Certification to Utah Supremes on Whether Comment K Applies to Medical Devices – Part 2

by Reed Smith
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Last weekend we returned to Utah, one of the most beautiful states in the USA.  Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the Sundance Festival.  This time was different.  It was an occasion to explore Zion National Park, where wind, water, and time have carved splendor out of the rocks.  The apricot-colored natural amphitheaters put on quite a show in February.  Mule deer didn’t mind us at all as they chomped on rough, stubborn grass, mere feet away from us and a frozen waterfall. We drove through a mile-long tunnel with occasional natural ‘windows’ allowing light in from the canyons.  Every sublime inch of the place, every cactus skirted by snow, every stone arch, every smiling hiker, every helpful ranger, supplied further proof that the National Park system truly is America’s best idea.  If Yellowstone, Yosemite, and Grand Canyon do not already clinch the argument, Zion silences the debate with one long shadow cast from the Court of the Patriarch peaks or one gurgling note from the demure but insistent Virgin River.

It was good to get back to Utah.

Today’s post also gets back to Utah.  Three weeks ago we reported on a federal court decision in Burlingame v. Wright Medical Group, Inc., (D. Utah), a product liability personal injury case involving a hip implant.  The defendant filed a motion for summary judgment.  The solitary vexing issue was whether comment k to section 402A of the Restatement (Second) of Torts applies to medical devices so as to shield them strict liability design defect.  Utah law governed, and it is absolutely clear that Utah law applied comment k across the board to prescription drugs. But what about medical devices?  Our take on that question is to wonder why devices and drugs should be any different.  The need for a prescription should be enough to establish the “unavoidably unsafe” element of comment k, so the issue should be clear.

That’s apparently what the defendant in Burlingame thought, too, as it argued that the federal court had all the case law it needed to apply comment k and dismiss the strict liability claim.  The plaintiff  also was content with existing law, but in a different way, as the plaintiff argued that the federal court could conclude that medical devices fell outside of comment k.  Neither party asked the court to certify the question to the Utah Supreme Court, but that is what happened. It not only happened sua sponte, it happened over both sides’ objections.  That is what we reported on three weeks ago.

But it is not the end of the story.   The federal court then invited the parties to try to agree on what issues should go to the Utah Supreme Court.  Well, inasmuch as neither party wanted to add the Utah Supreme Court to the festivities, should anyone really be surprised that the parties could not agree? The federal court certainly seemed surprised, and more than a little disappointed.   In a new opinion, Burlingame v. Wright Medical Group, Inc., 2018 U.S. Dist. LEXIS 25637 (D. Utah Feb. 15, 2018), the federal court blasts the parties for submitting one-sided, self-serving position papers.  Isn’t that a little like Captain Renault in Casablanca declaring how shocked he is that gambling has been going on at Rick’s Cafe?  Anyway, the federal judge grabbed a pen and crafted the following questions for the Utah Supreme Court to enjoy and resolve:

1.  Under Utah law, does the unavoidably unsafe exception to strict liability in design defect recognized in Comment K to section 402(A) of the Restatement (Second) of Torts apply to implanted medical devices?

2.  If the answer to Question 1 is in the affirmative, does the exception apply to all implanted devices, or does the exception apply only to some devices on a case-by-case basis?

3.  If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

4.  If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market approval through the FDA’s premarket approval process as opposed to the 510(k) clearance process?

Dear reader, we hope you do not think it presumptuous if we draft answers on behalf of the Utah Supreme Court:

1.  Yes, comment k applies to medical devices.  The number of courts that have distinguished between drugs and devices with respect to application of comment k is truly miniscule.  And the reasoning is … unimpressive. Why would Utah want to join such a dreadful, dull minority? But the correct adjective is “prescription,” not “implanted.”  Sure, any implanted device will require a prescription, but there are plenty of other medical devices that fit the unavoidably unsafe bill without being implants.  Ever heard of medical lasers?  Why some plaintiffs or courts fixate on implantation is beyond us.  The permanence of the thing shouldn’t matter.  Prescription drugs don’t stay in the system permanently.  If the court wants to stay parallel (not our favorite word in the DDL universe, but stay with us a moment) with drug comment k case law, the issue is whether or not a doctor’s prescription is required.

2.  The comment k exception should apply to all prescription medical devices.  Across the board.  Case-by-case noodling makes no sense, is a burden on the court, provides no guidance to parties and, all-in-all, is the way of nincompoops.

3.  See, by adopting across-the-board, we’ve already aided judicial economy by freeing you from answering this silly question.

4.  The only thing dumber than drawing a line between implant and no-implant would be to draw a line between preapproval and 510(k).  By the way, the court’s question mucks up the distinction between approval and clearance. More to the point, how does regulatory pathway determine the unavoidably unsafe categorization?  There is no logical connection whatsoever.  An implant that went through a PMA can then set the stage for a substantially similar product that goes through 510(k) clearance. You do know about the substantial similarity test, right?  Why in the world would one product go through preapproval and fit within the sweet, tender embrace of comment k, but a subsequent device that was substantially similar would be left to the not-so-tender mercies of a strict liability design defect claim?  The plaintiffs asked for this horrible question, didn’t they?  (To be fair, this is not the first time a court mixed up the 510(k) vs. PMA issue with comment k.  Last year, we grieved over an 11th Circuit decision that engaged in the selfsame heresy.)

Some of these certification questions strike us as being unsafe, but there is nothing remotely unavoidable about them.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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