[Drug and Device Law] A Long Time Ago . . .


We knew that Star Wars had overtaken Christmas in pop culture when we heard a junior high school band play a Jingle Bells/Star Wars mashup.  We were not surprised that this cross-cultural amalgamation received the largest and most immediate ovation of the program.  A couple of things did, however, come as unexpected.  The first surprise was that sleigh bells integrate very nicely into the Star Wars Cantina theme.  The second was that people of all ages and from all walks of life have embraced Star Wars in a way that we could not have foreseen when sitting on the edge of our seats in 1977 as Luke descended into the Death Star trench. 
Star Wars has become a unifying Force.  Sure, it’s crassly commercial – we will not be giving our loved ones Darth Vader pendants from the Star Wars collection at Kay Jewelers this holiday season.  We also have read the columns on the Internet written by people who say Star Wars is all too much, that it was just a campy sci-fi pirate tale, that the three “prequels” in the early 2000s were forgettable, and so on. 
To those people, we offer the intergalactic version of “Bah, humbug.”  You see, today is December 25, 2015.  Christmas Day.  A day off of work for many people, and a time that we hope you are spending with people you like, doing things you enjoy, perhaps even seeing a movie.  We spend most of our time finding reasons to disagree, and even though many do not celebrate this holiday, we will take one day off to celebrate something that people can find in common, even if that thing is a grossly overachieving motion picture.  People love it.  So if you are reading this, and we will forgive you if you do not, May the Force be with you.  And happy holidays. 
So why the title of this blog post (A Long Time Ago . . .)?  Well, the District of Kentucky just put an end to a case that has kicked around the federal courts for five years when it should have lasted less than five days.  The problem was the wrong-headed plaintiffs’ lawyers who insisted on suing branded drug manufacturers when their client took only generic drugs.  We call it innovator liability, and it is wrong. 
Fortunately, in Neeley v. Wolters Kluwer Health, Inc., Civ. No. 15-54-GFVT, 2015 WL 8967931 (E.D. Ky. Dec. 15, 2015), the district court got it right. 
It just took way too long.  The plaintiff filed her lawsuit in February 2010 in Missouri state court, and the defendants removed the case to the Eastern District of Missouri.  Then, after “[e]xtensive discovery and briefing of dispositive motions ensued,” the district judge in Missouri granted summary judgment for the listed manufacturers in July 2013.  Id. at *1.  Let’s pause for a moment to let that sink in.  Why was there “extensive discovery”?  Once pharmacy records (which the plaintiffs’ lawyers probably had before they filed their lawsuit) showed that the plaintiff did not use the defendants’ products, what else did she need to know? 
And why did it take more than three years to decide that companies who neither made nor sold the product that allegedly caused the injury were entitled to get out of the case?  We are aware of cases like Dolan v. GlaxoSmithKline in Illinois and especially Conte v. Superior Court in California.  But they are outliers against the overwhelming weight of authority, and we have criticized the purported basis for innovator liability any number of times (see our innovator liability scorecard here and our “Innovator Liability at 100” post here).  The Eastern District of Missouri decided the innovator liability issue correctly, although it got other issues wrong, which landed it on our 2013 bottom 10 list. 
Neeley’s dismissal of innovator liability should have been a no brainer, but instead the litigation took on a wasteful life of its own.  Certain defendants (certainly not the dismissed branded manufacturers) moved for reconsideration, where “further briefing ensued.”  Id. at *2.  The federal judge in Missouri resolved that motion by granting it in part and transferring the entire action to the Eastern District of Kentucky.  Id.  The plaintiff’s successor, finding himself before a new judge, then moved for reconsideration of the order granting summary judgment to the branded manufacturers and further asked the federal judge in Kentucky to certify questions of innovator liability to the Kentucky Supreme Court.  Id.  The irony is that the case was transferred to Kentucky because the plaintiff had forum shopped into Missouri and could not establish personal jurisdiction over the defendant there.  Having lost in her attempt to game the system, why not try again somewhere else? 
That’s two motions for reconsideration and a request for certification of questions to a state’s Supreme Court, in a case that does not seem all that complicated to us.  We were not there, and maybe we don’t know the long and short of it.  But we do know that branded drug manufacturers spent a pretty penny defending themselves against claims that had no merit from the outset.
On the merits, we will be brief.  The motion for reconsideration and request for certification of questions to the Kentucky Supreme Court were non-starters because the plaintiff waited too long and because Kentucky law was clear.  As the court observed,

[T]he Sixth circuit has made clear that certification should not be used simply as a means to procure a more favorable judgment after an unfavorable one has been imposed.  Certification is ‘disfavored when it is sought only after the district court has entered an adverse judgment.’  The appropriate time for a party to request certification is ‘before, not after, the district court has resolved the issue.’  A party may not, so to speak, use the certification procedure to take two bites from the same apple.

Id. at *3 (emphasis added, citations omitted).  The district court also noted that the case had been pending for nearly four years before it was transferred to Kentucky [id.], and it also cited Sixth Circuit authority finding that it was “settled law that the plaintiff must assert that the defendant’s product caused the plaintiff’s injury.”  Id. at *5.  In the end, where other cases dealt with splits of authority, “[t]he Court finds no such split in Kentucky.” 
So perhaps the branded drug manufacturers and their lawyers can enjoy the holiday, but to be sure, this order was no gift.  They deserved it. 


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Posted By Steven Boranian to Drug and Device Law at 12/25/2015 08:00:00 AM

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