Just in. United States Supreme Court rules unanimously in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”), that the Third Circuit got it wrong in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017). However, the majority opinion,
Further Thoughts on the Proposed DTC Advertising Drug Pricing Rule
To the surprise of almost nobody, the Centers for Medicare & Medicaid Services finalized their proposed direct-to-consumer advertising regulation the other day. That’s the one that would require a statement of the promoted drug’s “list price” in all DTC advertising. We’ve already discussed why we thought the regulation was on shaky ground in terms of
Yes, Virginia (Utah, Actually), There Is §510(k) Medical Device Preemption
We’ve explained at length why Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is an anachronism with respect to preemption, given the complete overhaul that Congress gave to §510(k). Still, strange things happen when preemption meets product liability, and there seems to be a conspiracy of silence among judges with respect to current FDA
If We’re Not All Wet, We’re Still Rather Damp
Late last year we published the post “Twiqbal for Defendants? Not If We Can Help It.” on the issue of whether the “plausibility” standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S 662 (2009), applied to “affirmative defenses (which we prefer to just
Update to Our 2011 Post on When Counsel Can Confer with Their Own Witnesses During Depositions
Of all the one-off posts that we’ve done, our post from 2011, “Depositions – When Can You Talk To Your Own Witness?,” has probably garnered the most ongoing use by litigators generally. Both inside or outside of our firms, we get questions or comments about it probably about once every other month. That’s
Standing Corrected
Recently we published a post, “One, Two, Three Strikes You’re Out,” about three recent (non-pelvic) mesh wins that occurred less than one week apart. We spent the most ink on Nowell v. Medtronic Inc., ___ F. Supp.3d ___, 2019 WL 1434971 (D.N.M. March 29, 2019), which also happened to be the longest
Errata Sheet Errors
Have you ever left a deposition feeling confident that you obtained the testimony you hoped to receive, and it’s time to move for summary judgment? Then (whether within the time period permitted by the relevant rule – in federal court Fed. R. Civ. P. 30(e)(1) – or otherwise) you get back a so-called “errata sheet”
One, Two, Three Strikes You’re Out
With new grass on the field, the 2019 baseball season is underway and optimism springs eternal. Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since, umm…., last year actually. But this year, having added possibly the best player and best catcher in the league,
A Word To The Wise – Locate Your FDA-Mandated Agents With Care
This message is directed primarily to our overseas readers, and those who represent non-United States drug and medical device companies. Under FDA registration regulations, non-United States manufacturers (and other regulated companies) that import their regulated products into this country are required to appoint a domestic “agent” for regulatory purposes:
(i) Registration of foreign establishments
(1)
Guest Post – Not a Moonshot, But Not a Fizzle Either − FDA’s Proposed Regulatory Framework for AI/Machine Learning Medical Devices Is A First Step Toward Total Product Lifecycle Regulation
If the promise of adaptive artificial intelligence (sometimes called “Machine Learning”) is to be achieved in the medical area, FDA’s regulation of medical devices is going to have to graduate from geometry to calculus. By its nature, machine learning changes the details of its output constantly. The rigid regulatory model requiring FDA pre-approval of all