A couple of years ago we penned a paean to Indiana and its cultural and legal triumphs. Now that another chunk of our family has decided to relocate to that happy state, our thoughts returned to Indiana’s many virtues. Sure, there’s the Indy 500, the fabulous covered bridges of Parke County, the Benjamin Harrison home,
When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker. It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo. It means you’re starting in the power position. Since the Supreme Court’s decision in Riegel v. Medtronic
We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06. In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations. It allows manufacturers of “biomaterials” – defined as “a
The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence (“AI”) in the medical field. The Act added this provision to the FDCA:
(o) Regulation of medical and certain decisions support software: (1) The term device . . . shall not include a software function that is intended
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A federal judge in one of our non-drug or device cases recently informed the parties that he was so busy with his criminal docket that it might be better to let the magistrate judge take over our case, including trial. We fretted over the prospect of losing a judge who had thus far been very
Back in May, 3M won the first MDL bellwether trial in In re: Bair Hugger Forced Air Warning Devices Prods. Liab. Litig. (D. Minn.). The case was Gareis v. 3M Company and at the time of trial, the only claim remaining in the case was for strict liability design defect under South Carolina law. 2018
Not quite a year ago, we prepared a 50-state survey on the status of claims that a foreign corporation’s compliance with a state’s corporate domestication statutes can be “consent” to general personal jurisdiction. This post went along with one of the DDL Blog’s cheat sheets called the “Post-BMS Personal Jurisdiction Cheat Sheet.”
Because
Some of your favorite Drug and Device Law bloggers will be presenting at Reed Smith’s Life Sciences CLE Day, which will be presented live in Reed Smith’s Philadelphia office and via videoconference to our Pittsburgh office on Thursday, November 15. This is a free, full-day CLE program designed for in-house counsel at life sciences
Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive
