Adverse Event Reporting

It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.  One would think so, but certain California breast implant plaintiffs (yes, some still exist) would beg to differ – at least they did before the recent decision in Mize v. Mentor Worldwide LLC, No. BC649083, slip op. (Cal. Super. Oct. 1, 2018).

One problem that that current breast implant litigants face that their more numerous predecessors did not is preemption.  All that earlier litigation caused the FDA to upclassify breast implants to Class III, pre-market approved devices, and PMA means preemption.

In California, that also means the filing of half-baked, failure-to-report claims that no self-respecting plaintiff would otherwise bring, as a way to allege something that gets around preemption.  Trouble is, these breast implant plaintiffs can’t even allege that the defendant didn’t report any adverse incidents.  Even what plaintiff did allege was notably speculative:

Plaintiff now has alleged, however, that if [defendant] had reported additional adverse incidents subsequent to 2000, and if the FDA had made such incidents public, and if Plaintiff’s doctors had been aware of such reports, Plaintiff’s doctors might have provided an earlier diagnosis leading to earlier surgery to remove the implants and Plaintiff’s damages . . . might have been lessened.

Slip op. at 5. That’s a lot of “what ifs” piled on top of “what ifs,” but this plaintiff couldn’t even get to that.

There weren’t any unreported adverse events.

So the plaintiff tried to make them up.

The entire questionable “causal chain” wasn’t based on any known, but unreported, events at all, but rather on allegations about how studies were conducted:

[I]t is premised on [defendant’s] failure to report adverse incidents that were not detected because of how [defendant] conducted the studies rather than on a failure to report adverse incidents that actually occurred.

Id.  Even for a liberal jurisdiction, that was just too much.  There must be something that actually wasn’t reported.

Because Plaintiff has failed to allege facts showing that [defendant] failed to report actual adverse events that in fact occurred, the failure to warn (failure to report adverse events) claim is preempted because plaintiff has failed to allege how [defendant’s] actions in conducting these studies violated federal law.

Id.

While the Mize court “adopted the reasoning” of Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017) – a case we discussed hereMize was really a step into fantasy beyond even Ebrahimi.  As pleaded, Ebrahimi at least involved allegations that (vaguely) alleged that events weren’t reported.  Mize didn’t.  She seems to have been alleging that the defendant was obligated to conduct studies in a way that maximized the number of reportable adverse events.  That “duty” is, of course, contrary to tort policy and medical ethics, both of which seek to reduce, not increase, product injuries.

The plaintiff in Mize also tried to allege a “manufacturing defect,” but that didn’t fare any better.  Lacking any direct evidence, plaintiff tried to rely on “allegations that supported . . . [a] 1998 Consent Decree.” Slip op. at 3.  But plaintiff’s implant wasn’t manufactured until at least two years after that decree, and the decree itself was “evidence of a promised change in practices,” so the decree could not be evidence of any defect in the device implanted in the plaintiff.  Id.  Again, simple logic seems beyond the plaintiff in Mize.

Finally, the Blog wishes to express its appreciation to Dustin Rawlin, of Tucker Ellis, and his team of, Peter Choate, Monee Hanna and Allison Burke, who not only won the case, but were thoughtful enough to send it along to us.  Keep up the good work.

If a court acknowledges that no state or federal appellate courts in the jurisdiction have addressed the question before it, we think at a minimum there also should be an acknowledgement of the Erie doctrine. Yet, in the case of Fogel v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sep. 28, 2018) you get the former without the latter. Fogel is one of our least favorite types of decisions, one that claims to be a prediction of state law but instead over reaches to create new liability where it did not previously exist. That is not the job of federal courts interpreting state law.

Under the Erie doctrine, in the words of the Supreme Court:

[a] federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975). And, not surprisingly, the Second Circuit agrees. See Runner v. New York Stock Exchange, Inc., 568 F.3d 383 (2d Cir. 2009) (“our role as a federal court sitting in diversity is not to adopt innovative theories that may distort established state law”). But Fogel disregarded Erie and then disregarded that New York has not recognized a failure to warn claim based on failure to report adverse events to the FDA.

Here are the facts. Defendant manufacturers a heart valve that underwent pre-market approval by the FDA. Fogel at *1. Plaintiff’s child underwent surgery in which her pulmonary heart valve was replaced with defendant’s valve. Two years later, the valve failed and plaintiff’s child had to undergo revision surgery during which complications occurred that caused permanent injuries. Id. at *2.

In deciding defendant’s motion to dismiss, the court found several of plaintiff’s claims were preempted. A fraud allegation that defendant concealed information from the FDA during the PMA process was preempted under Buckman as fraud-on-the-FDA. Id. at *4. Design defect was preempted under Riegel because the valve’s design was approved by the FDA and any challenge to that design would impose state law requirements that are “different from or in addition to” FDA requirements. Id. Manufacturing defect failed because plaintiff “failed to plausibly allege a manufacturing defect that violated FDA requirements.” Id. at *5. A conclusory allegation of a deviation was insufficient.

That leaves failure to warn – where the decision goes astray. As with Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc) and Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the Fogel court recognizes that a traditional state law failure to warn claim must be preempted under Riegel. “To the extent Plaintiff[] claim[s] that the [device’s] warning label was inadequate . . ., like the design-defect claim, must fail because the warning was approved by the FDA.” Fogel at *5. That should be the end of the story. Because “any attempt to predicate the [] claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Stengel, 704 F.3d at 1234. So let’s call failure-to-report claims what they really are – a sidestep around preemption. Frankly, they shouldn’t even get that far because what they really are are attempts at private enforcement of FDA reporting requirements which should be impliedly preempted under Buckman and 21 U.S.C. § 337(a).

That’s certainly the case in New York where a failure-to-report claim has not been recognized under state law. In fact, had the district court engaged in an Erie analysis it would have found that in other contexts New York has actually rejected state-law tort claims predicated on failure to report something to a governmental body. See 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); In re Agape Litigation, 681 F. Supp.2d 352, 360-61 (S.D.N.Y. 2010) (rejecting private cause of action premised on federal reporting requirements in Bank Secrecy Act). A more fulsome discussion of these analogous cases in other states can be found in our post here.

District courts faced with an undecided state law question are not allowed to create liability where it did not previously exist. It was not the district court’s job to expand New York’s duty to warn the medical community to include the FDA.

The federal requirements require that adverse events and other reports be made to the FDA. While New York law may require manufacturers to warn the medical profession, that is not the same as a duty to report to the FDA.

Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188, 201 (E.D.N.Y. 2015)(rejecting failure-to-report claims as preempted and not valid under NY law). So, under existing New York law, failure to warn physicians imposes an obligation different from and in addition to the FDA’s requirement to report adverse events. Making the claim both preempted as non-parallel and as purely FDCA-based.

 

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

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA. It is a claim that should not survive either express or implied preemption.

But, some courts do allow it, such as Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018). Now, we think the Bull court is overstating when it says “most courts” to have considered a failure to report claim have found it to be a parallel claim. We refer you to our PMA Preemption scorecard which clearly shows this is an issue on which courts are split. Nor is the reasoning of the opinion anything new. Defendant had a duty under state law to warn physicians and a duty under federal law to comply with adverse event reporting requirements and those two requirements aren’t in conflict with each other. Id. at *8. But just because two roads don’t intersect doesn’t mean they are parallel.

And, because Pennsylvania doesn’t recognize a state law failure to report claim, any such claim exists solely as a result of the FDCA and therefore should also be impliedly preempted. Again, having concluded there are parallel duties, Bull also concludes no implied preemption. The court found that plaintiff alleged a valid state law failure to warn claim that was based on a failure to comply with its federal duty to report adverse events to the FDA. Id. at *9.

We don’t like those conclusions, but it’s also not the first time we’ve seen them. Where we usually take solace is that more often than not a finding that a failure to report claim is not preempted is followed by a finding that it is also not adequately pleaded. We refer you back again to the PMA Preemption scorecard for the many, many decisions reaching that conclusion. The primary reason the claim fails TwIqbal – failure to sufficiently plead causation.

Unfortunately, the court in Bull gave plaintiff a pass on pleading physician-specific warning causation. The complaint “does not even allege that [plaintiff’s] doctors consulted the [FDA adverse event] database, or any other source of . . . adverse event reports, when making their treatment decisions.” Id. But the court found that unnecessary. Instead, all that was required was an allegation that prior to the implantation of the device in plaintiff, defendant failed to disclose adverse events that if disclosed may have led her doctor’s not to use the device. Id.

That shouldn’t be enough. Even Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which allowed a failure to report claim, acknowledged that causation is a particularly problematic hurdle for plaintiffs:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Therefore, the causal chain requires both that the FDA would do something differently (such as make the adverse events public), and that that hypothetical action by the FDA would have caused the prescriber, in turn, to change his/her prescribing decision in some way that would have prevented the claimed injuries. Plaintiff’s allegations in Bull, as set forth in the opinion, are much too vague to support a plausible causation claim.

And the analysis shouldn’t have stopped there. The opinion actually sets forth sufficient facts that were pleaded to support reaching just the opposite conclusion on causation.

First, would the FDA would have done something differently? Plaintiff had the device implanted in 2010 and began experiencing problems with it in 2015. Bull at *5. Per the facts alleged, in 2009 the FDA conducted an inspection of defendant’s manufacturing facility. Id. at *2. The report of that inspection included information about Medical Device Reports (MDRs) that were either untimely or not submitted to the FDA. Id. at *3. It also included an analysis of MDRs both at the company and within the FDA’s database. Id. at *2-3. So, what the facts establish is that the FDA became aware of these adverse events a year before plaintiff received the device and at no time prior to plaintiff’s surgery did the FDA require defendant to take any further action to warn physicians beyond the existing labeling and warnings. So there is no causal nexus between the alleged failure to report and plaintiff’s injury.

Moreover, to the extent plaintiff relies on a 2011 FDA Safety Officer Report and a 2012 483 Inspection, those took place after plaintiff was implanted with the device and if they involve allegedly unreported events after 2010 – they can have no bearing on causation. To establish causation plaintiff should be required to prove (and plead) that had the adverse events been properly reported to the FDA, the information would have reached plaintiff’s physician in time to prevent the alleged injuries.

Second, would plaintiff’s doctors have done something differently? Well, because the FDA didn’t take action the answer is there is nothing to trigger plaintiff’s doctors doing anything different either. But, there is also the added fact that in this case after the events were reported and the FDA did require some additional warnings and even after the FDA recalled the device – plaintiff’s doctors did not explant the device. Id. at *5. While we are only privy to what’s reported in the complaint, we think the second link in the causal chain is likely broken as well.

We have a hard time imagining this case getting beyond summary judgment on causation based on what we see as the regulatory history from the opinion. We’ve talked in greater detail about this causation hurdle in failure to report cases here. So, while defendant lost at this stage, we are optimistic about a win in the future.

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.

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York, but, as we reported here, summary judgment was granted for the defendants in all of those cases when Daubert motions disposed of the plaintiffs’ causation experts.  There is another group of Mirena plaintiffs, this time alleging that Mirena caused them to develop idiopathic intracranial hypertension (“IIH”), a serious brain disorder marked by increased pressure in the brain and central nervous system.

Exactly one published study has ever linked Mirena to IIH. The lead author was Mahyar Etminan, Pharm. D. – much more about him in a minute.  You can read the Etminan article here. The Etminan article reported the results of two analyses:  an epidemiological study and an analysis of adverse events reported in the FAERs database.  The epidemiological study – that is to say, the unbiased statistics – did not demonstrate an increased risk of IIH associated with Mirena use when compared to combined oral contraceptives.  But the article reported that the FAERs analysis demonstrated a higher-than-expected proportion of IIH reports with Mirena as compared to all other products in the FAERS database.  (We’ve devoted an entire post (and cheat sheet) to why adverse event reporting doesn’t, and can’t, demonstrate causation.)

The Etminan article was published in 2015 and included a standard “no conflict of interest” statement. In the ensuing months, Mirena IIH plaintiffs in a half-dozen district courts disclosed their experts.  Among them was none other than Mahyar Etminan, who, it turns out, had been on plaintiffs’ payroll all along in a blatant conflict of interest not disclosed in his article.  Etminan, along with three other causation experts, cherry-picked the results of the FAERs analysis to allege a causal relationship between Mirena and IIH but never dealt with the conflicting epidemiological data from the same article.

And it gets even better.   In December 2016, Etminan executed an affidavit, which you can see here.  In it, Etminan explained that the methodology of the FAERs analysis was flawed and did not support its conclusion.  Specifically, in comparing the proportion of IIH reports among Mirena users with the proportion among non-users in his FAERs analysis, Etminan failed to limit the comparator groups to women of reproductive age.  Because women of reproductive age have a higher background incidence of IIH than other age groups, failing to limit the comparator groups to these women introduced a bias against the Mirena group.  When the analysis was re-done with the correct comparator groups, the affidavit explains, the results did not support a claim that Mirena increases the risk of IIH.

And so Etminan, the source of the only published study claiming that Mirena causes IIH, publicly renounced his published conclusions. (Earlier, when the flaws in the FAERs analysis came to light, Etminan withdrew from the seven cases in which he’d been named as an expert.)  We don’t know that we have ever seen anything like this in all of our days litigating mass torts.  And we love watching the collapse of a house of cards erected on a foundation of paid (and undisclosed) advocacy.

But the story isn’t over yet. None of plaintiffs’ other causation experts – all of whom also relied on Etminan’s published FAERs analysis – has yet withdrawn.  And, just days ago, IIH cases were centralized in an MDL in the Southern District of New York.  (Plaintiffs had sought such an MDL in 2014, but the JPML rejected that request.)  Regular blog readers are familiar with our views of many MDL plaintiffs and their lawyers, spawned during countless hours fighting hordes of meritless claims that MDL judges allow to remain pending.  By rights, with no evidence of causation, plaintiffs should be out of court.  And, certainly, some threshold determination of merit should precede the formation of an MDL.  But mass torts exist for the masses, who queue up for settlement handouts that don’t depend on meritorious claims.  Can the new IIH MDL proceed very far down the litigation path when the plaintiffs’ causation claim has been debunked by its primary supporter?  Back in November, we learned never to say never.  So stay tuned.

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA.  Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.

To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):

[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.

Id. at 776.

Continue Reading Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

Desperate to get around preemption, in PM medical device and generic drug cases, plaintiffs have been pushing disguised fraud on the FDA claims under the rubric of “negligent failure to report.”  Even though such claims facially challenge the adequacy of information that a regulated party submits to the FDA (a Buckman no-no), some courts have cut plaintiffs a break where just about every other claim they might make would be preempted.  E.g., Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013); Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011); Stoddard
v. PLIVA USA, Inc.
, 2014 WL 4416085 (E.D.N.C. Sept. 8, 2014).

Even putting preemption aside, failure to report claims are lousy cases.  Causation, in particular, is a problem, as a concurring opinion in Stengel pointed out:

 Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [plaintiff’s] doctors in time to prevent his injuries.

 

704 F.3d at 1234.
Nor can plaintiffs alleging failure to report assert that the FDA would have acted differently, since that was what Buckman preemption was all about – common law claims predicated on the FDA itself doing something different inherently conflict with what the FDA actually did.  Causation in such a claim must focus, as Stengel observed, on a prescriber’s receipt of additional information.

As we’ve discussed at length – even with a cheat sheet on the subject – the FDA’s voluntary reporting databases have lots of problems, so much so that the FDA itself warns against using them to evaluate cause and effect.  One of these problems is that, for products unfortunate enough to become mass tort targets, lawyer-generated reporting (anybody can file a report) swamps legitimate adverse event reports filed by manufacturers or health care providers.

[T]he distortion in pharmacovigilance signals as a
result of excess reporting by attorneys is a cause for concern in a pharmacovigilance database with known underreporting of adverse events across all drugs.  This may result in an overestimation of the strength of association.

Stobaugh, et al., “Alleged Isotretinoin-Associated Inflammatory Bowel Disease:  Disproportionate Reporting by Attorneys to the Food and Drug Administration Adverse Event Reporting System,” 69 J. Am. Acad. Dermatology, 393, 397 (Sept. 2013).

Because of these problems, the FDA’s voluntary reporting system is in the process of being replaced by the “Sentinel” system, which allows the FDA to analyze “big data” – electronic patient records maintained by many of the largest health insurers in the country.  Together, Sentinel participants insure, and thus give the FDA access to records for, over 170 million people.  Here’s a description of Sentinel from a recent article:

The Sentinel network consists primarily of eighteen organizations that include some of the nation’s largest health insurers . . . and various disease registries.  In addition, other institutions have collaborated in establishing the network, and the FDA says that it has access to selected data from eighty-eight hospitals and other inpatient facilities.

 

Overall, the FDA and [the entity managing Sentinel] say that they have access to prescription medication data on approximately 178 million people, with the routine accrual of medication data on 48 million currently enrolled or treated at the eighteen core partner organizations.  Sentinel, they say, has 358 million person-years of data that include 4.0 billion prescriptions, 4.1 billion doctor or lab visits and hospital stays, and 42.0 million acute inpatient stays.

Health Policy Brief, “The FDA’s Sentinel Initiative,” at 3 (Wood Fdn. Jun. 4, 2015).  While the other side may have figured out how to game the FDA’s voluntary reporting systems to create phony “signals,” we don’t think they can easily game – or even access – Sentinel.

What that means for failure to report claims is that the FDA no longer relies chiefly on reporting systems (voluntary or mandatory) for seeking out pharmacovigilence “signals,” and probably won’t be relying on such reporting at all in the future. There goes causation out the window, since the reports in question will no longer (to the extent they ever were) be of much significance.

The widespread transition to electronic medical records has enabled a new era of FDA “big data” analysis of medical events that isn’t hamstrung by underreporting, biased reporting, or even purported “failure” to report.  With AERS, MAUDE and other FDA reporting systems in the process of being superseded by 21st Century technology, it will become impossible, if it isn’t already, for plaintiffs to establish that any defendant’s alleged “failure to report” adverse events had any impact at all on information relied upon by prescribing physicians.

A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.” The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle? Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected.

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County — in the Accutane Multicounty Litigation. This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plaintiffs’ verdicts. (See here and here, for example.)  But we were most pleasantly surprised this time.

In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.” Accutane, 2015 WL 753674 at *6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.

Continue Reading A Pleasant Surprise from the Accutane MCL

We saw the movie “Whiplash” last weekend.  In this Oscar contender, a drum student at a prestigious music conservatory seeks the approval of a harsh and punishing conductor, as well as a berth in the conductor’s competition jazz band.  The film is so tense and so consistently painful to watch that it would not be accurate to say that we “enjoyed” it, but we wouldn’t have missed it for the world.

Early in the movie, the conductor demands that the student play several measures over and over and over again in a relentless and seemingly futile attempt to find the correct tempo. In today’s decision out of the Denture Cream MDL pending in the Southern District of Florida (thanks to David Walz at Carleton Fields for sending it to us)  Plaintiffs are back, beating the same drum, in a repeat attempt to surmount defendant Procter & Gamble’s (“P & G’s”) Daubert challenges to their general causation experts.  In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga, 2015 U.S. Dist. LEXIS 9653 (S.D. Fla. Jan.. 28, 2015).  In these cases, Plaintiffs allege that, with long-term use of Fixodent denture adhesive, the zinc in the product causes copper deficiency and, ultimately, a neurological condition known as copper deficiency myeloneuropathy (“CDM”).  In 2011, the court granted P & G’s Daubert motions to exclude Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig. (Chapman, et al. v. Procter & Gamble Distributing, LLC), 795 F. Supp. 2d 1345 (S.D. Fla. 2011), aff’d, 766 F.3d 1296 (11th Cir. 2014) (“Chapman’).  As we discussed at the time, the Court held, “[Plaintiffs’] theory is not ridiculous, but neither is it necessarily true; it is ripe for testing.  . . . [T]aking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.”  795 F. Supp. 2d at 1367 (emphasis in original).  This past September, as we reported here, the Eleventh Circuit affirmed the District Court’ Chapman decision.

Continue Reading Daubert Decision Bites Denture Cream Plaintiffs Again

It takes time and effort to keep all our scorecards and cheat sheets up to date.  So we fell all over ourselves when a Reed Smith associate, Kevin Hara, offered to update our cheat sheet on adverse event reports.  The result is this guest post.  As you might guess, Kevin works out of the RS San Francisco office.  As with all guest posts, Kevin is due all the credit (and blame, if any) for what follows.  The AER cheat sheet has been simultaneously updated to include the case descriptions in Kevin’s post.

********************

As the San Francisco Giants completed their biennial foray deep into the playoffs, on their way to a third World Series title in the last five seasons, it makes us think of Adverse Event Reports (“AERs”) and Medical Device Reports.  How exactly do we relate baseball to AERs?  The Giants have managed to advance to the World Series with a seemingly rhythmic frequency, in 2010, 2012, and again this year.  Baseball fans even joke that because 2014 is an even numbered year, that was why the Giants won.  Are the two things related?  Do people really believe that the digits on the calendar determine the fate of the Bay Area baseball franchise?  Or is it simply a coincidence, and not a cause and effect relationship? Is it not more likely that consistently good pitching, defense, and timely hitting along with good management are reason that the Giants are winning, and it just happens to fall on even numbered years (although until last night the Kansas City Royals of course disagreed)?  Although Kevin Costner’s soliloquy in Bull Durham captures the idea that baseball players in general take superstition to the extreme, and might argue that the Giants’ success is as simple as the calendar year, the answer of course, is yes, there is much more to the analysis.

A similar analogy can be drawn between using AERs as evidence of causation in pharmaceutical drug and medical device litigation.  There are numerous other potential explanations that may be more likely and one simply cannot draw a conclusion that a drug or device caused an adverse event based on AER data.  The publicly available FDA Adverse Event Reporting System “FAERS,” launched on September 10, 2012, clearly cautions that “[t]he appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk.  It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

However, when required to submit evidence establishing medical causation of their injuries, plaintiffs in drug and device cases frequently attempt to submit expert opinions that rely heavily on AERs. As this blog has reported before, here, and here, AERs, often referred to as case reports, are not reliable indicia of causation.  A recent decision, Wendell v. Johnson & Johnson, which the blog covered here, underscored the fact that anecdotal evidence is not a reliable source of medical causation.  2014 WL 2943572, at *3-5 (N.D. Cal. June 30, 2014).  Although the experts in Wendell “cite[d] a handful of studies and case reports discussing possible causes of HSTCL, none of these purports to show that the specific combination of drugs prescribed to [plaintiff] actually causes HSTCL.”  Id. at *5 (emphasis added).  This straightforward application of the law of medical causation is elegant in its simplicity – if the plaintiff cannot show that the medicine, or in this case – combination of medicines – is even capable of causing the alleged injury, the defendant (rightly so)
prevails.

Continue Reading Guest Post on Adverse Event Reports & Updating Cheat Sheet