At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments.  Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts.  Sometimes, the trial court decisions are unpublished but interesting, and the appellate decisions are published but not too interesting.  When we saw the Sixth Circuit decision in Agee v. Alphatec Spine, Inc., — Fed. Appx. –, 2018 WL 1020078 (6th Cir. Feb. 22, 2018), on one of our standing searches, it was not interesting enough to merit a post.  A short per curiam decision noted how awful plaintiffs’ complaint was and how they had waived their position on preemption by mixing up express preemption with the implied preemption raised by the defendant’s motion to dismiss.  We were feeling sleuthy, however, so we tracked down the district court’s decision from a year ago.  It has a nice discussion of Buckman, and will now be published, so we are going to discuss it.

Agee v. Alphatec Spine, Inc., No. 1:15-cv-750, 2017 WL 5706002 (S.D. Ohio. Mar. 27, 2017), reads like the sort of case brought when the plaintiffs are looking for someone on whom to pin liability in the absence of a claim against the most logical defendant.  The plaintiffs claimed that a surgeon used defendant’s product in connect with unnecessary spinal surgeries without proper informed consent, but the surgeon fled the country with criminal charges pending.  So, the plaintiffs asserted various product liability claims against the manufacturers of the product, PureGen.  Usually, we would state clearly what type of product is at issue, but neither decision really says, other than to say the defendants are medical device companies and the product was used to stimulate bone growth.  We did a little looking and saw that PureGen is an “osteoprogenitor cell allograft” derived from donated adult stem cells.  We also saw that there was some history with FDA over whether this was a biologic, requiring approval of a Biologics License Application, or a device that might go through the 510(k) pathway.  In any event, plaintiffs seemed to claim defendants should be liable for their injuries—it was unclear that there were any physical injuries—solely because PureGen “had never been approved by FDA for use in the spine.”  Defendants moved to dismiss.

We will skip over the TwIqbal part of this—although there are nice statements and the interesting fact that some of the plaintiffs were suing in the same court with contrary allegations about another product—and the some of the details of Ohio law to get to the Buckman part.  After reiterating the Buckman standard and the cases explaining that a court is to look at the asserted claims to see if a violation of the FDCA is a critical element, the court did just that, providing something of a roadmap on what is preempted under Buckman.  The claim for defective manufacturing alleged that the failure to obtain FDA approval made the product produce injury.  (That is not close to a manufacturing defect claim under Ohio law, which has codified the claim under ORC 2307.74.)  The design defect claim was identical (and similarly off-target from ORC 2307.75).  The warning defect claim was also predicated on lack of approval of the product, but not even that the warning misrepresented the regulatory status.  The misrepresentation claim was predicated on a representation to plaintiffs and their doctors that the product was approved or concealing from them that it was not.  A similar claim for nonconformance with representation (under ORC 2307.77) was slightly less clear, in that it referenced “representations made by defendants concerning the product and/or with applicable federal requirements.”

The court’s analysis of these claims was clear and quotable:

Each of the above-quoted claims is clearly dependent upon the FDCA to a degree that the claims would not exist but for the statute. It may or may not be the case that the promotion and distribution of PureGen for use in the surgeries references in the complaint was in violation of the FDCA and relevant FDA regulations.  However, if that is the case, it is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.

Well-reasoned. And dispositive.  And now affirmed on appeal.

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.

Claims predicating prescription medical product liability claims on purported failure to report adverse events to the FDA – á la Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300 (App. 2014), were almost unheard of prior to the recognition of preemption in medical device cases in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We know of only one decision, a prescription drug case at that, Axen v. American Home Products Corp., 974 P.2d 224, 235 (Or. App. 1999), that addressed such claims pre-Riegel.

Because failure-to-report claims are transparent attempts at common-law enforcement of FDA reporting requirements, our first reaction to such claims is that they should be impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. § 337(a), as purely FDCA-based claims.  Some courts have agreed, others (like the three cases cited above) – have been reluctant to put plaintiffs totally out of court on preemption grounds – so they have distorted the law by jamming the square peg of failure-to-report claims into the round hole of plain vanilla failure-to-warn product liability claims.

But what about that square peg?  We’ve never (and we haven’t seen it anywhere else, either) taken a look at the purely state-law issue of whether, in contexts beyond prescription medical products, the common law has ever given thumbs up – or thumbs down – to state-law tort claims actually predicated on failure to report something to some governmental body (excluding the FDA for these purposes).

Such laws do exist in a variety of areas.  The most significant example are so-called “mandated reporting statutes” that obligate differing groups of statutorily designated persons to report child abuse (and more recently, elder abuse) to state or local authorities.  The details differ, but from what we can tell, practically every state has a mandated reporting statute.

With plaintiffs being always on the lookout for extra deep pockets, no matter how bizarre the liability theory, surely somebody out there has tried to predicate liability on a purely state-law failure to report.

So we did some research that validated that gut feeling.  Indeed, it turns out that state-law failure-to-report claims have been asserted fairly often.

Fortunately for the good guys, most states have rejected those claims, and even the minority of adverse decisions are mostly distinguishable.

Here goes.

Perhaps the leading case is Perry v. S.N., 973 S.W.2d 301 (Tex. 1998).  In Perry, “[t]he sole issue [was] whether plaintiffs may maintain a cause of action for negligence per se based on the Family Code, which requires any person having cause to believe a child is being abused to report the abuse to state authorities.”  Id. at 302.  Before the Texas Supreme Court, that dog didn’t hunt.  “[W]e will not apply the doctrine of negligence per se if the criminal statute does not provide an appropriate basis for civil liability.”  Id. at 304 (footnote omitted).  That the injured plaintiff was a person within the scope of the statute’s protection was not enough.  Id. at 305.  The claim being asserted “corresponds to no common law duty.”  Id. at 306.

[W]e have considered the following factors regarding the application of negligence per se to the . . . child abuse reporting provision:  (1) whether the statute is the sole source of any tort duty from the defendant to the plaintiff or merely supplies a standard of conduct for an existing common law duty; (2) whether the statute puts the public on notice by clearly defining the required conduct; (3) whether the statute would impose liability without fault; (4) whether negligence per se would result in ruinous damages disproportionate to the seriousness of the statutory violation, particularly if the liability would fall on a broad and wide range of collateral wrongdoers; and (5) whether the plaintiff’s injury is a direct or indirect result of the violation of the statute.  Because a decision to impose negligence per se . . . would impose immense potential liability under an ill-defined standard on a broad class of individuals whose relationship to the abuse was extremely indirect, we hold that [liability] is not appropriate.

Id. at 309.

Another interesting case is Ward v. Greene, 839 A.2d 1259 (Conn. 2004), which held that, while a cause of action for failure to report might be brought on behalf of the “identified” abused child him or herself, the statute did not protect other “unidentified” abused children allegedly injured by the same pattern of failure to report child abuse:

[W]e conclude that the [statute] appears to be directed at the child, or children in the case of multiple children placed at risk in a singular incident, who should be the subject of a report of abuse or neglect under the statute and are, accordingly, in need of services.  The policy statement thus suggests that the legislature intended to focus on children who already have been exposed to conduct that amounts to a reportable event, and we do not find merit in the plaintiff’s argument that the statute creates a duty of care to every child who has been in the care of the defendant.

Id. at 1266-67.  The limited claim in Ward can’t translate to drug/device liability because a similar construction of the FDCA’s reporting requirements would not do plaintiffs any good.  Causation in product liability doesn’t work the same way.  In drug/device cases, every court to consider the issue has held that failure to report a plaintiff’s own adverse event cannot possibly be causal, since any failure to report necessarily happens after the plaintiff was injured.  See Johnson v. Hologic, Inc., 2015 WL 75240, at *4 (Mag. E.D. Cal. Jan. 5, 2015), adopted, 2015 WL 4745264 (E.D. Cal. March 6, 2015); Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235, at *3 (N.D. Cal. May 28, 2014); Simmons v. Boston Scientific. Corp., 2013 WL 1207421, at *5 (C.D. Cal. March 25, 2013).

Perry and Ward are examples of the distinct majority of precedent addressing similar claims of injury due to somebody’s failure to report child abuse.  Most states do not recognize any purely common-law, or negligence per se state-law, duty to report child abuse.  “The vast majority of courts . . . have held that their reporting statutes do not create a civil cause of action.”  Becker v. Mayo Foundation, 737 N.W.2d 200, 208 (Minn. 2007).

Alabama: C.B. v. Bobo, 659 So.2d 98, 102 (Ala. 1995) (“there is no indication of any legislative intent to impose civil liability for failure to report”).

Connecticut: Ward, supra, 839 A.2d at 1266-67.

Delaware: Doe 30’s Mother v. Bradley, 58 A.3d 429, 452 (Del. Super. 2012) (“the statutory obligation to report [suspected child abuse] does not equate to a common law duty to act”).

Florida: Welker v. Southern Baptist Hospital, Inc., 864 So. 2d 1178, 1182 (Fla. App. 2004) (the statute that “address[es] the subject of penalties for failure to report known or suspected child abuse . . . says nothing about the availability of a cause of action for damages.  Moreover, those courts which have been presented with the same question regarding predecessor versions . . . have all concluded that no cause of action was created”), quashed on other grounds, 908 So. 2d 317 (Fla. 2005); Mora v. South Broward Hospital Dist., 710 So. 2d 633, 634 (Fla. App. 1998) (recognizing, while rejecting analogous cause of action for failure to report elder abuse; that “Florida courts have consistently refused to impose civil liability for the failure to report suspected child abuse”); Fischer v. Metcalf, 543 So.2d 785, 790-91 (Fla. App. 1989) (“To find a legislative intent to provide a private right of action against non-reporters, we would have to ignore . . . the plain purpose and language of the statutes”).

Georgia: McGarrah v. Posig, 635 S.E.2d 219, 222 (Ga. App. 2006) (“The legal duty to report, however, is imposed in Georgia by statute, and . . . this statute does not give rise to a private cause of action for damages”) (emphasis original); Vance v. T.R.C., 494 S.E.2d 714, 716 (Ga. App. 1997) (“nothing within the provision of the law purports to create, or indicates an intention to create, a private cause of action in tort in favor of a child whose abuse is not detected or reported”); Cechman v. Travis, 414 S.E.2d 282, 284 (Ga. App. 1991) (child abuse reporting requirements not enforced by private liability).  Cf. Govea v. City of Norcross, 608 S.E.2d 677, 683 (Ga. App. 2004) (no negligence per se claim based on failure to report reasons why police officer had been terminated).

Illinois: Varela v. St. Elizabeth’s Hospital, Inc., 867 N.E.2d 1, 8 (Ill. App. 2006) (“it would be illogical to argue that although the Illinois legislature has not expressly or impliedly created a private right of action for violation of the Reporting Act individuals may nevertheless assert a private right of action for violation of the Reporting Act, so long as those individuals allege they are proceeding at common law rather than on a statutory basis”); Doe v. North Central Behavioral Health System., Inc., 816 N.E.2d 4, 8 (Ill. App. 2004) (“no evidence that the statute was designed to provide monetary remedies for victims of abuse or to impose civil liability on those who fail to report”); Sheetz v. Norwood, 608 F. Appx. 401, 406 (7th Cir. 2015) (following Doe and Cuyler); Doe-2 v. McLean County Unit Dist. No. 5 Board of Directors, 593 F.3d 507, 514 (7th Cir. 2010) (a “mandate to report child abuse does not create any duty to the abused child enforceable under Illinois tort law”); Cuyler v. United States, 362 F.3d 949 (7th Cir. 2004) (“Illinois common law did not impose on [defendant’s] employees a tort duty” and “an imposing line of cases from other jurisdictions dealing with the private-right question . . . have held that a private right should not be implied”) (Posner, J.) (emphasis original); Willis v. Williams, 2010 WL 4683965, at *3 (Mag. C.D. Ill. Sept. 27, 2010) (“Illinois common law creates no legal duty to report suspected sexual abuse of a child”), adopted, 2010 WL 4683624 (C.D. Ill. Oct. 26, 2010); Doe v. White, 627 F. Supp. 2d 905, 920 (C.D. Ill. 2009) (“there is no underlying common law duty to report” and “there is no tort liability for [a statutory] violation”).

Indiana: Sprunger v. Egli, 44 N.E.3d 690, 693 (Ind. App. 2015) (“Indiana does not recognize a private right of action for failure to report abuse”); C.T. v. Gammon, 928 N.E.2d 847, 854 (Ind. App. 2010) (“our legislature has declined to codify a civil cause of action against an adult who knowingly fails to report alleged child abuse”); J.A.W. v. Roberts, 627 N.E.2d 802, 813 (Ind. App. 1994) (“Absent codification, we are not convinced that extending a civil remedy to a victim of abuse or neglect against all persons who know of child abuse and fail to report child abuse is good public policy.”), abrogated on other grounds, Holt v. Quality Motor Sales, Inc., 776 N.E.2d 361 (Ind. App. 2002); Borne v. Northwest Allen County School Corp., 532 N.E.2d 1196, 1202-03 (Ind. App. 1989) (“the legislature did not intend to confer a private right of action for any breach of the duty to report imposed by the statute”).

Kansas: Kansas State Bank & Trust Co. v. Specialized Transportation Services., Inc., 819 P.2d 587, 604 (Kan. 1991) “There is no express indication of legislative intent to impose any liability for failure to report.”); E.P. v. United States, 835 F. Supp.2d 1109, 1117 (D. Kan. 2011) (the “common law does not recognize a cause of action for medical negligence based on failure to report child abuse”), aff’d, 520 F. Appx. 707, 716 (10th Cir. 2013) (“Kansas law does not hold healthcare professionals liable for failing to report child abuse”).

Massachusetts: Doe v. D’Agostino, 367 F. Supp.2d 157 (D. Mass. 2005); (“it is implicit from the penalty imposed for failure to report that the legislature did not intend to create a private cause of action for a statutory violation”).

Minnesota: Becker, 737 N.W.2d at 208 (“The plain language of the statute indicates that the legislature chose to impose criminal, but not civil, penalties on mandatory reporters who fail to report.”); Meyer v. Lindala, 675 N.W.2d 635, 641 (Minn. App. 2004) (the statute “does not create a private cause of action for violation of its reporting requirements or create a duty which could be enforced through a common-law negligence action”); Kuelbs v. Williams, 609 N.W.2d 10, 155 (Minn. App. 2000) (“Minnesota courts have been reluctant to recognize private causes of action under reporting acts”); Valtakis v. Putnam, 504 N.W.2d 264, 266-67 (Minn. App. 1993) (“There is no mention of a civil cause of action for failure to report nor is a civil action implied by the language of the subdivision;” “there was no underlying civil cause of action for failure to report suspected child abuse”).

Missouri: Bradley v. Ray, 904 S.W.2d 302, 312-15 (Mo. App. 1995) (“no private cause of action can be implied under the Child Abuse Reporting Act, [so] the alleged breach of the Act also does not amount to negligence per se”; no prima facie tort for non-reporting); American Home Assurance Co. v. Pope, 360 F.3d 848, 851 n.7 (8th Cir. 2004) (Missouri “has prohibited” claims for failure to report child abuse); Letlow v. Evans, 857 F. Supp. 676, 678 (W.D. Mo. 1994) (“the vast majority of courts . . . have found that reporting statutes such as the one at issue here, do not create a private right of action”); Thelma D. v. Board of Education, 669 F. Supp. 947, 950 (E.D. Mo. 1987) (plaintiffs “cannot recover under the Statute which only creates a public duty”); Doe “A” v. Special School District, 637 F. Supp. 1138, 1148 (E.D. Mo. 1986) (the Statute “creates a duty owed to the general public, not to specific individuals”); Nelson v. Freeman, 537 F. Supp. 602, 611 (W.D. Mo. 1982) (“the applicable [reporting] provisions of the Missouri Child Abuse statute cannot be said to support a private cause of action in favor of individuals”).

New Hampshire: Marquay v. Eno, 662 A.2d 272, 278 (N.H. 1995) (“imposition of civil liability for all reporting violations would represent a sharp break from the common law and neither the statute nor the legislative history directly reveal any such intent, we are unwilling to say that violation of the child abuse reporting statute supports a private right of action”).  Cf. Gauthier v. Manchester School Dist., 123 A.3d 1016, 1021 (N.H. 2015) (“declin[ing] . . .  to create a duty to report bullying”).

New Jersey: J.S. v. R.T.H., 714 A.2d 924, 934 (N.J. 1998) (“we do not conclude that the Legislature intended that the child-abuse reporting statute constitute an independent basis for civil liability or that its violation constitute negligence per se”); Zelnick v. Morristown-Beard School, 137 A.3d 560, 568 (N.J. Super. Law. Div. 2015) (“Child abuse reporting statutes do not typically create a duty of care or a basis for civil liability.”).

Oklahoma: Paulson v. Sternlof, 15 P.3d 981, 984 (Okla. App. 2000) (“the child abuse reporting statutes do not create a private right of action.  Knowing and willful failure to report is a criminal misdemeanor.  There is no provision, however, for civil liability.”).

South Carolina: Doe v. Marion, 645 S.E.2d 245, 249 (S.C. 2007) (“the statute in question is concerned with the protection of the public and not with the protection of an individual’s private right”).

Tennessee: Ham v. Hospital of Morristown, Inc., 917 F. Supp. 531, 534 (E.D. Tenn. 1995) (“the common law of Tennessee does not impose a duty on a treating physician to either report suspected child abuse or to prevent any such child abuse”).  However, Ham allowed a statutory cause of action (see below).

Texas: Perry, supra; Childers v. A.S., 909 S.W.2d 282, 289-90 (Tex. App. 1995) (rejecting civil liability for failure to report child abuse before Perry); Doe v. S & S Consolidated I.S.D., 149 F. Supp.2d 274, 299 (E.D. Tex. 2001) (following Perry), aff’d, 309 F.3d 307 (5th Cir. 2002).

Utah: Owens v. Garfield, 784 P.2d 1187, 1191 (Utah 1989) (“Although the statute is intended to address the problem of child abuse, we are not persuaded that it can be read to create a legally enforceable duty on the part of the [mandated reporter] to protect all children from child abuse in all circumstances”).

West Virginia: Barbina v. Curry, 650 S.E.2d 140, 145-46 (W. Va. 2007) (Arbaugh rationale precludes common-law negligence action for failure to report); Arbaugh v. Board of Education, 591 S.E.2d 235, 241 (W. Va. 2003) (the law “does not give rise to an implied private civil cause of action . . . for failure to report suspected child abuse where an individual with a duty to report under the statute is alleged to have had reasonable cause to suspect that a child is being abused and has failed to report suspected abuse”).

Wisconsin: Isely v. Capuchin Province, 880 F. Supp. 1138, 1148 (D. Mich. 1995) (“find[ing] nothing to indicate that the Wisconsin legislature intended to authorize a private cause of action for failure to report”) (applying Wisconsin law).

There are a number of states where the mandated reporting statute expressly includes a statutory right of action for non-reporting (Arbaugh listed Arkansas, Colorado, Iowa, Michigan, Montana, New York and Rhode Island, 591 S.E.2d at 239 n.3).  While not all of those states appear to have considered the issue, those that have hold the there isn’t any common-law liability for failure to report beyond the scope of the statutory action.  See:

Arkansas: First Commercial Trust Co. v. Rank, 915 S.W.2d 262, 268 (Ark. 1996) (affirming defense verdict on statutory failure to report claim) (note:  private cause of action repealed in 2009, and there have been no further failure to report claims).

Michigan: Murdock v. Higgins, 559 N.W.2d 639, 647 (Mich. 1997) (predicates to statutory cause of action “serve as deliberate limits to the scope” of civil liability); Marcelletti v. Bathani, 500 N.W.2d 124, 127 (Mich. App. 1993) (“the Legislature intended that liability under the statute be limited to claims for damages” meeting statutory requirements); Brent v. Wenk, 555 F. Appx. 519, 537, 2014 WL 486192 (6th Cir. 2014) (no liability for failure to report except for what statute allows).

New York: Heidt v. Rome Memorial Hospital, 724 N.Y.S.2d 139, 787 (N.Y. App. Div. 2007) (“Plaintiff has cited no authority to support the proposition that a physician has a common-law duty to report actual child abuse, let alone suspected child abuse.  There are good reasons for the absence of such a duty.”); Diana G-D v. Bedford Central School Dist., 932 N.Y.S.2d 316, 329 (N.Y. Sup. 2011), aff’d, 961 N.Y.S.2d 305 (N.Y. App. Div. 2013) (“there is simply no evidence that defendants’ failure to make such a report was knowingly and willful,” which was required for civil liability under child abuse reporting statute).

A few states have allowed private persons (usually in distinguishable situations) to bring civil actions seeking damages for failure to report child abuse.  Most notable – no surprise for its receptivity to novel claims – is:

California.  In Landeros v. Flood, 551 P.2d 389 (Cal. 1976), the plaintiff sued a doctor who had treated her in the emergency room for negligently failing to diagnose, and thus to report, her medical condition as “battered child syndrome.” Id. at 405-06.  The court recognized a private cause of action exists for intentional violation of the reporting statute.

If plaintiff wishes to satisfy that requirement [violation of statute], it will be necessary for her to persuade the trier of fact that defendant . . . treating doctor[] actually observed her injuries and formed the opinion they were intentionally inflicted on her.

Id. at 397-98.  The statutory language in Landeros, however, was amended to express “the Legislature’s . . . intent to create an objective standard in order to broaden the circumstances under which reporting is required.”  People v. Davis, 25 Cal. Rptr. 3d 92, 100 (Cal. App. 2005).  Thus the private cause of action originally recognized in Landeros has also been broadened. Pipitone v. Williams, 198 Cal. Rptr.3d 900, 917 (Cal. App. 2016) (applying lesser standard of amended statute to civil action).  See Garcia v. Clovis Unified School Dist., 627 F. Supp. 2d 1187, 1205 (E.D. Cal. 2009) (mandated reporter statute “may form the basis of a negligence per se claim”).

Other states allowing private suits for failure to report child abuse are:

Kentucky: Vanhook v. Somerset Health Facilities, LP, 67 F. Supp. 3d 810, 826 (E.D. Ky. 2014) (finding liability for failure to report child abuse based on unique Kentucky statute codifying negligence per se).  Note:  As we discussed at length here, the same statute precludes negligence per se statute for violations of federal enactments, so no failure to report analogy can help drug/device plaintiffs.

Nebraska: Chapa v. United States, 2005 WL 2170090, at *5 (D. Neb. Sept. 7, 2005) (a medical malpractice claim incorporating a duty to report was allowed; “the Court finds that there is a genuine issue of material fact regarding whether the applicable standard of care required the Physicians to report suspected child abuse”).  This decision disregards Erie to create liability never recognized by any state court.

Ohio: Yates v. Mansfield Board. of Education, 808 N.E.2d 861, 871 (Ohio 2004) (“a board of education may be held liable when its failure to report the sexual abuse of a minor student by a teacher . . . proximately results in the sexual abuse”).  Yates is a holdover from the Ohio dark ages when a pro-plaintiff high court majority was recognizing novel liability theories right and left.  Whether Yates would be decided the same way today is doubtful.

Pennsylvania:  In K.H. v. Kumar, 122 A.3d 1080, 1095-96 (Pa. Super. 2015), the court allowed a medical malpractice claim predicated on a doctor’s failure to report child abuse.  In Doe v. Liberatore, 478 F. Supp.2d 742, 763-64 (M.D. Pa. 2007), a similar claim was allowed against the clergy.  Failure-to-report has not been recognized in Pennsylvania outside the context of professional liability.  Even there, a contrary line of Pennsylvania precedent exists with respect to the duty of doctors to report to the state their patients’ medical conditions that would disqualify the patients from driving.  No liability for failure report has been recognized in those circumstances.  See Estate of Witthoeft v. Kiskaddon, 733 A.2d 623, 630 (Pa. 1999); Hospodar v. Schick, 885 A.2d 986, 989-90 (Pa. Super. 2005); Crosby v. Sultz, 592 A.2d 1337, 1345 (Pa. Super. 1991).  See also Gabriel v. Giant Eagle, Inc., 2015 WL 13240267, at *7 (Pa. C.P. June 30, 2015) (“members of a group of people harmed by the diversion of controlled substances” could not sue drugstore for failure to report thefts of such substances because “these reporting requirements are intended to protect the interests of the general public”).

South Dakota: Aman v. Cabacar, 2007 WL 2684866, at *2-3 (D.S.D. Sept. 6, 2007) (violation of mandatory abuse reporting statute can be negligence per se).  As with Chapa, above, Aman is another episode of a federal court predicting liability well beyond what any state court has done.

Tennessee: Doe v. Coffee County Board of Education, 852 S.W.2d 899, 909 (Tenn. App. 1992) (“teachers . . . have a non-discretionary duty to report students’ complaints of child sexual abuse.  Their failure to do so can give rise to liability.”); Ham v. Hospital of Morristown, Inc., 917 F. Supp. 531, 537 (E.D. Tenn. 1995) (following Doe).

Washington: Kim v. Lakeside Adult Family Home, 374 P.3d 121, 126 (Wash. 2016) (applying Beggs rationale to reporting statute concerning vulnerable adults); Beggs v. State, Dept. of Social & Health Services, 247 P.3d 421, 424 (Wash. 2011) (“the mandatory child abuse reporting statute, implies a cause of action against a professional named in the statute who fails to report suspected abuse”); Doe v. Corp. of President of Church of Jesus Christ of Latter-Day Saints, 167 P.3d 1193, 1201 (Wash. App. Div. 1 2007) (“it is reasonable to imply an intended remedy for child victims of sexual abuse when those required to report the abuse fail to do so”).

That completes what we’ve found on failure-to-report claims under child abuse/elder abuse mandated reporting statutes.  But that’s not all that’s out there for counsel tasked with debunking failure-to-report claims.

Various other statutes exist that require persons to report things to government entities.  One that popped up fairly often recently is the federal Bank Secrecy Act, which requires that certain financial transactions be reported.  This statute, being federal, is analogous in that respect to the FDCA.  These banking cases are good place to look for favorable precedent rejecting alleged reporting violations of a federal statute when asserted as negligence per se, or otherwise actionable, under state law.  “[I]t is now well settled that the anti-money-laundering obligations of banks, as established by the Bank Secrecy Act, obligate banks to report certain customer activity to the government but do not create a private cause of action permitting third parties to sue for violations of the statute.” El Camino Resources, LTD. v. Huntington National Bank, 722 F. Supp. 2d 875, 923 (W.D. Mich. 2010), aff’d, 712 F.3d 917 (6th Cir. 2013) (applying Michigan law). Accord, e.g., Belle Meade Title & Escrow Corp. v. Fifth Third Bank, ___ F. Supp.3d ___, 2017 WL 4837474, at *4 (M.D. Tenn. Oct. 17, 2017) (applying Tennessee law); Towne Auto Sales, LLC v. Tobsal Corp., 2017 WL 5467012, at *2 (N.D. Ohio Nov. 14, 2017) (applying Ohio law); Lundstedt v. Deutsche Bank National Trust Co., 2016 WL 3101999, at *5 (D. Conn. June 2, 2016) (applying Connecticut law); Taylor & Co. v. Bank of America Corp., 2014 WL 3557672, at *3 (Mag. W.D.N.C. June 5, 2014), adopted, 2014 WL 3557679 (W.D.N.C. July 18, 2014) (applying North Carolina law); Shtutman v. TD Bank, N.A., 2014 WL 1464824, at *2 (D.N.J. April 15, 2014) (following child abuse reporting cases) (applying New Jersey law); Spitzer Management, Inc. v. Interactive Brokers, LLC, 2013 WL 6827945, at *2 (N.D. Ohio Dec. 20, 2013) (reporting duty “owed to the government of the United States,” not to injured third parties) (applying Ohio law); Public Service Co. v. A Plus, Inc., 2011 WL 3329181, at *7-8 (W.D. Okla. Aug. 2, 2011) (applying Oklahoma law); In re Agape Litigation, 681 F. Supp.2d 352, 360-61 (S.D.N.Y. 2010) (applying New York law); Armstrong v. American Pallet Leasing, Inc., 678 F .Supp.2d 827, 874-75 (N.D. Iowa 2009) (applying Iowa law); Marlin v. Moody National Bank, N.A., 2006 WL 2382325, at *7 (S.D. Tex. Aug. 16, 2006) (the “obligation under that statute is to the government rather than some remote victim”), aff’d, 248 F. Appx. 534 (5th Cir. 2007) (applying Texas law); Aiken v. Interglobal Mergers & Acquisitions, 2006 WL 1878323, at *2 (S.D.N.Y. July 5, 2006) (applying New York law).  Both Ohio and Tennessee state law thus reject failure to report under this federal statute as a basis for state-law liability, notwithstanding adverse precedent under state mandated reporting statutes.

Thus, the first takeaway from our look at state-law failure-to-report claims is that most states don’t allow them. The second takeaway is that, if one is looking for state-law precedent to oppose the existence of failure-to-report claims, there are multiple, potentially fruitful avenues.  Failure to report child (or elder) abuse cases are a good place to start, but there are lots of others, such as financial reporting statutes, the drivers license revocation cases litigated in Pennsylvania, and even requirements to report things such as drug diversion and bullying.  If at first we don’t succeed, we should keep looking.

The Seventh Circuit taught us recently that the letter “A” is a powerful thing. Of course, we already knew that a well-placed A can convert the ordinary (“typical”) into the extraordinary (“atypical”), the melodic (“tonal”) into the dissonant (“atonal”), and the virtuous (“moral”) into the indifferent (“amoral”).  Adding a single A to a Scrabble board can result in a seriously high-value word, provided you can manage to place it on a triple word score appended to a word that already has high value letters, like H or Y, or if you are really lucky, X.

For today, A stands for “Abbreviated”—as in Abbreviated New Drug Application, or ANDA. It’s important because the Seventh Circuit held in Guilbeau v. Pfizer, Inc., No. 17-2056, 2018 WL 476343 (7th Cir. Jan. 19, 2018), that implied preemption of a failure-to-warn claim under Pliva v. Mensing depends not on a drug’s colloquial description as “generic” or “brand name,” but rather on the nature of the drug’s approval process.  If a drug is approved through an ANDA, federal regulation of drug labeling preempts state-law failure to warn claims—even if the drug is technically the “Reference Listed Drug.”

This ruling makes perfect sense, and here is how it works. In Guilbeau, the plaintiffs alleged that manufacturers of a testosterone replacement therapy product called Depo-T failed adequately to warn regarding cardiovascular events. Id. at *1.  Depo-T, however, had a slightly unusual regulatory history.  When a manufacturer applies for drug approval under an ANDA, it has to demonstrate that the drug has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id. at *2.  The predecessor drug is called the Reference Listed Drug. Id.

The Reference Listed Drug is usually the innovator product, approved through the NDA process and often referred to as a “brand-name” drug. The ANDA drug is often called “generic.”  If, however, an original innovator drug has been discontinued, the FDA can designate the remaining market-leading drug to take its place as the Reference Listed Drug. Id. Something like that (but not exactly) happened to Depo-T.  Because of unique circumstances surrounding the timing of the drug’s approval, the FDA classified Depo-T as an ANDA-approved drug, but the product also was designated the Reference Listed Drug for its kind of testosterone injection. Id. at *4.

So which is it? “Generic” or “brand name”?  It turns out those terms are neither useful nor dispositive when applying implied preemption.  Or, as the Seventh Circuit observed, “These colloquial terms are not quite precise enough for our purposes in this case.” Id.  The relevant distinction is NDA-approved versus ANDA-approved.  That distinction determines whether a drug manufacturer can unilaterally update its labeling through the changes being effected (or “CBE”) process and thus potentially lose the protection of implied preemption recognized in Pliva v. Mensing.  The Seventh Circuit explained it this way:

[D]espite potentially confusing references to brand-name and generic drugs—recall that the relevant FDA terms are NDA-approved and ANDA-approved—Mensing itself unambiguously refers to the lines drawn in the drug approval process as determining access to the CBE regulation. Mensing concludes that while NDA holders may use the CBE regulation to add warnings, ANDA holders (like [the manufacturer] here) may not. . . .

Despite their occasional use of these terms, the Supreme Court, Congress, and the FDA all agree that the meaningful difference is found in approval process classifications, not shorthand terms like brand-name and generic.

Id. at *6. The key point for the Seventh Circuit was that the CBE regulation is unavailable for products approved through the ANDA process.  And that goes for every ANDA product, even if it is the Reference Listed Drug—like Depo-T.  Because ANDA product manufacturers cannot change their labels unilaterally, it is impossible to change a label in response to state tort law without violating the federal duty of “sameness” that applies to all ANDA products.  That is Pliva v. Mensing implied preemption. Id. at **4-5.

The Guilbeau plaintiffs tried to avoid preemption by arguing that, because Depo-T was itself the Reference Listed Drug, the manufacturer’s duty was to have labeling the same as its own labeling.  According to the plaintiffs, that means the manufacturer could change the label all it wanted to and it would still be the “same” as itself. Id. at *5.  We appreciate the metaphysical nature of this argument:  How can something ever be different from itself?  But the answer is pretty easy.  The duty of “sameness” means that ANDA holders must match the labeling for the Reference Listed Drug as approved by the FDA, “not whatever the RLD’s manufacturer currently thinks would be best.”  Id. at *7.  In other words, “The statutes, the regulations, and the Mensing opinion do not draw the distinction plaintiffs advocate:  a difference in abilities and responsibilities between RLD ANDA holders and other ANDA holders.” Id.

In the end, ANDA drugs that are also Reference Listed Drugs are subject to a “duty of sameness indistinguishable from that of all other ANDA drugs.” Id. at *8.  They all must show that their labeling is the same as the approved labeling. Id. Thus, because Depo-T’s manufacturer “may not unilaterally change the FDA-approved language on Depo-T’s label,” a lawsuit under state law that seeks damages for the manufacturer’s failure to do so is preempted by federal law. Id.

One more important note: The Seventh Circuit held that the plaintiffs were not entitled to conduct further discovery.  The district court decided this case on a motion to dismiss, and because “preemption is a legal question for determination by courts . . . , discovery of facts may not be as vital to this inquiry as it could be to others.” Id. at *10.  With recent opinions from the Third Circuit and Ninth Circuit treating preemption as a factual issue on which discovery might be appropriate (discussed here  and here), the Seventh Circuit’s holding on discovery is most welcome.  Preemption can and should be decided on the pleadings in many instances, including the circumstances presented here.  The district court in Guilbeau correctly did exactly that, and the Seventh Circuit gave the order an A grade.

We recently read a news story about a man who was imprisoned for 39 years for a crime he did not commit. The crime was grisly and resulted in the violent deaths of a 24-year-old woman and a small child, leaving a community outraged and law enforcement officials determined to hold someone responsible.  So, burdens of proof be damned, the defendant was convicted despite the fact that relevant DNA recovered from the victims was not his.  Eventually, a crusading retired policeman succeeded in winning exoneration and freedom for the prisoner.   Now, we went to law school.  We know all about the differences between criminal law and civil law.  And we know we should be circumspect about fragile visceral analogies when we are well aware of the relevant distinctions.  Nevertheless, when we read a bad “innovator liability” decision – a decision holding an innovator drug manufacturer liable for injuries caused by a generic version of the drug – a drug manufactured by someone else – there is a simplistic part of us that fails to see how this is so different from imprisoning someone for a crime he did not commit

Today’s case, Garner v. Johnson & Johnson, et al., 2017 WL 6945335 (C.D. Ill. Sept. 06, 2017) (just surfacing though several months old), is just such a bad decision.  In Garner, the plaintiff alleged that a generic fluoroquinolone antibiotic caused her to suffer serious injuries.  She sued the generic drug manufacturer that actually made her drug along with the innovator drug company that manufactured the name-brand version of the drug.  The defendants moved to dismiss for failure to state a claim.

The court first considered the plaintiff’s claims against the generic drug manufacturer, and correctly concluded that, under Mensing, the claims, all rooted in alleged inadequacies of the generic drug’s warning label, were preempted.  But the court wanted to hold someone responsible.  So, noting that the Seventh Circuit had not yet addressed innovator liability, it undertook to circumvent Illinois law.

As we discussed in our “Innovator Liability at 100” post, Illinois has long required product identification for all product liability matters, as evinced by the Illinois Supreme Court’s rejection of industry-wide liability under both market share liability and public nuisance rubrics. See Young v. Bryco Arms, 821 N.E.2d 1078, 1087-91 (2004) (public nuisance); Smith v. Eli Lilly & Co., 560 N.E.2d 324, 337-39, 344-45 (Ill. 1990) (market share liability); City of Chicago v. American Cyanamid Co., 823 N.E.2d 126, 134-35 (Ill. App. 2005) (market share liability in public nuisance); Lewis v. Lead Industries Ass’n. Inc., 793 N.E.2d 869, 874-76 (2003) (same) (all four cases finding no causation as a matter of law without product identification). See also Leng v. Celotex Corp., 554 N.E.2d 468, 470-471 (Ill. App. 1990) (rejecting market share liability pre-Smith in asbestos case); York v. Lunkes, 545 N.E.2d 478, 480 (Ill. App. 1989) (rejecting market share liability pre-Smith in battery case); Poole v. Alpha Therapeutic Corp., 696 F. Supp. 351, 353 (N.D. Ill. 1988) (rejecting market share liability pre-Smith in blood products case); Coerper v. Dayton-Walther, 1986 WL 4111, at *1 (N.D. Ill. March 27, 1986) (rejecting market share liability pre-Smith in tire rim case).

Moreover, Illinois does not recognize a duty to warn about the risks of a competing product:

[Defendant] is under no duty to provide information on other products in the marketplace. Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies.  This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product.

Pluto v. Searle Laboratories, 690 N.E.2d 619, 621 (Ill. App. 1997).  Recently, an Illinois appellate court recognized in dictum that an “overwhelming majority of courts have held that generic consumers may not sue the brand-name manufacturer.” Guvenoz v. Target Corp., 30 N.E.3d 404, 409 n.1 (Ill. App. 2015). See id. at 416 (plaintiffs “cannot obtain relief from brand-name drug manufacturers whose products they did not ingest”).

But the Garner court disregarded all of this. The court acknowledged that, to state a claim for negligence, the plaintiff was required to establish that the defendants owed her a duty of care, and that the existence of such a duty turned on the reasonable foreseeability of the injury.  But it  held, “In the well-regulated pharmaceutical industry, . . . a brand-name manufacturer . . . is surely not blindsided to find out that the equivalent of its . . . [label] as imposed on generic versions of [its drug],” and that doctors and patients would rely on that label when prescribing and using the generic drug.   Garner, 2017 WL 6945335 at *7.  Further, the court held, it was “a common practice, and therefore foreseeable, for a doctor to prescribe a name brand drug and the pharmacy to fill it with the generic version.” Id. And so, though “other courts have expressed trepidation about the consequences of holding brand-name manufacturers liable for injury caused by generics,” id. (citations omitted), the court concluded that finding that the brand-name manufacturer had a duty of care to a plaintiff taking someone else’s drug “simply allows [the plaintiff] to attempt to recover from the one entity, under federal law, that has the unilateral ability to strengthen the label.” Id.  Even though that entity did not manufacture the product that allegedly injured her.

The court next addressed the issue of causation, acknowledging that “liability for negligence may not be imposed based merely on a breach of duty, without causation being established. Id. (citation omitted).  The plaintiff alleged that she would not have taken the generic drug if its label contained adequate warnings.  (Although the generic drug was a prescription drug, the court failed to analyze warnings causation from the perspective of the prescribing physician.) And the court held that “an extra link in the causal chain (here, the transfer of the identical label from the branded drug to the generic drug) does not break it.  It is possible for a plaintiff to show that injuries caused by mislabeling on a generic medication can be directly traced back to the brand name manufacturer’s creation of the label.” Id. (citations omitted).  As such, the court found that the plaintiff had “adequately alleged causation,” id., and, in derogation of its Erie duty to apply Illinois law, denied the innovator company’s motion to dismiss the plaintiff’s negligence claims.  Similar analysis allowed the plaintiff’s related claims to proceed.

We get the issue. We understand that the United States Supreme Court has limited the remedies of plaintiffs injured by generic drugs, even assuming they can prove a product defect, an injury, and causation in between.  But “someone’s gotta pay” cannot justify a decision that starts from a desired result and works backward, hurdling any doctrine or jurisprudence that gets in the way.  We defend innovator drug companies for a living, and we will continue to speak out against decisions like Garner. And we’ll keep you posted on what comes next.

Last weekend we returned to Utah, one of the most beautiful states in the USA.  Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the Sundance Festival.  This time was different.  It was an occasion to explore Zion National Park, where wind, water, and time have carved splendor out of the rocks.  The apricot-colored natural amphitheaters put on quite a show in February.  Mule deer didn’t mind us at all as they chomped on rough, stubborn grass, mere feet away from us and a frozen waterfall. We drove through a mile-long tunnel with occasional natural ‘windows’ allowing light in from the canyons.  Every sublime inch of the place, every cactus skirted by snow, every stone arch, every smiling hiker, every helpful ranger, supplied further proof that the National Park system truly is America’s best idea.  If Yellowstone, Yosemite, and Grand Canyon do not already clinch the argument, Zion silences the debate with one long shadow cast from the Court of the Patriarch peaks or one gurgling note from the demure but insistent Virgin River.

It was good to get back to Utah.

Today’s post also gets back to Utah.  Three weeks ago we reported on a federal court decision in Burlingame v. Wright Medical Group, Inc., (D. Utah), a product liability personal injury case involving a hip implant.  The defendant filed a motion for summary judgment.  The solitary vexing issue was whether comment k to section 402A of the Restatement (Second) of Torts applies to medical devices so as to shield them strict liability design defect.  Utah law governed, and it is absolutely clear that Utah law applied comment k across the board to prescription drugs. But what about medical devices?  Our take on that question is to wonder why devices and drugs should be any different.  The need for a prescription should be enough to establish the “unavoidably unsafe” element of comment k, so the issue should be clear.

That’s apparently what the defendant in Burlingame thought, too, as it argued that the federal court had all the case law it needed to apply comment k and dismiss the strict liability claim.  The plaintiff  also was content with existing law, but in a different way, as the plaintiff argued that the federal court could conclude that medical devices fell outside of comment k.  Neither party asked the court to certify the question to the Utah Supreme Court, but that is what happened. It not only happened sua sponte, it happened over both sides’ objections.  That is what we reported on three weeks ago.

But it is not the end of the story.   The federal court then invited the parties to try to agree on what issues should go to the Utah Supreme Court.  Well, inasmuch as neither party wanted to add the Utah Supreme Court to the festivities, should anyone really be surprised that the parties could not agree? The federal court certainly seemed surprised, and more than a little disappointed.   In a new opinion, Burlingame v. Wright Medical Group, Inc., 2018 U.S. Dist. LEXIS 25637 (D. Utah Feb. 15, 2018), the federal court blasts the parties for submitting one-sided, self-serving position papers.  Isn’t that a little like Captain Renault in Casablanca declaring how shocked he is that gambling has been going on at Rick’s Cafe?  Anyway, the federal judge grabbed a pen and crafted the following questions for the Utah Supreme Court to enjoy and resolve:

1.  Under Utah law, does the unavoidably unsafe exception to strict liability in design defect recognized in Comment K to section 402(A) of the Restatement (Second) of Torts apply to implanted medical devices?

2.  If the answer to Question 1 is in the affirmative, does the exception apply to all implanted devices, or does the exception apply only to some devices on a case-by-case basis?

3.  If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

4.  If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market approval through the FDA’s premarket approval process as opposed to the 510(k) clearance process?

Dear reader, we hope you do not think it presumptuous if we draft answers on behalf of the Utah Supreme Court:

1.  Yes, comment k applies to medical devices.  The number of courts that have distinguished between drugs and devices with respect to application of comment k is truly miniscule.  And the reasoning is … unimpressive. Why would Utah want to join such a dreadful, dull minority? But the correct adjective is “prescription,” not “implanted.”  Sure, any implanted device will require a prescription, but there are plenty of other medical devices that fit the unavoidably unsafe bill without being implants.  Ever heard of medical lasers?  Why some plaintiffs or courts fixate on implantation is beyond us.  The permanence of the thing shouldn’t matter.  Prescription drugs don’t stay in the system permanently.  If the court wants to stay parallel (not our favorite word in the DDL universe, but stay with us a moment) with drug comment k case law, the issue is whether or not a doctor’s prescription is required.

2.  The comment k exception should apply to all prescription medical devices.  Across the board.  Case-by-case noodling makes no sense, is a burden on the court, provides no guidance to parties and, all-in-all, is the way of nincompoops.

3.  See, by adopting across-the-board, we’ve already aided judicial economy by freeing you from answering this silly question.

4.  The only thing dumber than drawing a line between implant and no-implant would be to draw a line between preapproval and 510(k).  By the way, the court’s question mucks up the distinction between approval and clearance. More to the point, how does regulatory pathway determine the unavoidably unsafe categorization?  There is no logical connection whatsoever. Either pathway concludes in a determination of safety. You do know about the substantial similarity test, right?  The plaintiffs asked for this horrible question, didn’t they?  (To be fair, this is not the first time a court mixed up the 510(k) vs. PMA issue with comment k.  Last year, we grieved over an 11th Circuit decision that engaged in the selfsame heresy.)

Some of these certification questions strike us as being unsafe, but there is nothing remotely unavoidable about them.

We don’t often get to discuss decisions from Maine. In fact, a quick spin through the blog and you’ll see Maine really only comes up in various canvases or surveys of state law. We don’t dislike the state. We love the lobster — that they take very seriously. We can’t say we love the winters there (at least this blogger doesn’t), but the coastline is beautiful in summer. And perhaps our vision of Maine is just ever so slightly skewed by Stephen King having set so many of his horror novels there. While King’s frightening tales are set in fictional towns, avid readers and explorers have suggested that you can visit several real places in Maine that seem to have inspired King’s work. For instance, if you’re looking for Derry, you want to stop in Dexter, Maine (mind the sewers). If you are more of a Cujo or Needful Things fan, Castle Rock is supposedly based on Woodstock, ME. You won’t find a giant dome in Rumford, but you’ll probably notice its otherwise close resemblance to Chester’s Mill (Under the Dome). And finally, there is King’s hometown of Bangor which is rumored to be the inspiration for the town of Haven from The Tommyknockers.

So, we were quite pleased when Dustin Rawlin and Bill Berglund of Tucker Ellis sent us their recent, far from creepy, win from the 23rd state. The case is Novak v. Mentor Worldwide LLC, 2018 WL 893914 (D. Maine Feb. 14, 2018) and the primary issue is statute of limitations. Statute of limitations cases are also not something we spend too much time on here, but this one has a notable ruling specific to prescription medical products liability cases – the discovery rule does not apply.

In 2004, plaintiff underwent surgery during which defendant’s product, a vaginal sling, was implanted to treat stress urinary incontinence. Id. at *1. Around 8 months to 1 year after the surgery, plaintiff started to experience pain during intercourse and by the end of 2006 was experiencing vaginal leaking and bleeding. Id. at *2. Before the end of 2006, plaintiff informed her surgeon of her problems. He ordered tests, the first round of which were inconclusive and plaintiff failed to undergo furthering testing. Id. In 2013, plaintiff attributed her problems to defendant’s product which was partially removed in another surgery in 2014. Id. Plaintiff filed suit in 2016. Id. at *1.

Maine’s statute of limitations for all civil actions is 6 years from when the cause of action accrues. Id. at *3. Further, Maine follows the date-of-injury rule when it comes to accrual. “[M]ere ignorance of a cause of action does not prevent the statute of limitations from running.” Id. In other words, generally Maine does not apply the “discovery rule” to determine when the statute starts to run (in states that do, a claim does not accrue until the plaintiff discovers or should have discovered the wrongdoing or misconduct). There are, however, exceptions where Maine has expressly applied the discovery rule: legal malpractice, foreign object and negligent diagnosis medical malpractice; and asbestosis. Id. General products liability claims not included.

Maine has also acknowledged the continuing tort doctrine where the alleged tort occurs over a series or chain of incidents. In such cases, the claim would not accrue until the last act in the chain – such as cases of pollution or contamination. Id. at *4. The continuing tort doctrine does not apply in cases where plaintiff’s alleged injuries, while occurring or perhaps worsening over time, are allegedly caused by a single act of negligence. Id.

Because plaintiff filed suit in 2016, her claims are time-barred if they accrued before 2010. As we noted above, her surgery was in 2004 and her complications appear to have started within the first year thereafter. So, unless the court applied the discovery rule, her claims would be barred.

Plaintiff’s first argument was that the presence of the defendant’s medical device in her body constituted a continuing tort that didn’t end until the product was removed in 2014. Id. at *5. But the continuing tort doctrine isn’t about continuing harm. What plaintiff here, or in almost any drug or device products liability case is alleging is a “finite act or set of acts (manufacture, design, inadequate warning, or misrepresentation) that led to her injuries.” Id. Once the device was implanted, the alleged wrongful act was over.

[Plaintiff] underwent only one, readily-identifiable exposure to the [device] (her surgery), and all of [defendant’s] allegedly tortious conduct took place before that point. . . . [defendant’s] wrongful conduct may have caused the [device] to deteriorate, which in turn may have caused injuries over time. However, once those injuries had manifested, the fact that their full scope remained unknown did not stop the statute of limitations from running.

Id. at *9, n.6.

Plaintiff’s second argument was that there was a genuine dispute regarding whether her earlier symptoms, pre-2006, were caused by the defendant’s medical device. Perhaps plaintiff should have thought of that argument before submitting an expert report tying those early symptoms to the medical device. Id. at *6. Nor could plaintiff rely on her surgeon not identifying a connection between the device and her symptoms when his tests were only inconclusive and plaintiff opted not to do further testing. Id. For a jury to conclude that plaintiff’s early injuries were not caused by defendant’s product would require “complete speculation.” Id. The statute started to run when plaintiff first experienced symptoms, regardless of how minor those symptoms were. Id. at *9, n.7.

While the statute of limitations did away with almost all of plaintiff’s claims, her fraud based claims remained. On those, as well as any other claim based on a failure to warn, defendant argued plaintiff failed to meet her burden to prove causation – plaintiff had no evidence that a different warning or information would have changed her surgeon’s decision to implant the device. Id. at *7. First, it is noteworthy that the court applied the learned intermediary doctrine. Id. at *8. Maine’s high court has never discussed the rule. The court relied on other federal courts interpreting Maine law on the issue.

So, applying the learned intermediary, the court’s focus correctly shifted to plaintiff’s surgeon. Plaintiff did not dispute that her doctor was aware of various risks, including those experienced by plaintiff. Id. Instead, plaintiff’s tried to meet their causation burden by arguing that the doctor “may very well have decided” not to implant the device if he had been provided different warnings. Id. But, that is either an unsupported fact or mere speculation and neither are evidence. Id. Plaintiff next showed the court some medical literature concerning the risks of the medical device and the doctor’s deposition transcript. But offered no connection between the two.

[The doctor’s] deposition transcript reflects that [plaintiff’s] counsel failed to ask him whether additional information would have altered his decision to go ahead with [plaintiff’s medical device] surgery.

Id. at *9. While not discussed directly in the opinion, requiring affirmative evidence that the doctor would have changed his use of the product for plaintiff to survive summary judgment is certainly an implicit rejection of the heeding presumption. Nor was it defendant’s obligation to ask these questions at the doctor’s deposition. Id. at *9, n.14.

So, while Maine may more quickly bring to mind images of butter poached crustaceans or mysterious floating red balloons, it’s not a bad place for prescription medical products cases either.

Until very recently, the only state high court decisions (from VA and DE) on our ediscovery for defendants cheat sheet involved sanctions against plaintiffs for destroying social media evidence.

No longer.

In Forman v. Henkin, ___ N.E.3d ___, 2018 WL 828101 (N.Y. Feb. 13, 2018), the New York Court of Appeals reaffirmed that discovery of plaintiff social media is available to defendants on the same basis as any other discovery, and put the kibosh on plaintiff-friendly discovery restrictions that had lower New York courts had developed to hamstring defendants seeking access to plaintiffs’ social media.

Forman was about as far from prescription medical product liability as one can get and still involve personal injury.  The plaintiff fell off a horse, was badly injured, and sued the owner of the horse. Forman, 2018 WL 828101, at *1.  Plaintiff, who claimed to have become “reclusive” following the accident, was a heavy social media user:

At her deposition, plaintiff stated that she previously had a Facebook account on which she posted “a lot” of photographs showing her pre-accident active lifestyle but that she deactivated the account about six months after the accident and could not recall whether any post-accident photographs were posted.

Id.  She also claimed to “ha[ve] difficulty using a computer and composing coherent messages” after her accident.  Id.  Thus, the relevance of plaintiff’s social media activities was as plain as the nose on that horse’s face.  After plaintiff testified to these facts, social media information confirming or refuting them, at minimum, bears on credibility, and goes to damages, as well – right?

Well…. Not as the Appellate Division saw the issue (note: only plaintiff appealed, so the issues being considered are somewhat narrow).  It limited disclosure only “to photographs posted on Facebook that plaintiff intended to introduce at trial” and “eliminate[ed] the authorization permitting defendant to obtain data relating to post-accident messages.”  Forman, 2018 WL 828101, at *2.  Why?   The Appellate Division held that unless the defendant could find something in plaintiff’s public social media suggesting a specific basis for additional discovery, the defendant had no right to any discovery from the plaintiff’s private social media:

[T]he Appellate Division . . . employ[ed] a heightened threshold for production of social media records that depends on what the account holder has chosen to share on the public portion of the account. . . .  Several courts applying this rule appear to have conditioned discovery of material on the “private” portion of a [social media] account on whether the party seeking disclosure demonstrated there was material in the “public” portion that tended to contradict the injured party’s allegations in some respect.

Id. at *4 (citations omitted).

The defendant argued that its right to discover relevant evidence under the control of an opposing party is not predicated on the legal equivalent of a snipe hunt.  Id.  Thankfully, the Court of Appeals “agree[d],” id., and threw out the Appellate Division’s made up impediment to ediscovery for defendants.  First, discovery is discovery, no matter who seeks it:

Disclosure in civil actions is generally governed by CPLR 3101(a), which directs: “[t]here shall be full disclosure of all matter material and necessary to the prosecution or defense of an action, regardless of the burden of proof.”  We have emphasized that the words material and necessary are to be interpreted liberally to require disclosure, upon request, of any facts bearing on the controversy.

Id. at *2 (citation and quotation marks omitted).  New York recognizes only “three categories of protected materials” – “privileged matter,” “attorney[] work product,” and “trial preparation materials.”  Id.  A plaintiff’s (or defendant’s, for that matter) social media doesn’t fit in any of these categories.

Beyond the three categories, discovery may be limited if unduly “onerous.”  Id. at *3.  Discovery of photos actually posted by the plaintiff (with an exception for “nudity or romantic encounters” specified by the trial court) wasn’t “onerous” either, and plaintiff did not argue otherwise.  Id.

The Court of Appeals in Forman flatly rejected the plaintiff’s supposed precondition to social media discovery, recognizing that it would let plaintiffs hide the ball:

[A] threshold rule requiring that party [seeking discovery] to “identify relevant information in [the social media] account” effectively permits disclosure only in limited circumstances, allowing the account holder to unilaterally obstruct disclosure merely by manipulating “privacy” settings or curating the materials on the public portion of the account.  Under such an approach, disclosure turns on the extent to which some of the information sought is already accessible − and not, as it should, on whether it is “material and necessary to the prosecution or defense of an action.”

Forman, 2018 WL 828101, at *4 (citation, quotation marks and footnote omitted) (emphasis added).  Hear, hear.

Rather, the principle circumscribing social media discovery is the same as for all discovery – relevance to the theories and defenses of the particular case.  While blanket discovery of everything in every case, whether social media or otherwise, would be “onerous,” id., discovery tailored to the plaintiff’s claims and the defendant’s defenses is normal and proper:

[T]here is no need for a specialized or heightened factual predicate to avoid improper “fishing expeditions.”  In the event that judicial intervention becomes necessary, courts should first consider the nature of the event giving rise to the litigation and the injuries claimed, as well as any other information specific to the case, to assess whether relevant material is likely to be found on the [social media] account.

Id. at *5.  Plaintiffs would have a chance to assert “any specific ‘privacy’ or other concerns” about the social media discovery being sought.  Id.  In “a personal injury case . . . it is appropriate to consider the nature of the underlying incident and the injuries claimed.”  “Temporal limitations may also be appropriate” so that social media “posted years before an accident” may not “be germane.”  Id.

The Court of Appeals also rejected the plaintiff’s argument that social media discovery “necessarily constitutes an unjustified invasion of privacy.”  No it doesn’t.  A plaintiff who brings a lawsuit necessarily waives privacy with respect to evidence relevant to that action.

We assume . . . that some materials on a [social media] account may fairly be characterized as private.  But even private materials may be subject to discovery if they are relevant.  For example, medical records enjoy protection in many contexts under the physician-patient privilege.  But when a party commences an action, affirmatively placing a mental or physical condition in issue, certain privacy interests relating to relevant medical records − including the physician-patient privilege − are waived.  For purposes of disclosure, the threshold inquiry is not whether the materials sought are private but whether they are reasonably calculated to contain relevant information.

Forman, 2018 WL 828101, at *5 (citation omitted) (emphasis added).  We note that one of the omitted citations is to Arons v. Jutkowitz, 880 N.E.2d 831 (N.Y. 2007), the decision confirming defendants’ right to informal interviews with treating physicians in New York, which we blogged about, here).

In short, plaintiffs who don’t want to produce their social media shouldn’t be plaintiffs.  If you can’t stand the heat, get out of the courtroom.

Thus, it was “err[or]” to condition discovery of “private” social media on what a plaintiff might, or might not, have done on public social media.  The Appellate Division had “effectively denied disclosure of any evidence potentially relevant to the defense.”  Id. at *5 n.6.  Rather, plaintiff’s testimony about her social media activities “more than met [any] threshold burden of showing that plaintiff’s Facebook account was reasonably likely to yield relevant evidence.”  Id. at *5.  Any photos of plaintiff’s activities “might be reflective of her post-accident activities and/or limitations.”  Id.  Further, “data revealing the timing and number of characters in posted messages would be relevant to plaintiffs’ claim that she suffered cognitive injuries that caused her to have difficulty writing and using the computer.”  Id. at *6.

Forman thus confirms what we have always thought – anything a plaintiff puts on social media is fair game for discovery, to the same extent as any other information under the plaintiff’s custody and control.  Decisions that seek to impose additional limitations on social media discovery, because social media is somehow different or more private, are wrongly decided.

(Note that this post comes from the Cozen O’Connor side of the blog.)

Good morning. Do you have your coffee? If so, start sipping it. You will need it. Because this morning we’re going to discuss leads for implantable cardiac defibrillators (“ICD”), Riata Leads to be precise. Now, while this may not be the most thrilling subject, you have to admit that Riata Leads is a solid name. It sounds like something important, like rock-solid leads for selling real estate, the type of game-changing leads that Shelly “the Machine” Levene would plot to steal from his boss’s office. Like the Glengarry leads. But these are not the Glengarry leads. They truly are ICD leads, ones that detect a patient’s abnormal heartbeat and deliver an electric shock to restore a normal heartbeat. So take another sip of your coffee.

Plaintiff Richard Connelly alleges that in 2003 his doctors surgically connected Riata Leads to his heart but that, in 2010, the leads improperly shocked him 16 to 20 times while he slept, causing damage to his heart and requiring surgery to replace them. Connelly v. St. Jude Med., Inc., 2018 WL 732734, at *2 (N.D. Cal. Feb. 6, 2018). Plaintiff hired a lawyer and sued, claiming that St. Jude, the manufacturer, failed to file adverse event reports about the Riata Leads and that, if it had, plaintiff’s doctor would not have implanted them or, in the least, would have removed them after he did implant them. Id. at *1-2.

As you can probably tell already, this is another parallel violation claim. So take another sip. Plaintiffs file a lot of these claims. We write about them often. And they often fail, for many reasons. This one failed because plaintiff didn’t adequately allege causation. In particular, his complaint didn’t connect the defendant’s alleged failure to file adverse event reports about the Riata Leads to his doctor’s decision to implant them or leave them in.

In this respect, the allegations had a number of problems. They had a timing problem. The allegations did not plausibly suggest that the defendants failed to file adverse reports about the Riata Leads before they were implanted in plaintiff, which happened in 2003. Id. at 3. The allegations had regulatory problems. While the FDA issued a 483 Report covering the years 2002 to 2009 noting that the defendant failed to file adverse event reports on Riata Leads, plaintiff did not identify a single failure to file a report before the Riata Leads were implanted in him in 2003. Id. The allegations had defect identification problems. The FDA inspection that resulted in the 483 Report focused on malfunctions in the Riata Leads due to perforation, but the defect alleged by plaintiff had to do with improper abrasion. Id. OK, take one last sip of coffee. We’re almost there.

Finally, plaintiff claimed that defendant’s failed to file adverse event reports about Riata Leads after they were implanted in him, resulting in his doctor not removing them. This theory failed as a matter of California law, which does not allow such claims:

[T]o the extent Connelly’s claim is premised on a theory that St. Jude had a post-distribution (i.e., post-implantation) duty to warn, this fails as a matter of law. Under California law, a defendant may be held strictly liable for a failure to warn only if “the defendant did not adequately warn of a particular risk that was known or knowable…at the time of manufacture and distribution.” Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549, 558 (Cal. 1991).

Id. at 4.

Having already dismissed plaintiff’s complaint once before, this time the Court dismissed it with prejudice.

Ok, all done. Now “Put . . . that . . . coffee . . . down! (I’m here from downtown. . . . I’m here from Mitch and Murray.)