FYI- Thimerosal case, in case anybody wants to read it

[dennis99ss]

Case Law



2007 Ga. App. LEXIS 757,*

FERRARI et al. v. AMERICAN HOME PRODUCTS CORPORATION, D/B/A WYETH et al.

A07A0306.

COURT OF APPEALS OF GEORGIA, FOURTH DIVISION

2007 Ga. App. LEXIS 757

July 5, 2007, Decided

NOTICE:

THIS OPINION IS UNCORRECTED AND SUBJECT TO REVISION BY THE COURT.

DISPOSITION: [*1]

Judgment reversed.

JUDGES: SMITH, Presiding Judge. Barnes, C. J., and Miller, J., concur.

OPINION BY: SMITH

OPINION

Smith, Presiding Judge.

In this case involving an issue of first impression, we are called upon to address whether the National Childhood Vaccine Injury Compensation Act of 1986 ("Vaccine Act"), 42 USC § 300aa-1 et seq., preempts a lawsuit for injuries allegedly caused by the routine vaccination of a child. n1 The trial court concluded that a portion of the plaintiffs' claims are preempted by the Vaccine Act and granted partial summary judgment in favor of the defendants. For the reasons set forth below, we reverse.

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This appeal does not address the causation element of the plaintiffs' claims.
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Summary judgment is proper when no genuine issue of material fact appears and the movant is entitled to judgment as a matter of law. OCGA § 9-11-56 (c). We review the grant or denial of a motion for summary judgment de novo, construing the evidence and all reasonable inferences in the light most favorable to the nonmovant. Matjoulis v. Integon Gen. Insurance Corp., 226 Ga. App. 459 (1) (486 SE2d 684) (1997). So viewed, the record shows that Marcelo and Carolyn Ferrari, individually and on behalf of their minor son, [*2] Stefan Ferrari, sued nine children's vaccine manufacturers ("vaccine defendants"), n2 nine thimerosal manufacturers, n3 and one rhogam manufacturer n4 for alleged neurological damage to their son caused by vaccines containing thimerosal preservative, which in turn contained mercury. According to the Ferraris, their son's neurological damage was caused by the mercury, which is toxic to humans. The Ferraris also sued Georgia Power, claiming that mercury emissions from its power plants also injured their son. The Ferraris asserted claims under Georgia law for strict liability and negligence. The Ferraris alleged the vaccine defendants negligently researched, manufactured, tested or failed to test, warned or failed to warn, and failed to recall thimerosal-containing vaccines. According to the Ferraris, the vaccine defendants could and should have manufactured children's vaccines without thimerosal before their son was vaccinated in 1998.

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Sanofi Pasteur, Inc., Aventis Pharmaceuticals, Inc., SmithKline Beecham Corporation, GlaxoSmithKline, GlaxoSmithKline Biologicals, S.A., GlaxoSmithKline Belgium, Wyeth, Lederle, Inc., and Lederle Pharmaceutical.3

Eli Lilly and Company, Inc., Sigma-Aldrich, [*3] Inc., Sigma-Aldrich Corporation, Spectrum Laboratory Products, Inc., Meridian Chemical and Equipment Inc., American International Chemical, Inc., Dolder, Ltd., and Uriach Corporation.4

Ortho-Clinical Diagnostics.
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SmithKline Beecham Corporation, GlaxoSmithKline Biologicals, S. A., and Wyeth filed answers denying liability and moved for summary judgment in their favor, claiming that the Vaccine Act preempted the Ferraris' claims. The trial court found that the preemption doctrine applied and granted partial summary judgment to the vaccine defendants on the Ferraris' design defect claims, their failure-to-warn claims to the extent that they alleged a failure to warn the plaintiffs or the general public, and their breach of warranty claims to the extent they asserted that the vaccines were defectively designed. On appeal, the Ferraris assert that the trial court erred by: (1) finding that its design defect claims are preempted; and (2) refusing to consider constitutional arguments raised by the Ferraris after the court had orally announced its ruling in favor of the vaccine defendants.

The Vaccine Act

In 1986, Congress enacted the Vaccine Act "to prevent manufacturers from leaving vaccine [*4] production or significantly increasing their prices, while at the same time compensat[ing] victims of vaccine-related injuries quickly." Sykes v. Glaxo-SmithKline, Case No. 06-1111, slip op. at 18, 2007 U. S. Dist. LEXIS 22998 (E.D. Pa. March 28, 2007). The Vaccine Act creates a no-fault compensation system for victims of certain vaccine-related injuries and requires injured parties to file a petition in the Vaccine Court . Id. at 18-19; see also 42 USC §§ 300aa-11(a) (2) (A), 300aa13 (a) (1) (A) -(B). If the injured party is not satisfied with the outcome of the Vaccine Court process, he or she may pursue a traditional tort action, subject to certain restrictions imposed by the Vaccine Act. Sykes, slip op. at 20; see also 42 USC § 300aa21 (a) (1) - (2). These restrictions modify state law as follows:

(a) General rule. Except as provided in subsections (b), (c), and (e) State law shall apply to a civil action brought for damages for a vaccine-related injury or death.

(b) Unavoidable adverse side effects; warnings.

(1) 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 [*5] the effective date of this part [effective Oct. 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.

(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 USCS §§ 301 et seq.] and section 351 of the Public Health Service Act [42 USCS § 262] (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 2123(d)(2) [42 USCS § 300aa-23(d)(2)(A) or (B)], 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 [*6] arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part [effective Oct. 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 subtitle [42 USCS §§ 300aa-10 et seq.].(Emphasis supplied.) 42 USC § 300aa-22. The Vaccine Act also limits the recovery of punitive damages to cases in which

the manufacturer engaged [*7] in (A) fraud or intentional wrongful withholding of information from the [FDA] during any phase of a proceeding for approval of a vaccine . . . , (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.42 USC § 300aa-23 (d).

These restrictions expressly "convey Congress's intent to supersede, or preempt, state tort law standards and create legal protections that apply in any civil action brought against a vaccine manufacturer." Skyes, supra, Slip op. at 20. As in Sykes, the vaccine defendants argue that the Vaccine Act bars the Ferraris' design defect claims because "any vaccine-related injury would be deemed 'unavoidable' if the vaccine was properly prepared and accompanied by proper warnings." Id. at 24. The vaccine defendants essentially equate FDA approval with a determination that side effects are "unavoidable." See id.

The Ferraris, on the other hand, assert that design defect claims are barred only if the side effects [*8] are determined on a case-by-case basis to be "unavoidable." They argue that their child's injuries could have been avoided if the defendants had used a mercury-free preservative for multi-dose vials of their vaccines or if they had simply manufactured single-dose vials that did not require a preservative.

Judicial Interpretation of Scope of Vaccine Act Preemption

Only a handful of courts have addressed the scope of the preemption clause found in § 300aa-22, and each has concluded, after examining the legislative history of the Vaccine Act, that the issue of whether side effects are "unavoidable" cannot be litigated in civil actions. See Sykes, supra, slip op. at 33; Blackmon v. American Home Products Corp., 328 F.Supp. 2d 659, 664 (S.D. Tex. 2004); Militrano v. Lederle Laboratories, 3 Misc. 3d 523 (769 NYS2d 839) (2003), affirmed, Militrano v. Lederle Laboratories, 26 AD3d 475 (810 NYS2d 506) (2006). Each of these cases, however, was either decided before or fails to address the Supreme Court's landmark opinion n5 in Bates v. Dow Agrosciences LLC, 544 U. S. 431 (125 SC 1788, 161 LE2d 687) (2005), on traditional preemption analysis. The Ferraris assert that application of the reasoning [*9] in Bates, supra, mandates a different outcome. We agree.

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See Joseph Frueh, Pesticides, Preemption, and the Return of Tort Protection, 23 YALE J. on REG. 299, 309 (Summer 2006) ("Bates urges that courts must stay the hand of preemption unless given a nearly explicit mandate by the enabling statute."); Kim Ly, Bates v. Dow Agrosciences: Overcoming Federal Preemption and Giving the People a Voice, 26 J. NAT'L ***'N ADMIN. L. JUDGES 297, 336 (Spring 2006) ("the Bates Court has signaled a shift away and against federal preemption of common law tort claims"); Christene Beaupre, Case Comment: Product Safety - Food and Drug Laws: How Bates Changed the Face of Preemption, 82 N.D. L. REV. 579, 601 (2006) ("The Bates decision may reverse . . . the trend to uphold preemption claims and bar state law claims.").
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Bates

In Bates, the Supreme Court "overturned thirteen years of precedent during which pesticide companies enjoyed relative immunity from tort liability." Frueh, 23 YALE J. on REG. at 300. Before Bates, courts interpreted the following language from the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") n6 to bar tort claims: "State shall not impose or continue in effect any requirement [*10] for labeling or packaging in addition to or different from those required under FIFRA." 7 USC § 136v (b). Bates, supra, 544 U. S. at 436, nn.4,5. According to this view, judgments in civil actions might compel pesticide companies to change their labels and would therefore violate the prohibition contained in §136v (b). See id. at 443.

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7 U. S. C. §136 et seq.
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The Supreme Court rejected this approach, and adopted a "parallel requirements reading" of the phrase "in addition to or different from" in FIFRA to allow civil suits based upon common law standards of conduct that served FIFRA's primary purpose of preventing false or misleading statements or inadequate instructions or warnings. Id. at 447-448. In so holding, the Supreme Court noted that:

Conspicuously absent from the submission by Dow and the United States is any plausible alternative interpretation of "in addition to or different from" that would give that phrase meaning. . . . Even if Dow had offered us a plausible alternative reading of §136v (b) - indeed, even if its alternative were just as plausible as our reading of that text - we would nevertheless have a duty to accept the reading that disfavors pre-emption. "Because the [*11] States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action." [Cit.] "In areas of traditional state regulation, we assume that a federal statute has not supplanted state law unless Congress has made such an intention clear and manifest." [Cits.](Punctuation omitted; emphasis supplied.). Id. at 449. The emphasized language above drastically changes traditional preemption analysis.

Before Bates, application of a presumption against preemption to questions concerning the scope of an express preemption clause was controversial. See, e.g., Medtronic v.Lohr, 518 U. S. 470, 485 (116 SC 2240, 135 LE2d 700) (1996); Cipollone v. Liggett Group, 505 U. S. 504, 545-546 (112 SC 2608, 120 LEd 2d 407) (1992) (Scalia, J., dissenting). Furthermore, the presumption against preemption was rebuttable, n7 and courts examined legislative history to determine Congress's intent with regard to ambiguous language in express preemption clauses. n8

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See, e.g., Patrick Fur Farm v. United Vaccines, 286 Wis. 2d 774, 780 n.2 (703 NW2d 707) (Wis. App. 2005).8

See, e.g., Sykes, supra, slip op. at 26.
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The pivotal language in Bates changed [*12] traditional preemption analysis in two ways: (1) There is no longer a rebuttable presumption against preemption, but a duty to accept the reading of an express preemption statute that disfavors preemption; and (2) preemption analysis ends with an examination of the statutory language alone. Under this approach, it appears that legislative history should no longer be examined to discern Congressional intent when an express preemption clause has two plausible alternative readings.

Since Bates, one court has adopted these changes into its preemption analysis. See In the Matter of: Blue Flame Energy Corp., Case No. 05AP-1053, slip op. at 37, 2006 Ohio App. LEXIS 6809 (Ohio App. December 26, 2006) ("f the express preemption provision is ambiguous, a court has a duty to accept the reading that disfavors pre-emption, particularly in areas of traditional state regulation."). While adopting these changes, however, the Ohio Court of Appeals did not apply them, because it concluded that the express preemption clause before it was unambiguous. Id. at 43. Therefore, if we conclude that the Vaccine Act's preemption clause is subject to two alternative readings, this court may be the first to [*13] apply the changes created by Bates.

Application of Bates to the Vaccine Act

The statutory language at issue provides: "No vaccine manufacturer shall be liable in a civil action . . . 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." 42 USC § 300aa21 (b) (1). Two of the courts addressing this language have concluded that two alternative, plausible readings exist with regard to preemption of the issue of unavoidable side effects, and we agree with their conclusion. Sykes, supra, slip op. at 26; Militrano, supra, 769 NYS2d at 843-844. One reading is that vaccine injuries are "unavoidable" and subject to preemption if the vaccine was properly prepared and accompanied by proper directions and warnings. The other reading is that design defect claims are preempted only if the side-effects are determined to be unavoidable on a case-by-case basis.

We also agree with our fellow courts' conclusion that when the contemporaneous legislative history of the Vaccine Act is examined, Congress's intent to preempt this issue becomes clear. n9 Skyes, supra, slip op. at 35; Militrano, supra, 769 NYS2d at 843-844. [*14] A passage in the Report of the Committee on Energy and Commerce states:

Given the existence of the compensation system in the Vaccine Act, . . . [v]accine injured persons will now have an appealing alternative to the tort system. Accordingly, if they cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings they should pursue recompense in the compensation system, not the tort system.(Punctuation omitted.) Sykes, supra, slip op. at 29-30. See also Militrano, supra, 810 NYS2d at 508; Blackmon, supra, 328 F.Supp.2d at 664-665.

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The Ferraris point to subsequent legislative history accompanying an amendment to fund the Vaccine Act as evidence of a contrary intent. However, "subsequent legislative history is a hazardous basis for inferring the intent of an earlier Congress." (Citation omitted.) Pension Benefit Guaranty Corp. v. LTV Corp., 496 U.S. 633, 650 (110 SC 2668, 110 LE2d 579) (1990).
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1. Because two alternative readings of the Vaccine Act exist, application of the Supreme's Court's pronouncement in Bates, supra, is outcome determinative. n10 Under Bates, we "have a duty to accept the [*15] reading [of the Vaccine Act] that disfavors pre-emption," and we cannot resort to an examination of legislative history to discern Congress's intent. 544 U. S. at 449. Because two plausible, alternative readings of the Vaccine Act exist, we must conclude that the trial court erred by finding that the Ferraris' design defect claims are preempted.

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The vaccine defendants assert that Bates should be limited to its facts and apply only in cases involving the same or similar preemption statutes. We find no merit in the argument. The language used by the Supreme Court in Bates is very broad and applies to the analysis of any express preemption statute.
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While this result differs from that reached by other courts addressing the preemptive effect of the Vaccine Act, none of those courts addressed the impact of Bates on the analysis of ambiguous express preemption clauses. We recognize that this result is anomalous given the clear legislative history to the contrary, but we are constrained to follow the Supreme Court's explicit guidance in Bates. While the vaccine defendants urge us to limit the Supreme Court's pronouncement in Bates to the facts of the case before it, there is no rational basis [*16] for us to do so. The language at issue is very broad and addresses preemption analysis generally.

2. Our holding in Division One renders moot the Ferraris' remaining enumeration of error regarding the trial court's refusal to consider their constitutional claims.

Judgment reversed. Barnes, C. J., and Miller, J., concur.

 

[SueM in MN]

I'm moving this to the disABILITIES Community Board, where non-park related questions are the topics.

One interesting thing about Thimerosal and the concerns about mercury poisoning is how common exposure to mercury was in the past (Thimerosal is a mercury derivitive).
Most people in the US under the age of 35 or so have never heard of Mercurochrome, but most people over the age of 40 had lots of contact with it. Mercurochrome is one of the brand names for Merbromin, used as an antiseptic since 1919. It is still sold oveseas, but was banned in the US in the 1990s because of concern about its high mercury content.
Link to Wikipedia article about Mercurochrome
and a link to another article about Mercurochrome.

It was an orange liquid in a bottle with a 'dipper' that dipped into the bottle and you used the end of the dipper to daub it on the skin. I remember every time we got a cut or scrape, out came the Mercurochrome. Because it had a cool red/orange color, we ended up with it not only on the 'boo-boo', but all over. Before mom confiscated it, we usually ended up making designs of it all over our arms and legs (even the kids without 'boo-boos'). Because we were putting it on non-intact skin, it went right into our bloodstream. Sometimes, we were allowed to use it without any 'first aid need' to make 'tattoos.' I used it as a child, all my friends did, our parents did and their parents (and even in some cases, their grandparents too). My family didn't do this, but I knew some kids whose families swabbed it on the back of their throats to cure or prevent sore throats.

Thimerosal was used as a preservative in vaccines since the 1930s, so exposure in vaccines is not new. We also had exposure to mercury if a thermometer broke. In the past, if a thermometer broke, it meant the kids got to play with the neat silver liquid for a while before mom made us clean it up. Now, a tiny bit of mercury is toxic waste.
So, I personally think that if mercury was the 'smoking gun' there was much more exposure in the past than there has been for the last 20 years, so we should have seen neurologic problems from it many years ago rather than recently. But, I know other people feel differently - my sister's son has Aspergers and she feels very strongly that the MMR vaccine caused it (although the MMR vaccine does not and has never contained Thimersol).

The question can't be decided here, so hopefully no arguements or fighting will occur in this thread.

 

[dennis99ss]

Didn't put it up for a debate, etc. Just thought some people may want to know that at least one court ruled against thought that the vaccine act controls.

Your comments are to causation. The current fight is the ability to even argue causation.

Regards.

 

[Michigan]

Because it had a cool red/orange color, we ended up with it not only on the 'boo-boo', but all over. Before mom confiscated it, we usually ended up making designs of it all over our arms and legs (even the kids without 'boo-boos').

What a flash to the past I thought my friends and I were the only ones that painted ourselves with it.

Sue aren't our fillings in our teeth mercury too?

Cindy

 

[Forevryoung]

What a flash to the past I thought my friends and I were the only ones that painted ourselves with it.

Sue aren't our fillings in our teeth mercury too?

Cindy

Silver fillings are and strangely enough dentists are allowed to put them in your mouth and you can keep them there for quite awhile but when the dentist disposes of the murcury there are a million 'safeguards' for disposal. My dad is a dentist and he finds that rather odd in an entertaining sort of way.

Murcury has been around "forever" in much much higher doeses than the past 10-15 years.

 

[SueM in MN]

Didn't put it up for a debate, etc. Just thought some people may want to know that at least one court ruled against thought that the vaccine act controls.

Your comments are to causation. The current fight is the ability to even argue causation.

Regards.

Thanks.

I understand.
I had heard the news story about it so I was aware.

I was just trying to head off a debate on the general subject.

 

[dennis99ss]

Understand.
If you need add'l info, pm me.

 

[BeckyScott]

Sue, since I'm 41 I should barely remember that stuff, huh? I also have the smallpox (?) vaccine scar on my bicep, that's a real obvious "how old is she" right there! And there was some vaccine they gave in a sugar cube, remember that? Ohmigosh, I'm old!

dennis, thank you for posting this. The whole thing seemed to slip off the radar once it got going, sort of disappeared, I thought it would take longer for a decision so I wasn't paying much attention.

I don't think this will really change anything though. If I may-- the parents that believe the vaccines caused autism probably aren't terribly surprised by the "verdict" because of the un-likelihood of getting a totally fair trial. The parents that don't believe didn't have alot invested in it to start with. I am somewhere in the middle I guess- I don't think it was vaccines in our case but I believe it could be possible, and I also have lost alot of faith in our government in recent years. I remember when I first learned about this lawsuit, my first reaction was that they wouldn't win. Not that they shouldn't, but that they wouldn't.

 

[Michigan]

And there was some vaccine they gave in a sugar cube, remember that?

It was for polio, I remember waiting in line for hours to get it when I was little. Everyone had to go to a local school and have the department of health give it out.

 

[crazy_for_the_dis]

This reminded me of my ex-boss. She was a very attention to detail oriented person, and when she became pregnant, researched everything and came across the theory about vaccinations and autism. So, with both of her children (born around two years apart), she did not have them vaccinated. Surprisingly, she now deals with children that are diagnosed as "failure to thrive" and...... autistic. This has always made me wonder if some people jump to blame vaccinations as the cause due to the rise in cases in recent years, and not looking for other, and maybe more viable causes/explanations. I guess time will tell if the issue gets more publicized, and more people bypass vaccinations if those populations will see diagnoses of autism along the same numbers as those who still do vaccinate their children (I wonder if this is in even being followed....I would hope so, but I'm not sure either side of the debate would be willing to take the risk to learn the truth??) My child recieved all vaccinations, and even recent "optional" ones such as gardisol, so my thought is that vaccinations are still a good thing. But I don't remember the debate and publicity that the issue gets today (she is 12) when she was born, and wondering if it would have made me think twice then.

 

[dennis99ss]

there is no question that there are multiple causes, and multiple possible causes. Personally, I believe that some (not all nor not nearly all) cases are related to Thimerosal. I also believe there is a difference between "straight autism" and mercury induced autistic symptoms that are permanent. While I am no longer involved in the thimerosal litigation, I am glad to see it moving forward. I found the evidence compelling, but I also thought it was an uphill battle that would cost millions and millions to attempt to bring before a jury.

I know others feel differently. The shame is that we will never know because the vaccine act probably precludes our ever finding out (notwithstanding this opinion)

As far as I know, this is the first case to break through the vaccine act. There was one prior case that allowed suit to proceed against second tier defendants, but that case gutted the main defendants due to the vaccine act. the good thing is, that after 9/11 any suit against manufacturers was precluded and was written into anti-terrorism legislation. That portion of the anti-terrorism bill, however, was eventually withdrawn. I still don't understand how this was terrorism related, but for the almighty dollar. One of the defendants has billions of euros profit per quarter.

off my soapbox.

 

[BeckyScott]

Me again.

I do think that what this did, was keep autism in the news. There was a wave of press when they changed the stat to "one in 150". Then it died down again. Then the lawsuit, and there was media coverage again. Which is a good thing right there. Since we are pretty out-there with Justin's diagnosis, I had alot of friends and co-workers comment to me that they'd thought of us, etc.

I didn't think too much about it one way or the other, but within a couple of days of the lawsuit hitting the news... my MIL came over and informed me that there was something on the news about autism and vaccines, like I hadn't heard about this ever before and it was some big news flash. (this is typical of my MIL) Then my grandfather called and from out of the blue started giving me instruction on how to pick a good lawyer. (thanks Gramps) So it was pretty entertaining at our house for a little while.