tag:blogger.com,1999:blog-36762711.post9198854923031854490..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Dukakis and RiegelRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger6125tag:blogger.com,1999:blog-36762711.post-54373475933163038482008-03-17T16:37:00.000-04:002008-03-17T16:37:00.000-04:00Anonymous 1's moving story illustrates why the FDA...Anonymous 1's moving story illustrates why the FDA is not, and never will be, a neutral panel of experts. As Milton Friedman explains, “If you . . . approve a thalidomide[,] your name will be spread over the front page of every newspaper.” The FDA is, and continues to be, biased in favor of safety over innovation. Adding more responsibility to the FDA through allowing FDA preemption will only increase the FDA's exposure to public criticism and therefore, will cause the FDA to hold up the production of even more drugs and/or medical devices.<BR/><BR/>Even if one is in favor of promoting drug and medical device safety over innovation, do we really want the FDA in charge of our floor AND our ceiling? Despite the fact that 80% of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad, the FDA has not complied a single accurate database of foreign drug firms importing medicines into the United States, or even a list of approved drugs. This is not the track record of an agency that has it together!<BR/><BR/>Increasing the FDA's bureaucracy through FDA preemption will not fix our tort system.Unknownhttps://www.blogger.com/profile/10035280748704227025noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-20210052632905937502008-03-17T14:43:00.000-04:002008-03-17T14:43:00.000-04:00First. Have loved this blog. Great reading, esp. f...First. Have loved this blog. Great reading, esp. for young pharm defense attys such as myself. I understand that no lawyer who cares about winning clients is going to argue the other side. <BR/><BR/>Still, the "FDA is a neutral watchdog" argument is getting a little stale, at least for me. How do you account for the fact that FDA policy re: preemption was exactly the opposite under the more plaintiffs' bar friendly Clinton administration? Clearly the agency makes decisions based on politics as much as science. <BR/><BR/>Second, instead of making strange, offputting analogies between our drug company clients and rapists and murderers, let me suggest you practice what you preach and present some law and economics style arguments (i.e. facially neutral/objective) <B><I>and</I></B> data in favor of preemption. What are the costs of MDLs vs. the costs of plaintiffs' injuries in the aggregate? Are there studies evaluating the effect these trials have on pharmaceutical company practices? Would it make more sense to set up a larger system of governmental adjudication and payment of adverse drug experience claims like in the vaccine cases?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-77724469356121008202008-03-17T14:32:00.000-04:002008-03-17T14:32:00.000-04:00You are absolutely correct in your premise and Duk...You are absolutely correct in your premise and Dukakis is a great example. And just because the victims are easier to see than the hidden benefits does not mean that we should also yield to the pain that is right in front of our face. All of this is correct. We shouldn't not defer to the FDA because "how would you feel if you were a victim?" Instead, we should not defer to the FDA because it is stupid to ask the immates counsel to guard the prison.<BR/><BR/>The New York personal injury lawyer blog made a great point about how the logical extention of Reagan's theories about the perils of relying on government (even though you mocked it). This is no slam on the FDA in many ways. Why don't we get rid of the federal whistle blowers statute? We have prosecutors, right? While we are at it, the state tests doctors and lawyers, who are plaintiffs to suggest they committed malpractice? Why even have juries for any cases really?<BR/><BR/>Unless the FDA is actually doing its own research - multiply its budget by 10,000 - it can never have the information the drug companies have and can never be put in their shoes. That's what juries do, folks, they put themselves in the shoes of the companies looking at the entire picture from the company's vantage point to determine if they were negligent. <BR/><BR/>Ron MillerAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-63468063314359357842008-03-17T12:49:00.000-04:002008-03-17T12:49:00.000-04:00What we've learned, though, is that the "neutral e...What we've learned, though, is that the "neutral experts" often disagree profoundly among themselves.<BR/><BR/>Follow the histories of Zyprexa, Rezulin, fen-phen, et. al. - regulatory agencies in other countries - Japan, UK, et. al. = made radically different decisions concerning withdrawal and/or warnings with regard these and other medications. <BR/><BR/>Indeed, it could be suggested that the experts, internationally, have differed _more_ profoundly among themselves regarding a number drugs that ened up in litigation than lay juries in the U.S. have differed between each other. <BR/><BR/>So the "emotional immediacy" versus "neutral expert" issue should probably be taken with several scoops of salt. <BR/><BR/>So also the suggestion that different conclusions lead to some sort of dangerous chaos, as defenders of preemption often assert. Profound differences among international regulatory conclusions have led to no chaos whatsoever, as far as I can see. <BR/><BR/>Just differences.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-87117791281830585302008-03-17T12:45:00.000-04:002008-03-17T12:45:00.000-04:00What we've learned, though, is that the "neutral e...What we've learned, though, is that the "neutral experts" often disagree profoundly among themselves.<BR/><BR/>Follow the histories of Zyprexa, Rezulin, fen-phen, et. al. - regulatory agencies in other countries - Japan, UK, et. al. = made profoundly radically decisions concerning withdrawal and/or warnings with regard these and other medications. <BR/><BR/>Indeed, it could be suggested that the experts, internationally, have differed _more_ profoundly among themselves regarding a number drugs that went to litigation than lay juries in the U.S. have differed between each other. <BR/><BR/>So the "emotional immediacy" versus "neutral expert" issue should probably be taken with several scoops of salt. <BR/><BR/>So also the suggestion that different conclusions lead to some sort of dangerous chaos, as defenders of preemption often assert. Profound differences among international regulatory conclusions have led to no chaos whatsoever, as far as I can see. <BR/><BR/>Just differences.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-40231724550957394292008-03-17T12:08:00.000-04:002008-03-17T12:08:00.000-04:00I guess it's all in the way you look at it. Is it...I guess it's all in the way you look at it. Is it "punishment" that the jury is providing or "accountability"? My mother was handed a death sentence the day that the medical device that killed her was placed in her. All we are asking for is our day in court, something that is the right of every American, in order to hold the medical device company accountable for what they are selling to the public. <BR/>If we could truly count on the "neutral experts at the FDA" to evaluate the safety of drugs and devices, my mother would be alive today because the medical device that was placed in her would not be on the market.Anonymousnoreply@blogger.com