Drug & Device Law

The definitive source for intelligent commentary on the law that matters for drug and device cases

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By: Reed Smith LLP

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Annette van Beers
Beck/Herrmann
Derek Rollins (US)
dwalk
Eric Alexander
Genevieve Lay
Bexis
John Sullivan
mwojtylak
Michelle Yeary
Philipp Raben
Rachel B. Weil
Steven Boranian
Stephen McConnell
Wiebke Mattern
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Latest from Drug & Device Law

It’s Delaware week here at the DDL Blog.  A couple of days ago we brought you a particularly clear-minded order rejecting innovator liability in the First State (so nicknamed because Delaware was the first of the original 13 colonies to ratify the Constitution in 1787), and yesterday we reported on a pair of Delaware orders granting summary judgment in failure-to-warn cases on proximate causation. Today we highlight another particularly clear-minded application of warning causation in…
There will come a time when there is no such thing as the local radio station. Not only will transmission not occur via radio waves, but there will be nothing local about it. There also may be no banter from the DJ, short for “disc jockey”–a reference to placing flat, round pieces of plastic called records on a machine that spun them around and attracted sound through a needle. The songs or other content may…
It’s tax week, so expect a lot of cases this week from that wonderful no-tax paradise, Delaware. With light traffic (iffy on I-95, to be sure), one can get from our office to Delaware in under a half hour. That’s a worthwhile trip for buying anything in triple or higher digits. It’s also a worthwhile trip if one hankers for decent court rulings. The Philadelphia Court of Common Pleas is a Hobbesian war of all…
In this age of scrolling news, headline news, pop-up news, instant alerts – it’s tough to stay current.  For instance, if you were getting Masters updates on Sunday, the last few hours of lead changes, dropped strokes, balls in the water on 12, and nearly every swing Tiger made on the last 4 holes probably had your phone pinging like a pinball machine.  And, if that wasn’t what was blowing up your phone Sunday, it…
A jurisprudential milestone of sorts was recognized last month when the ever rising tide of federal MDL filings surpassed 50% − that’s right, over half – of all cases currently open in the federal judicial system now are contained in multi-district litigation.  As reported, “the 248 MDL dockets accounted for 52 percent of all pending federal civil cases at the end of the last fiscal year.”  Here’s a more detailed review: A year ago,…
Last year, we posted about Pennsylvania going off the personal jurisdictional “deep end” in Hammons v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018), and Webb-Benjamin, LLC v. International Rug Group, LLC, 192 A.3d 1133 (Pa. Super. 2018).  Well, unfortunately they’re still at it, and we’re afraid that the result could well be a lot like the Missouri talc cases, or a bunch of California mass torts – a lot of futile trial activity eventually…
The decision in Riera v. Somatics, LLC, 2018 WL 6242154 (C.D. Cal. Sept. 14, 2108), comes from California, a place in which private plaintiffs bring claims against medical device companies for violations of the FDCA all the time, despite the fact that the FDCA prohibits that very kind of thing. We won’t—yet again—get into how that came about or why negligence per se claims are allowed at all. We’ll take the Riera decision as it…
We saw recently that Centers for Medicare & Medicaid Services (“CMS”) has sent its proposed “Regulation To Require Drug Pricing Transparency” to the Office of Management & Budget (“OMB”). We’d heard about this proposed regulation, of course, but we hadn’t gotten around to reading it.  We finally took the time. Many readers probably already know, but for those who don’t, CMS is proposing “to require direct-to-consumer (DTC) television advertisements of prescription drugs and…
No.  It can’t be.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that.  Just look at our generic preemption scorecard – the proof is there.  The warnings on generic drugs must be the “same” as those on branded drugs.  Generic drug manufacturers cannot unilaterally alter, amend, or change any warning and therefore all warning related claims against them are preempted.  Well, that is unless you’re in the Seventh Circuit and the court…
Say what? That’s what we thought when we ran across Restatement §920 recently – it was by accident; we were researching something else. The 900 section of the Second Restatement of Torts is about damages, and §920 has to do with mitigation of damages: When the defendant’s tortious conduct has caused harm to the plaintiff or to his property and in so doing has conferred a special benefit to the interest of the plaintiff that…