On November 3, 2008 the US Supreme Court will hear opening arguments in the Wyeth vs. Levine case. This highly publicized lawsuit has been discussed by the New York Times and the Journal of the American Medical Association and will likely be the most important case during the upcoming Supreme Court term. However, neither source has fully explained the unexpected consequences to the consumer if Wyeth loses.
To get to the bottom of the issue, I interviewed Bert Rein, attorney for Wyeth. Bert has conducted interviews with NPR and the three major TV news networks. Please enjoy this exclusive podcast interview here at Getting Better with Dr. Val, or read my summary of our conversation below.
Dr.Val: Bert, please summarize for our listeners what has happened so far in the Wyeth vs. Levine case.
Rein: Ms. Levine is a guitarist who suffers from migraine headaches and associated nausea. One day she sought pain management therapy at a clinic in northeast Vermont – the same clinic where she regularly received care. They elected to treat her with a combination of demerol (for pain) and phenergan (for nausea). They delivered the drugs intramuscularly, but several hours later Ms. Levine returned, complaining of an unrelieved migraine headache.
The clinic’s physician realized that the drugs would be more potent if they were injected intra-venously so he asked the PA (physician assistant) to give another dose of the drugs through Ms. Levine’s vein. Unfortunately, the PA inserted a butterfly needle (rather than the usual heplock for an IV) into what she thought was Ms. Levine’s vein, and delivered the phenergan into or near a punctured artery. Phenergan’s label clearly states that the drug can cause tissue necrosis if it comes in contact with arterial blood. Ms. Levine experienced a necrotic reaction to the medication which resulted in the eventual amputation of her arm. She sued the clinic for negligence and was awarded $700,000 dollars in a cash settlement.
Ms. Levine then brought a separate lawsuit against Wyeth, claiming that the phenergan label did not offer sufficient instructions about how to administer it safely, though the risks of necrosis from arterial blood exposure to phenergan are well known and labeled in capital letters as a warning on the drug’s label. The package insert also offered cautionary instructions about how to use phenergan via IV push. It said that the dose must not exceed 25mg/L and that it should be injected slowly (no less than 1 minute), and that the correct placement of the IV/needle should be checked prior to injection of the drug. Ms. Levine argued that the label should have completely contraindicated IV push administration of the drug, and that Wyeth should have removed that administration choice from the providers in the clinic.
The jury returned a very large compensatory verdict, awarding Ms. Levine $7 million. The case was appealed to the Vermont Supreme Court and Wyeth took the position that its labeling had been approved by the FDA, with full knowledge of the risks of the drug. Because the FDA was aware of the risk of necrosis from administering the drug in or near an artery (Ms. Levine’s tragic arm loss was not an unknown or new risk) Wyeth should not be charged with violating a new and arbitrary, state-level labeling standard established by a jury with no particular medical expertise. In other words, even though the FDA approved the labeling, the local jury disagreed with the risk/benefit analysis made by the FDA and sought to establish a different labeling standard that seemed right to them.
When a jury looks at this case, they see a musician who lost her arm due to a migraine medicine and they want to hold the drug company responsible. But when the FDA looks at the drug, they see 200 million successful and safe administrations of it with less than 20 cases of provider error with severe consequences like Ms. Levine’s.
In essence, this case is about whether or not a local jury can override the authority and requirements of FDA standards in the pharmaceutical industry. The court system of Vermont believes that they have the right to hold industries (who are in compliance with FDA standards) to additional standards as juries see fit. Wyeth must now appeal to the US Supreme Court in order to establish the supremacy of federal law over state law.
Dr. Val: And what would happen if the US Supreme Court sided against Wyeth in this case?
Rein: It would establish a dual regulatory regime (both Federal and State) over health products, devices, and pharmaceuticals. Each state could set up their own safety commissions, and require all drug labels to be approved by them (in addition to the federal system). States would be able to disagree with federally established safety standards.
This would dramatically slow down the process of making drugs available to patients, impose additional requirements at will, and cause the manufacturers to add any possible risk they could think of to the warning labels on their products (in order to protect themselves from lawsuits like Wyeth vs. Levine). Of course, this would totally undercut the FDA’s most recent initiative to shorten drug labels. The clutter of the label essentially suppresses the most important information on it.
The FDA has a real challenge staffing itself with trained medical personnel. Imagine how difficult it would be for every state in the union to create an additional agency to handle these kind of drug risk-benefit analyses. These agencies would have to become risk averse to demonstrate their value – “I’ll show the people of this state just how safe we’re making drugs for you…” would be the thinking. That would result in confiscation of medications, removal of decision-making from healthcare providers, cluttered labels, and fewer choices for patients. And that’s just what the state-based agencies would be like. Imagine adding in a jury system that has the power to overturn and override state-based and federal standards. It would be utter chaos.
In my next blog post I’ll discuss what Bert had to say about improving post-market surveillance of adverse drug events, since Catherine DeAngelis’ recent JAMA editorial raised this issue.