We’ve heard that we should welcome some new subscribers, who aren’t that interested in drug and device litigation, per se, but have been attracted by our coverage of personal jurisdiction issues relating to tort litigation generally.  Thanks for joining.  Here is a brief description of our available personal jurisdiction resources.

First, we maintain a personal

Try as it might, the FDA just can’t seem to articulate sound regulatory policy relating to “promotion” (which still isn’t defined in any regulation) without running headlong into the wall of the First Amendment.  Recently, the FDA released, “for comment purposes only” two draft guidances relating to promotion on the internet.  One of them is called “Guidance for Industry − Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  You can read that one here.  The other one, entitled “Guidance for Industry − Internet/Social Media Platforms:  Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” can be accessed here.

Both draft guidances seek to regulate what regulated manufacturers can do to “promote” their products on their own websites.  Okay, we have no inherent problem with the Agency doing that.  FDA-regulated manufacturers are, after all, FDA regulated.

Unfortunately, the FDA never seems to be satisfied with regulating only those it is empowered to regulate.  Its bureaucratic empire builders always seem to overreach.  In these draft guidances, they do so by laying claim to authority over non-manufacturer websites that regulated manufacturers “influence.”  For example, in Interactive Promotional Media DG declares:  “A firm is responsible for product promotional communications on sites that are . . . influenced . . . by . . . the firm.” Id. at 3.  What does “influence” mean?  It’s hard to say because the FDA’s discussion is somewhat tautological, but here is the Agency’s “guidance” on that point:

In determining whether a firm must submit promotional material about its product(s) to FDA, the Agency considers whether the firm . . . is influencing . . . the promotional activity or communication in whole or part.  Thus, a firm is responsible if it exerts influence over a site in any particular, even if the influence is limited in scope.  For example, if the firm . . . has editorial, preview, or review privilege over the content provided, then it is responsible for that content.

Id. at 4.  Thus, “regardless of financial support, if a firm has any . . . influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.”  Id.

Continue Reading Social Media – Now The FDA Wants To Regulate . . . Us?

It’s no secret, we’ve been one of the biggest boosters of TwIqbal around, going back to the beginning of the blog.  Even though Twombly was an antitrust case, we were on it within days as something defense lawyers in the drug/device area should be utilizing – listing eleven specific allegations that should require factual support.  We quickly passed along the first Twombly win in our sandbox.  We jumped on Iqbal, too, almost as soon as it came down, even though substantively that case was even further afield.  We got quoted in the papers.  We jousted with pro-plaintiff law professors, both directly and indirectly, when they supported now-failed legislative attempts by the other side of the “v.” to kill the new and improved pleading standard in its cradle.

Beyond that, we started our “TwIqbal cheat sheet” (the first of the nine cheat sheets we maintain) on May 13, 2010, collecting drug/device wins under TwIqbal – and our standards are high, we add only cases where no TwIqbal argument that the defendant made lost.  The TwIqbal cheat sheet has more than 100 (139, to be exact) decisions.  We’ve also categorized favorable TwIqbal decisions, by what spec of pleading they address.

But the TwIqbal cheat sheet did something else.  It was our first use of the neologism/portmanteau “TwIqbal.”  And that was pretty close to a first.  There are 16 cases on Westlaw using the term “TwIqbal.”  The oldest one is RHJ Medical Center, Inc. v. City of DuBois, 754 F. Supp.2d 723, 730 (W.D. Pa. Dec. 10, 2010).

Continue Reading Etymology

Long time blog subscribers surely remember our co-founder, Mark Herrmann, who wrote for the blog for over three years, until late 2009.  Then, for his own good and sufficient reasons, he gave up the practice of product liability litigation and went in house at Aon, the insurance giant.  For a while, Mark stayed

It’s the most wonderful time of the year. Once again, the ABA Journal nominated us as one of the best blawgs. Once again, we are in the Torts category – which is a huge relief, since our posts on employment, family, or aviation law have been unimpressive. That is certainly nice. Perhaps we will seem immodest if we report that it is hardly a surprise. Unfortunately, it will also not be a surprise if we fail to win the popular vote to anoint the overall “winner” in our category. Why is that? We cannot completely discount the possibility that there are better blawgs out there. But there is also this: how do you solve a problem called Bexis? He is not just brilliant, hard-working, and committed; he is hideously high-minded. He thinks campaigning for votes is tacky. He always says that such pandering is beneath him. Fine. But is it beneath all of us DDL bloggers? No, ladies and gentlemen, it is not. (What if David Gregory, Rachel Maddow, or Jon Stewart confront us with our post about the 2012 Oscar awards, where we said that just being nominated was enough, and that we did not believe in trolling for votes? We respond by quoting America’s greatest poet: “Do we contradict ourselves? Very well, then, we contradict ourselves. We are vast. We contain multitudes.” And then we’ll change the subject.)

Why should you vote for the Drug and Device Law blog? As an initial matter, we are writing off the 47 percent of you who are the ‘takers’ and not the ‘makers’. (We are not talking about you guys who are holding onto your guns. We definitely want you on our side. Especially when the zombies attack). We expect to win by executing a ground game. That’s you. We will be sending out minivans to the key precincts, from the MDLs in Minnesota to the hellholes in Illinois, from stormy Atlantic City to Conte-crazy California. And we come bearing gifts.

Continue Reading Shameless Get-Out-the-Vote Bulletin

The more they stay the same.

Things are about to change at the DDLaw blog, but they will also remain the same.  First, after more than nine years, Bexis is changing law firms.  He’ll be leaving Dechert and joining Reed Smith (still in Philly) on May 14, 2012.  The reasons for the change are

We’ve been blogging now, with one lineup or another, since November of 2006 – over five years.  As we’ve said on a number of occasions, such as here, our philosophy has always been that a rising tide lifts all boats.  It’s the nature of stare decisis (that earlier court decisions are the precedent on which later decisions rest) that defense wins anywhere tend to help other defendants everywhere.  We thus strive to keep the pharmaceutical/medical device defense community abreast of new decisions, new arguments, and (when we’re lucky) new strategies that can help win cases.

We’re big firm lawyers.  We have big firm clients and big firm resources.  Not everybody is or does.  But cases not involving big/big/big can be every bit as important as those that do.  For instance, the two major product liability cases that established the (we’d say unfortunate) course of strict liability here in Pennsylvania are Azzarello v. Black Brothers Co., 480 Pa. 547, 391 A.2d 1020 (1978), and Berkebile v. Brantly Helicopter Corp., 462 Pa. 83, 337 A.2d 893 (1975).  Everyone who’s heard of the Black Brothers Co. or the Brantly Helicopter Corp. other than in connection with these cases raise your hands.

We thought so.

Those cases handled for those clients have screwed up the law in Pennsylvania since before some of us started practicing it.  We don’t think Pennsylvania’s unique.  The Fortune 500 and the AmLaw 100 aren’t anywhere near all that matters.

Thus, as much as we want to reach – and be thought well of by – our big firm colleagues around the country (and globe), we believe it’s probably even more important to reach the folks in the regional firms, and defending the smaller companies, who are involved in prescription medical product liability litigation.  Because those folks, and their clients, might not have the resources to do the kind of comprehensive research that we’re used to, we try to make what we do on this blog as helpful as possible, and we have even taken research requests on occasion.  That’s probably the chief reason we keep our scorecards and cheat sheets.  These concern important or current subjects, and provide (we hope) comprehensive and up-to-date legal research that anybody can use and craft to their particular cases.

Continue Reading Who Are We/What Can We Do?