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.Friday Fun- August 29, 2008 We're allowed to be completely silly on a Friday afternoon, heading into a weekend that marks the end of summer, aren't weThe instructions on this website are in Japanese. In English, here's what you do:1. Click on "start."'2. The game will count down "3, 2, 1," and then start.3. You'll see a few numbers. Remember the order of the numbers, from lowest to highest.4. The numbers will then disappear and be replaced with circles. Click on the circles in the order of where the lowest to highest...http://druganddevicelaw.blogspot.com/2008/08/friday-fun.html Manufacturer Ordered To Provide Experimental Drug- August 28, 2008 A little over a year ago we caught considerable flak for our posts about Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc), the case that ruled against any constitutional right of patient access to unapproved, experimental, but potentially lifesaving drugs. We said then that we were on the fence about the constitutional right itself, but that we agreed with the result for practical reasons because the inevitable next step would.http://druganddevicelaw.blogspot.com/2008/08/manufacturer-ordered-to-provide.html Accutane Affirmed- August 27, 2008 Just one week after oral argument, the Eleventh Circuit has issued an unpublished per curiam opinion affirming the trial court's decision to exclude plaintiffs' expert testimony supposedly linking Accutane to inflammatory bowel disease. The key sentence in the one-page decision is this:"We have considered the briefs, the relevant parts of the record, and the well-reasoned opinion by the district court and conclude that the district court did not abuse its discretion by excluding the evidence...http://druganddevicelaw.blogspot.com/2008/08/accutane-affirmed.html Issue Preclusion in Mass Torts- August 27, 2008 We haven't yet read this one, but we like the sound of it.Byron Stier, of Southwestern Law School, has posted at SSRN his manuscript, "Another Jackpot (In)Justice: Verdict Variability and Issue Preclusion in Mass Torts." Here's what the abstract tells us:"If there are no prior inconsistent verdicts, non-mutual offensive issue preclusion generally allows a finding by a single jury to bar relitigation, in future cases, of the issue by the defendant who lost in the prior case. This approach,...http://druganddevicelaw.blogspot.com/2008/08/issue-preclusion-in-mass-torts.html Brickman on "Litigation Screenings in Mass Torts"- August 27, 2008 We have no creativity.Professor Lester Brickman, of Cardozo School of Law, posted on SSRN his article about mass torts. Brickman asks a provocative question in his title: "The Use of Litigation Screenings in Mass Torts: A Formula for Fraud"If we were answering that question, we would have just written: "Yes." But that wouldn't have been long enough to publish in a scholarly journal.That's probably why Brickman's in academia and we're toiling away in private practice.Anyway, Brickman includes.http://druganddevicelaw.blogspot.com/2008/08/brickman-on-litigation-screenings-in.html Exploring The New CBE Rule- August 25, 2008 We've now had a chance to review the new "change being effected" (or "CBE") rule finalized by the FDA last week. (Here's a link.) For drugs, the rule is 21 C.F.R. Sec. 314.70(c)(6).This is what we found.First, the FDA made one change from the draft rule that it proposed in January to the final rule that it adopted last week. The draft rule said that "newly acquired information" included data "derived from new clinical studies, reports of adverse events of a different type or greater severity or.http://druganddevicelaw.blogspot.com/2008/08/exploring-new-cbe-rule.html The New CBE Rule Is Final- August 22, 2008 The FDA has finalized the new CBE rule. (That's the so-called "Change Being Effected" rule at 21 C.F.R. Sec. 314.70(c)(6) for drugs.)Here was our post on that subject when the FDA proposed the rule in January. (We explain there why this change is a big deal.)And here's a link to the final rule that went up at the FDA website today.http://druganddevicelaw.blogspot.com/2008/08/new-cbe-rule-is-final.html "The Case For Field Preemption of State Laws In Drug Cases"- August 22, 2008 We can't figure out how to italicize the title of a post, so we'll repeat that title here, with our emphasis added:"The Case for Field Preemption of State Laws in Drug Cases."That's the provocative title of Richard Epstein's piece posted yesterday at Northwestern University Law Review's Colloquy site. Here's a link.Everyone argues for conflict preemption in drug cases, but one rarely sees an argument for field preemption.Epstein has made this argument before. See Richard A. Epstein, "Why the..http://druganddevicelaw.blogspot.com/2008/08/case-for-field-preemption-of-state-laws.html (New) Medical Device Preemption Scorecard- August 21, 2008 After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected by preemption, was resoundingly answered yes.But since then, weve said repeatedly that we dont expect plaintiffs to just fold their tents and go away - and they haven't. Rather, we expect the other side to look for loopholes in Riegel even if we dont think there are any especially in the area.http://druganddevicelaw.blogspot.com/2008/08/new-medical-device-preemption-scorecard.html Chicken of the Sea is Sunk- August 20, 2008 Yesterday, the Third Circuit decided Fellner v. Tri-Union Seafoods LLC, No. 07-1238, slip op. (3d Cir. Aug. 19, 2008) (link here).The case involves our favorite subject: tuna fish.Aaah, no, we're just kidding. The case involves preemption.The FDA has authority to regulate the field of food safety. The Agency can set standards of food quality and set tolerance levels for poisonous substances in food. And the Agency has enforcement authority to enforce the FDCA's ban on selling adulterated or...http://druganddevicelaw.blogspot.com/2008/08/chicken-of-sea-is-sunk.html |