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Here’s another guest post from Reed Smith’s Eric Alexander, who is inching (being hauled) towards fullblogger status, but who isn’t there yet – so we’re posting this for him.

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We warn our readers that there will be a neck-snapping segue later in this post.  You might want to stretch before reading.  The segue was

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Posted in FDA

What follows is a “guest post” by Melissa Wojtylak of Reed Smith.  We place the term in quotes because Melissa has expressed an interest in becoming a member of our crew of merry blogsters.  We’re inclined to say yes (anything that reduces our own workloads is great), so expect to reading more of her work.

We (or at least Bexis) also has to say that Melissa, in addition to her other accomplishments, is also a very nice person.  We (or at least Bexis) were inclined to be quite a bit more sarcastic about the subject of this article.
As always, Melissa deserves all the credit and assumes all the blame for what follows.
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In our line of work, when you read anything that starts with the statement “[p]harmaceutical adverse effects are a leading cause of death and injury in America,” you know you’re at an away game.  This is precisely how a recent Comment in the George Mason Law Review begins.  As we noted in yesterday’s post, in the Comment, which is titled Picking Up the Tab for Your Competitors: Innovator Liability After Pliva, Inc. v. Mensing, the author waves the now-tattered banner of Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d (Cal. App. 2009), and sets out his argument for why, in a post-Mensing world, brand-name manufacturers should be held liable for failure-to-warn claims brought by users of generic drugs – in essence, the holding in Conte – a holding that’s been rejected more times than a telemarketer calling during an American Idol finale.
Regular readers of this blog know how we feel about Conte.  It’s safe to say that the George Mason Law Review Comment has not changed our minds, although it has made us wonder what they’re teaching these days in torts classes at the George Mason Law School.  In any event, from our perspective, the Comment offers no compelling argument – much less legal justification – that supports a rejection of decades of established law, well-supported by practical considerations such as linking liability with responsibility, which holds that manufacturers cannot be liable for injuries to users of products that they did not sell.
Continue Reading Innovator Liability for Generic Drugs: The Answer Is Still No

Sometimes (not that often) we run across a decision that so blatantly misses controlling precedent that we have to wonder who was asleep at the switch, the court or counsel.  The recent decision, Dorsett v. Sandoz, Inc., 2009 WL 3633874 (C.D.Cal. Oct 28, 2009), is one of those.
We first read Dorsett because it…

We were too busy – and none of our clients would pay for it in any event – so we didn’t attend yesterday’s Supreme Court oral argument in Riegel v. Medtronic. But fortunately for us, and by extension all of you reading this, one of our old friends (and a dedicated reader) was there…

We’ve had a couple of complaints that it’s hard to locate on this blog old posts that contain information of interest. (One of those complaints was Beck complaining to Herrmann; the other was Herrmann complaining to Beck.)
To make things easier, here’s an index of all of our posts to date, with hyperlinks to the…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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