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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

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Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be.  There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had.  For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively.  So definitively that it took our spot as top decision of 2015.  Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.

We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug.  In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug.  One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks.  Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about.  There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims

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One of the most basic prerequisites to having court rules is that the rules aren’t supposed to change substantive law.  With class action rules, like Fed. R. Civ. P. 23 and its state-law analogs, courts seem to have a hard time remembering that.  No substantive effect means that, if a plaintiff couldn’t bring the claim

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It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.Continue Reading Preemption (and Other Things) Defanging Depakote Claims

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A recent decision in the propoxyphene litigation – Schiller v. Eli Lilly & Co., No. 2:12-247-DCR (E.D. Ky. Apr. 7, 2014) – confirms a now basic premise of product liability law: if you claim to have been injured by a drug that you don’t identify, you will lose.

The plaintiff in Schiller, a resident

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The pelvic-mesh plaintiff wrote this in his affidavit:  “I do not know whether mesh was implanted in my body.”  Favor v. W.L. Gore Assocs., 2014 U.S. Dist. LEXIS 17134, *6 (S.D. Oh. Feb. 11, 2014).  We lead with that admission today because we thought it would be a good day to use the old

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Every now and then we run into a decision that we think is wrong in so many different ways that we call it an example of “spherical error” – that is, error no matter how one looks at it.  We only do that rarely.  Back in May, 2010 we first applied that description to In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334 (N.D. Ohio May 4, 2010).  Then in September of that year we likewise identified spherical error in Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 737 F. Supp.2d 380 (E.D. Pa. 2010) – or at least the Pennsylvania part of it, which dealt with the law we knew best.

That’s it – two cases earned that sobriquet in the blog’s six-plus years of existence.

Make that three.

The recent decision in Arters v. Sandoz Inc., 2013 WL 308768 (S.D. Ohio Jan. 25 2013), likewise bollixed up the law in so many different ways that we think it rises (falls?) to the level of spherical error.

Arters involved a question that a lot of courts have considered lately with almost (but not quite) uniformly good results – preemption in the context of generic drugs following PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  As in many generic preemption cases, the defendant sought to have the case dismissed under Rule 12.

That – Rule 12 – is the first error in Arters.  The decision states:

A motion for judgment on the pleadings pursuant to Rule 12(c) should not be granted “unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.”  Conley v. Gibson, 355 U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).

Arters, 2013 WL 308768, at *1.

Umm….  No.

Someone must have been the second coming of Rip Van Winkle and slept through the last five years.  In a rather well-publicized decision, back in 2007, the Supreme Court expressly overruled Conley on specifically this “no set of facts” point.  See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 561-63 (2007).
Twombly?  Maybe you’ve heard of it.  If so, you’re already one up on Arters.  Anyway, the Supreme Court in Twombly explicitly “retired” the Conley standard relied upon in Arters:

On such a focused and literal reading of Conley’s “no set of facts,” a wholly conclusory statement of claim would survive a motion to dismiss whenever the pleadings left open the possibility that a plaintiff might later establish some set of undisclosed facts to support recovery. . . .  It seems fair to say that this approach to pleading would dispense with any showing of a reasonably founded hope that a plaintiff would be able to make a case; Mr. Micawber’s optimism would be enough.

Seeing this, a good many judges and commentators have balked at taking the literal terms of the Conley passage as a pleading standard.  [many citations omitted]  We could go on, but there is no need to pile up further citations to show that Conley’s “no set of facts” language has been questioned, criticized, and explained away long enough. . . .  [A]fter puzzling the profession for 50 years, this famous observation
has earned its retirement.  The phrase is best forgotten as an incomplete, negative gloss on an accepted pleading standard.

Twombly, 550 U.S. at 561-63 (emphasis added).  Then, a couple of years later, the Court made clear that Twombly’s interment of the Conley language cited in Arters applies across the board to all types of cases.  See Ashcroft v. Iqbal, 556 U.S. 662, 684 (2009).Continue Reading Spherical Error Revisited

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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.)
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It’s Friday, so it’s time to say goodbye to the work week.  And since we’re expecting a sunny summer weekend here, it’s an emphatic goodbye — kind of like the buh-bye that David Spade used to give on SNL (if you don’t remember, we’ll remind you).
That’s the kind of goodbye that the court gave