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Drug and Device Law Blog

Articles: 1-10 of 427

Biomaterials Access for the 21st Century

USA - November 12 2018 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…

Final Curtain for Plaintiffs’ Experts in the Mirena IIH MDL

USA - November 9 2018 Kudos to the multi-firm defense counsel team that brought home the decision on which we report today, a victory that may well end up on our “best”…

The Diagnostic Artificial Intelligence Speedbump Nobody’s Mentioning

USA - November 8 2018 The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence (“AI”) in the medical field. The Act…

D. Colorado Applies Learned Intermediary Rule to Medical Devices

USA - November 7 2018 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…

Plaintiff’s Motion for New Trial Denied in Bair Hugger MDL

USA - November 6 2018 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…

Updating Our Post-Bauman 50-State Survey on General Jurisdiction by Consent

USA - November 5 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…

A Twist On The Old One-Two Punch

USA - November 2 2018 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…

Fosamax in U.S. Supreme Court - Justice Alito Un-Recuses

USA - November 1 2018 An unexpected bit of good news as we go into November. Bexis will be presenting at the Reed Smith annual client CLE program on big-deal pending cases…

On Prevention of Federal Fraud on the FDA Claims That Avoid Buckman

USA - October 29 2018 Private plaintiffs love to scream “fraud on the FDA”! Agency fraud is their magic potion for dissolving any FDA action that they don’t like. Just…

Pennsylvania Preemption Win Now Final

USA - October 26 2018 A year and a half ago we celebrated a rare prescription drug preemption win in the Philadelphia County Court of Common Pleas. Then the decision was…