Wyeth v. Levine

The latest U.S. Supreme Court ruling to be made and released to the public deals with a woman, Diana Levine, who sued a pharmaceutical company, Wyeth, for a drug of their making that caused her to lose an arm. They upheld a $6,700,000 jury award from a Vermont state trial. Apparently, Vermont law requires stronger warnings than the FDA requires.

Phenargen is an anti-nausea drug that can be administered via injection. Its public use was approved by the FDA decades ago, including the method of use at issue in this case, to treat nausea, and when used properly, it is safe and effective or so says both parties. While I feel sorry for her, she was, or should have been, aware of the risks of the drug which are printed on the label as they are on all drug labels.

While I still struggle with the constitutionality of this bureaucracy or at least its current size, scope and power, if it must exist "for the public good" and if they must have final say on the safety of foods and drugs made by private industry before public consumption and use, then how can drug makers then be held accountable for their drugs' misuse, despite warning labels, or for their side effects which may not be known for years or decades? How many millions of dollars are spent by these companies to make drugs that improves our quality of life, with minimal side effects, and how many more are spent getting approval from the FDA to sell it to the public? How much time passes from that first lab experiment designing a new drug to the first bottle on the store shelf? I realize this time will vary by drug, but I remember hearing some time ago that it takes an average of 12 years to get approval.

Imagine you are asked to make an investment in a new product that will not see any returns for 12 years. Would you do it? Well, "Big Pharma" does this all the time because they hope to sell that drug for even more decades after its FDA approval and see a return on their product. However, will they continue to make these investments of time and resources if they believe they will be sued because someone misuses the drug? They might still do so with malpractice insurance in place, which is an additional cost passed on to the consumer, or they may not do it at all, which is one less life quality-improving drug on the market.

Finally, to address the issue of state versus federal law, which is supreme? Wyeth only needed FDA approval, and thus their version of the proper warning label, to sell this drug in all states in this country. Unless federal law also dictates that they put an additional warning label to accomodate each state wherein the drug is sold, the drug maker should be immune from legal action. If they were required to do so, that would be another cost passed on to the consumer.

Some laws are good, but other ones only limit freedom and increase costs.