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Wyeth v. Levine went before the Supreme Court on Monday. The case was heavily covered, with articles appearing in national newspapers and on all four wire services. A number of papers described the court as divided and predicted that the case will be decided on narrow grounds.

        In an article on the front page of its Business section, theWashington Post (11/4, D1, Markon) reports that Diana Levine's suit against Wyeth is "one of the most hotly contested cases of the Supreme Court's term. The justices yesterday debated Wyeth's contention -- which is supported by the Bush administration -- that the lawsuit should be thrown out because federal law preempts such state court claims." There were "divisions within the conservative bloc on the court." Justice Samuel A. Alito Jr. questioned how the [Food and Drug Administration] (FDA) approved a drug "as 'safe and effective' when 'you have the risk of gangrene.'" Also, "Justice Anthony M. Kennedy disputed Wyeth's contention that it could not have followed the Vermont law under which Levine sued without violating the federal law that regulates drug labeling." However, "Justice Antonin Scalia grilled Levine's attorney intensively, scowling at him." There is "an intensifying national debate over 'preemption,'" and "Levine's lawsuit struck a particular nerve, with both sides mounting intensive media campaigns before yesterday's argument."

        The New York Times (11/4, A20, Lipak) reports that this "was supposed to be the term's blockbuster business case," but the argument "quickly turned into a search for limiting principles." According to the Times, "Several justices appeared open to the idea that preemption could follow from the FDA's approval of a drug label -- but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks," and "other justices seemed prepared to allow preemption -- but only if the drug agency had considered the particular risk before approving the label." The Times adds, "Given the justices' interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow."

        The AP (11/3, Sherman) added, "Several justices indicated that if the U.S. Food and Drug Administration had clear information about the risks of Wyeth Pharmaceuticals' anti-nausea drug Phenergan, and approved its warning label anyway, then Wyeth probably would prevail in its court fight against Diana Levine of Vermont." However, "there was considerable skepticism among the justices -- and disagreement between the opposing lawyers -- that the FDA had a clear picture of the disastrous consequences of improperly giving Phenergan by" IV push.

        The Wall Street Journal (11/4, A3, Bravin) notes, "Several Supreme Court justices expressed skepticism with arguments given Monday by business interests hoping for wide immunity from lawsuits over federally regulated products." 

        USA Today (11/4, Biskupic, Appleby) points out that "much of the give-and-take centered on what happened in Levine's case. A majority of the justices did not tip their hand, although they emphasized different issues." While "Justices Ruth Bader Ginsburg and Samuel Alito raised questions of patient safety and the adequacy of FDA review of the drug label," both "Chief Justice John Roberts and Justice Antonin Scalia focused on drugmakers' ability to meet federal requirements without further demands from the states." Another USA Today (11/4, Biskupic) article reports, "A majority of the justices did not tip their hand during the hour of oral arguments. Many suggested a key question may be how the FDA had handled any attempt by Wyeth to change its label to made clear the dangers from the particular administration used on Levine."

        The Legal Times (11/3, Mauro) reported, "The Supreme Court appeared torn" during the argument, and "the case could be decided narrowly, giving little guidance about broader preemption issues beyond the area of drug labeling." In contrast, McClatchy (11/3, Doyle) reported, "several justices appeared ready to declare that federal regulations preempted certain state lawsuits. That would be a major victory for the drug company." CongressDaily (11/3, Edney) also reports that Levine's lawyers "faced hefty skepticism from justices."

        The Los Angeles Times (11/4, Savage) reports, "If the court agrees with the administration, congressional Democrats have said, they will seek to revise the law and restore consumers' right to sue." The Kiplinger Letter (11/4, Craver) reports, "Lawmakers have already taken action to help remedy the issue. In reauthorization legislation for the Consumer Product Safety Commission, Congress nullified the preemption language by inserting a section that preserves the right of consumers to seek restitution from those who caused them harm." During President Bush's administration, "over 60 proposed or final regulations put out by government agencies include language aimed at shielding companies from product liability claims. Les Weisbrod, president of the American Association for Justice, said, "In effect the Bush administration has made the safety of Americans secondary to corporate profits."

        In the Health blog on the Wall Street Journal (11/3), Sarah Rubenstein wrote, "what happens in tomorrow's presidential election may be every bit as important as what the Supremes say about Wyeth v. Levine," because "a Wyeth victory in court could be offset by an Obama presidential victory and a Democratic Congress."

              Sen. Leahy argues Levine should prevail. In the Congress blog on The Hill (11/3), Sen. Patrick Leahy (D-Vt.), chairman of the Senate Judiciary Committee, wrote that "every American consumer will have a stake in the outcome" of this case. "The justices' ruling in Ms. Levine's case will affect the millions of Americans who use prescription drugs and may suffer avoidable injuries." Meanwhile, "the Bush Administration is taking the drug companies' side against consumers, putting corporate profits above all else." However, "corporate accountability and the right of American citizens to seek justice in their state courts hang in the balance." Should the Court overturn "the Vermont jury's decision, even the most misleading, inaccurate or insufficient drug label, if okayed by the FDA, will immunize a company from virtually all attempts by injured consumers like Ms. Levine to receive compensation."

        

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This Fall the United States Supreme Court will hear arguments concerning a Vermont Supreme Court opinion that allowed Diana Levine to keep her $6.7 million verdict against Wyeth, the manufacturer Phenergan. The drug manufacturer did not warn against injecting the drug which lead to the amputation of her arm. It found that "the drug's label offered insufficient warning about the danger of that injection method compared with two other, safer ways to administer the drug." The issue is whether drug manufacturers are immuned from being sued if they have obtained FDA approval. This ridiculous defense was cooked up by the Bush administration to protect the contributors to its campaign. The FDA is an underfunded agency that is relegated to approving drugs based on the reports provided to it by the drug company under pressure to get its product out on the market in advance of competitors. This case is Levine is supported by "47 states, public-health groups such as the Texas Medical Association and patient-advocacy organizations," while "the Bush administration, the US Chamber of Commerce and groups representing drug makers are siding with Wyeth."  The following are some excerpts from news reports regarding this offense to American consumers and our sense of right and wrong.

The Wall Street Journal (10/30, A3, Mundy) reports "Internal memos contradict the FDA's position in Wyeth v. Levine that "federal drug-approval and warning-label standards should trump stricter state laws." In the memos, two officials said "it is wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers." John Jenkins, the top official in the drug approval section, in 2003 wrote, "Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date." Additionally, "the associate director of the FDA's division for drug evaluation and research, Jane Axelrad, objected to the idea that companies would put too much safety information on the label if they weren't controlled by the FDA." Rep. Henry Waxman (D-CA) released the documents, which "are likely to encourage him and other Democrats in Congress who want to pass bills reversing the Bush administration's pre-emption policy." 

The Los Angeles Times (10/30, Savage) notes that the FDA officials said that "new information often comes to light that calls for new warnings to doctors and patients." The Times adds, "Contrary to the view of the White House and the FDA general counsel, the drug regulators said pharmaceutical manufacturers could not be trusted to warn patients of new risks." While "consumer-rights advocates said the internal documents showed that the staff experts at the FDA were overruled by the White House and its political appointees," the FDA Office of Public Affairs "defended its process."

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