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  October 18, 2005
The Honorable Michael B. Enzi
The Honorable Edward M. Kennedy
Re: National Biodefense Act of 2005
Dear Senators: The National Biodefense Act of 2005 will soon be considered by your Committee. We appreciate efforts to safeguard the welfare of our nation in the event of a bioterror attack or the pandemic spread of infectious disease, however, we are gravely troubled by the breadth of the bill’s liability exemption for drug makers, distributors, and health care providers. The far-reaching scope of the legal immunity conferred by this bill magnifies the public’s susceptibility to the dangerous side-effects of otherwise good intentions: heightened risk of injury, no forum in which to seek justice, and no compensation for damages. We urge you to reject legal incentives for the pharmaceutical industry and medical service providers that grossly exceed in potential public jeopardy what they hope to achieve in public benefit. More specifically, our major concerns with this bill are as follows: The bill immunizes manufacturers, distributors and medical providers from liability for negligent or reckless conduct that injures patients. Section 6 of the bill would preempt all state common law claims for loss of property, personal injury or death involving epidemic drugs or countermeasures, even where the cause of action is medical malpractice, negligent or intentional failure-to-warn, design defect, negligent or willful disregard in manufacturing, or breach of warranty. State unfair trade practice claims would be preempted where the injury is alleged to result from deceptive marketing. Section 14 expressly preempts antitrust statutes under certain circumstances. Consider the implications of such a policy in the case of medical malpractice alone. In 1999, the Institute of Medicine warned that up to 98,000 people die needlessly each year due to avoidable medical errors.1 Recent studies indicate that the problem is one of significantly greater magnitude. One revealed that adults seeking preventive, chronic or acute treatment had only a 50 percent chance of receiving care that met the recommended standard.2 Another study found that 1 in 20 hospital patients is given the wrong medication, 3.5 million patients a year are given infections from unhygienic or improper procedures, and 195,000 die as a result of preventable mistakes.3 Medical negligence itself has reached epidemic proportions in the U.S., and this under ordinary practice conditions. One could reasonably anticipate that recklessness and negligence would increase during a bioterror threat or an infectious disease outbreak; at the same time, preventive and curative treatments themselves would become more hazardous because of the relaxed standard of review for qualified countermeasures under the expedited approval process. Nevertheless, under this bill there would be no remedy whatsoever for those whose injuries involve a countermeasure that was prescribed, distributed, donated, sold or purchased during a declared public health emergency, "regardless of the date of alleged injury." Thus, the victim of a negligently-administered emergency drug that was contraindicated for his underlying condition would be subjected to uncompensated loss; a patient infected with a life-threatening disease by a health worker who negligently failed to use a clean syringe for a vaccination would be left helpless. Innocent individuals, families and communities would be saddled with the full measure of socio-economic consequences caused by the reckless acts of others. Such an outcome is offensive to fundamental American principles of justice, fairness, and personal responsibility—and it is bad public policy. The incentives offered to pharmaceutical companies, distributors, health administrators and others in this bill go far beyond the bill’s stated purpose of safeguarding the nation’s health—in fact, they arguably endanger public health by rendering individuals increasingly vulnerable to medical injury while depriving them of recovery for damages. Moreover, it is not at all certain that the bill’s liability shield will have an appreciable impact on new drug development and production. Vaccine shortages persist despite the 20-year existence of a no-fault compensation program for victims of vaccine injuries which, unlike the proposed bill, at least provides a remedy for those who are harmed. Harvard researchers recently noted that market factors, rather than fear of liability, were responsible for the drug industry’s lack of interest in vaccine production, indicating that the exemptions gifted to pharmaceutical companies in this bill would do little to solve the current shortage or ensure future supplies.4 State experiments with liability shields as economic incentives have failed to elicit the promised response from pharmaceutical manufacturers. For example, in 1996 Michigan passed the nation’s most sweeping prohibition of lawsuits against drug makers, with no exception even where company has allegedly perpetrated fraud. Proponents of the law contended that it would lead to cheaper drug prices and keep pharmaceutical jobs in Michigan. Ten years later, with Michigan’s drug prices among the highest in the nation and fewer pharmaceutical jobs than when the law was signed, there is a bipartisan movement to repeal the law. A bad law can always be corrected, but its consequences cannot. Over the intervening decade, drug makers who concealed the truth about FenFen, Vioxx and Rezulin injured hundreds of Michigan residents with impunity. The victims were barred from pursuing legal claims against the manufacturers.
The bill fails to make clear that immunity applies only when a product is used as a countermeasure or epidemic/pandemic product. The bill as currently drafted would preempt state common law claims pursuant to which a manufacturer, distributor, or health care provider could be held liable for loss of property, physical injury or death involving a designated countermeasure or epidemic/pandemic product. This preemption is triggered whenever the product is 1) in the Strategic National Stockpile, 2) deemed a security countermeasure, or 3) an epidemic or pandemic product. Even if one were to argue that national security interests during a disease outbreak trump an individual’s right to relief for injuries, because the bill does not clearly state that exemption from liability is limited to emergency use only, it could be read to apply to non-emergency uses of these pharmaceuticals as well. Thus, suppose a commercially-available drug approved to treat strep throat were also approved as a qualified countermeasure to treat smallpox. This provision could be construed to confer legal immunity on the drug ’s manufacturer or a health care provider administering it if a patient who was prescribed the medication for a strep infection suffered harm—e.g., as a result of product contamination, improper administration, or perhaps an adverse reaction foreseen by the manufacturer but against which the manufacturer failed to warn. Additionally, under 42 U.S.C. § 247d-6b, a product is considered part of the Stockpile so long as it is under the proprietary control of the Secretary of HHS—even though it is in the physical possession of a private vendor contracted to store the material. This arrangement raises security and quality assurance problems that are further exacerbated by allowing private contractors to escape responsibility for injuries caused by drugs that were spoiled or contaminated while in their custody. Eliminating tort liability means eliminating an effective tool to deter negligent or reckless conduct by the contractor that could compromise the viability of the material in its charge . Such a tool is all the more important under circumstances of reduced oversight capability. Consumers are burdened with impossibly onerous pre-conditions for filing suit based on injuries caused by intentional conduct. Manufacturers, distributors or health care providers who willfully or intentionally disregard patient safety could not be sued by their victims under the proposed legislation unless they violated either the Federal Food Drug and Cosmetics Act (FDCA) or the provisions of this bill. The bill, however, establishes pre-conditions to such lawsuits that are stacked so heavily against the victim as to effectively preclude this avenue of redress. Specifically, the bill requires the injured claimant first to petition the Secretary of the HHS to undertake an investigation. For a lawsuit to go forward, the Secretary must find clear and convincing evidence that a violation of the FDCA occurred, that the violation made the product a significant health risk, and that the violation was the proximate cause of the victim’s injury. Even if the Secretary agrees to investigate, the investigation would be fatally hampered by the inability to get all the information needed to make an informed determination. In civil litigation, a determination of culpability often follows years of document review and depositions on a variety of factual issues, which are then collated by both sides and presented to a judge or jury for application of the law to the facts. The bill, however, does not give the Secretary the authority to demand documents or to subpoena witnesses for interviews under oath. Without such authority, the Secretary would be unable to make the findings necessary to support a determination in the patient’s favor. The bill gives the Secretary sole discretion over whether or not to investigate a claim, and if the Secretary declines to do so, that decision is unreviewable. Unlike a petition to the EEOC claiming employment discrimination, where the agency issues a " right to sue" letter if it declines to investigat e and thereby entitles the claimant to file a private lawsuit, here the Secretary’s refusal is an absolute dead end. The injured claimant has no right to appeal, no alternative administrative or judicial venue in which to be heard, no source of compensation. On the other hand, if the Secretary somehow could gather enough information to make a determination in favor of the claimant, the bill entitles the company/defendant to seek review of that determination in a federal court of appeals. The claimant is not permitted to intervene in the case. This scheme makes it unlikely that victims will be able to hold manufacturers accountable, even where the Secretary has found by clear and convincing evidence that a company has intentionally violated a federal statute and as a result harmed a patient. Finally, under this scheme, health care providers are fully immune for all conduct with respect to the covered products. Because health care providers are not regulated under the FDCA, their conduct—even when based on an intent to cause the patient injury—does not violate the FDCA. Accordingly, the bill’s prerequisite to holding people or companies accountable for intentional injury will never be satisfied with respect to health care providers. The bill unfairly places the burden of loss on innocent victims and their families. This bill would force individuals to pay the price of misconduct by drug makers, distributors, administrators, and medical providers. Middle income families would be hit the hardest because they would not qualify for public assistance to help pay for injury-related medical expenses; those with health insurance may be denied coverage for treatment administered during an emergency, or involving a drug that did not meet regular FDA approval criteria. This is manifestly unfair. If Congress believes that legal immunity for distributors and health providers is necessary to ensure sufficient emergency drug supplies—something we nevertheless dispute—then the government should assume liability for injuries in their place. Spreading the risk among all taxpayers would significantly reduce the severity of the impact on those harmed. Moreover, because we all have an interest in the nation’s capacity to effectively confront infectious disease outbreaks, whether caused by malice, accident, or a nature, it is only fair that we all share the damage when innocent people are injured as a consequence of collective biodefense preparedness efforts. For the foregoing reasons, we strongly urge you to reject the current version of the National Biodefense Act of 2005. Alliance for Justice Center for Justice & Democracy Consumer Federation of America Public Citizen USAction more resources
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