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

Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she’s not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn’t quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).

At the heart of the Bard IVC Filters Litigation is an allegation that defendant’s filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.

The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant’s first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn’t matter if the physician wouldn’t have seen it. If the doctor’s testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also “by failing to adequately communicate the warning.” Id. at *324. The court looked beyond the label to “dear doctor letters, product pamphlets, and statements by company sales representatives.” Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.

Defendant’s second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff’s countered that the lack warning wasn’t about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff’s surgeon testified that higher complication rates is something “he would have wanted to know” before plaintiff’s surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.

Taking these two rulings together serves to emphasize the critical importance of the physician’s deposition. This court wanted “unequivocal” evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It’s a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.

The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It’s not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) (“For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It’s one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don’t include and face tort liability; include a face FDA violations for misbranding and misleading information.

Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court’s preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff’s attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff’s attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is “the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails.” Id. at *341.

Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won’t delve into the details here.

Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.


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.

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) Janus, like some of our opponents, is two-faced.  Janus looks both forward and backward.  Bexis last month took a couple of long looks backward at 2017’s best and worst cases.  We’re still scrolling through the various Ten Best of 2017 culture lists for ideas, confirmations, and occasional outrages.  An in-house lawyer we endlessly respect pointed us to The New Yorker’s  list of top tv programs.  It’s hard to quarrel with Emily Nussbaum’s choice of The Leftovers, a fever-dream about love and loss (and a lion sex boat) as the best drama.  She was also right to praise American Vandal, the show that made us laugh out loud the most.  (The Good Place came in second on that score.)  Nussbaum also gave honorable mention to Halt and Catch Fire, an AMC show that really did seem to catch fire after its first, flawed season.  HACF stopped acting like a Mad Men, difficult-guy retread, shifted focus to the female protagonists,  and successfully steered us through the digital revolution – from PC clones to gaming to community chat boards to security to the web to PayPal to Yahoo to something even sexier than a lion sex boat: the Next Idea.  In seasons 2-4, HACF managed to show us (rather than merely tell us) how “computers aren’t the thing; they are the thing that gets us to the thing.”  That ‘thing’ is human connection. But you already knew that, right? There is an episode after the death of a major character that is the best depiction of grief and its clumsy toggling between the transcendent and the quotidian that we’ve seen.  The dead leave a lot behind.  Some of it goes to Goodwill.  Some of it survives in silly stories.  Some of it gets caught in our throats and some of it squeezes our tear ducts hard.  If you are looking for something to binge, consider The Leftovers, American Vandal, and Halt and Catch Fire (and maybe Patriot, The Americans, and Mindhunter).  You might also want to set aside an hour to take in episode 8 of Twin Peaks: The Return because you need to relive your college experience of attending a midnight showing of something arresting and supremely weird. 

Today’s post takes us back to 2017 for a case that is neither particularly arresting nor even a little bit weird.  Rather, the result seems inevitable.  In Siddoway v. GlaxoSmithKline LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2017 U.S. Dist. LEXIS 203885 (E.D. Pa. December 12, 2007), the plaintiff alleged that he sustained a heart attack from taking Avandia, and that the label did not warn him adequately.  The facts here, both regarding the plaintiff’s use and the regulatory backdrop, lead ineluctably to the defendant’s victory on summary judgment.   The plaintiff was initially prescribed Avandia from 2001 through 2002. In 2003, the plaintiff suffered two heart attacks, and ultimately underwent a successful heart transplant operation. He blamed Avandia for those heart attacks.  Following the heart transplant, a different doctor prescribed Avandia to the plaintiff. The plaintiff continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition.

Let’s go backward for a moment.  When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug’s label contained no warning of an increased risk of heart attack. But in 2007 – four years after the plaintiff’s heart transplant — the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”  The FDA directed that a boxed cardio warning be added to the Avandia label.  So there’s your lawsuit, right?

Not quite.  Now let’s go forward.  After the label change and after the plaintiff filed his lawsuit, the manufacturer and the FDA conducted extensive research on Avandia’s safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. Thus, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.  Good science led to good news for patients, but not such good news for this particular patient’s lawsuit.  All of the plaintiff’s nine causes of actions essentially boiled down to failure to warn theories, and the facts on the ground had removed all support for that theory.  Even putting aside the question of whether the original label was inadequate because it lacked a warning that had now been repudiated by the FDA, the plaintiff’s case failed for inability to show that the alleged failure to warn was the proximate cause of the plaintiff’s injuries.  To the extent that specific claims bumped against the learned intermediary doctrine (Utah law governed, so the learned intermediary doctrine was alive and well), the plaintiff faced a huge problem when it came to posing the usual question to the prescriber:  knowing what you know today, would you still have prescribed this medicine to the plaintiff?  From his deposition testimony, it is clear that the prescriber’s “understanding of Avandia’s risk profile today is the same as it was when he prescribed Avandia to [the plaintiff]—that Avandia is not associated with an increased cardiovascular risk compared to other diabetes drugs.  He also testified that, if the current package insert were in place when he was prescribing Avandia to [the plaintiff], he still would have prescribed it.”  That is pretty inescapable logic.  John Adams once said that “facts are stubborn things.”  So is science.  So are label changes. 

But the plaintiff did try to escape the facts, the science, and the label changes.  He pointed to the prescriber’s testimony that he “quit using” Avandia for patients after 2007.  But that same prescriber’s testimony made clear that even when the 2007 data on which the plaintiff based his claims is considered along with the other Avandia risk data available today, he would still prescribe Avandia to the plaintiff, just as he had in 2001 and 2002, when there was no heart attack risk warning in the Avandia label. It is as if the plaintiff tried to preserve his case by seizing upon one favorable moment in time and excluding any other, subsequent facts that might prove inconvenient.  Don’t look forward, and don’t look backward.  Just look at the evidence in that nanosecond that might support a claim.  But no decent doctor would do that.  Nor would any sensible court.  Hence, the Siddoway court held that the plaintiff had failed to establish a genuine issue of material fact as to whether the prayed-for warning would have deterred the doctor from prescribing Avandia to the plaintiff before he suffered the 2003 heart attacks.  The court looked at all the evidence, forward and backward, and saw its way clearly towards complete dismissal of the case.   


Today Time Magazine announces its Person of the Year.  The publisher called us a week or so ago to say we were PROBABLY going to be named Man (Person) (Blog) of the Year, but we would have to agree to an interview and a major photo shoot.  We said “probably” is no good and took a pass. Thanks anyway!

[None of that actually happened.  You might even call it fake news.]

Still, we can see why this blog would receive a major award for its literary achievements.  We admit that we are not quite on the same level as, say, James Joyce’s Ulysses, which 84 years ago on this date was found by an SDNY judge not to be obscene.  We also must ruefully acknowledge that our case analyses are not as funny and transgressive as Lolita, which Vladimir Nabokov completed 64 years ago on this date.  But we have occasionally encountered preemption issues as mystifying as Ulysses and plaintiff pseudo-experts who made the unhinged Humbert Humbert character in Lolita seem rational.

If there is a product liability issue that lends itself to literary invention, it is the issue of warnings.  All that even a minimally creative plaintiff lawyer needs to do is parse an existing warning, then dream up some specification or adjective that would frighten doctors or patients just a tiny bit more.  Stephen King is a fine writer, and odds are that he could do a splendid job of boosting terror in both warning labels and failure to warn claims. Of course, let’s remember that we are talking about fiction.

It is not fictional that there are many assorted asinine warning labels out there based on fear of lawsuits.  A hairdryer bears a warning against use by folks “while sleeping.” A tag on an iron helpfully advises against ironing clothes while worn on the body.  A bag of peanuts cautions us that the product … contains nuts.  The instructions for a chainsaw counsel against trying to stop the chain with one’s hands. An over-the-counter bottle of sleeping pills lists possible side effects, including … drowsiness.

There is more than a little fiction at work in the failure to warn claim in Cerveny v. Aventis, Inc., 2017 U.S. Dist. LEXIS 197194 (D. Utah Nov. 29, 2017).  You may remember the name Cerveny.  This litigation has already produced one of the best decisions of 2017.  The crux of this latest Cerveny decision was the fiction that the plaintiffs’ proposed warning would pertain to the plaintiffs. The court ultimately arrives at a sensible ruling on inapplicability of a warning about a risk to a population group that did not contain the plaintiffs.  The court also makes clear that in fraud/negligent misrepresentation claims, a contraindication is not intended to induce reliance.

The plaintiffs in Cerveny were the parents and their child, who was born with certain physical defects.  The mother had taken a prescription fertility drug before pregnancy, but not during the pregnancy.  That rather obvious and fundamental temporal fact is central to the case. The FDA at one point proposed a warning of possible fetal harm when the drug is taken during pregnancy.  That warning was not on the medicine when taken by the mother in this case, and one of the claims was that it should have been.  The failure to warn claim was essentially that the future mother would not have taken the medicine before pregnancy if she knew that taking it during pregnancy could cause birth defects.

Courts all too often are all too tolerant of plaintiff failure to warn theories.  Those claims all contain a dose of speculation, but some are speculative to the point of implausibility. It might be tempting for the court to pass the question, no matter how absurd, to the jury.  Not the Cerveny court: “When a proposed warning does not apply to the plaintiff, she cannot prove defect or inadequacy.”  The Cerveny court quotes from Rivera v. Wyeth-Ayerst Labs, 283 F.3d 315, 321 (5th Cir. 2002), which rejected as “absurd,” and “too speculative to establish Article III standing” a claim based on an allegation that an “extra warning, though inapplicable to [the plaintiff] might have scared her and her doctor” from using the drug.  Cerveny and Rivera recognize that there must be a limitation to how speculative a  failure to warn theory can be, and that Article III standing must actually mean something.  Accordingly, the Cerveny plaintiffs cannot prevail on a cause of action based on a failure to warn about the risk of a medicine used during pregnancy when the use in the case was only prior to pregnancy.  That is a notable result.  We already have a post collecting opinions that likewise reject warning claims based on inapplicable risks.

There was another ground for rejecting the failure to warn claim.  The label for the drug might not have contained an express warning, but it did contain a contraindication vs. use during pregnancy.  So if that is what the plaintiffs claim needed to be said, it was said in the contraindication section, and that is enough.

What about the plaintiffs’ misrepresentation claims?  The contraindication discussed above also said that “no causative evidence of a deleterious effect” of the medicine on the human fetus had been seen. The plaintiffs contended that the “no causative evidence” language was false.  But even if that is so, the contraindication was not directed to the plaintiff, and it was not intended to induce her to take the medication.  The purpose of the contraindication was to inform doctors that their pregnant patients should not take the medicine.  The plaintiff was simply not in that category. The failure to warn theory conjured up by the plaintiff lawyers was clever and creative, but it was also wrong.

And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward and on the shorter side to post about as we clear our heads and shake off the haze. That’s not to say Mitchell v. Boehringer Ingelheim Pharma, Inc., 2017 U.S. Dist. LEXIS 192498 (W.D. Tenn. Nov. 21, 2017) isn’t noteworthy, it’s just not overly complicated. Sometimes that’s what you need to get the ball rolling again.

Plaintiff in Mitchell alleged that she suffered diabetic ketoacidosis (“DKA”) as a result of using the prescription drug Jardiance to treat her type-2 diabetes. Id. at *3. The drug, one of a class of drugs known as SGLT-2 inhibitors, was approved by the FDA in August 2014 and plaintiff began using it in February 2015. In May 2015, the FDA issued a safety alert warning about the risk of DKA with this class of drugs. The alert was based on a review of adverse event reports collected from March 2013 to June 2014 – before Jardiance was approved. Id. at *3-4.

Products liability claims in Tennessee are governed by the Tennessee Products Liability Act. Under the TPLA, drug manufacturers have a duty to minimize the risk or dangers from their products and they can discharge that duty by providing adequate warnings and instructions. Id. at *7. Plaintiff in Mitchell alleged defendant failed to satisfy that duty because it did not warn about DKA at the time the drug was approved and did not amend the warning via the FDA’s Changes Being Effected (“CBE”) process at any time before plaintiff was injured. Id. at *4.

We see CBE and we immediately start looking for a preemption discussion. Sure enough, there is one. As discussed here many times before, the CBE process allows a manufacturer to add or strengthen a warning based on “newly acquired information” without first obtaining FDA approval. Id. at *9-10. Where a CBE label change is an option for a manufacturer, the Supreme Court has held that failure to warn claims are not preempted. See Wyeth v. Levine, 555 U.S. 555 (2009).

But what about when a CBE is not an option? In Mitchell, the court broke the plaintiff’s failure to warn claim into two pieces – a challenge to the original labeling and a challenge to warning as it was at the time plaintiff used the drug. The court found the former preempted because defendant could not have changed the original FDA approved labeling. The data plaintiff relied on to support her allegation on this claim was pre-launch data. In other words, data that was known to the FDA at the time they approved the drug’s warnings – not newly acquired. “[T]he FDA is the exclusive judge of safety and efficacy based on information available at the commencement of marketing.” Id. at *11 (citing  In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015).

Similarly, plaintiff cannot base her failure to warn claim challenging defendant’s failure to amend the warning after the drug was introduced on the market on information that existed pre-FDA approval. Id. at *13. So plaintiff cannot rely on the adverse events collected before June 2014. Plaintiff’s allegations must be based on information that was not known by the FDA at the time of approval. In her complaint, plaintiff alleged that additional DKA adverse events were reported in 2015. Defendant, citing federal regulations, argued that while later in time, the additional reports did not provide any “new” information that would support a CBE. The court determined that was an issue better suited to a motion for summary judgment and that plaintiff had done enough to withstand a motion to dismiss. Id. at *15. Not a win yet, but the door is certainly still open.

The court made a few other rulings as well. Based on the learned intermediary doctrine, plaintiff cannot bring a failure to warn claim premised on failing to warn plaintiff directly. She is limited to a claim for failure to warn her prescriber. Id. at *17-18. And plaintiff must plead warning inadequacies with specificity. The court determined her allegations as to DKA were sufficient. But, plaintiff failed to state a claim to the extent she was looking to recover for “other related health complications.” Id. at *22. Plaintiff’s complaint neither specified the alleged complications nor how the drug’s warnings were inadequate as to those complications. So, as to unspecified complications, the failure to warn claim was dismissed.

In the end, plaintiff is left with a narrow failure to warn claim and the hurdle of proving proximate cause.

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under the “public policy” exception to the ordinary rules for sorting out choice of law issues.  This was also back in the halcyon days (for the other side) of essentially unlimited plaintiff forum shopping pre-Bauman, so the specter existed that, if this argument succeeded, plaintiffs from all over the country, or even the world, would flock to West Virginia, and by the mere fact of their litigation tourism, thereby rid themselves of one of our side’s most significant arguments.

A couple of West Virginia federal courts were sufficiently pro-plaintiff to buy that “public policy” choice-of-law analysis.  Woodcock v. Mylan, Inc., 661 F. Supp.2d 602, 609 (S.D.W. Va. 2009) (“[b]ecause West Virginia has rejected the learned-intermediary doctrine on public-policy grounds and applying Alabama law to the marketing defect claim would violate that public policy, West Virginia law applies to that claim”); Vitatoe v. Mylan Pharmaceuticals, Inc., 696 F. Supp.2d 599, 610 (N.D.W. Va. 2010) (“it is impossible to apply the substantive law of Louisiana to [plaintiff’s] inadequate warning claim without violating West Virginia public policy”; following “Woodcock’s helpful public policy analysis”).  For doing this, we trolled Woodcock with eighth place on our 2009 bottom ten decisions list:

This decision invoked “forum public policy” to apply West Virginia’s rejection of the learned intermediary rule to a forum shopping plaintiff from Alabama – a staunch learned intermediary state.  That can’t be right.  Practically all major tort law doctrines are grounded in a court’s sense of “public policy.”  Thus the “forum public policy” exception (previously limited to legislatively set policy) becomes another constitutionally suspect means of applying forum law to cases with no significant ties to the state in question.  Any other forum shopper can presumably make the same argument. We’re sure we haven’t seen the last of this.  We blogged about Woodcock here.

Fortunately, the West Virginia legislature stepped in and did the right thing, making its own declaration of West Virginia public policy in 2011:

Choice of Law in Pharmaceutical Product Liability Actions.

It is public policy of this state that, in determining the law applicable to a product liability claim brought by a nonresident of this state against the manufacturer or distributor of a prescription drug for failure to warn, the duty to warn shall be governed solely by the product liability law of the place of injury (“lex loci delicti”).

W. Va. Code §55-8-16(a).  We cheered that development here.

Of course, the entire Karl learned intermediary brouhaha became moot (or so we thought) several years later when the legislature did themselves one better and directly overruled Karl on the merits.  See W. Va. Code 55-7-30 (restoring the learned intermediary rule).  Even more vigorously, we cheered on that development – after the fact, of course, since we made sure not to breathe a word about this before it was a done deal (we know the other side reads our blog, so there are some things we do keep quiet about).

Given this background, it is with no small degree of schadenfreude that we bring to you M.M. v. Pfizer, Inc., ___ S.E.2d ___, 2017 WL 5077106 (W. Va. Nov. 1, 2017).  M.M. involved the West Virginia sojourn of other litigation tourists, this time from Michigan.  Id. at *2.  Michigan, as anyone involved in the defense of prescription medical product liability litigation knows, has a statute that provides the strongest FDA compliance defense in the country (although Texas is close):

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .

Mich. Comp. Laws Ann. §600.2946(5).  As we’ve mentioned before, that statute has produced a “diaspora” of Michigan plaintiffs all running away from the policy judgment made by the legislature of their chosen state of residence.  Those prior plaintiffs didn’t have much luck, and as it turns out, neither did this one.

This time, even if West Virginia courts might have been inclined to cut the Michigan plaintiffs a break, they ran headlong into the West Virginia choice-of-law statute mentioned above.  Even though it was passed to overturn half-baked Karl-based “public policy” determinations, the statute’s literal terms establish West Virginia choice of law “public policy” as to all prescription drug warning cases.  Thus, the M.M. plaintiff – despite having nothing to do with Karl – was entirely out of luck.  “Here, there is no dispute that the injuries alleged by [plaintiffs] all occurred in the State of Michigan.  Thus, [the] failure to warn claim is governed by Michigan law, which forecloses such a claim if the drug was approved by the FDA and the manufacturer complied with the FDA’s labeling requirements.”  2017 WL 5077106, at *3 (also discussing why fraud-on-the-FDA exception to statute doesn’t apply).  Thus, “Michigan law forecloses [plaintiffs’] failure to warn claim.” Id. Interestingly, the court added:

To recognize such a claim under West Virginia law where the same already is foreclosed in the same case by the law of another jurisdiction, however, would contradict the full faith and credit due our sister jurisdictions.

Id. (citations omitted).  “Full faith and credit”?   We confess we haven’t seen that much, indeed ever, before in prescription medical product liability litigation, but anything that keeps a plaintiff from relitigating something they’ve already lost finds favor here.

Unfortunately for these plaintiffs, they were also entirely unable to come up with any defect claim that wasn’t really a statutorily covered warning claim.  “[B]oth the strict liability and negligence claims allege that [defendant] improperly failed to include . . . warnings on its labeling, which, again, constitute allegations that [defendant] failed to warn.”  Id. at *4.  Even if West Virginia law could apply, the choice-of-law statute meant that West Virginia law kicked things back to Michigan, and was “foreclosed thereby.”  Id.  Both their strict liability and negligence claims, although making boilerplate allegations, were “merely a restatement of [plaintiffs’] failure to warn claim,” id. (strict liability), or “merely a reiteration of [plaintiffs’] failure to warn claim.”  Id. at *5 (negligence).  Any way one looked at the case, plaintiffs alleged only a failure to warn, and failure to warn claims had to be determined by Michigan law, where plaintiffs lost.

[B]ecause [plaintiffs’] failure to warn claim is governed by Michigan law, and the governing Michigan statutes provide that a manufacturer cannot be held liable where it has complied with the FDA reporting, disclosure, and labeling requirements, there exists no duty that could have been breached so as to establish a claim for negligence.

Id. at *5.

Now that BMS has pulled the welcome mat away from litigation tourists, we don’t expect much more of a Michigan diaspora, but even if there were, the West Virginia choice-of-law statute, enacted for an entirely different purpose, will preclude any of them from relying on more favorable West Virginia law.  See Id. at *3 n.2 (noting that §55-8-16(a) has since been expanded so that it applies to “all liability claims at issue,” not just warnings).

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.



Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense and jeering a decision for the plaintiff, we do see some cases as having an obvious right result, no matter how long it takes to get there. However, just because a case is from a “bad” jurisdiction does not mean that all the decisions will be bad. In Johnson & Johnson v. Fortenberry, No. 2015-CA-01369-SCT, 2017 Miss. LEXIS 421 (Miss. Oct. 19, 2017), the geriatric plaintiff was prescribed defendant’s antipsychotic medication for about two years before developing a mild oral tardive dyskinesia (something that had appeared with the second medication plaintiff had been on). This was the third medication that plaintiff took for her severe psychosis and it apparently worked well for her. Her prescribing physician was well aware of the risk of tardive dyskinesia with every antipsychotic at the time, considering that the medication had a lower risk of tardive dyskinesia and other extrapyramidal symptoms according to both the medical literature and defendant’s marketing materials. After pending for twelve years, the case went to trial in a notorious plaintiff-friendly jurisdiction before a similarly known judge. Plaintiff proceeded at trial on failure to warn and negligent misrepresentation theories and won a sizable compensatory verdict, although punitive damages did not go to the jury. An appeal and cross-appeal followed.

As we often do, we will focus on the parts of the decision that seem more relevant to us. First, the warnings claim. You may have already guessed that we think this should have been a slam dunk for the defense. You would be right. In addition to what we noted above about the prescriber’s knowledge and plaintiff’s medical course, the prescriber testified that specifically warned plaintiff and her daughter-caregiver (who later pursued the suit for plaintiff’s estate) of the risk of tardive dyskinesia and other extrapyramidal symptoms. Id. at *8. His awareness of the risk was consistent with the thorough warnings for tardive dyskinesia in the FDA-mandate class labeling for all antipsychotics, which he considered to be consistent with his understanding of the risk from other sources. Id. at **9-11. For plaintiff, the prescriber stood by his decision to prescribe the drug, noting “the psychotic symptoms which are terrible and unremitting and lead to very bad outcomes. And those are much more certain than the risks of possible side effects.” Id. at *19. Plaintiff attacked the class labeling as “cookie cutter” and the prescriber’s self-professed understanding of the risk as influenced by the marketing for the drug. Id. at **20-21.

The first question on appeal was whether the label itself was sufficient to warn of the risk of tardive dyskinesia. This was not a close call, as the “label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal.” Id. at *18. In addition, the prescriber “specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Risperdal users at the time he prescribed it to Taylor.” Id. at **18-19. It does not appear that the plaintiff, despite an array of willing expert, had much to say about the adequacy of the label itself. This may have never featured in the trial court, but there would have been an obvious problem with saying that the defendant needed to change the class labeling to avoid liability—implied preemption. In this situation, the drug’s manufacturer could not have taken an independent action to change the already robust class labeling. That did not come up on appeal because the plaintiff argued that marketing undercut the actual content of the label. However, the Mississippi Products Liability Act limits the inquiry to the label itself and the Mississippi Supreme Court was unwilling to allow marketing evidence to be considered. Id. at **21-23. Thus, after fifteen years, an obviously flawed warnings claim—we have not even mentioned the obvious lack of proximate cause—went away.

The negligent misrepresentation claim was another matter, as marketing evidence counted. As an initial matter, the parties agreed that the focus on such a claim for a prescription drug was on the representations to the prescribing physician. From the summary of the evidence at trial, it does not appear that there was a specific representation ever made to the plaintiff’s prescriber that was proven to be false and relied upon in connection with plaintiff’s care. Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber’s decisions with plaintiff. Id. at **26-32. There was no evidence that he saw any of the marketing pieces that plaintiff contended were misleading or acknowledged a specific representation that misled him.

Instead, plaintiff offered a less direct chain of purported proximate cause: 1) prescriber testimony that “I just remember the information about it, and I assume marketing as well as reading about it – I can’t always differentiate because I read journals and things, too – but all the information identified it as atypical and having fewer EPS side effects”; 2) his view from all sources was that the risk of tardive dyskinesia was lower with Risperdal than lower than with older antipsychotics; 3) that he probably would have prescribed another, unspecified medication if he believed the risk of tardive dyskinesia with Risperdal was actually equal to an older antipsychotic; and 4) expert testimony that plaintiff would not have developed tardive dyskinesia if she had been prescribed one of two other antipsychotic medications instead of switching to Risperdal. Id. at **26 & 33-37. For the court, this was enough to raise a jury question as to whether the marketing materials provided to the prescriber misrepresented “that the tardive dyskinesia risk was low and materially lower than the tardive dyskinesia risk from Haldol”—the drug plaintiff was initially prescribed, but not one of the drugs plaintiff’s expert said would have avoided her injury—whether the prescriber relied on such a misrepresentation, and whether it proximately caused plaintiff’s injury. Id. at **38-39.

Here are some problems with that analysis. For the same reason that an adequate pleading of a misrepresentation claim needs to include the who, what, where, and when of the representation, it is hard to see how a plaintiff can establish a misrepresentation without something more specific than what plaintiff offered here. Moreover, where the general representations to the prescriber were perceived as being consistent with what he understood from the medical literature and other sources, there does not seem to have been reliance on any misrepresentation. Any reliance also did not seem to result in the prescription to plaintiff, as the prescriber’s impression from medical literature also would have needed to have been different to affect the prescribing decision. Plaintiff’s evidence on proximate cause also did not seem to match up because the prescriber did not say he would have prescribed one of the two medications that plaintiff’s expert testified would have avoided her injury. That all does not sound like plaintiff established enough to get to a jury on a negligent misrepresentation claim, but, like we said, we might be a bit biased.

Part of why plaintiffs like misrepresentation claims is that they tend to be a better vehicle for punitive damages than failure to warn claims. Here, despite the broad evidence admitted on marketing, which plaintiff contended showed intent to justify punitive damages, the trial court did not let punitives go to the jury. Along the way, the court excluded the defendant’s guilty plea to allegations of improper marketing after plaintiff’s last prescription. Id. at *64. That is a correct decision, but still deserves some recognition. In Mississippi, the trial is supposed to evaluate all the evidence to see if a punitive damages claim should go to the jury. Id. at **65-66. Because the trial judge did that, the Mississippi Supreme Court affirmed. That deserves a little credit too.


Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us to the party. We just learned about the very nice preemption decision entered by the trial court in that litigation. Since it’s never too late to celebrate a preemption victory, here are the highlights.

Before we get into the case specifics, the court’s general preemption analysis merits a minute of our time. ‘[I]f the tort plaintiff’s failure to warn theory was already tested by FDA action or inaction or would have required the use of a label on a prescription drug which the FDA would have prohibited,” the claim is preempted. Risperdal and Invega Product Liability Cases, 2017 WL 4100102 at *5 (Cal. Super. Mar. 16, 2017). What remains for private plaintiffs to challenge in a tort setting, therefore, is the adequacy of the label or the reasonableness of the manufacturer in updating the label based on new or additional information not already considered by the FDA. Id.

 In discussing whether information was presented to the FDA for consideration, of course, fraud-on-the-FDA and Buckman enter the discussion. The court nicely summarized the public policy reasons supporting Buckman preemption:

The understandable concern is that allowing a private right of action for “fraud on the FDA” would embroil the agency’s staff, particularly its scientific staff, in court litigation to the derogation of their performance of their primary duties. This would result both from the consumption of time in litigation activity and from a concern that their routine duties, decision-making processes and public communications would all have to be vetted with litigation avoidance in mind.

Id. at *6.

Next the court establishes that the Wyeth v. Levine “clear evidence” standard does not require indisputable evidence, but rather defendants must establish impossibility preemption by “clear and convincing evidence.” Id. And finally, the court found that preemption is a question of law, not fact and therefore an issue for the court, not the jury. To the extent deciding preemption requires the court to rule on a factual dispute regarding what the FDA would do, “the dispute is one regarding a legislative fact, not an adjudicative fact. Thus it presents a legal question for judicial resolution.” Id. at *7.

With that as background, we turn to the specific facts of the case. Risperdal is an anti-psychotic medication. Id. at *1. The Risperdal label that plaintiffs claim is inadequate was modified in 2006 to include language about prolactin elevation and the reported rate of gynecomastia (enlargement of male breasts) among Risperdal users. Id. at *3. Plaintiffs allege that defendants failed to adequately warn of this risk because the labeling did not include the “true” rate of gynecomastia and should have included an instruction to physicians to monitor blood prolactin levels. Id. at *1. Defendants moved for summary judgment on preemption grounds in 5 cases involving plaintiffs from 4 different states. Id.

With respect to the rate of gynecomastia set forth in the label, the FDA specifically approved the pooling of data from 18 studies to arrive at the rate that was used in the labeling. Id. The FDA re-examined the label in 2007-2008 and concluded that it required no labeling changes regarding gynecomastia or prolactin elevations. Id. Plaintiffs argue that the pooled average was lower and that defendants should have disclosed the higher incident rates observed in 2 of the 18 studies. Id. at *8. Because those 2 studies were among those considered by the FDA during the approval process, “the FDA’s position is clear [as to] how information regarding the 18 studies should be described in the label.” Id. This portion of plaintiffs’ claim is therefore preempted.

As to plaintiffs’ allegation that defendants failed to adequately warn about monitoring prolactin levels, plaintiffs rely on “Table 21.” This is a table containing an analysis of 5 studies purportedly showing a statistically significant association between elevated prolactin levels and gynecomastia. Id. The table was in a draft of a journal article but not in the final publication and therefore not submitted to the FDA during the approval process. The studies reviewed in the table, however, were among those considered by the FDA. Id.

 Plaintiffs argued that based on the information in the table, defendants should have independently changed their label under the Changes Being Effected (“CBE”) regulations. However, to implement a CBE label change without prior FDA approval, the change must be based on “newly acquired information” which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. at *9. Table 21 doesn’t fit that definition. It may be a different analysis of the data, but it did not show a different type or greater severity or frequency of the risk of gynecomastia which is the focus of the CBE regulation. To the extent plaintiffs also tried to rely on their litigation experts’ analysis of the data, the court point out that that was a tactic tried and rejected in several other litigations as a means of avoiding preemption. Id. So, plaintiffs’ claims are also preempted because the data they rely on to suggest defendants could have changed the label is not newly acquired and could not serve as the basis for an independent label change.

Not only could defendants not have changed the label on their own, the court found clear evidence that the FDA also wouldn’t have approved it.  In 2012, one plaintiffs’ counsel submitted a Citizen’s Petition to the FDA alleging that the Risperdal label did not adequately address elevated prolactin levels, the need to monitor for elevated prolactin levels, or the rates of gynecomastia. Id. at *4. Essentially the same allegations raised in the litigation. In its response denying the petition, the FDA stated that it was commonly known that Risperdal increases prolactin and that gynecomastia is one of the manifestations of increased prolactin. Id. at *5. Based on that the court concluded:

This Court is persuaded that these reasons articulated by the FDA in response to the very claims alleged here provide the kind of “clear evidence” of “legislative fact” which the U.S. Supreme Court requires before a court can hold that impossibility preemption applies. By any standard, there is “clear evidence” that Plaintiffs’ entire theory of label inadequacy focused on prolactin levels was not only considered and rejected by the FDA but also rests on information (and allegations) known to the FDA and the medical community. The FDA’s review of the 18 clinical studies—which form the underlying data of any theory that Plaintiffs posit—both pre-approval and in subsequent reviews, and its subsequent inaction, seem to be the definite upshot of a conscious FDA choice on information before the agency. It is not this Court’s job to revisit a decision made by the FDA.

Id. at *11.

It may not be the court’s job to revisit FDA decisions, but it is certainly this blog’s job to visit strong preemption decisions like this one. So, just a reminder that if you get a good decision – forward it along. Don’t make us wait 6 months to join the party.