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Officials in Montgomery County, Md., are considering a plan to import medicine and drugs from Canada. And they’re not alone. Several mayors and a handful of governors across the country — including Mayor Thomas Menino of Boston and Gov. Craig Benson of New Hampshire — are pushing similar plans. All of them are flatly contrary to the dictates of federal law. As a Food and Drug Administration official said at a meeting in Montgomery County last week, “It’s undeniably illegal to import unapproved foreign drugs — there’s no question about that.” Not surprisingly, the FDA has emphatically resisted this swelling movement. It has gone so far as to use its limited enforcement resources to sue importers, obtaining an injunction against private firms pursuing the same aim of facilitating drug imports without complying with the FDA’s import rules. Gov. Benson and Mayor Menino must be aware of the FDA’s full regulatory plate, perhaps leading them to hope that they can evade federal law without suffering federal enforcement proceedings against them and their governments. But if Benson, Menino, and others succeed in promoting unauthorized importation of drugs, they may well also bring about the unintended result of substantial tort liability for state and municipal governments. YES, IT’S ILLEGAL There can be no real doubt but that the New Hampshire and Boston plans violate federal law. The FDA has taken the pain to respond clearly and at length to the request of Gov. Rod Blagojevich of Illinois for FDA approval to import unapproved drugs. According to the FDA, “there are very sound reasons why Congress has made the importation of unapproved drugs illegal, and why a ‘buyer beware’ drug supply is not acceptable health policy for the United States.” Menino, in announcing his unapproved drug import program for Boston, stated with remarkable candor that “it’s illegal.” Former Alabama Chief Justice Roy Moore, after he refused to comply with a federal court order to remove a stone rendering of the Ten Commandments from the state Supreme Court building, learned that failing to heed federal law has adverse consequences. There will also be consequences for New Hampshire and Boston if they flout federal law. But the dangers will not directly affect the politicians; rather, they will come from plaintiffs attorneys bringing multimillion-dollar lawsuits that will leave local taxpayers holding the bag. Because even safe and efficacious drugs can have effects that are untoward and, for a tiny proportion of users, even catastrophic, the potential for litigation is very real. For states and municipalities, injuries due to the inherent risks in drugs would be added to liability for purchasing stale, counterfeit, or ineffective medications. New Hampshire’s proposed program for buying drugs for prison inmates and certain Medicaid recipients is expected to save, at most, $1.6 million, according to New Hampshire officials. Boston’s program of buying Canadian drugs for current and retired city employees carries projected annual savings of $1 million. These savings could be dwarfed easily by a single judgment in a negligence or products liability suit. Drug manufacturers can readily be sued for injuries caused by their products. A plaintiffs attorney may want to add or substitute a state or municipality as a defendant to permit addition of viable theories to the complaint, and to eliminate defenses that manufacturers may possess but that governments could not assert. Local government liability can be predicated upon settled legal principles. States may fall prey to principles enunciated in the Torts Restatements denominated as “strict liability” — meaning that the government’s simple failure to furnish an adequate warning of the source of the medication could trigger liability for a plaintiff’s injury. In addition, plaintiffs counsel can be expected to develop numerous separate liability theories, such as theories grounded in misrepresentation, in “Good Samaritan” and negligence per se liability, and in still other pillars of tort law. THE CASE FOR LIABILITY To flesh out the factual basis of the misrepresentation theory in a “notice” pleading, counsel would likely plead the facts regarding how the state or city facilitated importation, and statements the government made in connection with the program. Despite any disclaimers, a plaintiff would likely have little difficulty establishing his reliance upon the local government’s approval of the imported drug. Good Samaritan liability — which requires a voluntary act to be performed in a reasonably safe manner — in this context would require a plaintiff to establish an increased risk of harm due to the state or city program. The problem for the defendant would be in rebutting the prima facie case made when violation of FDA directives is established (or conceded). The negligence per se theory of liability drives this point home: In many jurisdictions, violation of a mandatory legal rule intended to protect the public’s safety establishes negligence as a matter of law. Here, the violation of the FDA’s mandatory directives regarding importation of drugs is at the core of the state and municipal schemes. Some might say that these concerns are overblown because states are immune from monetary liability absent a waiver of sovereign immunity; municipal liability is similarly confined within limits state law sets. In the abstract, limits on state and municipal liability may seem to prevent local taxpayers from bearing the cost of tort judgments for the decisions of their officials. But reliance on sovereign immunity is misguided. Generally, state and municipal immunity from tort liability is narrower than the immunity the federal government has preserved in the Federal Tort Claims Act. It is therefore useful to examine the extent to which the drug importation activities at issue are within the FTCA’s immunity regime — that is, if the federal schemes would provide no immunity, it is thus unlikely that state law would. Under the FTCA, sovereign immunity is preserved for performing or “failure to exercise or perform a discretionary function . . . whether or not the discretion involved be abused.” In many states, only planning or high-level activities of state officials are immune from liability even if a discretionary function is at issue. In other words, the carrying out of discretionary plans is protected at the federal level, but may well not be protected in many states, where these “operational” activities are not encompassed with the states’ discretionary function immunity. At a minimum, if even the FTCA would not immunize local officials’ conducting or sponsoring drug importation programs, state immunity would not shield state and local governments from tort claims and judgments, either. The FTCA also does not immunize activities in violation of mandatory rules, such as the specific drug importation directives the FDA administers. The Supreme Court has made this perfectly clear. Berkovitz v. United States (1988) is the leading case. Berkovitz arose in the context of claims alleging that the FDA had violated its own directives in the course of licensing the Sabin oral polio vaccine, and in permitting release by manufacturers to the public of lots of the vaccine. The Supreme Court’s holding, succinctly put, is that “when a suit charges an agency with failing to act in accord with a specific mandatory directive, the discretionary function exception does not apply.” Therefore, federal directives preclude implementation of the local drug importation plans. Under our Constitution’s supremacy clause, state and local authorities have no discretion to disregard federal law. For this reason, there will be no discretionary function or similar immunity under state law to protect state and local taxpayers. The denouement of the Sabin oral polio litigation itself illustrates the potential liability. On remand from the Supreme Court, the District Court acknowledged that the vaccine released was “state of the art.” But it nonetheless imposed on the government multimillion-dollar financial liability for injuries due to polio contracted from the vaccine — a known, but rare, risk of the product. The 4th Circuit affirmed. Focusing upon the District Court’s acknowledgement that the agency’s officials were “motivated by what they perceived to be the public interest,” the 4th Circuit explicitly rejected this intent as a defense to liability. It quoted with approval the District Court’s holding that the officials “arrogated to themselves the power to define what constituted an acceptable risk, thereby undermining the rule of law and threatening long-term public confidence in the regulatory system itself.” GOOD INTENTIONS NOT ENOUGH These rulings apply with equal — if not stronger — force to state and local officials’ efforts to undercut federal drug importation regulatory policy — no matter how good their intentions may be. Indeed, similar reasoning would likely invalidate any attempt by a state government to expand its sovereign immunity to cover importation programs. That is, since the programs are illegal, the U.S. Constitution’s supremacy clause may well prohibit states from changing their law to grant immunity from this one kind of liability. It will take some time to measure fully the impact on taxpayers from drug importation in violation of federal law. The costs of disregarding federal drug importation policy could be huge, and they are avoidable. Officials concerned about the costs of drugs now should stay alert to avoid the costs from litigation that will surely follow. Jeffrey Axelrad was director of the U.S. Department of Justice’s Torts Branch, responsible for Federal Tort Claims Act litigation, from 1977 to 2003. He now serves as an adjunct professor at George Washington University Law School in Washington, D.C. He can be reached at [email protected].

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