This post is from the non-Reed Smith side of the blog.

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (S.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).


Continue Reading Another Slam Dunk Infuse Win – Preemption and More

This post is from the non-Reed Smith side of the blog.

It’s been awhile since we’ve posted about PMA preemption in an Infusion case – but that litigation continues to make good law.  This time in Minnesota state court which fortunately took a lot of its cues from strong federal law.  In Stiltner v. Medtronic Inc., 2016 WL 4005471 (Minn.Dist.Ct. Jul. 25, 2016) the court dismissed all of plaintiffs’ claims as preempted and while the dismissal is without prejudice, the court laid down tough pleading standards for plaintiff to meet if he wants to try a comeback.

Plaintiff had an Infusion pain pump installed and that particular pump model was recalled about one year later.  Three years after the recall, plaintiff began experiencing complications which necessitated revision and re-implantation surgeries.  Id. at *1.   Plaintiff brought claims for manufacturing defects, failure to warn, negligence, breach of express and implied warranties, and violations of the Minnesota Consumer Fraud Act.  Id.  Because the Infusion pain pump was Pre-Marketed Approved (“PMA”) by the FDA, it is subject to both Riegel express preemption and Buckman implied preemption.  Therefore, in response to defendants’ motion to dismiss, plaintiff had to demonstrate that his claims fit within the “narrow gap” left open between Riegel and Buckman – emphasis on the “narrow” part.  To pass through, plaintiff needs to be suing for conduct that violates the FDCA (the state law claim must parallel device-specific regulations to survive express preemption) but not suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted).  Id. at *4.

Plaintiff attempted to overcome preemption by relying on the recall and by citing to certain FDA actions such as warning letters issued to defendants to establish that defendants violated Current Good Manufacturing Practices (“CGMP”) regulations.  Id. at *1.  But in assessing the sufficiency of plaintiff’s pleadings, the court concluded that plaintiff simply surmised that “because of the [FDA warnings] and Defendants’ . . . recall of the Device, Defendants must have violated federal regulations which must have resulted in injury to Plaintiff.”  Id. at *6.  “Must have” is about on par with “would of, should of, could of.”  Not nearly enough.


Continue Reading In Minnesota PMA Preemption Requires Plaintiffs to be Specific, Very Specific

This post does not come from the Reed Smith side of the blog.

Some of us here at the DDL Blog aren’t fans of typical New Year’s resolutions.  You never follow through, and you end up with an unused ab cruncher, a juicer of some sort that stays in the box, and a refrigerator full of rotting fruits.  We prefer atypical resolutions, ones that are more like affirmations.  For instance, I resolve to re-subscribe to Netflix.  I resolve to sleep even later on Sundays.  I resolve to deepen my relationship with chocolate.  I definitely resolve to continue to drink scotch.  Those are viable resolutions, ones that we’ll follow through on.  They remind us what we like to do and that we should do them.  No guilt.  You only feel good.

Along these lines, we hope that some plaintiffs’ counsel have resolved this New Year to miss deadlines.  Courts don’t always enforce missed deadlines.  But when they do the defense usually benefits.  In Thorn v. Medtronic, Inc., 2015 U.S. App. LEXIS 22582 (6th Cir. Dec. 15, 2015), an infuse case, the trial court granted defendant’s motion to dismiss based, for the most part, on preemption.  Id. at *3.  The court entered judgment.  Mr. Thorn, the plaintiff, did not appeal.

Thereafter, he sought leave to amend his complaint and add a fraud count.  Id.  He made the ordinary FRCP 15 amendment arguments—the defendant would not be prejudiced and an amended complaint would be in the interests of justice.  Id.


Continue Reading Plaintiff Tries To Amend Under Fed. R. Civ. P. 15 But Is Denied Under Fed. R. Civ. P. 59 & 60

This post is from the non-Reed Smith side of the blog.

It has been over 2 months since we lasted posted about an InFuse decision.  What’s been happening (outside the DDL Blog world) since that last post.  The Cuban flag was raised at its embassy in Washington DC officially restoring full diplomatic relations between the

This post is from the non-Reed Smith side of the blog only.

That’s an admonition that plaintiffs in Cales v. Medtronic, Inc. should have heeded. Last November, they became another of the many InFuse plaintiffs to have the bulk of their claims dismissed with prejudice on the grounds of preemption, with non-preempted claims dismissed without prejudice for failure to plead with sufficient particularity. See Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Ct. Nov. 21, 2014).  Rather than spending their time drafting a well-pleaded amended complaint for their remaining causes of action, plaintiffs moved for reconsideration.  Cales v. Medtronic, Inc., No. 14-CI-1774, slip op. (Ky. Cir. Ct. Jul. 1, 2015).  Not only was their motion denied — the court found a few other things that had slipped through the cracks that should have been dismissed as well.  In other words, plaintiffs aren’t any better off for their motion; in fact, their worse.

The crux of plaintiffs’ motion for reconsideration is that the court applied the federal TwIqbal standard of pleading rather than Kentucky’s “notice” pleading standard. It turns out that plaintiffs’ complaint was so poorly crafted that the error was harmless – plaintiffs’ complaint failed even the less-demanding requirements.

But plaintiffs’ complaint wasn’t the only thing poorly crafted.  So too were plaintiffs’ arguments on reconsideration.  The court spends pages of its decision admonishing plaintiffs for “selectively cherry-pick[ing] quotes from a number of unpublished appellate decisions and out-of-context dictum to support their argument that merely pleading bald, legal conclusions satisfies Kentucky’s liberal pleading standard.”  Cales, slip op. at 5.  Challenging plaintiffs’ “Frankenstein-esque construction of notice pleading,” id. at 7, the court is clear that notice pleading does not “relieve [plaintiffs] of a responsibility to produce some factual basis to support the elements of their various claims.”  Id.


Continue Reading Be Careful What You Ask For

This post comes from the non-Reed Smith side of the blog.

Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases.  Think of it like taking a shot on goal.  The shot deflects off the goalie’s stick and goes wide – that’s express preemption.  The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements.  You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion.  Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot.  Wrong. No free shot.  No empty net.  All the obstacles remain in place.  Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series.  Go Capitals!).


Continue Reading InFuse State Court Appellate Win

This post is from the non-Reed Smith side of the blog.

We’ve been reporting on the amazing success Medtronic has had in the InFuse litigation for over two years.  And, it all started with Caplinger.  Caplinger was the first (and arguably one of the best) of the lot, accepting propositions that PMA preemption applies to devices, not uses; that “off-label promotion” is not a proper parallel claim; that any claim dependent on the scope of the FDA’s label is really a disguised FDCA violation claim; and any claim premised on a PMA device’s safety and effectiveness is preempted.  What more could we have asked for?  A Tenth Circuit affirmance.  Now we’ve got it.

In an extremely well-written decision the Tenth Circuit (2-1) affirmed the complete dismissal of Caplinger v. Medtronic, Inc., No. 13-6061, slip op. (10th Cir. Apr. 21, 2015). It is so well-written we really could quote from most of it verbatim.  But we’ll try to resist that urge and give you an abbreviated version today (we do however recommend reading the whole thing, we think you’ll enjoy it).


Continue Reading It All Started With Caplinger

This post is from the non-Reed Smith side of the blog.

We’ve been reporting on individual InFuse cases that have been chopped down by defendant swinging a preemption axe of sorts.  One by one, the cases have toppled. Occasionally, a branch or two hangs on, but they’re often too weak or flimsy to survive for long.  But yesterday, the Western District of Tennessee took a bulldozer to 141 InFuse cases.  The decision strikes a decisive blow to plaintiffs’ off-label promotion theories, while reinforcing the predominance of preemption in PMA medical device cases.

The decision was entered in Hafer v. Medtronic, Inc., No. 2:13-cv-02340-JTF-dkv, slip op. (W.D. Tenn. Apr. 13, 2015), but applies to the entire group of InFuse cases that were consolidated before a single judge in that jurisdiction.  The allegations are essentially the same as we’ve seen in other InFuse cases, discussed here.   Namely, that plaintiffs’ surgeons opted use the InFuse device, a multi-component spinal fusion medical device, in an off-label manner.  In so doing, say plaintiffs, they were not implanted with a PMA approved device and so preemption should not apply.


Continue Reading Breaking News: 141 InFuse Plaintiffs Have Their Cases Clipped by Preemption