We Need a No-Fault Compensation System for Drug Injuries

The Evolution of Federal Regulation

The original federal drug regulatory regime, codified in the 1906 Pure Food and Drugs Act, had a narrow purpose: regulating 'adulterated' and 'misbranded' products ' ie, products whose actual composition deviated from that specified in their labels. Pure Food and Drugs Act, Pub. L. No. 59-384, ” 6, 8, 10, 34 Stat. 768, 770-71 (1906). As long as a product's label accurately reflected its composition, the product fell outside the 1906 Act's regulatory scope. Drugs were not pre-cleared for safety or effectiveness. Tort law claims based on injuries from those products provided an important check on the careless introduction into the market of unsafe products, giving manufacturers the incentive to ensure their products were not dangerous, therefore avoiding the possibility of liability for injuries arising from these products.

In 1938, Congress enacted the Federal Food Drug and Cosmetic Act (FDCA), which dramatically expanded the FDA's regulatory authority, prohibiting new drugs from reaching the market until the agency had verified the safety of the product 'for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.' Federal Food Drug and Cosmetic Act, Pub. L. No. 75-717, ' 505(d)(1), 52 Stat. 1040, 1052 (1938) (codified as amended at 21 U.S.C. ' 355(d)(1)). In 1962, Congress further amended the FDCA to require manufacturers seeking new drug approval to demonstrate to the FDA that their proposed products were not only safe but also effective for each labeled use. Drug Amendments of 1962, Pub. L. No. 87-781, ' 102(c), 76 Stat. 780, 781-82 (1962) (codified at 21 U.S.C. ' 355(d)(5)). Through these and subsequent congressional actions, Congress has given the FDA the comprehensive mandate of ensuring that products entering the marketplace have been tested for both safety and effectiveness, as well as final control over which drugs are to be sold in the marketplace. See Jeffrey E. Shuren, The Modern Regulatory Administrative State: A Response to Changing Circumstances, 38 Harvard J. on Legis. 291, 299-315 (2001).

As discussed in the May, 2003 issue of this newsletter, the FDA has responded to this mandate by implementing a regulatory system that regulates prescription drugs from cradle to grave, such that it is difficult to identify areas of potential risk reduction that the FDA does not extensively regulate.

Ideally, a federal regulatory regime for prescription drugs should encourage innovation and the timely approval of new products while ensuring access to pharmaceutical products and maximizing patient protection. The FDA accomplishes this last goal through its testing requirements, labeling requirements and continuing oversight of marketed drugs.

Ensuring Patient Safety and Drug Efficacy

The FDA's oversight of prescription-drug safety encompasses three broad areas. First, the agency must approve each new drug product as safe and effective before it can be marketed. This is accomplished through review of applications submitted by manufacturers, containing extensive information on a drug's chemistry, pharmacology, toxicity and manufacturing, as well as clinical safety and effectiveness information from human trials.

Second, the agency must determine that a drug product's labeling accurately conveys necessary directions. The FDA cannot approve a drug until it is satisfied that the labeling accurately describes the drug's indications and dosages, routes, methods, frequency and duration of administration, and any relevant hazards, warnings, contraindications, side effects and precautions of use. 21 C.F.R. ” 201.100(c)(1); 314.125(b). This permits prescribers to identify those individuals who can benefit from a drug, individuals who should not use a product because the possible risks to them outweigh the drug's benefits, and contingent risks patients should understand prior to taking the drug.

Third, the FDA continues to monitor products after they are marketed. Drugs may sometimes have unforeseeable adverse effects on certain populations. For example, serious adverse events may occur in some subpopulations at a rate too low to be detected as significant in clinical trials, and thus may not appear until after marketing. The FDA thus imposes on manufacturers a continuing duty to promptly review all adverse drug experience information received from any source, foreign or domestic, and to report such events to the FDA either periodically or, for more serious events, on an expedited basis. 21 C.F.R. ' 314.80. Manufacturers must also report annually all new information that might affect the safety, effectiveness or labeling of the drug. The FDA inspects manufacturers routinely to ensure, among other things, compliance with reporting requirements, and can impose significant administrative and criminal penalties for violations. In addition, the FDA solicits adverse event information from health care practitioners and the public on a voluntary basis. The agency may also require certain post-marketing studies from the manufacturer as a condition of approval.

The goal of the FDA's comprehensive regulation of drugs is to ensure that risks posed by medical products to the public throughout products' life cycles are as limited as possible. FDA, Task Force on Risk Management, Managing the Risks From Medical Product Use: Creating a Risk Management Framework (May 1999) (hereinafter, 'Managing Medical Risks'). However, the FDA recognizes the simple truth that no drug is without risk, and that drug approval must be based on a scientific analysis of the benefits to the public health as a whole versus the risk of individual harm posed by a drug. According to the FDA, 'safety does not mean zero risk. A safe product is one that has reasonable risks, given the magnitude of the benefit expected and the alternatives available.' Id., pt. 4 at 1.

The FDA's risk-management scheme also reflects a commitment to continual evolution, incorporating new management tools and emerging technology. For example, the agency has recently published a series of concept papers on risk management to facilitate public discussion and get public input on new agency proposals in the areas of assessing risk during drug development (FDA, Concept Paper: Premarketing Risk Assessment (March 2003), at www.fda.gov/cder/meeting/riskManageI.htm), individualized risk management programs for drugs as part of the approval process (FDA, Concept Paper: Risk Management Programs (March 2003), at www.fda.gov/cder/meeting/riskManageII.htm), and improving pharmacovigilance (FDA, Concept Paper: Risk Assessment of Observational Data: Good Pharma-covigilance Practices and Pharma- coepidemiologic Assessment (March 2003), at www.fda.gov/cder/meeting/riskManageIII.htm).

These papers include proposals for maximizing the value of the overall process of risk management planning, which encompasses the efforts of a manufacturer to minimize the risk from its product's use through a variety of means, including labeling, risk assessment, pharmacovigilance, and special studies or interventions. The agency is also working with partners such as New York's Columbia Presbyterian Hospital on developing tools that utilize current information technology to give the FDA immediate access to information about possible adverse drug events. FDA Commissioner Mark B. McClellan, Speech Before FDLI (April 1, 2003) at http://www.fda.gov/oc/speeches/2003/fdli0401.html.

In addition, in August 2002, the agency began a major initiative on 'Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach,' which is designed to update cGMPs to reflect advances in manufacturing technologies and methods and evaluate and improve upon the agency's approach to reviews and inspections related to the manufacturing of human and animal drugs and biologics. In March 2003, the FDA also announced two proposed rules: a requirement for bar codes on drugs to reduce the number of medication errors by verifying that the right drug is being given to the right patient at the right time (FDA, Bar Code Label Requirement for Human Drug Products and Blood, Proposed Rule, 68 Fed. Reg. 12,500 (March 15, 2003)), and a proposed revamping of safety-reporting requirements aimed at enhancing 'the agency's ability to effectively monitor and improve the safe use of medications' by improving the quality and usefulness of safety reports submitted to FDA (HHS News Release, 'Secretary Thompson Announces Steps to Reduce Medication Errors' (March 13, 2003), at http://www.hhs.gov/news/press/2003pres/20030313.html).

The Tort System Conflicts with the FDA's Regulatory Regime

The tort system should, in theory, benefit society by providing incentives to make drug products safe and by providing compensation to persons injured by the unavoidable risks of such products. Currently, however, the tort system serves to undermine rather than reinforce the FDA's safety regulation of drugs.

Prescription drug tort suits typically allege that a patient has been injured by a prescription drug due to the drug's defective design or the failure of the product to warn the user of the risks posed by the product. A design defect claim necessarily undermines the FDA's determination that a product's benefits exceed its risk; to be successful, such a claim must show that the risks posed by the drug outweigh its foreseeable benefits. Restatement (Third) of Torts, ' 6(c) (1998). Failure-to-warn claims likewise entail a finding that the FDA erred in its determination that the labeling of a drug provided adequate directions and warnings for its safe and effective use. In either case, tort verdicts may counsel the withdrawal of drugs the FDA considers, on balance, safe and effective.

Unlike the FDA, the tort system relies not on experts, but on lay judges and juries operating under often-conflicting state laws. When faced with a sympathetic plaintiff who has allegedly been harmed by a drug product, these laypersons are ill-equipped to determine whether, from a scientific standpoint, a product's benefits outweigh its risks to the public as a whole ' and therefore the drug is not defectively designed ' or whether a product's labeling sufficiently warned of its risks.

Furthermore, the incentives provided to manufacturers by the tort system are in direct contrast to the goals of the FDA's post-marketing risk surveillance of drugs. The agency's post-marketing scheme is based on the rapid and accurate reporting of risks posed by products, including newly discovered risks, so that the FDA can take into account all known information about a drug and communicate these risks to physicians and patients. Rather than recognizing that some risks posed by prescription drugs are unknowable until the products have been broadly used, and encouraging the reporting of such risks by all entities involved in the health care system, the tort system punishes manufacturers for reporting such data, using it as evidence that a manufacturer has failed to warn of risks, even though these risks were not discoverable by manufacturers until the product had been marketed.

Essentially, the tort system fails to properly recognize the inherent risk of drugs and to weigh these risks against their benefits to the public at large. Manufacturers are left to operate in a legal system that first determines that their products are safe and effective for use as labeled and have benefits outweighing risks, then leaves them vulnerable to claims ' often for millions of dollars ' proffered by trial lawyers, and ultimately decided by judges or juries with no scientific background, that directly contradict this determination.

The tort system does, however, still serve one role that is not covered by the FDA's regulatory scheme ' it offers patients unavoidably injured by drug products an opportunity for compensation. In this way, the system does attempt to serve the important function of ensuring that those injured by the unavoidable and inherent risks of prescriptions drugs are fairly compensated.

However, the shortcomings of the tort system in filling this role are increasingly apparent, as demonstrated by the recent rise of entrepreneurial, lawyer-driven, advertising-centered pharmaceutical litigation that systematically takes advantage of the weaknesses of the tort system in dealing with alleged drug injuries. The trial bar skillfully exploits the lay judge and juries' ignorance of the complex scientific issues raised by these cases and patient fears through massive advertising campaigns designed to amass large inventories of claims regardless of their merit. These cases are often brought in so-called 'magic jurisdictions,' ie, jurisdictions with a history of huge verdicts against out-of-state businesses. As a result, the trial bar is able to garner occasional multi-million or billion dollar verdicts, making these suits worth their while. Successfully defending against these types of (often meritless) claims costs manufacturers significant amounts each year, while even one such large verdict is enough to undercut a manufacturer's incentives to develop products that may subject them to such liability. Finally, the majority of injured patients are left with no compensation, as only a lucky and largely random few receive this type of favorable verdict.

In sum, the tort system has led to the development of an industry devoted to finding the next big case, regardless of the merits of the underlying claims, in which compensation for injury is determined on a lottery-like basis rather than a rational, science-based benefit/cost evaluation of a drug. This provides huge disincentives for drug developers, raising the constant possibility that their product could become the next big case for tort lawyers, regardless of its actual risk-benefit profile. The system thus negatively impacts both the FDA's public health goals and the motivation of drug manufacturers to continue to develop new products, and at the same time fails to fairly compensate those who are injured by unavoidably dangerous drugs.

Alternatives?

Where important public objectives have been frustrated by the tort liability system in the past, 'no-fault' systems have been developed to allow those harmed to receive fair compensation in an efficient manner. For example, Congress has previously passed legislation limiting or displacing tort suits against manufacturers of childhood vaccines and manufacturers of materials used in medical devices where out-of-control product liability suits had threatened to drive most manufacturers from the market. National Childhood Vaccine Injury Act of 1986, 42 U.S.C. ' 300aa et seq. (2001); Biomaterials Access Assurance Act of 1998, 21 U.S.C. ” 1601-1606 (2001). Congress has taken similar actions in the areas of workers' compensation, no-fault auto insurance, and in the creation of the fund for victims of 9/11.

The tort system's negative impacts on the functioning of the FDA's comprehensive regulatory regime and its failure to ensure that injured patients are fairly compensated counsels consideration of a no-fault compensation system for all prescription drugs, not just discrete groups of products such as vaccines. Such a system could support FDA oversight of drugs, provide increased incentives for manufacturers to develop new drugs and improve patient care as a result.

Conclusion

Tort liability is no longer either necessary or dependable for ensuring patient safety, and it is time to find a suitable alternative for filling its other role ' the compensation of those who suffer harm from prescription drugs ' that does not have the same negative influence on the FDA's regulation of these products that tort liability does. A no-fault compensation system has the potential for accomplishing just this, and the development of such a system could greatly aid the successful functioning of our health care system.

Bert W. Rein, William A. McGrath, and Kristin Davis, Esqs., are members of Wiley Rein & Fielding LLP, in Washington, D.C. Mr. Rein also serves on the Editorial Board of this publication.

The FDA's approval of a prescription drug or biologic is the product of an often-delicate risk-benefit analysis of public benefit as opposed to individual safety. The therapeutic balance of these products must always be weighed against the risks inherent in their use. And there are always inherent risks associated with their use. Accordingly, while millions of Americans reap the benefits of prescription drugs every day, these same drugs may pose an unavoidable health hazard to a narrow, and often unidentifiable, subset of potential users. The American legal system currently regulates these risks by two means ' through the federal regulatory system as administered by the FDA, and through the common-law tort liability regime.

When the federal regulatory system was initially developed in the early 20th century, these two systems played important roles in protecting the public health. Today, however, while the FDA comprehensively and effectively manages the unavoidable risks of prescription drugs, it is becoming increasingly clear that the tort liability system may not do the same. In fact, the tort liability regime may actually undermine the FDA's risk-management scheme, to the detriment of the public.

The development of an alternative means for compensating those injured by prescription drugs is therefore appropriate.

The Evolution of Federal Regulation

The original federal drug regulatory regime, codified in the 1906 Pure Food and Drugs Act, had a narrow purpose: regulating 'adulterated' and 'misbranded' products ' ie, products whose actual composition deviated from that specified in their labels. Pure Food and Drugs Act, Pub. L. No. 59-384, ” 6, 8, 10, 34 Stat. 768, 770-71 (1906). As long as a product's label accurately reflected its composition, the product fell outside the 1906 Act's regulatory scope. Drugs were not pre-cleared for safety or effectiveness. Tort law claims based on injuries from those products provided an important check on the careless introduction into the market of unsafe products, giving manufacturers the incentive to ensure their products were not dangerous, therefore avoiding the possibility of liability for injuries arising from these products.

In 1938, Congress enacted the Federal Food Drug and Cosmetic Act (FDCA), which dramatically expanded the FDA's regulatory authority, prohibiting new drugs from reaching the market until the agency had verified the safety of the product 'for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.' Federal Food Drug and Cosmetic Act, Pub. L. No. 75-717, ' 505(d)(1), 52 Stat. 1040, 1052 (1938) (codified as amended at 21 U.S.C. ' 355(d)(1)). In 1962, Congress further amended the FDCA to require manufacturers seeking new drug approval to demonstrate to the FDA that their proposed products were not only safe but also effective for each labeled use. Drug Amendments of 1962, Pub. L. No. 87-781, ' 102(c), 76 Stat. 780, 781-82 (1962) (codified at 21 U.S.C. ' 355(d)(5)). Through these and subsequent congressional actions, Congress has given the FDA the comprehensive mandate of ensuring that products entering the marketplace have been tested for both safety and effectiveness, as well as final control over which drugs are to be sold in the marketplace. See Jeffrey E. Shuren, The Modern Regulatory Administrative State: A Response to Changing Circumstances, 38 Harvard J. on Legis. 291, 299-315 (2001).

As discussed in the May, 2003 issue of this newsletter, the FDA has responded to this mandate by implementing a regulatory system that regulates prescription drugs from cradle to grave, such that it is difficult to identify areas of potential risk reduction that the FDA does not extensively regulate.

Ideally, a federal regulatory regime for prescription drugs should encourage innovation and the timely approval of new products while ensuring access to pharmaceutical products and maximizing patient protection. The FDA accomplishes this last goal through its testing requirements, labeling requirements and continuing oversight of marketed drugs.

Ensuring Patient Safety and Drug Efficacy

The FDA's oversight of prescription-drug safety encompasses three broad areas. First, the agency must approve each new drug product as safe and effective before it can be marketed. This is accomplished through review of applications submitted by manufacturers, containing extensive information on a drug's chemistry, pharmacology, toxicity and manufacturing, as well as clinical safety and effectiveness information from human trials.

Second, the agency must determine that a drug product's labeling accurately conveys necessary directions. The FDA cannot approve a drug until it is satisfied that the labeling accurately describes the drug's indications and dosages, routes, methods, frequency and duration of administration, and any relevant hazards, warnings, contraindications, side effects and precautions of use. 21 C.F.R. ” 201.100(c)(1); 314.125(b). This permits prescribers to identify those individuals who can benefit from a drug, individuals who should not use a product because the possible risks to them outweigh the drug's benefits, and contingent risks patients should understand prior to taking the drug.

Third, the FDA continues to monitor products after they are marketed. Drugs may sometimes have unforeseeable adverse effects on certain populations. For example, serious adverse events may occur in some subpopulations at a rate too low to be detected as significant in clinical trials, and thus may not appear until after marketing. The FDA thus imposes on manufacturers a continuing duty to promptly review all adverse drug experience information received from any source, foreign or domestic, and to report such events to the FDA either periodically or, for more serious events, on an expedited basis. 21 C.F.R. ' 314.80. Manufacturers must also report annually all new information that might affect the safety, effectiveness or labeling of the drug. The FDA inspects manufacturers routinely to ensure, among other things, compliance with reporting requirements, and can impose significant administrative and criminal penalties for violations. In addition, the FDA solicits adverse event information from health care practitioners and the public on a voluntary basis. The agency may also require certain post-marketing studies from the manufacturer as a condition of approval.

The goal of the FDA's comprehensive regulation of drugs is to ensure that risks posed by medical products to the public throughout products' life cycles are as limited as possible. FDA, Task Force on Risk Management, Managing the Risks From Medical Product Use: Creating a Risk Management Framework (May 1999) (hereinafter, 'Managing Medical Risks'). However, the FDA recognizes the simple truth that no drug is without risk, and that drug approval must be based on a scientific analysis of the benefits to the public health as a whole versus the risk of individual harm posed by a drug. According to the FDA, 'safety does not mean zero risk. A safe product is one that has reasonable risks, given the magnitude of the benefit expected and the alternatives available.' Id., pt. 4 at 1.

The FDA's risk-management scheme also reflects a commitment to continual evolution, incorporating new management tools and emerging technology. For example, the agency has recently published a series of concept papers on risk management to facilitate public discussion and get public input on new agency proposals in the areas of assessing risk during drug development (FDA, Concept Paper: Premarketing Risk Assessment (March 2003), at www.fda.gov/cder/meeting/riskManageI.htm), individualized risk management programs for drugs as part of the approval process (FDA, Concept Paper: Risk Management Programs (March 2003), at www.fda.gov/cder/meeting/riskManageII.htm), and improving pharmacovigilance (FDA, Concept Paper: Risk Assessment of Observational Data: Good Pharma-covigilance Practices and Pharma- coepidemiologic Assessment (March 2003), at www.fda.gov/cder/meeting/riskManageIII.htm).

These papers include proposals for maximizing the value of the overall process of risk management planning, which encompasses the efforts of a manufacturer to minimize the risk from its product's use through a variety of means, including labeling, risk assessment, pharmacovigilance, and special studies or interventions. The agency is also working with partners such as New York's Columbia Presbyterian Hospital on developing tools that utilize current information technology to give the FDA immediate access to information about possible adverse drug events. FDA Commissioner Mark B. McClellan, Speech Before FDLI (April 1, 2003) at http://www.fda.gov/oc/speeches/2003/fdli0401.html.

In addition, in August 2002, the agency began a major initiative on 'Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach,' which is designed to update cGMPs to reflect advances in manufacturing technologies and methods and evaluate and improve upon the agency's approach to reviews and inspections related to the manufacturing of human and animal drugs and biologics. In March 2003, the FDA also announced two proposed rules: a requirement for bar codes on drugs to reduce the number of medication errors by verifying that the right drug is being given to the right patient at the right time (FDA, Bar Code Label Requirement for Human Drug Products and Blood, Proposed Rule, 68 Fed. Reg. 12,500 (March 15, 2003)), and a proposed revamping of safety-reporting requirements aimed at enhancing 'the agency's ability to effectively monitor and improve the safe use of medications' by improving the quality and usefulness of safety reports submitted to FDA (HHS News Release, 'Secretary Thompson Announces Steps to Reduce Medication Errors' (March 13, 2003), at http://www.hhs.gov/news/press/2003pres/20030313.html).

The Tort System Conflicts with the FDA's Regulatory Regime

The tort system should, in theory, benefit society by providing incentives to make drug products safe and by providing compensation to persons injured by the unavoidable risks of such products. Currently, however, the tort system serves to undermine rather than reinforce the FDA's safety regulation of drugs.

Prescription drug tort suits typically allege that a patient has been injured by a prescription drug due to the drug's defective design or the failure of the product to warn the user of the risks posed by the product. A design defect claim necessarily undermines the FDA's determination that a product's benefits exceed its risk; to be successful, such a claim must show that the risks posed by the drug outweigh its foreseeable benefits. Restatement (Third) of Torts, ' 6(c) (1998). Failure-to-warn claims likewise entail a finding that the FDA erred in its determination that the labeling of a drug provided adequate directions and warnings for its safe and effective use. In either case, tort verdicts may counsel the withdrawal of drugs the FDA considers, on balance, safe and effective.

Unlike the FDA, the tort system relies not on experts, but on lay judges and juries operating under often-conflicting state laws. When faced with a sympathetic plaintiff who has allegedly been harmed by a drug product, these laypersons are ill-equipped to determine whether, from a scientific standpoint, a product's benefits outweigh its risks to the public as a whole ' and therefore the drug is not defectively designed ' or whether a product's labeling sufficiently warned of its risks.

Furthermore, the incentives provided to manufacturers by the tort system are in direct contrast to the goals of the FDA's post-marketing risk surveillance of drugs. The agency's post-marketing scheme is based on the rapid and accurate reporting of risks posed by products, including newly discovered risks, so that the FDA can take into account all known information about a drug and communicate these risks to physicians and patients. Rather than recognizing that some risks posed by prescription drugs are unknowable until the products have been broadly used, and encouraging the reporting of such risks by all entities involved in the health care system, the tort system punishes manufacturers for reporting such data, using it as evidence that a manufacturer has failed to warn of risks, even though these risks were not discoverable by manufacturers until the product had been marketed.

Essentially, the tort system fails to properly recognize the inherent risk of drugs and to weigh these risks against their benefits to the public at large. Manufacturers are left to operate in a legal system that first determines that their products are safe and effective for use as labeled and have benefits outweighing risks, then leaves them vulnerable to claims ' often for millions of dollars ' proffered by trial lawyers, and ultimately decided by judges or juries with no scientific background, that directly contradict this determination.

The tort system does, however, still serve one role that is not covered by the FDA's regulatory scheme ' it offers patients unavoidably injured by drug products an opportunity for compensation. In this way, the system does attempt to serve the important function of ensuring that those injured by the unavoidable and inherent risks of prescriptions drugs are fairly compensated.

However, the shortcomings of the tort system in filling this role are increasingly apparent, as demonstrated by the recent rise of entrepreneurial, lawyer-driven, advertising-centered pharmaceutical litigation that systematically takes advantage of the weaknesses of the tort system in dealing with alleged drug injuries. The trial bar skillfully exploits the lay judge and juries' ignorance of the complex scientific issues raised by these cases and patient fears through massive advertising campaigns designed to amass large inventories of claims regardless of their merit. These cases are often brought in so-called 'magic jurisdictions,' ie, jurisdictions with a history of huge verdicts against out-of-state businesses. As a result, the trial bar is able to garner occasional multi-million or billion dollar verdicts, making these suits worth their while. Successfully defending against these types of (often meritless) claims costs manufacturers significant amounts each year, while even one such large verdict is enough to undercut a manufacturer's incentives to develop products that may subject them to such liability. Finally, the majority of injured patients are left with no compensation, as only a lucky and largely random few receive this type of favorable verdict.

In sum, the tort system has led to the development of an industry devoted to finding the next big case, regardless of the merits of the underlying claims, in which compensation for injury is determined on a lottery-like basis rather than a rational, science-based benefit/cost evaluation of a drug. This provides huge disincentives for drug developers, raising the constant possibility that their product could become the next big case for tort lawyers, regardless of its actual risk-benefit profile. The system thus negatively impacts both the FDA's public health goals and the motivation of drug manufacturers to continue to develop new products, and at the same time fails to fairly compensate those who are injured by unavoidably dangerous drugs.

Alternatives?

Where important public objectives have been frustrated by the tort liability system in the past, 'no-fault' systems have been developed to allow those harmed to receive fair compensation in an efficient manner. For example, Congress has previously passed legislation limiting or displacing tort suits against manufacturers of childhood vaccines and manufacturers of materials used in medical devices where out-of-control product liability suits had threatened to drive most manufacturers from the market. National Childhood Vaccine Injury Act of 1986, 42 U.S.C. ' 300aa et seq. (2001); Biomaterials Access Assurance Act of 1998, 21 U.S.C. ” 1601-1606 (2001). Congress has taken similar actions in the areas of workers' compensation, no-fault auto insurance, and in the creation of the fund for victims of 9/11.

The tort system's negative impacts on the functioning of the FDA's comprehensive regulatory regime and its failure to ensure that injured patients are fairly compensated counsels consideration of a no-fault compensation system for all prescription drugs, not just discrete groups of products such as vaccines. Such a system could support FDA oversight of drugs, provide increased incentives for manufacturers to develop new drugs and improve patient care as a result.

Conclusion

Tort liability is no longer either necessary or dependable for ensuring patient safety, and it is time to find a suitable alternative for filling its other role ' the compensation of those who suffer harm from prescription drugs ' that does not have the same negative influence on the FDA's regulation of these products that tort liability does. A no-fault compensation system has the potential for accomplishing just this, and the development of such a system could greatly aid the successful functioning of our health care system.

Bert W. Rein, William A. McGrath, and Kristin Davis, Esqs., are members of Wiley Rein & Fielding LLP, in Washington, D.C. Mr. Rein also serves on the Editorial Board of this publication.