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It probably won’t surprise you to know that Bexis keeps a scorecard of the number of posts we’ve done over the years. Bexis likes scorecards. This post will be a big one. It’s the 2000th in Drug and Device Law Blog history. It’s taken a lot of law – and a lot of other silly stuff – to get us here. We’ve rehashed good preemption decisions and blasted bad ones, explained fraudulent joinder and complained that plaintiffs get away with it way too much, attached in limine decisions and explained what’s right and wrong with them, dissected Daubert decisions and pointed out the good experts, the bad ones and, even worse, Dr. Parisian. We’ve gone round and round on the learned intermediary doctrine, heeding presumptions, Linsanity (which Bexis later described as Temporary Linsanity), good movies, bad movies, doomed personal injury class actions, and good barbecue.
That’s all taken us to here: post 2000. And as P2K approached, we at the blog worried greatly about what might happen when we click the “publish” button and the scorecard flips over to 2000. Would all the posts disappear? Maybe just the really good ones, like the cheat sheets, the scorecards or heaven forbid the Parisian transcript list? Would Mensing suddenly vanish, never actually having happened? Or Buckman? Or Caronia? Would we lose Yeary’s invaluable posts on fraudulent joinder? Would we unlearn what we’ve learned about McConnell’s admiration of Diane Keaton? Would Bexis become a plaintiff’s lawyer? All too terrifying to consider. So we decided to just come out swinging and discuss one of our favorite topics: Dr. Parisian. In some sense it’s appropriate. Dr. Parisian’s seemingly unending expert witness career has provided constant material for this blog. Plus, like the blog, we bet that Dr. Parisian is likely approaching her 2000th expert report.
The recent decision on Dr. Parisian in the Aredia litigation – Jenkins v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 176697 (E.D. Tn. December 13, 2012) – is a good one. Like many courts before it, the Eastern District of Tennessee decided that Dr. Parisian can’t talk about a lot of the stuff that she usually puts in her expert reports. We’ll focus on two aspects of the opinion: Dr. Parisian’s proposed testimony about Novartis’s knowledge; and her proposed testimony about causation. The court excluded both.
Dr. Parisian almost always tries to tell juries what the defendant company knew. She will usually go further and try to tell juries what the company intended, but the plaintiffs gave up on that opinion here even before the court had the chance to exclude it. Id. at *15 (“the parties have agreed that Dr. Parisian cannot testify to . . . . the intent and/or motives of Novartis”). But the plaintiffs still claimed that she was a “company knowledge” expert. Of course, she isn’t. She has no particular expertise that would allow her to know what Novartis, or really any company other than maybe her own, knows. She certainly has no more expertise than a jury. And the court said so:
She may not, however, decide what Novartis knew and did not know at various times during the relevant period. Novartis's knowledge is an issue for the jury. Dr. Parisian has no specialized knowledge or scientific/medical expertise that provides her with a superior ability to judge Novartis's knowledge, and there is no basis for finding that the jury needs her assistance in evaluating Novartis's knowledge.
Id. at *16.
What’s even more heartening is that the court saw that Dr. Parisian, who does not appear to have practiced medicine for decades, did not have the expertise to opine on causation. The majority of her career has been spent addressing regulations, mostly while in litigation, not while practicing medicine. And even the practical medical experience that she had years ago didn’t involve the type of medical issues involved in the Aredia litigation:
The Court finds that Dr. Parisian is not qualified to testify as to the mechanism by which Zometa and Aredia, or bisphosphonates generally, cause ONJ. While Dr. Parisian holds a doctor of medicine, she testified that the vast majority of her career has been spent in the field of medical regulation rather than the practice of even general medicine. Moreover, the Plaintiff has not presented any evidence indicating that Dr. Parisian has any special experience treating bisphosphonate-related disorders, jaw conditions, or bone conditions. Further, there is no evidence in the record to indicate that Dr. Parisian has either treated ONJ or studied ONJ in an academic setting.
Id. at *17.
Now, the court did allow Dr. Parisian to testify about certain FDA requirements, including the labeling process and requirements. Id. at *16. And, while we’d challenge even that expertise given that Dr. Parisian’s FDA experience was two decades ago, for barely 3 years, and on the device not the drug side, we’re happy with this decision. Much of the bad stuff was ruled out by the court or conceded away by plaintiffs. That’s a victory.
Well, that’s all we have to say today. So this is it. We’re ready to click the “publish” button. We hope everything’s still intact when we’re done and that Bexis is still on our side. Alright. Hold your breath. Here goes . . . . . .
3 Ocak 2013 Perşembe
The Bottom Ten – The Worst Prescription Drug/Medical Device Decisions Of 2012
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Do we have to? That depends on whether we mean “must” or should.” There’s relatively little that’s really a“must,” but quite a bit that’s a strong “should.” So yes, we have to. It’s that time of year again, and we’re lookingback over the past twelve months for the decisions that, in this instance, weliked the least. Because we like to endthe year on a high note, we always examine the bad decisions before the good ones, and thisyear’s no exception.
This post thus goes to show that you – that is, we– can’t win them all. So for our fifthstraight year we’re looking at the coal that has found its way into ourChristmas stockings, specifically the ten worst prescription medical productliability decisions of 2012. There's no particular pattern, these blots on the law are from all over, both in federal andstate court. While we’ve seen ATRA’slatest list of hellhole jurisdictions, our bottom ten doesn’t particularly correspond, probably since ATRA’s latest listhas less to do with drugs and medical devices than the in some prior years.
Yeah, we’re procrastinating. Like most lawyers, we’d rather focus on winsthan losses – that and 2012 still has a week and a half left for still morebottom-dwelling decision to come down. That said, we can’t delay any longer. Here are the jurisprudential dregs of 2012.
1. Bartlett v. Mutual Pharmaceutical Co., 678 F.3d30 (1st Cir. 2012). Terrible result andworse reasoning, on several levels. After the plaintiff lost his warning claims for the prescriber’s failureto read the warning, he pursued a design defect claim with no alternative design thatamounted to a demand that an FDA-approved generic drug should be removed fromthe market altogether. All that wasbefore Mensing. After Mensingwe couldn’t see how the plaintiff could retain this $20 million+ verdict, butthe First Circuit found a way – a bad way, but a way. Even though the opinion all but conceded that designclaims would fail under the “sameness” analysis used by the SupremeCourt in Mensing, the First Circuit decided that reasoningdidn’t matter, dug in its heels, and ruled that, no matter what, it wasn’tgoing to preempt the plaintiff’s solesurviving claim. Period; full stop. The decision's rationale was that nothing requires amanufacturer actually to sell a drug that the FDA has approved, but argument that (likethe lobbying argument rejected in Mensing) proves way too much. The same thing could be said about any product in any case. Moreover, nothing could more directly conflict with the FDA’sauthority over drug approval than a state-law claim that says, “So what? You can’t sell that here.” "Yes" directly conflicts with "no." Finally, to the extent that Hatch Waxman wassupposed to promote the availability of generic drugs, banning them outright isthe antithesis of that purpose. We bloggedabout this stinker here and here. The only good thing we can say about Bartlettis that the Supreme Court recently accepted the challenge and granted certiorari. So we’re hopeful that the worstdecision of 2012 might produce the best of 2013. Fingers crossed.
2. Caldwell ex rel. State v. Janssen Pharmaceutical,Inc., ___ So.3d___, 2012 WL 3761900 (La. App. Aug. 31, 2012). What do you get when a state hirescontingent fee counsel and lets that counsel pick the most pro-plaintiff county(called “Parishes” in Louisiana) in the state to sue over alleged failures towarn that were never actually hurt anybody? How about an eye-popping $257 million verdictalong with an extra $73 million fee and cost award for said counsel. Most ginned up state false claims suits like this oneget thrown out, at least on appeal, but not in Louisiana (at least not yet). On appeal, the court found no error in thetrial court’s allowing the plaintiff to proceed on an absolute liability theory from West Virginia that (unmentioned in Caldwell) the West Virginia Supreme Court later threw out as a matter of law. The language of the relevant statute wasoutright ignored in Caldwell, and both injury and causation were effectuvekt presumed (the “materials inand of themselves cause harm and injury”). The opinion also affirmed total exclusion of evidence (includingstatistics) that the defendant’s supposedly false statements were in factscientifically valid. The opinion itself is an embarrassment, consisting mostly of the court quoting the trial court’s barely coherent rulingsand reciting that there was no “manifest error.” Theonly saving grace is that the Louisiana Supreme Court might think so too. We excoriated Caldwell here.
3. Dolan v. Hilo Medical Center, 278 P.3d 382 (Haw.App. 2012). In this absurd medicaldevice decision, the manufacturer was found liable where: (1) the hospital never inventoried the devicekit that it received, and (2) the surgeon used a screw driver as a substitutefor a spinal rod when he couldn’t find the right part during surgery. The screw driver, of course, broke almostimmediately, since it was not designed (let alone FDA approved) for implantation. Oh ... and the defendantmanufacturer produced an undisputed packing slip indicating that it had shipped all theproper parts to the hospital. And there's more: the doctors andhospital concealed from the patient what they had done. The jury got it right – hammering themalpractice defendants and excusing the manufacturer. Inexplicably, however, the appellate courtreversed, on the lame excuse that the judge used an outdated juryinstruction on substantial change. Sowhat? This wasn’t a substantial changecase, rather it involved blatant and outrageous product misuse. It may not be the worst decision of the year,but it sure is the dumbest. We dissentedhere.
4. In re Chantix Varenicline Products LiabilityLitigation, ___ F. Supp.2d ___, 2012 WL 3871562 (N.D. Ala. Aug. 21,2012). A really, really bad Daubert decision. Seven causation experts were allowed totestify that the drug caused suicide (of all injuries, one of the hardest to prove) despite lacking even one medicalstudy (at least none were cited) to support their opinions. Basically, the decision holds thatqualifications are enough and everything else is cross-examination fodder. Daubert? What Daubert? Opinions based on statistically insignificantdata? That’s OK. Adverse reactions that the FDA itself saysaren’t to be used for drawing causation conclusions? That’s OK, too. Extrapolation from animal studies with hugedosages? You bet. Ditto for cherry-picked data. The defendant’s labeling mentioning therisk also supported causation. Damned if you do; damned if youdon’t – even though FDA regulations outright specify that “a causalrelationship need not have been proven.” Also, any decision that favorablycites the pre-Daubert Wells v. Ortho decision raises our hackles. Even the good rulings (corporate intent,misleading the FDA), were precluded on a lame “speculative” basis rather thanfor being blatantly improper subjects of expert testimony. We found this opinion largely indigestiblehere.
5. Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J.2012). Usually adverse state supremecourt cases rank pretty high on our list. Cornett isn’t ranked higher because all of it isn’t bad –specifically the court blew out the lead plaintiff’s case on unrelated statute oflimitations grounds, whichought to count for something (not all that much), and placedsome decent summary judgment limits on the claims it permitted to go forward (somewhat better). But those good points can’t make up formessing up two of our favorite issues, preemption and off-label use, in thesame opinion. In a PMA medical devicecase, the court allowed a plaintiff to get by the pleading stage with a“parallel claim” based on off-label promotion, even though there’s not any FDAregulation that bars such promotion (the regs call it no more than “evidence”),and the FDA guidance that enunciates an outright ban doesn’t have force of law and thusshouldn’t support any negligence per se action at all. The off-label promotion claim was nothing more than an ill-disguisedinadequate warning claim (preempted under Riegel), but the court went along with the plaintiffs' ruse of renaming the claim. Still,the court did impose some decently strong restrictions on the claim before itcould survive summary judgment. If thetrial courts enforce these, there may not be all that many claims. But the tough nut remains, how can a statelaw claim be “genuinely equivalent” to anything when it’s based on a document that the FDAitself does not give legal force? Cornettends up with a “parallel” claim that in fact isn’t parallel to anything, sinceessential elements of fraud/misrepresentation such as reliance are simply notpresent in the FDA’s scheme of things (that’s still true even after Caronia. For setting such a claim loose on the law, Cornettmakes our bottom ten. We scratched ourheads over Cornett here.
6. Hawkins v. Medtronic, Inc., ___ F. Supp. ___, 2012WL 4364171 (S.D. Ohio Sept. 24, 2012), interlocutory certification denied,2012 WL 6059361 (S.D. Ohio Dec. 6, 2012). Ugly times two on medical device preemptionand TwIqbal. It’s a PMA device,so there’s Riegel preemption. Theplaintiff’s attempt to plead a parallel claim was pathetic. The complaint simply listed a bunch of statutory andregulatory sections and alleged, without any explanation, that they were“violated” − classic boilerplate conclusions of law that aren’t allowed anymore, except in Hawkins. Theopinion mentions “precise contours” but from the indefinite “contours” in this complaint,Cleveland might as well still be part of Connecticut. On this flimsy pleading, the opinion allowed claimssuch as warning, design defect and warranty, that other decisions almost uniformlydismiss on the pleadings, to survive. Then,on a second motion, the fact that Lohr preceded TwIqbal waslikewise ignored. Hawkins is a goodcandidate for the worst PMA device preemption decision of the year. It’s only saving grace is that, on summaryjudgment, the plaintiff will have to back up these vague allegations (after thedefendant, of course, has to spend lots of time and money). We sounded off on Hawkins here.
7. Whitener v. PLIVA, Inc., 2012 WL 39487974 (E.D.La. Sept. 10, 2012). There’s expresspreemption and there’s implied preemption. As the Supreme Court has held repeatedly, these two forms of preemptionoperate independently. Whitenerdidn’t get the memo from the Supreme Court. The case involved generic drug preemption under Mensing. The plaintiffs alleged illegal off-labelpromotion. Even putting aside theproblem (highlighted in recent opinions) that neither the FDCA nor any FDAregulation prohibit off-label promotion, the proper response is, so what? Assuming there was an FDCA violation, thatdoesn’t matter in an implied preemption case. The notion of a “parallel violation claim” is wholly a consequence ofthe particular language of an express preemption clause applicable only tomedical devices. It has nothing to dowith generic drugs or implied impossibility preemption. For completely messing up fundamental preemptionconcepts and giving generic drug plaintiffs an out they are not entitled tounder Mensing, this decision makes our list. We tried to put a stop to things here.
8. Bonander v. Breg, Inc., 2012 WL 4128386 (D.Minn. Sept. 18, 2012). Reading thisdecision, you wouldn’t believe that the plaintiff had the burden of proving causationin warning cases. These facts – that thedoctor never read the allegedly defective warning and didn’t listen to salesreps – have resulted in summary judgment in innumerable cases, but not in Bonander. Instead, the decision allowed rank speculationunsupported by any affirmative testimony to substitute for proof. The prescriber changed his practice based ona medical journal article years after the fact. Maybe something from the manufacturer (whom the prescriber already testified he didn’t pay attention to) would have done the trick. “Foreclosing a possibility” simply isn’t thesame as testimony that would meet the burden of proof. As Carl Sagan was fond of saying, “absence ofevidence is not evidence of absence.” Atbest, Bonander was an absence of evidence case, which the plaintiffshould have lost, and that’s being charitable. The most vacuous warning causation case of 2012. We analogized it to monkeys at a typewriterhere.
9. Shiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa.June 1, 2012); Shiff v. Hurwitz, 2012 WL 1828035 (W.D. Pa. May 18, 2012); andShiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012). Three differently situated defendants movedto dismiss this oddball case alleging that the plaintiff was injured during thecourse of an allegedly underground, totally unauthorized clinical trial. The result was a troika of opinions thatdisregarded multiple settled principles of federal and/or Pennsylvania law –those being: (1) no separate duty totest; (2) no private FDCA causes of action are permitted (3) no strictliability against manufacturers (except maybe manufacturing defect); (4) nostrict liability, ever, against doctors or hospitals; (5) no consumer fraudclaims involving medical treatment; (6) hospitals don’t obtain informedconsent; (7) informed consent is limited to risks, benefits, and alternativesto medical procedures; and (8) federal courts sitting in diversity aren’tsupposed to make up novel claims and call them predictions of state law. We described exactly how all this doesn't fit together here. Shiff would have ranked higherbut for only one state’s law being impacted.
10. Murthy v. Abbott Laboratories, 2012 WL 6020157 (S.D.Tex. Dec. 3, 2012). This case is arepeat performer. Last year, a decisionon payments to investigators and the (non-existent) direct-to-consumer exception made thebottom 10 at #8 (the DTC ruling now being overruled under Texas law – see ourupcoming Top 10). Murthy’s latestmangling of Texas law misreads the state’s immunity statute to allow theplaintiff to amend to allege a claim under the exceptions for off-labelmarketing. The exception, however, is worded to apply where the“defendant prescribed” off-label, so that obviously is intended to preserveclaims against physicians. The opinionpounds the square peg of a claim against a manufacturer into this very roundhole by asserting that the prescriber could be the manufacturer’s “agent.” Thus, Murthy appears to be doublingdown on the investigator payments = non-independence rationale of last year’slump of coal. This case might rank higher, exceptfor it being so state specific. We calledout this “bad penny” of a case here.
So there they are. We hope none of these not-just-wrong-but-loud-wrong losses were yours –if they were, we sympathize. We didconsider several other candidates; those that came closest to making the cutwere: Schilf v. Eli Lilly & Co.,687 F.3d 947 (8th Cir. 2012) (the facts were arguably squishy); Bass v.Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (the bad parts were tempered byaffirmance of the dismissal of so much of the case); Winter v. NovartisPharms. Corp., 2012 WL 827305 (Mag. W.D. Mo. March 8, 2012) (it’s a badParisian decision, but the worst was excluded – and the defendant later won (verdict less than the costs of trying the case) attrial); and the reconsideration in Fisher v. Pelstrung, 817 F. Supp.2dat 830-40 (D.S.C. Jan. 11, 2012) (while it was bad, it was only areconsideration).
Now that our unpleasant and masochistic exercise inrecapitulating our side’s worst defeats is over, stay tuned for next week (orpossibly the following Monday) when we have fun – reviewing and celebrating thetop ten best drug/device decisions of 2012.
Do we have to? That depends on whether we mean “must” or should.” There’s relatively little that’s really a“must,” but quite a bit that’s a strong “should.” So yes, we have to. It’s that time of year again, and we’re lookingback over the past twelve months for the decisions that, in this instance, weliked the least. Because we like to endthe year on a high note, we always examine the bad decisions before the good ones, and thisyear’s no exception.
This post thus goes to show that you – that is, we– can’t win them all. So for our fifthstraight year we’re looking at the coal that has found its way into ourChristmas stockings, specifically the ten worst prescription medical productliability decisions of 2012. There's no particular pattern, these blots on the law are from all over, both in federal andstate court. While we’ve seen ATRA’slatest list of hellhole jurisdictions, our bottom ten doesn’t particularly correspond, probably since ATRA’s latest listhas less to do with drugs and medical devices than the in some prior years.
Yeah, we’re procrastinating. Like most lawyers, we’d rather focus on winsthan losses – that and 2012 still has a week and a half left for still morebottom-dwelling decision to come down. That said, we can’t delay any longer. Here are the jurisprudential dregs of 2012.
1. Bartlett v. Mutual Pharmaceutical Co., 678 F.3d30 (1st Cir. 2012). Terrible result andworse reasoning, on several levels. After the plaintiff lost his warning claims for the prescriber’s failureto read the warning, he pursued a design defect claim with no alternative design thatamounted to a demand that an FDA-approved generic drug should be removed fromthe market altogether. All that wasbefore Mensing. After Mensingwe couldn’t see how the plaintiff could retain this $20 million+ verdict, butthe First Circuit found a way – a bad way, but a way. Even though the opinion all but conceded that designclaims would fail under the “sameness” analysis used by the SupremeCourt in Mensing, the First Circuit decided that reasoningdidn’t matter, dug in its heels, and ruled that, no matter what, it wasn’tgoing to preempt the plaintiff’s solesurviving claim. Period; full stop. The decision's rationale was that nothing requires amanufacturer actually to sell a drug that the FDA has approved, but argument that (likethe lobbying argument rejected in Mensing) proves way too much. The same thing could be said about any product in any case. Moreover, nothing could more directly conflict with the FDA’sauthority over drug approval than a state-law claim that says, “So what? You can’t sell that here.” "Yes" directly conflicts with "no." Finally, to the extent that Hatch Waxman wassupposed to promote the availability of generic drugs, banning them outright isthe antithesis of that purpose. We bloggedabout this stinker here and here. The only good thing we can say about Bartlettis that the Supreme Court recently accepted the challenge and granted certiorari. So we’re hopeful that the worstdecision of 2012 might produce the best of 2013. Fingers crossed.
2. Caldwell ex rel. State v. Janssen Pharmaceutical,Inc., ___ So.3d___, 2012 WL 3761900 (La. App. Aug. 31, 2012). What do you get when a state hirescontingent fee counsel and lets that counsel pick the most pro-plaintiff county(called “Parishes” in Louisiana) in the state to sue over alleged failures towarn that were never actually hurt anybody? How about an eye-popping $257 million verdictalong with an extra $73 million fee and cost award for said counsel. Most ginned up state false claims suits like this oneget thrown out, at least on appeal, but not in Louisiana (at least not yet). On appeal, the court found no error in thetrial court’s allowing the plaintiff to proceed on an absolute liability theory from West Virginia that (unmentioned in Caldwell) the West Virginia Supreme Court later threw out as a matter of law. The language of the relevant statute wasoutright ignored in Caldwell, and both injury and causation were effectuvekt presumed (the “materials inand of themselves cause harm and injury”). The opinion also affirmed total exclusion of evidence (includingstatistics) that the defendant’s supposedly false statements were in factscientifically valid. The opinion itself is an embarrassment, consisting mostly of the court quoting the trial court’s barely coherent rulingsand reciting that there was no “manifest error.” Theonly saving grace is that the Louisiana Supreme Court might think so too. We excoriated Caldwell here.
3. Dolan v. Hilo Medical Center, 278 P.3d 382 (Haw.App. 2012). In this absurd medicaldevice decision, the manufacturer was found liable where: (1) the hospital never inventoried the devicekit that it received, and (2) the surgeon used a screw driver as a substitutefor a spinal rod when he couldn’t find the right part during surgery. The screw driver, of course, broke almostimmediately, since it was not designed (let alone FDA approved) for implantation. Oh ... and the defendantmanufacturer produced an undisputed packing slip indicating that it had shipped all theproper parts to the hospital. And there's more: the doctors andhospital concealed from the patient what they had done. The jury got it right – hammering themalpractice defendants and excusing the manufacturer. Inexplicably, however, the appellate courtreversed, on the lame excuse that the judge used an outdated juryinstruction on substantial change. Sowhat? This wasn’t a substantial changecase, rather it involved blatant and outrageous product misuse. It may not be the worst decision of the year,but it sure is the dumbest. We dissentedhere.
4. In re Chantix Varenicline Products LiabilityLitigation, ___ F. Supp.2d ___, 2012 WL 3871562 (N.D. Ala. Aug. 21,2012). A really, really bad Daubert decision. Seven causation experts were allowed totestify that the drug caused suicide (of all injuries, one of the hardest to prove) despite lacking even one medicalstudy (at least none were cited) to support their opinions. Basically, the decision holds thatqualifications are enough and everything else is cross-examination fodder. Daubert? What Daubert? Opinions based on statistically insignificantdata? That’s OK. Adverse reactions that the FDA itself saysaren’t to be used for drawing causation conclusions? That’s OK, too. Extrapolation from animal studies with hugedosages? You bet. Ditto for cherry-picked data. The defendant’s labeling mentioning therisk also supported causation. Damned if you do; damned if youdon’t – even though FDA regulations outright specify that “a causalrelationship need not have been proven.” Also, any decision that favorablycites the pre-Daubert Wells v. Ortho decision raises our hackles. Even the good rulings (corporate intent,misleading the FDA), were precluded on a lame “speculative” basis rather thanfor being blatantly improper subjects of expert testimony. We found this opinion largely indigestiblehere.
5. Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J.2012). Usually adverse state supremecourt cases rank pretty high on our list. Cornett isn’t ranked higher because all of it isn’t bad –specifically the court blew out the lead plaintiff’s case on unrelated statute oflimitations grounds, whichought to count for something (not all that much), and placedsome decent summary judgment limits on the claims it permitted to go forward (somewhat better). But those good points can’t make up formessing up two of our favorite issues, preemption and off-label use, in thesame opinion. In a PMA medical devicecase, the court allowed a plaintiff to get by the pleading stage with a“parallel claim” based on off-label promotion, even though there’s not any FDAregulation that bars such promotion (the regs call it no more than “evidence”),and the FDA guidance that enunciates an outright ban doesn’t have force of law and thusshouldn’t support any negligence per se action at all. The off-label promotion claim was nothing more than an ill-disguisedinadequate warning claim (preempted under Riegel), but the court went along with the plaintiffs' ruse of renaming the claim. Still,the court did impose some decently strong restrictions on the claim before itcould survive summary judgment. If thetrial courts enforce these, there may not be all that many claims. But the tough nut remains, how can a statelaw claim be “genuinely equivalent” to anything when it’s based on a document that the FDAitself does not give legal force? Cornettends up with a “parallel” claim that in fact isn’t parallel to anything, sinceessential elements of fraud/misrepresentation such as reliance are simply notpresent in the FDA’s scheme of things (that’s still true even after Caronia. For setting such a claim loose on the law, Cornettmakes our bottom ten. We scratched ourheads over Cornett here.
6. Hawkins v. Medtronic, Inc., ___ F. Supp. ___, 2012WL 4364171 (S.D. Ohio Sept. 24, 2012), interlocutory certification denied,2012 WL 6059361 (S.D. Ohio Dec. 6, 2012). Ugly times two on medical device preemptionand TwIqbal. It’s a PMA device,so there’s Riegel preemption. Theplaintiff’s attempt to plead a parallel claim was pathetic. The complaint simply listed a bunch of statutory andregulatory sections and alleged, without any explanation, that they were“violated” − classic boilerplate conclusions of law that aren’t allowed anymore, except in Hawkins. Theopinion mentions “precise contours” but from the indefinite “contours” in this complaint,Cleveland might as well still be part of Connecticut. On this flimsy pleading, the opinion allowed claimssuch as warning, design defect and warranty, that other decisions almost uniformlydismiss on the pleadings, to survive. Then,on a second motion, the fact that Lohr preceded TwIqbal waslikewise ignored. Hawkins is a goodcandidate for the worst PMA device preemption decision of the year. It’s only saving grace is that, on summaryjudgment, the plaintiff will have to back up these vague allegations (after thedefendant, of course, has to spend lots of time and money). We sounded off on Hawkins here.
7. Whitener v. PLIVA, Inc., 2012 WL 39487974 (E.D.La. Sept. 10, 2012). There’s expresspreemption and there’s implied preemption. As the Supreme Court has held repeatedly, these two forms of preemptionoperate independently. Whitenerdidn’t get the memo from the Supreme Court. The case involved generic drug preemption under Mensing. The plaintiffs alleged illegal off-labelpromotion. Even putting aside theproblem (highlighted in recent opinions) that neither the FDCA nor any FDAregulation prohibit off-label promotion, the proper response is, so what? Assuming there was an FDCA violation, thatdoesn’t matter in an implied preemption case. The notion of a “parallel violation claim” is wholly a consequence ofthe particular language of an express preemption clause applicable only tomedical devices. It has nothing to dowith generic drugs or implied impossibility preemption. For completely messing up fundamental preemptionconcepts and giving generic drug plaintiffs an out they are not entitled tounder Mensing, this decision makes our list. We tried to put a stop to things here.
8. Bonander v. Breg, Inc., 2012 WL 4128386 (D.Minn. Sept. 18, 2012). Reading thisdecision, you wouldn’t believe that the plaintiff had the burden of proving causationin warning cases. These facts – that thedoctor never read the allegedly defective warning and didn’t listen to salesreps – have resulted in summary judgment in innumerable cases, but not in Bonander. Instead, the decision allowed rank speculationunsupported by any affirmative testimony to substitute for proof. The prescriber changed his practice based ona medical journal article years after the fact. Maybe something from the manufacturer (whom the prescriber already testified he didn’t pay attention to) would have done the trick. “Foreclosing a possibility” simply isn’t thesame as testimony that would meet the burden of proof. As Carl Sagan was fond of saying, “absence ofevidence is not evidence of absence.” Atbest, Bonander was an absence of evidence case, which the plaintiffshould have lost, and that’s being charitable. The most vacuous warning causation case of 2012. We analogized it to monkeys at a typewriterhere.
9. Shiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa.June 1, 2012); Shiff v. Hurwitz, 2012 WL 1828035 (W.D. Pa. May 18, 2012); andShiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012). Three differently situated defendants movedto dismiss this oddball case alleging that the plaintiff was injured during thecourse of an allegedly underground, totally unauthorized clinical trial. The result was a troika of opinions thatdisregarded multiple settled principles of federal and/or Pennsylvania law –those being: (1) no separate duty totest; (2) no private FDCA causes of action are permitted (3) no strictliability against manufacturers (except maybe manufacturing defect); (4) nostrict liability, ever, against doctors or hospitals; (5) no consumer fraudclaims involving medical treatment; (6) hospitals don’t obtain informedconsent; (7) informed consent is limited to risks, benefits, and alternativesto medical procedures; and (8) federal courts sitting in diversity aren’tsupposed to make up novel claims and call them predictions of state law. We described exactly how all this doesn't fit together here. Shiff would have ranked higherbut for only one state’s law being impacted.
10. Murthy v. Abbott Laboratories, 2012 WL 6020157 (S.D.Tex. Dec. 3, 2012). This case is arepeat performer. Last year, a decisionon payments to investigators and the (non-existent) direct-to-consumer exception made thebottom 10 at #8 (the DTC ruling now being overruled under Texas law – see ourupcoming Top 10). Murthy’s latestmangling of Texas law misreads the state’s immunity statute to allow theplaintiff to amend to allege a claim under the exceptions for off-labelmarketing. The exception, however, is worded to apply where the“defendant prescribed” off-label, so that obviously is intended to preserveclaims against physicians. The opinionpounds the square peg of a claim against a manufacturer into this very roundhole by asserting that the prescriber could be the manufacturer’s “agent.” Thus, Murthy appears to be doublingdown on the investigator payments = non-independence rationale of last year’slump of coal. This case might rank higher, exceptfor it being so state specific. We calledout this “bad penny” of a case here.
So there they are. We hope none of these not-just-wrong-but-loud-wrong losses were yours –if they were, we sympathize. We didconsider several other candidates; those that came closest to making the cutwere: Schilf v. Eli Lilly & Co.,687 F.3d 947 (8th Cir. 2012) (the facts were arguably squishy); Bass v.Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (the bad parts were tempered byaffirmance of the dismissal of so much of the case); Winter v. NovartisPharms. Corp., 2012 WL 827305 (Mag. W.D. Mo. March 8, 2012) (it’s a badParisian decision, but the worst was excluded – and the defendant later won (verdict less than the costs of trying the case) attrial); and the reconsideration in Fisher v. Pelstrung, 817 F. Supp.2dat 830-40 (D.S.C. Jan. 11, 2012) (while it was bad, it was only areconsideration).
Now that our unpleasant and masochistic exercise inrecapitulating our side’s worst defeats is over, stay tuned for next week (orpossibly the following Monday) when we have fun – reviewing and celebrating thetop ten best drug/device decisions of 2012.
Resolutions Lost, Power Posing, and the Lives of Others
To contact us Click HERE
Therewas a temptation today to dash off a typical New Year's resolutions column, withweakly drawn parallels to legal topics. If most resolutions involve cuttingback on vices and shedding pounds, we could talk about our determination to gocold turkey on our use of hackneyed phrases (e.g., “the next time xhappens will be the first”) and inappropriate pop culture analogies (e.g.,wishing we were in front of Judges Judy or Mathis instead of some hellholejurisdiction), or reducing the weight of our motion papers. But we all knowthat resolutions are destined to be broken. There will come a time in thenot-so-distant future when we tell some poor, put-upon associate that a replybrief cannot possibly exceed five pages, then we will edit it and add ourvarious brilliancies and Homeric catalogues to nudge it closer to fifteenpages. And is there really a need to find a proxy for the excess tonnage point?In a recent run-up to trial, as were surveying a courtroom for locations of thetechnology, including terminals and screens, a techie from Generation Zuncharitably suggested that we could project depo videos on our backside.Moreover, there is a story in today’s Journal of the American Medical Associationthat people who are a bit overweight are less likely to die within any givenperiod than people of normal weight. So much for that resolution. And yes, wewill have the crème brulee.
Weare also not likely to abjure pop culture, certainly not when something likethe following happens. Do any of you find your inbox littered with emails fromlitigation consultants, offering all sorts of free advice on how to woo jurorsand win cases? How many of you ever read that stuff? If you are like us, youprobably feel too busy to give these items even a glance, and you press the deletebutton with ferocity and celerity. But that might be a mistake. While most ofour friends take vacation days in the week between Christmas and New Years, welike to come in the office then, as it is so quiet and peaceful. It is a goodtime to catch up on correspondence, even of the slightly frivolous kind. Weeven took a peek at consultant bulletins. One of them attached a couple of TEDvideos on storytelling and persuasion. If you do not already browse through TEDvideos, you should. The speakers are usually smart and engaging. What’s more,the presentations are done beautifully – they are a remarkable and instructivecontrast to the usual bullet-ridden Power Point presentations that waltz us offto sleep. It reminds us of comedian Don McMillan's bit onLife After Death by PowerPoint.
Oneof the presentations was by Harvard B-school professor and social psychologistAmy Cuddy on body language. Better for you to watch it (it is only about 20minutes long) than accept our summary, but let’s leave it at this: our state ofmind affects our body posture, and the reverse is equally true. Thus, whenpeople are triumphant or dominant, they literally spread out, extending armsand legs and make themselves look bigger. Take a look at Usain Bolt crossingthe finish line. When people are feeling submissive or vulnerable, theycover themselves up and make themselves smaller. That much is obvious. What isfascinating is that if one is gearing up for a presentation/meeting and one isfeeling nervous, going through some victory poses (e.g., hands on hips, feetwide apart) for a few minutes can make one feel more confident. Cuddy ends hertalk with a very personal, touching story about herself, and then urges heraudience to share the story, including the underlying science.
Sowe did. During a New Year’s Eve party, in between the Pictionary and champagne,we recounted Cuddy’s advice about how to “fake it to make it.” We wereexpecting gasps of astonishment. Maybe even some gratitude. Nope. A couple ofour friends merely nodded and said that they had heard about this a couple ofyears ago on Oprah. Score it pop culture 1, litigation consultants 0. We arenot giving up on pop culture just yet.
Weare no longer sure anymore what is the difference between high and low browcultures. Have you seen college course offerings? You (or your kid) cantake classes on Saved By the Bell or the Semiotics of Barney. A lot of whatcalls itself high culture is fixated on low culture. There was an article in thisweek’s NY Times Book Review on collections of essays. One of the essayists,Daniel Mendelsohn, was highly praised. What caught our attention in the reviewwas a reference to an essay Mendelsohn wrote in the NY Review of Books back inFebruary 2011 on Mad Men. We normally steer clear of the NY Review of Books because thereviews usually end up being more of a review of the reviewer’s obsessions thanthe actual work allegedly being reviewed. The articles exude more neurosis andbitterness than illumination. They seem to be written by and for people withmigraines. (We are still smarting from Renata Adler’s long ago takedown ofPauline Kael. Sure, some of Adler’s points about Kael’s verbal tropes werecorrect, but none of the nastiness could dislodge Kael from the Pantheon. It’slike our favorite moment in the Beatles Anthology video, where McCartneywearily recites the chorus of complaints about the White Album, how it hadmoments of self-indulgence and would have made a better single album: “It’s theBeatles' White Album! Shut up!”)
Weare not (yet) putting Mad Men up there with Kael or the Beatles. ButMendelsohn’s article does not convince us that the show is as frail anddispensable as, say, Alf. Mendelsohn’s review of Mad Men is yet another NYRBexercise in dyspepsia. Put plainly, he pretty much hates the show. Mendelsohnis a smart guy and a fine writer, and there’s no way we will do justice to hisanalysis (wrong-headed though it may be). He seems to think that Mad Men,besides suffering from sins of implausible plotting and shallowcharacterizations, depicts the social and business mores of the 1960s onan entirely superficial level. The program almost amounts to Rat Pack eraporn. We look up from our iPad at the tv screen and see characters hoistinghighballs in the afternoon, or see a pregnant woman light up a Marlboro Red,and smile smugly. Mendelsohn does not seem to think that the show digs deeplyenough or explains enough. We are not sure that there is more explanation ortexture in other series that Mendelsohn admires, such as The Sopranos or TheWire, and we suspect that any pat explanation of characters’ motivations wouldbe greeted with contempt by Mendelsohn or some other acerbic critic, and rightlyso. At the end of Mendelsohn’s review he arrives at a conclusion that seemsto us absolutely correct and insightful (and confirmatory of something wealready thought): if the milieu of Mad Men seems opaque, it is because it isviewed not from the perspective of the main characters such as Don Draper or PeggyOlson, but is viewed from the perspective of the kids, who can only gaze attheir misbehaving elders in wonder and fear. The demographic cohort that is inlove with the show is not the people who lived and acted out the doings in theshow (those people would largely now be octogenarians) but babyboomers – thekids of that smoking, boozing, philandering, utterly wonderful, mixed-up, maybe even greatest generation. The self-absorbed boomers never fretted about the interior livesof their parents back then. Now they (we) do. But having direct conversationswith parents on those issues, many of them terribly awkward, is impossibleor irritating or unreliable now. Like most works of art, Mad Men takes us outof ourselves. Shelley (whose life would make a pretty good cable mini-series)said that poetry is a great spiritual and even civic exercise, because it makesus consider about how others live and think and feel.
Itoccurs to us that considering how others live and think and feel has a littlesomething to do with successful litigation. Thus, all kidding aside about thenew JAMA article, we are more likely to put down the spoon than the remotecontrol.
Therewas a temptation today to dash off a typical New Year's resolutions column, withweakly drawn parallels to legal topics. If most resolutions involve cuttingback on vices and shedding pounds, we could talk about our determination to gocold turkey on our use of hackneyed phrases (e.g., “the next time xhappens will be the first”) and inappropriate pop culture analogies (e.g.,wishing we were in front of Judges Judy or Mathis instead of some hellholejurisdiction), or reducing the weight of our motion papers. But we all knowthat resolutions are destined to be broken. There will come a time in thenot-so-distant future when we tell some poor, put-upon associate that a replybrief cannot possibly exceed five pages, then we will edit it and add ourvarious brilliancies and Homeric catalogues to nudge it closer to fifteenpages. And is there really a need to find a proxy for the excess tonnage point?In a recent run-up to trial, as were surveying a courtroom for locations of thetechnology, including terminals and screens, a techie from Generation Zuncharitably suggested that we could project depo videos on our backside.Moreover, there is a story in today’s Journal of the American Medical Associationthat people who are a bit overweight are less likely to die within any givenperiod than people of normal weight. So much for that resolution. And yes, wewill have the crème brulee.
Weare also not likely to abjure pop culture, certainly not when something likethe following happens. Do any of you find your inbox littered with emails fromlitigation consultants, offering all sorts of free advice on how to woo jurorsand win cases? How many of you ever read that stuff? If you are like us, youprobably feel too busy to give these items even a glance, and you press the deletebutton with ferocity and celerity. But that might be a mistake. While most ofour friends take vacation days in the week between Christmas and New Years, welike to come in the office then, as it is so quiet and peaceful. It is a goodtime to catch up on correspondence, even of the slightly frivolous kind. Weeven took a peek at consultant bulletins. One of them attached a couple of TEDvideos on storytelling and persuasion. If you do not already browse through TEDvideos, you should. The speakers are usually smart and engaging. What’s more,the presentations are done beautifully – they are a remarkable and instructivecontrast to the usual bullet-ridden Power Point presentations that waltz us offto sleep. It reminds us of comedian Don McMillan's bit onLife After Death by PowerPoint.
Oneof the presentations was by Harvard B-school professor and social psychologistAmy Cuddy on body language. Better for you to watch it (it is only about 20minutes long) than accept our summary, but let’s leave it at this: our state ofmind affects our body posture, and the reverse is equally true. Thus, whenpeople are triumphant or dominant, they literally spread out, extending armsand legs and make themselves look bigger. Take a look at Usain Bolt crossingthe finish line. When people are feeling submissive or vulnerable, theycover themselves up and make themselves smaller. That much is obvious. What isfascinating is that if one is gearing up for a presentation/meeting and one isfeeling nervous, going through some victory poses (e.g., hands on hips, feetwide apart) for a few minutes can make one feel more confident. Cuddy ends hertalk with a very personal, touching story about herself, and then urges heraudience to share the story, including the underlying science.
Sowe did. During a New Year’s Eve party, in between the Pictionary and champagne,we recounted Cuddy’s advice about how to “fake it to make it.” We wereexpecting gasps of astonishment. Maybe even some gratitude. Nope. A couple ofour friends merely nodded and said that they had heard about this a couple ofyears ago on Oprah. Score it pop culture 1, litigation consultants 0. We arenot giving up on pop culture just yet.
Weare no longer sure anymore what is the difference between high and low browcultures. Have you seen college course offerings? You (or your kid) cantake classes on Saved By the Bell or the Semiotics of Barney. A lot of whatcalls itself high culture is fixated on low culture. There was an article in thisweek’s NY Times Book Review on collections of essays. One of the essayists,Daniel Mendelsohn, was highly praised. What caught our attention in the reviewwas a reference to an essay Mendelsohn wrote in the NY Review of Books back inFebruary 2011 on Mad Men. We normally steer clear of the NY Review of Books because thereviews usually end up being more of a review of the reviewer’s obsessions thanthe actual work allegedly being reviewed. The articles exude more neurosis andbitterness than illumination. They seem to be written by and for people withmigraines. (We are still smarting from Renata Adler’s long ago takedown ofPauline Kael. Sure, some of Adler’s points about Kael’s verbal tropes werecorrect, but none of the nastiness could dislodge Kael from the Pantheon. It’slike our favorite moment in the Beatles Anthology video, where McCartneywearily recites the chorus of complaints about the White Album, how it hadmoments of self-indulgence and would have made a better single album: “It’s theBeatles' White Album! Shut up!”)
Weare not (yet) putting Mad Men up there with Kael or the Beatles. ButMendelsohn’s article does not convince us that the show is as frail anddispensable as, say, Alf. Mendelsohn’s review of Mad Men is yet another NYRBexercise in dyspepsia. Put plainly, he pretty much hates the show. Mendelsohnis a smart guy and a fine writer, and there’s no way we will do justice to hisanalysis (wrong-headed though it may be). He seems to think that Mad Men,besides suffering from sins of implausible plotting and shallowcharacterizations, depicts the social and business mores of the 1960s onan entirely superficial level. The program almost amounts to Rat Pack eraporn. We look up from our iPad at the tv screen and see characters hoistinghighballs in the afternoon, or see a pregnant woman light up a Marlboro Red,and smile smugly. Mendelsohn does not seem to think that the show digs deeplyenough or explains enough. We are not sure that there is more explanation ortexture in other series that Mendelsohn admires, such as The Sopranos or TheWire, and we suspect that any pat explanation of characters’ motivations wouldbe greeted with contempt by Mendelsohn or some other acerbic critic, and rightlyso. At the end of Mendelsohn’s review he arrives at a conclusion that seemsto us absolutely correct and insightful (and confirmatory of something wealready thought): if the milieu of Mad Men seems opaque, it is because it isviewed not from the perspective of the main characters such as Don Draper or PeggyOlson, but is viewed from the perspective of the kids, who can only gaze attheir misbehaving elders in wonder and fear. The demographic cohort that is inlove with the show is not the people who lived and acted out the doings in theshow (those people would largely now be octogenarians) but babyboomers – thekids of that smoking, boozing, philandering, utterly wonderful, mixed-up, maybe even greatest generation. The self-absorbed boomers never fretted about the interior livesof their parents back then. Now they (we) do. But having direct conversationswith parents on those issues, many of them terribly awkward, is impossibleor irritating or unreliable now. Like most works of art, Mad Men takes us outof ourselves. Shelley (whose life would make a pretty good cable mini-series)said that poetry is a great spiritual and even civic exercise, because it makesus consider about how others live and think and feel.
Itoccurs to us that considering how others live and think and feel has a littlesomething to do with successful litigation. Thus, all kidding aside about thenew JAMA article, we are more likely to put down the spoon than the remotecontrol.
Guest Post – Illinois Supreme Court And Forum Non Conveniens
To contact us Click HERE
The following post was sent to us by Brendan Kenny of Blackwell Burke. It concerns a new Illinois Supreme Court casethat could have significant impact on out-of-state plaintiffs’ ability to keeptheir cases in Madison, St. Clair, etc.
As always with guest posts, the credit/blame goessolely to the poster. We’re only thepiano player.
****************
I just learned of a December 28, 2012 publishedIllinois Supreme Court forum nonconveniens 5-1 decision that will be helpful to defendants in Illinois byemphasizing that Illinois trial courts must grant a defendant’s forum non conveniens motion if theplaintiff has no significant connection to the forum and there is analternative forum that is more convenient.
The case is Fennell v. Illinois Central Railroad,and here’s a copy. In Fennell, the Court held that the trial court abused its discretionwhen it denied defendant Illinois Central’s forumnon conveniens motion and that the appellate court had erred in affirmingthe trial court's denial. Then the Courtremanded the case to the trial court with instructions to dismiss as a matterof law. Fennell strengthensdefendants’ challenges to asbestos, pharmaceutical, and other out-of-state plaintiffs’forum shopping in plaintiff-friendly locales like Madison County. The defendants will have a better chance tomove such cases to more favorable forums. This will reduce the settlement value of casesand increase the likelihood of winning the cases that defendants try.
Facts
Fennell was an asbestos case. The plaintiff claimed 37-year exposure toasbestos-containing products while working for the Illinois Central Railroad. The plaintiff did not live in Illinois, butrather lived and often worked in Mississippi. As a railroad worker, plaintiff, also worked across the county for therailroad, and he alleged that he was exposed to asbestos-containing productswherever he worked. In 2002, plaintiff Fennelland a class of 80 other plaintiffs sued Illinois Central in Mississippi state court. In that case, Illinois Central filed amotion to dismiss, and in 2006 the Mississippi court dismissed the case withoutprejudice.
In 2009, rather than re-file in Mississippi,Fennell filed an individual action against Illinois Central in Saint ClairCounty, Illinois. He alleged that he wasexposed to asbestos and other toxic substances while working for IllinoisCentral, but he did not allege aninjury in Saint Clair County. InMay 2010, Illinois Central filed a forumnon conveniens motion. The trialcourt denied the motion because: (1)Illinois Central’s lawyers had significant evidence in Saint Clair County, (2)two of Fennell’s important witnesses would testify in Illinois but not inMississippi, (3) Saint Clair County is closer for Fennell’s Chicago-basedexpert witness than Mississippi, (4) Saint Clair citizens have an interest in “travelingasbestos and other harmful substances”; and (5) Saint Clair County's docketsare uncongested.
Illinois Central appealed, and a dividedappellate-court panel affirmed. IllinoisCentral appealed to the Illinois Supreme Court, and several amici filed briefs.
General Principles
A trial court’s denial of a forum non conveniens motion is reviewed for abuse of discretion – astringent standard. Under the forum non conveniens doctrine, a trialcourt may decline jurisdiction if it appears that another forum can betterserve the parties' convenience and the ends of justice. When ruling on the motion, trial court mustconsider what forum the totality of public and private-interest factors favor.
Private-interest factors include the parties’convenience, access to evidence, ability to compel witnesses to appear fortrial, coast of presenting willing witnesses at trial, possibility of viewingthe premises at issue, and any other factors that make a trial “easy,expeditious, and inexpensive.” Critically,trial courts should also consider that courts have never favored forumshopping, and that a plaintiff’s interest in selecting a forum is less if theplaintiff is foreign to the forum and the action arose outside the forum. As the court stated:
[W]hen the plaintiff is foreign to the chosen forum andwhen the action giving rise to the litigation did not occur in the chosenforum, the plaintiff’s choice of forum is accorded less deference. A plaintiff’s home forum for purposes of aninterstate forum non conveniensmotion is the plaintiff’s home State.
Also, courts have never favored forum shopping. Decent judicial administration cannottolerate forum shopping as a persuasive or even legitimate reason for burdeningcommunities with litigation that arose elsewhere and should, in all justice, betried there. Indeed, a concern animatingour forum non conveniensjurisprudence is curtailing forum shopping by plaintiffs.
Fennell, slip op. at 6 ¶¶18-19 (citations andquotation marks omitted).
Public-interest factors include the congestion ofthe forum’s courts, the unfairness of imposing jury duty on residents in acommunity unconnected to the litigation, and the interests of local communitiesin deciding local issues.
The Supreme Court held that the trial court abusedits discretion because it failed to properly apply the public andprivate-interest factors:
Application of Private-Interest Factors
Fennell was from Mississippi and his cause ofaction arose outside Illinois. TheSupreme Court noted that trial court ignored that Fennell initially filed inMississippi and re-filed in Illinois. Itemphasized that Fennell lives less than 25 miles from the Mississippicourthouse, but 530 miles away from the Saint Clair courthouse, and that almostno one connected with Fennell's case lives in Illinois. Nothing suggested that having the case inMississippi would unduly hamper the parties’ discovery. The Court held that Fennell's Chicago-basedexpert’s convenience was entitled to little weight because he is compensatedfor his travel, and factoring the convenience of plaintiffs' expert would makeforum shopping even easier.
The Illinois Supreme Court also rejected the trialcourt’s conclusion that two of Fennell’s important witnesses would not testifyin court in Mississippi because these witnesses were defendant Illinois Central’semployees. That status makes it unlikelythat Fennell would have difficulty compelling them to testify in Mississippi. The Mississippi-based witnesses could not becompelled to testify in Saint Clair County, and bringing the willing witnessesthere would cost more.
The Illinois Supreme Court was not persuaded thatIllinois Central having counsel in Saint Clair County was significant. Even assuming that the law firm had manyIllinois Central documents relevant to the case there, the Illinois SupremeCourt noted that modern technology allows litigants to copy and transport thedocuments long distance easily and cheaply. On the other side of the ledger, the Courtobserved that a Saint Clair County jury, unlike a Mississippi one, could noteasily view the premises at issue in this case, which would be Fennell'sMississippi job site.
In sum, plaintiff resides in Mississippi; the allegedexposure occurred in Mississippi and Louisiana; the vast majority of the identifiedwitnesses, including the treating physicians, are located in Mississippi andare not subject to Illinois subpoenas; and a jury view of the premises wouldoccur outside of Illinois. On the whole, we conclude that the private interestfactors weigh heavily in favor of the convenience of a Mississippi forum overan Illinois forum.
Fennell, slip op. at 11 ¶41. Of note is the fact that the prior litigationin Mississippi played very little role in the Court’s consideration of theprivate interest factors.
Application of Public-Interest Factors
The Supreme Court in Fennell held that because there wasinsignificant evidence to determine which forum’s docket was more congested, itdid not take this factor into account. Butit found that Saint Clair County had a strong interest in avoiding subjectingits citizens to jury duty in a case unrelated to their community. And assuming that Saint Clair County citizenshad an interest in “traveling asbestos and other harmful substances,” they havea greater interest in not being burdened with litigation they have no connectionto.
That the action had no Illinois connection wasdispositive of the public interest factors:
If Illinois had any relevant or practical connectionwith this litigation, then it would have an interest in providing a forum. However, plaintiff resides in Mississippi,works in Mississippi, and was allegedly exposed to asbestos in Mississippi orLouisiana. Illinois’ only connectionwith this lawsuit is: the offices of the parties’ counsel; accessible andtransportable documents in the possession of defendant’s counsel; and acompensated expert witness for plaintiff. This does not provide a significantfactual connection with the instant case to justify imposition of the burdensof the litigation upon the citizens and court system of St. Clair County and Illinois.
Fennell, slip op. at 13 ¶46. Here, the prior Mississippi litigation playedno role at all.
In short, only Mississippi’s citizens that have theinterest in the litigation. Thus theCourt remanded with instructions to dismiss on grounds of forum non conveniens. Id.at 14 ¶51.
The following post was sent to us by Brendan Kenny of Blackwell Burke. It concerns a new Illinois Supreme Court casethat could have significant impact on out-of-state plaintiffs’ ability to keeptheir cases in Madison, St. Clair, etc.
As always with guest posts, the credit/blame goessolely to the poster. We’re only thepiano player.
****************
I just learned of a December 28, 2012 publishedIllinois Supreme Court forum nonconveniens 5-1 decision that will be helpful to defendants in Illinois byemphasizing that Illinois trial courts must grant a defendant’s forum non conveniens motion if theplaintiff has no significant connection to the forum and there is analternative forum that is more convenient.
The case is Fennell v. Illinois Central Railroad,and here’s a copy. In Fennell, the Court held that the trial court abused its discretionwhen it denied defendant Illinois Central’s forumnon conveniens motion and that the appellate court had erred in affirmingthe trial court's denial. Then the Courtremanded the case to the trial court with instructions to dismiss as a matterof law. Fennell strengthensdefendants’ challenges to asbestos, pharmaceutical, and other out-of-state plaintiffs’forum shopping in plaintiff-friendly locales like Madison County. The defendants will have a better chance tomove such cases to more favorable forums. This will reduce the settlement value of casesand increase the likelihood of winning the cases that defendants try.
Facts
Fennell was an asbestos case. The plaintiff claimed 37-year exposure toasbestos-containing products while working for the Illinois Central Railroad. The plaintiff did not live in Illinois, butrather lived and often worked in Mississippi. As a railroad worker, plaintiff, also worked across the county for therailroad, and he alleged that he was exposed to asbestos-containing productswherever he worked. In 2002, plaintiff Fennelland a class of 80 other plaintiffs sued Illinois Central in Mississippi state court. In that case, Illinois Central filed amotion to dismiss, and in 2006 the Mississippi court dismissed the case withoutprejudice.
In 2009, rather than re-file in Mississippi,Fennell filed an individual action against Illinois Central in Saint ClairCounty, Illinois. He alleged that he wasexposed to asbestos and other toxic substances while working for IllinoisCentral, but he did not allege aninjury in Saint Clair County. InMay 2010, Illinois Central filed a forumnon conveniens motion. The trialcourt denied the motion because: (1)Illinois Central’s lawyers had significant evidence in Saint Clair County, (2)two of Fennell’s important witnesses would testify in Illinois but not inMississippi, (3) Saint Clair County is closer for Fennell’s Chicago-basedexpert witness than Mississippi, (4) Saint Clair citizens have an interest in “travelingasbestos and other harmful substances”; and (5) Saint Clair County's docketsare uncongested.
Illinois Central appealed, and a dividedappellate-court panel affirmed. IllinoisCentral appealed to the Illinois Supreme Court, and several amici filed briefs.
General Principles
A trial court’s denial of a forum non conveniens motion is reviewed for abuse of discretion – astringent standard. Under the forum non conveniens doctrine, a trialcourt may decline jurisdiction if it appears that another forum can betterserve the parties' convenience and the ends of justice. When ruling on the motion, trial court mustconsider what forum the totality of public and private-interest factors favor.
Private-interest factors include the parties’convenience, access to evidence, ability to compel witnesses to appear fortrial, coast of presenting willing witnesses at trial, possibility of viewingthe premises at issue, and any other factors that make a trial “easy,expeditious, and inexpensive.” Critically,trial courts should also consider that courts have never favored forumshopping, and that a plaintiff’s interest in selecting a forum is less if theplaintiff is foreign to the forum and the action arose outside the forum. As the court stated:
[W]hen the plaintiff is foreign to the chosen forum andwhen the action giving rise to the litigation did not occur in the chosenforum, the plaintiff’s choice of forum is accorded less deference. A plaintiff’s home forum for purposes of aninterstate forum non conveniensmotion is the plaintiff’s home State.
Also, courts have never favored forum shopping. Decent judicial administration cannottolerate forum shopping as a persuasive or even legitimate reason for burdeningcommunities with litigation that arose elsewhere and should, in all justice, betried there. Indeed, a concern animatingour forum non conveniensjurisprudence is curtailing forum shopping by plaintiffs.
Fennell, slip op. at 6 ¶¶18-19 (citations andquotation marks omitted).
Public-interest factors include the congestion ofthe forum’s courts, the unfairness of imposing jury duty on residents in acommunity unconnected to the litigation, and the interests of local communitiesin deciding local issues.
The Supreme Court held that the trial court abusedits discretion because it failed to properly apply the public andprivate-interest factors:
Application of Private-Interest Factors
Fennell was from Mississippi and his cause ofaction arose outside Illinois. TheSupreme Court noted that trial court ignored that Fennell initially filed inMississippi and re-filed in Illinois. Itemphasized that Fennell lives less than 25 miles from the Mississippicourthouse, but 530 miles away from the Saint Clair courthouse, and that almostno one connected with Fennell's case lives in Illinois. Nothing suggested that having the case inMississippi would unduly hamper the parties’ discovery. The Court held that Fennell's Chicago-basedexpert’s convenience was entitled to little weight because he is compensatedfor his travel, and factoring the convenience of plaintiffs' expert would makeforum shopping even easier.
The Illinois Supreme Court also rejected the trialcourt’s conclusion that two of Fennell’s important witnesses would not testifyin court in Mississippi because these witnesses were defendant Illinois Central’semployees. That status makes it unlikelythat Fennell would have difficulty compelling them to testify in Mississippi. The Mississippi-based witnesses could not becompelled to testify in Saint Clair County, and bringing the willing witnessesthere would cost more.
The Illinois Supreme Court was not persuaded thatIllinois Central having counsel in Saint Clair County was significant. Even assuming that the law firm had manyIllinois Central documents relevant to the case there, the Illinois SupremeCourt noted that modern technology allows litigants to copy and transport thedocuments long distance easily and cheaply. On the other side of the ledger, the Courtobserved that a Saint Clair County jury, unlike a Mississippi one, could noteasily view the premises at issue in this case, which would be Fennell'sMississippi job site.
In sum, plaintiff resides in Mississippi; the allegedexposure occurred in Mississippi and Louisiana; the vast majority of the identifiedwitnesses, including the treating physicians, are located in Mississippi andare not subject to Illinois subpoenas; and a jury view of the premises wouldoccur outside of Illinois. On the whole, we conclude that the private interestfactors weigh heavily in favor of the convenience of a Mississippi forum overan Illinois forum.
Fennell, slip op. at 11 ¶41. Of note is the fact that the prior litigationin Mississippi played very little role in the Court’s consideration of theprivate interest factors.
Application of Public-Interest Factors
The Supreme Court in Fennell held that because there wasinsignificant evidence to determine which forum’s docket was more congested, itdid not take this factor into account. Butit found that Saint Clair County had a strong interest in avoiding subjectingits citizens to jury duty in a case unrelated to their community. And assuming that Saint Clair County citizenshad an interest in “traveling asbestos and other harmful substances,” they havea greater interest in not being burdened with litigation they have no connectionto.
That the action had no Illinois connection wasdispositive of the public interest factors:
If Illinois had any relevant or practical connectionwith this litigation, then it would have an interest in providing a forum. However, plaintiff resides in Mississippi,works in Mississippi, and was allegedly exposed to asbestos in Mississippi orLouisiana. Illinois’ only connectionwith this lawsuit is: the offices of the parties’ counsel; accessible andtransportable documents in the possession of defendant’s counsel; and acompensated expert witness for plaintiff. This does not provide a significantfactual connection with the instant case to justify imposition of the burdensof the litigation upon the citizens and court system of St. Clair County and Illinois.
Fennell, slip op. at 13 ¶46. Here, the prior Mississippi litigation playedno role at all.
In short, only Mississippi’s citizens that have theinterest in the litigation. Thus theCourt remanded with instructions to dismiss on grounds of forum non conveniens. Id.at 14 ¶51.
Presuming Preemption Out
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We readthe decision in Tigert v. Ranbaxy Pharms.,No. 12-00154 (RBK/JS), 2012 U.S. Dist. LEXIS 178475 (D.N.J. Dec. 18, 2012),with interest. It involved a recurringquestion that the Supreme Court failed to address in Warner-Lambert Co. v. Kent, 552 U.S. 440 (2007)—whether statestatutory provisions that require a plaintiff to prove some version offraud-on-the-FDA as a predicate to recovery on certain claims are preempted by Buckman Co. v. Plaintiff’s Legal Comm.,531 U.S. 341 (2001), in situations where FDA has not concluded that such afraud occurred. Well, that is how weframe the question, having dealt with dealt for a while with Buckman, state tort reform statutes, andplaintiffs who think the jury should be allowed to award big bucks based on itsconclusion that the FDA was defrauded by what the sponsor-defendant did or didnot submit as long as the verdict form lacks a section entitled “CAUSE OFACTION #3 – FRAUD ON THE FDA (pssst, answer Yes for free donuts).” This subject, of course, has been addressedin several http://druganddevicelaw.blogspot.com/2007/09/warner-lambert-v-kent-whats-at-stake.html prior http://druganddevicelaw.blogspot.com/2009/09/embedded-fraud-on-fda.htmlposts http://druganddevicelaw.blogspot.com/2010/01/fraud-on-fda-its-garcia-over-desiano-in.html, and it is no secret that we think Garciav. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), was right on theMichigan statute where Desiano v.Warner-Lambert, 467 F.3d 85 (2d Cir. 2006), was wrong and Lofton v. McNeil Consumer & SpecialtyPharms., 672 F.3d 372 (5th Cir. 2012), was right on the Texas statute. http://druganddevicelaw.blogspot.com/2012/12/our-favorites-best-prescription.html;So, we hoped that the analysis in Tigertof the same Texas statute as in Loftonwould follow Lofton. We were disappointed. (Despite the time of year, we are trying torefrain from references to holidays, resolutions, or our memories of the pastyear. We leave such to others.)
Tigert involved a fairly straightforwarddrug claim—plaintiff took Solodyn, a prescription acne medication made bydefendant Medicis Pharmaceutical Corporation, experienced liver failure whileon the medication, and sued. Since theprescriptions and use were apparently in Texas—the decision never says that—andthe Second Amended Complaint—yes, like we pointed out in prior posts, we seemto see serial amendments of complaints for weak cases—alleged that the Solodynlabel had warnings approved by FDA, the defendant teed up a 12(c) motion forjudgment on the pleadings that the presumption against liability where anallegedly inadequate warning was approved by FDA would hold because theexception for fraud on the FDA was preempted by Buckman. Much like shoddywrapping or a package in the shape of socks, there were some signs we were notgoing like where this decision ended up. (We waited two whole sentences, one a complete run-on, before failing torefrain.)
The firsthint was that the plaintiff was identified as “a 21 year old college student,”which does not seem relevant to the 12(c) standard of whether “plaintiff canprove no set of facts in support of [her] claim which would entitle [her] torelief.” 2012 U.S. Dist. LEXIS 178475,** 2 & 4. The second was in the lackof detail about what was plead—remember this is a motion for judgment on thepleadings, addressing the adequacy of the third version of the complaint. The opinion characterized the complaint asclaiming the label “grossly understated the risks” of the drug, even though itwas approved by FDA. Id. at *2. The risk of liver failure? Therisk of something else? Were thewarnings allegedly inadequate based upon information that existed beforeapproval or only after approval? Whatwas wrong with the warnings according to the complaint? Tigertalso never stated that the complaint alleged any specific fraud on FDA, relatedto liver failure or otherwise, pre-approval or post-approval. That struck us as strange. The decision ultimately did decline toconsider whether the plaintiff failed to allege fraud with particularity asrequired by Fed. R. Civ. P. 9(b) because the argument was not raised until thereply. While we find it hard to believethat defendant’s motion did not identify the shortcomings of plaintiff’s fraudallegations, all we can say from this decision on the adequacy of the pleadingsis that we still do not know what plaintiff pled on fraud.
Thedetails matter because the exemption at issue requires the plaintiff toestablish that “the defendant, before or after pre-market approval . . .withheld from or misrepresented to the United States Food and DrugAdministration requiredinformation that was materialand relevant to the performance ofthe product and was causallyrelated to the claimant’s injury” (emphasis added). That means not just any allegations of fraudon the FDA should suffice for this case. At a minimum, the alleged non-disclosure or misrepresentation would needto have related to the risk of liver failure. If it did not, then the opinion should not have reached theconstitutional issue of preemption and should have just granted the motion forjudgment on the pleadings. If plaintiffchose to allege that the label was approved—she did—without alleging the relevantfraud on FDA to meet the statutory exemption—maybe she did—then the pleadingdid not state a claim for relief under Texas law.
Instead, Tigert jumped to an issue ofconstitutional law that perhaps it did not have to reach and then proceeded todiscuss it without any consideration of the alleged facts of the case. For Tigert,the issue was whether to follow the Fifth Circuit’s decision in Lofton that the Texas exemption waspreempted or the Second Circuit’s decision in Desiano that the Michigan exemption was not preempted. Huh? Did we miss the D.N.J. moving to the Second Circuit or Michigan annexingTexas? While the opinion rejected thearguments that it should follow Loftonsimply because it was the only circuit decision on the Texas statute and thatTexas is within the Fifth Circuit, the promise to “evaluate the question offederal preemption independently” did not materialize. Rather, the remaining headings in the opinionwere “The Lofton Decision” and“Reconsidering Lofton,” each of whichcritiqued the reasoning in Lofton orcompared it to the reasoning in Desiano. Any “independent” analysis of Buckman, the FDCA, preemption, and theTexas statute was nowhere to be found. Also missing was any mention of the non-precedential holding in Kent, the appeal of Desiano.
We havepreviouslyslammed questioned the reasoning of Desiano that Buckmanpreemption did not apply to the Michigan exemption because the plaintiff wasnot really choosing to assert a fraud on the FDA claim when trying to proceedunder the exemption. http://druganddevicelaw.blogspot.com/2006/11/federal-courts-should-remember.html With limited consideration of Buckmanitself—which it characterized without analysis as a “narrow ruling,” the Tigert opinion missed the flaws in Desiano and endorsed its approach. It then figured the Fifth Circuit had notcome to the same conclusion—Loftonrightly determined that making fraud on the FDA a predicate to recovery wasenough under Buckman—because it had“[s]kirt[ed] the question of whether the presumption against preemptionapplied.” Id. at *12. Based on adistinction without difference, Tigertconcluded that Lofton had “failed torecognize the applicability of the presumption against preemption and expanded Buckman preemption to §82.007(b)(1).” Id. at *14. Thus, “the Courtfinds that § 82.007(b)(1) is not preempted by federal law.” Id.at *15. Perhaps it would have been agood idea actually to review exactly why Buckmanousted the presumption against preemption:
Policing fraud against federal agencies is hardly a fieldwhich the States have traditionally occupied, such as to warrant a presumptionagainst finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between afederal agency and the entity it regulates is inherently federal in characterbecause the relationship originates from, is governed by, and terminatesaccording to federal law.
Buckman, 531 U.S.at 347 (citations and quotation marks omitted). Does the Texas statute involve “the relationship between a federalagency and the entity it regulates”? Onits face, it does by specifying that the defendant must have “withheld from ormisrepresented to the United States Food and Drug Administration.” § 82.007(b)(1). One simply cannot apply a presumption againstpreemption in this situation without ignoring Buckman. But that isprecisely what Tigert (and Desiano) did.
So, notonly was Tigert engaged in a misguidedcritique of Lofton rather than the promisedindependent evaluation of federal preemption, it also answered the wrongquestion. Under 12(c), a court is supposedto decide whether the pleadings, construed favorably to the non-movant, stateda claim for failure to warn under Texas law given that the live complaintalleged the warnings were approved by FDA, apparently had some allegationsrelating to some sort of fraud of FDA, and apparently did not allege that FDAhad found that such a fraud had been perpetrated. It is not a matter of whether § 82.007(b)(1)is preempted, but whether the cause of action that plaintiff had pled ispreempted.
Somewhatironically, Tigert made note of whatcould have been a rational path to a decision on the issue actuallypresented. In setting up how brilliantit thought Desiano was, the opinion notedthat the Sixth Circuit’s Garciadecision held “that unless the FDA itself had already found fraud, plaintiffcould not attempt to overcome the presumption of non-liability by invoking the‘fraud-on-the-FDA’ [Michigan] statutory exception.” Id.at *8. If the plaintiff had decided toplead that FDA had concluded that it was defrauded with regard to “informationthat was material and relevant to the performance of the product and wascausally related to the claimant’s injury”—in addition to pleading that thedrug came with an FDA-approved label for some reason—then she would have gottenpast preemption at this stage. Perhapssome concern over the facts or Rule 11 precluded the plaintiff from making theallegation about what FDA had concluded. And perhaps, in 2013 or beyond, when it is apparent that the plaintiffhas no evidence of a relevant fraud on FDA or FDA’s finding of such a fraud, Tigert will be kicked on another motion,the over-inflated, wrongly-applied, and (perhaps after Mensing) non-existent presumption against preemptionnotwithstanding.
Tigert involved a fairly straightforwarddrug claim—plaintiff took Solodyn, a prescription acne medication made bydefendant Medicis Pharmaceutical Corporation, experienced liver failure whileon the medication, and sued. Since theprescriptions and use were apparently in Texas—the decision never says that—andthe Second Amended Complaint—yes, like we pointed out in prior posts, we seemto see serial amendments of complaints for weak cases—alleged that the Solodynlabel had warnings approved by FDA, the defendant teed up a 12(c) motion forjudgment on the pleadings that the presumption against liability where anallegedly inadequate warning was approved by FDA would hold because theexception for fraud on the FDA was preempted by Buckman. Much like shoddywrapping or a package in the shape of socks, there were some signs we were notgoing like where this decision ended up. (We waited two whole sentences, one a complete run-on, before failing torefrain.)
The firsthint was that the plaintiff was identified as “a 21 year old college student,”which does not seem relevant to the 12(c) standard of whether “plaintiff canprove no set of facts in support of [her] claim which would entitle [her] torelief.” 2012 U.S. Dist. LEXIS 178475,** 2 & 4. The second was in the lackof detail about what was plead—remember this is a motion for judgment on thepleadings, addressing the adequacy of the third version of the complaint. The opinion characterized the complaint asclaiming the label “grossly understated the risks” of the drug, even though itwas approved by FDA. Id. at *2. The risk of liver failure? Therisk of something else? Were thewarnings allegedly inadequate based upon information that existed beforeapproval or only after approval? Whatwas wrong with the warnings according to the complaint? Tigertalso never stated that the complaint alleged any specific fraud on FDA, relatedto liver failure or otherwise, pre-approval or post-approval. That struck us as strange. The decision ultimately did decline toconsider whether the plaintiff failed to allege fraud with particularity asrequired by Fed. R. Civ. P. 9(b) because the argument was not raised until thereply. While we find it hard to believethat defendant’s motion did not identify the shortcomings of plaintiff’s fraudallegations, all we can say from this decision on the adequacy of the pleadingsis that we still do not know what plaintiff pled on fraud.
Thedetails matter because the exemption at issue requires the plaintiff toestablish that “the defendant, before or after pre-market approval . . .withheld from or misrepresented to the United States Food and DrugAdministration requiredinformation that was materialand relevant to the performance ofthe product and was causallyrelated to the claimant’s injury” (emphasis added). That means not just any allegations of fraudon the FDA should suffice for this case. At a minimum, the alleged non-disclosure or misrepresentation would needto have related to the risk of liver failure. If it did not, then the opinion should not have reached theconstitutional issue of preemption and should have just granted the motion forjudgment on the pleadings. If plaintiffchose to allege that the label was approved—she did—without alleging the relevantfraud on FDA to meet the statutory exemption—maybe she did—then the pleadingdid not state a claim for relief under Texas law.
Instead, Tigert jumped to an issue ofconstitutional law that perhaps it did not have to reach and then proceeded todiscuss it without any consideration of the alleged facts of the case. For Tigert,the issue was whether to follow the Fifth Circuit’s decision in Lofton that the Texas exemption waspreempted or the Second Circuit’s decision in Desiano that the Michigan exemption was not preempted. Huh? Did we miss the D.N.J. moving to the Second Circuit or Michigan annexingTexas? While the opinion rejected thearguments that it should follow Loftonsimply because it was the only circuit decision on the Texas statute and thatTexas is within the Fifth Circuit, the promise to “evaluate the question offederal preemption independently” did not materialize. Rather, the remaining headings in the opinionwere “The Lofton Decision” and“Reconsidering Lofton,” each of whichcritiqued the reasoning in Lofton orcompared it to the reasoning in Desiano. Any “independent” analysis of Buckman, the FDCA, preemption, and theTexas statute was nowhere to be found. Also missing was any mention of the non-precedential holding in Kent, the appeal of Desiano.
We havepreviously
Policing fraud against federal agencies is hardly a fieldwhich the States have traditionally occupied, such as to warrant a presumptionagainst finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between afederal agency and the entity it regulates is inherently federal in characterbecause the relationship originates from, is governed by, and terminatesaccording to federal law.
Buckman, 531 U.S.at 347 (citations and quotation marks omitted). Does the Texas statute involve “the relationship between a federalagency and the entity it regulates”? Onits face, it does by specifying that the defendant must have “withheld from ormisrepresented to the United States Food and Drug Administration.” § 82.007(b)(1). One simply cannot apply a presumption againstpreemption in this situation without ignoring Buckman. But that isprecisely what Tigert (and Desiano) did.
So, notonly was Tigert engaged in a misguidedcritique of Lofton rather than the promisedindependent evaluation of federal preemption, it also answered the wrongquestion. Under 12(c), a court is supposedto decide whether the pleadings, construed favorably to the non-movant, stateda claim for failure to warn under Texas law given that the live complaintalleged the warnings were approved by FDA, apparently had some allegationsrelating to some sort of fraud of FDA, and apparently did not allege that FDAhad found that such a fraud had been perpetrated. It is not a matter of whether § 82.007(b)(1)is preempted, but whether the cause of action that plaintiff had pled ispreempted.
Somewhatironically, Tigert made note of whatcould have been a rational path to a decision on the issue actuallypresented. In setting up how brilliantit thought Desiano was, the opinion notedthat the Sixth Circuit’s Garciadecision held “that unless the FDA itself had already found fraud, plaintiffcould not attempt to overcome the presumption of non-liability by invoking the‘fraud-on-the-FDA’ [Michigan] statutory exception.” Id.at *8. If the plaintiff had decided toplead that FDA had concluded that it was defrauded with regard to “informationthat was material and relevant to the performance of the product and wascausally related to the claimant’s injury”—in addition to pleading that thedrug came with an FDA-approved label for some reason—then she would have gottenpast preemption at this stage. Perhapssome concern over the facts or Rule 11 precluded the plaintiff from making theallegation about what FDA had concluded. And perhaps, in 2013 or beyond, when it is apparent that the plaintiffhas no evidence of a relevant fraud on FDA or FDA’s finding of such a fraud, Tigert will be kicked on another motion,the over-inflated, wrongly-applied, and (perhaps after Mensing) non-existent presumption against preemptionnotwithstanding.
2 Ocak 2013 Çarşamba
Thousands of Ohio homeowners foreclosed on improperly
To contact us Click HERE
Newspaper (Cleveland Plain Dealer) coverage: on our previously reported story:
MARC DANN (Former OHIO AG) of DANN, DOBERDRUK & WELLEN, LLC
Explosive Legal News:
Cuyahoga County: Court of Common PleasLinda Clark, Doehner, Lowery, Whiteman, Laura YEAGER
Plaintiffs
Urgent Update: CALL to ACTION for plaintiff being evicted (HERE)VS.Lender Processing Services (LPS)
LPS Default Solutions
DOCX LLC (DocX)
Fidelity National Information Services (FNIS)
American Home Mortgage Bank Servicing (AHMSI)
LERNER, SAMPSON & ROTHFUS (LSR)
MANLEY, DEAS KOCHALSKI LLC (MDK)
REIMER, ARNOVITZ, CHERNEK& JEFFREY CO LPA
Defendants
The complaint clearly spells out the criminal behaviour of the co-conspiring entities which acted in concert while participating and perpetrating enormous FRAUD in OHIO's foreclosures. Our former Attorney General along with some powerful legal allies have filed this action on behalf of a proposed class consisting of:
ALL OHIO CITIZENS who were (a) defendants in judicial foreclosure actions {with} first lien mortgages on their homes that were purportedly held by securitization trusts, and that were knowingly initiated and prosecuted by Defendants on behalf of parties that lacked legal standing to do so, and (b) who were damaged by Defendants’ abusive foreclosure practices, including: (i) preparing, executing, and notarizing fraudulent court documents and assignments of mortgages and other property records that were used to initiate and prosecute such foreclosures, and (ii) imposing inflated, unfair, unreasonable and/or fabricated fees for “default management services” (the “Class”)
Three (3) categories of defendants {Servicers, Foreclosure document venders, and Foreclosure Mills) acted in concert and conspired in furtherance of the fraudulent scheme to generate enormous profits from default servicing fees by knowingly initiating foreclosure actions on behalf of entities that lacked legal standing to bring such actions.
92 page Class Action Complaint: DOWNLOAD HERESadly, in what appeared to be an instant counter action and outrageous and unconscionable retaliatory attack - a 10-day eviction notice was posted on Plaintiff Michael and Laura YEAGER's home - the day after the complaint was filed! It has since been followed up with another! The PREDATOR DRONE foreclosure mill law firm (REIMER, ARNOVITZ, CHERNEK& JEFFREY CO LPA ) apparently tasked co-defendant paper filing drones' (Manley Deas Kocholski) to execute the writ-of-possession while the morally corrupt bank sponsored attorney - Kristi Pallen* - (kpallen@reimerlaw.com) (330-405-1199) continues the fight to legally block the Yeager's request for a Stay (of an eviction). Reimer (Pallen) has also refused a supersedeas property bond offer (collateral), or to accept a previously agreed upon short sale. *Kristi Pallen - Previousirresponsible, bank-sponsored, failed action ADMONISHED: READ HERE on admonished behaviour: U.S. Bank National Association v. Lenor*Plaintiff’s counsel, Attorney Kristi Brown, also identified as Attorney Kristi Pallen, filed this matter on behalf of bogus Plaintiff, U.S. Bank National Association. The Court finds Plaintiff’s counsel (Kristi Brown kna Kristi Pallen) did not follow Local Rule 4.2. filing procedures for service by Certified Mail....and... The Court strikes all entries pertaining to service and further, the Court finds Plaintiff’s counsel failed to prosecute this matter...and.. Therefore, it is ORDERED this case is dismissed, without prejudice, .....and for Want of Prosecution. It is further ORDERED this case is dismissed... for failure to perfect service within 120 days, according to Fed.R.Civ.P 4.Plaintiff’s counsel is admonished !!!!! as to Service by Certified Mail
Thousands of Ohio homeowners were foreclosed on improperly, lawsuit claims
Ohio Bombshell: Former AG takes on LPS, Mills & Servicers
CLASS ACTION COMPLAINT filed in Cuyahoga County (Cleveland)MARC DANN (Former OHIO AG) of DANN, DOBERDRUK & WELLEN, LLC
Explosive Legal News: Cuyahoga County: Court of Common PleasLinda Clark, Doehner, Lowery, Whiteman, Laura YEAGER
Plaintiffs
Urgent Update: CALL to ACTION for plaintiff being evicted (HERE)VS.Lender Processing Services (LPS)
LPS Default Solutions
DOCX LLC (DocX)
Fidelity National Information Services (FNIS)
American Home Mortgage Bank Servicing (AHMSI)
LERNER, SAMPSON & ROTHFUS (LSR)
MANLEY, DEAS KOCHALSKI LLC (MDK)
REIMER, ARNOVITZ, CHERNEK& JEFFREY CO LPA
Defendants
The complaint clearly spells out the criminal behaviour of the co-conspiring entities which acted in concert while participating and perpetrating enormous FRAUD in OHIO's foreclosures. Our former Attorney General along with some powerful legal allies have filed this action on behalf of a proposed class consisting of:
ALL OHIO CITIZENS who were (a) defendants in judicial foreclosure actions {with} first lien mortgages on their homes that were purportedly held by securitization trusts, and that were knowingly initiated and prosecuted by Defendants on behalf of parties that lacked legal standing to do so, and (b) who were damaged by Defendants’ abusive foreclosure practices, including: (i) preparing, executing, and notarizing fraudulent court documents and assignments of mortgages and other property records that were used to initiate and prosecute such foreclosures, and (ii) imposing inflated, unfair, unreasonable and/or fabricated fees for “default management services” (the “Class”) Three (3) categories of defendants {Servicers, Foreclosure document venders, and Foreclosure Mills) acted in concert and conspired in furtherance of the fraudulent scheme to generate enormous profits from default servicing fees by knowingly initiating foreclosure actions on behalf of entities that lacked legal standing to bring such actions.
92 page Class Action Complaint: DOWNLOAD HERESadly, in what appeared to be an instant counter action and outrageous and unconscionable retaliatory attack - a 10-day eviction notice was posted on Plaintiff Michael and Laura YEAGER's home - the day after the complaint was filed! It has since been followed up with another! The PREDATOR DRONE foreclosure mill law firm (REIMER, ARNOVITZ, CHERNEK& JEFFREY CO LPA ) apparently tasked co-defendant paper filing drones' (Manley Deas Kocholski) to execute the writ-of-possession while the morally corrupt bank sponsored attorney - Kristi Pallen* - (kpallen@reimerlaw.com) (330-405-1199) continues the fight to legally block the Yeager's request for a Stay (of an eviction). Reimer (Pallen) has also refused a supersedeas property bond offer (collateral), or to accept a previously agreed upon short sale. *Kristi Pallen - Previous
Home is Where the Vote Is
To contact us Click HERE
OHIO is being called the most important swing state for the 2012 election!
NEWSFLASH:
President Obama - you - and Governor Romney will be competing for votes of millions of homeowners. As presidential candidates, you need to address ALL the housing issues (Underwater Mortgages, Fraudclosure, Fannie & Freddie holdings) in big swing states such as Ohio, Colorado, Nevada and Florida. Current estimates show there are between 12 - 16 million underwater homeowners, in addition to millions of fraudulent foreclosures that are NOT being counted in these totals.
OHIO:
The housing crisis has hit OHIO harder....than but a handful of states. As a result, many OHIO VOTERS are underwater on their mortgages (mortgage debt is greater than value of home) Recent housing market data shows more than a half a million (529,834) OHIO mortgages are underwater. What does that mean?
1 Million (1,000,258) Ohio eligible voters are underwater
12% of the eligible voters - underwater
528,834 home mortgages - underwater
To put these numbers in perspective, the number of Underwater Voters in Ohio (1,000,258) is OVER one third of the total votes cast for the winning presidential candidate in 2008. **
MESSAGE:
OHIO VOTERS: please join the New Bottom Line Campaign:
HOME IS WHERE THE VOTE IS
It's not just Ohio's underwater homeowners - it's millions of homeowners being impacted
Washington, DC: - Today (August 22nd) - a national campaign will put the agenda of 16 million underwater homeowners squarely on the national political agenda. ‘Home is Where the Vote Is’ will engage in a 8 state campaign to influence the presidential election with on-the-ground actions led by underwater homeowners along the travel routes of both candidates. The campaign will give a voice to the underwater voter -- a key voting bloc - this election cycle. Swing states included in the campaign are some of the hardest hit by the foreclosure crisis, including OH, CO, NV, FL, IA, MI.
'Home is Where the Vote Is' is organized by The New Bottom Line, a growing movement of community organizations, congregations, and individuals working together to challenge big bank interests and fight for principal reduction for underwater homeowners. Allies in highlighting and mobilizing underwater voters this season include Rebuild the Dream, Right to the City, Home Defenders League, Ohio FRAUDclosure and the hundreds of thousands of underwater homeowner and voting families.
READ Huffingtonpost Business Blog:
Underwater Voters Take Aim at Obama and Romney over Housing
Neither President Obama nor Governor Romney has proposed the bold solutions needed to address the housing crisis at the root of the American economy’s troubles. Resetting mortgages to fair market value is essential to keeping families in their homes and the recovery of the US economy and job market. Economists from both sides of the political spectrum support it.
'Home is Where the Vote Is' will elevate the real stories and power of underwater voters to the level that the campaigns will be forced to respond. Nationally, there are 16 million underwater homes, worth $2.8 trillion, that are $1.2 trillion underwater. Resetting those mortgages to fair market value would save the average underwater homeowner $543 per month, pumping $104 billion into the national economy every year. This would create 1.5 million jobs nationally
The candidate that fails to seriously address Wall Street , underwater homeowners, and the resulting housing crisis WILL BE the candidate that loses.
More Americans Speak Out About Underwater Housing - (OH, NV, CO)
Our neighborhoods are being destroyed by foreclosed homes. It's our communities that are deprived of hundreds of millions of dollars in revenue because too many homeowners have to unfairly pay the big banks instead of investing in local businesses. Entire communities are being blighted across our state and nation because of the failed policies and the on-going fraudulent practices of the big banks.
MORE: ...Huffington Post Business Blog - by Tracy Van Slyke
NEWSFLASH:
President Obama - you - and Governor Romney will be competing for votes of millions of homeowners. As presidential candidates, you need to address ALL the housing issues (Underwater Mortgages, Fraudclosure, Fannie & Freddie holdings) in big swing states such as Ohio, Colorado, Nevada and Florida. Current estimates show there are between 12 - 16 million underwater homeowners, in addition to millions of fraudulent foreclosures that are NOT being counted in these totals.
OHIO:
The housing crisis has hit OHIO harder....than but a handful of states. As a result, many OHIO VOTERS are underwater on their mortgages (mortgage debt is greater than value of home) Recent housing market data shows more than a half a million (529,834) OHIO mortgages are underwater. What does that mean?
1 Million (1,000,258) Ohio eligible voters are underwater
12% of the eligible voters - underwater
528,834 home mortgages - underwater
To put these numbers in perspective, the number of Underwater Voters in Ohio (1,000,258) is OVER one third of the total votes cast for the winning presidential candidate in 2008. **
MESSAGE:
OHIO VOTERS: please join the New Bottom Line Campaign:
HOME IS WHERE THE VOTE IS
It's not just Ohio's underwater homeowners - it's millions of homeowners being impacted
Washington, DC: - Today (August 22nd) - a national campaign will put the agenda of 16 million underwater homeowners squarely on the national political agenda. ‘Home is Where the Vote Is’ will engage in a 8 state campaign to influence the presidential election with on-the-ground actions led by underwater homeowners along the travel routes of both candidates. The campaign will give a voice to the underwater voter -- a key voting bloc - this election cycle. Swing states included in the campaign are some of the hardest hit by the foreclosure crisis, including OH, CO, NV, FL, IA, MI.
'Home is Where the Vote Is' is organized by The New Bottom Line, a growing movement of community organizations, congregations, and individuals working together to challenge big bank interests and fight for principal reduction for underwater homeowners. Allies in highlighting and mobilizing underwater voters this season include Rebuild the Dream, Right to the City, Home Defenders League, Ohio FRAUDclosure and the hundreds of thousands of underwater homeowner and voting families.
READ Huffingtonpost Business Blog:
Underwater Voters Take Aim at Obama and Romney over Housing
Neither President Obama nor Governor Romney has proposed the bold solutions needed to address the housing crisis at the root of the American economy’s troubles. Resetting mortgages to fair market value is essential to keeping families in their homes and the recovery of the US economy and job market. Economists from both sides of the political spectrum support it.
'Home is Where the Vote Is' will elevate the real stories and power of underwater voters to the level that the campaigns will be forced to respond. Nationally, there are 16 million underwater homes, worth $2.8 trillion, that are $1.2 trillion underwater. Resetting those mortgages to fair market value would save the average underwater homeowner $543 per month, pumping $104 billion into the national economy every year. This would create 1.5 million jobs nationally
The candidate that fails to seriously address Wall Street , underwater homeowners, and the resulting housing crisis WILL BE the candidate that loses.
More Americans Speak Out About Underwater Housing - (OH, NV, CO)
Our neighborhoods are being destroyed by foreclosed homes. It's our communities that are deprived of hundreds of millions of dollars in revenue because too many homeowners have to unfairly pay the big banks instead of investing in local businesses. Entire communities are being blighted across our state and nation because of the failed policies and the on-going fraudulent practices of the big banks.
MORE: ...Huffington Post Business Blog - by Tracy Van Slyke
The Big Lie - Foreclosure issues resolved
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The current administration is revisiting the so called "Foreclosure Settlement"
* First....consider the settlement that the Obama Administration is now beginning to trumpet as one of its greatest achievements. This is the joint forty-nine state & federal settlement wherein the banks claim to eventually settle...by paying a paltry $25 billion. (the 'headline number' provided by the White House) Not only is this a completely "disingenuous" claim, but it was systematically and totally dismantled by Yves Smith of Naked Capitalism (Top ranked financial blog).
In reality, and with maybe... a mere $5 billion (moved around on their books), the five criminal banks were released from ALL STATE lawsuits stemming from the massive and systemic fraud that went into the origination and servicing of housing loans throughout the bubble and into the crash. For this paltry sum, the banks were released from all liability stemming from a decade-long-run of illicit activities that fleeced millions of customers and inflated a bubble that eventually destroyed the economy of the United States and much of the world. Now, you might ask, to what did the five large banks, party to the settlement (Bank of America, Wells-Fargo, Morgan Stanley, Citibank, and Ally Bank) agree to do in exchange for this wonderful bounty of sweeping immunity? They committed themselves, after much dodging and wrangling, to follow the law of the land! (Are you serious ! Really!) Specifically, they promised to stop engaging in fraudulent foreclosure practices. That is harsh! (sarcasm!)
Consider the massive evidence of FRAUD -- besides the reams of paper and court documents, this includes the many witnesses who have spoken to the media, written testimonials or books, already testified in court on related matters, etc. Then, consider even this partial list of crimes to be investigated. Accounting fraud screams out for action under Sarbanes-Oxley; loan origination fraud (including, by 2006, almost universal appraisal fraud); the robo-signing, forgeries, and post-dating of documents that for years were routinely submitted to courts during legal proceedings; the myriad of tax avoidance scams and lost paperwork that were a core feature of the mortgage electronic registration systems; the deliberate misrepresentation in the "Warrants and Reps" attached to the packaging and sale of mortgage-backed securities and derivatives thereof; and on and on it goes. (I should add that, coincidentally, soon after this settlement was signed, several states inexplicably dropped or settled what were very promising criminal investigations.)
But, let us be fair, the Administration got more than that (exaggeration !) Contingent on their meeting a number of criteria, families found to have lost their home through fraudulent actions taken by one of these five gigantic loan servicers were to be eligible to receive $1,500 to $2,000! Now, I cannot speak for you. But if, as a consequence of fraud or negligence on the part of a major bank, I lost my home and as a consequence also lost my credit rating, neighborhood, dignity, and the ability of any children I might have to remain in the schools and with the teachers with whom they were familiar, I would be very angry. If, years later, I got a check for $2,000, such a paltry payment for all that I had lost would strike me as only one more of a long line of humiliations. Some real personal homeowner humiliations are shared below
Apparently, Obama's campaign managers believe that remindingvoters listeners of this most awful settlement, one that so clearly defines and encapsulates everything that is so wrong about the Administration's approach to disciplining fraudulent financial institutions, is their best strategy for convincing voters that things would be so much worse under a Romney Administration
* Excerpts above ....come from a brilliant HuffingtonPost Blog by Robert Prasch titled:
Related post: Home is Where the Vote Is (HERE)
.
The current administration is revisiting the so called "Foreclosure Settlement"
* First....consider the settlement that the Obama Administration is now beginning to trumpet as one of its greatest achievements. This is the joint forty-nine state & federal settlement wherein the banks claim to eventually settle...by paying a paltry $25 billion. (the 'headline number' provided by the White House) Not only is this a completely "disingenuous" claim, but it was systematically and totally dismantled by Yves Smith of Naked Capitalism (Top ranked financial blog).
In reality, and with maybe... a mere $5 billion (moved around on their books), the five criminal banks were released from ALL STATE lawsuits stemming from the massive and systemic fraud that went into the origination and servicing of housing loans throughout the bubble and into the crash. For this paltry sum, the banks were released from all liability stemming from a decade-long-run of illicit activities that fleeced millions of customers and inflated a bubble that eventually destroyed the economy of the United States and much of the world. Now, you might ask, to what did the five large banks, party to the settlement (Bank of America, Wells-Fargo, Morgan Stanley, Citibank, and Ally Bank) agree to do in exchange for this wonderful bounty of sweeping immunity? They committed themselves, after much dodging and wrangling, to follow the law of the land! (Are you serious ! Really!) Specifically, they promised to stop engaging in fraudulent foreclosure practices. That is harsh! (sarcasm!)
Consider the massive evidence of FRAUD -- besides the reams of paper and court documents, this includes the many witnesses who have spoken to the media, written testimonials or books, already testified in court on related matters, etc. Then, consider even this partial list of crimes to be investigated. Accounting fraud screams out for action under Sarbanes-Oxley; loan origination fraud (including, by 2006, almost universal appraisal fraud); the robo-signing, forgeries, and post-dating of documents that for years were routinely submitted to courts during legal proceedings; the myriad of tax avoidance scams and lost paperwork that were a core feature of the mortgage electronic registration systems; the deliberate misrepresentation in the "Warrants and Reps" attached to the packaging and sale of mortgage-backed securities and derivatives thereof; and on and on it goes. (I should add that, coincidentally, soon after this settlement was signed, several states inexplicably dropped or settled what were very promising criminal investigations.)
But, let us be fair, the Administration got more than that (exaggeration !) Contingent on their meeting a number of criteria, families found to have lost their home through fraudulent actions taken by one of these five gigantic loan servicers were to be eligible to receive $1,500 to $2,000! Now, I cannot speak for you. But if, as a consequence of fraud or negligence on the part of a major bank, I lost my home and as a consequence also lost my credit rating, neighborhood, dignity, and the ability of any children I might have to remain in the schools and with the teachers with whom they were familiar, I would be very angry. If, years later, I got a check for $2,000, such a paltry payment for all that I had lost would strike me as only one more of a long line of humiliations. Some real personal homeowner humiliations are shared below
Apparently, Obama's campaign managers believe that reminding
* Excerpts above ....come from a brilliant HuffingtonPost Blog by Robert Prasch titled:
The Obama Administration, the 49 State Mortgage Settlement, and the Spin: A Study in Shamelessness (HERE)
Related post: Home is Where the Vote Is (HERE)
.
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