December 2012

Photo of Bexis

Here is another post by Reed Smith’s Eric Alexander, quasi-member of our blog.  At this point, we think he’s only holding off becoming a full blogger because as long as he doesn’t have his own blogger account, somebody else (like Bexis) has to take the time to input his posts.
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We welcome ourselves back after our hiatus.  Not that blogging/blawging is not real work, but we sometimes have clients pay for our quips—and, perhaps, occasional legal insights.  Plus, the product liability decisions have been fairly slim, particularly after more venerable—they would say venerated—posters call “dibs.”  So, we wade into the wonderful world of the False Claims Act (FCA).  We products lawyers might say that we sometimes view FCA cases as red headed stepchildren if we were not a little afraid of retribution from the soulless GLA (Ginger Liberation Army).  Since we will not say such a thing, we will say that FCA cases do not involve plaintiffs with real or trumped-up physical injuries or state court judges and juries.  They do involve issues of compliance with FDA regulations, some Latin phrases, and often a “U.S.” on the other side of the v.  That makes them relevant to what we do and what this ABA-nominated blog does.  (Non-products lawyers can vote too.  There is no hair color or prevalence requirement.  That comes from a footnote in the Harper v. Virginia Board of Elections on poll taxes.  Bexis says it is precedential; McConnell says it is only dicta because it does not use a form of the words “hold” or “find.”)
U.S. ex rel. Polansky v. Pfizer, Inc., No. 04 Civ. 0704 (BMC), 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), is the final dismissal of a FCA case filed in 2004 that was on its Fifth Amended Complaint at the end.  Setting aside why it took eight years and six complaints to get rid of what was ultimately not a cognizable claim, this is a nice decision.  We cannot quite set aside that the U.S. chose to intervene in this case and the chance that its intervention increased the lifespan and defense costs of the case.  The basic claim was that the defendant promoted its product (Lipitor) off-label, allowing for Medicare and Medicaid to pay for prescriptions written and filled for patients who were not within the approved indication for the product.  That part is pretty standard.Continue Reading FCA, FDA, What’s The Difference?

Photo of John Sullivan
We talk a lot about the learned intermediary doctrine.  It’s rooted in the reality of the physician-patient relationship.  Patients gain access to prescription drugs only through doctors who have the expertise to understand and weigh the risks and benefits of the drugs.  The learned intermediary doctrine, accordingly, says that pharmaceutical companies’ duty is to warn

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Photo of Stephen McConnell

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

Drug & Device Resources

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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