Law

New Hampshire has always marched to its own flinty tune. It was the first colony to establish a government independent of British authority.  It holds the first presidential primary every four years, insisting that candidates visit waffle shops and bloviate to the amused Yankee locals. You've probably seen New Hampshire license plates with the "Live Free or Die" motto.  That motto supplied the title for episodes of both The Sopranos and Breaking Bad.  What other state can make that boast?  And what other state with such a small population can list among its offspring such eloquent luminaries as "Go West Young Man" editor Horace Greeley, "Liberty and Union, now and forever, one and inseparable" Senator Daniel Webster, "And miles to go before I sleep"  poet Robert Frost, and we-can't-think-of-a-quote President Franklin Pierce?  

New Hampshire has played a significant role in American legal history.  Daniel Webster won a case against the Devil.  One of the early major U.S. Supreme Court cases involved Dartmouth College.  We cannot remember what the case was about, though we think it had something to do with Delta House being put on double secret probation.  The Bartlett v Mutual product liability case gave rise to some awful rulings in the New Hampshire federal court before the Supreme Court set things right in what might be our favorite case of the last five years. 

In today's case, Murray  v. Hogan, #226-2013-CV-00600 (New Hampshire App. Ct. Feb. 2, 2015), a New Hampshire court addresses Riegel preemption, as well as the dreaded parallel claim exception.   As far as we can tell, it is the first such decision from the Granite State. (We gratefully tip our cybercap to David Ferrara at Nutter McClennen for sending the case our way.)  The plaintiffs in Murray brought negligence and products liability claims claiming injuries from a knee replacement gone wrong.  The plaintiffs sued several defendants, including the manufacturer of the artificial knee, as well as the sale rep who was in the operating room and assisted in preparing the artificial knee for insertion.  The artificial knee was a class III medical device, so it comes as no shock that the company moved for summary judgment against all of the plaintiffs’ claims as being preempted by federal law.  Even less of a surprise, the plaintiffs disagreed, arguing that federal preemption does not apply because: (1) the artificial knee did not meet federal regulations, (2) the plaintiffs would like to have some discovery, please, and (3) the company is vicariously liable for the conduct of the sales rep. 

Okay, that last one does come as something of a surprise. More on that later.  

The artificial knee went through the PMA process.  Consequently, the New Hampshire court had no difficulty concluding that the plaintiffs’ direct liability claims against the company were preempted by Section 360k(a), because  to succeed on their claims, the plaintiffs would be required to show that the artificial knee “was unsafe or ineffective despite the PMA process, thereby interfering with the requirements already established by the [Act], which has preempted safety and effectiveness determinations for a device.”  That bit was easy.  Almost as easy was the court’s rejection of the parallel claim exception.  The complaint made no explicit mention of a parallel claim, nor did it outline sufficient facts to support such a claim.  There were not even any allegations that the company violated FDA regulations. 

The word “parallel” refers to things being side by side, having the same distance continuously between them.  Think of two lines.  But in the Murray complaint, there was no second line (the federal violation).  In fact, it is not even clear that there was a first line.  The court simply had to dismiss the claim.  The court did not have to give the plaintiffs an opportunity to amend their complaint – but that it is what it did.   The plaintiffs can go back to the drawing board.  They can try to trace those parallel lines.  We bet they can’t.

The court’s generosity went further when it came to the vicarious liability claim.  Because the complaint stated that the sale rep “was an employee, agent, and/or servant” of the defendant company, and because the complaint also stated that the sales rep “was in the operating room during the surgery for the purpose of, among other things, providing technical guidance,” the court held that, at least for now, the plaintiffs sufficiently stated a claim for vicarious liability.  Once again, the presence of a sales rep in the operating room seems to register a significant impact with the court. We know that it does with juries, too. That fact is bad enough. Doctors often find it useful to have a sale rep nearby to answer questions about the product, or to have extra parts available.   Do we really want to deter something that doctors believe helps them treat their patients?  Liability -- even mere threatened liability -- is much, much worse if plaintiffs can now evade preemption by pointing to something sales reps did or did not do and then cobbling together a claim of vicarious liability against companies.  Call it creative on the part of plaintiff attorneys.  Call it desperate.  Call it crazy. Whatever - we wish the courts would call it off.   And, ultimately, that is what we think the courts will do.  For reasons that we have covered in earlier posts, we think the sales rep cannot be held liable, so it should then follow that the vicarious liability claim cannot last very long.  Stay tuned.  

In the meantime, we cannot help but think of those lines from Thornton Wilder's play Our Town, which was set in New Hampshire: "Wherever you come near the human race there's layers and layers of nonsense."



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Posted By Steve McConnell to Drug and Device Law at 2/18/2015 07:30:00 AM

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