Sometimes discovery can feel like a four-letter word.  Take your pick – hunt, seek, find, dump, onus, cost(ly).  When we are talking about responding to interrogatories and document requests, we can add a few more – dull, drag, bore . . .  In other words, it’s not the most exciting part of litigation.  But the

And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward

In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment

In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee.  Downtown Memphis had not yet undergone “gentrification,” so a short walk in any direction from the Federal Building had to be undertaken with some caution.  In addition to barbecue and blues, a federal litigant’s visit to Memphis held the prospect of appearing before any one of an interesting assemblage of district judges.  Judge Odell Horton had taken senior status after a long stint as chief judge of the district; he was a Carter appointee and exceedingly nice to everyone.  He was also the first African American federal judge in Tennessee since Reconstruction.  Judge Julia Smith Gibbons had taken over as the chief judge after starting on the federal bench at 33—a Reagan appointee—and everyone knew she would be heading up to the Sixth Circuit at some point.  Judge Jerome Turner was another Reagan appointee, who we recall mostly for taking his clerks to lunch regularly and for an untimely death a few years later.  Judge Bernice Donald assumed the bench while we were there, having been tapped to jump up from the bankruptcy court by the first President Clinton.  (The actor/Senator who was in Die Hard 2: Die Harder showed up for the swearing in ceremony.)  Judge McCalla had been appointed by the first President Bush and clerked (for Judge Bailey Brown, before he went up to the Sixth Circuit) in the same chambers some years earlier.  He had the military bearing you would expect from his pre-law background as an office in Vietnam and a well-deserved reputation for being “by the book” and “no nonsense.”  (The softer side that attorneys appearing before him missed was evident when he was with his family, including the puppy we helped train while housesitting.)

Twenty years later, we discuss Judge McCalla’s decision in Fleming v. Janssen Pharms., Inc., No. 2:15-cv-02799-JPM-dkv, 2016 WL 3180299 (W.D. Tenn. June 6, 2016), which follows the memorable Yates decision authored by Judge Gibbons, who did, indeed, head up to the Sixth Circuit.  Hence why we recounted the iudicis personae of the Western District from our relative youth. Fleming involves asserted state law claims in connection with plaintiff’s alleged kidney injuries from a branded prescription diabetes drug.  Defendants moved to dismiss on various grounds, which we will discuss in the order of importance to us.

First, of course, was the argument that plaintiff’s design defect claim was preempted as pleaded. This angle of attack is noteworthy because winning any kind of preemption for a branded prescription drug at the motion to dismiss phase is rare and because the progression from Bartlett to Yates (decided on summary judgment) to such motions being viable was something we forecast/urged. As discussed more later, plaintiff had pretty barebones design defect allegations that suggested that all drugs within this class of anti-diabetic agents was too risky and that there were “several safer alternative products”—not alternative designs for this product. Id. at *1.  In response to defendant’s argument for impossibility preemption, plaintiff contended that its claim was based on a “duty to design the drug differently before FDA approval,” which could have been characterized as “never start selling theory.” Id. at *5.  “The Sixth Circuit, however, found this type of argument to be ‘too attenuated’ and ‘speculat[ive]’ because it requires several assumptions as to FDA approval and a patient’s selections of and medical reaction to the alternative design.” Id. (quoting Yates, 808 F.3d 281, 199-300).  While a case with the same drug in the Eleventh Circuit had rejected Yates impossibility preemption while granting a motion to dismiss, the analysis in Fleming was straightforward.  “The Court finds that Plaintiffs’ design defect claims are preempted by federal law because preemption can apply to both generic and branded drugs and because it would have been impossible for Defendants to comply with both state and federal law.” Id. Like we said, this is a “by the book” judge.  Other judges taking a similar approach could provide the advantage of getting obviously preempted design defect claims out early, narrowing the scope of fact and expert discovery.


Continue Reading Dismissing Drug Design Defect Based on Preemption

The key to appreciating the latest order granting summary judgment for the defense in the Ortho-Evra birth control patch MDL is to start with the order’s last paragraph:

The Court has found that the Defendants provided adequate warnings sufficient to discharge their duty to warn.  Because the Defendants exercised reasonable care by communicating the risks involved with the Ortho Evra® patch to [the plaintiff’s] physician, and those warnings were not faulty, [the plaintiff] has not established a claim of negligent misrepresentation under Tennessee law.

Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 145415 (N.D. Ohio Oct. 10, 2014).  Ah, the familiar ring of the learned intermediary doctrine, the beat to which the Drug and Device Law Blog most often marches.  But what’s this?  The doctrine applied to negligent misrepresentation?  Some background is in order:  The plaintiff in Brown alleged that her use of hormonal contraceptives caused blood clots, which is one of the most widely known drug risks ever known to medical science.  As we said when we first reported on this case, every doctor and medical student knows about the risk—so do most women—and the labeling for hormonal contraceptives has fully disclosed the risk of clots for decades.

The defendants therefore moved for judgment on the pleadings, which the district court granted on the failure-to-warn claims back in April 2014.  See Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014).  This was absolutely the correct result as far as it went, but there were still several claims left over—manufacturing defect, negligence, and fraud.


Continue Reading Without Failure To Warn, Other Claims Collapse