Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts.  Yikes.  And it is not as if the bad appellate decisions were spread around.  Two came from our home circuit, the Third.  Two came from the reliably problematic Ninth Circuit.  But the ‘winner’ was the Eleventh Circuit, with three terrible opinions.  For defense practitioners, Eleventh Circuit precedents can create something of an obstacle course. 


It turns out that good federal district judges in SEC country also can be frustrated with what their appellate brethren hath wrought.  Last week we were sent an interesting example of this: Rowe v. Mentor Worldwide, LLC, No. 8:17-cv-2438-T-30CPT (M.D. Fla. March 2, 2018).  In that case, the plaintiff sued for negligence, strict liability, and breach of warranty arising out of injuries allegedly caused by a silicone gel breast implant. The breast implants are class 3 devices requiring premarket approval from the FDA.  The plaintiff’s implants had ruptured.  The plaintiff asserted that the defendant failed to conduct proper studies and failed to warn about known risks.  The defendant filed a motion to dismiss.  The district court wrote a thorough and well-reasoned opinion, concluding that all of the claims save one must be dismissed.  All of the claims would have been dismissed had it not been for a pesky Eleventh Circuit case that is unsound and inconsistent with other Eleventh Circuit cases.  The district judge acknowledged being stuck, but was none too happy about it.  The Rowe court’s opinion is laid out logically, and we will do our best to track it.




The court addresses “a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings.” Slip op. at 4. We get an Iqbal name-check.  The Rowe court recognizes the liberalities of notice pleading, but also recognizes that “[t]here is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material.”  Id. at 5  The complaint in this case was 60 pages, with 151 pages of exhibits.  The negligence claim includes “six separate negligence theories that are confusingly interwoven among each other.”  Id. at 5.  In short, the plaintiff “threw every allegation into the Complaint to see what would stick.”  Id. at 6.  But instead of throwing out the complaint wholesale, the court examined the particular causes of action to see which ones, in fact, would stick.


Preemption Overview


For its preemption analysis, the Rowe court largely relied on the recent Eleventh Circuit decision in Godelia.  That ends up having its ups and downs.  But the general preemption analysis is straightforward enough.  The threshold questions is whether the claims are valid under Florida state law, which governs the case.  If not, those claims are gone.  If so, the next questions is whether those claims are preempted by federal law.


Negligence failure to warn 


The plaintiff does not allege that the defendant failed to give the warning required by FDA. Therefore, the plaintiff must be seeking to impose a warning requirement that is different from or in addition to federal law.  Such a claim is expressly preempted by statute. Slip op. at 9.


Failure to report adverse events 


As any even semi-faithful reader of this blog knows, we think this claim is hogwash.  It should fail both on simple causation grounds as well as preemption.  We wrote about this issue earlier this week.  Some of you might know that the Ninth Circuit is a devilishly bad place for defendants on this issue.  But the Rowe court is not in the Ninth Circuit.  Instead, it is Eleventh Circuit law that supplies the framework, and this is one area where the Eleventh Circuit is pretty good, as it sees failure to report claims under Florida law as essentially alleging a claim of fraud on the FDA, which is preempted by Buckman. Slip op. at 10.


Failure to comply with federal laws 


The claims under this category pertain to alleged breaches of federal requirements and regulations. One example mentioned in the complaint is failure to do required studies.  But Florida law imposes no such requirement. So this claim flunks the preliminary test.  Even if the claim somehow survived that test, it would be impliedly preempted.  Id. at 11.


Negligent misrepresentation  


The plaintiff offered only the most general allegations of failures to disclose the risks of the implants. The court deemed these allegations to fall far short of Fed. R. Civ. P. 9(b), which requires specificity of fraud allegations.  The plaintiff “never identifies what the misrepresentations were, when they were made, how they were made, where they were made, or who made them.”  Id. at 12. In any event, the misrepresentations seemed to involve what was and was not told to the FDA.  Accordingly, those claims are impliedly preempted under BuckmanId. at 13.


Negligence per se 


Violation of a federal statute does not establish negligence per se if there is no federal private cause of action.  No such federal private cause of action exists here.  The complaint does not state a parallel claim, and is therefore impliedly preempted. Id. at 14.


Manufacturing defect 


Everything had been gliding along so smoothly up to this point.  Now we hit a rough patch.  The plaintiff alleged deviations from requirements in the device’s PMA, departures from good manufacturing practices, and vague failures to exercise care in the manufacturing process.  The defendant argued that the plaintiff never pointed to any device-specific requirements. It supported its argument by citing WolickiGables (11th Cir. 2011).  The Rowe court agreed that the Wolicki-Gables standard would require dismissal of the complaint.  But recent Eleventh Circuit decisions in Mink and Godelia cut the other way.  “The holdings in Mink and Godelia are directly at odds with Wolicki-Gables and appear to announce a new standard the Eleventh Circuit is directing courts to apply.”  Slip op. at 16-17.  (We listed Mink as the eighth worst DDL case of 2017.  Here is the post where we explained why we think Mink stinks.)  The Rowe court felt stuck.  Under recent rulings, the plaintiff could conceivably state a claim under parallel requirement.  At the same time, the court recognized that the “negligence count is nearly eviscerated by the Court’s ruling on the other theories.”  Id. at 17.  This, just to ensure there really is some there there, the court directed the plaintiff to replead the one surviving claim in an amended complaint. 


(This kerfuffle over what to do about competing circuit precedents reminds us of our time clerking on the Ninth Circuit, which is so huge and spread out that, believe it or not, inconsistent holdings proliferate.  What to do?  Assume there was  no en banc decision, which is what it should take to alter circuit precedent.  Does a panel need to follow the earlier or later decisions.  Your instincts might prompt you to conclude that it is always the most recent precedent that controls.  But if the recent decision’s reversal of precedent was improper, maybe even illegitimate, because it did not go the en banc route, should it really command respect?  We wrote a bit on this issue last year, as part of our extended Fosamax mourning period, and argued that the earlier precedent should control and the later deviation deserves no respect.)



Strict liability – failure to warn 


The analysis here is the same as for negligent failure to warn, and so is the result: preempted. Slip op. at 18.


Strict liability – manufacturing defect 


Remarkably, the result here is different from the negligent manufacturing defect claim.  For some unknown reason, the plaintiff did not ladle any specific federal requirements into this claim. Instead, the plaintiff simply relied on good manufacturing practices.  Not good enough.  Such allegations do not pass muster under either old or new Eleventh Circuit precedent.  Id. at 18.


Breach of implied warranty 


Plaintiffs constantly toss in warranty claims as an apparent afterthought.  Or maybe it is a no-thought.  The Rowe case is controlled by Florida law, and Florida law requires privity.  That is all perfectly obvious.  Equally obvious is that breast implants are not available for purchase directly by consumers.  The plaintiff pretty much conceded absence of privity and absence of a legal basis for proceeding with this claim, by not responding to the argument.  The court dismissed the warranty claim. 


Final scorecard


All that is left is the negligent manufacturing defect claim.  That should be a hard one for the plaintiff to win.


It occurs to us that good district judges such as Rowe’s are not the only folks who must grit their teeth and do battle with the Eleventh Circuit’s doctrinal wanderings.  Defense DDL practitioners are in the same boat.  We can relate, inasmuch as the Third Circuit (think of Fosamax) has done us few favors lately.  So we commiserate with excellent defense lawyers such as the ones who fought for and won as complete a victory as reasonably possible in the Rowe case.  Congratulations to Dustin Rawlin, Monee Hanna, and Allison Burke of Tucker Ellis, and David Walz of Carlton Fields.



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

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.


[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

This should not be controversial. It has been settled since Hahn v. Richter, 673 A.2d 888 (Pa. 1996) that in Pennsylvania prescription drugs are exempt from strict liability. And since Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) re-worked Pennsylvania’s strict liability law, we’ve only reported one federal court decision that erroneously, in our opinion, concluded that Tincher allowed a strict liability manufacturing defect claim in a prescription medical device case. But that hasn’t stopped plaintiffs from continuing to try to pursue strict liability under Pennsylvania law. The most recent federal court to be confronted with the argument rejected it outright. Some TwIqbal and preemption are in the mix too so this one really hits on some of our favorites.

Plaintiff alleged he developed an acute kidney injury as a result of taking the prescription drug Jardiance. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 24802, *1 (W.D. Pa. Feb. 15, 2018). Defendants moved to dismiss the complaint on three grounds: 1) Pennsylvania law bars all non-negligence based claims; 2) the complaint fails to satisfy TwIqbal across the board; and 3) the claims against the non-NDA holding entity are preempted. Id. at *2-3.

Defendants’ first argument sought to dismiss not only strict liability design defect and failure to warn, but also gross negligence, breach of express and implied warranty, and all fraud and misrepresentation claims. Plaintiff’s response on strict liability was that Hahn is “antiquated.” Id. at *7. Hahn may be about to turn 22, but that means it’s only been legally drinking in bars for a year. Hardly over the hill. Not to mention, antiquated isn’t a legal standard that would allow a federal court to simply ignore the controlling law as announced by a state Supreme Court. Further, the court points out that Tincher expressly recognized the Hahn prescription drug exception (as did Lance v Wyeth, 85 A.3d 434 (Pa. 2014) which demonstrates that the Pennsylvania Supreme Court has not changed its position – Hahn is still good law. See Bell at *7-8.

But Hahn doesn’t just say no strict liability, it says “that negligence is the ‘only’ recognized basis of liability” in prescription drug cases. Id. at *8. So, on that basis, and ample federal precedent, the court dismissed plaintiff’s breach of warranty claims. Id. at *8-9. The case law applying Hahn to fraud and misrepresentation claims appears to be more divided and on this one the court opted to follow the cases that adopted a more narrow interpretation. Id. at *9-10. We think Hahn’s negligence only holding could easily be read as a bar to intentional misrepresentation and fraud which do not sound in negligence. The Bell court, however, concluded that because Hahn requires manufacturers to warn of both risks that should have been known as well as risks that were known, the latter is akin to a claim of intentional concealment of a known risk which would support a fraud or misrepresentation claim. So, those claims were not barred by Hahn.

The last challenge was to plaintiff’s gross negligence claim which the court dismissed as not recognized as an independent cause of action in Pennsylvania. Id. at *11.

But we need to quickly return to plaintiff’s surviving negligence and fraud/misrepresentation claims. They aren’t barred, but neither were they adequately pleaded. Apparently plaintiff’s counsel did not do a good job proofing the complaint because the court pointed out it appeared to be cut and paste from another complaint filed by a woman. Id. at *13 (complaint uses “her” and “she” pronouns). Cookie cutter complaints don’t survive under TwIqbal because they lack any of the necessary factual detail to support plaintiff’s claims. This complaint contained

no factual details about when Bell contracted diabetes, whether he has type I or type II diabetes, whether he has other medical conditions, who his treating physicians were, why he decided to take Jardiance, what alternatives to Jardiance were discussed, whether he read the warnings, how long he took Jardiance or at what dose or why he believes his acute renal failure was caused by Jardiance.

Id. The complaint was equally lacking regarding defendants. There were no specific allegations concerning how the warnings “fell below the standard of care,” how any defendant’s alleged breach of duty caused plaintiff’s injury, how the design was defective, or what safer alternatives existed. Id. at *13-14. The court was unwilling to “infer defectiveness” based only on “a generic description of how [the class of drugs] work[s]” and “formulaic legal conclusions.” Id. at *15.

All claims were dismissed under TwIqbal, but plaintiff only gets to amend his complaint to try to state a claim for those that survived the first part of the court’s analysis as recognized under state law.

So, that brings us to the final question – are the claims against the non-NDA holder preempted on the grounds that it had no ability to change the drug’s label or design. The plaintiff seemingly concedes that post-approval design defect claims would be preempted, but that he is making a claim that the defendant should have designed a safer product before approval. Id. at *17-18. The court briefly discussed some cases that have dealt with the issue of pre-approval design defect claims. We cover it here, along with our analysis that there is no such valid claim. But, because none of plaintiff’s claims survived TwIqbal, the court didn’t have to decide the preemption issue. Defendant can re-raise it after plaintiff files his amended complaint.


Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials.  As always our guest posters are 100% responsible for what they write and deserve 100% of the credit (and any blame) for what follows.  Take it away Liz.


Ever since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in cases involving premarket-approved (“PMA”) devices, plaintiffs have taken to loading their complaints with allegations of violations of federal requirements in an attempt to escape federal preemption.  Fortunately, many courts have demonstrated a willingness to sort through these allegations and throw out those that do not fit through the oft-cited “narrow gap” between express and implied preemption described in In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010).  See the blog’s PMA preemption scorecard.  In Gravitt v. Mentor Worldwide, LLC, 2018 U.S. Dist. LEXIS 4822 (N.D. Ill. Jan. 11, 2018), the Northern District of Illinois once again did just that.

In Gravitt, the plaintiffs alleged that the wife plaintiff was implanted with a premarket-approved silicone breast implant (in the wake of the Breast Implant mass tort of the 20th century, such implants were required to obtain PMA, and are now protected by preemption). Id. at *8-9.  The plaintiffs asserted the usual claims against the defendant manufacturer: negligence, strict products liability (manufacturing and marketing), strict products liability (failure to warn), and loss of consortium. Id. at *10.

Obviously anticipating a preemption motion, the plaintiffs packed their complaint with allegations of violations of federal requirements—including novel theories attacking the defendant’s conduct of certain post-approval studies and patient follow-up required by the FDA’s PMA letter. Id. at *4-*6.  According to the plaintiffs, the defendant’s conduct was deficient because:

  1. Participant follow-up in one study supporting the PMA application was 6 years, instead of 10;
  2. Participant follow-up in the same study supporting the PMA application was less than 100%;
  3. A post-approval study did not have a sufficient number of participants;
  4. Participant follow-up in that post-approval study was not high enough; and
  5. The defendant did not provide sufficient detail about why study participants required additional surgical intervention.

Id. at *4-*6.

The court methodically addressed each of these alleged deficiencies to determine whether any fit through the “narrow gap” between express and implied preemption. Unfortunately for the plaintiffs, fortunately for the defense, none did.  Thus, defendants achieved a rare preemption win in a court bound by the notoriously bad decision, Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).

First, the court analyzed each deficiency through the lens of express preemption—i.e., asking, “did this alleged deficiency actually violate a federal requirement?”  The court found that the first three deficiencies (if true) would violate specific requirements enumerated in the PMA letter. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *21-*22.  However, the court found no federal requirement addressing the last two purported deficiencies because “the [PMA] letter does not require any particular follow-up rate for that study” and the plaintiffs did not even allege “that the [PMA] letter or any other federal law required [defendant] to provide more detailed reasons for re-operation than it actually provided.” Id. at *18-*19.  Thus, items 4 and 5 were expressly preempted.

Second, the court analyzed the three remaining deficiencies through the lens of implied preemption—i.e., asking “did this alleged deficiency violate a traditional tort duty under Illinois law?”  Here, the court answered “no” for every one of the remaining purported deficiencies, rendering them impliedly preempted.  The court reasoned that there was no “well-recognized duty owed to [the plaintiffs] under state law” requiring the defendant to follow up with study participants for 6 instead of 10 years, follow-up with all study participants, or enroll a specific number of study participants. Id. at *24-*25 (quoting Bausch, 630 F.3d at 558).  More generally, there simply are no state law requirements relating in any way to the methodology of FDA-mandated post-approval studies. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *25.  Further, the plaintiffs made no effort to analogize these alleged deficiencies to any traditional state law failure to warn claim. Id.  Accordingly, the court dismissed plaintiffs’ novel claims based on alleged deficiencies in post-approval studies, id., creating valuable precedent in case any other plaintiff tries this type of preemption dodge.

Apart from the alleged deficiencies in the post-approval studies, the plaintiffs also alleged that the defendant had violated manufacturing standards based on allegations that the FDA had cited the defendant for non-compliance with manufacturing standards several times. Id. at *7-*8.  While the court recognized that, under Bausch, such a claim might survive express preemption (id. at *22), the court dismissed this theory as impliedly preempted because the plaintiffs failed to tie the alleged non-compliance with manufacturing standards to any state law claim that her specific device was defectively manufactured. Id. at *26.

The court did allow one narrow Stengel-type (failure to report) claim to survive based on the plaintiffs’ allegations that the defendant was aware of a higher rate of implant ruptures than it reported to the FDA. Id. at *27-*28.  The court reasoned that, were the plaintiffs to prove that the defendant concealed the true rate of implant ruptures from the FDA in violation of federal law, then the defendant “may have breached its state law duty to warn potential customers—and their physicians—of the product’s risks.” Id. at *31.

Overall, a solid win for the defense that significantly narrowed the scope of the plaintiffs’ claims going forward.

Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s there. What do you find? Old empty checkbooks. Gift card to a restaurant that closed two years ago. Any variety of expired items from coupons to salad dressing to cough medicine. And of course that half-eaten bag of cookies that are so stale you can use them as coasters. But, sometimes you also find a hidden gem. Like the cord to charge your radio that you haven’t been able to use for the last 6 months. Or the great family photo from Aunt Susie’s 80th birthday. Or your favorite pair of socks. How did they get there?

Well cases, just like socks and salad dressing, can get pushed to the back of the shelf – where they too get stale. And if courts still used paper dockets, the file in Beswick v. Sun Pharmaceutical Industries, Ltd., 2018 U.S. Dist. LEXIS 15012 (W.D.N.Y. Jan. 30, 2018) would be covered in an inch of dust with discolored pages stuck together from sitting at the bottom of a pile in a basement storeroom. The decision rendered just last week is on a motion that was filed in June 2012 on the basis of the Supreme Court’s ruling in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). A 5 ½ year old motion based on a 6 ½ year old ruling. Fortunately, the decision is to dismiss the case, but it’s a decision that could have been entered a long time ago. We imagine the delay has not been without some financial consequences to the defendant. Indeed, plaintiff’s counsel withdrew back in 2015, likely recognizing the folly of pursuing what is essentially a failure to warn case against a generic drug manufacturer. But still the case sat.

The complaint, alleging plaintiff suffered from Stevens Johnson Syndrome as a result of using defendant’s generic anticonvulsant drug to treat his epilepsy, was filed in 2010. Id. at *1, *4-5. In early 2011, the court granted defendant’s motion to dismiss all claims except those alleging breach of express and implied warranty. Id. at *2. The case was then stayed pending the Supreme Court’s decision in Mensing. Id. A year after Mensing, defendant file a motion for judgement on the pleadings on the two remaining claims and the motion was fully briefed by August 2012. Defendant then filed supplemental declarations in support of its motion in November 2012 and again in August 2013. In 2015, defendant formally requested that the stay be lifted and filed yet another supplemental declaration in support of its motion. Id. at *3-4. The supplements we assume necessitated by the development of the law over the years the motion was pending. And finally, three years later the motion was ruled on.

It should come as little surprise that the warranty claims, premised on a failure to warn, were found to be preempted.  Plaintiff alleged that defendant breached its express warranty that the drug was safe and effective by failing to disclose known risks of side effects including SJS. Id. at *6-7. Plaintiff similarly alleged that defendant breached the implied warranties of merchantability and fitness for the drug’s intended use by failing to warn about the drug’s side effects and risks. Id. at *7-8.

The court then analyzed both claims in light of Mensing and Bartlett (5 years old itself) which we know held that because generic drug manufacturers are prohibited from making any unilateral change to the drug’s label, federal law “preempts any duty the generic drug manufacturer otherwise would have under state law to provide additional warnings.” Id. at *18. Therefore, because plaintiff’s warranty claims are essentially “state law tort claims attacking a drug label warning as insufficient” they are preempted. Regardless of the theory, if the claim is premised on a failure to warn, it is preempted. See id. at *22.

Plaintiff attempted to advance two arguments to avoid preemption. First, plaintiff argued that defendant didn’t have to change its label but rather could have sent out Dear Doctor letters containing additional warnings. The Supreme Court deferred to the FDA that such letters would be misleading because they would imply a “therapeutic difference” between the brand and generic drugs. Id. Second, plaintiff argued that defendant should have pulled the drug off the market. This too has been rejected by the Supreme Court. When faced with a conflict between federal and state law, the manufacturer is not obligated to stop selling. If that were the case, “impossibility preemption would be all but meaningless.” Id. at *23 (citing Mensing).

There is nothing new or novel about the court’s decision other than the amount of time it took to be entered. The case simply hung around for way too long and could have been disposed of five years ago. Like the receipt for the gloves you bought your mom for Christmas 2014.

Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do.  But occasionally….

The other day, Reed Smith’s Health Industry Washington Watch blog described a couple of pieces of legislation that, without much fanfare, passed a subcommittee of the House of Representatives (Energy and Commerce Health Subcommittee ) while everyone was distracted, watching the Senate’s struggles to keep the government functioning.

We’re interested because both of them, were they ever to be enacted into law, could affect our sandbox.

The first bill, H.R. 2026, is the Pharmaceutical Information Exchange (“PIE”) Act (see here for more information)  This bill would be another step forward in the now decades-long struggle to legalize truthful manufacturer communications about off-label uses.  It’s not very long – one paragraph:

Health care economic information or scientific information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for coverage, reimbursement, or other population-based health care management, shall not be considered false or misleading or any other form of misbranding . . ., if it is based on competent and reliable scientific evidence and relates to an investigational new drug or an investigational use of an approved drug. In order for information relating to an investigational use of an approved drug to be provided pursuant to this subparagraph, there must have been submitted to the Secretary a supplemental application for approval of such use, or the study or studies needed to support the submission of a supplemental application for such use must have been completed with the intention that a supplemental application will be submitted to the Secretary for approval of the use.  For purposes of this subparagraph, scientific information includes clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition of use being investigated or developed.

We’re not sure why, but as phrased PIE only applies to drugs, but not medical devices.  [subsequent note:  This has been fixed by this amendment, so that PIE applies to both drugs and devices.]

As passed by the House, PIE allows off-label communications basically to third-party payors (“TPPs”), about off-label uses.  Communications can begin when “the study or studies needed to support the submission of a supplemental application [to the FDA] for such use . . . have been completed.”  If the supplemental application has been submitted, great, but it doesn’t need to be.  And more than just studies can be discussed – so can “clinical and pre-clinical data and results,” as long as it qualifies as “competent and reliable scientific evidence.”

PIE still doesn’t comport with the First Amendment, since it limits both the audience and the circumstances under which manufacturers may speak about truthful scientific information, while not imposing any limits on anyone else.  Thus it still discriminates both by topic and speaker under Reed v. Town of Gilbert, 135 S. Ct. 2218, 2230 (2015).  Nonetheless PIE would be a decent step in the right direction in terms of litigation.

First, it would greatly reduce litigation by TPPs over alleged off-label promotion.  Second, it would be another exception to the FDA’s increasingly tattered prohibition of truthful off-label speech, and each exception makes the ban itself less defensible against First Amendment challenges.  See Greater New Orleans Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 190 (1999) (holding the “regulatory regime is so pierced by exemptions and inconsistencies that the Government cannot hope to exonerate it”).  Third, it makes the other side’s rhetoric against off-label promotion less credible, particularly on occasions when the exact same information is already being transmitted to TPPs.  Indeed, one could argue that a prescribing physicians’ medical practice is a “similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for . . . other population-based health care management.”

The second bill is called the Over-the-Counter Monograph Safety, Innovation, and Reform Act (“OM-SIRA”).  Apparently the subcommittee passed a “discussion draft” that doesn’t even have an “H.R.” number.   Without making a word-for-word comparison, this draft appears substantively the same as S.2315, which is available here.  OM-SIRA deals with nonprescription drugs that are marketed without an approved new drug application.  Yes, there are such things, and we blogged about preemption issues related to them here.  And preemption is what piques our interest about OM-SIRA.  As summarized by the Reed Smith blog, OM-SIRA:

would create a system for future changes to drug monographs through an administrative order procedure with the opportunity for development meetings or other consultations, submission of comments on proposed orders, and dispute resolution procedures.

This means that OTC drugs under OM-SIRA would be subject to the administrative proceedings created by the bill before their manufacturers could modify those products or their labels.  Interestingly, the FDA can act unilaterally to modify a label, but not OTC manufacturers.  §505G(b)(4)(B)).   Manufacturers can act unilaterally only as to “minor” changes that do not affect “safety and effectiveness”  §505G(c).

If OM-SIRA were enacted in its present form, it appears to us that the administrative approval procedures in the bill would provide a basis for implied impossibility preemption under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  Since implied preemption operates independently of express preemption, it would not be subject to the partial savings clause in 21 U.S.C. §379r(e), which would be very good thing for defendants in such litigation.

With respect to both bills, we’ll see what happens.  Maybe Congress won’t be PIE in the sky this time around.

There are plenty of f-words in this post, but fear not, for they are all fully capable of traveling in polite company. Most are even family-friendly. The most tasty f-word here is the “F” in FDA: food. While we focus on drug and device cases in this blog, we frequently find that food cases furnish fine fodder for some of the legal issues we fiddle with, such as in this 2008 post on food as a four letter word.  Food cases can also suggest flanking maneuvers to prop up our favorite f-word defense, federal preemption. For example, feast your eyes on the recent case of Organic Consumers Ass’n v. Hain Celestial Grp., Inc., 2018 U.S. Dist. LEXIS 1053 (D.D.C. Jan. 3, 2018). The plaintiff alleged that the defendant’s infant formulas were falsely labeled as “organic” because they contained products that flunked the federal Organic Food Production Act of 1990 (“OFPA”). The defendant filed a motion to dismiss the complaint on the ground that private enforcement of organic labelling is preempted by the OFPA.

The court fastidiously began with the standing issue, and held that the Organic Consumers Association had standing to sue. Then the court forfeited some more goodwill with us by presuming that “Congress does not cavalierly preempt state causes of action.” Such reference to a presumption against preemption is foolish and makes us feel forlorn. (As we have blogged before, the presumption against preemption has fallen by the wayside when it comes to express preemption.)  At this early point in the decision, we are fidgeting and fuming. But then the court mentioned another, much more formidable principle: that “the purpose of Congress is the ultimate touchstone.” That further point should foreclose the need to indulge in any feckless presumption against preemption, because, in enacting the OFPA, Congress made forcefully clear its purpose to establish national standards for marketing organic products, to assure consumers of consistency, and to facilitate interstate commerce of organic products. These purposes were folded into a USDA final rule that created the National Organic Program, with regulations requiring that a product can be sold as “organic” only if it contains at least 95% organically produced products, with the remaining five percent consisting of synthetic ingredients included on a “National” list. The OFPA also provides for a “certifying agent” to certify a manufacturer’s fidelity to an approved organic plan.

The products in question in the Organic Consumers case were certified, but the plaintiff argued that such certification is not synonymous with OFPA compliance. The plaintiff argued that its lawsuit would not foil the federal scheme but, in fact, was faithful to it. That position seems to be, in a literal sense, fantastic. The plaintiff’s position certainly failed to convince the judge.

This is not the first case to face the issue of preemption under the OFPA. Far from it. In the only appellate case on point, In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F.3d 781 (8th Cir. 2010), the Eight Circuit held that any attempt to hold the defendant liable under state law for products mislabeled as organic would directly conflict with the OFPA and the role of the certifying agent. The Eighth Circuit rejected the defendant’s express and field preemption arguments, but concluded that the plaintiff’s lawsuit present an obstacle to the federal scheme. Permitting private suits to challenge the federal certification of a product as “organic” would result in different interpretations and different enforcement, inevitably plunging manufacturers and consumers into a fog of confusion. Based on the fundamental need for uniformity, the plaintiff’s claims were fatally preempted.

We are unabashedly fond of the Aurora case, and we are hardly alone. F. Supp. 3d is filled with cases that followed Aurora’s reasoning. (We will not make the mistake of praising the Aurora court for its “fulsome” reasoning. “Fulsome” is not a dressed-up stand-in for other, perfectly adequate words such as “complete,” “thorough,” or, perish the thought, the simple, direct “full.” Most uses in our presence of the word “fulsome” are wrong.  We become flush and fight hard to contain our fury. You see, we adhere to the primary dictionary definition of “fulsome” as “excessively flattering.” Yes, we have become fossilized. We follow Fowler’s Modern English Usage – the oldest, crankiest edition. Get off our lawn.)

But, of course, there is one pesky fluke out there: Segedie v. Hain Celestial Grp., Inc., 2015 U.S. Dist. LEXIS 60739 (S.D.N.Y. May 7, 2015). Not to put too fine a point on it, but the Segedie is not a favorable decision to those of us who are fans of preemption. The reasoning in Segedie is sheer folly, but one cannot be sure that some other courts won’t flock to its flawed logic just because of SDNY’s fame. The Segedie court found fault with Aurora‘s preemption analysis, and concluded that private enforcement of what is and is not “organic” would boost consumer confidence, and that the risk of divergent interpretations did not present a “sharp” obstacle to uniformity. That logic is hard to fathom. We were not aware that the degree of “sharp”-ness – whatever that is – is a factor in preemption analysis.  Segedie is a flop.

The Organic Producers court sided with Aurora and declined to adopt the faux reasoning of Segedie. Permitting a plaintiff to sue on the basis that a product labeled and federally certified as organic is not, in fact, organic runs afoul of all three purposes of the OFPA:

1. Local fact-finders can be fickle and there is no reason to expect uniformity from their outcomes. Forget about ever having a national standard. What is “organic” in Florida might not be on F Street in D.C.
2. Consumers would be flummoxed by the different rules governing what is and is not organic.
3. Rather than foster interstate commerce, the differing outcomes would provide the worst possible feedback to food manufacturers – they would not be able to sell their products in certain parts of the country where some jurors decided that the “organic” should be forbidden for such products.

Naturally, the plaintiff fought against the flow of this reasoning. The plaintiff made a foray into the usual anti-preemption fallback position that states can impose more restrictive standards. But the plaintiff forgot that the federal system included an enforcement system that never mentioned private enforcement but, rather, forged a system of inspections, compliance reviews, suspensions or revocation of certifications, and other civil and criminal penalties. Permitting private enforcement would be unnecessary and would flirt with disaster.

We are not merely fond of the Organic Producers because it is a fair statement of food preemption. Nope. We think that Organic Producers represents a return to first principles of preemption law, which are just as applicable to personal injury drug and device litigation as to food labeling. Flipping issues of drug or device product defect and adequate warning to various jurors scattered around the country, including jurors flailing about in that fever-dream litigation festival known as an MDL, wrecks uniformity, fans the flames of confusion, and is a fist to the gut of interstate commerce. Rather than flatter jurors, we ought to acknowledge that their foibles and the varying, frenzied, irrational outcomes they permit plaintiff lawyers to foist on the public are a rotten way to fix health and safety problems.

The pro-preemption holding in Organic Producers flat-out makes sense. It should flourish. It should be the way forward.

We’ve been aware of the other side attempting to construct a First Amendment counter-argument to our preemption defense for some time.  It first cropped up in a 2015 360 article by a P-side thought leader (no, not necessarily an oxymoron) soon echoed by a comment to one of our posts on the Amarin First Amendment decision. DDL, and we addressed it here.  Late the same year, we addressed it again, this time in response to an ATLA article, and set forth our views in more detail.

In a nutshell, the plaintiffs’ position is that, assuming truthful promotional speech about drugs is constitutionally protected (as we agree), our clients purportedly have a state-law tort “duty” to ignore the FDA and put on our labels whatever any particular plaintiff claims is “truthful” in any given case, even if we would otherwise be required to obtain FDA pre-approval.  The First Amendment’s protection, these articles have argued, dissolves impossibility preemption because the First Amendment eliminates any FDA “prior restraint” on protected speech.

This argument has some rather glaring flaws, starting with the other side’s necessary concession that the speech in question is constitutionally protected, which in and of itself would preclude state-law tort liability under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  Further, an FDA pre-approval requirement, designed to make sure that only truthful speech appears on drug labeling (which is quite broadly defined), would seem to be a reasonable time, place and manner requirement – given its public health-based rationale.

That was where things stood the end of 2015.  Not much happened (from our perspective) for almost two years.  We thought the primary target of any argument the First Amendment defeats impossibility preemption would be generic preemption.  After all, generic plaintiffs don’t have much more to lose, so why not give this a flyer?  But, nothing.  Nor did we see the argument being made anywhere else − until a few weeks ago.

In their infinite wisdom, the other side decided to debut their First Amendment argument against preemption in the Depakote litigation.  It first raised its ugly head in Swanson v. Abbott Laboratories, 2017 WL 5903362 (S.D. Ohio Nov. 28, 2017).  Previous rulings in Depakote cases had found preemption of certain warning claims under the Levine “clear evidence” standard, and also preempted design defect claims under the Mensing/Bartlett impossibility rationale.  See Rheinfrank v. Abbott Laboratories, Inc., 680 F. Appx. 369, 385-88 (6th Cir. 2017); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035, 1040-41 (S.D. Ohio 2015); Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749, 766-70 (S.D. Ohio 2015), aff’d, 680 Fed. Appx. 369 (6th Cir. 2017); In re Depakote, 87 F. Supp.3d 916, 922-23 (S.D. Ill. 2015).

The same preemption arguments were made – and prevailed – supporting summary judgment in Swanson.  2017 WL 5903362, at *7-8.  The new wrinkle was plaintiffs arguing “that Defendants have not met their burden in proving impossibility because the First Amendment protects their right to communicate non-FDA approved information through other means.”  Id. at *8.  The court found plaintiffs’ reliance on off-label promotion cases “irrelevant” to a product liability case involving no such thing:

Such cases, however, are not applicable in the instant matter. . . .  [T]he ability to promote off-label uses is irrelevant as to whether the FDA’s rejection of a labeling change for an on-label use constitutes clear evidence of conflict with state law.

Id.  “Labeling” includes Dear Doctor letters.  Id.  Therefore, “[t]o hold that Defendants First Amendment right prevents preemption is contrary to case law finding preemption based on FDA regulations.”  Id. (pointing out that Mensing and Bartlett also involved FDA-approved labeling).

The same defendant also obtained summary judgment in Willis v. Abbott Laboratories, 2017 WL 5988215 (W.D. Ky. Dec. 1, 2017).  Again, preemption was a big part of the win.  The defendant’s showing of “clear evidence” in Willis was no different than that which had prevailed both in the district court and on appeal in Rheinfrank. Willis, 2017 WL 5988215, at *4.  Plaintiff threw the First Amendment hail Mary – arguing that, “because [defendant] has a First Amendment right to speak in a truthful and non-misleading manner about Depakote, it cannot claim that the FDA’s rejection of its label changes made it ‘impossible’ for it to comply with” state law.  Id. at *5.  Again, the argument fell woefully short:

The plaintiffs cite to no standard the Court should look to in evaluating whether [defendant] has a First Amendment right to include a warning about developmental delay in the Depakote label or whether the FDA’s rules and practices regarding drug labeling unconstitutionally infringe upon that right. . . .  Instead, they cite to a line of cases which pertain exclusively to the marketing, as opposed to labeling, of drugs and seek to apply them to the present case. . . .  The Court finds each of these cases, as well as the other out-of-circuit district court cases cited, to be distinguishable and unpersuasive.  The plaintiffs essentially ask the Court to find that the FDA’s authority to reject proposed label changes regarding drug safety amounts to an unconstitutional suppression of a drug manufacturer’s speech.  None of the cases cited by the plaintiffs support such a broad proposition, and understandably so, given the recognition courts have long given to the role of the FDA in regulating the labeling of drugs.

Id. (citations omitted).  Likewise, the FDA’s control of “labeling” extended to the other means (such as “Dear Doctor” letters) that plaintiffs claimed the defendant should have employed.  Id.  The First Amendment simply didn’t force the defendant to speak in the manner that plaintiffs demanded.

“Comparatively,” the Supreme Court preemption precedent on which the defendant relied (chiefly Mensing/Bartlett) “spoke directly on the FDA’s power to regulate what speech appears in a drug’s ‘label’ and when that power takes preemptive effect over what is required by state tort law.”  Id. at *6.  Thus, the application of the First Amendment to FDA administrative actions was not analogous to preemption in product liability litigation:

The plaintiffs’ argument would require the Court to cast aside both cases and the scheme of preemption that they endorse.  The Court is not persuaded that the First Amendment requires it to do so.  Therefore, the Court rejects the plaintiffs’ First Amendment argument.


We find it somewhat odd to see the plaintiffs’ First Amendment argument trotted out for the first time in a branded drug preemption case.  Compared to generic plaintiffs, those in Depakote aren’t nearly as devoid of alternative arguments.  In any event, our dismissive opinion of that argument is only reinforced by these decisions.  First Amendment principles are implicated by absolute FDA bans applicable to drug marketing.  Free speech is not impinged in nearly the same way by the FDA having a say over what goes into drug labeling.  Indeed, to the extent that plaintiffs invoke the First Amendment to pursue some state-law duty that would force the defendants to speak by changing their labels, they would be standing free speech on its head.

There is more to Swanson and Willis than just their preemption rulings, however.  In Swanson, plaintiffs tried nitpicking which alleged birth defect risks extended past the first trimester, as opposed to which did not.  That argument was quickly shut down.  “Plaintiffs’ claim that [defendant] failed to warn that Depakote use’s risk continued during pregnancy beyond the first trimester is too intertwined with the [preempted] developmental delay claim to remain.”  2017 WL 5903362, at *10.  As far as other products being “safer,” they simply weren’t an option in Swanson:

[I]n 1996, Plaintiff did not have other bipolar medication options that would have worked for her. . . .  Plaintiffs’ treating physician during her hospitalizations, testified that no other bipolar medications available in 1996 were viable options to treat [her].

Id.  Thus, “no dispute of material fact remain[ed] for the jury to decide.”  Id.  Given how bad the facts were for the plaintiff in Swanson, we’re surprised (and pleased) that the other side didn’t just drop the case.

Willis is a substantially longer decision than Swanson.  Additional rulings in Willis put no stock in the peculiar “clear evidence” preemption standards propounded in In re Fosamax, 852 F.3d 268 (3d Cir. 2017).  Willis, 2017 WL 5988215, at *6.  “[T]he Sixth Circuit has already determined that the evidence in Rheinfrank, which is identical to the evidence in this case, met the ‘clear evidence’ standard.  Therefore, whatever ‘clear’ means, it has been met.”  Id.  The court accepted the defendant’s regulatory evidence that the FDA’s rejection of proposed label changes extended to autism, id. at *7, and rejected a variety of evidentiary attacks on that evidence. Id. at *8-9.  Plaintiffs’ attempt to construct a “design defect” claim out of “the drug’s indications” also failed:

[T]he lack of contraindications for the drug would still not be considered a part of its design but rather its “warnings and instructions.”  Thus, the Court will not let the plaintiffs’ claim proceed under a theory that the failure to contraindicate Depakote made the drug’s design defective.

Id. at *10.

Daubert motions in Willis only knocked out one of the plaintiffs’ three experts, id. at *12-15, but those causation motions did succeed in significantly limiting the scope of the injuries at issue – by removing from consideration the only birth defect that the minor plaintiff allegedly suffered.  Id. at *15.  Thus, plaintiffs remaining warning-based claims – for negligent misrepresentation and fraud failed for lack of cognizable injury.  Id. at *16 (plaintiff “cannot assert a claim for negligent misrepresentation, as he suffered no cognizable injury that was allegedly caused by the misrepresentations”), *17 (same result for fraud).

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

When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be no surprise that those ten songs go right to the top of the list. And, if you too are a true fan you’ll already know that Nebraska is actually mostly demos that Springsteen recorded as an experiment on a four-track cassette recorder. When the songs were tried later with the full power of the E Street Band behind them – most of them didn’t work. Born in the USA, Downbound Train, Pink Cadillac, and Working on the Highway found a home on later albums. But for songs like Atlantic City, Highway Patrolman, and My Father’s House – a guitar and a harmonic sold those songs more than a heavy back beat. Nebraska isn’t Springsteen’s only stripped-down album (The Ghost of Tom Joad and Devils & Dust), but for this Jersey Girl, it’s the one with the power. And it was recorded in a New Jersey bedroom one day in January 1982.

Nowhere in any of that did we connect Nebraska to preemption. That is until now. Until Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630 (D. Neb. Dec. 12, 2017). Based on our review, and please correct us if we’ve missed something, this is the first case to find a complaint was deficient for failure to plead any facts to establish why the warning claim involved “newly acquired evidence” that would allow it to escape preemption under Wyeth v. Levine, 555 U.S. 555 (2009).

Plaintiff alleged that defendant failed to warn about the risks of an intrauterine device. While the device was being removed, a piece of it broke off and embedded in plaintiff’s uterus. The broken piece later had to be surgically removed. Ideus, at *1. To support her claim, plaintiff alleged that the device’s brochure and package insert, lacked any warning that the device “could break during removal, or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded.” Id. A quick aside. This distinction between the device as a whole and a piece of the device made us look at the device’s label. As a disclaimer, we simply looked at the available label on line, but it appears that product contains a warning that the device can become embedded and require surgery to remove. So, in essence, plaintiff’s claim is that while the manufacturer did warn of embedding and surgery as to the whole device, it didn’t warn about those things with a piece of the device. And plaintiff’s other claim is that the manufacturer didn’t warn the device could break. From our perspective, that’s a claim for something that was warned about and something that is a general risk of every product in the world. We don’t think much of plaintiff’s claims.

But we told you this was about preemption, so let’s get back to that. Defendant challenged plaintiff’s claims on the grounds of preemption. The warnings were FDA approved and therefore, plaintiff’s claims don’t survive conflict preemption. Id. As non-surprising as a Jersey Girl loving Springsteen, is a plaintiff raising the FDA’s Changes Being Effected (“CBE”) regulations in response to a failure to warn preemption challenge. Because CBE regulations allow a manufacturer to change the device’s warning without prior FDA approval, per Wyeth, it is possible for a manufacturer to change its warning and not run afoul of federal law. Hence, no preemption. But, what the court said in Ideus is that CBE isn’t a “magic” word that gets plaintiff around preemption even at the pleadings stage. More is required.

A CBE is only allowed based upon “newly acquired information,” not previously submitted to the FDA. “In the absence of such information, the [manufacturer] cannot alter its product’s labeling, and any state regulation or law requiring it to do so is necessarily preempted.” Id. at *2. The court in Ideus, therefore concluded that because “newly acquired information” is a pre-requisite for a valid CBE, facts to support the existence of such new information must be affirmatively pleaded in the complaint. The court cites three cases in support of its finding. We’ve discussed all three on this blog here, here, and here. The difference between those cases and Ideus is that in the prior cases the plaintiff had alleged some facts regarding “new” evidence. The courts were able to examine those allegations and reach conclusions regarding whether they demonstrated new information sufficient to support a CBE. They did not address the specific question of “whether the plaintiff must affirmatively plead the existence of “newly acquired information” to state a cognizable claim for relief.” Id. The closest earlier case was Utts v. BMS, 251 F.Supp.3d 644, 661 (S.D.N.Y 2017) which said:

In sum, if the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

Sounds like a pleading requirement to us.  Even construing the allegations in a light most favorable to plaintiff, “dismissal is nonetheless appropriate . . . if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted.” Ideus, at *3 (citations omitted). Because “some indication of newly acquired information [is required] to trigger the applicability of the CBE regulation,” those allegations are required to be in the complaint. Id.

And, of course, they must then meet the requirements of TwIqbal. So, while plaintiff is being given an opportunity to amend her complaint, she “must plead with specificity any newly acquired evidence which may have warranted a change” in the device’s warning after the device was approved but before it was implanted in plaintiff.” Id.  Given our earlier aside about the substance of the claims, we wonder if there was nothing in plaintiff’s complaint because there is nothing. We’ll wait and see, but in the meantime Nebraska, in addition to lending its name to a classic rock album, has given us a significant ruling in our preemption arsenal.

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We collect then all here.

Nevertheless, there are some judges, particularly (but not all) in state court, who react negatively to the very concept of preemption.  Thus, a word to the wise is not to put all your dismissal eggs in one basket.  One logical alternative argument starts with the same premise as preemption – that “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.”  Riegel, 552 U.S. at 323.

The “almost no deviations” limitation, of course applies to device design.  E.g., Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012); Blunt v. Medtronic, Inc., 760 N.W.2d 396, 409 (Wis. 2009); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 810 (E.D. Pa. 2016); Kitchen v. Biomet, Inc., 2014 WL 694226, at *3 (E.D. Ky. Feb. 21, 2014); Miller v. DePuy Spine, Inc., 638 F. Supp. 2d 1226, 1229 (D. Nev. 2009).

Which brings us to Restatement (Second) of Torts §402A, comment k (1965), “which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.”  Rodriguez v. Stryker Corp., 680 F.3d 568, 575 (6th Cir. 2012) (applying Tennessee law).  Putting aside the separate (albeit important) issue whether comment k applies to prescription medical products generally or only on a case-by-case basis, courts on both sides of that question equate “unavoidably unsafe” with the absence of an alternative design:

[N]umerous state and federal courts ha[ve] interpreted comment k to mean that a product is “unavoidably unsafe” when, given proper manufacture and labeling, no feasible alternative design would reduce the safety risks without compromising the product’s cost and utility.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 256 (2011) (Breyer, J. concurring) (footnote containing string citation omitted) (emphasis added).  In other words, “a defendant seeking to invoke the [comment k] defense must first show that the product is highly useful and that the danger imposed by the product could not have been avoided through a feasible alternative design.”  Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2487 (2013) (applying New Hampshire law).  To avoid a claim of “unavoidable risk, there must be, at the time of the subject product’s distribution, no feasible alternative design which on balance accomplishes the subject product’s purpose with a lesser risk.”  Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987).  “The purpose of comment k is to protect from strict liability products that cannot be designed more safely.” Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).  Grundberg and Toner don’t agree on much when it comes to comment k, but they agree on the importance of alternative design.

Thus, that a PMA-approved device must be made with “almost no deviations” from its specified design means (in addition to preemption) that there is no legal alternative design that would allow the plaintiff to avoid a manufacturer’s comment k defense.  To use a non-approved alternative design would be illegal – and illegal designs cannot serve as “feasible” alternative designs.  See Lewis v. American Cyanamid Co., 715 A.2d 967, 981 (N.J. 1998} (“plaintiff may not succeed on an alternative design theory that would have required the defendant manufacturer to violate the law”); White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753-54 (Ohio 1988) (alternative design not feasible where “it was not possible for [defendant] to have legally marketed a [product] design using [the alternative design] at the time [plaintiff] was inoculated”); Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 401 (6th Cir. 1990) (following White; alternative designs did not “exist[]” where it was “indisputable” that “[w]ithout an FDA license to produce another design, [defendant] was legally prohibited from distributing” those designs) (applying Ohio law); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 572 (E.D. Pa. 2011) (when “[t]here exists no FDA-approved alternative form of [the product],” “there is no available alternative design”); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 847-48 (N.Y. Sup. 2003) (where plaintiff proposed a non-FDA-approved alternative, defendant “could not have marketed a reasonable alternative”), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); In re Alloderm Litigation, 2015 WL 5022618, at *12 (N.J. Super. Law Div. Aug. 14, 2015 (no feasible alternative where design plaintiff advocated “was not approved by the Food and Drug Administration until” after plaintiffs’ surgeries); Totterdale v. Lederle Laboratories, 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008) (where FDA approval not until after plaintiff’s injury plaintiff did “not provide[] any new material facts to raise a genuine issue as to whether [the product] was avoidably unsafe”).

Thus, in Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), comment k applied to “a Class III medical device which received FDA approval pursuant to the PMA process.” Id. at 481 (footnote omitted).

Moreover, the inherently rigorous nature of the premarket approval process and the contraindications, warnings, and precautions described in the [device’s] Summary of Safety and Security Data all suggest that [it] is an “unavoidably unsafe” product to which strict liability does not apply.

Id. at 482.  “As a result, the [device] can be considered a prescription medical device that falls within the scope of comment k to § 402A.”  Id.

Similarly, the court employed the non-preemption path of comment k in Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio 2016).  While Ohio (at the relevant time, this has now changed, Ohio Rev. Code Ann. §2307.75(D)) was a case-by-case comment k state, the PMA approved nature of the device, and the constraints the FDA’s approval placed on alternative designs, meant that comment k had to apply:

Defendant argues . . . that [the device’s] classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe and that Comment K’s prohibition of strict liability claims therefore applies. Defendant’s argument is well taken.  Class III devices . . . are, as relevant here, defined as devices that are “for a use which is of substantial importance in preventing impairment of human health, or…present[] a potential unreasonable risk of illness or injury.”  21 U.S.C. §360c(a)(1)(C)(ii). . . .

[T]here is no alternative design for [the device] that could lawfully be marketed.  “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications…that would affect safety or effectiveness.” There is therefore no basis for an in-depth evidentiary inquiry into alternative designs.

Aaron, 209 F. Supp.3d at 1013-14 (quoting Riegel, 552 U.S. at 319) (other citations omitted).

So while preemption should do the trick with design defect claims involving PMA approved medical devices, courts may sometimes have an easier time with alternative, non-constitutional arguments such as the lack of any legal alternative design under Restatement §402A, comment k.  Consider giving judges this other way to the end result that we all want – dismissal of design defect claims.