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Patients v. Big Pharma: Supreme Court to Decide Landmark Case
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This story originally appeared on Health Beat.
On November 3rd the Supreme Court will hear the case of Wyeth v. Levine, which has been called the "business case of the century" -- and with good reason. In essence, Monday's ruling will decide if patients have the right to sue pharmaceutical companies for personal injuries stemming from prescription drugs approved by the Food and Drug Administration (FDA). This is the big one, folks.
First, the details of the case: In the spring of 2000, Diana Levine of Vermont received treatment for migraines which consisted of the painkiller Demerol and Phenergan, an antihistamine manufactured by Wyeth Pharmaceuticals. Phenergan is typically injected directly into the muscle or dripped into the vein through steady doses (a procedure called an "IV drip"). When administering the drug, clinicians must be careful not to expose it to blood in the arteries; doing so causes "swift and irreversible gangrene," to use an evocative phrase from a September New York Times article on Levine's case.
Unfortunately, the physician assistant who attended to Levine administered Phenergan neither through muscular injection nor IV drip, but through a process called "IV push" -- a direct intravenous shot in the arm. The assistant missed and hit an artery. Over the next few weeks, Levine, who was an avid guitarist, saw her right hand and forearm turn purple and then black -- until both were finally amputated.
The court battle is over whether or not Wyeth Pharmaceuticals sufficiently warned against the dangers of IV push on its packaging for Phenergan -- packaging that had been approved by the FDA. The drug's labeling did warn that it was preferable to give Phenergan through IV drip, and warned that "inadvertent intra-arterial injection" -- accidentally injecting the drug into an artery -- could cause "gangrene requiring amputation." But nowhere on the Phenergan label was there an express warning that the method of IV push is extremely risky for this very reason.
In 2006, the Vermont Supreme Court upheld a jury decision in state court to grant Levine $6.7 million from Wyeth on grounds that the company should have more expressly prohibited IV pushing on the drug's labeling. Wyeth appealed, arguing that, because the packaging was FDA approved, patients had no right to question it through state laws. In effect, Wyeth claims that federal approval preempts state-based challenges to regulatory standards.
The Preemption Wars
This principle of preemption makes for one of the most heated and important Court cases in a very long time. Levine is really about more than just drug labeling: it's about whether or not the FDA can be second-guessed, even after a patient has been harmed by a product that the agency has approved.
Earlier this year, the U.S. Supreme Court upheld this principle in deciding that preemption applied to medical devices in the case of Riegel v. Medtronic. New Yorker Charles Riegel and his wife, Donna, brought suit against Medtronic Inc. after a catheter it had manufactured burst inside Riegel's coronary artery during heart surgery. In February, the High Court ruled against Riegel in an 8-1 decision.
When the Court announced its decision, I lamented Medtronic's victory as a "blank check" for medical device makers in that it effectively shields them from law suits once they manage to get FDA approval for their products. But the stakes around Levine are even higher -- in the words of the Times, Monday's case is the "next frontier" in preemption.
That's because, at its heart, Riegel was a question of statutory interpretation. In 1976, Congress passed a Medical Device Amendment to the Food, Drug, and Cosmetic Act (FDCA), the law that effectively created the FDA. This amendment expressly calls for preemption in the regulation of medical devices. As such, the Court's decision was relatively simple, albeit ultimately dangerous. In that case, the Justices pretty much just read the letter of the law.
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