Download PDF

In American Home Products Corp. v. Ferrari,1 the Supreme Court of Georgia held that the National Child Vaccine Injury Act of 1986 does not preempt all state law claims that a vaccine has been defectively designed.  Instead, relying on its reading of the statutory text and the legislative history, the court held that the Act preempts such claims if it is determined, on a case-by-case basis, that the vaccine’s injurious side effects were unavoidable.2  In so doing, the court reached a conclusion that differed from the conclusion reached by the Third Circuit Court of Appeals and other courts.3

The National Childhood Vaccine Injury Act of 1986 was enacted in response to a sharp rise in the number of vaccine-related lawsuits filed against the manufacturers of those vaccines.  The cost of defending those lawsuits and the related increases in insurance costs were chasing manufacturers from the market, threatening the supply of vaccines.  The Act establishes an alternative, mandatory forum for the resolution of vaccine-injury claims.  Those claims are heard in the first instance by a Vaccine Court which is part of the Court of Federal Claims.  Claimants dissatisfied with the result in that forum can appeal to the Court of Appeals for the Federal Circuit or can pursue certain limited claims in federal or state court.4

In pertinent part, the subsection (b)(1) of the Act provides, “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.”5 As one court, which found that the Act preempted design defect claims related to the pertussis vaccine, observed, this provision can be read in two ways. Either “any injury caused by a covered vaccine is deemed ‘unavoidable’ as a matter of law provided that the vaccine was properly prepared and accompanied by proper warnings,” or defective design claims are barred only when the injury is unavoidable, with unavoidability to be determined on a case-by-case basis.6

In Ferrari, the Georgia Supreme Court noted that the courts considering the issue had universally recognized that Congress based the preemption provision set forth in subsection (b)(1) on comment (k) to § 402A of the Restatement (Second) of Torts. Comment K addresses “[u]navoidably unsafe products,” pointing out that, while some products cannot be “made safe for their intended and ordinary use,” those products are neither defective nor unreasonably dangerous when “properly prepared and accompanied by proper directions and warning.”7 The Georgia Supreme Court noted that Comment K “distinguishes three fundamental types of products liability: defects in design, manufacturing, and packaging or marketing.”8

That parsing of Comment K led the Georgia Supreme Court to disagree with the other courts which had considered the issue.  Those courts had overlooked the fact that “most of the states, including Georgia, that have adopted Comment K have applied it in a... limited fashion and on a case-by-case basis.”9  Accordingly, when Congress adopted Comment K, it “understood that comment in the same way” as the majority of the courts understood it.10

Furthermore, the Georgia Supreme Court pointed out that the text of subsection (b)(1) is conditional, providing that there is no liability “if the injury or death resulted from side effects that were unavoidable.”  In its view, that logically meant that some injuries were avoidable, and, for those injuries, the manufacturer could be civilly liable.  Congress “could easily” have omitted the conditional language, but those words should not be read out of the statute.11  With the conditional language, subsection (b)(1) preempted defective manufacturing and most defective packaging claims, but did not preempt design defect claims unless the “side eff ects… were not avoidable by a safer design.”12

The Georgia Supreme Court supported its reading of subsection (b)(1) by referring to the legislative history, both from the 1986 Act and subsequent legislative history from 1987.  In 1986, the House Committee on Energy and Commerce stated that it “intend[ed] that the principle in Comment K regarding ‘unavoidably unsafe’ products... apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system.”13  Congress then established an alternative compensation scheme that allowed for compensation “even if the manufacturer has made as safe a vaccine as possible.”14  The court went on to state:

Accordingly, if the [injured persons] 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.15

The Georgia Supreme Court stated that the Committee did not “use language which indicates that use of the compensation system is mandatory.”16 Instead, it assumed that the new Vaccine Court “would attract even vaccine-injured persons who may be able to prove that the vaccine was not made as safe as reasonably possible.”17  Characterizing that assumption of Congress as “certainly questionable, to say the least,” the Georgia Supreme Court concluded that Congress intended “only” that “if a vaccine-injured person does not have a claim for a manufacturing or warning defect, he should find the compensation system appealing even though he is authorized to attempt to prove the existence of a safer design in the tort system.”18  But, the legislative history does not mean that subsection (b)(1) preempts all design defect claims.

The Georgia Supreme Court also pointed to the legislative history for the 1987 amendments to the Act, subsequent legislative history that the Georgia Court of Appeals had declined to consider.  That report, prepared by the same Committee that prepared the 1986 Report, states:

[T]he codification of Comment (k) of The Restatement (Second) of Torts was not intended to decide as a matter of law the circumstances in which a vaccine should be deemed unavoidably unsafe. The Committee stresses that there should be no misunderstanding that the Act undertook to decide as a matter of law whether vaccines were unavoidably unsafe or not.  This question is left to the courts to determine in accordance with applicable law.19

The Georgia Supreme Court saw this language as “strikingly clear and emphatic” confirmation of its conclusion that subsection (b)(1) does not preempt all design defect claims.20  It also noted that, in 1987, an amendment that would have made it clear “that a manufacturer’s failure to develop [a] safer vaccine was not grounds for liability was rejected by the Committee during its original consideration of the Act.”21

The Georgia Supreme Court concluded by rejecting a reading of subsection (b)(1) that would “have the perverse eff ect of granting complete [tort] immunity from design defect liability to an entire industry...”22  It held that subsection (b)(1) provides only that a vaccine manufacturer “cannot be held liable for defective design if it is determined, on a case-by-case basis, that the particular vaccine was unavoidably unsafe.”23

The court said that its rejection of industry-wide immunity would stand “until the Supreme Court of the United States has spoken on the issue.”24  A petition for certiorari is pending, and, on June 8, 2009, the Court asked the Solicitor General for its views.  To date, the Solicitor General has not responded, and the Court’s next term began on October 5, 2009.

* Jack Park is a former Assistant Attorney General for Alabama and the former Special Assistant to the Inspector General for the Corporation for National and Community Service.

 

Endnotes

1  668 S.E.2d 236 (Ga. 2008).

2  Id. at 237-8.

3  See Bruesewitz v. Wyeth, Inc., 561 F. 3d 233 (3d Cir. 2009); Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007); Blackmon v. American Home Products Corp., 328 F. Supp. 2d 659 (S.D. Tex. 2004); Militrano v. Lederle Laboratories, 3 Misc. 3d 523, 769 N.Y.S. 2d 839 (2003), 26 A.D. 3d 475, 810 N.Y.S. 2d 506 (2006).     

4  42 U.S.C. §§ 300aa-11, 12(f), 21.

5  42 U.S.C. § 300aa-22(b)(1).

6  Militrano v. Lederle Laboratories, 769 N.Y.S. 2d at 843-44.

7  Restatement (Second) of Torts § 402A cmt. K.

8  668 S.E.2d at 239.

9  Id. (quoting Bryant v. Hoff man-La Roche, 585 S.E.2d 723 (Ga. Ct. App. 2003)).

10  Id. at 240.

11  Id.

12  Id.

13  H. Rep. 99-908, at 26, 1986 U.S.C.C.A.N. at 6367.

14  Id.

15  Id.

16  Id. at 241.

17  Id.

18  Id.

19  668 S.E.2d at 241 (quoting H.R. Rep. 100-391(I), at 691, as reprinted in 1987 U.S.C.C.A.N. 2313-1, 2313-365).   

20  668 S.E.2d at 241.

21  Id. (quoting H. Rep. 100-391(I) at 691, 1987 U.S.C.C.A.N. at 2313-365).

22  Id. at 243 (quoting Doyle v. Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518 (Ga. 1997), itself quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 498 (IV)(1996)).

23  668 S.E.2d at 242.

24  Id. at 243.

Note from the Editor: The Federalist Society takes no positions on particular legal and public policy matters. Any expressions of opinion are those of the author. We welcome responses to the views presented here. To join the debate, please email us at [email protected].