Photo of Michelle Yeary

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

Photo of Michelle Yeary

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

Photo of Michelle Yeary

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

Having to report on a negative InFuse decision happens about as often as meteorologists correctly predict snowstorms.  Boy did they get it wrong for New Jersey and Pennsylvania this week.  Talk about deflated snowfall expectations.  Speaking personally for a minute, this non-skiing, non-snowboarding, warm-weather-loving blogger was not disappointed at this turn of events. And, we actually feel a little sorry for weather forecasters whose sole job it is to predict the often unpredictable, but who are held to exacting standards.  Next time a blizzard is predicted, people will mock the forecast, go to work, get stuck in ten inches of snow, slip and slide the whole way home, and then complain that the warning wasn’t strong enough.  Meteorologists really can’t win.

Defendants in the InFuse litigation, however, usually do. But like meteorologists who occasionally hit it right on, sometimes an InFuse judge gets it wrong.  When that judge is confined by having to apply Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010), the result isn’t completely shocking. Disappointing, but not shocking.

The basic allegations in Garross v. Medtronic, Inc., 2015 U.S. Dist LEXIS 6675 (E.D. Wis. Jan. 21, 2015) are like those in all of the other InFuse cases.  The InFuse bone fusion system is a Class III, pre-market approved medical device.  As such, plaintiff’s claims should only survive if they can squeeze through the “narrow gap” left after application of express and implied preemption.  Notably, the Garross court called it only “a gap,” id. at *7, suggesting a more spacious opening then we believe is supported by the case law.Continue Reading Deflated PMA Preemption: Off-label Promotion and Failure to Report Keep InFuse Case Alive

Photo of Michelle Yeary

We often report on cases that are dismissed at the pleadings stage but in which plaintiff is afforded an opportunity to “fix” his or her complaint.  And almost as often, we refer to this as plaintiff getting a “second bite at the apple.”  Not overly creative, but it conveys the point nicely.  In the InFuse cases, for instance, the large majority of plaintiffs’ claims have been dismissed as preempted.  Typically, the claims that survive preemption are for fraud and misrepresentation and more often than not those have been dismissed for pleading deficiencies. Less often do we see blogworthy decisions on the result of plaintiff’s second bite. So we were surprised to happen upon two such decisions in the InFuse litigation issued just days apart.  Plaintiff’s second attempt in one case was more well received by the court, but even that decision has some positive notes for defendants.

To start, we’ve posted a lot about the great success defendants have had in the InFuse litigation defeating off-label promotion claims.  So, we aren’t going to reiterate all the details.  You can check out all our posts on the InFuse cases here, including our post on Martin v. Medtronic which is one of our follow-up cases today.

In Martin, the court dismissed all of plaintiff’s claims.  The preempted claims (fraud based on the labeling, failure to warn based on off-label promotion, design defect, negligent failure to warn based on labeling, negligent design/manufacture, and negligence based on off-label promotion) were dismissed with prejudice.  Plaintiff was given leave to amend her remaining claims: fraud based on misrepresentations in off-label promotion, failure to report adverse events to the FDA, and breach of express warranty.  Martin v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 164980 at *8-9 (D. Ariz. Nov. 24, 2014).  She didn’t fare much better on the second go-round.  First, plaintiff re-pleaded all of her preempted claims and the court quickly dismissed them again.  Id. at *11-12.Continue Reading InFuse Update

Photo of Michelle Yeary

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

It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two.  It is a tried and true metaphor, like its modern English counterpart — between a rock and a hard place.  But it is particularly fitting in products cases dealing with pre-market approved medical devices.  So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:Continue Reading The Scylla and Charybdis of PMA Preemption

Photo of Michelle Yeary

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

These wins are becoming routine – but we’re not taking them for granted.  In fact, we’ve given them their own label on the blog and we highly recommend you peruse this collection if you are facing off-label promotion allegations.  It is an overwhelming body of precedent establishing that almost all claims in pre-market approved (“PMA”) medical devices are preempted and that off-label use does not change the analysis or the conclusion.   And one of the great benefits of tallying up all of these favorable decisions from courts across the country is citing them to courts considering the issue.  Both of the recent InFuse wins demonstrate that the vast authority supporting preemption is quite compelling.

A quick reminder of the core issue in the InFuse litigation.  The InFuse bone graft device is a Class III, PMA device.  The Supreme Court has determined that the PMA process imposes federal requirements that preempt state law tort claims.  That express preemption combined with the implied preemption of claims that seek private enforcement of the FDCA leave only a “narrow gap” through which a claim must fit to survive.  Plaintiffs most often used method for threading that needle is to allege a parallel claim – a violation of a state law duty that is genuinely equivalent to federal requirements.  Since so few claims even come close to being parallel claims, the InFuse plaintiffs allege that because their surgeons implanted the device in an off-label manner, the standard preemption analysis shouldn’t apply.  First, they argue that the PMA requirements for InFuse should be inapplicable to off-label uses and without specific requirements, the first prong of the express preemption analysis isn’t met.  Alternatively, even if the requirements apply, plaintiffs allege their claims are parallel claims because the FDA prohibits off-label promotion.Continue Reading Two More InFuse Victories

Photo of Michelle Yeary

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

We’ve all been through it.  We’ve spent painstaking hours drafting a brief or a memo.  We’ve combed through each page, paragraph, and sentence. We’ve cut, copied, and pasted.  Then, when we are satisfied with the result we hand it to someone else to review.  We move on to something else, almost forgetting about what we conceived of as masterful and persuasive prose.  Until . . . we get the redline.

While there are certainly times when you don’t agree with “suggested” edits that you are given, more often than not the person playing the role of the editor does what you previously believed to be impossible – he/she has improved your product.  Inconceivable? Not really.  That’s the job of an editor.  First, the editor is coming at the project with fresh eyes and more objectivity.  Second, a good editor will read the entire piece first giving him a different perspective than the author.   Third, think of your editor as your guinea pig.  If he didn’t “get it,” it’s unlikely anyone else will either.  Fourth, editors pay attention to detail that authors often overlook.  Finally, your editor is your partner.  Not in the law firm sense, but in the collaborative process sense.  You both want the same thing – a better brief.Continue Reading Court Takes A Red Pen to InFuse Complaint

Photo of Michelle Yeary

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

We’re going to be right up front with you today.  It’s a work day.  It’s the World Cup.  The US is playing Belgium in the Round of 16 at 4:00 EDT.  We don’t want to miss it.  And soccer — unlike sports like football and baseball — has no time-outs, no 7th inning stretch.  There aren’t even any commercials.  You look away for a minute to answer an e-mail, you could miss the only goal of the game.  So, we’ll get right to the point.

Medtronic scored another InFuse victory in Dunbar v. Medtronic, No. 2:14-cv-01529-RGK-AJW, slip op. (C.D. Cal. Jun. 25, 2014).  The allegations in this complaint, like all of the others we’ve previously discussed, focus almost exclusively on off-label use of the Class III, PMA spinal fusion device.  Seeing Class III and PMA in the description of the medical device should almost certainly guarantee a defense win on preemption as most courts have acknowledged that there is only a “narrow gap” between Riegel preemption and Buckman preemption in which plaintiffs can state a claim.  And that is why the InFuse plaintiffs have tried, with only limited success, to get courts to recognize a preemption exception when a PMA device is used off-label.Continue Reading Latest InFuse Win – Good on Negligence Per Se

Photo of Michelle Yeary

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

It is a bit chilly and dreary in the Mid-Atlantic region today.  So, we went looking for something to warm and brighten up our day.  And we found a tropical twofer (do radio stations still do Twofer Tuesdays?) from one of our recent