Linking Autism Injuries to Childhood Vaccines

Does the Vaccine Act preempt all design defect claims in state and federal court? Parents convinced that their children's autism has been caused by inoculations, and their attorneys, recently achieved a surprising victory on the issue when the Georgia Supreme Court ruled that a plaintiff's design defect claims are not barred by the Vaccine Act's preemption clause. Vaccine makers, despite recent decisions in the special Vaccine Court rejecting scientific evidence linking autism and vaccines, worry that the Georgia opinion could open the floodgates to litigation. They have moved for certiorari to the United States Supreme Court.

Background

Congress enacted the Vaccine Act in 1986 to stabilize the vaccine market and thereby safeguard the vaccine supply, and to ensure adequate compensation for children injured by vaccines. See http://www.hrsa.gov/vaccinecompensation (last visited Sept. 22, 2009). The Act was a response to concerns that rising numbers of vaccine-related claims would cause manufacturers to abandon the vaccine market. See National Childhood Vaccine Injury Compensation Act of 1985: Hearing Before the S. Comm. on Labor and Human Resources, 99th Cong. 8 at 256 (Dec. 9, 1985). In addition, evidence suggested that the tort system often failed to provide adequate compensation for children injured by vaccines whose potential recovery was too small to make their cases attractive to attorneys. See National Childhood Vaccine-Injury Compensation Act: Hearing Before the S. Committee on Labor and Human Resources, 98th Cong. 171 at 146 (May 3, 1984).

The Vaccine Act established the National Vaccine Injury Compensation Program, a no-fault alternative compensation scheme under which children injured by vaccines could receive compensation for their injuries. 42 U.S.C.A. ” 300aa-1 et seq. Instead of suing manufacturers or health-care professionals, people claiming injury from vaccines must first file a petition for compensation with the U.S. Court of Federal Claims, which refers the petition to a Vaccine Court ' an office within the court of special masters. The Secretary of Health and Human Services is named as a respondent; vaccine manufacturers are not parties to Vaccine Act proceedings. The Vaccine Act requires that the special master of the Vaccine Court consider the petition, make findings of facts and conclusions of law, and issue a decision within 240 days. After a decision by the special master, either party may seek review before the Court of Federal Claims. Thereafter, either party may appeal that decision to the Federal Circuit.

Vaccine Injury Compensation Trust Fund

Where findings are in favor of the petitioner, payment of compensation is made from the “Vaccine Injury Compensation Trust Fund,” which is funded by a manufacturers' excise tax on vaccines covered by the Act. Since 1989, the Vaccine Court has issued more than 2,300 awards, totaling over $1.7 billion. See National Vaccine Injury Compensation Program, Statistic report, http://www.hrsa.gov/vaccinecompensation/statistics_report.htm (last visited Sept. 22, 2009).

If a petitioner rejects the judgment of the Court of Claims, he or she may then bring a civil action for the injury, subject to the Vaccine Act's preemption provision, 42 U.S.C.A. ' 33aa-22. Section 22 provides that “[n]o vaccine manufacturer shall be liable in a civil action” if the injury “resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” Id. Until recently, courts have consistently ruled that the provision expressly preempts all design defect claims. See American Home Products Corp. v. Ferrari, 668 S.E.2d 236, 239 (Ga. 2008) (noting that all non-Georgia courts to consider the issue in published opinions have held that Section 22 preempts all claims that a vaccine was defectively designed). As a result, plaintiffs have effectively been limited to the Vaccine Court's judgment except for narrow categories of claims (i.e., those for injuries that could have been avoided by proper preparation or proper directions and warnings).

Autism Claims

Since 1999, more than 5,500 families have filed autism-related claims under the Vaccine Injury Compensation Program. To manage the large number of claims, the Vaccine Court in 2002 created an Omnibus Autism Proceeding. See In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder, 2002 WL 31696785 (Fed. Cl. July 3, 2002). As is common in mass tort proceedings, the court focused on a few test cases that represent plaintiffs' theories of how vaccines can cause autism. Decisions in those cases would be used to guide future proceedings in the Vaccine Court.

In February 2009, the Vaccine Court issued opinions in three test cases evaluating evidence based on the theory that the MMR (measles, mumps, and rubella) vaccine, in combination with vaccines containing the preservative thimerosal, cause autism. See Hazlehurst v. Sec. of Health & Human Servs., No. 03-654V (Fed. Cl. Feb. 12, 2009); Cedillo v. Sec. of Health & Human Servs., No. 98-916V (Fed. Cl. Feb. 12, 2009); Snyder v. Sec. of Health & Human Servs., No. 01-162V (Fed. Cl. Feb. 12, 2009); all opinions available at http://www.uscfc.uscourts.gov/node/5026 (last visited July 31, 2009). In lengthy opinions, all three special masters rejected the proposition that the MMR and thimerosal combination caused autism. Id. After considering voluminous evidence ' including weeks of testimony, over 900 medical and scientific journal articles, and over 50 expert reports ' the special masters found that though the children in the cases tragically suffered from autism and other severe conditions, petitioners had failed to demonstrate that vaccinations played any role in causing those problems. Id.

The same three special masters are currently deliberating on a second set of autism cases in which the families claim that thimerosal alone caused autism. See http://www.hrsa.gov/vaccinecompensation/omnibusproceeding.htm (last visited Sept. 22, 2009). However, in their opinions rejecting the MMR and thimerosal combination theory, the special masters expressed skepticism toward the idea that autism could be caused by an after-birth injury. See, e.g., Cedillo v. Sec. of Health & Human Servs., No. 98-916V at 95-99 (Fed. Cl. Feb. 12, 2009) (describing as “weak” scientific evidence that postnatal factors can cause autism). It appears unlikely, therefore, that the special masters will accept petitioners' thimerosal single-agent theory.

A Major Hurdle

The Vaccine Court's rulings in the first three test cases should prove a major hurdle for petitioners. The Georgia Supreme Court ruling that a vaccine injury design defect claim was not necessarily preempted by Section 22 of the Vaccine Act may, however, provide opportunities for families of autistic children who seek to sue manufacturers based on an alleged autism-vaccine connection.

The case before the Georgia Supreme Court involved claims that Stefan Ferrari developed severe neurological injuries as a result of receiving thimerosal-laden vaccines. See American Home Products Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008). Ferrari's parents first submitted a petition to the Vaccine Court, but when the Special Master failed to render a decision within 240 days, withdrew their petition and proceeded to sue the vaccine makers in state court in Georgia. The vaccine manufacturers moved for summary judgment on the basis of preemption. Ferrari v. American Home Products Corp., 650 S.E.2d 585 (Ga. App. 2007). The trial court agreed and entered summary judgment dismissing the design defect claims on the ground that Section 22 of the Vaccine Act preempted such claims. Id. The Georgia Court of Appeals reversed. Id. It found that it could interpret Section 22 in one of two ways: 1) the statute preempts all design defect claims; or 2) design defect claims are preempted only if the side effects are determined to be unavoidable on a case-by-case basis. Id. The Georgia Supreme Court affirmed, holding that the Vaccine Act's preemption clause “clearly does not preempt all design defect claims against vaccine manufacturers,” “but instead provides that a vaccine manufacturer cannot be held liable for defective design if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable.” American Home Products Corp. v. Ferrari, 668 S.E.2d 236 at 242. Thus, the Georgia Supreme Court ruled that it was premature to conclude that Ferrari's design defect claim was preempted by the Act.

What About the Manufacturers?

Vaccine manufacturers worry that the Georgia Supreme Court's decision, construing Section 22 as a narrow rather than a broad preemption provision, could lead to a deluge of litigation in state court over the autism-vaccine link ' no matter that the Vaccine Court special masters have so far rejected the scientific evidence in favor of such a link. See Petition for Writ of Certiorari, American Home Products Corp. v. Ferrari, 2009 WL 598046 at *22-23 (U.S. March 5, 2009).

The manufacturers have brought the issue to the United States Supreme Court. In moving for certiorari, they argue that the Georgia Supreme Court ruling will reduce the Vaccine Court to nothing but a base that plaintiffs touch en route to court. Id. at 7. The unpredictability of liability, they argue, could drive vaccine manufacturers from the market and halt future production and development of vaccines. Id. at 19. Thus, the Georgia Supreme Court ruling could precipitate the same crisis that Congress sought to avert in passing the Vaccine Act ' the possibility of vaccine shortages and a resulting increase in the number of non-immunized children. Id. at 21.

In March of this year, after the vaccine manufacturers moved for certiorari in the Ferrari case, the U.S. Court of Appeals for the Third Circuit issued an order rejecting Ferrari's approach and holding that Section 22 does broadly preempt design defect claims in state and federal court. In Bruesewitz v. Wyeth, 561 F.3d 233 (3d Cir. 2009), the Third Circuit affirmed summary judgment on grounds of express preemption under the Vaccine Act. Interpreting the statute's legislative history as demonstrating congressional intent to preempt, sufficient to overcome any presumption against preemption, the Third Circuit reasoned that if the Vaccine Act is interpreted to allow case-by-case analysis of whether particular vaccine side effects are avoidable, then every design defect claim is subject to evaluation by a court. Id. at 246. If that were the case, the court reasoned, then each of the objectives extolled in the Vaccine Act's legislative history would be undermined. Id. Therefore, the court concluded that the statutory text, structure, and legislative history of Section 22 showed a “clear and manifest” expression of congressional intent to preempt design defect claims. Id. at 246.

The Bruesewitz court distinguished the recent U.S. Supreme Court opinion on preemption in Wyeth v. Levine, 129 S. Ct. 1187 (2009). In that case, the Supreme Court examined whether federal law preempted state tort claims alleging that a drug manufacturer failed to adequately warn of the dangers associated with a drug. Though recognizing that the Supreme Court concluded that state tort law claims were not preempted in that case, the Bruesewitz court found Levine “readily distinguishable.” Bruesewitz, 561 F.3d at 247, fn. 8. First, the Levine court explicitly noted the absence of an express preemption provision and found Congress's silence, coupled with its awareness of the prevalence of state tort litigation, powerful evidence against an intent to create broad preemption. Id. With the Vaccine Act, however, “Congress included an express preemption provision that was prompted ' by the prevalence of state tort litigation.” Id. Second, the Supreme Court in Levine recognized that under federal law, a drug manufacturer could strengthen a drug's label without pre-approval from the FDA. Id. The Third Circuit reasoned that this stood in contrast to the FDA's more extensive control and oversight of the approval of a drug's design and alteration. Id. Therefore, the finding of preemption in the Levine warning context was inapposite to whether preemption should apply in the Bruesewitz design defect context.

Plaintiffs' Argument

In responding to the petition for certiorari in Ferrari, plaintiffs argue that the Third Circuit decision does not actually create a sharp split with the Georgia Supreme Court decision, and that certiorari is not warranted. Rather, plaintiffs assert that the Third Circuit in Bruesewitz created a narrow holding that was specific to the DPT vaccine at issue in that case and that the Court's sweeping statements about the scope of the Vaccine Act's preemption provision are merely dicta. See Respondents' Brief in Opposition to Certiorari, American Home Products Corp. v. Ferrari, 2009 WL 1312859, *15-21 (U.S. May 8, 2009). Plaintiffs also contend that Congress never intended the Vaccine Act to set up an administrative compensation scheme as an exclusive remedy, but rather that the Act preserves victims' rights to bring a civil lawsuit if they are dissatisfied with the administrative compensation route. Id. at 1. Therefore, plaintiffs argue, rather than broadly preempt state tort remedies, Congress carved out a narrow limitation on vaccine manufacturers' civil tort liability under state law in Section 22 of the Vaccine Act. Id.

Conclusion

Despite plaintiffs' arguments against certiorari, the Supreme Court appears interested in the Ferrari case. On June 8, the Court sought an opinion from the U.S. Solicitor General on whether it should accept certiorari. If the Solicitor General advocates accepting certiorari, her position will bolster the manufacturers' efforts to obtain Supreme Court review of this issue. Of course, even if plaintiffs win the preemption issue and are able to take their claims to court, they will still have to show a link between vaccines and autism ' a scientific theory that, as discussed above, has been rejected by the Vaccine Court. Nevertheless, absent preemption, vaccine makers could face significant litigation costs ' regardless of whether the scientific community has reached consensus against an autism-vaccine link. This will be a decision to watch both for the vaccine manufacturers and all who are interested in where the Supreme Court will take its decision in Levine.

Kristin Ekert is Senior Writer in the Communications Department at the University of Pennsylvania Law School. She previously practiced law at Dechert LLP, where she was a member of the firm's mass tort and product liability group.

Does the Vaccine Act preempt all design defect claims in state and federal court? Parents convinced that their children's autism has been caused by inoculations, and their attorneys, recently achieved a surprising victory on the issue when the Georgia Supreme Court ruled that a plaintiff's design defect claims are not barred by the Vaccine Act's preemption clause. Vaccine makers, despite recent decisions in the special Vaccine Court rejecting scientific evidence linking autism and vaccines, worry that the Georgia opinion could open the floodgates to litigation. They have moved for certiorari to the United States Supreme Court.

Background

Congress enacted the Vaccine Act in 1986 to stabilize the vaccine market and thereby safeguard the vaccine supply, and to ensure adequate compensation for children injured by vaccines. See http://www.hrsa.gov/vaccinecompensation (last visited Sept. 22, 2009). The Act was a response to concerns that rising numbers of vaccine-related claims would cause manufacturers to abandon the vaccine market. See National Childhood Vaccine Injury Compensation Act of 1985: Hearing Before the S. Comm. on Labor and Human Resources, 99th Cong. 8 at 256 (Dec. 9, 1985). In addition, evidence suggested that the tort system often failed to provide adequate compensation for children injured by vaccines whose potential recovery was too small to make their cases attractive to attorneys. See National Childhood Vaccine-Injury Compensation Act: Hearing Before the S. Committee on Labor and Human Resources, 98th Cong. 171 at 146 (May 3, 1984).

The Vaccine Act established the National Vaccine Injury Compensation Program, a no-fault alternative compensation scheme under which children injured by vaccines could receive compensation for their injuries. 42 U.S.C.A. ” 300aa-1 et seq. Instead of suing manufacturers or health-care professionals, people claiming injury from vaccines must first file a petition for compensation with the U.S. Court of Federal Claims, which refers the petition to a Vaccine Court ' an office within the court of special masters. The Secretary of Health and Human Services is named as a respondent; vaccine manufacturers are not parties to Vaccine Act proceedings. The Vaccine Act requires that the special master of the Vaccine Court consider the petition, make findings of facts and conclusions of law, and issue a decision within 240 days. After a decision by the special master, either party may seek review before the Court of Federal Claims. Thereafter, either party may appeal that decision to the Federal Circuit.

Vaccine Injury Compensation Trust Fund

Where findings are in favor of the petitioner, payment of compensation is made from the “Vaccine Injury Compensation Trust Fund,” which is funded by a manufacturers' excise tax on vaccines covered by the Act. Since 1989, the Vaccine Court has issued more than 2,300 awards, totaling over $1.7 billion. See National Vaccine Injury Compensation Program, Statistic report, http://www.hrsa.gov/vaccinecompensation/statistics_report.htm (last visited Sept. 22, 2009).

If a petitioner rejects the judgment of the Court of Claims, he or she may then bring a civil action for the injury, subject to the Vaccine Act's preemption provision, 42 U.S.C.A. ' 33aa-22. Section 22 provides that “[n]o vaccine manufacturer shall be liable in a civil action” if the injury “resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” Id. Until recently, courts have consistently ruled that the provision expressly preempts all design defect claims. See American Home Products Corp. v. Ferrari , 668 S.E.2d 236, 239 (Ga. 2008) (noting that all non-Georgia courts to consider the issue in published opinions have held that Section 22 preempts all claims that a vaccine was defectively designed). As a result, plaintiffs have effectively been limited to the Vaccine Court's judgment except for narrow categories of claims (i.e., those for injuries that could have been avoided by proper preparation or proper directions and warnings).

Autism Claims

Since 1999, more than 5,500 families have filed autism-related claims under the Vaccine Injury Compensation Program. To manage the large number of claims, the Vaccine Court in 2002 created an Omnibus Autism Proceeding. See In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder, 2002 WL 31696785 (Fed. Cl. July 3, 2002). As is common in mass tort proceedings, the court focused on a few test cases that represent plaintiffs' theories of how vaccines can cause autism. Decisions in those cases would be used to guide future proceedings in the Vaccine Court.

In February 2009, the Vaccine Court issued opinions in three test cases evaluating evidence based on the theory that the MMR (measles, mumps, and rubella) vaccine, in combination with vaccines containing the preservative thimerosal, cause autism. See Hazlehurst v. Sec. of Health & Human Servs., No. 03-654V (Fed. Cl. Feb. 12, 2009); Cedillo v. Sec. of Health & Human Servs., No. 98-916V (Fed. Cl. Feb. 12, 2009); Snyder v. Sec. of Health & Human Servs., No. 01-162V (Fed. Cl. Feb. 12, 2009); all opinions available at http://www.uscfc.uscourts.gov/node/5026 (last visited July 31, 2009). In lengthy opinions, all three special masters rejected the proposition that the MMR and thimerosal combination caused autism. Id. After considering voluminous evidence ' including weeks of testimony, over 900 medical and scientific journal articles, and over 50 expert reports ' the special masters found that though the children in the cases tragically suffered from autism and other severe conditions, petitioners had failed to demonstrate that vaccinations played any role in causing those problems. Id.

The same three special masters are currently deliberating on a second set of autism cases in which the families claim that thimerosal alone caused autism. See http://www.hrsa.gov/vaccinecompensation/omnibusproceeding.htm (last visited Sept. 22, 2009). However, in their opinions rejecting the MMR and thimerosal combination theory, the special masters expressed skepticism toward the idea that autism could be caused by an after-birth injury. See, e.g., Cedillo v. Sec. of Health & Human Servs., No. 98-916V at 95-99 (Fed. Cl. Feb. 12, 2009) (describing as “weak” scientific evidence that postnatal factors can cause autism). It appears unlikely, therefore, that the special masters will accept petitioners' thimerosal single-agent theory.

A Major Hurdle

The Vaccine Court's rulings in the first three test cases should prove a major hurdle for petitioners. The Georgia Supreme Court ruling that a vaccine injury design defect claim was not necessarily preempted by Section 22 of the Vaccine Act may, however, provide opportunities for families of autistic children who seek to sue manufacturers based on an alleged autism-vaccine connection.

The case before the Georgia Supreme Court involved claims that Stefan Ferrari developed severe neurological injuries as a result of receiving thimerosal-laden vaccines. See American Home Products Corp. v. Ferrari , 668 S.E.2d 236 (Ga. 2008). Ferrari's parents first submitted a petition to the Vaccine Court, but when the Special Master failed to render a decision within 240 days, withdrew their petition and proceeded to sue the vaccine makers in state court in Georgia. The vaccine manufacturers moved for summary judgment on the basis of preemption. Ferrari v. American Home Products Corp. , 650 S.E.2d 585 (Ga. App. 2007). The trial court agreed and entered summary judgment dismissing the design defect claims on the ground that Section 22 of the Vaccine Act preempted such claims. Id. The Georgia Court of Appeals reversed. Id. It found that it could interpret Section 22 in one of two ways: 1) the statute preempts all design defect claims; or 2) design defect claims are preempted only if the side effects are determined to be unavoidable on a case-by-case basis. Id. The Georgia Supreme Court affirmed, holding that the Vaccine Act's preemption clause “clearly does not preempt all design defect claims against vaccine manufacturers,” “but instead provides that a vaccine manufacturer cannot be held liable for defective design if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable.” American Home Products Corp. v. Ferrari , 668 S.E.2d 236 at 242. Thus, the Georgia Supreme Court ruled that it was premature to conclude that Ferrari's design defect claim was preempted by the Act.

What About the Manufacturers?

Vaccine manufacturers worry that the Georgia Supreme Court's decision, construing Section 22 as a narrow rather than a broad preemption provision, could lead to a deluge of litigation in state court over the autism-vaccine link ' no matter that the Vaccine Court special masters have so far rejected the scientific evidence in favor of such a link. See Petition for Writ of Certiorari, American Home Products Corp. v. Ferrari, 2009 WL 598046 at *22-23 (U.S. March 5, 2009).

The manufacturers have brought the issue to the United States Supreme Court. In moving for certiorari, they argue that the Georgia Supreme Court ruling will reduce the Vaccine Court to nothing but a base that plaintiffs touch en route to court. Id. at 7. The unpredictability of liability, they argue, could drive vaccine manufacturers from the market and halt future production and development of vaccines. Id. at 19. Thus, the Georgia Supreme Court ruling could precipitate the same crisis that Congress sought to avert in passing the Vaccine Act ' the possibility of vaccine shortages and a resulting increase in the number of non-immunized children. Id. at 21.

In March of this year, after the vaccine manufacturers moved for certiorari in the Ferrari case, the U.S. Court of Appeals for the Third Circuit issued an order rejecting Ferrari's approach and holding that Section 22 does broadly preempt design defect claims in state and federal court. In Bruesewitz v. Wyeth , 561 F.3d 233 (3d Cir. 2009), the Third Circuit affirmed summary judgment on grounds of express preemption under the Vaccine Act. Interpreting the statute's legislative history as demonstrating congressional intent to preempt, sufficient to overcome any presumption against preemption, the Third Circuit reasoned that if the Vaccine Act is interpreted to allow case-by-case analysis of whether particular vaccine side effects are avoidable, then every design defect claim is subject to evaluation by a court. Id. at 246. If that were the case, the court reasoned, then each of the objectives extolled in the Vaccine Act's legislative history would be undermined. Id. Therefore, the court concluded that the statutory text, structure, and legislative history of Section 22 showed a “clear and manifest” expression of congressional intent to preempt design defect claims. Id. at 246.

The Bruesewitz court distinguished the recent U.S. Supreme Court opinion on preemption in Wyeth v. Levine , 129 S. Ct. 1187 (2009). In that case, the Supreme Court examined whether federal law preempted state tort claims alleging that a drug manufacturer failed to adequately warn of the dangers associated with a drug. Though recognizing that the Supreme Court concluded that state tort law claims were not preempted in that case, the Bruesewitz court found Levine “readily distinguishable.” Bruesewitz, 561 F.3d at 247, fn. 8. First, the Levine court explicitly noted the absence of an express preemption provision and found Congress's silence, coupled with its awareness of the prevalence of state tort litigation, powerful evidence against an intent to create broad preemption. Id. With the Vaccine Act, however, “Congress included an express preemption provision that was prompted ' by the prevalence of state tort litigation.” Id. Second, the Supreme Court in Levine recognized that under federal law, a drug manufacturer could strengthen a drug's label without pre-approval from the FDA. Id. The Third Circuit reasoned that this stood in contrast to the FDA's more extensive control and oversight of the approval of a drug's design and alteration. Id. Therefore, the finding of preemption in the Levine warning context was inapposite to whether preemption should apply in the Bruesewitz design defect context.

Plaintiffs' Argument

In responding to the petition for certiorari in Ferrari, plaintiffs argue that the Third Circuit decision does not actually create a sharp split with the Georgia Supreme Court decision, and that certiorari is not warranted. Rather, plaintiffs assert that the Third Circuit in Bruesewitz created a narrow holding that was specific to the DPT vaccine at issue in that case and that the Court's sweeping statements about the scope of the Vaccine Act's preemption provision are merely dicta. See Respondents' Brief in Opposition to Certiorari, American Home Products Corp. v. Ferrari, 2009 WL 1312859, *15-21 (U.S. May 8, 2009). Plaintiffs also contend that Congress never intended the Vaccine Act to set up an administrative compensation scheme as an exclusive remedy, but rather that the Act preserves victims' rights to bring a civil lawsuit if they are dissatisfied with the administrative compensation route. Id. at 1. Therefore, plaintiffs argue, rather than broadly preempt state tort remedies, Congress carved out a narrow limitation on vaccine manufacturers' civil tort liability under state law in Section 22 of the Vaccine Act. Id.

Conclusion

Despite plaintiffs' arguments against certiorari, the Supreme Court appears interested in the Ferrari case. On June 8, the Court sought an opinion from the U.S. Solicitor General on whether it should accept certiorari. If the Solicitor General advocates accepting certiorari, her position will bolster the manufacturers' efforts to obtain Supreme Court review of this issue. Of course, even if plaintiffs win the preemption issue and are able to take their claims to court, they will still have to show a link between vaccines and autism ' a scientific theory that, as discussed above, has been rejected by the Vaccine Court. Nevertheless, absent preemption, vaccine makers could face significant litigation costs ' regardless of whether the scientific community has reached consensus against an autism-vaccine link. This will be a decision to watch both for the vaccine manufacturers and all who are interested in where the Supreme Court will take its decision in Levine.

Kristin Ekert is Senior Writer in the Communications Department at the University of Pennsylvania Law School. She previously practiced law at Dechert LLP, where she was a member of the firm's mass tort and product liability group.