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This is the time of year when our thoughts start migrating southward.  We can see all those birds’ nests in our suddenly denuded poplar trees.  The driveway is a skating rink of damp leaves.  The baseboards in our home now gurgle from the operation of an ancient oil heating system.

Over the last two weeks our posts leaned against a pair of intemperate blasts from a Vermont federal court.  The results were dreary and/or indecipherable.  Thus, it is with some relief that we bask in the warm glow of a nice, straightforward decision from the happiest place on Earth, the federal court in Orlando.  In Stanifer v. Corin USA Ltd, Inc., 2014 U.S. Dist. LEXIS 158587 (M.D. Fla. Nov. 10, 2014), a hip resurfacing system was implanted into the body of the plaintiff during a right hip arthroplasty procedure.  Subsequent failure of the system allegedly caused the plaintiff to suffer a revision left total hip arthroplasty and surgical removal of the system.  The plaintiff filed a lawsuit in state court seeking to recover “damages and losses” from the defendants based on state law strict liability claims for breach of warranty, manufacturing defect,  and design defect.  After removal of the action to federal court, the defendants moved to dismiss the claims based on federal preemption.

The hip system was a class III device, and therefore subject to the PMA process and the attendant federal preemption.  After the Supreme Court’s decision in Reigel, a plaintiff injured due to use of a Class III PMA device can escape preemption only by asserting a “parallel” state law claim.   As readers of this blog likely know, we think of the parallel claim exception as something crazy and made-up, like a fairy tale or a Johnny Depp movie.  Luckily, the Stanifer case is governed by the law of the Eleventh Circuit, a place that knows how to deal with such things. The Stanifer court embraced Eleventh Circuit precedent to the effect that plaintiffs cannot effectively state a “parallel claim” absent allegations that the defendant violated a “particular federal specification.”  Ah – we are far from the windy incoherence of Vermont (or Chicago – the Bausch case still stands as the babbling zenith of parallel claim doofus-prudence).Continue Reading Far from Dumbo: M.D. Fla. Gets “Parallel Claim” Case Right

The Fifth Circuit’s decision in Bass v. Stryker allowing a parallel violation claim to survive a motion to dismiss based on allegations of violations of CGMPs earned an honorable mention in our worst decisions for 2012.  The reason it wasn’t ranked higher is largely because the complaint in that case was fairly detailed and as we posted here provided a pretty good checklist of what a plaintiff has to have pleaded, under TwIqbal, to state an unpreempted manufacturing defect “parallel violation” claim:

  1. The identity of the particular product that the plaintiff claims caused injury;
  2. The nature of the claimed “parallel” violation (“the FDA had previously warned [defendant] of bioburden in excess of FDA regulations in its final rinse of the [device]”);
  3. That the violation could be causal in that it pertained to the plaintiff’s device (“after [plaintiff’s] surgery, [defendant] ultimately voluntarily recalled [the device], including the [device] specifically used in [plaintiff’s] implant”);
  4. The nature of the plaintiff’s injury;
  5. That the violation could be causal in that it bore a relation to the plaintiff’s claimed injury (“the lack of bony ingrowth is a known effect of an excess of bioburden and manufacturing residuals on [the device]”); and
  6. That the alleged violation be of a sufficiently specific FDA regulation (which could include a CGMP as applied to the device by particular specifications in the approved PMA).

Bass v. Stryker, 669 F.3d 501, 510, 511-12 (5th Cir. 2010).Continue Reading How to Flunk the Bass v. Stryker “Parallel Violation” Claim Checklist

We talk a lot about preemption here.  Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts.  That isn’t surprising.  Preemption can end a litigation, and we all want to hit the game-winning home run.

But plaintiffs know that too.  So, rather than taking preemption head on, we often find ourselves dealing instead with plaintiff’s attempts to get around it via “parallel violations” claims.  Now, we have problems with the very existence of such claims.  Among other things, they often appear to be improper attempts to bring private rights of action under the FDCA.  But, unfortunately, they exist, and courts recognize them.  Given that reality, however, we’d like courts to at least view them with a scrutinizing eye.  The court in Cline v. Advanced Neuromodulation Sys., Inc., 2014 U.S. Dist. LEXIS 56669 (N.D. Ga. Mar. 31, 2014), did just that.

In Cline, the plaintiff had an opportunity for limited discovery (which we’ll discuss later) into the PMA specifications that came with the approval of an implantable pulse generator (“IPG”) implanted into plaintiff. Plaintiff then filed her third amended complaint in an attempt to state parallel violation claims related to the failure of her IPG.  It didn’t go exceedingly well.  The court lowered the microscope to look at those claims for what they really were, and almost all them did not survive.Continue Reading A District Court Takes an Exacting Look at Parallel Violation Claims

San Francisco has always been a great restaurant town, and if anything, the food and dining options have only gotten better over the last 20 years.  Come to think of it, the food and dining scene has improved most everywhere, to the point that you can find a great meal in all parts across the country.  We’ve had the best shrimp and catfish we’ve ever eaten while taking depositions in the South, and, while recently vacationing in a New England town where we spent part of our youth, we could not help but notice the number of really good eateries that were not there before.  (Although one beloved greasy spoon had converted to a Starbucks, so not every change was an improvement.)  Our collective obsession with food is seen further in the proliferation of food-related television programming, including a Food Network, which we will unabashedly admit to watching and enjoying somewhat regularly.

We are waxing on about San Francisco and food for two reasons.  First, this is your blogger’s inaugural blog post, and my law practice is based in the City by the Bay.  I have long admired the Drug and Device Law Blog and especially its contributors, who for many years have carried a banner for those of us on the “right side of the v” with intelligence, wit, and above all relentlessness.  Day in and day out.  Although I am cut from much the same cloth as my co-bloggers, my voice originates from a point west of Princeton, Philadelphia and Washington, D.C., and I am thrilled to be joining the effort.

Second, the Northern District of California has become somewhat a center for food-related litigation. Some refer to it as the “Food Court,” although we believe that label is largely promoted by those interested in seeing food-related litigation gain legitimacy and expand.  We have written many times about food litigation, including here and here, because even though we are the Drug and Device Law Blog, the “F” in FDCA stands for Food, and we take lessons from food on such topics as preemption, primary jurisdiction, and claims for consumer remedies.

This leads to a recent order from the Northern District of California where the court dismissed food-related claims in ways that we like, but did not embrace one of our favorite grounds for dismissal – federal preemption.  In Kane v. Chobani, Inc., No. 12-cv-02425, 2013 U.S. Dist. LEXIS 98752 (N.D. Cal. July 12, 2013), the plaintiffs alleged that the defendant had mislabeled its “Greek” yogurt products in three ways – by referring to the yogurt’s sweetener as “evaporated cane juice” when it essentially is just sugar; by falsely claiming “no sugar added” on its website; and by falsely stating that the products were “all natural.”  Id. at *3-*6.  Lawsuits of these kinds, and particularly those focused on whether products are “all natural,” unfortunately have become  familiar, which begs the question in our minds of how much consumers (1) read alleged representations like these and (2) attribute meaning to them in making their purchasing decisions.  Maybe they do, maybe they don’t.  We can’t tell without asking them.Continue Reading Is Kane Sugar Parallel to Cane Sugar?

This post is from the Dechert side of the blog only. McBride v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 96438 (W.D. La. July 10, 2013), is an opinion in a medical device case, and it is a joy for two reasons, one substantive and the other entirely stylistic. As to substance, it doesn’t allow plaintiffs to muse into existence a state law claim on which to base their parallel violation claims.  As to style, the opinion, written by Judge Trimble, is a smooth and enjoyable read because it doesn’t jam its paragraphs chock full of citations, italics, underlining, parentheticals and other distractions that are best placed elsewhere.

We’ll take the last point first.  Lawyers somehow pride themselves on being the only group of writers and readers who identify their sources in the text. Most professions, industries and for that matter schoolchildren know that a written piece with many sources should identify those sources in footnotes, not the text. Rather than turn paragraphs into a game of visual hopscotch, let the text be the text and identify citations at the bottom of the page where readers can easily find them when they want to.  A written piece – particularly one intended to persuade – should be a clean, crisp trip down the highway.  Not with lawyers.  With them, it’s a herky-jerky ride down Rt. 1 in New Jersey.  There’s a light at every intersection.  You’re forced to constantly be on the look-out for cars entering the road from every direction.  And you’ve got a congestion headache.  Lawyers seem to take pride in the pain they cause themselves, as if developing the skill to quickly read a page-long paragraph that has two actual sentences is something to be proud of.  Law students starting out on law journals seem to understand that this is not the way to do it.  They put citations in footnotes at the bottom of the page.  Then they graduate and become lawyers . . .
Continue Reading McBride v. Medtronic: Of Footnotes and Parallel Violations Claims That Have No Basis in State Law

In a post Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), world – plaintiffs most often attempt to avoid preemption of products liability suits involving PMA (Premarket Approval) medical devices by alleging a parallel violation.  While they’ve had some success in getting past the pleadings stage on this theory, to the extent any PMA medical device case survives preemption, what survives is only a small slice of the usual panoply of products claims.  Further, proving a state law claim for violation of a federal regulation is far from a slam dunk.

So, what’s a better way to avoid PMA preemption?  Claim the product at issue isn’t actually a PMA medical device.  But if the device actually did go through the PMA process, how do you claim it didn’t?  By taking the device apart.  Well, at least that’s what plaintiffs have tried to make courts believe.  But so far, no takers.

And, just yesterday, a New Jersey court said no to both – rejecting plaintiffs’ component theory of liability and casting serious doubt on the viability of parallel violation claims in PMA medical device cases.  The case is Smith v. Depuy Orthopaedics, Inc., No. 11-4139 (JAP), slip op. (D.N.J. Mar. 18, 2013).  To start, if you aren’t versed in the PMA process, the decision contains a thoughtful recitation of the process and of the defendant’s compliance with FDA requirements at every turn.  See slip op. at 2-9.  It also explains the difference between the rigorous PMA process, during which the FDA determines whether the device is safe and effective for its intended purpose, and the 510k premarket approval process, which has to do with a finding of substantial equivalence rather than safety and efficacy.  Id. at 7.  It was this distinction that led to Riegel and PMA preemption. And, it is what has plaintiffs attempting to strip medical devices like a mechanic disassembling a junker for its parts.  Sometimes that’s all an old car is good for.  Sometimes, the whole – say a 1967 Mustang GT 500 – even with scratches and dents, is worth significantly more than the sum of its parts.

The same is true for medical devices.  When determining whether state law claims are preempted, you look at the device as a whole.  “[A] device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption.”  Slip op. at 21 (citations omitted).    It doesn’t matter if some of its components were originally cleared through the 510k process.  Once those components are made part of a medical device that gets submitted to the FDA for PMA, then those components go through the PMA process too.  Id. Continue Reading New Jersey Court Finds No Parallel Claim and No Component Liability

These parallel violation claims, they seem to vex some courts, and then frustrate us.  We think it should be fairly simple to apply preemption when the medical device in question in the litigation was approved under the FDA’s PMA process.  TwIqbal pleading principles should make it even easier.  If a plaintiff’s state-law claims have requirements different from or in addition to federal requirements, they’re preempted.  If they don’t have enough detail for the court to make that analysis, they should be dismissed under TwIqbal.  If they seek to enforce the FDCA or FDA regulations, they should be dismissed because there’s no private right of action under the FDCA.  Yet, still, some courts seem to miss these basic principles when considering Riegel’s “parallel” violation exception to preemption.
Take Hawkins v. Medtronic, Inc., 2012 WL 4364171 (S.D. Oh. Sep. 24, 2012).  Please.
There, the plaintiff used a device cleared under the FDA’s PMA process.  OK, so Riegel preemption is in play.  The plaintiff made typical claims – design and manufacturing defect, failure to warn, express and implied warranty, and negligent and intentional misrepresentation.  He also made a couple of more unusual claims called negligent handling and failure to report.  He plead few facts on the device’s regulatory history and fewer on how the device or the defendant deviated from FDA regulations.  What plaintiff did instead was recite in his complaint the language from the Ohio Revised Code that authorized claims for manufacturing and design defect and failure to warn, lay out the common-law elements to his warranty claims, and provide a string of very general provisions from the FDCA and CFR about medical devices.
For the court, this was enough.
Looking at all this general language, the court held that the defect, warranty and failure to warn claims could survive a motion to dismiss because they were “premised on the theory that Defendant violated federal law.”  Id. at *6, *7, *8.  But, as we’ve said on this blog many times, private plaintiffs aren’t authorized to enforce the FDCA or FDA regulations.  Only the United States can do that.  (Note: the misrepresentation, failure to report and negligent handling claims, for unsatisfactory reasons, were dismissed.)
Continue Reading Parallel Violation Claims – Why So Hard?

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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