We were in western Tennessee last week for an argument.   We stayed at a beautiful and venerable hotel, most famous for twice-daily “march of the ducks.” Every morning, at 11 a.m. sharp (at least 30 minutes after guests have packed the lobby), an elevator door opens, and a uniformed “duck master” leads a perfect procession

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 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 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 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

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

The InFuse litigation has certainly given us quite a lot to talk about – and almost all of it positive.  It has been a treasure trove for defendants on off-label marketing and promotion claims.  We’ve collected this bounty of riches here.  While each case has its own nuances, they are all really slight variations on a theme – the almost unanimous rejection of plaintiffs’ attempts to use off-label marketing to thread the preemption needle.  While the reasoning varies from court to court, the over-arching message is the same – off-label marketing does not change the preemption analysis.  The InFuse device, regardless of how it was used by a particular surgeon in a particular surgery, is a PMA-approved, Class III device and therefore covered by both Riegel express preemption and Buckman implied preemption.  Very little slips through the small space between the two.

If you want a more complete history of the InFuse litigation, we point you to our collection referenced above.   For even casual readers of our blog, we think you’ve probably seen some of our writings on the topic and so we aren’t going to wade back through the details.  Today’s post is more of an update.  Here are the latest four InFuse victories.

Truthful v. Untruthful Promotion

First up is Byrnes v. John Small, 2015 U.S. Dist. LEXIS 33555 (M.D. Fla. Mar. 18, 2015). This case is fairly typical for InFuse. Failure to warn and design defect claims are preempted, id. at *13-14, *17-19.  We will point out that this is another court that understands that the FDA approves devices, not “specific uses” of devices.  Id. at *18.  More importantly, Byrnes is also another outright rejection of our least favorite InFuse case, Ramirez, and points out the poor logic of that ruling.  Id. at *18-19.

Continue Reading Let’s Talk InFuse

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

Most of our reports on the InFuse litigation have been positive — credits rather than debits.  Last week, we had to move to the other side of the ledger and report on case that in our belief was definitely lacking.  But that one case was hardly enough to unbalance the account.  And just a few days later, three new decisions came down pushing the InFuse Litigation even further into the pink.

For a full accounting, you can examine our InFuse posts here.  We won’t reiterate all that has come before, but overall plaintiffs have met with very limited success in their attempts to use allegations of off-label promotion and/or use to get around the dual protection afforded by PMA express preemption (Riegel) and implied preemption (Buckman).  As today’s post demonstrates, the overwhelming defense wins are not going unnoticed by either federal or state court judges.

These latest InFuse wins come from the Western District of Michigan – the companion cases of Wright v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 7681 (W.D. Mich. Jan. 23, 2015) and Thorn v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 7687 (W.D. Mich. Jan. 23, 2015) – and Florida state court – Buccelli v. Mayer, No. 2014-CA-001667 NC, slip op. (Fla. Cir. Ct. Jan. 27, 2015).

Continue Reading InFuse Litigation Still In the Pink