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242 published works
Drug & Device Law
When You Cannot Compel the Manufacturer to Make More of the Drug You Want to Take, You Cannot Force the Government to Compel the Manufacturer to Make More of the Drug You Want to Take
“Necessity is the mother of invention.” “Desperate times call for desperate measures.” “Bad facts make bad law.” We see two of three of these adages play out in Carik v.…
Drug & Device Law
Litigation Over “Meal Replacement” Cannot Replace FDA’s Primary Jurisdiction
The recent Thanksgiving weekend and the hearty meals that exemplify that great American holiday give us a segue to a post on food. Specifically we write today on another interesting…
Drug & Device Law
A Black Friday for Plavix Plaintiffs
We expect that most of our readers enjoyed yesterday with the American rituals of gluttony, football, and traffic. For some, today is an opportunity to see if doing nothing is the best way…
Drug & Device Law
Knowledge and Intended Use
By Bexis
Our post last week on the three-ringed FCA circus in U.S. v. King Vassel, got us thinking about another way that misguided plaintiffs try to criminalize off-label use. Deviating from the…
Drug & Device Law
Aredia-Zometa Court Rejects PA Heeding Presumption, Finds Black Box Preempted, and Garbles Some Other Issues
In the index to this blog, we list 39 posts about the Aredia-Zometa litigation. After today it will be 40. And counting. That might actually be understating our coverage. (We’re…
Inside Global Tech
FDA Releases Final Mobile Medical Apps Guidance
On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. The guidance describes FDA’s approach for regulating…
Drug & Device Law
Another Notch on Medtronic’s Preemption Belt
This is from the Dechert side of the blog only. Last week we gave you a lot of Medtronic decisions to mull over and to mostly be happy about. And,…
Drug & Device Law
On Litigation, Great and Small
By Bexis
The following post is exclusively the work of the Reed Smith side of the blog. Sometimes the smallest, least significant type of lawsuit can illustrate cracks in the edifice of the largest,…
Drug & Device Law
Preemption – A Counter To Dean Chemerinsky’s Proposal
By Bexis
Anybody who has ever had the pleasure of listening (as we have) to Dean Erwin Chemerinsky expound upon the Supreme Court’s constitutional decisions knows that the man is drop-dead brilliant. …
Drug & Device Law
Rose Presents Thorny Issues for UCL Drug and Device Plaintiffs
This post is from the Dechert side of the blog only. When product-liability plaintiffs suing drug or medical device manufacturers assert California’s Unfair Competition Law (“UCL”) using a purported “violation” of the Food,…