Search results for: infuse

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

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

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

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

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

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…

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

We’ve been updating you regularly on the equally regular dismissal of the majority of claims in the Infuse litigation on the grounds of preemption and TwIqbal.  Well, here’s a quick reminder that preemption isn’t the only arrow in device manufacturers’ quivers.  All those…

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

Since September we’ve been bringing you news from the Infuse litigation on about a monthly basis.  The overwhelming majority of that news has been positive.  And, when you’ve got a good thing going, you want to keep it going.  You also don’t want…

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