Drug and Device LawThis blog contains JIM BECK and MARK HERRMANN's personal views of various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Our first post, dated October 2006, contains a disclaimer about the nature of this blog. Please read it, and understand that you are accepting its terms, before reading any of our posts.Defense Reply Brief in Levine- September 16, 2008 We've got a copy of the Reply Brief filed by defendant Wyeth in the Wyeth v. Levine case. Here are the highlights as we see them (we're trying to stay away from the Phenergan or Wyeth specific stuff):Conflict preemption operates by the direct force of the constitution. Express congressional intent to preempt thus is not an issue. It's enough that Congress intended to have drug labeling decisions made by the FDA. Contrary state-law claims interfere with the accomplishment of that objective, and..http://druganddevicelaw.blogspot.com/2008/09/defense-reply-brief-in-levine.html We're Duty-Bound To Post (Pre-Service Removal)- September 16, 2008 We really shouldn't complain about the burden after we voluntarily assume a duty.After all, we created the Drug Preemption Scorecard, the Device Preemption Scorecard, the No Injury Scorecard, and the Cross-Jurisdictional Class Action Tolling Scorecard, and we know that, having created those resources, we're duty-bound to keep 'em current. (But we're not your lawyers! We're not giving legal advice here! And if we inadvertently overlook a case that belongs in one of those scorecards, you can't...http://druganddevicelaw.blogspot.com/2008/09/were-duty-bound-to-post-pre-service.html We're Not Heartless, Jeremy!- September 15, 2008 Everybody's a critic.We published a post last month analyzing Gunvalson v. PTC Therapeutics (here's a link), in which a federal judge ordered a company to provide an experimental drug to a dying patient who did not qualify for a clinical trial. We wrote:"Basically, a drug company would be crazy to open a compassionate use program for just one person nor could one person afford to pay the 'cost' of all the overhead compassionate use requires."The court dismissed these cost considerations as...http://druganddevicelaw.blogspot.com/2008/09/were-not-heartless-jeremy.html Is The FDA Really So Weak- September 15, 2008 We've grown accustomed to hearing complaints that the Food and Drug Administration is powerless. "How can the Agency possibly cause companies to act responsibly," critics (and plaintiffs' counsel) ask. Historically, the FDA lacked the power to order product recalls, and its authority is limited in other ways. Companies, we're told, run roughshod over the Agency.We've always known (from personal experience and things we've heard in the industry) that this wasn't true, but it hasn't always been...http://druganddevicelaw.blogspot.com/2008/09/is-fda-really-so-weak.html Holding The Line On The Duty To Warn- September 11, 2008 Having been in this business (defending pharmaceutical product liability) for a long time now, weve learned that what happens to prescribing doctors often comes back to haunt our clients. Nowhere is that better illustrated than with the thankfully discredited theory of regulatory informed consent, which since weve already discussed it, here, we wont go into again in any depth.You can stop cheering now.That theory that the docs had to tell their patients about off-label use was ginned up for...http://druganddevicelaw.blogspot.com/2008/09/holding-line-on-duty-to-warn.html To Arms!- September 11, 2008 This post, at TortDeform, tells us that a consortium of plaintiffs' firms will now be paying law students to work the new media -- blogs, forums, Facebook, Twitter, and the like -- in favor of plaintiff's-side causes:"Initial duties will be to assist the firms with their public relations campaigns through blogging on the InjuryBoard.com blog network. A major goal of the coordinated effort by these firms is to educate the public on the importance of the civil justice system and why protecting...http://druganddevicelaw.blogspot.com/2008/09/to-arms.html Okay, We'll Play: 5 Blogs and 5 Blawgers.- September 10, 2008 Yesterday, we were ignorant.Today, we're still ignorant, but at least we know where the words "meme" and "Internet meme" come from. You can click through those links for all the details, but here's the money quote from Wikipedia's definition of an "Internet meme":"At its most basic, an Internet meme is simply the propagation of a digital file or hyperlink from one person to others using methods available through the Internet (for example, email, blogs, social networking sites, instant...http://druganddevicelaw.blogspot.com/2008/09/okay-well-play.html More Upcoming Talks- September 10, 2008 Summer's over, and that means that the speaking invitations are starting to arrive.The biggest of the events at which one of us has accepted an invitation to speak is ACI's 13th Annual Drug and Medical Device Litigation conference in New York City on December 9 through 11.Here's a link to the conference brochure.And -- for a limited time only, and just for readers of this blog! . . . actually, we're not sure whether that's true.But, in any event, if you use registration code 877CXMN, you'll...http://druganddevicelaw.blogspot.com/2008/09/more-upcoming-talks.html How Long Does The MDL Process Take- September 9, 2008 This is a follow-up to last week's post describing the multidistrict litigation process.Once clients understand the basic mechanics of the MDL process, the next question is: How long will it takeIf someone files a motion for centralization with the MDL Panel today, when will the Panel hear argument and issue its decision, and, if the Panel grants the motion, when will we have the first case management conference before the transferee courtHappily, Judge John Heyburn, the Chair of the MDL Panel,.http://druganddevicelaw.blogspot.com/2008/09/how-long-does-mdl-process-take.html Exciting Drug and Device TV- September 8, 2008 We just received this e-mail about a video webcast that will be available tomorrow:"Courtroom View Network ("CVN") will provide a live and on demand video webcast of oral arguments on a motion to remand State of West Virginia v. Eli Lilly & Co. back to West Virginia state courts on Tuesday, September 9. Oral arguments are also expected on trial discovery orders.The hearing is scheduled for 2 p.m. in United States District Court for the Eastern District of New York before Hon. Jack...http://druganddevicelaw.blogspot.com/2008/09/exciting-drug-and-device-tv.html |