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

Would you have bet on the Red Sox to win the 1986 World Series?  Would you have booked passage on the Titanic?  Would you have bought a ticket to see the movie Ishtar?  If someone asked us these questions today, we all would answer in the negative because we already know the outcomes.  The

This post is written by our Reed Smith colleague, Adam Masin, who is solely responsible for its content.  He gets all the credit and all the blame.

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This blog has previously written about Tennessee’s unusual statute of repose, herehere, and here, which bars claims “within one (1) year after the expiration date of the anticipated life of the product.”  Tenn. Code Ann. Sec. 29-28-103.  “Anticipated life” is a curious term.  For example, the season finale of Homeland had many of its main characters wondering what their own “anticipated life” might be like given their circumstances.  But we are not here to discuss the rather unrealistic-yet-compelling Homeland universe in which a bipolar CIA agent who never follows orders and is carrying the baby of the brainwashed former almost-terrorist who may not have bombed the CIA but still pretty much murdered the Vice-President can somehow find herself sent to Iran on purpose to oversee an impossible mission that involves trying to save her magically detoxed boyfriend (no spoilers here!).  That’s a different blog post we’d like to write.  We are here now to talk about “anticipated life” as it refers to products in Tennessee, the state that shares a border with the state where Homeland is filmed.

In Tennessee, “anticipated life of the product” is the “expiration date placed on the product by the manufacturer when required by law but shall not commence until the date the product was first purchased for use or consumption.” Id. at Sec. 29-28-102.  In Wahl v. General Electric Company, 2013 U.S. Dist. LEXIS 162320 at *19 (M.D. Tenn. Nov. 14, 2013), that meant that the plaintiff’s claims were barred by the statue of repose well before the plaintiff knew she had developed the condition she based her lawsuit on.  The same was true in Montgomery v. Wyeth, and Spence v. Miles Lab.  Other states have carved out latency or similar exceptions to their statues of repose that might apply to prescription medical products for various reasons, but Tennessee has not chosen that path.

Perhaps the only thing more unusual than Tennessee’s “anticipated life” statute of repose, however, is how courts have reacted to it.  In Montgomery, the trial court began its opinion by questioning the propriety of the law:

Rarely does this Court suggest that a legislative body reconsider one of its enactments. The Court believes its role is simply to apply the law applicable to the case before it and not concern itself with the merits of the case. However, because of the result in this case, this is one of those rare cases where the Court believes it is appropriate to urge the Tennessee legislature to look closely at the law governing this case.

The court in Wahl ended its own opinion doing the same thing:

the court views the result in this case as manifestly unjust. Through no fault of her own, Wahl is left with an essentially incurable degenerative condition for which she has no recourse, because Tennessee extinguished her claims against GE before she could have discovered them. The time period here between the procedures at issue and Wahl’s NSF diagnosis was only about four years, which is not a time period that shocks the conscience. This court, as did Judge Collier in Montgomery, 540 F. Supp. 2d at 936 and 945, urges the Tennessee General Assembly to revisit the TPLA and its effect on Tennessee citizens injured by pharmaceutical products.


Continue Reading Guest Post – Homeland and Anticipated Life (under Tennessee law): Being On the Wrong Side of Policy Isn’t Always Unjust

This post is not from the Dechert side of the blog, since they are involved in Reglan litigation.

Last evening, just before quitting time on the East Coast, we found the Sixth Circuit’s affirmance of the Rule 12 dismissal (that means no expensive discovery necessary) of seven Reglan cases under Tennessee Law.  See Strayhorn v. Wyeth Pharmaceuticals, Nos. 12-6195, et al.slip op. (6th Cir. Dec. 2, 2013).  The court also affirmed summary judgment against another set of defendants – affiliated with the original innovator manufacturer.

Because of that, we call this type of result a “onetwo punch” case.  That means that the plaintiffs – who took the generic version of the drug only – are:  (1) knocked out of the box against the generic manufacturer by preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013); and (2) barred from suing the original innovator manufacturer of the drug by the very simple and basic fact that the plaintiff never used that defendant’s product.

First, the generic side:

Plaintiffs had filed the usual kitchen-sink type complaint alleging everything from design defect to consumer fraud.  Plaintiffs abandoned consumer and unjust enrichment claims, but appealed dismissal of everything else.  Strayhorn, slip op. at 7.

They lost.


Continue Reading Lucky Seven − Strayhorn Affirmed