the Bruesewitz v Wyeth decision take away that remedy? and if not, given that it stops the petitioner from bringing a design defect claim, then on what grounds could a petitioner conceivably file a civil action?
In other words, the 1986 Act explicitly preempts "failure to warn" torts in State court, and the Court just said that the 1986 Act preempts design defects. Does this mean that a manufacturing defect is the only grounds for a tort in State court--that the vaccine must have been mixed wrong or contaminated in order for a petitioner to bring a case in State court? That doesn't seem right. For the 1986 Act to explicitly say that a petitioner can choose (after pursuing the case in the Court of Federal Claims) to file a claim in State court means that *some* grounds must exist for a petitioner to bring the case--so how could the 1986 Act also preempt all three types of defects recognized by products liability law?
Posted by: Theresa O | February 25, 2011 at 12:07 AM
Great article! People for the American Way also had an excellent article on this decision. http://blog.pfaw.org/content/bruesewitz-v-wyeth-sotomayor-comes-out-strong-against-pro-corporate-judicial-activism-scalia It's nice to know that people out side of our community have the humanity to see things from a human (and not corporate) perspective.
Posted by: Nancy | February 24, 2011 at 11:12 PM
Theresa O: Yes, they were attempting to seek a judgement against a vaccine manufacturer. They were doing it, however, in a state court. The Supreme Court basically stated that the legislation creating the vaccine court takes precendence and that the vaccine court was brought in with a no-cause clause (you don't have to actually prove a vaccine caused an injury in vaccine court, only that an injury on the vaccine injury table happened at about the same time as a vaccination, a much lower standard) in exchange for immunity from civil complaints in state courts. Bruesewitz didn't get the response they wanted in vaccine court, so they tried to sue in civil court and the Supreme Court said that's not allowed due to the legislation in question.
Posted by: Marc | February 24, 2011 at 10:01 PM
Oh Theresa and Nora, that link practically made the vomit come up in my mouth. What complete crap! I am just horrified by this. So this girl is now messed up for life and has no recourse. I was under the impression that seizures were a known side effect of vaccines myself, so you were not the only ones to think this. "It's not acknowledged in our list, so oh well!" Nice to hear such "compassion" for our kids, huh?!
Posted by: Julie Leonardo | February 24, 2011 at 09:56 PM
My biggest worry is that soon the government will announce that all those millions of vaccine-injured children are too heavy burden for the state, and hence they must be euthanized. This is really close to demanding that all children must be vaccinated (and many injured, crippled or killed) with toxic vaccines against the will of their parents. It is not true that just a few children are injured. Al heavily vaccinated children are injured in some way - some more, others less.
Posted by: Zofie | February 24, 2011 at 08:49 PM
Sofie,
These are treasonous acts no doubt...but Homeland Security isn't going to break ranks and turn against another gov't agency like HHS even though I think Sebellius and her ilk is a total snake in the grass...the government will close ranks and defend itself ... so we must protect ourselves and our families...
To borrow a great quote:
"The Barbarians are no longer at the gate, they've crashed through and are now running the show"
Posted by: Sarah | February 24, 2011 at 08:18 PM
AussieMum, I believe Kagan did not participate in hearing the case because she represented the US federal government (which sided with the respondent, Wyeth) when she was Solicitor General, before being appointed to the Supreme Court. She would not have been neutral. (Roberts was considered neutral, though, despite having sold his Pfizer shares just before arguments began. Hmm.)
Posted by: Theresa O | February 24, 2011 at 08:13 PM
Since the vaccines are now being called "unavoidably unsafe", aren't there any smart lawyers out there making a case for parents not wanting to be forced to put their kids in unavoidably unsafe predicaments. How can they force us to be unavoidably unsafe? Surely there is a civil right there.
Posted by: fanofthefew | February 24, 2011 at 08:09 PM
Australia
Kent, why was Justice Kagan exempt to take part in the consideration or decision of this case and what does this mean for future cases?
Or did she still have an opinion (concurring or dissenting), but it had no bearing on the case?
Over here we have a common expression for that:- "sitting on the fence" whereby an individual will not voice their opinion in fear of being criticised or judged.
Australians with vaccine-injured children, were also waiting for the outcome of this case.
We are now waiting for the media onslaught and their misrepresentation of the decision of this case.
Remember:- The harder they (BIG PHARMA) knocks us down, the harder we bounce back!
Posted by: AussieMum | February 24, 2011 at 08:00 PM
I believe we have a solid basis to declare the big pharma and the government vaccine pushers to be the enemies of the state for crippling and killing thousands and thousands of Americans. These vaccine pushers are much more dangerous than Al Kaida. We should report them to the Department of Homeland Security and demand their trial and punishment. We must stand firm and united to defend the most vulnerable citizens of this country – our children.
Posted by: Zofie | February 24, 2011 at 07:50 PM
Well put, Michael. Painfully so.
Posted by: Sandy Gottstein | February 24, 2011 at 07:35 PM
So lets see where we stand today. The Supreme Court decision in the Citizens United said "Corporations are People" and have all the First Amendment rights of people. The Bruesewitz Supreme Court decision said these "People" can produce products which kill and injure other people, but can't be held accountable. Wall Street Corporations and Banks blew up the whole F***king world economy and no one is in jail. Pharmaceutical companies are killing 275,000 people a year with their FDA approved products and no one is in jail.
But if I see anything potentially dangerous or suspicious in Walmart I need to report that to the Department of Homeland Security; would that include injecting a dangerous neurotoxin into children and pregnant women?
However, I'm pretty sure someone's going to end up in jail for selling raw milk. Where's Lewis Black when you need him?
Posted by: michael framson | February 24, 2011 at 07:19 PM
Zofie said: "This is something that an enemy would like to do to a country, which it wants to destroy"
Exactly... the mantra of war is "disrupt, disable and destroy"... I think this is exactly what is happening in the US...but this is a covert attack not overt... is the enemy among us?
Disrupt: 9/11
Disable: Autism crisis plus other chronic debilitating diseases slowly eroding our country; environmental poisoning, economic woes, crippling debt, war
Destroy: God only knows, how or when.. was H1N1 a dry run??
...very scary stuff.
Posted by: Sarah | February 24, 2011 at 05:56 PM
Addition to my previous post. One should not be surprised by the catastrophic state of American primary and secondary education, documented by the fact that for the past two decades in academic tests the US children scored much lower than their peers from all developed and many underdeveloped countries. While the US education system has many intrinsic problems, the main problem is, IMO, the inferior quality of American students, who are so massively neurologically damaged by vaccines. Many have learning disabilities, nearly half have ADHD, many have autism and numerous other disabling health problems. Therefore I believe that recent p. Obama initiative to improve the US education will be largely fruitless, because so many children are damaged. This is a national disaster in the making. This is something that an enemy would like to do to a country, which it wants to destroy.
It seems to me that now the only healthy children in the US are those, whose parents followed their own instincts and not the medical dictates of big pharma and government officials, who refused to vaccinate their children, or selected just one or two vaccines. The only way to save future generations of children is to demand from the US Congress and state legislatures to radically change the vaccination laws and make all vaccines completely voluntary in a way similar to the UE countries. Vaccines are really XIX century medications, which are supposed to prevent transient and easily treatable now infectious diseases in some people, but in reality generate massive crippling of whole populations.
Posted by: Zofie | February 24, 2011 at 05:31 PM
Oh, Nora, I shouldn't have even clicked that link.
Now everyone who has ever been injured by a vaccine (not just the autism community) is going to be told that their injuries are a myth: "Despite the overwhelming scientific evidence that vaccines do not cause permanent disorders like autism and epilepsy."
Read more: http://healthland.time.com/2011/02/24/bruesewitz-v-wyeth-what-the-supreme-court-decision-means-for-vaccines/#ixzz1Ev7xTNPV
Wait? "Overwhelming evidence" that vaccines do not cause epilepsy? I thought VICP regularly compensated individuals with vaccine-induced seizure disorders.
Posted by: Theresa O | February 24, 2011 at 05:08 PM
Kent, I have a technical question:
The decision says, "The Act provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the Health and Human Services Secretary as the respondent; that the court must resolve the case by a specified deadline; and that the claimant can then decide whether to accept the court’s judgment or reject it and seek tort relief from the vaccine manufacturer."
It's the last part I don't get. Wasn't that what the Bruesewitz family was trying to do, "seek tort relief from the vaccine manufacturer"?
If the Court believes that design defects are pre-empted by the Act, then on what grounds are claimants supposed to seek tort relief?
Posted by: Theresa O | February 24, 2011 at 04:49 PM
Here we go:
http://healthland.time.com/2011/02/24/bruesewitz-v-wyeth-what-the-supreme-court-decision-means-for-vaccines/#comments
Posted by: Nora | February 24, 2011 at 04:47 PM
But how many will even hear in the news that the 2 woman justices dissented or even will know what that means?
Posted by: Sheri Nakken, former RN, MA | February 24, 2011 at 04:38 PM
@ Sandy Gottstein - Your article, "Scandals - The Perfect Business Plan", has certainly come to fruition. You saw the handwriting on the wall, almost 6 years ago.
The only way that we can fight this, is collectively, using our political voice. We need to continue to educate the public.
You said it best, in your article of 2005, which is every bit as timely today:
"How much craziness are we going to tolerate?"
Enough already! Just say no to pharma! They want to drug us, inoculate us, debilitate us, incapacitate us, and control us, in order to sell more of their toxic concoctions. It’s their business plan. They will buy or bribe everything in their path to achieve these ends. They are merchants of propaganda and fear. They have no conscience. They will be the death of us all, if we don’t stop them.
Posted by: patrons99 | February 24, 2011 at 04:26 PM
The US is the only „civilized” country, which enforces toxic vaccines on its people. Forced medication with toxic drugs was a practice of genocidal Nazis. It has nothing to do with protection of the population from diseases, which are mild and easily treatable now, but everything to do with controlling and destroying the US population. The European countries are much wiser and all vaccinations there are only voluntary, hence European populations are much healthier than Americans.
We know that practically all vaccines are now made cheaply in China, India, or Korea without any oversight by the FDA. We have no idea what is inside these vaccines, but it is almost certain that there are many unlisted toxins in addition to the listed ones. If Chinese are permitted by the US government to send toxic or radioactive toys, clothing, building materials, appliances, and food to the US, it is certain they are permitted to send as well toxic drugs, including vaccines. IMO, the main problem is that US government including the Congress is currently bought and controlled by China, whose primary goal is to destroy US population and power with American money. They already succeeded destroying a whole generation of American children, so the US has no future as developed country. It soon will become a third-world country of physically and neurologically crippled people, unable to defend or even to feed itself. I am sorry to be saying this, but this is how I see it.
Posted by: Zofie | February 24, 2011 at 03:42 PM
I should have mentioned you, too, Zofie! You are 100% right!!!!
Posted by: Sandy Gottstein | February 24, 2011 at 03:31 PM
On a business blog, a columnist ridiculed Justice Sotomayor for warning that manufacturers' incentives for improving product safety are lacking. The columnist haughtily sniffed that the CDC, FDA and free market can watchdog our nation's vaccines.
Unbelievable stupidity, or journalistic corruption. You decide.
Posted by: nhokkanen | February 24, 2011 at 03:25 PM
Thanks, as always, Kent, for an excellent piece.
Patrons99, I couldn't agree with you more. The only leverage we really have is our right to refuse vaccination.
Please forgive me for bringing this up again, but an older piece I wrote, "The Perfect Business Plan", currently listed in the news section of AofA, couldn't be more relevant, in spite of its age: http://www.vaccinationnews.com/Scandals/2005/Dec_23/Scandal75.htm
Another one, "Forced Vaccinations: Musings on what the road to Hell is paved with" might interest some of you as well: http://www.vaccinationnews.com/Scandals/Jun_17_10/Scandal96.htm
It will only get worse if we don't take back our health freedom rights. Health freedom is not free, though, and it will take setting aside our differences and working beyond hard in order to focus on this all-important goal to make it happen.
Hopefully this decision will be the straw that breaks the public's backing of its insane complicity in denying itself these rights.
Posted by: Sandy Gottstein | February 24, 2011 at 03:22 PM
Zofie - Bravo! You nailed it. You've expressed it much more succinctly than I could. It bears repeating what you said, because it's right on the mark! This must be our message! It must be clear and succinct!
"Now Americans have only one choice. Since the government refuses to demand vaccine safety from the manufacturers, all vaccines must be recognized as unsafe, hence the people have all the right to refuse them for themselves and their children."
Posted by: patrons99 | February 24, 2011 at 02:34 PM
Zofie said, "Since the government refuses to demand vaccine safety from the manufacturers, all vaccines must be recognized as unsafe, hence the people have all the right to refuse them for themselves and their children."
This is essentially what I've been thinking. Not that vaccines "must be recognized as unsafe," but that all must be recognized as "potentially unsafe." And, as there is no recourse in the event of "manufacturer's defect" or "adverse reaction" no one is taking any responsibility for any harm that will be induced. Therefore, it is solely the parent's responsibility. In which case, as the only responsible party, the parent MUST be allowed to refuse something potentially harmful to his/herself or child on ANY GROUNDS WHATSOEVER.
Posted by: Zoey O'Toole | February 24, 2011 at 01:52 PM
We should lobby for repeal of the National Childhood Vaccine Injury Act of 1986. Eliminate liability protection for the multinational drug consortium. It's become pretty simple now. Either pharma controls us, or we control pharma. How do we wish to live our lives?
A "total liability shield" plus vaccine mandates is a recipe for an even greater public health disaster than we now face. It also represents medical fascism. Pharma is pushing to eliminate vaccine exemptions, in each state. This will ultimately give pharma complete control over our food supply. Not only do they wish to control what we eat, they want to force-feed us. Vaccine mandates and codex alimentarius are examples.
As recent events have shown, we can not depend on a legal remedy from the courts. Our numbers have grown. We are becoming a stronger group, politically. Our religious values and spirituality remain strong. We should carry our message to the political and religious arenas. We have always been on the high ground, morally and spiritually.
There ought to be a rallying cry by people of faith the world over. We are all in this together. Pharma seeks to ban religious exemptions, globally. Medical freedom and freedom of religion are God-given inalienable rights. It's time for some new legislation.
“Vaccine philosophical exemptions: A moral and ethical imperative” by Alan Phillips, J.D. on February 18, 2011.
http://www.naturalnews.com/z031389_vaccines_philosophical_exemptions.html
Posted by: patrons99 | February 24, 2011 at 12:55 PM
Now Americans have only one choice. Since the government refuses to demand vaccine safety from the manufacturers, all vaccines must be recognized as unsafe, hence the people have all the right to refuse them for themselves and their children.
Posted by: Zofie | February 24, 2011 at 12:38 PM
Conspiracy Theorist
I can't see what you are saying: Sotomayor was arguing in favour of manufacturer liability. Of course, both sides should have been trying to decide what the act meant rather than expressing their own views of what the law should be. Sotomayor's dissent, at least, paves the way for possible reform, though it is terrbly hard to imagine modern day legislators doing anything reasonable or decent.
Posted by: John Stone | February 24, 2011 at 12:36 PM
These developments on the legal front should tell us something. They tell me that we need to present a united front to government and to orthodox medicine. That message being that our opposition to vaccine mandates is our collective, non-negotiable position.
Taking a nuanced position as to vaccine safety is actually counter-productive. Pharma will use that argument to their advantage, claiming they are working to “green” our vaccines, while they are really work to “force-feed” us vaccines, green or otherwise.
Parsing our arguments as to the role of germs v. jabs v. genes is counterproductive. Pharma will use that argument to their advantage, as a clever self-perpetuating misdirection, e.g. use of genetic arguments as justification for more genetic “engineering”.
Our use of the “a” word may actually be counterproductive. Pharma has used the word autism to marginalize and divide us. The issues surrounding vaccine safety are much bigger than just ASD alone, although ASD is certainly the quinessential vaccine-induced brain injury.
The only position that can unite us all is that of medical freedom, and that includes vaccine freedom. Vaccine advocates can be assured that their right to choose to be vaccinated will be protected. New legislation is needed to protect our right to opt-out of vaccination. This right arises from our God-given rights to privacy, medical freedom, and religious freedom. Informed consent and the precautionary principle are essential components of medical freedom.
Vaccine mandates violate both 14th and 5th Amendment Equal Protection under the U.S. Constitution. Vaccine mandates pose a clear and present danger and imminent risk of harm to everyone, including “class of one” vaccine-injured litigants. Disclaimer: I'm not an attorney, but I can still pray that our court's and lawmakers "get it right".
MEDICAL FREEDOM NOW
END MEDICAL FASCISM NOW
END VACCINE MANDATES NOW
END VACCINE EPIDEMICS NOW
EDUCATE BEFORE YOU VACCINATE
Posted by: patrons99 | February 24, 2011 at 12:03 PM
The problem is that there was a baby in the bathwater those old men threw out.
Do the Justices realize that Alzheimer's, too, may be a result of their yearly flu shots? Because the Supreme Court's male members don't have a science background, they have, as yet, only babies to toss out. Will the Justices one day realize that old folks, too, might be affected by vaccine?
By the way it has always baffled me how it is possible that none of the special masters in the vaccine court have any background in medical sciences.
Posted by: Birgit Calhoun | February 24, 2011 at 11:36 AM
I'm one of those crazy conspiracy theorists those provacciners love to hate. If I remember correctly Sotomayor was chosen by Obama, right? If not, disregard this theory. If so, I believe they are all in cahoots with each other.
Obama got a lot of campaign money from big pharma, more then people know about. Coincidentally, (wink, wink) swine flu broke shortly after he was in office, and Obama expressed this emergency to get jabbed. Then there was the wonderful health care bill, you know the one that includes the "No Child Left Behind Flu Shot" program. I'm assuming Sotomayor is just another one of his cronies that has to bow down to big pharma, after-all Obama got her the job. Its the least she could do.
I hate to talk politics and I know this can be a sensitive subject for most but the reality can sometimes be a tough pill to sallow, no pun intended. This portion of my comment may not seem like it fits with the discussion but really it does. Party is of no concern to me, both are corrupt and instead of fighting with each other on the left, right, liberal, conservative, blue or red what we have to remember, so we can learn from our mistakes, is we can be easily bamboozled if we don't keep our eye on the prize. Or else we will have more situations like this. Its important for the future to look past good looks and charisma and focus more on the corrupt connections.
Posted by: Conpiracy Theorist | February 24, 2011 at 11:33 AM
Bear with me while I play the devil's advocate.
Every product can always be made more safely, at a cost, and somewhere a line must be drawn to balance the two. The intent of the act was to protect public health policy from having to fight potentially large numbers of cases in a judicial system known for sometimes granting awards in a fickle way. Vaccines were given special consideration since, unlike most medications, they target illnesses on a global scale that may never actually be contracted.
The act was vaguely worded as part of the compromise necessary to get it passed, which has led to the problem now, as it has put judges 25 years later in a difficult position - to remove all accountability from the manufacturers, or to allow a 25 year backlog of cases to bankrupt the medical industry. It is also a short step from manufacturer liability to government liability, which could bankrupt the entire country.
Everybody reading AoA understands first hand the consequences of an absence of accountability, and every comment decrying the implications of the decision is spot on, but let us look at the regulatory authorities who have failed to monitor adverse reactions and allowed this situation to develop, rather than the nature of judges who should never have been forced to legislate from the bench.
Posted by: GH | February 24, 2011 at 11:14 AM
Harry,
I think the weak link is inadequacy of FDA inspections overseas of China based drug manufacturing plants... if I would put my money on a big part of the problem it's in the quality (or lack thereof) overseas manufacturing of drugs destined for the US market.
Congress is well aware of this problem and Pharma should be held accountable for quality control of it's overseas drug manufacturing operations or they should be forced to pull the plug.
The list of ingredients and directions are only as good as the cook making the cake and I've a feeling we've a lot of bad cooks overseas...God only knows what toxic concoctions they are blending and shipping to the US...don't trust what on the label is what is in the bottle... buyer beware!!
Posted by: Sarah | February 24, 2011 at 10:45 AM
It would appear that the only legal recourse we have left is to have congress pass a revised version of the law holding vaccine manufacturers to a higher standard than "unavoidably unsafe".
With the pro-business republican/tea party runing roughshod over D.C. the odds of the Cubs winning the World Series are infinitely better.
Posted by: Harry H. | February 24, 2011 at 09:56 AM
Linda,
I agree.. they also should disclose the country of origin that manufacturers active ingredients in drug product..I've read that 80% of the active ingredient in drugs headed for the US market are made in China... not good! See CNN's Lou Dobbs report below:
Dangerous Imports- CNN- Lou Dobbs
From transcript of the show aired Nov. 3, 2007:
DOBBS: Christine Romans.
Disturbing testimony in Washington this week. It usually is disturbing of late. Former FDA employees testifying their agency simply doesn't have enough resources to protect American consumers from those dangerous drug imports. This year the United States will expect fewer than two percent of all the drug facilities in communist China that are manufacturing products for export to this country. As Lisa Sylvester reports now the FDA isn't even sure how many foreign drug facilities plants that it has in fact inspected. Your government at work. It's a lovely thing.
(BEGIN VIDEOTAPE)
SYLVESTER (voice-over): It was a sugarless cough medicine. It took the lives of more than 100 people in Panama last year. Glycerin is a key ingredient of this medicine. But, in this case, a poison called diethylene glycol was substituted for glycerin imported from China.
During a congressional hearing, a former FDA insider testified the same thing could happen here.
CARL NIELSEN, FORMER DIRECTOR, FOOD AND DRUG ADMINISTRATION: FDA knows very little about the actual condition of manufacture of most imported drugs. And that should be found totally unacceptable in a professed risk-based approach.
SYLVESTER: Eighty percent of the active pharmaceutical ingredients in U.S. drugs come from abroad, primarily India and China. Yet, the FDA inspects only about 7 percent of the known foreign drug importers a year, according to the Government Accountability Office.
And the agency doesn't even have an accurate count of how many foreign firms are shipping drugs to the United States. Another former FDA employee who worked at the agency for 30 years testified, commissioners have not had the resources for adequate testing of food and drug imports.
WILLIAM HUBBARD, COALITION FOR A STRONGER FDA: And all of them were forced to play this public health version of the kids game Whack- A- Mole, in which they were forced to ship resources to whatever the squeakiest wheel was of the day and try to fix that. And the result was that nothing ever seemed to get fixed.
SYLVESTER: The FDA says it has begun updating its databases and is considering posting inspectors in foreign countries.
ANDREW VON ESCHENBACH, FDA COMMISSIONER: We have been and are the world's gold standard, and we intend to continue to maintain that standard of excellence. But it will require change.
SYLVESTER: The problem is not new. The GAO issued a critical report outlining similar problems in 1998. Congress held hearings in 2000. But the same problems persist, with potential for toxic medicines ending up in American medicine cabinets.
(END VIDEOTAPE)
SYLVESTER (on camera): Domestic firms are required to be inspected every two years, but there is no comparable law for foreign inspections. Domestic inspections are unannounced. That's not the case with foreign inspections. And finally, language has been a barrier with FDA inspectors having to rely on company representatives for translation instead of using independent translators. Lou?
DOBBS: Lisa, thank you.
(COMMERCIAL BREAK)
http://transcripts.cnn.com/TRANSCRIPTS/0711/03/ldtw.01.html
Posted by: Sarah | February 24, 2011 at 09:53 AM
The Roberts court is the most pro-business court in living memory so no surprise in the decision but I don't think that it is a democratic vs republican issue at all. I think that if Justice O'Connor was still on the court, she would have sided with the dissenters as well.
Posted by: EV | February 24, 2011 at 09:42 AM
I am not a lawyer, but there may be a loophole here. Justice Scalia states when vaccine is properly prepared and is accompanied by PROPER DIRECTIONS AND WARNINGS lawsuits over its side effects are not allowed. Ok Justice Scalia, how about defining proper directions and warnings. I was told by my pediatricians that side effects to vaccinations were so rare, autism was completely genetic and no one in my family had autism, so why worry? I asked the questions ten years ago before my child was vaccinated and I was told to give him tylenol and relax. No one mentioned SIDS, asthma, diabeties, autism or anything about autoimmune disorders. As far as I am concerned, the pediatricians are more guilty than the pharmas as they took an oath to do no harm. Proper warning does not constitute handing me an insert in a completely different language and telling me not to worry. Its time to start demanding an ingredient list that is in plain language before getting vaccinated, If phenooxyethanol is in your vaccination, the insert should read anitfreeze. All three of my children have been diagnosed with autoimmune disorders and the doctors are clueless and inept when it comes to helping them. Proper warning will equal informed consent. The public needs the ability to opt out now that product liability doesn't exist. If I don't like a car's safety rating, I don't have to drive it.
Posted by: LInda | February 24, 2011 at 09:29 AM
I'm not acustom to interpreting the laws, but I see this differently. There is a law in place, judges had to find if the "right to sue" was a right that could be found within this law. Most found no loophole, while two felt the law could and should provide for more "tightening up", as it's giving too much power to the pharmaceuticals. Isn't it in their interpretation , if they accept the law that's in place as being "pure" in the sense of constraints . Given the two dessents, the publicity, (very wonderful) wouldn't it be now time for congress to take this issue back and reform by ammendment a "better" law, one that holds the pharms to a level of liability for NOT providing safe vaccines for our children? Years and more damaged children as the wheels turn in the way of the proverbial justice line "exceedingly slow".
Posted by: barbaraj | February 24, 2011 at 09:26 AM
Shame on the 6 Justices who voted in favor of Big Pharma with complete disregard for our children.
Thank you Justices Sotomayor and Ginsburg.
The 6-2 votes which I learned about on Medscape (An information site for Physicians, sponsored of course by drug companies) first, left me speechless. I am equally ashamed of Medscape, evidently rejoicing at the Supreme Court's decision
Posted by: Marie-Anne Denayer, M.D. | February 24, 2011 at 08:26 AM
I haven't see any comments from you, Bob on Kent's post. Perhaps it didn't go through. I usually manage early am moderation - feel free to repost. Tbanks. KIM
Posted by: Managing Editor/Moderator | February 24, 2011 at 08:13 AM
TO THE AOA MODERATOR OF COMMENTS:
Did my comments disagreeing with Kent's focus on politics and gender not meet the high standards for AoA post?
Posted by: Bob Moffitt | February 24, 2011 at 08:07 AM
This ruling isn't really unexpected. Scalia and Thomas have a history of saying, in essence Congress has the authority to pass stupid, but constitutional laws and the forum for changing them is Congress, not the courts. I haven't read the opinion (and likely would fall asleep before getting a third of the way through), but I wouldn't be surprised if this is just Scalia and Thomas being consistent in their judicial philosophies. I don't like the outcome in this case, but in general I support their interpretation of limitations on court power.
Posted by: Rob Smith | February 24, 2011 at 08:07 AM
I have to admit I am infuriated by the language of the act: surely the very tortuousness of it represents an unwillingness to decide certain issues, even moral evasiveness. Could it be that Congress decided to leave the manufacturers without any obligation to ensure their products were as safe as they should be? Scalia thinks they did, and Sotomayor thinks they didn't. I suspect Sotomayor is more right because they didn't want to decide anything so extraordinary while being heavily lobbied to do so, so we end up with the appalling circumlocutory language (or speaking as an Englishman, you do). The result of last 25 years is that they can lobby for any junk that they make to be injected into your child, and there is nothing that you can do about it - no balance and no redress, and very bad law.
In England, or should I say little Britain, we order the things differently. Theoretical redress against industrial and business interests is controlled by a political body, the Legal Services Commission, and and in real terms is virtually non-existent: we couldn't even mount a prosecution against Merck for Vioxx after it had all be conceded in the US court. You take everything at your own risk. What a racket!
I think we can draw very intersting and terrible conclusions about the political systems we now live under, and the way they have been perverted by global business interests and fawning politicians.
Posted by: John Stone | February 24, 2011 at 08:03 AM
Not an MD
I think Kent was suggesting that both the sex divide and the political one were potentially interesting - of course 8 people is rather a small sample. Perhap, just political history of how Repulican administrations have stacked the court with 'reliable people' is what is most significant in this case.
Posted by: John Stone | February 24, 2011 at 07:58 AM
Sorry, Mr. Heckenlively, Esq., but I think the decision may not reflect Republican vs. Democratic differences, but the difference between men and women, and how they think. Women are typically the primary nurturers of their children. Women have deep insight into the human condition as well. Women usually notice the suffering of their children first, and they fret over every new freckle, blemish, or bruise that appears on them, too.
Justices Sotomayor and Ginsburg knew the intent to remove all design defect liability for vaccine manufacturers was not specifically written into the legislation before them. They saw what was written, what was not written, how it was written, and with what intent, with their own eyes, and it mattered to them. I applaud these two female Justices for standing up, and stating what they actually saw. May we all (men included, of course) have the strength to do the same for the sake of our children.
Posted by: Not an MD | February 24, 2011 at 07:29 AM