$00:0100005451:BE3503000000154B:<LNI='4J1J-DTV0-0060-D0GV-00000-00' MINREV='00000' ERPT=BE350300>$01:$=T1*=SS_#NEW-MAIN# Return to the EXTRA Main Menu.$%$?$%**********************************************************$03:$=N1298*31$10:MARCELO A. FERRARI and CAROLYN H. FERRARI, Individually and as Parents and Next Friend of STEFAN R. FERRARI, Plaintiffs, v. AMERICAN HOME PRODUCTS CORP. d/b/a WYETH; WYETH LABORATORIES; WYETH-AYERST; WYETH-AYERST LABORATORIES; WYETH LEDERLE; WYETHER LEDERLE; WYETHER LEDERLE VACCINES and LEDERLE LABORATORIES; ORTHO-CLINICAL DIAGNOSTICS, INC.; SMITHKLINE BEECHAM CORPORATION; GEORGIA POWER COMPANY; and JOHN DOES 1-20 who are individuals, proprietorships, corporations or other entities whose names and identities are otherwise unknown to the plaintiffs, Defendants.$20:CIVIL ACTION FILE NO. 02 VS 031404-F$25:STATE OF GEORGIA, FULTON COUNTY$30:$T$=<$=V08576002005000183*1298 2005 Extra LEXIS 183$=>$40:$?$%November 30, 2005, Decided$110:$=P1298*1 SUSAN B. FORSLING, Judge.$115:SUSAN B. FORSLING$120:$T$U$=BORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS WYETH, SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE, AND GLAXOSMITHKLINE BIOLOGICALS S.A.'S MOTION FOR SUMMARY JUDGMENT, OR ALTERNATIVELY, MOTION TO DISMISS OR REQUIRE REPLEADING OF ALLEGATIONS$=R$O$TPlaintiffs allege in this product liability action that the minor plaintiff suffers from a neurological condition that was caused, in part, by exposure to FDA-approved vaccines containing the preservative thimerosal. Before the Court is a Motion for Summary Judgment, or Alternatively, Motion to Dismiss or Require Repleading of Allegations filed by Defendants WYETH (f/k/a AMERICAN HOME PRODUCTS CORPORATION), SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE and GLAXOSMITHKLINE BIOLOGICALS S.A. (collectively the "Vaccine Defendants"). The Vaccine Defendants argue that the Court should grant summary judgment because the National Childhood Vaccine Injury Compensation Act, $=<$=T4*42_USC_300AA-1 $=L01919000042000300*000300 42 U.S.C. $S 300aa-1$=> $Uet seq.$O ($Uhereinafter$O the "Vaccine Act"), pre-empts all of Plaintiffs' claims. The Vaccine Defendants assert that all of Plaintiffs' claims, including$=P1298*2 failure to warn, are pre-empted by Section 22(b) of the Vaccine Act because the claims are all based on a singular design defect allegation, $Ui.e.,$O that the FDA-approved vaccines at issue should not have contained the preservative thimerosal. The Vaccine Defendants also contend that Section 22(c) of the Vaccine Act bars Plaintiffs' claims for failure to warn Plaintiffs and the general public. The Vaccine Defendants additionally seek dismissal of Plaintiffs' fraud-based allegations pursuant to O.C.G.A. $Z 9-11-9(b) and 9-11-12 for failure to plead such allegations with particularity.$TIn support of their Motion, the Vaccine Defendants filed a memorandum, a statement of material facts and theories of recovery, the affidavit of Karen Raby Monson with attached exhibits A-H, and a reply memorandum in further support of their Motion. Plaintiffs filed a brief in opposition to the Motion and a response to the Vaccine Defendants' statement of material facts and theories of recovery. The Court has reviewed the papers submitted by each party, and on July 8, 2005, the Court heard oral argument on the Motion from counsel. At the conclusion of the argument, the Court ruled on the Vaccine Defendants' $=P1298*3 Motion. This Order reflects that ruling and the Court's supporting reasons. For the reasons that follow, the Vaccine Defendants' Motion for Summary Judgment, or Alternatively, Motion to Dismiss or Require Repleading of Allegations is hereby $=BGRANTED IN PART$=R and $=BDENIED IN PART.$=R$T$U$=BBACKGROUND$=R$O$TOn or about April 15, 2002, plaintiffs Marcelo and Carolyn Ferrari, individually and on behalf of the minor plaintiff, Stefan R. Ferrari, commenced the instant proceeding by filing a complaint alleging that the minor plaintiff allegedly suffers from a neurological condition, which Plaintiffs claim was caused by exposure to FDA-approved vaccines containing the preservative thimerosal. Plaintiffs asserted claims under Georgia law for strict tort liability, negligence, fraud and deceit, negligent misrepresentation, and breach of warranty. Plaintiffs also sought punitive damages based upon assertions of gross negligence.$TThis Court dismissed without prejudice the claims of the minor plaintiff on January 6, 2003. On February 20, 2003, all discovery in this case was stayed until further order of the Court. On October 15, 2003, this Court dismissed without prejudice the claims alleged by the$=P1298*4 parent plaintiffs (other than their separate state law claims for loss of services and emotional distress). The dismissals afforded Plaintiffs the opportunity to file a petition in Vaccine Court. In October 2004, Plaintiffs, having filed a Vaccine Court petition, elected to terminate their proceeding in that forum and filed a Second Amended Complaint on October 25, 2004, asserting that they had "complied with all prerequisites under the National Vaccine Injury Compensation Act." The Court lifted the stay of proceedings on April 20, 2005.$TThe Vaccine Defendants filed the motion for summary judgment that is the subject of this Order on May 27, 2005, and filed a corrected Motion on May 31, 2005. n1 Plaintiffs filed their brief in opposition on July 1, 2005, and the Vaccine Defendants filed a reply memorandum in further support of their Motion on July 7, 2005.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn1 GlaxoSmithKline Biologicals s.a. ("Biologicals") did not appear in this action until it filed an answer with this Court on July 7, 2005. At that time, Biologicals also filed a notice of joinder in the Vaccine Defendants' Motion.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*5 $T$U$=BDISCUSSION$=R$O$T$=BA. $UThe Vaccine Act$O$=R$TChildhood vaccines play a central role in national health policy, and the Vaccine Act, which covers Plaintiffs' claims here, is integral to that policy. In 1986, the United States Congress passed the Vaccine Act, and created "a new system for compensating individuals who have been injured by vaccines routinely administered to children." H.R. Rep. 99-908, 99th Cong., 2d Sess. (1986), at 3, $Ureprinted in$O 1986 U.S.C.C.A.N. 6344, 6344. The Vaccine Act's legislative history documents the concerns that spurred enactment of the law. It notes the inability of the tort system to predictably and properly deal with claims on behalf of children alleging vaccine-related injuries, and that costly litigation without predictable results created an incentive for vaccine manufacturers to withdraw from making childhood vaccines critical to public health. $USee id.$O at 6344-48; $Usee also $=<$=T3*1 $=L00440000844001108*001116 Abbot v. American Cyanamid Co.,$O 844 F.2d 1108, 1116-17 (4th Cir. 1988)$=> (Wilkins, J., concurring) ("As a . . . consequence of the increase in litigation, . . . manufacturers are reconsidering their future role in the vaccine market. . . . $=P1298*6 The withdrawal of any  manufacturer from the market poses a serious threat to public health, in the form of vaccine shortages with resulting decreased immunization and a possible resurgence of these diseases.").$TThe Vaccine Act reflects two specific policy goals of Congress. First, the federal legislative scheme aimed to simplify the procedure and the substantive rules of law applicable to vaccine-related injury claims, and so make it easier for injured parties to obtain compensation. To implement this policy, Congress established a special court ("Vaccine Court") as part of the United States Court of Federal Claims to adjudicate claims of "vaccine-related injury" n2 and to award compensation to injured individuals. $USee $=<$=T3*1 $=L01917000514000268*000269 Shalala v. Whitecotton,$O 514 U.S. 268, 269 (1995)$=> ("For injuries and deaths traceable to vaccinations, the $(Vaccine$) Act establishes a scheme of recovery designed to work faster and with greater ease than the civil tort system."). A claimant may recover by proving an injury plus causation. Proof that the vaccine at issue was negligently manufactured, defectively designed, or inadequately labeled is not required to obtain compensation on $=P1298*7 any Vaccine Court petition. $USee$O $=<$=T4*42_USC_300AA-11 $=L01919000042000300*000300 42 U.S.C. $Z 300aa-11$=>(c)(1); 300aa-13(a)(1). Approximately 4,500 petitions seeking compensation based on allegations that thimerosal-containing vaccines and/or the Measles-Mumps-Rubella ("MMR") vaccine caused autism or autism spectrum disorder are currently pending before the Vaccine Court. $USee In re Claims For Vaccine Injuries Resulting In Autism Spectrum Disorder Or A Similar Neurodevelopmental Disorder,$O Autism Master File -- Autism Update (Ct. Fed. Cl. June 27, 2005) (Hastings, S.M.).$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn2 "Vaccine-related injury" "means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine." $=<$=T4*42_USC_300AA-33 $=L01919000042000300*000300 42 U.S.C. $S 300aa-33$=>(5). It includes claims alleging injury from thimerosal contained in FDA-approved vaccines. $USee, e.g., $=<$=T3*1 $=L04830000267000667*000673 Blackmon v. Am. Home Prods. Corp.,$O 267 F. Supp. 2d 667, 673-75 (S.D. Tex. 2002);$=> $ULeroy v. Sec'y of HHS,$O No. 02-392$=<$=T3*1 $=L04538002002730680*730680 V, 2002 WL 31730680,$=> at *17 (Fed. Cl. Oct. 11, 2002); $=<$=T3*1 $=L00180000851000908*000911 $UAshton v. Aventis Pasteur, Inc.,$O 851 A.2d 908, 911-13 (Pa. Super. Ct. 2004).$=>$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*8 $TSecond, Congress intended to protect the supply of childhood vaccines in the United States by protecting vaccine manufacturers from the burden of costly litigation with unpredictable outcomes. The Vaccine Act protects vaccine manufacturers from costly civil litigation by: (i) barring civil actions such as this arising from vaccine-related injuries unless the claim was first presented in the Vaccine Court and the remedy exhausted n3; (ii) immunizing vaccine manufacturers from liability for alleged vaccine-related injuries caused by vaccines that were properly prepared and accompanied by proper directions and warnings; and (iii) establishing legal presumptions as to the adequacy of vaccine warnings and against the imposition of puni tive damages except in cases involving substantial wrongdoing. $USee$O $=<$=T4*42_USC_300AA-11 $=L01919000042000300*000300 42 U.S.C. $Z 300aa-11;$=> 300aa-22; 300aa-23(d); $Usee also$O 1986 U.S.C.C.A.N. at 6367. In addition to requiring that any vaccine-related injury claim be first presented in Vaccine Court, the Vaccine Act sets substantive and procedural rules that control the conduct of every civil action on claims of injury arising from post-October 1, 1988 vaccine$=P1298*9 administrations. Those limitations bar certain claims -- including certain of the claims Plaintiffs assert in their Complaint -- from being litigated in any civil action.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn3 Congress expected that a significant number of claims would be resolved in the Vaccine Court forum under the Vaccine Act's provisions for generous compensation. $USee$O 1986 U.S.C.C.A.N. at 6354.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$T$=BB. $UThe Vaccine Act's Express Pre-emption Of State Products Liability Law$O$=R$TThe Vaccine Defendants argue that Section 22 of the Vaccine Act pre-empts all state law design defect claims arising from vaccine-related injuries. Plaintiffs contend that the Vaccine Act merely supplements state products liability law, rather than displacing it. For the reasons set forth, the Court concludes that the Vaccine Act pre-empts all claims based on a theory of design defect.$TFederal law may pre-empt state law in three ways:$=S$%$?$%First, in enacting the federal law, Congress may explicitly define the extent to which it intends to preempt state law. (Citation omitted.) $=P1298*10 Second, even in the absence of express pre-emptive language, Congress may indicate an intent to occupy an entire field of regulation, in which case the states must leave all regulatory activity in that area to the Federal Government. (Citations omitted.) Finally, if Congress has not displaced state regulation entirely, it may nonetheless pre-empt state law to the extent that the state law actually conflicts with federal law.$=I$%$?$%$=<$=T3*1 $=L01917000467000461*000469 $UMich. Canners & Freezers Ass'n, Inc. v. Agric. Mktg. & Bargaining Bd.,$O 467 U.S. 461, 469 (1984).$=>$TSection 22 of the Vaccine Act is an example of express pre-emption, as indicated by Section 22(a), which states that: "Except as provided in subsections $(22$)(b), $(22$)(c), and $(22$)(e) of this section State law shall apply to a civil action brought for damages for a vaccine-related injury or death." $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(a).$TSection 22(b)(1) of the Vaccine Act states:$=S$%$?$%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 $=P1298*11 side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.$=I$%$?$%$=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(b)(1). That section states the express limitation on civil actions against vaccine manufacturers: it bars all civil actions arising from a vaccine-related injury if the injury could not have been avoided by proper preparation or proper labeling of the vaccine.$TThe cases Plaintiffs cite for the proposition that the Vaccine Act does not pre-empt state tort law are inapposite. The claims in those cases arose b efore the effective date of the Vaccine Act and concern vaccinations administered before October 1, 1988. The issue in those cases was whether state law claims had been impliedly pre-empted by federal law. Thus, the cases do not address whether Section 22 of the Vaccine Act expressly pre-empts design defect claims. $USee $=<$=T3*1 $=L00438000742000239*000246 Mazur v. Merck & Co., Inc.,$O 742 F. Supp. 239, 246-47 (E.D. Pa. 1990);$=> $=<$=T3*1 $=L00440000844001108*001113 $UAbbot v. American Cyanamid Co.,$O 844 F.2d 1108, 1113-14 (4th Cir. 1988);$=> $=<$=T3*1 $=L00440000863001173*001178 $UHurley v. Lederle Labs. Div. of American Cyanamid Co.,$O 863 F.2d 1173, 1178 (5th Cir. 1989).$=>$=P1298*12 $T$=BC. $UPlaintiffs' Design Defect Claims$O$=R$TWith regard to Plaintiffs' design defect claims, the only issue before the Court is the extent of the pre-emptive effect of Section 22(b) of the Vaccine Act. Plaintiffs contend that Section 22(b)(1) simply codifies Comment k of Section 402A of the Restatement (Second) of Torts and directs states to determine under their tort law whether an alleged vaccine-related injury or death resulted from side effects that were unavoidable under any circumstances, including design standards that might be imposed by state tort law. Plaintiffs maintain that the Vaccine Act only bars their design defect claims here if the Court determines under Georgia products liability law that the side effects of the vaccines at issue are unavoidable.$TPlaintiffs construe the statute as if it ended with the words "side effects that were unavoidable." The statute continues, however, that vaccine manufacturers are not subject to civil liability where the alleged "injury or death resulted from side effects that were $Uunavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.$O" $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>$=P1298*13 (b)(1) (emphasis added). Plaintiffs' interpretation therefore does not account for all elements of the statute. $USee $=<$=T3*2 $=L00465000264000744*000747 $=L01811000452000476*000479 Gilbert v. Richardson,$O 264 Ga. 744, 747-48, 452 S.E.2d 476, 479 (1994)$=> ("It is a basic rule of construction that a statute . . . should be construed 'to make all its parts harmonize and to give a sensible and intelligent effect to each part.'" (citation omitted)). By its express terms, the statute immunizes vaccine manufacturers from liability for side effects that inevitably occur even though a vaccine is properly prepared in every respect according to its approved design specifications and is properly labeled. Thus, a manufacturer that properly prepares and labels a vaccine in accordance with the applicable federal law is immune from civil liability for side effects that nonetheless occur, even if, theoretically, an alternatively-designed vaccine might have prevented the alleged injury.$TTo date, two other cases have addressed the pre-emptive impact of the Vaccine Act on claims arising from vaccine-related injuries attributed to FDA-approved pediatric vaccines, $UBlackmon v. American Home Products Corp.$O and $UMilitrano $O $=P1298*14 $Uv. Lederle Laboratories.$O This Court's interpretation of Section 22 is in accord with the holdings of both $UBlackmon$O and $UMilitrano. See $=<$=T3*1 $=L04830000328000659*000663 Blackmon v. American Home Prods. Corp.,$O 328 F. Supp. 2d 659, 663-66 (S.D. Tex. 2004)$=> (holding that Section 22(b) forecloses all design defect claims against vaccine manufacturers); $=<$=T3*1 $=L01586000769000839*000845  $UMilitrano v. Lederle Labs.,$O 769 N.Y.S.2d 839, 845 (Sup. Ct. Kings Co. 2003)$=> (holding that Section 22(b) bars all design defect claims because "Congress did not intend that national vaccine policy be determined by the vagaries of a jury's determination on a case-by-case basis").$TPlaintiffs contend that the Georgia Court of Appeals in $UBryant v. Hoffman-LaRoche, Inc.$O has already decided that federal law does not pre-empt civil actions alleging injury caused by defectively designed prescription drugs, including vaccines. $UBryant,$O however, did not mention, much less interpret, the Vaccine Act, and thus could not have decided whether the Vaccine Act bars design defect claims arising out of a $Uvaccine-related injury. See $=<$=T3*2 $=L00466000262000401*000401 $=L01811000585000723*000723 Bryant v. Hoffman-LaRoche, Inc.,$O 262 Ga. App. 401, 585 S.E.2d 723 (2003).$=>$=P1298*15 Indeed, $UBryant$O involved the heart medication Posicor, not a pediatric vaccine. $USee $=<$=T3*2 $=L00466000262000401*000401 $=L01811000585000723*000725 id.$O at 401, 585 S.E.2d at 725.$=> $UBryant$O held that Georgia courts should determine whether a prescription drug is "unavoidably unsafe" under Comment k of Section 402A of the Restatement (Second) of Torts on a case-by-case basis. $USee $=<$=T3*2 $=L00466000262000401*000406 $=L01811000585000723*000723 id.$O at 406;$=> $=<$=T3*2 $=L00466000262000401*000401 $=L01811000585000723*000728 585 S.E.2d at 728.$=>$TWhile Congress clearly looked to the principles contained in Comment k of Section 402A of the Restatement (Second) of Torts when drafting Section 22(b) of the Vaccine Act, Congress did not codify the exact language of Comment k or adopt the interpretation some Georgia courts have given to Comment k. n4 $UCompare$O Restatement (Second) of Torts $S 402A cmt. k (2002) (stating, with respect to a vaccine, that "such an $(unavoidably unsafe$) product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous") $Uwith$O $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(b)(1) (providing that "no vaccine manufacturer shall be liable" for alleged$=P1298*16 "injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."). Nor did Congress leave vaccine design standards open to reexamination under the laws of each state, with the potential for interstate conflict: the Vaccine Act sets one rule, applicable nationwide, that pre-empts design defect claims.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn4 Comment k and Section 22(b)(1) differ in two notable aspects. First, Comment k refers to "unavoidably unsafe" products, while Section 22(b)(1) does not use that term. Second, while Comment k's language is directed to strict liability claims, Section 22(b)'s plain language is all-encompassing, including claims grounded in negligence, as well as those based on strict liability. Section 22(b)(1)'s statement that "no manufacturer shall be liable in a civil action for damages" plainly bars all claims based on the alleged design defect, whether characterized as negligence, strict liability, or by any other legal label. $USee $=<$=T3*1 $=L04830000328000659*000665 Blackmon,$O 328 F. Supp. 2d at 665-66.$=>$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*17 $TCongress intended that "the principle in Comment K regarding 'unavoidably unsafe' product s, $Ui.e.,$O those products which in the present state of human skill and knowledge cannot be made safe, apply to the vaccines covered in the $(Act$) and $Uthat such products not be the subject of liability in the tort system.$O" 1986 U.S.C.C.A.N. at 6367 (emphasis added). Thus, the view of Comment k that Congress adopted when it enacted Section 22(b) immunizes manufacturers of "properly prepared" products that are "accompanied by proper directions and warnings" from all design defect claims. That statutory standard, not the common law case-by-case approach advocated by certain Georgia courts, governs the Court's analysis here. $USee $=<$=T3*1 $=L01586000769000839*000845 Militrano,$O 769 N.Y.S.2d at 845$=> (stating that "the language in the House Committee report supports the conclusion that Congress intended to view Comment k and the $(Vaccine$) Act as immunizing vaccines from liability for design defects.").$TThe legislative history of Section 22 that is contemporaneous with that 1986 enactment confirms Congress's intention as expressed in Section 22(b):$=S$%$?$%Given the existence of the compensation system in $(the$=P1298*18 Vaccine Act$), the Committee strongly believes that Comment k is appropriate and necessary as the policy for civil actions seeking damages in tort. Vaccine-injured persons will now have an appealing alternative to the tort system. $UAccordingly, 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.$O$=I$%$?$%H.R. Rep. No. 99-908, 99th Cong., 2d Sess. (1986), at 4, $Ureprinted in$O 1986 U.S.C.C.A.N. 6344, 6367 (emphasis added); $Usee also $=<$=T3*1 $=L04830000328000659*000665 Blackmon,$O 328 F. Supp. 2d at 665$=> (finding that the relevant legislative history "rather clearly" indicates that the Act bars design defect claims). n5$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn5 Plaintiffs rely on statements from a subcommittee report from 1987, the year after enactment of the Vaccine Act, as evidence of Congress's intent, in 1986, in adopting the Act. $USee$O H. R. Rep. 100-391(I), at 691, reported in 1987 U.S.C.C.A.N. at 2313-365. The Court concludes that the 1987 statements are not entitled to any weight. Post-enactment statements are not reliable indicators of earlier congressional intent, particularly where, as here, they do not relate to any legislation passed at the time that the statements are made. $USee, e.g., $=<$=T3*1 $=L01917000596000633*000650 Pension Benefit Guar. v. LTV Corp.,$O 596 U.S. 633, 650 (1990)$=> ("Subsequent legislative history is a 'hazardous basis for inferring the intent of an earlier' Congress"); $Usee also $=<$=T3*1 $=L00440000803000613*000616 Ewing & Thomas, P.A. v. Heye,$O 803 F.2d 613, 616 (11th Cir. 1986).$=> The 1987 statements, as interpreted by Plaintiffs, directly contradict the 1986 legislative history of Section 22 cited above, which explicitly rejects Plaintiffs' argument that Section 22(b)(1) permits design defect claims. Furthermore, the statements do not assist the Court in construing Section 22(b)(1) because the statements do not track the language of Section 22(b)(1), referring instead to "unavoidably unsafe" vaccines.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*19 $TThe intent to establish one national standard for vaccine design and to remove that from the purview of state tort law  is further demonstrated by the Vaccine Act's specific delegation of questions of vaccine safety to the Secretary of Health and Human Services. $USee$O $=<$=T4*42_USC_300AA-27 $=L01919000042000300*000300 42 U.S.C. $S 300aa-27;$=> $Usee also$O $=<$=T4*42_USC_300AA-2 $=L01919000042000300*000300 42 U.S.C. $S 300aa-2$=>(a)(2) (directing HHS to coordinate and direct programs to develop safe and effective vaccines). n6 Section 27 mandates that HHS "promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 27, 1987, and promote the refinement of such vaccines." $UId.$O $S 300aa-27(a)(1). It further directs the Secretary to "make or assure improvements in . . . the licensing, manufacturing, processing, testing, labeling, warning, . . . and research on vaccines, in order to reduce the risks of adverse reactions to vaccines." $UId.$O $S 300aa-27(a)(2). Section 27 also directs HHS to "establish a task force on safer childhood vaccines," consisting of "the Director of the National Institutes of Health, the Commissioner $=P1298*20 of the Food and Drug Administration, and the Director of the Centers for Disease Control," which is to consult with the Advisory Commission on Childhood Vaccines to make recommendations to increase vaccine safety and efficacy. $UId.$O $S 300aa-27(b).$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn6 $USee also$O $=<$=T4*42_USC_300AA-1 $=L01919000042000300*000300 42 U.S.C. $S 300aa-1$=> ("The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines."); $UId.$O $S 300aa-5 (establishing the National Vaccine Advisory Committee, which, $Uinter alia,$O studies and recommends "ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States); $UId.$O $S 300aa-19 (establishing the Advisory Commission on Childhood Vaccines to, $Uinter alia,$O "advise the Secretary in implementing the Secretary's responsibilities under section 300aa-27 of this title regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions.").$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*21 $TThe FDA's authority to determine the uniform national design for childhood vaccines would be undermined if these Plaintiffs were allowed to challenge vaccine design under Georgia law (or under any state's law). Section 22(b) is properly read to foreclose all design defect claims against vaccine manufacturers in order to prevent plaintiffs from mounting such a collateral attack on FDA decisions through the tort system.$TAccordingly, this Court enters summary judgment dismissing all of Plaintiffs' design defect claims. The dismissal of Plaintiffs' design defect claims is not limited to Plaintiffs' strict liability design defect and negligent design claims. Plaintiffs' failure to warn, fraud, gross negligence, and breach of warranty claims are also barred by Section 22(b)(1) to the extent that those claims are based solely on the inclusion of thimerosal in the design of the vaccines at issue.$T$=BD. $UPlaintiffs' Failure-To-Warn Claims$O$=R$TThe Vaccine Defendants argue that Section 22(c) of the Vaccine Act explicitly forecloses Plaintiffs' claims based on a duty to provide direct warnings to Plaintiffs and the  general public. Section 22(c) provides that:$=S$%$?$%No vaccine manufacturer shall$=P1298*22 be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.$=I$%$?$%$=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(c). To the extent that Plaintiffs' failure-to-warn claims are based on allegations that the Vaccine Defendants failed to warn Plaintiffs or the public generally, they are hereby dismissed.$TThe Vaccine Defendants further argue that all of Plaintiffs' failure-to-warn claims restate their design defect claims. Plaintiffs' Complaint alleges that thimerosal is a "powerful and dangerous neurotoxin poison." Compl. P9. The Vaccine Defendants contend that Plaintiffs' theory is no warning could have made safe any universally-administered childhood vaccine containing what is alleged to be a "dangerous neurotoxin poison."$TIn order for Plaintiffs to allege a valid failure-to-warn claim, they must assert that the vaccines at issue could$=P1298*23 have been sold safely if they contained a warning about thimerosal. $USee $=<$=T3*2 $=L00465000234000868*000870 $=L01811000218000580*000582 Center Chem. Co. v. Parzini,$O 234 Ga. 868, 870, 218 S.E.2d 580, 582 (1975).$=> As currently pled, Plaintiffs' failure-to-warn claims are essentially a restatement of their design defect claims, which are barred by Section 22(b)(1) of the Vaccine Act. The Court concludes, however, that Plaintiffs should have another opportunity to plead a failure-to-warn claim that could satisfy the notice pleading standard of O.C.G.A. $S 9-11-8. Therefore, the Court $=BGRANTS$=R Plaintiffs leave to replead this claim by way of an amended Complaint to be filed with the Court within fifteen (15) days of the date of this Order. The amended Complaint should assert allegations beyond the fact that the vaccines at issue contain thimerosal and should also clarify the nature of the warnings that Plaintiffs contend the vaccines at issue required. n7 Plaintiffs should be afforded the opportunity to conduct discovery related to their amended failure-to-warn claims that is consistent with the provisions of Section 22(b)(2) of the Vaccine Act. The Vaccine Defendants, however, may present another motion$=P1298*24 for summary judgment on Plaintiffs' failure-to-warn claims after discovery pertinent to that issue has been conducted.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn7 Plaintiffs allege in their complaint that the Vaccine Defendants "impliedly and expressly warranted to the Plaintiffs that these Thimerosal-containing products . . . were safe, when in fact, the products were not safe. Each of $(the Vaccine Defendants$) was negligent for distributing a defective product without providing adequate warnings and without first determining that the products were safe." Compl. P53. In light of this Court's ruling that Section 22(b)(1) bars all design defect claims, Plaintiffs' breach of warranty claim would only be viable to the extent it alleges that the vaccines at issue were defective due to inadequate warnings.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$T$=BE. $UPlaintiffs' Manufacturing Defect Claims$O$=R$TThe Vaccine Defendants argue th at Plaintiffs have failed to allege a valid manufacturing defect claim. Plaintiffs' Complaint simply states that the vaccines were "defectively designed, manufactured, marketed and$=P1298*25 distributed." Compl. P28. Plaintiffs disagree, contending that they have adequately plead a manufacturing defect claim and that they are entitled to conduct discovery with regard to that claim.$T"$(A$) manufacturing defect will always be identifiable as a deviation from some objective standard or a departure from the manufacturer's specifications established for the creation of the product." $=<$=T3*1 $=L04830000231001228*001236 $UJones v. Amazing Prods., Inc.,$O 231 F. Supp. 2d 1228, 1236 (N.D. Ga. 2002).$=> Because thimerosal is part of the FDA-approved formula for the vaccines at issue, Plaintiffs cannot contend that the inclusion of thimerosal was a manufacturing defect in the vaccines at issue and the cause of Plaintiffs' injuries. To the extent that Plaintiffs' manufacturing defect claims are based on the inclusion of thimerosal, they are barred by Section 22(b) as repackaged design defect claims. The Court concludes, however, that Plaintiffs' manufacturing defect allegations satisfy the notice pleading requirements set forth by O.C.G.A. $S 9-11-8. Plaintiffs would need to prove a defect in manufacturing, to sustain their claim, and not just that the vaccine contained thimerosal as part of its$=P1298*26 formula. The Vaccine Defendants may present another motion for summary judgment on Plaintiffs' manufacturing defect claims after discovery pertinent to that issue has been conducted.$T$=BF. $UPlaintiffs' Fraud-Based Claims, Gross Negligence Claim, And Punitive Damages Claim$O$=R$TThe Vaccine Defendants have moved to dismiss Plaintiffs' fraud-based claims on the ground that they contain unspecified and unattributed allegations of fraud that do not meet the standard set forth by O.C.G.A. $S 9-11-9(b). $USee $=<$=T3*2 $=L00466000267000859*000866 $=L01811000601000177*000185 R.W. Holdco, Inc. v. Johnson,$O 267 Ga. App. 859, 866, 601 S.E.2d 177, 185 (2004).$=> While the Complaint lacks any reference to particular false statements made or specific information concealed, and groups all defendants together into conclusory paragraphs, $USee$O Compl PP46, 47, the Court will allow Plaintiffs fifteen days from the date of this Order to replead by way of an amended Complaint to be filed with the Court within fifteen (15) days of the date of this Order. n8$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn8 The Vaccine Defendants allege that there is an issue of whether Plaintiffs have standing to allege their fraud claims here. Pursuant to Section 22(c) of the Vaccine Act, the Vaccine Defendants argue that they have no duty to warn Plaintiffs or the general public of any potential dangers resulting from the administration of the vaccines at issue.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*27 $TFor the same reasons, Plaintiffs have leave to replead their gross negligence and punitive damage claims. The Vaccine Act precludes the imposition of punitive damages on vaccine manufacturers absent a showing of "fraud or intentional and wrongful withholding of information" during the regulatory process or "other criminal or illegal activity relating to the safety and effectiveness of vaccines." $=<$=T4*42_USC_300AA-23 $=L01919000042000300*000300 42 U.S.C. $S 300aa-23$=>(d)(2). Such claims must be pled in accordance with the particularity requirements of O.C.G.A. $S 9-11-9(b). Plaintiffs shall have fifteen (15) days from the date of this Order to file an amended Complaint.$T$=BG. $UThe Parent Plaintiffs' Claims$O$=R$TPlaintiffs argue that even if minor plaintiff's claims are barred, the parent plaintiffs' claims for loss of services, infliction of emotional distress, and medical expenses incurred for minor plaintiff are not subject to the liability limitations of Section 22(b). This argument ignores the plain language of Section 22(b), which expressly extends to $Uany$O "civil action $(against a vaccine manufacturer$) for damages arising from a vaccine-related injury" associated with a vaccine administered$=P1298*28 after October 1, 1988. $USee$O $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(b)(1). Because the parent plaintiffs' claims necessarily arise from minor plaintiff's alleged "vaccine-related injury," they are subject to the liability limitations of Section 22(b)(1) of the Act by its explicit terms. The case relied upon by Plaintiffs, $=<$=T3*1 $=L03737000381000501*000501 $UMoss v. Merck & Co.,$O 381 F.3d 501 (5th Cir. 2004),$=> is inapposite. That case concerned whether the pre-suit administrative exhaustion provisions imposed by Section 11 of the Vaccine Act extended to independent parental claims that could not be presented in Vaccine Court. $=<$=T3*1 $=L03737000381000501*000504 $UId.$O at 504-05.$=> It does not matter, for purposes of applying Section 22, whether or not the parent plaintiffs' claims could or could not have been asserted in administrative compensation proceedings. Therefore, these claims are $=BDISMISSED WITH PREJUDICE.$=R$T$U$=BCONCLUSION$=R$O$TFor the reasons stated above, Defendants Wyeth (f/k/a American Home Products Corporation), SmithKline Beecham Corporation d/b/a GlaxoSmithKline, and GlaxoSmithKline Biologicals s.a.'s Motion for Summary Judgment, or Alternatively, Motion to $=P1298*29 Dismiss or Require Repleading of Allegations is hereby $=BGRANTED IN PART$=R and $=BDENIED IN PART.$=R Plaintiffs' design defect claims are $=BDISMISSED WITH PREJUDICE$=R pursuant to Section 22(b)(1) of the Vaccine Act. Plaintiffs' failure-to-warn claims are hereby $=BDISMISSED WITH PREJUDICE$=R to the extent that they allege a failure to warn Plaintiffs or the general public. The remainder of Plaintiffs' failure-to-warn claims, in addition to their fraud, gross negligence, and punitive damage claims are hereby $=BDISMISSED WITHOUT PREJUDICE$=R with leave to replead. Plaintiffs' breach of warranty claims are $=BDISMISSED WITH PREJUDICE$=R to the extent that they allege that the vaccines at issue were defective solely due to their design. The claims alleged individually by the parent plaintiffs are $=BDISMISSED WITH PREJUDICE$=R pursuant to Section 22(b)(1) of the Vaccine Act. To the extent that Plaintiffs' manufacturing defect claims are based on the inclusion of thimerosal in the vaccines at issue, they are hereby $=BDISMISSED WITH PREJUDICE.$=R As there is no just reason for delay, it is directed that final judgment be immediately entered on the claims herein dismissed with prejudice. The Vaccine$=P1298*30 Defendants' motion for summary judgment on the remainder of Plaintiffs' manufacturing defect claims is $=BDENIED.$=R$T$=BSO ORDERED$=R this 30th day of November, 2005.$T$=BSUSAN B. FORSLING$=R$T$=BJudge, State Court of Fulton County$=R$%$?$%Copies to:$%$?$%Counsel of record$%via LexisNexis File & Serve$%$?$%January 9, 2006$%$?$%Department of Public Safety$%2206 Eastview Parkway$%P.O. Box 80447$%Conyers, Georgia 30013$%$?$%Attention: Ms. Shelly Parker$%$?$%G entlemen:$%$?$%Regal Insurance Company filed suit against Dennis Butler being number 04VS067198 in the State Court of Fulton County. The basis of this lawsuit was an alleged automobile accident occurring on the 23rd day of August, 2002. Road of occurrence 2790 Bankhead Hwy not at its intersection but 50 feet West of Yates Dr, NW, and continuing in the direction checked above the next reference point is Peek Rd NW, Atlanta, Fulton County, Georgia.$%$?$%Defendant Dennis Bulter was served personally a copy of this lawsuit on the 26th day of January, 2004 at 2326 Lindmont Cir. Apt B, Atlanta, Georgia 30324.$%$?$%On the 26th day of July, 2005 judgment was rendered in favor of the plaintiff against defendant for the sum of $ 8,715.00 principal, plus $ 0.00 attorney fees, all $=P1298*31 court cost, and future interest at the legal rate on the judgment. This judgment has not been satisfied of record, and time for appeal has expired.$%$?$%Sincerely,$%$?$%Stefani R. Searcy, Chief Clerk$%State Court of Fulton County$%$?$%SRS/tab$%$?$%Enc.$%$?$%$=BMary A. Miller & Associates$=R$%$=BP.O. Box 1588$=R$%$=BNorcross, GA 30091-1588$=R$200:#170502M0010K8010#$?$?#SID015000000I2J0F#$? #LS060113LEhamielrx#$?#060113PLXC0010040#$?$220:#EXTR#$?#FERRARI-AMERICAN# $00:0100005574:C00FE27F000015C6:<LNI='4MX4-6NY0-0060-D0MT-00000-00' MINREV='00000' ERPT=C00FE27F>$01:$=T1*=SS_#NEW-MAIN# Return to the EXTRA Main Menu$%$?$%**********************************************************$03:$=N1298*13$10:RICHARD JEWELL, Plaintiff, v. COX ENTERPRISES, INC., et al., Defendants,$20:CIVIL ACTION NO. 97 VS 0122804$25:STATE COURT OF FULTON COUNTY, STATE OF GEORGIA$30:$T$=<$=V08576002006000075*1298 2006 Extra LEXIS 75$=>$40:$?$%October 2, 2006, Decided$110:$=P1298*1 The Honorable John R. Mather, Judge State Court of Fulton County.$115:John R. Mather$120:$T$U$=BORDER$=R$O$TThis action came regularly before the Court and was heard on Plaintiff's $IObjection To The Use Of Unauthenticated And Hearsay Evidence In Support Of AJC's Motion For Summary Judgment.$N Both parties were represented by counsel. After oral argument and consideration of the applicable record, the Court hereby issues the following Order:$TIn this motion Plaintiff seeks to exclude portions of the record that are pertinent to the defendant's pending $IMotion For Summary Judgment.$N Specifically, Plaintiff objects to the consideration of the United States Justice Department's OPR Report, n1 printed newspaper articles, and pleadings asserted in another action on grounds of authenticity and hearsay. As the parties contest which has the burden on this issue, the Court begins by observing that the defendant's burden on summary judgment may be carried by demonstrating that the record evidence fails to support an essential element of the plaintiff's theory of recovery. It is only after the defendant has successfully pierced the pleadings that the plaintiff is required to demonstrate that an active question$=P1298*2 of fact remains for trial. Accordingly, as it is the defendant that relies on the OPR Report and other evidence of record to demonstrate the non-existence of a question for trial, it is the defendant's burden as the proponent of the document, upon proper objection, to establish its admissibility.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn1 The full title of the OPR Report is the $ISummary Of The Investigation By The Office Of Professional Responsibility Into The Circumstances Surrounding The Interview Of Richard A Jewell In The Centbom Case.$N This report was prepare d by the U.S. Justice Department and included in the hearing record published by the Senate Judiciary Committee.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$T$=B$I1. The OPR Report$N$=R$TAs discussed in previous Orders of this Court, the OPR report contains a conference call summary which relates a conversation between unnamed PBAU n2 agents. According to the report: "Mr. Jewell was also discussed, and it was mentioned that the PBAU agents who had reviewed the televised interviews concurred with Atlanta's assessment that Jewell fit the profile$=P1298*3 of a person who might create an incident so he could emerge as a hero." (OPR Report at page 11).$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn2 PBAU are the initials for the Profiling and Behavioral Assessment Unit of the FBI.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$TThis passage proved significant to this Court's previous ruling on Plaintiff's $IMotion To Compel.$N In denying Plaintiff's motion to compel the confidential source for the report that "investigators believe that Jewell fit the profile of the lone bomber," this Court relied on the OPR report as foreclosing the issue of substantial falsity. Plaintiff now squarely challenges the admission of the report for purposes of summary judgment raising grounds of authenticity and hearsay.$T$=B$Ia. Authentication$N$=R$TIn attempting to establish the authenticity of the OPR report, Defendant's raises three arguments: (1) That Plaintiff waived the issue of authenticity by relying repeatedly on the same official report in this litigation; (2) That Plaintiff waived the issue of authenticity by failing to object to the report before this Court's prior ruling$=P1298*4 on confidential sources; and (3) that the OPR is a self-authenticating federal publication.$TAs evidence of waiver, Defendant refers to Plaintiff's citation to the report in a footnote of their supplemental brief in opposition to Defendant's $IMotion For Summary Judgment.$N In footnote 24, Plaintiff refers to the report as evidence that the Special Agent in Charge knew of the brief time period that elapsed between the bombing and the placing of the 911 call. References to the OPR report also appear in Plaintiff's $IStatement Of Material Facts.$N$THowever, Defendant's authorities for finding a waiver arise in dissimilar contexts. In $=<$=T3*1 $=L00466000203000740*000740 $UPenaranda v. State,$O 203 Ga. App. 740 (1992),$=> the Court found a waiver where the defendant made first use of an unauthenticated tape on cross-examination, and called for its admission, then raised the lack of foundation on appeal. The second case cited by the Defendant, $=<$=T3*1 $=L00465000278000779*000779 $UCody v. State,$O 278 Ga. 779 (2004),$=> stands for the proposition that the failure to object to testimony until after the hearing will result in a waiver. As the present facts do not approach either case cited, the Court declines to $=P1298*5 find a waiver here.$TIn contending that the OPR is a self-authenticating federal publication, the Defendant relies on language from $=<$=T3*1 $=L00466000178000748*000748 $URice v. State,$O 178 Ga. App. 748 (1986),$=> in which it was recognized that substantial compliance with federal statutory requirements is the equivalent of satisfying state common law authenticity requirements. Defendant contends that the OPR report specifically complies with Federal Rule Of Civil Procedure 44 and is therefore authenticated for purposes of Georgi a evidence law. Defendant also cites $UUS v. Aluminum Co. of America,$O 1, F.R.D. 71 (S.D.N.Y. 1939) which referenced Rule 44 and held "that the authenticity of an official document is sufficiently established when a copy of it is offered which purports to have been printed by authority of the Government." In relevant part, the current version of Rule 44 provides:$=S$%$?$%Authentication.$%(1) $IDomestic.$N An official record kept within the United States, or any state, district, or commonwealth, or within a territory subject to the administrative or judicial jurisdiction of the United States, or an entry therein, when admissible for any purpose, may be evidenced by an official$=P1298*6 publication thereof....$=I$TAs it is undisputed that the OPR report submitted by the Defendant is part of an official publication, the Court finds that authenticity has been satisfied pursuant to $=<$=T3*1 $=L00466000178000748*000748 $URice v. State,$O 178 Ga. App. 748 (1986)$=> and Rule 44 of the Federal Rules Of Civil Procedure. The Court now turns to the more thorny issue of hearsay.$T$=B$Ib. Hearsay$N$=R$TWhile the Defendant has, in this context of countering a hearsay objection, again urged this Court to find a waiver in Plaintiff's use of the OPR report for his own purposes, Georgia law clearly holds that hearsay evidence is without probative value- even when the matter is admitted without objection. $=<$=T3*1 $=L00466000181000872*000872 $UJeweler's Financial Svcs. v. Chapes, Ltd.,$O 181 Ga. App. 872,$=> (1987). As hearsay evidence does not become admissible by waiver, the report must satisfy a hearsay objection. $=<$=T3*1 $=L00466000227000585*000585 $UHagan v. Goody's Family Clothing,$O 227 Ga. App. 585 (1997).$=>$TThe hearsay exception contended by the Defendant to be applicable is the doctrine of necessity recognized in O.C.G.A. $S 24-3-1(b). n3 In order to demonstrate necessity under this exception, three prongs must be$=P1298*7 satisfied:$=S$%$?$%....the declarant must be unavailable, there must be particular guarantees of trustworthiness, and the statement must be shown to be relevant to a material fact and more probative of that material fact than other evidence that might be procured and offered. $I$=<$=T3*2 $=L00465000270000151*000155 $=L01811000510000802*000802 $UChapel v. State,$O$N$U 270 Ga. 151, 155 (4) (510 S.E.2d 802) (1998).$=>$O "The court must consider the totality of the circumstances that surround the making of the statement to determine its reliability. 'The test is whether "the declarant's truthfulness is so clear from the surrounding circumstances that the test of cross-examination would be of marginal utility.'"" $I$=<$=T3*2 $=L00465000275000550*000553 $=L01811000570000269*000269 $UYancey v. State,$O$N$U 275 Ga. 550, 553 (2) (a) (570 S.E.2d 269) (2002).$=>$O$=I$%$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn3 "(b) Hearsay evidence is admitted only in specified cases from necessity."$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$THere, the first prong of unavailability is satisfied because the Justice Department has invoked federal privilege in opposition to discovery requests. $=P1298*8 $TAs to the second requirement of trustworthiness, the evidence should provide some level "detail or flavor of the declarations to determine if they meet the high standard of being a "circumstantial guaranty of trustworthiness" or "something the law considers the substitute for the oath of the declarant and his cross examination." $=<$=T3*1 $=L00466000257000 389*000389 $UTorstenson v. Doe,$O 257 Ga. App. 389 (2002)$=> Hearsay must be necessary and must be accompanied by particular guarantees of trustworthiness in order to be admissible under the necessity exception. $UO.C.G.A. $S 24-3-1 (b); $=<$=T3*2 $=L00465000270000151*000154 $=L01811000510000802*000802 Chapel v. State, 270 Ga. 151, 154-156(4) (510 S.E.2d 802) (1998).$=>$O A trial court should view the proffered hearsay within the totality of the circumstances of its origin, and, because the "factors that speak to the reliability of hearsay statements will vary depending on the nature of the statements," the determination of trustworthiness is inescapably subjective. $=<$=T3*2 $=L00465000270000151*000155 $=L01811000510000802*000802 $UId. at 155.$=> $=<$=T3*1 $=L00465000272000704*000704 Gissendaner v. State,$O 272 Ga. 704 (2000).$=>$TThe following non-exclusive factors are probative in assessing reliability: (1) consistency$=P1298*9 of the statements; (2) lack of a motive to fabricate; (3) the nature of the statements; (4) the relationship between the declarant and the accused; and (5) whether the statement was based upon a faulty recollection or observation. $=<$=T3*2 $=L00465000270000151*000151 $=L01811000510000802*000802 $UChapel v. State,$O 270 Ga. 151 (1998).$=>$THere, Defendant relies on the argument that because the report was prepared by the Justice Department it is lent "compelling guarantees of reliability." In passing upon this argument, the Court observes that the passage in issue actually contains several layers of potential hearsay. Not only does the segment purport to describe a conference call, it also characterizes the opinion of two unnamed agents who were apparently not in attendance - who then concur with an "Atlanta assessment" that Plaintiff fit a profile.$THowever, it is also significant that the report was submitted under oath by the Director of the FBI, Louis Freeh, and the Director of OPR of the Justice Department, Michael Shaheen, and was submitted to become part of the congressional record. The FBI agents, while unnamed, have no interest in this litigation and no apparent motive to fabricate. The statement that$=P1298*10 the PBAU agents concurred with the assessment of the Atlanta office that Plaintiff fit a profile only provides an appraisal in furtherance of their investigation of the bombing. While considerations of trustworthiness usually begin with knowing at least the identity of the declarant, the Court finds that the context in which the statements appear in the record confer a sufficient measure of reliability.$THaving found admissible the statement that PBAU agents concur with the assessment that Plaintiff fit a profile, it is unnecessary to determine if the "Atlanta assessment," at the next level of hearsay, is also admissible under the necessity doctrine. The concurrence of the PBAU agents equates to the existence of a profile that is applicable to the plaintiff.$TUnder the last prong of the necessity exception: "the statement must be shown to be relevant to a material fact and more probative of that material fact than other evidence that might be procured and offered." As other probative FBI witnesses have been prevented from testifying by the invocation of privilege, the Court finds the last prong satisfied.$T$=B$III. Newspaper Articles And Television Transcripts$N$=R$TIn moving to exclude, $=P1298*11 Plaintiff has made only a broadside objection to admission of all articles and television transcripts. As the Defendant correctly points out, a general hearsay objection to the evidence as a whole is insufficient if any portion of it is admissible. $=<$=T3*1 $=L00465000273000818*000818 $UGivens v. State,$O 273 Ga. 818 (2001).$=>$THere, at least some of the published articles are outside the definition of hearsay since they are not offered for the truth of the matter asserted. Evidence is non-hearsay when offered only "as proof that such a statement was made." See $=<$=T3*1 $=L00466000184000558*000558 $UWalker v. State,$O 184 Ga. App. 558 (1987).$=> Further, authenticity becomes an issue under O.C.G.A. $S 24-7-1 only when the contents are disputed. See $=<$=T3*1 $=L00465000238000081*000081 $USpringer v. State,$O 238 Ga. 81 (1976);$=> $=<$=T3*1 $=L00466000184000558*000558 $UWalker v. State,$O 184 Ga. App. 558 (1987).$=> As Plaintiff has not disputed the contents, the Court declines to exclude the articles from consideration.$T$=B$IIII. Pleadings filed in Barbara Jewell v. United States$N$=R$THere, Plaintiff objects generally on grounds of authenticity and hearsay to the admission of pleadings filed in an action brought by his mother against the$=P1298*12 United States. Particularly, Plaintiff seeks to exclude the Answer filed by the government in which it was admitted that a "personality assessment" of Plaintiff was prepared by the FBI and provided to the Atlanta Division of the FBI.$TPretermitting whether the statement regarding the personality assessment was actually an admission, admissions in properly certified pleadings operate as evidentiary admissions which may be explained when introduced in a different action. See $=<$=T3*1 $=L00466000157000554*000554 $UFoster v. State,$O 157 Ga. App. 554 (1981);$=> $=<$=T3*1 $=L00466000224000348*000348 $UKhamis Enterprises, Inc. v. Boone,$O 224 Ga. App. 348 (1997).$=> As Plaintiff's objections have not addressed the potential admission of the pleadings as an admission, the Court declines, at this time, to exclude the pleadings from consideration. n4$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn4 It should be noted that, for purposes of ruling on the existence of a profile, the Court did not explicitly rely on the government's Answer in summary judgment Order. See footnote 4 in summary judgment Order.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*13 $T$=B$IIV. FBI files$N$=R$THere, Plaintiff again makes generalized, one paragraph, objections on authenticity and hearsay grounds. As Plaintiff has not demonstrated that the authenticity of the documents are "in issue," See $=<$=T3*1 $=L00465000238000081*000081 $USpringer v. State,$O 238 Ga. 81 (1976);$=> $=<$=T3*1 $=L00466000184000558*000558 $UWalker v. State,$O 184 Ga. App. 558 (1987),$=> and as it appears that at least some documents may be admitted as non-hearsay, Plaintiff's motion is DENIED.$T$=BSO ORDERED$=R this the 2nd day of October 2006.$TThe Honorable John R. Mather$TJudge State Court of Fulton County$200:#170502M0010K8010#$?$?#SID015000000JOLKB#$? #LS070126LEtysoncm#$?#070126PLXC0010021#$?$220:#EXTR# #JEWELL-COX#                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         $00:0100005451:BE3503000000154B:<LNI='4J1J-DTV0-0060-D0GV-00000-00' MINREV='00000' ERPT=BE350300>$01:$=T1*=SS_#NEW-MAIN# Return to the EXTRA Main Menu.$%$?$%**********************************************************$03:$=N1298*31$10:MARCELO A. FERRARI and CAROLYN H. FERRARI, Individually and as Parents and Next Friend of STEFAN R. FERRARI, Plaintiffs, v. AMERICAN HOME PRODUCTS CORP. d/b/a WYETH; WYETH LABORATORIES; WYETH-AYERST; WYETH-AYERST LABORATORIES; WYETH LEDERLE; WYETHER LEDERLE; WYETHER LEDERLE VACCINES and LEDERLE LABORATORIES; ORTHO-CLINICAL DIAGNOSTICS, INC.; SMITHKLINE BEECHAM CORPORATION; GEORGIA POWER COMPANY; and JOHN DOES 1-20 who are individuals, proprietorships, corporations or other entities whose names and identities are otherwise unknown to the plaintiffs, Defendants.$20:CIVIL ACTION FILE NO. 02 VS 031404-F$25:STATE OF GEORGIA, FULTON COUNTY$30:$T$=<$=V08576002005000183*1298 2005 Extra LEXIS 183$=>$40:$?$%November 30, 2005, Decided$110:$=P1298*1 SUSAN B. FORSLING, Judge.$115:SUSAN B. FORSLING$120:$T$U$=BORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS WYETH, SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE, AND GLAXOSMITHKLINE BIOLOGICALS S.A.'S MOTION FOR SUMMARY JUDGMENT, OR ALTERNATIVELY, MOTION TO DISMISS OR REQUIRE REPLEADING OF ALLEGATIONS$=R$O$TPlaintiffs allege in this product liability action that the minor plaintiff suffers from a neurological condition that was caused, in part, by exposure to FDA-approved vaccines containing the preservative thimerosal. Before the Court is a Motion for Summary Judgment, or Alternatively, Motion to Dismiss or Require Repleading of Allegations filed by Defendants WYETH (f/k/a AMERICAN HOME PRODUCTS CORPORATION), SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE and GLAXOSMITHKLINE BIOLOGICALS S.A. (collectively the "Vaccine Defendants"). The Vaccine Defendants argue that the Court should grant summary judgment because the National Childhood Vaccine Injury Compensation Act, $=<$=T4*42_USC_300AA-1 $=L01919000042000300*000300 42 U.S.C. $S 300aa-1$=> $Uet seq.$O ($Uhereinafter$O the "Vaccine Act"), pre-empts all of Plaintiffs' claims. The Vaccine Defendants assert that all of Plaintiffs' claims, including$=P1298*2 failure to warn, are pre-empted by Section 22(b) of the Vaccine Act because the claims are all based on a singular design defect allegation, $Ui.e.,$O that the FDA-approved vaccines at issue should not have contained the preservative thimerosal. The Vaccine Defendants also contend that Section 22(c) of the Vaccine Act bars Plaintiffs' claims for failure to warn Plaintiffs and the general public. The Vaccine Defendants additionally seek dismissal of Plaintiffs' fraud-based allegations pursuant to O.C.G.A. $Z 9-11-9(b) and 9-11-12 for failure to plead such allegations with particularity.$TIn support of their Motion, the Vaccine Defendants filed a memorandum, a statement of material facts and theories of recovery, the affidavit of Karen Raby Monson with attached exhibits A-H, and a reply memorandum in further support of their Motion. Plaintiffs filed a brief in opposition to the Motion and a response to the Vaccine Defendants' statement of material facts and theories of recovery. The Court has reviewed the papers submitted by each party, and on July 8, 2005, the Court heard oral argument on the Motion from counsel. At the conclusion of the argument, the Court ruled on the Vaccine Defendants' $=P1298*3 Motion. This Order reflects that ruling and the Court's supporting reasons. For the reasons that follow, the Vaccine Defendants' Motion for Summary Judgment, or Alternatively, Motion to Dismiss or Require Repleading of Allegations is hereby $=BGRANTED IN PART$=R and $=BDENIED IN PART.$=R$T$U$=BBACKGROUND$=R$O$TOn or about April 15, 2002, plaintiffs Marcelo and Carolyn Ferrari, individually and on behalf of the minor plaintiff, Stefan R. Ferrari, commenced the instant proceeding by filing a complaint alleging that the minor plaintiff allegedly suffers from a neurological condition, which Plaintiffs claim was caused by exposure to FDA-approved vaccines containing the preservative thimerosal. Plaintiffs asserted claims under Georgia law for strict tort liability, negligence, fraud and deceit, negligent misrepresentation, and breach of warranty. Plaintiffs also sought punitive damages based upon assertions of gross negligence.$TThis Court dismissed without prejudice the claims of the minor plaintiff on January 6, 2003. On February 20, 2003, all discovery in this case was stayed until further order of the Court. On October 15, 2003, this Court dismissed without prejudice the claims alleged by the$=P1298*4 parent plaintiffs (other than their separate state law claims for loss of services and emotional distress). The dismissals afforded Plaintiffs the opportunity to file a petition in Vaccine Court. In October 2004, Plaintiffs, having filed a Vaccine Court petition, elected to terminate their proceeding in that forum and filed a Second Amended Complaint on October 25, 2004, asserting that they had "complied with all prerequisites under the National Vaccine Injury Compensation Act." The Court lifted the stay of proceedings on April 20, 2005.$TThe Vaccine Defendants filed the motion for summary judgment that is the subject of this Order on May 27, 2005, and filed a corrected Motion on May 31, 2005. n1 Plaintiffs filed their brief in opposition on July 1, 2005, and the Vaccine Defendants filed a reply memorandum in further support of their Motion on July 7, 2005.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn1 GlaxoSmithKline Biologicals s.a. ("Biologicals") did not appear in this action until it filed an answer with this Court on July 7, 2005. At that time, Biologicals also filed a notice of joinder in the Vaccine Defendants' Motion.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*5 $T$U$=BDISCUSSION$=R$O$T$=BA. $UThe Vaccine Act$O$=R$TChildhood vaccines play a central role in national health policy, and the Vaccine Act, which covers Plaintiffs' claims here, is integral to that policy. In 1986, the United States Congress passed the Vaccine Act, and created "a new system for compensating individuals who have been injured by vaccines routinely administered to children." H.R. Rep. 99-908, 99th Cong., 2d Sess. (1986), at 3, $Ureprinted in$O 1986 U.S.C.C.A.N. 6344, 6344. The Vaccine Act's legislative history documents the concerns that spurred enactment of the law. It notes the inability of the tort system to predictably and properly deal with claims on behalf of children alleging vaccine-related injuries, and that costly litigation without predictable results created an incentive for vaccine manufacturers to withdraw from making childhood vaccines critical to public health. $USee id.$O at 6344-48; $Usee also $=<$=T3*1 $=L00440000844001108*001116 Abbot v. American Cyanamid Co.,$O 844 F.2d 1108, 1116-17 (4th Cir. 1988)$=> (Wilkins, J., concurring) ("As a . . . consequence of the increase in litigation, . . . manufacturers are reconsidering their future role in the vaccine market. . . . $=P1298*6 The withdrawal of any  manufacturer from the market poses a serious threat to public health, in the form of vaccine shortages with resulting decreased immunization and a possible resurgence of these diseases.").$TThe Vaccine Act reflects two specific policy goals of Congress. First, the federal legislative scheme aimed to simplify the procedure and the substantive rules of law applicable to vaccine-related injury claims, and so make it easier for injured parties to obtain compensation. To implement this policy, Congress established a special court ("Vaccine Court") as part of the United States Court of Federal Claims to adjudicate claims of "vaccine-related injury" n2 and to award compensation to injured individuals. $USee $=<$=T3*1 $=L01917000514000268*000269 Shalala v. Whitecotton,$O 514 U.S. 268, 269 (1995)$=> ("For injuries and deaths traceable to vaccinations, the $(Vaccine$) Act establishes a scheme of recovery designed to work faster and with greater ease than the civil tort system."). A claimant may recover by proving an injury plus causation. Proof that the vaccine at issue was negligently manufactured, defectively designed, or inadequately labeled is not required to obtain compensation on $=P1298*7 any Vaccine Court petition. $USee$O $=<$=T4*42_USC_300AA-11 $=L01919000042000300*000300 42 U.S.C. $Z 300aa-11$=>(c)(1); 300aa-13(a)(1). Approximately 4,500 petitions seeking compensation based on allegations that thimerosal-containing vaccines and/or the Measles-Mumps-Rubella ("MMR") vaccine caused autism or autism spectrum disorder are currently pending before the Vaccine Court. $USee In re Claims For Vaccine Injuries Resulting In Autism Spectrum Disorder Or A Similar Neurodevelopmental Disorder,$O Autism Master File -- Autism Update (Ct. Fed. Cl. June 27, 2005) (Hastings, S.M.).$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn2 "Vaccine-related injury" "means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine." $=<$=T4*42_USC_300AA-33 $=L01919000042000300*000300 42 U.S.C. $S 300aa-33$=>(5). It includes claims alleging injury from thimerosal contained in FDA-approved vaccines. $USee, e.g., $=<$=T3*1 $=L04830000267000667*000673 Blackmon v. Am. Home Prods. Corp.,$O 267 F. Supp. 2d 667, 673-75 (S.D. Tex. 2002);$=> $ULeroy v. Sec'y of HHS,$O No. 02-392$=<$=T3*1 $=L04538002002730680*730680 V, 2002 WL 31730680,$=> at *17 (Fed. Cl. Oct. 11, 2002); $=<$=T3*1 $=L00180000851000908*000911 $UAshton v. Aventis Pasteur, Inc.,$O 851 A.2d 908, 911-13 (Pa. Super. Ct. 2004).$=>$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*8 $TSecond, Congress intended to protect the supply of childhood vaccines in the United States by protecting vaccine manufacturers from the burden of costly litigation with unpredictable outcomes. The Vaccine Act protects vaccine manufacturers from costly civil litigation by: (i) barring civil actions such as this arising from vaccine-related injuries unless the claim was first presented in the Vaccine Court and the remedy exhausted n3; (ii) immunizing vaccine manufacturers from liability for alleged vaccine-related injuries caused by vaccines that were properly prepared and accompanied by proper directions and warnings; and (iii) establishing legal presumptions as to the adequacy of vaccine warnings and against the imposition of puni tive damages except in cases involving substantial wrongdoing. $USee$O $=<$=T4*42_USC_300AA-11 $=L01919000042000300*000300 42 U.S.C. $Z 300aa-11;$=> 300aa-22; 300aa-23(d); $Usee also$O 1986 U.S.C.C.A.N. at 6367. In addition to requiring that any vaccine-related injury claim be first presented in Vaccine Court, the Vaccine Act sets substantive and procedural rules that control the conduct of every civil action on claims of injury arising from post-October 1, 1988 vaccine$=P1298*9 administrations. Those limitations bar certain claims -- including certain of the claims Plaintiffs assert in their Complaint -- from being litigated in any civil action.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn3 Congress expected that a significant number of claims would be resolved in the Vaccine Court forum under the Vaccine Act's provisions for generous compensation. $USee$O 1986 U.S.C.C.A.N. at 6354.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$T$=BB. $UThe Vaccine Act's Express Pre-emption Of State Products Liability Law$O$=R$TThe Vaccine Defendants argue that Section 22 of the Vaccine Act pre-empts all state law design defect claims arising from vaccine-related injuries. Plaintiffs contend that the Vaccine Act merely supplements state products liability law, rather than displacing it. For the reasons set forth, the Court concludes that the Vaccine Act pre-empts all claims based on a theory of design defect.$TFederal law may pre-empt state law in three ways:$=S$%$?$%First, in enacting the federal law, Congress may explicitly define the extent to which it intends to preempt state law. (Citation omitted.) $=P1298*10 Second, even in the absence of express pre-emptive language, Congress may indicate an intent to occupy an entire field of regulation, in which case the states must leave all regulatory activity in that area to the Federal Government. (Citations omitted.) Finally, if Congress has not displaced state regulation entirely, it may nonetheless pre-empt state law to the extent that the state law actually conflicts with federal law.$=I$%$?$%$=<$=T3*1 $=L01917000467000461*000469 $UMich. Canners & Freezers Ass'n, Inc. v. Agric. Mktg. & Bargaining Bd.,$O 467 U.S. 461, 469 (1984).$=>$TSection 22 of the Vaccine Act is an example of express pre-emption, as indicated by Section 22(a), which states that: "Except as provided in subsections $(22$)(b), $(22$)(c), and $(22$)(e) of this section State law shall apply to a civil action brought for damages for a vaccine-related injury or death." $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(a).$TSection 22(b)(1) of the Vaccine Act states:$=S$%$?$%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 $=P1298*11 side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.$=I$%$?$%$=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(b)(1). That section states the express limitation on civil actions against vaccine manufacturers: it bars all civil actions arising from a vaccine-related injury if the injury could not have been avoided by proper preparation or proper labeling of the vaccine.$TThe cases Plaintiffs cite for the proposition that the Vaccine Act does not pre-empt state tort law are inapposite. The claims in those cases arose b efore the effective date of the Vaccine Act and concern vaccinations administered before October 1, 1988. The issue in those cases was whether state law claims had been impliedly pre-empted by federal law. Thus, the cases do not address whether Section 22 of the Vaccine Act expressly pre-empts design defect claims. $USee $=<$=T3*1 $=L00438000742000239*000246 Mazur v. Merck & Co., Inc.,$O 742 F. Supp. 239, 246-47 (E.D. Pa. 1990);$=> $=<$=T3*1 $=L00440000844001108*001113 $UAbbot v. American Cyanamid Co.,$O 844 F.2d 1108, 1113-14 (4th Cir. 1988);$=> $=<$=T3*1 $=L00440000863001173*001178 $UHurley v. Lederle Labs. Div. of American Cyanamid Co.,$O 863 F.2d 1173, 1178 (5th Cir. 1989).$=>$=P1298*12 $T$=BC. $UPlaintiffs' Design Defect Claims$O$=R$TWith regard to Plaintiffs' design defect claims, the only issue before the Court is the extent of the pre-emptive effect of Section 22(b) of the Vaccine Act. Plaintiffs contend that Section 22(b)(1) simply codifies Comment k of Section 402A of the Restatement (Second) of Torts and directs states to determine under their tort law whether an alleged vaccine-related injury or death resulted from side effects that were unavoidable under any circumstances, including design standards that might be imposed by state tort law. Plaintiffs maintain that the Vaccine Act only bars their design defect claims here if the Court determines under Georgia products liability law that the side effects of the vaccines at issue are unavoidable.$TPlaintiffs construe the statute as if it ended with the words "side effects that were unavoidable." The statute continues, however, that vaccine manufacturers are not subject to civil liability where the alleged "injury or death resulted from side effects that were $Uunavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.$O" $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>$=P1298*13 (b)(1) (emphasis added). Plaintiffs' interpretation therefore does not account for all elements of the statute. $USee $=<$=T3*2 $=L00465000264000744*000747 $=L01811000452000476*000479 Gilbert v. Richardson,$O 264 Ga. 744, 747-48, 452 S.E.2d 476, 479 (1994)$=> ("It is a basic rule of construction that a statute . . . should be construed 'to make all its parts harmonize and to give a sensible and intelligent effect to each part.'" (citation omitted)). By its express terms, the statute immunizes vaccine manufacturers from liability for side effects that inevitably occur even though a vaccine is properly prepared in every respect according to its approved design specifications and is properly labeled. Thus, a manufacturer that properly prepares and labels a vaccine in accordance with the applicable federal law is immune from civil liability for side effects that nonetheless occur, even if, theoretically, an alternatively-designed vaccine might have prevented the alleged injury.$TTo date, two other cases have addressed the pre-emptive impact of the Vaccine Act on claims arising from vaccine-related injuries attributed to FDA-approved pediatric vaccines, $UBlackmon v. American Home Products Corp.$O and $UMilitrano $O $=P1298*14 $Uv. Lederle Laboratories.$O This Court's interpretation of Section 22 is in accord with the holdings of both $UBlackmon$O and $UMilitrano. See $=<$=T3*1 $=L04830000328000659*000663 Blackmon v. American Home Prods. Corp.,$O 328 F. Supp. 2d 659, 663-66 (S.D. Tex. 2004)$=> (holding that Section 22(b) forecloses all design defect claims against vaccine manufacturers); $=<$=T3*1 $=L01586000769000839*000845  $UMilitrano v. Lederle Labs.,$O 769 N.Y.S.2d 839, 845 (Sup. Ct. Kings Co. 2003)$=> (holding that Section 22(b) bars all design defect claims because "Congress did not intend that national vaccine policy be determined by the vagaries of a jury's determination on a case-by-case basis").$TPlaintiffs contend that the Georgia Court of Appeals in $UBryant v. Hoffman-LaRoche, Inc.$O has already decided that federal law does not pre-empt civil actions alleging injury caused by defectively designed prescription drugs, including vaccines. $UBryant,$O however, did not mention, much less interpret, the Vaccine Act, and thus could not have decided whether the Vaccine Act bars design defect claims arising out of a $Uvaccine-related injury. See $=<$=T3*2 $=L00466000262000401*000401 $=L01811000585000723*000723 Bryant v. Hoffman-LaRoche, Inc.,$O 262 Ga. App. 401, 585 S.E.2d 723 (2003).$=>$=P1298*15 Indeed, $UBryant$O involved the heart medication Posicor, not a pediatric vaccine. $USee $=<$=T3*2 $=L00466000262000401*000401 $=L01811000585000723*000725 id.$O at 401, 585 S.E.2d at 725.$=> $UBryant$O held that Georgia courts should determine whether a prescription drug is "unavoidably unsafe" under Comment k of Section 402A of the Restatement (Second) of Torts on a case-by-case basis. $USee $=<$=T3*2 $=L00466000262000401*000406 $=L01811000585000723*000723 id.$O at 406;$=> $=<$=T3*2 $=L00466000262000401*000401 $=L01811000585000723*000728 585 S.E.2d at 728.$=>$TWhile Congress clearly looked to the principles contained in Comment k of Section 402A of the Restatement (Second) of Torts when drafting Section 22(b) of the Vaccine Act, Congress did not codify the exact language of Comment k or adopt the interpretation some Georgia courts have given to Comment k. n4 $UCompare$O Restatement (Second) of Torts $S 402A cmt. k (2002) (stating, with respect to a vaccine, that "such an $(unavoidably unsafe$) product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous") $Uwith$O $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(b)(1) (providing that "no vaccine manufacturer shall be liable" for alleged$=P1298*16 "injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."). Nor did Congress leave vaccine design standards open to reexamination under the laws of each state, with the potential for interstate conflict: the Vaccine Act sets one rule, applicable nationwide, that pre-empts design defect claims.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn4 Comment k and Section 22(b)(1) differ in two notable aspects. First, Comment k refers to "unavoidably unsafe" products, while Section 22(b)(1) does not use that term. Second, while Comment k's language is directed to strict liability claims, Section 22(b)'s plain language is all-encompassing, including claims grounded in negligence, as well as those based on strict liability. Section 22(b)(1)'s statement that "no manufacturer shall be liable in a civil action for damages" plainly bars all claims based on the alleged design defect, whether characterized as negligence, strict liability, or by any other legal label. $USee $=<$=T3*1 $=L04830000328000659*000665 Blackmon,$O 328 F. Supp. 2d at 665-66.$=>$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*17 $TCongress intended that "the principle in Comment K regarding 'unavoidably unsafe' product s, $Ui.e.,$O those products which in the present state of human skill and knowledge cannot be made safe, apply to the vaccines covered in the $(Act$) and $Uthat such products not be the subject of liability in the tort system.$O" 1986 U.S.C.C.A.N. at 6367 (emphasis added). Thus, the view of Comment k that Congress adopted when it enacted Section 22(b) immunizes manufacturers of "properly prepared" products that are "accompanied by proper directions and warnings" from all design defect claims. That statutory standard, not the common law case-by-case approach advocated by certain Georgia courts, governs the Court's analysis here. $USee $=<$=T3*1 $=L01586000769000839*000845 Militrano,$O 769 N.Y.S.2d at 845$=> (stating that "the language in the House Committee report supports the conclusion that Congress intended to view Comment k and the $(Vaccine$) Act as immunizing vaccines from liability for design defects.").$TThe legislative history of Section 22 that is contemporaneous with that 1986 enactment confirms Congress's intention as expressed in Section 22(b):$=S$%$?$%Given the existence of the compensation system in $(the$=P1298*18 Vaccine Act$), the Committee strongly believes that Comment k is appropriate and necessary as the policy for civil actions seeking damages in tort. Vaccine-injured persons will now have an appealing alternative to the tort system. $UAccordingly, 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.$O$=I$%$?$%H.R. Rep. No. 99-908, 99th Cong., 2d Sess. (1986), at 4, $Ureprinted in$O 1986 U.S.C.C.A.N. 6344, 6367 (emphasis added); $Usee also $=<$=T3*1 $=L04830000328000659*000665 Blackmon,$O 328 F. Supp. 2d at 665$=> (finding that the relevant legislative history "rather clearly" indicates that the Act bars design defect claims). n5$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn5 Plaintiffs rely on statements from a subcommittee report from 1987, the year after enactment of the Vaccine Act, as evidence of Congress's intent, in 1986, in adopting the Act. $USee$O H. R. Rep. 100-391(I), at 691, reported in 1987 U.S.C.C.A.N. at 2313-365. The Court concludes that the 1987 statements are not entitled to any weight. Post-enactment statements are not reliable indicators of earlier congressional intent, particularly where, as here, they do not relate to any legislation passed at the time that the statements are made. $USee, e.g., $=<$=T3*1 $=L01917000596000633*000650 Pension Benefit Guar. v. LTV Corp.,$O 596 U.S. 633, 650 (1990)$=> ("Subsequent legislative history is a 'hazardous basis for inferring the intent of an earlier' Congress"); $Usee also $=<$=T3*1 $=L00440000803000613*000616 Ewing & Thomas, P.A. v. Heye,$O 803 F.2d 613, 616 (11th Cir. 1986).$=> The 1987 statements, as interpreted by Plaintiffs, directly contradict the 1986 legislative history of Section 22 cited above, which explicitly rejects Plaintiffs' argument that Section 22(b)(1) permits design defect claims. Furthermore, the statements do not assist the Court in construing Section 22(b)(1) because the statements do not track the language of Section 22(b)(1), referring instead to "unavoidably unsafe" vaccines.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*19 $TThe intent to establish one national standard for vaccine design and to remove that from the purview of state tort law  is further demonstrated by the Vaccine Act's specific delegation of questions of vaccine safety to the Secretary of Health and Human Services. $USee$O $=<$=T4*42_USC_300AA-27 $=L01919000042000300*000300 42 U.S.C. $S 300aa-27;$=> $Usee also$O $=<$=T4*42_USC_300AA-2 $=L01919000042000300*000300 42 U.S.C. $S 300aa-2$=>(a)(2) (directing HHS to coordinate and direct programs to develop safe and effective vaccines). n6 Section 27 mandates that HHS "promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 27, 1987, and promote the refinement of such vaccines." $UId.$O $S 300aa-27(a)(1). It further directs the Secretary to "make or assure improvements in . . . the licensing, manufacturing, processing, testing, labeling, warning, . . . and research on vaccines, in order to reduce the risks of adverse reactions to vaccines." $UId.$O $S 300aa-27(a)(2). Section 27 also directs HHS to "establish a task force on safer childhood vaccines," consisting of "the Director of the National Institutes of Health, the Commissioner $=P1298*20 of the Food and Drug Administration, and the Director of the Centers for Disease Control," which is to consult with the Advisory Commission on Childhood Vaccines to make recommendations to increase vaccine safety and efficacy. $UId.$O $S 300aa-27(b).$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn6 $USee also$O $=<$=T4*42_USC_300AA-1 $=L01919000042000300*000300 42 U.S.C. $S 300aa-1$=> ("The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines."); $UId.$O $S 300aa-5 (establishing the National Vaccine Advisory Committee, which, $Uinter alia,$O studies and recommends "ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States); $UId.$O $S 300aa-19 (establishing the Advisory Commission on Childhood Vaccines to, $Uinter alia,$O "advise the Secretary in implementing the Secretary's responsibilities under section 300aa-27 of this title regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions.").$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*21 $TThe FDA's authority to determine the uniform national design for childhood vaccines would be undermined if these Plaintiffs were allowed to challenge vaccine design under Georgia law (or under any state's law). Section 22(b) is properly read to foreclose all design defect claims against vaccine manufacturers in order to prevent plaintiffs from mounting such a collateral attack on FDA decisions through the tort system.$TAccordingly, this Court enters summary judgment dismissing all of Plaintiffs' design defect claims. The dismissal of Plaintiffs' design defect claims is not limited to Plaintiffs' strict liability design defect and negligent design claims. Plaintiffs' failure to warn, fraud, gross negligence, and breach of warranty claims are also barred by Section 22(b)(1) to the extent that those claims are based solely on the inclusion of thimerosal in the design of the vaccines at issue.$T$=BD. $UPlaintiffs' Failure-To-Warn Claims$O$=R$TThe Vaccine Defendants argue that Section 22(c) of the Vaccine Act explicitly forecloses Plaintiffs' claims based on a duty to provide direct warnings to Plaintiffs and the  general public. Section 22(c) provides that:$=S$%$?$%No vaccine manufacturer shall$=P1298*22 be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.$=I$%$?$%$=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(c). To the extent that Plaintiffs' failure-to-warn claims are based on allegations that the Vaccine Defendants failed to warn Plaintiffs or the public generally, they are hereby dismissed.$TThe Vaccine Defendants further argue that all of Plaintiffs' failure-to-warn claims restate their design defect claims. Plaintiffs' Complaint alleges that thimerosal is a "powerful and dangerous neurotoxin poison." Compl. P9. The Vaccine Defendants contend that Plaintiffs' theory is no warning could have made safe any universally-administered childhood vaccine containing what is alleged to be a "dangerous neurotoxin poison."$TIn order for Plaintiffs to allege a valid failure-to-warn claim, they must assert that the vaccines at issue could$=P1298*23 have been sold safely if they contained a warning about thimerosal. $USee $=<$=T3*2 $=L00465000234000868*000870 $=L01811000218000580*000582 Center Chem. Co. v. Parzini,$O 234 Ga. 868, 870, 218 S.E.2d 580, 582 (1975).$=> As currently pled, Plaintiffs' failure-to-warn claims are essentially a restatement of their design defect claims, which are barred by Section 22(b)(1) of the Vaccine Act. The Court concludes, however, that Plaintiffs should have another opportunity to plead a failure-to-warn claim that could satisfy the notice pleading standard of O.C.G.A. $S 9-11-8. Therefore, the Court $=BGRANTS$=R Plaintiffs leave to replead this claim by way of an amended Complaint to be filed with the Court within fifteen (15) days of the date of this Order. The amended Complaint should assert allegations beyond the fact that the vaccines at issue contain thimerosal and should also clarify the nature of the warnings that Plaintiffs contend the vaccines at issue required. n7 Plaintiffs should be afforded the opportunity to conduct discovery related to their amended failure-to-warn claims that is consistent with the provisions of Section 22(b)(2) of the Vaccine Act. The Vaccine Defendants, however, may present another motion$=P1298*24 for summary judgment on Plaintiffs' failure-to-warn claims after discovery pertinent to that issue has been conducted.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn7 Plaintiffs allege in their complaint that the Vaccine Defendants "impliedly and expressly warranted to the Plaintiffs that these Thimerosal-containing products . . . were safe, when in fact, the products were not safe. Each of $(the Vaccine Defendants$) was negligent for distributing a defective product without providing adequate warnings and without first determining that the products were safe." Compl. P53. In light of this Court's ruling that Section 22(b)(1) bars all design defect claims, Plaintiffs' breach of warranty claim would only be viable to the extent it alleges that the vaccines at issue were defective due to inadequate warnings.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$T$=BE. $UPlaintiffs' Manufacturing Defect Claims$O$=R$TThe Vaccine Defendants argue th at Plaintiffs have failed to allege a valid manufacturing defect claim. Plaintiffs' Complaint simply states that the vaccines were "defectively designed, manufactured, marketed and$=P1298*25 distributed." Compl. P28. Plaintiffs disagree, contending that they have adequately plead a manufacturing defect claim and that they are entitled to conduct discovery with regard to that claim.$T"$(A$) manufacturing defect will always be identifiable as a deviation from some objective standard or a departure from the manufacturer's specifications established for the creation of the product." $=<$=T3*1 $=L04830000231001228*001236 $UJones v. Amazing Prods., Inc.,$O 231 F. Supp. 2d 1228, 1236 (N.D. Ga. 2002).$=> Because thimerosal is part of the FDA-approved formula for the vaccines at issue, Plaintiffs cannot contend that the inclusion of thimerosal was a manufacturing defect in the vaccines at issue and the cause of Plaintiffs' injuries. To the extent that Plaintiffs' manufacturing defect claims are based on the inclusion of thimerosal, they are barred by Section 22(b) as repackaged design defect claims. The Court concludes, however, that Plaintiffs' manufacturing defect allegations satisfy the notice pleading requirements set forth by O.C.G.A. $S 9-11-8. Plaintiffs would need to prove a defect in manufacturing, to sustain their claim, and not just that the vaccine contained thimerosal as part of its$=P1298*26 formula. The Vaccine Defendants may present another motion for summary judgment on Plaintiffs' manufacturing defect claims after discovery pertinent to that issue has been conducted.$T$=BF. $UPlaintiffs' Fraud-Based Claims, Gross Negligence Claim, And Punitive Damages Claim$O$=R$TThe Vaccine Defendants have moved to dismiss Plaintiffs' fraud-based claims on the ground that they contain unspecified and unattributed allegations of fraud that do not meet the standard set forth by O.C.G.A. $S 9-11-9(b). $USee $=<$=T3*2 $=L00466000267000859*000866 $=L01811000601000177*000185 R.W. Holdco, Inc. v. Johnson,$O 267 Ga. App. 859, 866, 601 S.E.2d 177, 185 (2004).$=> While the Complaint lacks any reference to particular false statements made or specific information concealed, and groups all defendants together into conclusory paragraphs, $USee$O Compl PP46, 47, the Court will allow Plaintiffs fifteen days from the date of this Order to replead by way of an amended Complaint to be filed with the Court within fifteen (15) days of the date of this Order. n8$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn8 The Vaccine Defendants allege that there is an issue of whether Plaintiffs have standing to allege their fraud claims here. Pursuant to Section 22(c) of the Vaccine Act, the Vaccine Defendants argue that they have no duty to warn Plaintiffs or the general public of any potential dangers resulting from the administration of the vaccines at issue.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*27 $TFor the same reasons, Plaintiffs have leave to replead their gross negligence and punitive damage claims. The Vaccine Act precludes the imposition of punitive damages on vaccine manufacturers absent a showing of "fraud or intentional and wrongful withholding of information" during the regulatory process or "other criminal or illegal activity relating to the safety and effectiveness of vaccines." $=<$=T4*42_USC_300AA-23 $=L01919000042000300*000300 42 U.S.C. $S 300aa-23$=>(d)(2). Such claims must be pled in accordance with the particularity requirements of O.C.G.A. $S 9-11-9(b). Plaintiffs shall have fifteen (15) days from the date of this Order to file an amended Complaint.$T$=BG. $UThe Parent Plaintiffs' Claims$O$=R$TPlaintiffs argue that even if minor plaintiff's claims are barred, the parent plaintiffs' claims for loss of services, infliction of emotional distress, and medical expenses incurred for minor plaintiff are not subject to the liability limitations of Section 22(b). This argument ignores the plain language of Section 22(b), which expressly extends to $Uany$O "civil action $(against a vaccine manufacturer$) for damages arising from a vaccine-related injury" associated with a vaccine administered$=P1298*28 after October 1, 1988. $USee$O $=<$=T4*42_USC_300AA-22 $=L01919000042000300*000300 42 U.S.C. $S 300aa-22$=>(b)(1). Because the parent plaintiffs' claims necessarily arise from minor plaintiff's alleged "vaccine-related injury," they are subject to the liability limitations of Section 22(b)(1) of the Act by its explicit terms. The case relied upon by Plaintiffs, $=<$=T3*1 $=L03737000381000501*000501 $UMoss v. Merck & Co.,$O 381 F.3d 501 (5th Cir. 2004),$=> is inapposite. That case concerned whether the pre-suit administrative exhaustion provisions imposed by Section 11 of the Vaccine Act extended to independent parental claims that could not be presented in Vaccine Court. $=<$=T3*1 $=L03737000381000501*000504 $UId.$O at 504-05.$=> It does not matter, for purposes of applying Section 22, whether or not the parent plaintiffs' claims could or could not have been asserted in administrative compensation proceedings. Therefore, these claims are $=BDISMISSED WITH PREJUDICE.$=R$T$U$=BCONCLUSION$=R$O$TFor the reasons stated above, Defendants Wyeth (f/k/a American Home Products Corporation), SmithKline Beecham Corporation d/b/a GlaxoSmithKline, and GlaxoSmithKline Biologicals s.a.'s Motion for Summary Judgment, or Alternatively, Motion to $=P1298*29 Dismiss or Require Repleading of Allegations is hereby $=BGRANTED IN PART$=R and $=BDENIED IN PART.$=R Plaintiffs' design defect claims are $=BDISMISSED WITH PREJUDICE$=R pursuant to Section 22(b)(1) of the Vaccine Act. Plaintiffs' failure-to-warn claims are hereby $=BDISMISSED WITH PREJUDICE$=R to the extent that they allege a failure to warn Plaintiffs or the general public. The remainder of Plaintiffs' failure-to-warn claims, in addition to their fraud, gross negligence, and punitive damage claims are hereby $=BDISMISSED WITHOUT PREJUDICE$=R with leave to replead. Plaintiffs' breach of warranty claims are $=BDISMISSED WITH PREJUDICE$=R to the extent that they allege that the vaccines at issue were defective solely due to their design. The claims alleged individually by the parent plaintiffs are $=BDISMISSED WITH PREJUDICE$=R pursuant to Section 22(b)(1) of the Vaccine Act. To the extent that Plaintiffs' manufacturing defect claims are based on the inclusion of thimerosal in the vaccines at issue, they are hereby $=BDISMISSED WITH PREJUDICE.$=R As there is no just reason for delay, it is directed that final judgment be immediately entered on the claims herein dismissed with prejudice. The Vaccine$=P1298*30 Defendants' motion for summary judgment on the remainder of Plaintiffs' manufacturing defect claims is $=BDENIED.$=R$T$=BSO ORDERED$=R this 30th day of November, 2005.$T$=BSUSAN B. FORSLING$=R$T$=BJudge, State Court of Fulton County$=R$%$?$%Copies to:$%$?$%Counsel of record$%via LexisNexis File & Serve$%$?$%January 9, 2006$%$?$%Department of Public Safety$%2206 Eastview Parkway$%P.O. Box 80447$%Conyers, Georgia 30013$%$?$%Attention: Ms. Shelly Parker$%$?$%G entlemen:$%$?$%Regal Insurance Company filed suit against Dennis Butler being number 04VS067198 in the State Court of Fulton County. The basis of this lawsuit was an alleged automobile accident occurring on the 23rd day of August, 2002. Road of occurrence 2790 Bankhead Hwy not at its intersection but 50 feet West of Yates Dr, NW, and continuing in the direction checked above the next reference point is Peek Rd NW, Atlanta, Fulton County, Georgia.$%$?$%Defendant Dennis Bulter was served personally a copy of this lawsuit on the 26th day of January, 2004 at 2326 Lindmont Cir. Apt B, Atlanta, Georgia 30324.$%$?$%On the 26th day of July, 2005 judgment was rendered in favor of the plaintiff against defendant for the sum of $ 8,715.00 principal, plus $ 0.00 attorney fees, all $=P1298*31 court cost, and future interest at the legal rate on the judgment. This judgment has not been satisfied of record, and time for appeal has expired.$%$?$%Sincerely,$%$?$%Stefani R. Searcy, Chief Clerk$%State Court of Fulton County$%$?$%SRS/tab$%$?$%Enc.$%$?$%$=BMary A. Miller & Associates$=R$%$=BP.O. Box 1588$=R$%$=BNorcross, GA 30091-1588$=R$200:#170502M0010K8010#$?$?#SID015000000I2J0F#$? #LS060113LEhamielrx#$?#060113PLXC0010040#$?$220:#EXTR#$?#FERRARI-AMERICAN# $00:0100005574:C00FE27F000015C6:<LNI='4MX4-6NY0-0060-D0MT-00000-00' MINREV='00000' ERPT=C00FE27F>$01:$=T1*=SS_#NEW-MAIN# Return to the EXTRA Main Menu$%$?$%**********************************************************$03:$=N1298*13$10:RICHARD JEWELL, Plaintiff, v. COX ENTERPRISES, INC., et al., Defendants,$20:CIVIL ACTION NO. 97 VS 0122804$25:STATE COURT OF FULTON COUNTY, STATE OF GEORGIA$30:$T$=<$=V08576002006000075*1298 2006 Extra LEXIS 75$=>$40:$?$%October 2, 2006, Decided$110:$=P1298*1 The Honorable John R. Mather, Judge State Court of Fulton County.$115:John R. Mather$120:$T$U$=BORDER$=R$O$TThis action came regularly before the Court and was heard on Plaintiff's $IObjection To The Use Of Unauthenticated And Hearsay Evidence In Support Of AJC's Motion For Summary Judgment.$N Both parties were represented by counsel. After oral argument and consideration of the applicable record, the Court hereby issues the following Order:$TIn this motion Plaintiff seeks to exclude portions of the record that are pertinent to the defendant's pending $IMotion For Summary Judgment.$N Specifically, Plaintiff objects to the consideration of the United States Justice Department's OPR Report, n1 printed newspaper articles, and pleadings asserted in another action on grounds of authenticity and hearsay. As the parties contest which has the burden on this issue, the Court begins by observing that the defendant's burden on summary judgment may be carried by demonstrating that the record evidence fails to support an essential element of the plaintiff's theory of recovery. It is only after the defendant has successfully pierced the pleadings that the plaintiff is required to demonstrate that an active question$=P1298*2 of fact remains for trial. Accordingly, as it is the defendant that relies on the OPR Report and other evidence of record to demonstrate the non-existence of a question for trial, it is the defendant's burden as the proponent of the document, upon proper objection, to establish its admissibility.$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn1 The full title of the OPR Report is the $ISummary Of The Investigation By The Office Of Professional Responsibility Into The Circumstances Surrounding The Interview Of Richard A Jewell In The Centbom Case.$N This report was prepare d by the U.S. Justice Department and included in the hearing record published by the Senate Judiciary Committee.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$T$=B$I1. The OPR Report$N$=R$TAs discussed in previous Orders of this Court, the OPR report contains a conference call summary which relates a conversation between unnamed PBAU n2 agents. According to the report: "Mr. Jewell was also discussed, and it was mentioned that the PBAU agents who had reviewed the televised interviews concurred with Atlanta's assessment that Jewell fit the profile$=P1298*3 of a person who might create an incident so he could emerge as a hero." (OPR Report at page 11).$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn2 PBAU are the initials for the Profiling and Behavioral Assessment Unit of the FBI.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$TThis passage proved significant to this Court's previous ruling on Plaintiff's $IMotion To Compel.$N In denying Plaintiff's motion to compel the confidential source for the report that "investigators believe that Jewell fit the profile of the lone bomber," this Court relied on the OPR report as foreclosing the issue of substantial falsity. Plaintiff now squarely challenges the admission of the report for purposes of summary judgment raising grounds of authenticity and hearsay.$T$=B$Ia. Authentication$N$=R$TIn attempting to establish the authenticity of the OPR report, Defendant's raises three arguments: (1) That Plaintiff waived the issue of authenticity by relying repeatedly on the same official report in this litigation; (2) That Plaintiff waived the issue of authenticity by failing to object to the report before this Court's prior ruling$=P1298*4 on confidential sources; and (3) that the OPR is a self-authenticating federal publication.$TAs evidence of waiver, Defendant refers to Plaintiff's citation to the report in a footnote of their supplemental brief in opposition to Defendant's $IMotion For Summary Judgment.$N In footnote 24, Plaintiff refers to the report as evidence that the Special Agent in Charge knew of the brief time period that elapsed between the bombing and the placing of the 911 call. References to the OPR report also appear in Plaintiff's $IStatement Of Material Facts.$N$THowever, Defendant's authorities for finding a waiver arise in dissimilar contexts. In $=<$=T3*1 $=L00466000203000740*000740 $UPenaranda v. State,$O 203 Ga. App. 740 (1992),$=> the Court found a waiver where the defendant made first use of an unauthenticated tape on cross-examination, and called for its admission, then raised the lack of foundation on appeal. The second case cited by the Defendant, $=<$=T3*1 $=L00465000278000779*000779 $UCody v. State,$O 278 Ga. 779 (2004),$=> stands for the proposition that the failure to object to testimony until after the hearing will result in a waiver. As the present facts do not approach either case cited, the Court declines to $=P1298*5 find a waiver here.$TIn contending that the OPR is a self-authenticating federal publication, the Defendant relies on language from $=<$=T3*1 $=L00466000178000748*000748 $URice v. State,$O 178 Ga. App. 748 (1986),$=> in which it was recognized that substantial compliance with federal statutory requirements is the equivalent of satisfying state common law authenticity requirements. Defendant contends that the OPR report specifically complies with Federal Rule Of Civil Procedure 44 and is therefore authenticated for purposes of Georgi a evidence law. Defendant also cites $UUS v. Aluminum Co. of America,$O 1, F.R.D. 71 (S.D.N.Y. 1939) which referenced Rule 44 and held "that the authenticity of an official document is sufficiently established when a copy of it is offered which purports to have been printed by authority of the Government." In relevant part, the current version of Rule 44 provides:$=S$%$?$%Authentication.$%(1) $IDomestic.$N An official record kept within the United States, or any state, district, or commonwealth, or within a territory subject to the administrative or judicial jurisdiction of the United States, or an entry therein, when admissible for any purpose, may be evidenced by an official$=P1298*6 publication thereof....$=I$TAs it is undisputed that the OPR report submitted by the Defendant is part of an official publication, the Court finds that authenticity has been satisfied pursuant to $=<$=T3*1 $=L00466000178000748*000748 $URice v. State,$O 178 Ga. App. 748 (1986)$=> and Rule 44 of the Federal Rules Of Civil Procedure. The Court now turns to the more thorny issue of hearsay.$T$=B$Ib. Hearsay$N$=R$TWhile the Defendant has, in this context of countering a hearsay objection, again urged this Court to find a waiver in Plaintiff's use of the OPR report for his own purposes, Georgia law clearly holds that hearsay evidence is without probative value- even when the matter is admitted without objection. $=<$=T3*1 $=L00466000181000872*000872 $UJeweler's Financial Svcs. v. Chapes, Ltd.,$O 181 Ga. App. 872,$=> (1987). As hearsay evidence does not become admissible by waiver, the report must satisfy a hearsay objection. $=<$=T3*1 $=L00466000227000585*000585 $UHagan v. Goody's Family Clothing,$O 227 Ga. App. 585 (1997).$=>$TThe hearsay exception contended by the Defendant to be applicable is the doctrine of necessity recognized in O.C.G.A. $S 24-3-1(b). n3 In order to demonstrate necessity under this exception, three prongs must be$=P1298*7 satisfied:$=S$%$?$%....the declarant must be unavailable, there must be particular guarantees of trustworthiness, and the statement must be shown to be relevant to a material fact and more probative of that material fact than other evidence that might be procured and offered. $I$=<$=T3*2 $=L00465000270000151*000155 $=L01811000510000802*000802 $UChapel v. State,$O$N$U 270 Ga. 151, 155 (4) (510 S.E.2d 802) (1998).$=>$O "The court must consider the totality of the circumstances that surround the making of the statement to determine its reliability. 'The test is whether "the declarant's truthfulness is so clear from the surrounding circumstances that the test of cross-examination would be of marginal utility.'"" $I$=<$=T3*2 $=L00465000275000550*000553 $=L01811000570000269*000269 $UYancey v. State,$O$N$U 275 Ga. 550, 553 (2) (a) (570 S.E.2d 269) (2002).$=>$O$=I$%$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn3 "(b) Hearsay evidence is admitted only in specified cases from necessity."$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$THere, the first prong of unavailability is satisfied because the Justice Department has invoked federal privilege in opposition to discovery requests. $=P1298*8 $TAs to the second requirement of trustworthiness, the evidence should provide some level "detail or flavor of the declarations to determine if they meet the high standard of being a "circumstantial guaranty of trustworthiness" or "something the law considers the substitute for the oath of the declarant and his cross examination." $=<$=T3*1 $=L00466000257000 389*000389 $UTorstenson v. Doe,$O 257 Ga. App. 389 (2002)$=> Hearsay must be necessary and must be accompanied by particular guarantees of trustworthiness in order to be admissible under the necessity exception. $UO.C.G.A. $S 24-3-1 (b); $=<$=T3*2 $=L00465000270000151*000154 $=L01811000510000802*000802 Chapel v. State, 270 Ga. 151, 154-156(4) (510 S.E.2d 802) (1998).$=>$O A trial court should view the proffered hearsay within the totality of the circumstances of its origin, and, because the "factors that speak to the reliability of hearsay statements will vary depending on the nature of the statements," the determination of trustworthiness is inescapably subjective. $=<$=T3*2 $=L00465000270000151*000155 $=L01811000510000802*000802 $UId. at 155.$=> $=<$=T3*1 $=L00465000272000704*000704 Gissendaner v. State,$O 272 Ga. 704 (2000).$=>$TThe following non-exclusive factors are probative in assessing reliability: (1) consistency$=P1298*9 of the statements; (2) lack of a motive to fabricate; (3) the nature of the statements; (4) the relationship between the declarant and the accused; and (5) whether the statement was based upon a faulty recollection or observation. $=<$=T3*2 $=L00465000270000151*000151 $=L01811000510000802*000802 $UChapel v. State,$O 270 Ga. 151 (1998).$=>$THere, Defendant relies on the argument that because the report was prepared by the Justice Department it is lent "compelling guarantees of reliability." In passing upon this argument, the Court observes that the passage in issue actually contains several layers of potential hearsay. Not only does the segment purport to describe a conference call, it also characterizes the opinion of two unnamed agents who were apparently not in attendance - who then concur with an "Atlanta assessment" that Plaintiff fit a profile.$THowever, it is also significant that the report was submitted under oath by the Director of the FBI, Louis Freeh, and the Director of OPR of the Justice Department, Michael Shaheen, and was submitted to become part of the congressional record. The FBI agents, while unnamed, have no interest in this litigation and no apparent motive to fabricate. The statement that$=P1298*10 the PBAU agents concurred with the assessment of the Atlanta office that Plaintiff fit a profile only provides an appraisal in furtherance of their investigation of the bombing. While considerations of trustworthiness usually begin with knowing at least the identity of the declarant, the Court finds that the context in which the statements appear in the record confer a sufficient measure of reliability.$THaving found admissible the statement that PBAU agents concur with the assessment that Plaintiff fit a profile, it is unnecessary to determine if the "Atlanta assessment," at the next level of hearsay, is also admissible under the necessity doctrine. The concurrence of the PBAU agents equates to the existence of a profile that is applicable to the plaintiff.$TUnder the last prong of the necessity exception: "the statement must be shown to be relevant to a material fact and more probative of that material fact than other evidence that might be procured and offered." As other probative FBI witnesses have been prevented from testifying by the invocation of privilege, the Court finds the last prong satisfied.$T$=B$III. Newspaper Articles And Television Transcripts$N$=R$TIn moving to exclude, $=P1298*11 Plaintiff has made only a broadside objection to admission of all articles and television transcripts. As the Defendant correctly points out, a general hearsay objection to the evidence as a whole is insufficient if any portion of it is admissible. $=<$=T3*1 $=L00465000273000818*000818 $UGivens v. State,$O 273 Ga. 818 (2001).$=>$THere, at least some of the published articles are outside the definition of hearsay since they are not offered for the truth of the matter asserted. Evidence is non-hearsay when offered only "as proof that such a statement was made." See $=<$=T3*1 $=L00466000184000558*000558 $UWalker v. State,$O 184 Ga. App. 558 (1987).$=> Further, authenticity becomes an issue under O.C.G.A. $S 24-7-1 only when the contents are disputed. See $=<$=T3*1 $=L00465000238000081*000081 $USpringer v. State,$O 238 Ga. 81 (1976);$=> $=<$=T3*1 $=L00466000184000558*000558 $UWalker v. State,$O 184 Ga. App. 558 (1987).$=> As Plaintiff has not disputed the contents, the Court declines to exclude the articles from consideration.$T$=B$IIII. Pleadings filed in Barbara Jewell v. United States$N$=R$THere, Plaintiff objects generally on grounds of authenticity and hearsay to the admission of pleadings filed in an action brought by his mother against the$=P1298*12 United States. Particularly, Plaintiff seeks to exclude the Answer filed by the government in which it was admitted that a "personality assessment" of Plaintiff was prepared by the FBI and provided to the Atlanta Division of the FBI.$TPretermitting whether the statement regarding the personality assessment was actually an admission, admissions in properly certified pleadings operate as evidentiary admissions which may be explained when introduced in a different action. See $=<$=T3*1 $=L00466000157000554*000554 $UFoster v. State,$O 157 Ga. App. 554 (1981);$=> $=<$=T3*1 $=L00466000224000348*000348 $UKhamis Enterprises, Inc. v. Boone,$O 224 Ga. App. 348 (1997).$=> As Plaintiff's objections have not addressed the potential admission of the pleadings as an admission, the Court declines, at this time, to exclude the pleadings from consideration. n4$F$%$?$%- - - - - - - - - - - - - - - - - -Footnotes- - - - - - - - - - - - - - - - - -$Tn4 It should be noted that, for purposes of ruling on the existence of a profile, the Court did not explicitly rely on the government's Answer in summary judgment Order. See footnote 4 in summary judgment Order.$%$?$%- - - - - - - - - - - - - - - - -End Footnotes- - - - - - - - - - - - - - - - -$E$=P1298*13 $T$=B$IIV. FBI files$N$=R$THere, Plaintiff again makes generalized, one paragraph, objections on authenticity and hearsay grounds. As Plaintiff has not demonstrated that the authenticity of the documents are "in issue," See $=<$=T3*1 $=L00465000238000081*000081 $USpringer v. State,$O 238 Ga. 81 (1976);$=> $=<$=T3*1 $=L00466000184000558*000558 $UWalker v. State,$O 184 Ga. App. 558 (1987),$=> and as it appears that at least some documents may be admitted as non-hearsay, Plaintiff's motion is DENIED.$T$=BSO ORDERED$=R this the 2nd day of October 2006.$TThe Honorable John R. Mather$TJudge State Court of Fulton County$200:#170502M0010K8010#$?$?#SID015000000JOLKB#$? #LS070126LEtysoncm#$?#070126PLXC0010021#$?$220:#EXTR# #JEWELL-COX#