Levine V. Wyeth
Levine V. Wyeth
Back in 2000, a musician named Diana Levine was in the midst of a migraine headache when she walked into a clinic in Vermont. Anyone who suffers from migraines can easily testify as to how disabling they can be. While the pain is excruciating, there are also side effects like blurred vision and nausea. If you find yourself in the grip of a migraine, it’s a safe bet that you won’t be doing much of anything until it goes away.
The medical staff at the clinic gave her Demerol for the pain and an anti-nausea drug called Phenergan for her stomach. After a few days, Ms. Levine’s arm began to turn black and gangrenous, which left doctors with little choice but to amputate her right forearm.
What caused the gangrene was the way the medicine was administered. If Phenergan comes into contact with arterial blood, it causes gangrene. It is not the sort of drug that should be injected quickly. So just for the sake of caution, the safest way to do administer the drug is through a slow-acting (and constantly monitored) intra-venous drip. Injecting it into a vein any faster, such as a method called an IV push, is an incredibly risky way to do it, partly because the drug is very caustic, but mainly because if the person injecting misses the vein and fails to notice, the Phenergan could easily come into contact with arterial blood. Since mistaking a vein for an artery is not at all a rare medical occurrence, Phenegran is a drug that should be administered with as much care and supervision as possible.
Ms. Levine did not receive the sort of care and supervision that was required when the physician’s assistant injected her with Phenergan, which he did without even explaining to her what the risks of the drug were.
The FDA-approved label that came with Phenegran recommended against, but did not specifically prohibit, the use of an IV push while administering the drug.
This was the premise of Ms. Levine’s lawsuit against Wyeth, the manufacturer of Phenergan. Surely if a drug carries with it the danger of gangrene, then wouldn’t it be the responsibility of the drug maker to expressly prohibit a practice under which circumstances said gangrene could occur?
According to the state of Vermont, the answer was yes. According to the Bush administration, the answer was no.
Levine v. Wyeth worked its way through the court system of Vermont until the Vermont Supreme Court ruled in favor of Ms. Levine. If the case was based simply on whether or not the label was sufficient, then in all probability the case wouldn’t have even gotten to the appellate level. But Wyeth was taking advantage of a series of shifts in policy that occurred during the administration of George W. Bush. Specifically, in January of 2006, President Bush enacted what was called “implied pre-emption” with regards to federal versus state regulations when it comes to drug safety. In other words, if a drug company complied with federal FDA regulations in terms of labeling, packaging and marketing, then that would supersede the need to comply with any state laws.
There were very dangerous implications to this policy. Since the great majority of lawsuits involving pharmaceutical drugs are filed in state courts, President Bush’s implied pre-emption offered a way out for big pharmaceutical in thousands of law suits all over the country. All that the big pharmaceutical companies would have to do, as they did in the case of Ms. Levine, was to argue that they had done the best that they could in accordance with what was required of them by the FDA, and therefore any case filed in state courts involving labeling or marketing would be rendered invalid.
And despite the fact that it is supposedly the final arbiter of food and drug safety in the United States, the Food and Drug Administration is understaffed, underfunded and gets most of its information from the drug companies themselves. The process of doing something as simple as getting a change in a label takes about as long as it took for Ms. Levine’s case to work its way through the courts. First a question about the packaging or the side effects are raised. Then a report is filed. Then the pharmaceutical company is asked about the report. Then the pharmaceutical company has an opportunity to respond. Then the response is analyzed. Then a hearing with an “Independent Advisory Panel” is called, where the data is run by a series of experts, many of whom have financial ties to the drug companies themselves. According to the Center for Science in the Public Interest, among the 32 doctors and researchers on the FDA’s “Independent Advisory Panel:”
“CSPI found ten (10) physician/researchers with direct ties to Pfizer, Merck or Novartis (including G.D. Searle and Pharmacia, which are now part of Pfizer).”
In other words, even getting a label change at the FDA is a lengthy bureaucratic process in which the people giving the advice have a financial stake in the people being questioned.
This labyrinthine process is very damaging to the public, and it often makes the FDA a reactive agency rather than a proactive one. The makers of Fen-Phen and Vioxx were deep in the process of arguing with the FDA over label warnings right up to and after the point where people were starting to die. To this day there are thousands of lawsuits on dockets all over the country that involve drugs that are still sold freely and marketed aggressively, all while we wait for the FDA to do something. But they rarely ever do.
When Levine v. Wyeth finally made its way to the Supreme Court, the pharmaceutical companies were waiting with baited breath, and probably a sense of optimism. After all, the John Roberts court has very recently made it clear how it feels about lawsuits:
“Exxon Mobil, the giant oil corporation appearing before the Supreme Court yesterday, had earned a profit of nearly $40 billion in 2006, the largest ever reported by a U.S. company -- but that's not what bothered Roberts. What bothered the chief justice was that Exxon was being ordered to pay $2.5 billion -- roughly three weeks' worth of profits -- for destroying a long swath of the Alaska coastline in the largest oil spill in American history.
‘So what can a corporation do to protect itself against punitive-damages awards such as this?’ Roberts asked in court.
But fortunately, the majority decision ruled in favor of Ms. Levine. Justice John Paul Stevens claimed that Congress never intended for the FDA to be the only method through which drug and food safety was insured, any more than they expected them to take over the health and sanitation inspections in every restaurant and supermarket in America. In their opinion, reports and lawsuits from states should be taken into consideration by the FDA when they deliberate matters of drug safety, and in fact that was exactly what the FDA did prior to the implied pre-emption of 2006.
Americans dodged a bullet here. Debates about states’ rights versus federal rights are always contentious, but President Bush’s implied pre-emption was not a debate that was carried out in the light of day. It was pushed into practice practically in secret with no debate allowed, and had he been successful, not only would thousands of victims of bad prescription drugs have no legal recourse for their suffering, but also the Food and Drug Administration would have been legally able to stumble along with no input from anyone but themselves and big pharmaceutical companies, which in many cases turned out to be the exact same thing.
If you want to learn more about dangerous, or defective or bad drug products, please read our defective products page.
Problems with prescription drugs are very real and very dangerous. If you or a loved one has suffered from complications while using prescription drugs, contact Greenberg and Bederman for a free legal consultation today.
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