Still think preemption is a good idea?
The major premise of preemption is that lay juries shouldn't "second guess" the experts at the FDA. The phrase "second guess" implies that juries are looking at the same information the FDA did. Unfortunately, that's often not the case. In many instances, pharmaceuticals submit incorrect or incomplete information to the FDA. Only during product liability lawsuits does the correct & complete information get revealed.
One scary example of a pharmaceutical hiding and obfuscating data is Paxil. GlaxoSmithKline determined that Paxil wasn't effective at treating depression in adolescents and increased the risk of suicides among adolescents. So they tweaked the results of the study until they claimed that the drug was both safe and effective. Alison Bass, a reporter at the Boston Globe has written a book about GSK's antics. Here's an excerpt of an interview with her by Pharmalot:
Pharmalot: What was the most surprising info you came across while researching the book?
Bass: What I found most surprising was they doctored the research on the Paxil study. When I looked back at memos I received from the Institutional Review Board from Brown, teenagers were withdrawn from the study and called non-complaint when they were in suicidal as a result from Paxil and should’ve been counted in the study as adverse effects. If these had been appropriately coded, there would have been an even greater risk of suicidal effects from Paxil. That was really amazing. There were many indications this Paxil study, it was called study 329, was doctored. But because it was published in a prestigious medical journal, Journal of the American Academy of Child & Adolescent Psychiatry in 2001, doctors paid attention.
Pharmalot: In reading the book, you don’t get much of Glaxo’s voice. Did the company not cooperate?
Bass: They didn’t respond to my requests. I spoke with Wick (Joseph Sollers, an attorney with King & Spalding, which represented Glaxo) on the phone a few times. I asked if I could interview some of their top officials, but they wouldn’t grant the requests. I did speak with the spokeswoman several times, as you could tell. But there were a lot of unseen documents from lawsuits. That’s how I got the smoking gun memo saying not to publish negative studies.
The already-overburdened FDA lacks the manpower and the willpower to fully investigate the results of pharmaceutical trials; personal injury attorneys don't. If FDA preemption becomes the law of the land, pharmaceuticals will be emboldened to hide or misrepresent data because the odds of being caught will drastically decrease. Unless and until we change the drug approval process so the FDA conducts studies, unethical pharmaceutical executives will always have the ability to distort test results in order to win FDA approval.