SCOTUS rules against Bruesewitz Family claims ... - Mothering Forums

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Old 02-23-2011, 01:32 AM - Thread Starter
 
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Enjoy ...

http://www.aap.org/advocacy/washing/AAPPressReleaseBruesewitzRuling_2_22_11.PDF

 

or

 

http://www.businessweek.com/news/2011-02-22/suits-against-vaccine-makers-curbed-by-u-s-supreme-court.html

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Old 02-23-2011, 06:14 AM
 
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The NYT describes Sotomayor's dissent as "vigorous".

 

These statements stuck out for me from the Businessweek article:

 

"Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented. Sotomayor said the ruling “leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”"

 

"The family’s Supreme Court lawyer, David Frederick, said the ruling “eliminates the only mechanism for ensuring that manufacturers stop subjecting children to outmoded and unnecessarily dangerous vaccines.”"

 

 

I also think it's very interesting that the AAP, in lauding this ruling, does not state anything about the importance of ensuring safe vaccines, only their ongoing supply.


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Old 02-23-2011, 07:12 AM
 
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This, while not surprising, makes me ill.

 

No other drug or medical intervention has this type of protection. That in and of itself should tell you something. Vaccines are also the only compulsory medical intervention in this country, also should tell you something.

 

This part made me laugh. "The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries"

 

Yes. It's quite efficient if the goal is to make it practically impossible to win a claim. eyesroll.gif


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Old 02-23-2011, 08:22 AM
 
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I am not a US citizen, but this does not look good for parents, specifically if exemptions become a thing of the past.

 

I am curious what selective/delayed parents think about this.


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Old 02-23-2011, 08:47 AM
 
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I find it funny that they state that the vaccine manufacturer's fund the compensation...they absolutely do not.  There is an added charge on the cost of the vaccine that is used for the compensation that EACH AND EVERY PERSON pays every time they get a vaccine, so it does not affect the Vaccine Manufacturer's bottom line.

 

I knew this ruling was going to happen, but it's bull.  If you make a product, you accept liability for that product.  If you cannot afford the massive amounts of lawsuits due to your faulty, unsafe product, then you go out of business.  I cannot believe that the VM's got this "green light" and are absolved of all accountability for their products.  Just hogwash!!!

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Old 02-23-2011, 09:09 AM
 
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I am not a US citizen, but this does not look good for parents, specifically if exemptions become a thing of the past.

 

I am curious what selective/delayed parents think about this.


It is rather Orwellian that "medical experts" feel that the best situation would no exemptions, compulsory vaccination, and no possibility of litigation.
 


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Old 02-23-2011, 10:51 AM - Thread Starter
 
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Kagan did not offer a statement.  It was my understanding from the beginning that she and Roberts own stock in Wyeth.  

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Old 02-23-2011, 12:04 PM
 
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We had another thread going about public trust in vaccines.  In my mind, this ruling damages that.  I'd be much more inclined to "trust" vaccines if I knew that there were accountability for a failed product.


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Old 02-23-2011, 12:14 PM
 
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Keep in mind that the Court wasn't deciding what the policy should be.  They were simply deciding what the Vaccine Act says.  I always hate to agree with Scalia, but I think he's got the right of it this time.  Of course the remedy is to change the law (which IMO was clearly designed to prevent these sorts of lawsuits), not to expect the courts to interpret it in an unintended way.  

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Old 02-23-2011, 12:41 PM
 
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Originally Posted by NaturalBirthGoddes View Post

I find it funny that they state that the vaccine manufacturer's fund the compensation...they absolutely do not.  There is an added charge on the cost of the vaccine that is used for the compensation that EACH AND EVERY PERSON pays every time they get a vaccine, so it does not affect the Vaccine Manufacturer's bottom line.

Actually, the excise tax is levied on the manufacturer, not the consumer. In other words: for every MMR sold by Merck (for example), Merck pays a tax of 2.25 to the government, which goes into the Vaccine Injury Compensation Trust Fund.



 

 

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Old 02-23-2011, 06:18 PM
 
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Kagan did not offer a statement.  It was my understanding from the beginning that she and Roberts own stock in Wyeth.  

 

Kagan was the Solicitor General's counsel of record in an amicus brief in American Home Products v. Ferrari, the Georgia case that found the opposite of the Third Circuit in Bruesewitz. Stock can simply be sold to avoid a recusal.

 

It's unclear to me what the Bruesewitzes think they would have accomplished in state court other than a more burdensome do-over in hopes of a settlement.

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Old 02-23-2011, 08:56 PM
 
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Actually, the excise tax is levied on the manufacturer, not the consumer. In other words: for every MMR sold by Merck (for example), Merck pays a tax of 2.25 to the government, which goes into the Vaccine Injury Compensation Trust Fund.



LOL...and you think the VM take this on?  It is most definitely passed on to the consumer.  In fact, they stated that since the formation of the NVIC, they would be raising the cost of the vaccines to account for this "taxation".  So, yes, every consumer who purchases a vaccine is paying the cost themselves.

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Old 02-24-2011, 06:40 AM
 
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That's the case with pretty much any excise tax. Nevertheless, the tax is still levied against the manufacturer.



 

 

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Old 02-24-2011, 10:59 AM
 
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This was put out by Pfizer

 

http://mediaroom.pfizer.com/news/pfizer/20110222007021/en/U.S.-Supreme-Court-Decision-Bruesewitz-V.-Wyeth

 

 

Quote:
 In its amicus brief, the American Academy of Pediatrics and 21 other physician and public health organizations noted that a Court ruling against Wyeth could “precipitate the same crisis that Congress sought to avert in passing the Vaccine Act: ‘the very real possibility of vaccine shortages, and, in turn increasing numbers of unimmunized children,

 

Now we can't have that can we.....Can you imagine the ramifications? Will never be allowed to happen.

 

 

Quote:
 

In its amicus brief, the U.S. Government wrote that the Vaccine Act has resulted in “a robust federal framework that encourages the development of even safer vaccines and that provides compensation where Congress deemed it appropriate.”

 

Totally disagree. It has taken away any financial incentive for making vaccines as safe as possible.....


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Old 02-24-2011, 12:55 PM
 
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Originally Posted by Otto View Post

 

It's unclear to me what the Bruesewitzes think they would have accomplished in state court other than a more burdensome do-over in hopes of a settlement.

 

 

Vaccine court has its own rules and is not an open or easy process for the petitioners.

 

 

A good article here about the case:

 

http://www.pittsburghlive.com/x/pittsburghtrib/news/breaking/s_724106.html

 

 

Quote:
"During a hearing, they weren't allowed to cross-examine government experts, who disputed their claim, Russell Bruesewitz said. And they weren't allowed to discover what documents, if any, the government relied on to remove seizure disorders from the side-effects table.

"It's really a sham of a court," he said."


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Old 02-24-2011, 09:45 PM
 
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Vaccine court has its own rules and is not an open or easy process for the petitioners.


I'm not sure what you mean by "open" here. Is it easy? I don't think winding up in court is ever easy. The evidentiary standards, though, are undeniably lower than what they would have been in state court.

 

 

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Originally Posted by Jadzia View Post

A good article here about the case:

 

http://www.pittsburghlive.com/x/pittsburghtrib/news/breaking/s_724106.html

 

Quote:
"During a hearing, they weren't allowed to cross-examine government experts, who disputed their claim, Russell Bruesewitz said. And they weren't allowed to discover what documents, if any, the government relied on to remove seizure disorders from the side-effects table.

"It's really a sham of a court," he said."

 

To the extent that "good" equates with undocumented and uncritically accepting, yes, it is. I don't mean to sound unsympathetic to the Bruesewitzes' situation, but they were unable to show causation to the standard of the Office of Special Masters, and they don't appear to have appealed. (I don't see what bearing the change in table injuries would have in a state action.) The question remains how they would suppose to prove causation when held to an even higher standard. I do not in any way doubt the sincerity of their claim, but I also don't see where they would have to go aside from trying to force endless discovery in hopes of (1) demonstrating sinister machinations by Wyeth or (2) making it cheaper for Pfizer to settle.

 

Perhaps the intent was in fact just to establish precedent. I remain dubious that, had the Bruesewitzes prevailed in the Supreme Court, the state case even would have made it to discovery. So, cui bono?

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Old 02-25-2011, 12:12 PM
 
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I don't think the family is asking for anyone's sympathy, just for a fair process. The girl had an injury that was an acknowledged vaccine injury a month before she filed (and at the the time of her injury.) Her diagnosis was suddenly removed from the acknowledged injury list with no explanation. Not being allowed to cross-examine witnesses, being denied the right of discovery as well as being denied a jury stacks the deck against the families. The one person deciding the case is a government judge employed to represent the interests of a government program - hardly a fair court.

 

If she had been injured by any other type of pharmaceutical, she could sue in a normal court. Why should vaccines get special treatment? Let's see them put their witnesses and  their science in a public courtroom and see if it holds up to scrutiny. Put it out in the public record, not some secret vaccine court that has closed proceedings.


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Old 02-25-2011, 01:24 PM
 
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I don't think the family is asking for anyone's sympathy, just for a fair process. The girl had an injury that was an acknowledged vaccine injury a month before she filed (and at the the time of her injury.) Her diagnosis was suddenly removed from the acknowledged injury list with no explanation. Not being allowed to cross-examine witnesses, being denied the right of discovery as well as being denied a jury stacks the deck against the families. The one person deciding the case is a government judge employed to represent the interests of a government program - hardly a fair court.

 

If she had been injured by any other type of pharmaceutical, she could sue in a normal court. Why should vaccines get special treatment? Let's see them put their witnesses and  their science in a public courtroom and see if it holds up to scrutiny. Put it out in the public record, not some secret vaccine court that has closed proceedings.



The reason it was removed is because during the 1980's and 1990's there was extensive research done in several countries to see whether there was more incidence of seizures in those who recieved the TDaP than those who did not. The studies repeatedly found that there was no evidence of a correlation. So having that on the list of prosecutorial injuries was incorrect. You can only sue for damages that are proved to be related to the vaccine in question. That way they can't be sued for just every little thing that ever happens to a person. Like, you can't sue because your kid got freckles after getting a TDaP shot (using a ridiculous scenario to make an example, obviously).

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Old 02-25-2011, 02:26 PM
 
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Quote:

Originally Posted by Jadzia View Post

The girl had an injury that was an acknowledged vaccine injury a month before she filed (and at the the time of her injury.) Her diagnosis was suddenly removed from the acknowledged injury list with no explanation.

 

This is a rather disingenuous portrayal. HHS put out the notice of proposed rulemaking in 1992, based on the 1991 IOM report. There was a six-month public comment period and a public hearing. The rulemaking was put on hold because of the ****** study, with an additional 30-day public comment period. The whole shebang was reviewed in 1994, with a further public comment period. The final rule was published in the Federal Register in February 1995. There was nothing particularly sudden or unexplained about it, and there is plenty of detail for all to see at 60 Fed. Reg. 7678-7696 (residual seizure disorder is detailed starting at p. 7689).

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Old 02-25-2011, 02:48 PM
 
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The reason it was removed is because during the 1980's and 1990's there was extensive research done in several countries to see whether there was more incidence of seizures in those who recieved the TDaP than those who did not. The studies repeatedly found that there was no evidence of a correlation. So having that on the list of prosecutorial injuries was incorrect. You can only sue for damages that are proved to be related to the vaccine in question. That way they can't be sued for just every little thing that ever happens to a person. Like, you can't sue because your kid got freckles after getting a TDaP shot (using a ridiculous scenario to make an example, obviously).



Regarding the bold text- who makes this determination?

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Old 02-25-2011, 03:33 PM
 
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Regarding the bold text- who makes this determination?



From some brief googling I got this:

 

"The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP. "

 

It looks like when you submit a case, it automatically is biased toward the individual:

 

"If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found. For example, if you received the tetanus vaccines and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found. "

 

However, if your injury is not on the Vaccine Injury Table, you can still make a case for it:

 

"If your injury/condition is not on the Table or if your injury/condition did not occur within the time period on the Table, you must prove that the vaccine caused the injury/condition. Such proof must be based on medical records or opinion, which may include expert witness testimony."

 

I got all of this from http://www.hrsa.gov/vaccinecompensation/table.htm 
 

 

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Old 02-25-2011, 04:19 PM
 
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"If your injury/condition is not on the Table or if your injury/condition did not occur within the time period on the Table, you must prove that the vaccine caused the injury/condition. Such proof must be based on medical records or opinion, which may include expert witness testimony."


More specifically, the standard for causation in off-table claims is "to show by preponderant evidence that the vaccination brought about [the] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.... unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine." (Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278; it's an interesting read and emphasizes that the special masters do not displace the courts.)

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Old 02-25-2011, 04:35 PM
 
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This is the part that stood out to me

 

 

Quote:
The issue for the Supreme Court was whether the 1986 law leaves open the possibility that patients can sue manufacturers when the side effects were avoidable. The Obama administration joined Wyeth, acquired in 2009 by New York-based Pfizer, in urging the justices to bar those types of suits.

:irked

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Old 02-25-2011, 06:21 PM
 
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Quote:
The issue for the Supreme Court was whether the 1986 law leaves open the possibility that patients can sue manufacturers when the side effects were avoidable. The Obama administration joined Wyeth, acquired in 2009 by New York-based Pfizer, in urging the justices to bar those types of suits.


That's a peculiar way for Bloomberg to have put it, in that it puts the cart before the horse, but I guess the peculiarness of § 22(b)(1) is the reason the decision wound up being a textual analysis in the first place. Obviously, one can still sue directly for manufacturing and warning defects, which are avoidable. What the Bruesewitzes were apparently arguing was that every design-defect claim should have "avoidability" litigated, including, hypothetically, dredging up IPV vs. OPV suits (this is right at the end of the oral argument). The majority seems to have rejected the "comment k" arguments on both sides. I don't know what the upshot of this position, if upheld, would have been if someone wanted to break things down into subpopulations--reductio ad absurdum, one might say that everyone should have a vaccine developed just for them.

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Old 02-26-2011, 06:18 AM - Thread Starter
 
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I personally like the decision.  It says what I have known all along. 

 

http://healthland.time.com/2011/02/24/bruesewitz-v-wyeth-what-the-supreme-court-decision-means-for-vaccines/

http://www.slate.com/id/2286194/

 

The design defects and neurotoxicity of the P portion of the DPT has been known in medical and professional journals since the 1940s.  

 

Pertussis vaccine doesn't prevent transmission  but the ACIP is still recommending that employers push their staff to accept the vaccine. 

 

http://www.cidrap.umn.edu/cidrap/content/other/news/feb2311acip.htm

 

"…any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives” 

 

http://www.pediatricsupersite.com/view.aspx?rid=81006

 

"Jennifer Liang, MD, an epidemiologist in the CDC’s National Center for Immunization and Respiratory Diseases, who is involved with the committee’s pertussis working group, also discussed maternal vaccination in the second trimester as a strategy to prevent pertussis in newborns."

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Old 02-26-2011, 03:00 PM
 
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Quote:
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More specifically, the standard for causation in off-table claims is "to show by preponderant evidence that the vaccination brought about [the] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.... unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine." (Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278; it's an interesting read and emphasizes that the special masters do not displace the courts.)


But who makes this determination and what is the process?

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Old 02-26-2011, 03:23 PM
 
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But who makes this determination and what is the process?

 

It's made by the special master. After that, the path is review by a judge of the Court of Federal Claims, the Court of Appeals (which may be de novo), and petitioning the Supreme Court. The practice guidelines and CFC rules are here.

 

[ETA.--I'm referring here to demonstration of causation-in-fact. Defining the table injuries is ultimately the job of HHS, under the strictures of the NCVIA. Again, 60 Fed. Reg. 7678-7696 gives an idea of this process.]

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Old 02-26-2011, 06:01 PM
 
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It's made by the special master. After that, the path is review by a judge of the Court of Federal Claims, the Court of Appeals (which may be de novo), and petitioning the Supreme Court. The practice guidelines and CFC rules are here.

 

[ETA.--I'm referring here to demonstration of causation-in-fact. Defining the table injuries is ultimately the job of HHS, under the strictures of the NCVIA. Again, 60 Fed. Reg. 7678-7696 gives an idea of this process.]

 

So it's like going to trial without the trial to see if you can go to trial?


 

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Old 02-26-2011, 06:03 PM
 
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And who are the Special Masters? What are their backgrounds, stance on vaccines, etc? How are they selected?

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Old 02-26-2011, 07:22 PM
 
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Special Masters are appointed by the US Court of Federal Claims

http://www.uscfc.uscourts.gov/special-masters-biographies



 

 

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