Recently, Matthew Davis and Melinda Derish handled a difficult but worthy case in which a California teenager got a prescription for antidepressants from a doctor in Colorado. That doctor, Christian Hageseth, prescribed the medication without ever meeting his patient, let alone examining or evaluating him. Shortly after getting the prescription, the young man committed suicide. Mr. Davis and Ms. Derish prosecuted the family's medical negligence and wrongful death case against Dr. Hageseth and other defendants.
Yesterday, Dr. Hageseth pled guilty to charges of illegally practicing medicine. Bay Area News sources covered the story, including this CBS 5 segment that features Ms. Derish. The case is another example of Walkup attorneys being willing to take a challenging case to help a deserving and grieving family.
Tuesday, March 10, 2009
Thursday, March 5, 2009
Supreme Court:
Jury Trials Still Important for Holding Drug Companies in Check
The U.S. Supreme Court’s 2009 Wyeth v. Levine opinion yesterday reaffirmed the integral role of civil juries in holding pharmaceutical companies accountable. Levine shows that, in the absence of clear Congressional intent to preempt state regulation, the Court is still willing to recognize the right of States to protect their citizens, and the ability of the civil jury system to harmoniously coexist with federal regulatory bodies.
The Levine case arose because a Vermont jury dared to “second-guess” the FDA’s finding of safety. The jury learned that Ms. Levine, a professional musician, had to have her arm amputated after a “push injection” of the drug Phenargen (prescribed for nausea) caused the drug to enter an artery, resulting in gangrene. Although the pharmaceutical company, Wyeth, had long known that the “push injection” method of administration (as opposed to IV drip) carried a high risk of gangrene and loss of limb, it did not bar the “push” method nor did it specifically warn of this correlation.
The jury also learned that the FDA had approved injectable Phenergan, along with its accompanying labels and warnings, back in 1955. The FDA had remained deeply involved in monitoring Phenergan ever since, even recommending specific language for Phenergan labels.
The trial judge instructed the jury that although compliance with FDA requirements was a factor that could be considered, it did not establish that the warnings were adequate. Thus, the jury independently evaluated the adequacy of Wyeth’s warnings and, applying a higher standard than that set by the FDA, found the warnings inadequate and awarded $7,400,000 to Ms. Levine.
When the FDA reviews a new drug application, it makes a determination that the drug is “safe.” Wyeth’s appeal, the FDA’s amicus brief, and the dissenting opinion all insisted that a jury should not be permitted to “second guess” this “safety” determination.
However “safe” can be a relative term. In fact, given that the FDA suffers from admittedly insufficient resources, and is responsible for monitoring more than 11,000 drugs (along with foods, dietary supplements, medical devices, veterinary products, and cosmetics), it is not uncommon for unreasonably dangerous drugs to slip through the screening process (think Vioxx, Baycol, Rezulin . . . ). The Levine Court took note of the FDA’s limitations, and held that there was room for States, and their juries, to add another layer of accountability.
Justice Stevens, writing for the Court, rejected Wyeth’s contention that the FDA regulations establish both a “floor and a ceiling” for drug regulation (leaving no room for state input). “The most glaring problem with this argument,” he wrote, “is that all evidence of Congress’ purposes is to the contrary.” He noted that Congress’ stated purpose in bestowing authority on the FDA was to bolster, not diminish, consumer protection, and that Congress made the choice not to expressly preempt state-law suits.
The Levine Court held that, since FDA standards are merely a “floor” upon which States can build, juries are free to raise the bar for companies, as long as they do not instruct companies in a way that directly conflicts with FDA regulations. The Court also rejected Wyeth’s attempt to shirk responsibility, and reaffirmed that the burden of ensuring public safety rests squarely on the manufacturer’s shoulders:
Despite some limitations, Levine promises to have a lasting effect. The Court emphasized the presumption against preemption, which is only overcome by “the clear and manifest purpose of Congress.” It also reaffirmed the “historic police powers of the State” and the role that tort suits play in protecting the public and compensating wrongfully harmed individuals.
Jury Trials Still Important for Holding Drug Companies in Check
The U.S. Supreme Court’s 2009 Wyeth v. Levine opinion yesterday reaffirmed the integral role of civil juries in holding pharmaceutical companies accountable. Levine shows that, in the absence of clear Congressional intent to preempt state regulation, the Court is still willing to recognize the right of States to protect their citizens, and the ability of the civil jury system to harmoniously coexist with federal regulatory bodies.
The Levine case arose because a Vermont jury dared to “second-guess” the FDA’s finding of safety. The jury learned that Ms. Levine, a professional musician, had to have her arm amputated after a “push injection” of the drug Phenargen (prescribed for nausea) caused the drug to enter an artery, resulting in gangrene. Although the pharmaceutical company, Wyeth, had long known that the “push injection” method of administration (as opposed to IV drip) carried a high risk of gangrene and loss of limb, it did not bar the “push” method nor did it specifically warn of this correlation.
The jury also learned that the FDA had approved injectable Phenergan, along with its accompanying labels and warnings, back in 1955. The FDA had remained deeply involved in monitoring Phenergan ever since, even recommending specific language for Phenergan labels.
The trial judge instructed the jury that although compliance with FDA requirements was a factor that could be considered, it did not establish that the warnings were adequate. Thus, the jury independently evaluated the adequacy of Wyeth’s warnings and, applying a higher standard than that set by the FDA, found the warnings inadequate and awarded $7,400,000 to Ms. Levine.
When the FDA reviews a new drug application, it makes a determination that the drug is “safe.” Wyeth’s appeal, the FDA’s amicus brief, and the dissenting opinion all insisted that a jury should not be permitted to “second guess” this “safety” determination.
However “safe” can be a relative term. In fact, given that the FDA suffers from admittedly insufficient resources, and is responsible for monitoring more than 11,000 drugs (along with foods, dietary supplements, medical devices, veterinary products, and cosmetics), it is not uncommon for unreasonably dangerous drugs to slip through the screening process (think Vioxx, Baycol, Rezulin . . . ). The Levine Court took note of the FDA’s limitations, and held that there was room for States, and their juries, to add another layer of accountability.
Justice Stevens, writing for the Court, rejected Wyeth’s contention that the FDA regulations establish both a “floor and a ceiling” for drug regulation (leaving no room for state input). “The most glaring problem with this argument,” he wrote, “is that all evidence of Congress’ purposes is to the contrary.” He noted that Congress’ stated purpose in bestowing authority on the FDA was to bolster, not diminish, consumer protection, and that Congress made the choice not to expressly preempt state-law suits.
The Levine Court held that, since FDA standards are merely a “floor” upon which States can build, juries are free to raise the bar for companies, as long as they do not instruct companies in a way that directly conflicts with FDA regulations. The Court also rejected Wyeth’s attempt to shirk responsibility, and reaffirmed that the burden of ensuring public safety rests squarely on the manufacturer’s shoulders:
Despite some limitations, Levine promises to have a lasting effect. The Court emphasized the presumption against preemption, which is only overcome by “the clear and manifest purpose of Congress.” It also reaffirmed the “historic police powers of the State” and the role that tort suits play in protecting the public and compensating wrongfully harmed individuals.
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