Litigation Upfdate

Supreme Court Holds Federal Vaccine Statute Expressly Preempts All State Law Design Defect Claims Against Vaccine Manufacturers Rather Than Only Claims Where Injury Could Not Have Been Avoided By Feasible Alternative Design

In Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 'Feb. 22, 2011), a child's pediatrician administered doses of the diphtheria-tetanus-pertussis (DTP) vaccine according to the Center for Disease Control's recommended childhood immunization schedule. Within 24 hours of her vaccination, the child began to experience seizures, suffering over 100 of them within a single month. Her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” Thereafter, the child's parents commenced a proceeding seeking compensation for her injuries pursuant to procedures set forth in the National Childhood Vaccine Injury Act of 1986 (NCVIA).

Under the NCVIA, a person injured by a vaccine may file a petition for compensation from the manufacturer in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. Within 240 days, a special master is required to make an informal adjudication of the petition applying a detailed no-fault compensation scheme set forth in the statute. Any objections are subject to review under similar time constraints by the claims court, which then enters final judgment. A claimant may choose either to accept the court's judgment or forego a tort action against the manufacturer or reject the judgment and pursue such an action.

After the special master denied plaintiffs' claim and the claims court confirmed the denial, plaintiffs filed suit in Pennsylvania state court, alleging that the defective design of the DTP vaccine caused their child's disabilities and the manufacturer was subject to both strict and negligence liability for defective design under Pennsylvania common law. Upon removal of the action to federal court, the United States District Court for the Eastern District of Pennsylvania granted summary judgment for the defendant, holding that Pennsylvania law was expressly preempted by an NCVIA provision that “[n]o 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.” Plaintiffs appealed, and the United States Court of Appeals for the Third Circuit affirmed. The United States Supreme Court granted certiorari to address the scope of the NCVIA's preemption provision.

The Court held that the NCVIA preempts all design defect claims seeking compensation for injury or death caused by a vaccine's side-effects. The Court reasoned that the language of the provision referring to side-effects that were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings” took the vaccine's particular design as a given and thus extinguished liability for injuries arising out of that design. In addition, the three traditional bases for product liability are defects in design, manufacture and warnings, and the provision's mention only of the latter two suggested that claims arising from the first were what Congress intended to preempt. By contrast, plaintiffs' argument that the NCVIA preempts only claims arising from side-effects that were unavoidable by the adoption of feasible alternative designs was not supported by the statutory language. Further, plaintiffs' contention that design defect claims were immunized only if the manufacturer had properly manufactured the vaccine and warned about its risks was not grammatically supported, as the statute used the phrase “even though” rather than “and” after the word “unavoidable.”

Beyond the language of the preemption clause itself, the Court noted that other provisions of the statute, and of the United States Food and Drug Administration (FDA) regulations thereunder, impose various requirements on both vaccine manufacture and vaccine warnings, while there are no provisions about vaccine design. Thus both the statutory structure and language supported the result reached by the Court. In light of this, the Court stated there was no need to resort to consideration of legislative history, but in any event, examination of that history provided no support for plaintiffs' arguments. Indeed, part of a House committee report counseled claimants who could not prove a manufacturing or warning defect to pursue the compensation scheme rather than a tort remedy, again supporting the conclusion that there was no tort remedy for design defects.

MA Federal District Court Holds Defense Expert's Testimony on Lack of Causal Link Between Drug and Suicide Attempts Admissible Because Expert Relied on His Own Peer-Reviewed Study

In In re Neurontin Marketing and Sales Practices and Products Liability Litigation, 2011 WL 1048971 (D. Mass. Mar. 18, 2011), over 100 individuals experienced behavioral disturbances, depression and ultimately suicidal actions, including completed suicide, after their doctors prescribed an anti-epileptic drug, gabapentin. The individuals and their estates' representatives sued the drug's manufacturers in the United States District Court for the District of Massachusetts, alleging the drug caused the individuals' injuries and deaths. Since 2004, gabapentin has been the subject of a protracted multi-district litigation with two distinct parts: 1) “sales and marketing” actions brought by consumer purchasers and third-party payors stemming from an alleged fraudulent off-label marketing scheme; and 2) “products liability” actions, such as this one, alleging injuries resulting from the use of gabapentin. In the latter type of action, plaintiffs bear the burden of establishing both general and specific causation. As explained in the Federal Judicial Center's Reference Manual on Scientific Evidence, cited by the court, “General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease ' . Specific, or individual, causation, however, is established by demonstrating that a given exposure is the cause of an individual's disease ' .”

In support of their theory of general causation, plaintiffs relied upon a meta-analysis by the FDA of various manufacturers' clinical trials. The analysis supported an association between one class of anti-epileptic drugs ' which included gabapentin and four others ' and an elevated risk of suicidal thoughts and behavior short of an actual suicide attempt. The Defendants' expert, however, conducted studies specifically of gabapentin, which were published in a peer-reviewed journal, from which he concluded that, regardless of whether the drug causes an increase in suicidal thoughts or behavior, there was no increased risk of actual suicide attempts. In an unpublished supplemental report, the expert expanded his conclusion, opining that the drug did not even increase the risk of suicidal thinking or behavior.

Plaintiffs moved to partially exclude the testimony of the defendants' expert because the methodology of his studies was unreliable. Specifically, plaintiffs argued the expert's findings should be characterized in terms of “associations” rather than “causal inferences,” and attacked his methodology on the basis that it did not take into account the concomitant effect of certain other drugs taken by the gabapentin patients.

The court denied the motion to exclude the defendants' expert's testimony despite finding that plaintiffs' criticisms “undermined” the expert's opinion. Citing the publication of the expert's study in a peer-reviewed journal, the court explained that the expert's opinion was not so fundamentally unsupported that it must be excluded. Instead, the conflicting views of the plaintiffs' and defendants' experts should be explored through cross-examination and submitted for a jury's consideration. However, the court did preclude the defendants' expert from testifying that his studies supported any conclusion relating to suicidal thoughts (as discussed in his unpublished supplemental report), as the studies had been specifically limited to the issue of suicide attempts.

David R. Geiger is a Partner and Chair of Foley Hoag's Product Liability and Complex Tort Practice Group. He has been recognized by The Best Lawyers in America, New England SuperLawyers and Who's Who Legal for his accomplishments. Creighton K. Page is an Associate in the firm's Litigation Department.

Supreme Court Holds Federal Vaccine Statute Expressly Preempts All State Law Design Defect Claims Against Vaccine Manufacturers Rather Than Only Claims Where Injury Could Not Have Been Avoided By Feasible Alternative Design

In Bruesewitz v. Wyeth LLC , 131 S. Ct. 1068 'Feb. 22, 2011), a child's pediatrician administered doses of the diphtheria-tetanus-pertussis (DTP) vaccine according to the Center for Disease Control's recommended childhood immunization schedule. Within 24 hours of her vaccination, the child began to experience seizures, suffering over 100 of them within a single month. Her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” Thereafter, the child's parents commenced a proceeding seeking compensation for her injuries pursuant to procedures set forth in the National Childhood Vaccine Injury Act of 1986 (NCVIA).

Under the NCVIA, a person injured by a vaccine may file a petition for compensation from the manufacturer in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. Within 240 days, a special master is required to make an informal adjudication of the petition applying a detailed no-fault compensation scheme set forth in the statute. Any objections are subject to review under similar time constraints by the claims court, which then enters final judgment. A claimant may choose either to accept the court's judgment or forego a tort action against the manufacturer or reject the judgment and pursue such an action.

After the special master denied plaintiffs' claim and the claims court confirmed the denial, plaintiffs filed suit in Pennsylvania state court, alleging that the defective design of the DTP vaccine caused their child's disabilities and the manufacturer was subject to both strict and negligence liability for defective design under Pennsylvania common law. Upon removal of the action to federal court, the United States District Court for the Eastern District of Pennsylvania granted summary judgment for the defendant, holding that Pennsylvania law was expressly preempted by an NCVIA provision that “[n]o 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.” Plaintiffs appealed, and the United States Court of Appeals for the Third Circuit affirmed. The United States Supreme Court granted certiorari to address the scope of the NCVIA's preemption provision.

The Court held that the NCVIA preempts all design defect claims seeking compensation for injury or death caused by a vaccine's side-effects. The Court reasoned that the language of the provision referring to side-effects that were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings” took the vaccine's particular design as a given and thus extinguished liability for injuries arising out of that design. In addition, the three traditional bases for product liability are defects in design, manufacture and warnings, and the provision's mention only of the latter two suggested that claims arising from the first were what Congress intended to preempt. By contrast, plaintiffs' argument that the NCVIA preempts only claims arising from side-effects that were unavoidable by the adoption of feasible alternative designs was not supported by the statutory language. Further, plaintiffs' contention that design defect claims were immunized only if the manufacturer had properly manufactured the vaccine and warned about its risks was not grammatically supported, as the statute used the phrase “even though” rather than “and” after the word “unavoidable.”

Beyond the language of the preemption clause itself, the Court noted that other provisions of the statute, and of the United States Food and Drug Administration (FDA) regulations thereunder, impose various requirements on both vaccine manufacture and vaccine warnings, while there are no provisions about vaccine design. Thus both the statutory structure and language supported the result reached by the Court. In light of this, the Court stated there was no need to resort to consideration of legislative history, but in any event, examination of that history provided no support for plaintiffs' arguments. Indeed, part of a House committee report counseled claimants who could not prove a manufacturing or warning defect to pursue the compensation scheme rather than a tort remedy, again supporting the conclusion that there was no tort remedy for design defects.

MA Federal District Court Holds Defense Expert's Testimony on Lack of Causal Link Between Drug and Suicide Attempts Admissible Because Expert Relied on His Own Peer-Reviewed Study

In In re Neurontin Marketing and Sales Practices and Products Liability Litigation, 2011 WL 1048971 (D. Mass. Mar. 18, 2011), over 100 individuals experienced behavioral disturbances, depression and ultimately suicidal actions, including completed suicide, after their doctors prescribed an anti-epileptic drug, gabapentin. The individuals and their estates' representatives sued the drug's manufacturers in the United States District Court for the District of Massachusetts, alleging the drug caused the individuals' injuries and deaths. Since 2004, gabapentin has been the subject of a protracted multi-district litigation with two distinct parts: 1) “sales and marketing” actions brought by consumer purchasers and third-party payors stemming from an alleged fraudulent off-label marketing scheme; and 2) “products liability” actions, such as this one, alleging injuries resulting from the use of gabapentin. In the latter type of action, plaintiffs bear the burden of establishing both general and specific causation. As explained in the Federal Judicial Center's Reference Manual on Scientific Evidence, cited by the court, “General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease ' . Specific, or individual, causation, however, is established by demonstrating that a given exposure is the cause of an individual's disease ' .”

In support of their theory of general causation, plaintiffs relied upon a meta-analysis by the FDA of various manufacturers' clinical trials. The analysis supported an association between one class of anti-epileptic drugs ' which included gabapentin and four others ' and an elevated risk of suicidal thoughts and behavior short of an actual suicide attempt. The Defendants' expert, however, conducted studies specifically of gabapentin, which were published in a peer-reviewed journal, from which he concluded that, regardless of whether the drug causes an increase in suicidal thoughts or behavior, there was no increased risk of actual suicide attempts. In an unpublished supplemental report, the expert expanded his conclusion, opining that the drug did not even increase the risk of suicidal thinking or behavior.

Plaintiffs moved to partially exclude the testimony of the defendants' expert because the methodology of his studies was unreliable. Specifically, plaintiffs argued the expert's findings should be characterized in terms of “associations” rather than “causal inferences,” and attacked his methodology on the basis that it did not take into account the concomitant effect of certain other drugs taken by the gabapentin patients.

The court denied the motion to exclude the defendants' expert's testimony despite finding that plaintiffs' criticisms “undermined” the expert's opinion. Citing the publication of the expert's study in a peer-reviewed journal, the court explained that the expert's opinion was not so fundamentally unsupported that it must be excluded. Instead, the conflicting views of the plaintiffs' and defendants' experts should be explored through cross-examination and submitted for a jury's consideration. However, the court did preclude the defendants' expert from testifying that his studies supported any conclusion relating to suicidal thoughts (as discussed in his unpublished supplemental report), as the studies had been specifically limited to the issue of suicide attempts.

David R. Geiger is a Partner and Chair of Foley Hoag's Product Liability and Complex Tort Practice Group. He has been recognized by The Best Lawyers in America, New England SuperLawyers and Who's Who Legal for his accomplishments. Creighton K. Page is an Associate in the firm's Litigation Department.