The Supreme Court is scheduled to hear a case next week that could have a far-reaching effect on American consumers. If the High Court eventually takes the side of drugmakers in Wyeth vs. Levine, the right to sue drug companies for deaths or injuries caused by defective medicines will be sharply curbed.
Wyeth vs. Levine involves a Vermont woman who alleged she lost her arm from adverse events tied to Wyeth’s nausea and motion sickness drug Phenergan. Levine, who was awarded more than $6 million in her state court claim against Wyeth, said she was administered Phenergan at her local hospital emergency room. The product normally is administered intramuscularly, but hospital staff used a method called I.V. push of injecting the drug into her vein, which resulted in an inadvertent arterial injection. Inadvertent arterial injection of Phenergan is known to be dangerous. Levine, a guitar player, developed gangrene in her arm, which resulted in it being amputated.
Levine has contended that Phenergan’s labeling failed to adequately warn about the dangers of using the I.V. push method. In 2000, the same year Levine sustained her injury, Wyeth changed the label of Phenergan to warn that the drug should not be given by intra-arterial injection because of the risk of gangrene.
Wyeth claims that the Food & Drug Administration (FDA) had weighed the risks and benefits of Phenergan in approving the drug’s prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but did not require the label to specifically warn about the technique used with Levine. Wyeth claims that the FDA’s judgment in such matters cannot be overruled by a state court.
According to The Wall Street Journal, the case is worth tens of billions of dollars to the pharmaceutical industry. The Bush Administration has backed the industry’s claim that FDA approval pre-empts the filing of state product liability lawsuits, and other industries are salivating over the thought that any Supreme Court ruling favoring pre-emption in Wyeth vs. Levine could apply to their businesses as well.
Consumer groups, on the other hand, argue that it is vital that a consumer’s right to sue over a defective drug are fully upheld. They point out that the FDA approval process does not always catch safety problems, and in some instances, drug makers purposely withhold vital information from the agency. As a recent editorial in the New England Journal of Medicine pointed out, often litigation is the only way such wrongdoing is ever made public.
In an Amicus Brief to the High Court, the editors of the Journal wrote that the “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety.’’ Without the discoveries found by plaintiff’s lawyers during the course of defective drug lawsuits, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.’’
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March 14th, 2009 at 7:21 am
I wonder about more of the details of this case. Intra-arterial is not a purposeful technique of medication administration for any drug. Phernergan is also a significant irritant to veins if given IVP. Many hospitals have policies that require diluting phergan in at least 50ml of NS and infusing over 30 minutes. IM would be just as effective. This Vermont hospital must not have been noticing the increase in phlebitis at intravenous injection sites and a need to replace IV cannulas more frequently. Patient should be well aware of the risk of any medication and particular modes of administration. Health care providers are responsible to understand the risk vs. benefits prior to administering medications.