Parallel Violation Claims

One doesn’t see many new PMA preemption issues raised, but we found a case that does just that – Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016). We are used to seeing plaintiffs try to use off-label use to circumvent PMA preemption. Just check out any of our Infuse posts to see how badly that has worked out for plaintiffs. They largely unsuccessfully have argued that if a product is used off-label, it is used for a purpose for which its PMA approval does not apply and therefore, the PMA requirements likewise don’t apply which plaintiffs contend means preemption should not apply. The courts have disagreed.

In Vincent, plaintiffs tried a similar end run around preemption. Plaintiff underwent surgical implantation of a pacemaker on February 12, 2004. The pacemaker lead used in the surgery was a Class III, PMA medical device. Shortly before plaintiff’s surgery, Medtronic had submitted the lead for supplemental pre-market approval. The approval was granted on March 10, 2004. Id. at *1. Ten years later, plaintiff had to undergo explant surgery due to a fractured lead and then filed a products liability suit. Id. at *2. In addition to standard claims based on failure to warn and design defect, plaintiff alleged that the lead had not received FDA approval at the time of the initial procedure, which was not disclosed to plaintiff or his surgeon. Id.

Continue Reading A Twist on PMA Preemption

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

When we last talked about Shuker v. Smith & Nephew PLC, No. 13-6158 (E.D. Pa.), it was with high praise for the court’s decision tossing out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. Our post on that decision is here. The court gave plaintiff a second chance to re-plead the non-preempted claims, which he did. Defendant again moved to dismiss and this time it was granted with prejudice. Shuker, 2016 WL 5461900 (E.D. Pa. Sep. 29, 2016).

Plaintiff underwent hip replacement surgery. For that surgery, plaintiff’s surgeon opted to use defendant’s R3 hip replacement system, but also used a component, the metal liner, from defendant’s BHR hip resurfacing system. Admittedly, an off-label use. Plaintiff suffered complications that required multiple revision surgeries. Id. at *3.

In its original decision, the court’s leave to amend went only to parallel claims based on allegations of off-label promotion. Id. at *1. Those claims were for “tortious misconduct based on off-label promotion” and fraud. Id. at *4. Plaintiff cites to a single press release to support his allegation that defendant “actively marketed” the metal liner as an option for the R3 system “in a way that led” doctors to believe the liner was a component of the R3 system and safe to use with the R3 system. Id.

Continue Reading Hip Implant Off-Label Promotion Follow-Up

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 (W.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 comes from the non Reed Smith side of the blog.

 

Minnesota is one of our most beautiful states and the setting for much of the terrific TV anthology series Fargo. But Minnesota is also home to a significant number of well-reasoned preemption decisions. While we’ll concede that beautiful lakes and Fargo are (way) more interesting and entertaining than preemption law, this is a drug and device law blog. So today’s visit to Minnesota will offer you the wonderful opportunity to review a well-reasoned preemption decision, not to enjoy a lazy, scenic day on a lake or a mesmerizing, voyeuristic view of fake true-crime drama. You can visit Minnesota and its lakes on your own time. And we’ll certainly talk about Fargo once season three starts next year. But, for now, you get Lutz Cummings v. Medtronic, Inc., 2016 WL 3082314 (Minn. D. Ct. May 31, 2016) and preemption.

In Lutz, one of the plaintiffs had complications from a pain-pump implant and filed a complaint in Minnesota state court alleging a host of state-law claims. Since the pain pump is a PMA device, plaintiffs’ state-law claims are preempted unless they can properly state parallel violation claims. The court effectively described how express and implied preemption work together to create a near air-tight seal that leaves plaintiffs only a “narrow gap” into which try to fit such claims. Their claims must be premised on conduct that violates FDA regulations but cannot seek to directly enforce those regulations. Rather, their state-law claims must be such that they would give rise to a recovery even if the FDA regulations didn’t exist:

Narrow Gap Between Express and Implied Preemption. State law claims involving an FDA-approved medical device are expressly and impliedly preempted by federal laws and regulations. A plaintiff may pursue state law claims involving an FDA-approved medical device only to the extent plaintiff can show that such claims escape express and implied federal preemption as contemplated by existing federal regulations and case law. In evaluating an allowable claim, the Minnesota federal district court in Riley v. Cordis Corp., states:

Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by section 360 k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). For a state-law claim to survive, then, the claim must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.

625 F. Supp.2d 769, 777 (D. Minn. 2009).

Lutz, 2016 WL 3082314, at *4 (all emphasis in original). Not only did plaintiffs have to deal with the limited availability of parallel violation claims, they also had to allege facts that made those claims plausible under the pleading requirements of TwIqbal. With this construct in place, the court set about dismissing plaintiffs’ attempted parallel violation claims one at a time.

Continue Reading Minnesota Gives Us Another Excellent Preemption Decision

This post comes from the Cozen O’Connor side of the blog.

Last week, the New York Appellate Division upheld a preemption decision in a medical device case involving alleged off-label promotion. Pitkow v. Lautin, 2016 WL 2746469 (N.Y. App. Div. May 12, 2016). While the Appellate Division’s opinion was only three-paragraphs long, it affirmed the trial court’s ruling in every respect, making the trial court’s lengthier opinion that much more important. We obtained a copy, and here it is.

The plaintiff’s claims were based on complications that arose after her use of an injectable product, Sculptra, for cosmetic purposes, which was an off-label use. Plaintiff sued the doctors who injected her and the manufacturers of Sculptra. Among other things, she alleged that the manufacturers had improperly promoted off-label use of Sculptra.

After discovery, the manufacturers moved for summary judgment, arguing that all of plaintiff’s claims were preempted. The trial court agreed and, quite effectively, walked through the manner in which both Riegel and Buckman preempted plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at parallel violation claims.

First up was Riegel preemption, since Sculptra was approved under the FDA’s PMA process:

Sculptra is a Class III medical device that was undeniably approved through the PMA process. What is more, all of the plaintiff’s claims against the [manufacturers] regard the safety and effectiveness of the device or require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA via the PMA process . . . . Thus, the claims are preempted by the federal law.

Slip. Op. at 8-9.

Continue Reading New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion

This post is not from the Reed Smith side of the blog.

A federal court in the Ninth Circuit has held that PMA preemption extends beyond claims involving medical devices approved through the more traditional PMA process. It now also includes claims involving devices that were approved under the FDA’s humanitarian device exemption, or HDE. See Brandt v. Medtronic, Inc., 2016 U.S. Dist. LEXIS 43512 (D. Nev. Mar. 31, 2016). For those of us who didn’t know, HDE applies to devices that treat or diagnose conditions that affect fewer than 4,000 people per year. The device implanted in the plaintiff in Brandt was an HDE device intended to treat gastropareses, a relatively rare stomach condition that leads to chronic nausea and vomiting. Id. at *1. The plaintiff ultimately suffered medical complications and brought a lawsuit asserting the usual line-up of defect and other claims.

The court granted Medtronic’s motion to dismiss based on PMA preemption. The court held that, under Riegel, plaintiff’s claims would be preempted if the device had been approved under the PMA process, the device implanted in plaintiff was an HDE device, and there was no real dispute that HDE devices are subject to the FDA’s PMA process. Id. at *8. In fact, the Riegel decision itself used an HDE device as an example of a device subject to the PMA process. Id. n.2 (citing Riegel v. Medtronic, 552 U.S.312, 318 (2008)).

Accordingly, the court applied PMA preemption. The Court dismissed plaintiff’s defect, warranty and fraud claims because each was based on a Medtronic’s allegedly flawed design, manufacture, production and distribution of the device, all of which are issues squarely addressed in the FDA’s PMA review process. Id. at *9. The court further held that, even if plaintiff’s claims were read to allege that Medtronic misled the FDA, they would still be preempted under Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). Id. at *11.

Now, this isn’t quite the end of this case. The court gave the plaintiff an opportunity to replead her parallel violation claims, which were based on Medtronic’s alleged failure to report certain events or risks to the FDA. But plaintiff’s limited (and likely short-lived) victory does not overshadow the key ruling of Brandt: PMA preemption applies to HDE devices. This is the first decision of this kind that we’ve seen. With it now on the books, we will watch how other courts treat this additional application of PMA preemption.

Last November we blogged about “specialized” preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a metal-on-metal hip replacement. What made the Mink case unusual was that the plaintiff had been a clinical trial participant. Thus, in addition to the usual product liability personal injury claims, the plaintiff also challenged the early termination from the clinical trial, calling it a breach of contract. The hip replacement system had made it through the FDA’s rigorous Pre-Market Approval (PMA) process, and the court dismissed the plaintiff’s claims because, as summarized in our deathless prose, “participation in post-approval clinical trials doesn’t provide any extra basis for a plaintiff avoiding Riegel preemption.”

The plaintiff was afforded an opportunity to amend the complaint, and did so by adding much specificity as to how the medical device allegedly deviated from manufacturing and regulatory requirements. The claims at issue were: (1) negligence, (2) strict liability, (3) breach of contract, and (4) misrepresentation. But the result was no different: the court still dismissed the claims. Check that; the result was different. This time the dismissal was with prejudice. That decision is Mink v. Smith & Nephew, Inc., 2016 U.S. Dist. LEXIS 32519 (S.D. Fla. March 11, 2016), and some of the court’s prose, as well as its reasoning, is pretty deathless, too.

Continue Reading Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims

Movie makers have been sharing their vision of post-apocalyptic worlds for decades now.  They keep making them because we keep watching them.  Arid landscapes, plague, squalor.  The struggle between hope and hopelessness; between abandon and a belief that there will be a better tomorrow.  The topic begs for epic movie treatment and there are quite a few good ones. Last year saw what many would consider one of the best in the genre – Mad Max: Fury Road.  It won 6 Oscars for almost everything that assaults your eyes and ears in a film — costume design, makeup, sound editing, sound mixing, production design and film editing.  But it is in no means the only post-apocalyptic film worthy of a couple of hours in the dark.  Among some of the more recent entries in this film category The Road stands out not only as a fairly good novel adaptation but also for provoking the audience to think “what would you do?” There is also Children of Men dealing not only with the devastation of world war but with the extinction of humans from infertility.  And if you haven’t seen Terry Gilliam’s Twelve Monkeys, well just shame on you.  And, if this is all just a bit too heavy for your tastes, you can still enjoy the genre through the beautifully animated, heart-string pulling, Pixar’s WALL-E about a small waste-collecting robot left alone on Earth who ends up saving humankind.  (We know we haven’t even scratched the surface, and haven’t mentioned Hunger Games, but you get the idea).

Continue Reading Parallel Claims – What Happens Post Surviving Preemption

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

Today’s mainstream media may be all about another “first” that happened yesterday, but our attention is drawn to a state to the south and west of all that hoopla, Oklahoma.  Oklahoma doesn’t wade into the presidential political process until Super Tuesday, but in the drug and device world, Oklahoma gets center stage for getting PMA preemption just right.

The case is Nevolas v. Boston Scientific Corporation, 2016 U.S. Dist. LEXIS 9893 (W.D. Okla. Jan. 28, 2016) and it involved a spinal cord stimulator which is a Class III, pre-market approved medical device.  That means the product is subject to the express preemption provision of the Medical Device Amendments of 1976 (“MDA”).  As a reminder that provision provides that:

[N]o State . . . may establish or continue in effect with respect to a device intended for human use any requirement —  (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a).  With that, few if any products claims survive preemption.  See Nevolas at *5.  To do so, the claim must be a parallel violation claim.  A parallel claim is a state law claim in which damages are sought for conduct that violates a specific federal regulation – thus state and federal law are equivalent and express preemption doesn’t apply.  But the claim itself must be a recognized state law claim.  Plaintiffs cannot sue solely because defendant’s conduct violated federal regulations – that would be an impermissible attempt to privately enforce the FDCA.

Continue Reading First Complete PMA Preemption Win of 2016