Next week, the US Supreme Court will hear a case that is being closely watched because of the enormous health and legal implications for drugmakers and parents, among many, many others - whether the family of an 18-year-old Pennsylvania woman should be allowed to proceed with a lawsuit against Wyeth for defects with its diphtheria, pertussis and tetanus, or DTP vaccine. She was vaccinated when she was six months old and now suffers from residual seizure disorder.
At issue is the underlying notion of preemption - in this case, whether a federal law known as the National Childhood Vaccine Injury Act of 1986 prevents the family of Hannah Bruesewitz to press their lawsuit, which was rejected by (the federal vaccine court) that is empowered to provide compensation. The Bruesewitz family then filed a lawsuit in state court before it was moved to federal court and, later, dismissed (see this).
The law says that a vaccine maker should not be held liable in a civil acdtion if an injury was caused by unavoidable side effects, "even if the vaccine was properly prepared and was accompanied by proper directions and warnings." In other words, the provision bars lawsuits in state courts but with an exception - claims except those alleging a manufacturing defect or a failure to warn. And that is what the family is citing as it proceeds to the US Supreme Court.
In their brief, the family argues that allowing design-defect claims for "preventable harms" would provide incentive for vaccine makers to conduct adequate research, design their vaccines as safely as possible, and incorporate scientific advances into vaccine design to protect the public from unnecessary harm." They also maintain that lawsuits can promote FDA because they help to disclose side effect info the agency does not require as part of the regulatory approval process." And they add that, if the Supreme Court lets the previous decision stand, "injured children would be denied redress even for injuries caused by recklessly designed vaccines or vaccines that a manufacturer knew would cause unnecessary harm. No sound policy justifies such a result."
The opposing brief from Wyeth, which is now owned by Pfizer argues the law has succeeded by providing incentives and compensation, and that overturning the apple cart will overwhelm vaccine makers with litigation that will stymie further research. "Over twenty new childhood vaccines have been brought to market since the effective date of the Act; adverse events are promptly reported to the government under the VAERS system (adverse events reporting); and over $1.8 billion in compensation has been awarded to petitioners by Vaccine Court. Thus, no policy consideration supports restricting the scope of the preemption provision that Congress enacted in 1986." (You can read all of the supporting briefs from other groups here, thanks to the ABA).
In an interview with a Pittsburgh television station the other day (you can watch the video here), Hannah's mom strikes a populist chord: "It's now an opportunity for us to come out and say that vaccine manufacturers need to be more responsible," says Robie Bruesewitz. "Wyeth Labs needs to be held accountable for what happened to my daughter." But what do you think? This is an important matter. Please vote and then tell us what you think.
Should The Supreme Court Allow The Bruesewitz Lawsuit To Proceed?
- No (60%, 69 Votes)
- Yes (40%, 46 Votes)
Total Voters: 115
pix appears from WTAE
8 Comments
Perhaps this wouldn't be an issue if the vaccine court functioned as the original legislation intended, as a non-adversarial forum where those injured by vaccines could receive appropriate compensation for their medical care. Many parents who are deemed anti-vaccine are actually those who vaccinated their children, and when their children showed clear signs of medical injury, the parents found they were abandoned by the medical community and the gov't. While the vaccine inserts list many possible side effects and injuries, and theoretically doctors and the gov't admit the possibility, in practice they refuse to believe that vaccines are ever the cause of a child's medical problems.
My immediate reaction was that the family postion "has a lot of traction" as they used to say. That said, science is not about perfection and there are always going to be issues for some individuals within a public health context, no matter what standards we follow. Personal sympathy, which I do have for the parents, does not mean that a decision in their favor would make either good science or sound case law.
Cindy is spot on. If the vaccine court would ever recognize that vaccines do sometimes cause injury and would award accordingly, this would not even be an issue. However, the "big fear" that cases with monetary settlement in the vaccine courts would serve as justification for parents to refuse to vaccinate their children has made the vaccine court dysfunctional. The whole point of making pharmaceutical products list possible side effects and injuries is to allow the physician and consumer to decide if they deem the risk too great.
Welcome to the catch-22 of Big Brother medicine. Have we reached the final frontier where "the needs of the many outweigh the needs of the few, ... or the one".
Does anyone know if drug makers lobbied to contribute to the loss of personal choice and freedom as it pertains to mandated vaccines to attend public school? How about for the newer vaccines, any lobbying there?
Although I personally sympathize with the family, the Vaccine Court was started to keep pharmaceutical companies producing vaccines in the US. The number of lawsuits had increased to such an extent that the last two manufacturers were going to withdraw from the US market. If the SCOTUS overturns the ruling, we may be put back in the same position. In recent years, there have been a large number of specious cases brought before the Vaccine Court, most notably the Autism Omnibus (AO) hearings. The burden of proof for the Vaccine Court is significantly lower than "regular" court (thanks to the Daubert ruling), yet the majority of AO plaintiffs failed because they were unable to prove their cases: that their children became autistic after vaccines containing thimerosal were administered. (Hannah Poling being the sole exception - she had a mitochondrial disease, which apparently became more complicated after she was given a vaccine.)
Vaccination is a safe way to prevent yourself, your children, your loved ones, and others from catching preventable diseases with often life-threatening consequences.
WRT vaccination as a prerequisite to attending public schools. It's a common-sense, public health matter. There are those who cannot be vaccinated for various reasons: not old enough to receive the vaccine, immunocompromised or immunochallenged, those with allergies to certain constituents of the vaccine (e.g. eggs - flu vaccine), etc. A certain percentage of the population needs to be vaccinated to maintain herd immunity. Vaccinate - for yourself, for the ones you love, for the ones who can't be vaccinated.
Unfortunately, there is little transparency in the vaccine business, in Big Pharma altogether. Not only are 'non-placebo's' used in many of the studies (Gardasil), but the individuals in the studies oftentimes do not represent the population to be vaccinated. For instance, many individuals with northern European origins have a genetic tendency toward hemochromatosis (pk deficiency, hfe, hh, metal overload). It is the most prevalent genetic trait in the USA and yet many vaccine studies are done in places like South America, etc. where clearly the results would not be indicative of the outcome in the general US population. Many physicians either don't know about these genetic traits or aren't told about them by the sales reps (hfe only came to light in the mid 90's I believe). Big Pharma doesn't fully educate their sales people OR the doctors about newer genetic tendencies because it would hurt their sales ... and so the doctors don't know to look for them. (I'm assuming they don't have knowledge because I hate the thought of them intentionally harming children.) The FDA and CDC aren't helpful on this issue either and turn their backs on anyone who questions. They do NOT look out for the normal 'Joe' and parents are left to fend for themselves. This is wrong.
IMO, vaccine studies can easily be skewed. Just depends on how the data is submitted to the FDA. I think it may be time for more individualized medicine ... how about we test/educate for vitamin deficiencies to get at some of the true health issues rather than push a pill? I know Americans want a quick fix, but at what risk?
The views on Bruesewitz v Wyeth are off-base because they begin by ignoring the 7th Amendment to the Constitution, which states: “In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law” and then ignore the reality that the section of the NVICP (42 U.S.C. Sec. 300aa-22) that contains the language in question is ONLY meant to be an ISSUE decided within a TRIAL as set forth in 42 U.S.C. Sec. 300aa-23 and NOT an issue to be decided by any judge or judges including the US Supreme Court's justices.
Either the Seventh Amendment, which applies to all people, is an absolute right to a civil trial as stated in: "In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved" or the US Constitution's Seventh Amendment can be overturned by judicial caprice.
Further, according to the NVICP, such liability decisions belong to the trial jury is clearly set forth in § 300aa-23. Trial, which at § 300aa-23(b), states: “(b) Liability The first stage of such a civil action shall be held to determine if a vaccine manufacturer is liable under section 300aa-22 of this title”.
Moreover, the Establishment’s arguments knowingly ignore § 300aa-22(b) with respect “warnings”, in general, and § 300aa-22(b)(2), in specific, which states: “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 - …”
Since: • As the putative causative DTP vaccine in question is a Thimerosal-preserved vaccine given to the child and • The vaccine manufacturers have admitted knowingly failing to comply with Title 21 of the Code of Federal Regulations (21 CFR) as set forth in section 610.15(a) (21 CFR § 610.15(a)), which requires the level of preservative must be proven to be “sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient”, in testimony given before a Congressional committee which investigated the actions of the vaccine makers and the US Food & Drug Administration from 1999 and which subsequently published a formal Congressional report, “Mercury in Medicine – Taking Unnecessary Risks” in 2003, and the requirement in question is a material requirement under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as well as a safety regulation issued under the provisions in “section 262 of this title”, the Wyeth defendant is clearly guilty of failing to comply “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”.
Moreover, recognizing defendant Wyeth’s knowing and intentional failure to comply with the black letter law, when it hears the case this fall, the US Supreme Court should: a. find for the Bruesewitz plaintiffs and b. take whatever actions needed to ensure that the Bruesewitz plaintiffs are awarded appropriate punitive damages for defendant Wyeth’s knowing and willful failure to comply with 21 CFR § 610.15(a) for the preservative Thimerosal in the vaccine that caused the harm to the Bruesewitz child.
However, given the Establishment’s denial of reality of vaccine-induced mercury toxicity in susceptible children, like the Bruesewitz child, who were, and are still being, given vaccines preserved with Thimerosal (49.55% mercury by weight) and the power that the Establishment wields, the people will be lucky if the US Supreme Court finds for the Bruesewitz plaintiffs.
Finally, should the US Supreme Court find for Wyeth, then, the people will most assuredly know that both the Establishment and the US Supreme Court are knowingly severing those who bring vaccine cases against the vaccine manufacturers in the legal manner provided by NVICP from the right to a civil jury trial for damages that is supposedly guaranteed by the Seventh Amendment to the Constitution of the USA.
Before January of 2009 I trusted doctors and never even thought about vaccines or what they did in the body. Buth since my daughter was injected with 2 of the 3 Gardasil vaccines that were basically forced on us during a doctor visit and after my daughter became very sick with all sorts of horrible side effects that she is still suffering from, I have studied and researched and found out soo much disturbing information surrounding Big Pharm and vaccines. I now know what is in vaccines and what damages they can do to our children.
There is no need to inject a newborn within hours of birth with Hep B if the mother isn't positive for Hep B or if the mom hasn't been exposed! The Vitamin K vaccine that is injected at birth is also another one that causes serious problems in a newborn...research it and you will see.
If only parents would educate themselves before their children are bombarded with soo many vaccines within such a short period of time, and find out all they can with what is IN each vaccine! Once vaccinated its too late.The guilt is overwhelming from a mothers standpoint...I know..I am one of those moms. If only I could go back to that day and say NO...Let me do some research first..then my daughter would still be that happy and healthy 17 year old that she was BEFORE Gardasil!
The problem with VAERS is that most people don't even know about it...or the doctors don't know about it...or when the child is injured from a vaccine and they take the child to the doctor and question is this from the vaccine, most doctors deny the link and the parents trust and believe the doctor. Therefore VAERS reports numbers are estimated to be between 1 to 10% of the actual true number of vaccine adverse events.
My two daughters both have babies...one is 6 months old and the other is 9 months old. Since we know of the problems with vaccines, both of my grandbabies have had no vaccines yet. Both of these babies are developing way ahead of most babies in their age groups...both babies are very healthy. The 6 month old is standing and trying to walk...the 9 month old is standing alone..saying words..has 8 teeth already..it blows me away. My niece has a 15 month old that has had every vaccine on the schedule and has been sick almost every day of his life. He has had tubes put in his ears. He didn't start crawling until he was almost a year and just started walking. He didn't reach for toys until he was 10 months old...his development has been slowed.
I can't stress enough to educate yourselves...research the vaccines and the toxic chemicals that are in them and the side effects from the chemicals. Thimerasol is very toxic..aluminum is toxic at 1 microgram yet each of the 3 Gardasil vaccines has 225 micrograms of reactive aluminum. After getting all 3 Gardasil jabs, that totals 675 micrograms of reactive aluminum injected into their bodies. Our gardasil girls are still suffering years later!
I stand behind the Bruesewitz family and pray for them in their fight for their daughter. Yes its true there are side effects to all drugs and vaccines but as parents we have the right to be told of the side effects. We also shouldn't be treated as crazy people when we have an injured child from a vaccine by the medical community. When my daughter was injured and I took her back to the same dr that injected her with Gardasil, she stood there and told me it was NOT from the vaccine. I asked her how could she be so sure when the vaccine was so new. Her answer was: Because they did clinical trials. I told her about the placebos having the aluminum in them..her reply was They do that with ALL placebos. WRONG!
All I can say is to please educate and research before you vaccinate. If you decide to vaccinate then at least wait til the child is 3...give their little immune systems a chance to develop and mature. Spread out the vaccine schedule. Don't overload the child with 3 or 4 at a time to catch up. If you will do your research as I have and many others have, you might have a change of heart.
Doctors are overloaded and don't have time to sit and research every single drug or vaccine to hit the market. They trust the drug reps. There have been many of these drug reps that have left their jobs and now speak out against the same companies that they used to work for. Do some research...you will see. Be prepared to be shocked!