This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of information on its labeling without adjacent…
Blog Archives
FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels
Posted in FDA
Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure
Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an important cautionary tale and one that is…
Sweet Victory: Whole Foods Uses FDA Regulations to Dismiss Complaint in Greek Yogurt MDL
This month, United States District Judge Sam Sparks of the Western District of Texas dismissed a Second Amended Consolidated Complaint in an MDL styled In re: Whole Foods Market, Inc., Greek Yogurt Marketing and Sales Practices Litigation. At issue in…
Whose Choice Is It Anyway? Split Decisions Over Choice of Law and The Impact On Your Defense Strategy
Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, has been embroiled in a mass tort MDL in Philadelphia for its anti-psychotic drug, Risperdal, for almost a year now. So far in 2015, the juries have split – three in…
Posted in Choice of Law, FDA
When Good Food Goes Bad: Contamination and Product Liability
Last week, lunch came back to bite dozens of unsuspecting diners throughout Washington and Oregon. Something in Chipotle’s fresh, healthy, and responsibly-sourced fast food caused uncharacteristic sickness for those partaking. The likely culprit, E. coli bacteria, left Chipotle patrons seriously…
