August 2014

Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog.

These wins are becoming routine – but we’re not taking them for granted.  In fact, we’ve given them their own label on the blog and we highly recommend you peruse this collection if you are facing off-label promotion allegations.  It is an overwhelming body of precedent establishing that almost all claims in pre-market approved (“PMA”) medical devices are preempted and that off-label use does not change the analysis or the conclusion.   And one of the great benefits of tallying up all of these favorable decisions from courts across the country is citing them to courts considering the issue.  Both of the recent InFuse wins demonstrate that the vast authority supporting preemption is quite compelling.

A quick reminder of the core issue in the InFuse litigation.  The InFuse bone graft device is a Class III, PMA device.  The Supreme Court has determined that the PMA process imposes federal requirements that preempt state law tort claims.  That express preemption combined with the implied preemption of claims that seek private enforcement of the FDCA leave only a “narrow gap” through which a claim must fit to survive.  Plaintiffs most often used method for threading that needle is to allege a parallel claim – a violation of a state law duty that is genuinely equivalent to federal requirements.  Since so few claims even come close to being parallel claims, the InFuse plaintiffs allege that because their surgeons implanted the device in an off-label manner, the standard preemption analysis shouldn’t apply.  First, they argue that the PMA requirements for InFuse should be inapplicable to off-label uses and without specific requirements, the first prong of the express preemption analysis isn’t met.  Alternatively, even if the requirements apply, plaintiffs allege their claims are parallel claims because the FDA prohibits off-label promotion.Continue Reading Two More InFuse Victories

Photo of John Sullivan

This post is from Bexis:

In a decision reflective of how attorney solicitation dredges up bad cases that should never have been filed, a New Jersey appellate court has handed the defense three wins in its Accutane litigation involving inflammatory bowel disease (“IBD”).  Gaghan v. Hoffman-La Roche, Inc.,Nos. A-2717-11T2, et al., slip op. (New Jersey Super. A.D. Aug. 4, 2014).  Gaghan involved three appeals, two from defense verdicts and one from a plaintiff’s verdict, affirming the defense wins and reversing the one adverse verdict.  The trial had been something of a circus – three unrelated Accutane plaintiffs’ cases tried together.  All three plaintiffs were litigation tourists from California, so that state’s law applied, which is probably why the decision is unpublished.  It certainly is detailed enough to be published, had it not been one state’s courts opining on the law of another state.Continue Reading Accutane Triple Win in Jersey

Photo of Eric Alexander

As Bexis demonstrated yesterday, we can have strongly held views.  When we do, we are not always subtle about letting our readers know what those views are.  When a rant builds, it can pour like an avalanche coming down a mountain—with more vinegar than cinnamon or sugar.  When we read In re Actiq Sales and Marketing Practices Litigation, No. 07-4492, 2014 U.S. Dist. LEXIS 984411 (E.D. Pa. July 21, 2014), we felt the rant coming on.  The case involves Daubert in a case with outsourced
representation and collective causation evidence related to alleged off-label promotion of a prescription drug, so a few things we care about were brewing.

But it is now the first day of August and a tropical vacation is looming.  School for the kids and other rituals signaling the transition from summer to fall will be here soon.  Thus, we resolved to keep this post somewhat calm despite a bad result, questionable analysis, and a fundamental misunderstanding of the relationship between FDA regulation of drug companies and what doctors do with their own patients.  Rest assured, though, that we would have many more snarky comments about the opinion if not for our resolve to stay “chill,” as much as we ever do.Continue Reading Assuming What You Are Trying to Prove in A Third-Party Payor Case

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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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