Legislative Solutions to Toxic Torts: Congress and the Thimerosal and Asbestos Litigations Part One of a Two-Part Series

Part One of a Two-Part Series

Over the course of the last 2 years, Congress has tried to find a legislative solution to two very different alleged toxic torts. In November 2002, a rider was attached to the Homeland Security Act of 2002 that would have effectively brought one of the most recent toxic tort litigations ' the thimerosal litigation ' to an abrupt end. Throughout the spring and summer of 2003, Congress tried to establish a $115 billion national trust fund for perhaps the largest and oldest and possibly most abused toxic tort litigation ' the asbestos litigation. Neither of these attempts, for very different reasons, was successful ' the thimerosal rider was repealed in early 2003 and in November 2003, the Senate decided not to vote on the Fairness in Asbestos Injury Resolution Act of 2003. What follows is an overview of those legislative initiatives.

Legislating Away the Thimerosal Litigation

Thimerosal (pronounced thigh-MARE-uh-sol) is a mercury-based preservative, which, until quite recently, was used for beneficial reasons in various pediatric vaccines. Beginning in 1999, vaccine manufacturers voluntarily agreed to stop using thimerosal due to a purported rise in “regressive autism” (ie, normally developing infants suddenly regressing neurologically). By Nov. 25, 2002, when the Homeland Security Act was signed by President Bush, more than 100 lawsuits had been filed by parents of autistic children attempting to blame a number of large pharmaceutical companies for their children's condition. In order to help safeguard America's vaccine program, Congress transformed any claim against a vaccine's “components or ingredients” into a claim against the vaccine itself and, thereby, made any such claim go through a special federal program that pays limited damages for vaccine-related injuries before it can be litigated in court.

National Childhood Vaccine Injury Act of 1986

The National Childhood Vaccine Injury Act of 1986 (42 U.S.C. ”300aa-1 – 300aa-34) (“Vaccine Injury Act”) created the National Vaccine Injury Compensation Program (the “Program”) and provides that no one may sue a vaccine manufacturer or administrator for more than $1000 for death or injury caused by any of the vaccines set forth in the statute's Vaccine Injury Table, unless he or she files a petition for compensation under the program, and the U.S. Court of Federal Claims issues a judgment on the petition. The Program, which is funded by a tax on vaccines, provides more limited recovery than is generally allowed under state tort law, but provides relatively fast no-fault compensation.

To eliminate the threat of unlimited liability, recovery under the Program is restricted to actual unreimbursable expenses, up to $250,000 for pain and suffering and emotional distress, $250,000 in the event of a vaccine-related death, actual and anticipated loss of earnings, and attorneys' fees and other costs, but no punitive damages. A petitioner dissatisfied with his or her recovery under the Program may sue a vaccine manufacturer or administrator under state tort law, with some limitations. For example, manufacturers are not liable for failure to provide warnings directly to the injured party: A warning to a vaccine administrator is deemed sufficient. Moreover, there are rebuttable presumptions that manufacturers who comply with federal regulations are not subject to liability for failure to warn or punitive damages. At the time of the Vaccine Injury Act's passage, it was hoped that “the relative certainty and generosity of the systems' awards will divert a significant number of potential plaintiffs from litigation.” H.R. Rep. No. 99-908, Part I, 99th Cong., 2d Sess. 13 (1986).

The History and Rise of the Thimerosal Litigation

Beginning in the mid- to late-1980s, vaccine manufacturers switched from single dose vials of infant vaccines to multidose vials. In order to guard against contamination when a pediatrician would use the same vial to vaccinate several children, vaccine manufacturers added thimerosal to the vaccines in order to prevent fungal and bacteria growth.

Thimerosal, which has been used safely by drug manufacturers since the 1930s, is broken down by the body to a form of ethylmercury, a chemical cousin to methylmercury. In some studies, prenatal exposure to methylmercury has been associated with subtle neurodevelopmental abnormalities. High doses of ethylmercury and methylmercury are generally recognized as kidney and nerve toxins. The question posed by the thimerosal litigation is whether low doses of ethylmercury can cause autism in children. Plaintiffs contend that over the same period of time that thimerosal was added to infant vaccines, a marked rise occurred in the incidence of autism across the United States. Defendants argue that correlation is not causation and point to the complete absence of any epidemiological evidence of causation.

In the spring of 1999, the U.S. Food and Drug Administration (FDA) determined that under the recommended childhood immunization schedule, some infants risked possible exposure to cumulative doses of ethylmercury that exceeded some federal guidelines governing exposure to methylmercury. However, significantly, the FDA found no evidence whatsoever of harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions.

In the summer of 1999, strictly as a precautionary measure only, the U.S. Public Health Service (including the FDA, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration) and the American Academy of Pediatrics issued a Joint Statement, urging vaccine manufacturers to reduce or eliminate thimerosal in vaccines as soon as possible. Over the course of the last 2 years most vaccine manufacturers, out of an abundance of caution, voluntarily removed thimerosal from their pediatric vaccines.

In the fall of 2001, the Institute of Medicine's Immunization Safety Review Committee (Committee) concluded that the evidence is inadequate to either accept or reject a causal relationship between thimerosal exposure from childhood vaccines and the neurodevelopmental disorders of autism, attention deficit hyperactivity disorder, and speech or language delay. The Committee did conclude, however, that the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders was “biologically plausible.” As of December 2003, however, not a single study had conclusively linked thimerosal-containing vaccines to autism or other neurodegenerative effects. Indeed, a University of Rochester study (published in The Lancet shortly after the Homeland Security Act was signed) found that the small amount of thimerosal in childhood vaccines should be considered safe.

The conclusion that thimerosal was at least, hypothetically, a biologically plausible cause of autism led to a wave of lawsuits. By November 2002, approximately 100 lawsuits had been filed against various drug manufacturers, with the potential for thousands more lawsuits to be filed in the near future.

The Courts and Thimerosal

By its very terms, the Vaccine Injury Act did not extend the Program to a vaccine-related injury or death “associated with an adulterant or contaminant intentionally added to such vaccine.” 42 U.S.C. '300aa-33(5) (emphasis added). However, neither “adulterant” nor “contaminant” is defined by the Vaccine Injury Act. Consequently, the language of the Vaccine Injury Act begged the question of whether a claim about thimerosal, an allegedly injury-causing ingredient, was a vaccine “component” and, therefore, subject to the Program or an “adulterant” or a “contaminant” that was not subject to the Program.

Courts have consistently held that thimerosal is not an “adulterant” or a “contaminant” as those terms are used in the Vaccine Injury Act. Instead, courts have held that thimerosal is a “component” and therefore covered by the Program. See, e.g., Liu v. Aventis Pasteur, 219 F. Supp. 2d 762 (W.D. Tex 2002) (holding thimerosal plaintiffs' injuries were “vaccine-related” and, and as result, had to be filed first in Federal Claims court); Strauss v. American Home Products Corp., 208 F. Supp. 2d 711 (S.D. Tex. 2002) (finding injuries from thimerosal are “vaccine-related” under the Vaccine Injury Act); Owens v. American Home Products Corp., 203 F. Supp.2d 748 (S.D. Tex. 2002) (holding thimerosal was not an “adulterant or contaminant,” but rather, a “constituent material” of the vaccines).

Congress and Thimerosal

Despite this consistent body of case law, Congress decided to clarify that the Program was applicable not only to vaccines in the Vaccine Injury Table, but to “any component or ingredient of any such vaccine.” Congress made this clarification near the very end of the Homeland Security Act of 2002 (the “Homeland Security Act”), Sections 1714-1717. Section 1715 of the Homeland Security Act provided that the terms “adulterate or contaminant shall not include any component or ingredient.” Section 1717 of the Homeland Security Act further provided that this clarification was “applicable to all actions or proceedings on or after the date of the enactment of this Act,” which was Nov. 25, 2002.

At the time that the Homeland Security Act was passed, the thimerosal rider attracted a great deal of media attention. Most of this attention, however, was focused on process rather than substance. The thimerosal rider was appended to the Homeland Security Act shortly before it was approved, but no legislator was willing to take credit for inserting the thimerosal rider into the Act, thereby triggering a rash of articles and op-ed pieces. See, eg, “Homeland Bill Rider Aids Drugmakers,” Washington Post, Nov. 15, 2002, p. A7. In the end, the criticism of the rider and concern about the legislative process were enough to cause Congress to reverse itself.

On Feb. 13, 2003, less than 3 months after the clarification became law, Congress repealed it. P.L. 108-7 (2003), Division L, '102 repealed Section 1714-1717, and provided that the Program “shall be applied and administered as if the sections … had never been enacted. … No inference shall be drawn from enactment of sections 1714 through 1717 … or from this repeal, regarding the law prior to enactment of sections 1714 through 1717. … Further, no inference shall be drawn that [this repeal] affects [sic] any change in that prior law. …”Part two of this article will discuss the asbestos litigation and the manner in which courts and Congress have dealt with it.

Part One of a Two-Part Series

Over the course of the last 2 years, Congress has tried to find a legislative solution to two very different alleged toxic torts. In November 2002, a rider was attached to the Homeland Security Act of 2002 that would have effectively brought one of the most recent toxic tort litigations ' the thimerosal litigation ' to an abrupt end. Throughout the spring and summer of 2003, Congress tried to establish a $115 billion national trust fund for perhaps the largest and oldest and possibly most abused toxic tort litigation ' the asbestos litigation. Neither of these attempts, for very different reasons, was successful ' the thimerosal rider was repealed in early 2003 and in November 2003, the Senate decided not to vote on the Fairness in Asbestos Injury Resolution Act of 2003. What follows is an overview of those legislative initiatives.

Legislating Away the Thimerosal Litigation

Thimerosal (pronounced thigh-MARE-uh-sol) is a mercury-based preservative, which, until quite recently, was used for beneficial reasons in various pediatric vaccines. Beginning in 1999, vaccine manufacturers voluntarily agreed to stop using thimerosal due to a purported rise in “regressive autism” (ie, normally developing infants suddenly regressing neurologically). By Nov. 25, 2002, when the Homeland Security Act was signed by President Bush, more than 100 lawsuits had been filed by parents of autistic children attempting to blame a number of large pharmaceutical companies for their children's condition. In order to help safeguard America's vaccine program, Congress transformed any claim against a vaccine's “components or ingredients” into a claim against the vaccine itself and, thereby, made any such claim go through a special federal program that pays limited damages for vaccine-related injuries before it can be litigated in court.

National Childhood Vaccine Injury Act of 1986

The National Childhood Vaccine Injury Act of 1986 (42 U.S.C. ”300aa-1 – 300aa-34) (“Vaccine Injury Act”) created the National Vaccine Injury Compensation Program (the “Program”) and provides that no one may sue a vaccine manufacturer or administrator for more than $1000 for death or injury caused by any of the vaccines set forth in the statute's Vaccine Injury Table, unless he or she files a petition for compensation under the program, and the U.S. Court of Federal Claims issues a judgment on the petition. The Program, which is funded by a tax on vaccines, provides more limited recovery than is generally allowed under state tort law, but provides relatively fast no-fault compensation.

To eliminate the threat of unlimited liability, recovery under the Program is restricted to actual unreimbursable expenses, up to $250,000 for pain and suffering and emotional distress, $250,000 in the event of a vaccine-related death, actual and anticipated loss of earnings, and attorneys' fees and other costs, but no punitive damages. A petitioner dissatisfied with his or her recovery under the Program may sue a vaccine manufacturer or administrator under state tort law, with some limitations. For example, manufacturers are not liable for failure to provide warnings directly to the injured party: A warning to a vaccine administrator is deemed sufficient. Moreover, there are rebuttable presumptions that manufacturers who comply with federal regulations are not subject to liability for failure to warn or punitive damages. At the time of the Vaccine Injury Act's passage, it was hoped that “the relative certainty and generosity of the systems' awards will divert a significant number of potential plaintiffs from litigation.” H.R. Rep. No. 99-908, Part I, 99th Cong., 2d Sess. 13 (1986).

The History and Rise of the Thimerosal Litigation

Beginning in the mid- to late-1980s, vaccine manufacturers switched from single dose vials of infant vaccines to multidose vials. In order to guard against contamination when a pediatrician would use the same vial to vaccinate several children, vaccine manufacturers added thimerosal to the vaccines in order to prevent fungal and bacteria growth.

Thimerosal, which has been used safely by drug manufacturers since the 1930s, is broken down by the body to a form of ethylmercury, a chemical cousin to methylmercury. In some studies, prenatal exposure to methylmercury has been associated with subtle neurodevelopmental abnormalities. High doses of ethylmercury and methylmercury are generally recognized as kidney and nerve toxins. The question posed by the thimerosal litigation is whether low doses of ethylmercury can cause autism in children. Plaintiffs contend that over the same period of time that thimerosal was added to infant vaccines, a marked rise occurred in the incidence of autism across the United States. Defendants argue that correlation is not causation and point to the complete absence of any epidemiological evidence of causation.

In the spring of 1999, the U.S. Food and Drug Administration (FDA) determined that under the recommended childhood immunization schedule, some infants risked possible exposure to cumulative doses of ethylmercury that exceeded some federal guidelines governing exposure to methylmercury. However, significantly, the FDA found no evidence whatsoever of harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions.

In the summer of 1999, strictly as a precautionary measure only, the U.S. Public Health Service (including the FDA, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration) and the American Academy of Pediatrics issued a Joint Statement, urging vaccine manufacturers to reduce or eliminate thimerosal in vaccines as soon as possible. Over the course of the last 2 years most vaccine manufacturers, out of an abundance of caution, voluntarily removed thimerosal from their pediatric vaccines.

In the fall of 2001, the Institute of Medicine's Immunization Safety Review Committee (Committee) concluded that the evidence is inadequate to either accept or reject a causal relationship between thimerosal exposure from childhood vaccines and the neurodevelopmental disorders of autism, attention deficit hyperactivity disorder, and speech or language delay. The Committee did conclude, however, that the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders was “biologically plausible.” As of December 2003, however, not a single study had conclusively linked thimerosal-containing vaccines to autism or other neurodegenerative effects. Indeed, a University of Rochester study (published in The Lancet shortly after the Homeland Security Act was signed) found that the small amount of thimerosal in childhood vaccines should be considered safe.

The conclusion that thimerosal was at least, hypothetically, a biologically plausible cause of autism led to a wave of lawsuits. By November 2002, approximately 100 lawsuits had been filed against various drug manufacturers, with the potential for thousands more lawsuits to be filed in the near future.

The Courts and Thimerosal

By its very terms, the Vaccine Injury Act did not extend the Program to a vaccine-related injury or death “associated with an adulterant or contaminant intentionally added to such vaccine.” 42 U.S.C. '300aa-33(5) (emphasis added). However, neither “adulterant” nor “contaminant” is defined by the Vaccine Injury Act. Consequently, the language of the Vaccine Injury Act begged the question of whether a claim about thimerosal, an allegedly injury-causing ingredient, was a vaccine “component” and, therefore, subject to the Program or an “adulterant” or a “contaminant” that was not subject to the Program.

Courts have consistently held that thimerosal is not an “adulterant” or a “contaminant” as those terms are used in the Vaccine Injury Act. Instead, courts have held that thimerosal is a “component” and therefore covered by the Program. See, e.g., Liu v. Aventis Pasteur , 219 F. Supp. 2d 762 (W.D. Tex 2002) (holding thimerosal plaintiffs' injuries were “vaccine-related” and, and as result, had to be filed first in Federal Claims court); Strauss v. American Home Products Corp., 208 F. Supp. 2d 711 (S.D. Tex. 2002) (finding injuries from thimerosal are “vaccine-related” under the Vaccine Injury Act); Owens v. American Home Products Corp., 203 F. Supp.2d 748 (S.D. Tex. 2002) (holding thimerosal was not an “adulterant or contaminant,” but rather, a “constituent material” of the vaccines).

Congress and Thimerosal

Despite this consistent body of case law, Congress decided to clarify that the Program was applicable not only to vaccines in the Vaccine Injury Table, but to “any component or ingredient of any such vaccine.” Congress made this clarification near the very end of the Homeland Security Act of 2002 (the “Homeland Security Act”), Sections 1714-1717. Section 1715 of the Homeland Security Act provided that the terms “adulterate or contaminant shall not include any component or ingredient.” Section 1717 of the Homeland Security Act further provided that this clarification was “applicable to all actions or proceedings on or after the date of the enactment of this Act,” which was Nov. 25, 2002.

At the time that the Homeland Security Act was passed, the thimerosal rider attracted a great deal of media attention. Most of this attention, however, was focused on process rather than substance. The thimerosal rider was appended to the Homeland Security Act shortly before it was approved, but no legislator was willing to take credit for inserting the thimerosal rider into the Act, thereby triggering a rash of articles and op-ed pieces. See, eg, “Homeland Bill Rider Aids Drugmakers,” Washington Post, Nov. 15, 2002, p. A7. In the end, the criticism of the rider and concern about the legislative process were enough to cause Congress to reverse itself.

On Feb. 13, 2003, less than 3 months after the clarification became law, Congress repealed it. P.L. 108-7 (2003), Division L, '102 repealed Section 1714-1717, and provided that the Program “shall be applied and administered as if the sections … had never been enacted. … No inference shall be drawn from enactment of sections 1714 through 1717 … or from this repeal, regarding the law prior to enactment of sections 1714 through 1717. … Further, no inference shall be drawn that [this repeal] affects [sic] any change in that prior law. …”Part two of this article will discuss the asbestos litigation and the manner in which courts and Congress have dealt with it.