Wright v. Aventis Pasteur, Inc.

CONCURRING AND DISSENTING OPINION BY

SHOGAN, J.:

Although the Majority has provided a thorough discussion of statutory interpretation and the law of preemption, I discern no basis on which to disturb the trial court’s entry of summary judgment in favor of Vaccine Defendants on both the failure-to-warn and design defect claims. Accordingly, I concur in part and dissent in part.

Plaintiffs filed a complaint in state court, alleging that Vaccine Defendants were negligent in designing the vaccines to include thimerosal, and that Vaccine Defendants failed to warn of the dangers of using thimerosal. Second Amended Complaint, 12/9/03, at ¶¶ 25-27, 39. The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C.A. §§ 300aa-l et seq., provides for the preemption of state design defect claims and affords a presumption of proper warning to vaccine manufacturers. 42 U.S.C.A. § 300aa-22(b). The question before the trial court with regards to the design defect claim was the scope of preemption. 1 Plaintiffs advocated a case-by-case determination by a trial court of whether the vaccine design was defective, i e., whether a safer alternative to thimerosal should have been used, before vaccine manufacturers would be able to obtain the protections of Section 22(b). Vaccine Defendants argued that the Vaccine Act preempts all design defect claims, without use of a case- *885 by-case determination of whether a particular vaccine is unavoidably unsafe.

Citing the language of Section 22(b), the Federal Drug Administration’s (“FDA”) licensing process, federal cases favoring preemption in this context, and legislative intent, the trial court concluded that Congress intended to preempt design defect claims without a preliminary showing that thimerosal-containing vaccines were unavoidably unsafe. Trial Court Opinion, 8/27/08, at 19. Considering, inter alia, subsequent legislative history, the Majority concludes that the trial court erred and holds that Section 22(b)(1) requires a trial court to conduct a case-by-case inquiry to determine if a vaccine’s side effects are unavoidable before deciding whether a design defect claim is preempted. I cannot agree.

The first part of Section 22(b)(1) speaks plainly and broadly, while the second part is conditional:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

42 U.S.C.A. § 800aa-22(b)(1). Determining whether side effects are unavoidable, whether the vaccine was properly prepared, and whether proper warnings were provided is the function of the FDA. As the trial court observed, the FDA regulates the formation (including ingredients and preservatives), the production, and the labeling of vaccines. Trial Court Opinion, 8/27/08, at 4 n. 6 (citing 21 U.S.C.A. §§ 301 et seq.; 21 C.F.R. § 610.15 ). The FDA’s licensing process requires demonstration that a product is “safe, pure, and potent.” Id. at 5 n. 6 (citing 42 U.S.C.A. § 262 (a)(2)(C)). 2 Thus, as the trial court opined, use of a case-by-case approach is unnecessary because “[a]n FDA-approved design includes the side-effects of that vaccine, and is, therefore, by statutory definition, the unavoidably safe product subject to ... immunity.” Trial Court Opinion, 8/27/08, at 18 (citation omitted). 3

Federal decisions favoring preemption in this context further support the trial court’s decision. See, e.g., Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3d Cir.2009), cert. granted, — U.S. -, 130 S.Ct. 1734 , 176 L.Ed.2d 211 (2010) (holding that Vaccine Act preempts design defect claims without a determination of whether the vaccine is unavoidably unsafe); 4 Sykes v. *886 Glaxo-SmithKline, 484 F.Supp.2d 289 (E.D.Pa.2007) (same); Blackmon v. American Home Prods. Corp., 328 F.Supp.2d 659 (S.D.Tx.2004) (holding that Vaccine Act totally bars design defect and failure-to-warn claims); see also Militrano v. Lederle Labs., 26 A.D.3d 475 , 810 N.Y.S.2d 506 (App.Div.2d Dept.2006) (holding that Vaccine Act preempts state law design defect claims and provides presumption of proper warning). Even- the Georgia state decision, cited by the Majority as adopting a case-by-case approach, recognized the reasonableness of interpreting the statute as preempting all design defect claims. See Ferrari v. American Home Prods. Corp., 650 S.E.2d 585 , 286 Ga.App. 305 (Ga.Ct.App.2007) (agreeing with previous court rulings regarding congressional intent to preempt all design defect claims).

Finally, the legislative history of the Vaccine Act favors preemption of all design defect claims and, hence, supports the trial court’s ruling. 5 In concluding that “the basic presumption against preemption does not accord with Congress’ intent in enacting the Vaccine Act,” the trial court observed:

[cjoncerns which led to the Vaccine Act legislation included the inadequacy— from both the injured persons and the vaccine manufacturers perspective — of the tort system in compensating vaccine-injured children and the instability and uncertainty of the childhood vaccine market inevitably caused by the risk of tort litigation. See ELR.Rep. No. 99-908 at 7 ... With case-by-case determination, vaccine manufacturers “would again be subjected to the unpredictability and expense of the tort system and companies would be dissuaded from remaining [in] or entering the vaccine market.” Sykes, 484 F.Supp.2d at 302 . Such an approach “would do nothing to protect vaccine manufacturers from suit from design defects, since such an inquiry would require a fact finder to consider the manufacturer’s design against a purported safer alternative.” Bruesewitz, 508 F.Supp.2d at 445.

Trial Court Opinion, 8/27/08, at 16-17.

The trial court found further support for preemption in H.R.Rep. No. 99-908, as follows: 6

Given the existence of the compensation system [provided for in the Vaccine Act], the Committee strongly believes that Comment K is appropriate and necessary ... Vaccine-injured persons will now have an appealing alternative to the tort system. Accordingly, if they cannot demonstrate under applicable law either [1] that a vaccine was improperly prepared or [2] that it was accompanied by improper directions or inad *887 equate warnings [they] should pursue recompense in the compensation system, not the tort system.

Id. at 17 (quoting H.R.Rep. No. 99-908 at 26) (emphasis and bracketed material in original).

Finally, the trial court found Section 22 to be even broader than Comment K and rejected Plaintiffs’ position that the court should adopt a case-by-case approach based on Comment K. Id. at 18. I am constrained to agree. See Blackmon, 328 F.Supp.2d at 666 (“[Section 22(b)’s] phrase ‘a civil action for damages’ encompasses products liability claims based on negligence as well as those based on strict liability. While comment K is restricted to strict liability claims, § 22(b) is not.”).

Plaintiffs raised design defect and failure-to-warn claims. As discussed in the trial court’s very thorough and well-reasoned opinion, the statutory language, FDA functions, federal case law, and legislative intent support the trial court’s conclusions that the Vaccine Act preempts the design defect claim and that Vaccine Defendants were entitled to the presumption of proper warning. Therefore, I do not consider the trial court’s entry of summary judgment in favor of Vaccine Defendants on both claims an abuse of discretion or an error of law.

. Vaccine Defendants contended that the failure-to-warn claim was also preempted by the Vaccine Act. I agree with the trial court that Plaintiffs failed to distinguish that claim, as to the injured party, from their design defect claim. See Trial Court Opinion, 8/27/08, at 19-22.

. Notably, the FDA "has concluded that no ill effects ‘other than minor local reactions at the site of injection' have been established for thimerosal in childhood vaccines.” FDA, Thimerosal in Vaccines, at 3 (August 18, 2008).

. Section 22(b)(1) is an express preemption provision. Since Wyeth v. Levine, 555 U.S. 555 , 129 S.Ct. 1187 , 173 L.Ed.2d 51 (2009), dealt with implied preemption, it is of limited relevance in our analysis. In fact, the issue in Levine of whether federal labeling law preempted the plaintiffs' inadequate labeling claim is directly addressed by Section 22(b)(2), which provides that:

a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C.A. §§ 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought.

42 U.S.C.A. § 300aa-22(b)(2).

. The United States Supreme Court heard oral argument in the Bruesewitz case on October 12, 2010.

. In examining legislative intent, I respectfully disagree with the Majority that we should consider "subsequent legislative history” in this case. In my opinion, the expressions of the legislature relating to the 1987 funding amendments to the Vaccine Act do not fall within the scenario described by Justice Scalia- in his concurring opinion in the social security disability case, Sullivan v. Finkelstein, 496 U.S. 617, 632 , 110 S.Ct. 2658 , 110 L.Ed.2d 563 (1990) (Scalia, J., concurring in part) ("[T]he expression of a legislator relating to a previously enacted statute ... would i be useful, if at all, not because it was subsequent legislative history of the earlier statute, but because it was plain old legislative history of the later one.”). Consideration of subsequent legislative history of an earlier statute can be construed simply as a form of revisionist history.

. "Preemption is a question of Congressional intent,” and "[t]he best source for divining that intent is the committee reports on the bill.” Militrano, 810 N.Y.S.2d at 508 (citing California Federal Sav. & Loan Assn. v. Guerra, 479 U.S. 272, 280 , 107 S.Ct. 683 , 93 L.Ed.2d 613 (1987); Garcia v. United States, 469 U.S. 70, 76 , 105 S.Ct. 479 , 83 L.Ed.2d 472 (1984)).