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When Congress enacted HIPAA and its Privacy Rule in the mid-1990s, it was a big deal. Healthcare providers surely protected patient privacy in the pre-HIPAA days, but the federal statute gave them a standard set of rules with which to comply and a uniform referent against which to gauge their privacy practices.  All told, HIPAA’s…

This past weekend, we paid a return visit to Cleveland, the home of our best law school friend, who braved the (figurative) waters of New Haven with us so many years ago.  In deference to the Drug and Device Law Traveling Companion, we visited the Pro Football Hall of Fame.  In contrast to the stunning rotunda of our beloved Country Music Hall of Fame, the Football Hall stacks all of the inductees’ busts against a single wall – sort of a warehouse of disembodied heads.  We felt like we were in the parts department of Dr. Frankenstein’s laboratory.  But we enjoyed the visit and paid fond homage to the bust of Tommy McDonald.  We also visited the Rock and Roll Hall of Fame, which we had seen before and which we continue to find both impressive and tons of fun.  This time, we lingered at the “One-Hit Wonders” display, commemorating so many recording artists who disappeared after just a bit of noise, never to be heard from again.

The plaintiff in today’s case followed the same trajectory, albeit after his apparently meritless case languished on an MDL docket for eight years.  In Wilhelm v. Pfizer, Inc. 2016 U.S. Dist. LEXIS 127269 (D. Nev. Sept. 19, 2016), the complaint was originally filed in 2006 in the District of Nevada by fourteen plaintiffs alleging that the defendant’s product caused suicidal ideations.  The JPML transferred the case to the Neurontin MDL after it was filed, and remanded it back to the transferor court in July 2013 with three plaintiffs remaining.   One month later, the court permitted counsel for these plaintiffs to withdraw.  Two of the plaintiffs dropped out, leaving a single plaintiff, proceeding pro se. In February 2014, the defendant moved for summary judgment, arguing that the plaintiff could not produce any expert evidence proving that the defendant’s product caused his injuries.  The plaintiff filed for Chapter 7 bankruptcy in June 2014.  He never disclosed his product liability lawsuit in the course of his bankruptcy proceedings.Continue Reading The End of the Road for Pro Se Neurontin Plaintiff with No Evidence of Causation

Ever since the FDA decided that discretion was the better part of valor – or read the handwriting on the wall – and decided not to appeal United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), to the United States Supreme Court, we’ve been wondering where the next First Amendment opportunity is going…

About a year ago, we discussed precedent establishing that off-label use can be, and often is, the medical standard of care.  Conversely, that means that it could be considered medical malpractice not to prescribe certain off-label therapies.  All of a sudden, that issue has popped up again, with two cases in the last week, both dealing with the off-label use of drugs in the abortion context.

We stay away from politics on this blog – whether it’s the merits of Obamacare or the merits of  legal restrictions on medical abortion. But where legal questions associated with this sort of controversial issue impact matters relevant to drug/device defense, we will cautiously venture into such territory, as we did here (ACA could render medical monitoring cause of action unnecessary) and here (FDCA preemption in abortion litigation context).  This time, it’s off-label use.
We’ll polish off the lesser of the two off-label use decisions quickly.  In Planned Parenthood of Greater Texas Surgical Health Services v. Abbott, ___ F. Supp.2d ___, 2013 WL 5781583 (W.D. Tex. Oct. 28, 2013) (“Abbott”), stay granted in part on other grounds, ___ F.3d ___, 2013 WL 5857853 (5th Cir. Oct.  31, 2013), an “off-label protocol” for terminating pregnancy using drugs rather than surgery was, as with the other off-label uses we discussed in our earlier post, determined to be the medical standard of care, and conversely, the FDA-approved intended use of the same key drug (mifepristone, also known as RU-486) was obsolete.  As the court stated:

Abortion-performing physicians have since developed a medication-abortion protocol using mifepristone that, although varying significantly from the FDA protocol, has become the de facto standard of care in Texas.  This protocol, or one substantially identical, accounts for the vast majority of medication abortions performed nationwide since 2007.  The new protocol [is] endorsed by the American College of Obstetricians and Gynecologists.

Id. at *7 (footnote omitted).  We omitted a footnote.  We now add it back in, because it is more relevant to our product liability defense-related concerns than most of the opinion:

Continue Reading A New Off-Label Use Hot Spot

It’s no secret that non-medical device preemption arguments haven’t been as successful after Wyeth v. Levine as they were before.  Here at the Drug and Device Law Blog, we like to provide information, but we also follow a defense Hippocratic Oath not to do harm by doing the other side’s research for them.  Our “…

We’ve previously offered our collective four cents worth about tactical considerations that pharmaceutical defendants need to think about in deciding whether or not to bring preemption motions in particular cases. Given the importance of the issue, and (until 2008) the relative equipoise in the opposing positions, we strongly recommended the Hippocratic Oath – “First, do…

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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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