Hoosier Daddy, Part 510(k): FDA Clearance is Admissible
It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern...
View ArticleGuest Post – 510(k) Clearance of a Class II Device Can Be, as a Matter of...
Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court...
View ArticleGuest Post − How Much Is Too Much Deference To FDA Warning Letters in...
Today’s guest post is by Camille L. Fletcher and Joshua Kipnees, both with Patterson Belknap. We actually sought out this guest post, which is rare. We first saw it on one of Patterson’s in-house...
View ArticleWhy Should FDA Warning Letters Be Any Different?
We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s). We’ve cited precedent,...
View ArticleNew Jersey Rejects Bogus Exclusion of FDA Device Clearance Evidence
We have been consistently critical of the MDL system for encouraging judges presiding over such massive aggregations to manipulate the applicable law to create settlement pressure on defendants. We’ve...
View ArticleMixson Somewhat Mixed, But We’ll Take It
The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no...
View ArticleGuest Post – What a Product Liability Defense Lawyer Learned While Working...
Today’s guest post is by Jim Fraser of Greenberg Traurig. Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel...
View ArticleThe FDA and Feasible Alternative Designs
In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. Quite a few states, as well as...
View ArticleAnother Decision Admitting Evidence of FDA §510(k) Clearance
Kelley v. C.R. Bard, Inc., 2023 WL 2565853 (N.D. Ga. March 17, 2023), reconsideration denied, 2023 WL 3032063 (N.D. Ga. April 21, 2023), became the latest decision to follow what used to be (before the...
View ArticleDealing with the Pennsylvania Supreme Court’s Non-Decision on Standards...
As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict...
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