Bush Administration Begins To Intervene in Product Liability Lawsuits, New York Times Reports
The Bush administration has begun to intervene in product liability lawsuits filed against pharmaceutical and medical device companies over claims that consumers cannot recover damages for injuries from products approved by FDA, the New York Times reports. In court documents, the Justice Department acknowledged that the position represents a "change in governmental policy" and is different from the "views that the government advanced in 1997" before the U.S. Supreme Court. In 1997, the federal government argued that FDA approval of medical treatments established the minimum standard for product liability and that states could provide "additional protection to consumers." However, the Bush administration today claims that FDA approval of medical treatments "sets a ceiling as well as a floor" for product liability. The administration also maintains that the threat of lawsuits might prompt pharmaceutical and medical device companies to withdraw their products from the market or issue new warnings that overemphasize potential risks, which could "harm the public health" though the "underutilization of beneficial treatments." The administration first outlined plans for FDA involvement in product liability lawsuits at a 2002 legal symposium and "has been methodically pursuing that strategy," the Times reports.
In a case in which a Pennsylvania widow sued the manufacturer of a heart pump that allegedly caused the death of her husband, the administration said that such lawsuits would "undermine public health" and encourage "lay judges and juries to second-guess" FDA, a practice that could interfere with federal regulation of prescription drugs and medical devices. The administration also said that such lawsuits would "disrupt a comprehensive nationwide system of drug regulation," because "if a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the FDA after years of rigorous testing and evaluation," the Times reports. In the Pennsylvania case, a federal appeals court in Philadelphia sided with the administration and ruled that FDA decisions are entitled to deference because the agency is "uniquely qualified" to determine when federal law should supersede state law. In a case in Tennessee that involved the manufacturer of a cardiac pacemaker, the administration told a state trial court, "It is inappropriate for a jury to second-guess FDA's scientific judgment on a matter that is within FDA's particular expertise," adding that if juries in different states reach different conclusions about the safety of a medical device, it would cause "chaos for the regulated industry and FDA." In a case in which a California woman said that her husband committed suicide after he took the antidepressant Zoloft, the administration said that FDA officials did not require a warning on the label about a potential increase in suicide risk when they approved the medication, and that such a warning could "deprive patients of beneficial, possibly life-saving treatment." In a separate California case over demands that GlaxoSmithKline restrict advertisements for the antidepressant Paxil, the administration argued that such restrictions "would overly deter use of a life-improving medication."
Rep. Maurice Hinchey (D-N.Y.) said that the administration has "taken the FDA in a radical new direction, seeking to protect drug companies instead of the public." Hinchey added that FDA attorneys, led by Chief Counsel Daniel Troy, have "repeatedly interceded in civil suits on behalf of drug and medical device manufacturers." Allison Zieve, an attorney for the Public Citizen Litigation Group who represented the plaintiff in the Pennsylvania case, said that if courts accept the position of the administration, pharmaceutical and medical device companies would have improper protection from product liability lawsuits. However, Jay Lefkowitz, former director of the Domestic Policy Council, said that the position of the administration represents "good health policy and good tort reform." In addition, five former FDA chief counsels sent a letter to Congress dated July 15 to support the position of the administration. They said that "there is a greater need for FDA intervention today because plaintiffs are intruding more heavily on FDA's primary jurisdiction than ever before" (Pear, New York Times, 7/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.