tag:blogger.com,1999:blog-36762711.post5895574651761655432..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Much Is Given, Much Is ExpectedRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger7125tag:blogger.com,1999:blog-36762711.post-54758471045929044422008-03-06T06:38:00.000-05:002008-03-06T06:38:00.000-05:00Score one for the Supreme Court. It should be agre...Score one for the Supreme Court. It should be agreed that everyone in any industry does their best to produce a product supreme quality regardless of the industry. This holds true for any medical device industry. With the regulations put in place by the FDA, consistent audits to ensure compliance, there have been huge strides in product safety and oversight. By any means there is no possibility for negligence. There is only possibility for research, development and progress. For the nay Sayers who disagree on the concept that a life may be lost, the ultimate goal is still in place that there will be a greater number of lives saved.Steve0hhttps://www.blogger.com/profile/07440175687674444744noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-7689438093133235502008-02-22T10:33:00.000-05:002008-02-22T10:33:00.000-05:00You nailed it on the head with this post. If medi...You nailed it on the head with this post. If medical device manufacturers do the right thing, then we end up with safe devices, and not having to spend untold resources on litigation allows more resources to make them safer. Litigation can and often does unfairly cripple progress.GraniteKeyhttps://www.blogger.com/profile/16651541705914029500noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-13609451158476967752008-02-22T07:41:00.000-05:002008-02-22T07:41:00.000-05:00Plaintiffs' lawyers need to consider their own exc...Plaintiffs' lawyers need to consider their own excesses. The Riegel case involved a product used for a contraindicated use (calcified arteries) and them misused (overinflated) on top of that. Yet it was the manufacture that got sued.<BR/><BR/>And then there's the whole mass tort industry. Any recall, and almost any warning letter or other adverse information of any sort about a prescription drug or medical device becomes within a week there are ten class actions filed and massive solicitation.<BR/><BR/>The plaintiff's side never had Scalia. But five justices voted against preemption as recently as Lohr - indeed, as recently as Bates. The plaintiffs' side lost four of those five. That should say something.<BR/><BR/>The tort system has gotten out of control. It's tried to usurp the role of the FDA. It's not surprising to see courts looking for ways to rein it in.Beck/Herrmannhttps://www.blogger.com/profile/17150638020283243716noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-49506396535965221212008-02-22T03:44:00.000-05:002008-02-22T03:44:00.000-05:00The FDA is a complete joke and you know it. Stop ...The FDA is a complete joke and you know it. Stop pretending like there's some kind of rational basis for total preemption beyond your clients spending a bunch money to limit their liability. Money talks and B.S. walks.<BR/><BR/>Just be honest about it...you guys have engaged in some great lawyering and have managed to get lucky with a pro-business supreme court that, fortunately for you, happens to have a profound dislike for plaintiffs' lawyers. Seriously, Scalia could barely contain himself in Riegel. When reading his opinion, I thought he was going to just come out and say that plaintiffs' lawyers are spawn of the devil and that stupid state court juries just aren't smart enough to decide ANY complex cases. <BR/><BR/>Well, if Scalia is correct, I guess that means we ought to just get rid of the whole jury system. If a jury can decide a benzene lymphoma case then why can't it also decide a drug or device case. This is completely absurd.<BR/><BR/>I guess in the future when we handle voie dire, we need to find a bunch of smart, learned, folks like scalia who really know what's good for the country and can think broadly in a more "utilitarian" fashion. Maybe then we'd get some "fair" verdicts, right?<BR/><BR/>Wow...eight years of Bush certainly has its consequences.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-19422830453606703102008-02-21T14:59:00.000-05:002008-02-21T14:59:00.000-05:00I am including a somewhat revised version of a com...I am including a somewhat revised version of a comment also provided on the Pharmalot blog in a thread responding precisely to this thread here. Not being a lawyer, there is no "30%" involved for me, of for anyone with whom I am associated. Thus, just as I agree that most people in the drug and device industry are people of integrity, I hope you will grant that most - if not all - profoundly opposed to preemption are also people of integrity. Please don't tar all of us if you ask not to be tarred yourself.<BR/><BR/>Everything we have learned about industry, FDA, and their relationship over the past decade (and much longer) tells us that they will not step up to the plate. On the FDA side, they simply do not have the means to do the kind of job you describe.<BR/><BR/>I believe it a certainty, therefore, that disaster will occur, and it will be on a scale much larger and more devastating than anything we have seen because most of it will happen in the dark. When the levee breaks, it will entail more than burying the bodies and hoping for a Congressional fix. Trust in the FDA and the industry will be shattered for a very, very long time. And that itself will result in both economic and public health disaster. We will have a lot of dead people. And a lot of dead companies. So I agree - the situation will be profoundly worse for the industry, and all of us, than it is now.<BR/><BR/>That is one reason I have been arguing for several years that preemption has never been in industry’s interest. Entirely, the opposite. And the disapproval rates one sees now will be looked back upon as very good days compared to what is to come.<BR/><BR/>I am sorry to be so negative. Trust me, this is not a political statement. And it is precisely the opposite of anti-industry. It is looking a policy in the face - the policy of preemption - and simply saying what cannot be blinked away: it is logically, practically, and ethically bankrupt. It is a preemptive strike that will cost more, in both lives and treasure, than the preemptive strike on Iraq. It is an avoidable disaster (in the drug arena), but one that will almost certainly not be avoided. <BR/><BR/>And, sad to say, those who are on the inside of the industry know this best of all. And many of them have told me this, just as I am sure, in one way or another, they have told you.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-92052584245677296672008-02-21T14:58:00.000-05:002008-02-21T14:58:00.000-05:00The FDA is no joke. Like it or not, it is the fed...The FDA is no joke. Like it or not, it is the federal agency charged by Congress with overseeing the safety of drugs, medical devices, food, vaccines, and a lot of other stuff that keeps us alive and functioning.<BR/><BR/>The FDA only becomes a "joke" if congress refuses to adequately fund it and otherwise give it the tools it needs to do the job, and if the administration fails to provide the leadership and will for the Agency to do it's job.<BR/><BR/>There's no small measure of sour grapes here. We remember when, under Kessler, plaintiffs had a love-in with the FDA. Now the shoe's on the other foot and all we see are remarks like this.Beck/Herrmannhttps://www.blogger.com/profile/17150638020283243716noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-69860499239979968392008-02-21T12:59:00.000-05:002008-02-21T12:59:00.000-05:00You wrote:"The FDA will have to display, day in an...You wrote:<BR/><BR/>"The FDA will have to display, day in and day out, the “rigor” that the Riegel majority found in its approval and post-approval processes. If the Agency doesn’t provide strong regulatory oversight, then inevitably unsafe medical devices will enter the market and people ..."<BR/><BR/>The FDA is a joke. Udnerfunded, understaffed. IF you presume in the academic that the FDA does what it was supposed to do, I'd be fine with it. <BR/><BR/>As a panel just wrote:<BR/><BR/>The Food and Drug Administration is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety, an advisory panel to the FDA says in a report to be discussed Monday. <BR/><BR/>gency responsibilities. Instead of being proactive, the agency is often in "fire-fighting" mode.<BR/><BR/>•A workforce with a "dearth" of scientists who understand emerging technologies. Turnover rates in some scientific positions at the FDA run twice that of other government agencies.<BR/><BR/>•An "obsolete" information-technology system.<BR/><BR/>The report says that the FDA's IT systems are so lacking that reports of product dangers are not rapidly compared and analyzed, and that inspectors' reports are handwritten and slow to move through the system. <BR/><BR/>Putting pruduct thorugh a broken system is ridiculous. Shame.Anonymousnoreply@blogger.com