Big Pharma just keeps getting bigger and bigger, while the FDA grows more and more incompetent. Drug lobbyists have a powerful hold on our government and I don’t imagine that will change any time soon.
Just this past Monday, in a 5-4 ruling, the Supreme Court ruled that people injured by dangerous generic drugs cannot sue manufacturers over pulling those drugs from the market. But this is just another nail in the coffin for patients’ rights. A previous Supreme Court ruling protected generics from almost all lawsuits over their warning labels, while some states continued to allow lawsuits over product safety itself.
This most recent ruling concerns a woman whose skin burned off and turned into an open wound, resulting in permanent disabilities caused by a generic painkiller. Because the painkiller was approved by the Food and Drug Administration (FDA) which warned about the dangers of this drug, as did its label, lawyers for the drug company and Justice Department argued that her case should be “preempted.” They claimed that federal laws require the FDA to balance risks against benefits of drugs, and juries should not be allowed to question the FDA’s “expert” determinations. What expert determinations? So many drugs have been approved by the FDA only to be taken off the market due to serious injuries incurred by their victims. When doctors prescribe these drugs, they don’t tell patients, “Okay, I’m going to prescribe this drug, but you should know you may be seriously injured by it.” From our experience in personal injury law, rarely are patients warned of ANY risks. They rely on their doctors to make decisions on which drugs are safe.
But where do doctors get their information? From the drug companies, of course. Pharmaceutical reps are literally “drug peddlers” who give doctors free samples, espousing the fantastic benefits of the drugs they sell. I would venture to say that many doctors don’t take the time to research the dangers of these drugs for themselves.
Additionally, the FDA is so underfunded and incompetent, the organization only tests a fraction of drugs on the market. And they do a highly ineffective job, as previous posts to this blog have indicated. So for attorneys to claim that jurors should not question the FDA’s “expert” determinations is, in a word, absurd.
Justice Sonia Sotomayer had a dissenting opinion (and one with which I agree). She said the company had the option to stop selling the drug altogether. But unfortunately, majority ruled and the Generic Pharmaceutical Association praised that ruling. According to GPhA President Ralph Neas, “The experts at the FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions.” That statement would be laughable if it wasn’t just plain sad.