We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play.  It was entirely dialogue-driven, so everything the audience learned came out of a character’s mouth – there was no action to speak of.  It was also perfectly cast, well-acted, and absorbing.  By the end of the first 75 minutes, we cared a lot about the characters and were anxious to learn how their story ended.  Then came the revelation (residents of our neighborhood who intend to see this play should skip this spoiler) that nothing we had seen and heard had actually happened, at least in anything like the fashion we had come to understand.  The (mostly glowing) reviews described this as a “plot twist.”  This wasn’t a plot twist.  A plot twist is when something unexpected happens, taking the story in a new direction.  This was a gimmick – a dishonest device that relieved the playwright of the burden to maintain plot integrity and create a plausible dramatic arc.  And we felt angry and betrayed, and somewhat “fool me twice” duped, as this was the second play in a single year that employed a “Bobby Ewing in the shower” ploy like this one.  (Only readers who share our dotage will understand that reference.)  We love the theatre more than almost anything, and we are sad to see this sort of trickery gain traction.  From now on, we will try to remember that we can’t rely on anything that any character says.

Of course, we already knew that about a lot of plaintiffs’ mass tort causation experts. Last month, we blogged about the exclusion of one plaintiff’s experts in a hernia mesh case.  Today’s case, like the Bowersock case that was the subject of our last post, is a case that was remanded to its transferor court when the hernia mesh MDL shut down.  In Olmo v. Davol, Inc. and C.R. Bard., Inc., Case No. 13-62260-CIV-COHN/SELTZER, United States District Court for the Southern District of Florida, the court recently decided the defendants’ motion to exclude the plaintiff’s causation expert and their Motion for Summary Judgment.   You can see the order here.

In Olmo, the plaintiff’s abdominal hernia was repaired with the defendants’ Composix Kugel (“CK”) hernia repair patch in 2005.  In the CK patch, the mesh patch is attached to two memory recoil rings intended to stabilize the device.  Six years after her CK patch was implanted, the plaintiff experienced abdominal pain, and her CK patch was explanted and replaced with a different hernia mesh product.  The explanting physician observed that a corner of the CK patch had lost fixation and folded under, causing mesh to erode into the plaintiff’s bowel.  The explanter did not observe buckling in the explanted device, did not determine whether the rings had broken, and did not discern what had caused the mesh to fold.  The explanted patch was not preserved and was not photographed before it was discarded.

In her complaint, the plaintiff alleged that a break in one or both of the memory recoil rings in her CK patch caused the mesh to come into contact with her bowel. She submitted the report of a biomedical engineering expert who briefly chimed in with his assent to the plaintiff’s theory, stating, “The fact that the mesh had folded such that the porous polypropylene layer contacted internal organs, unequivocally leads to the conclusion that the outer and perhaps also the inner memory recoil rings did not prevent folding, which is only possible subsequent to . . . [ring] breakage . . . .”  Order, p. 7.  But, as the court noted, the remainder of the expert’s report was “devoted almost entirely to explaining why [he] believes that [the defendants’] product testing and design of the CK patch were unsatisfactory,” and did not explain “why folding necessarily leads to the conclusion that a ring break occurred.” Id. (citation omitted).  Nor did the expert clear this up at his deposition.  Instead, when asked how he reached his conclusion that a ring had broken, the expert responded that “major folding of the device,” such as that described by the plaintiff’s explanter, is only possible when a ring breaks.  The expert did no tests to confirm his theory.  He did no tests to rule out an alternative theory.  He was not aware of any scientific studies or literature supporting his conclusion.  And he could point to no evidence that “engineering or medical communities would accept the premise that the folding described by [the explanter] is only possible with a ring break.”  The expert did add that the folding of the plaintiff’s patch was greater than he had observed in cases in which a ring break was documented, but he couldn’t identify any of those cases.  Citing Joiner, the court concluded that there was “too great an analytical gap” between the data on which the expert relied and his “broken ring” conclusion, and excluded the expert’s testimony in its entirety.

With no admissible evidence of medical causation, the plaintiff could not satisfy her burden of proof of her warnings and design defect claims, and her remaining claims – punitive damages and loss of consortium – could not survive alone. So the court granted summary judgment and dismissed all of the plaintiff’s claims with prejudice.

We love this. You have heard us rant and rave enough times about mass tort plaintiffs who get money for claims they can’t prove.  It was nice to see aggressive lawyering and a brave and sensible judge lock the vault with this plaintiff’s open hand safely outside.  And, just maybe, plaintiff lawyers will someday think twice about relying on experts who skip the step of employing reliable (or any) methodology.  We can always hope.  Just as we will the next time the house lights dim, the curtain opens, and a theatrical journey begins.

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

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

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

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

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

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

Back in 2013, we published a comprehensive post on the checkered Daubert history of the notorious and prolific (in equal amounts) plaintiff-side “FDA expert” (although she routinely attempts to opine way beyond FDA matters) – “Dr.” Suzanne Parisian.  We use quotation marks, because although Parisian is technically an MD, she hasn’t seen a single patient in decades.  See, e.g., In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 475 (S.D.N.Y. 2016) (“she has not treated a live patient since 1988 and has not practiced pathology since the 1990s”).  Since the rumors we had heard of Dr. Parisian retiring appear to be greatly exaggerated, we thought it would be a good idea to update the post with additional Parisian-related Daubert rulings over the past three years.

As before, we’re categorizing the exclusions by topic – indeed, we’ve added a couple of new topics − starting with those opinions that exclude her altogether as a witness, and working our way down.  As always, because we don’t believe in doing the other side’s research for them, we’re not listing topics on which she was allowed to testify.  We caution, however, that unless a decision is in the first paragraph of this post, that means that Dr. Parisian was allowed to testify about something.

Here goes:

Cases Totally Excluding Dr. Parisian’s Testimony: Miller v. Stryker Instruments, 2012 WL 1718825, at *10-12 (D. Ariz. March 29, 2012) (no coherent methodology; unhelpful; legal conclusions; narrative testimony; unqualified to give medical testimony; ipse dixit; reliance on after-the-fact events); Kaufman v. Pfizer Pharmaceuticals, Inc., 2011 WL 7659333, at *6-10 (S.D. Fla. Aug. 4, 2011) (ipse dixit; conclusory; lack of methodology; opinions not tied to FDA regulations or to facts; irrelevant bases; intent/state of mind; outside scope of expertise; outside relevant time period), reconsideration denied, 2011 WL 10501233 (S.D. Fla. Aug. 10, 2011) (narrative testimony; lack of methodology; outside relevant time period); Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *2-3 (E.D.N.Y. April 24, 2011) (FDA issues irrelevant; unqualified as to industry standards); Lopez v. I-Flow Inc., 2011 WL 1897548, at *9-10 (D. Ariz. Jan. 26, 2011) (legal conclusions; conclusory; improper state of mind/intent opinions; narrative testimony; bases not connected to conclusions; ipse dixit; speculative; outside expertise); In re Trasylol Products Liability Litigation, 709 F. Supp.2d 1323, 1336-51 (S.D. Fla. 2010) (unqualified as to foreign regulations and medical causation; narrative testimony; ipse dixit; corporate knowledge and intent; FDA violation testimony conclusory and not tied to regulations; opinions beyond scope of report; improper reliance on internal documents; lack of methodology; speculation; advocate not an expert), certification denied, 2010 WL 2541892 (S.D. Fla. June 22, 2010); In re Prempro Products Liability Litigation, 554 F. Supp.2d 871, 879-87 (E.D. Ark. 2008) (erroneous admission of Parisian testimony required new trial on punitive damages; narrative testimony, ipse dixit; testimony not connected to FDA regulations), aff’d in pertinent part, reversed in part on other grounds, 586 F.3d 547, 571 (8th Cir. 2009); Jacobs v. Caesars Entertainment, Inc., 2007 WL 594714, at *4 (E.D. La. Feb. 21, 2007) (insufficient factual basis; unreliable methodology), reconsideration denied, 2007 WL 1558717, at *2 (E.D. La. May 30, 2007), aff’d, 280 F. Appx. 424 (5th Cir. 2008); Nelson v. C.R. Bard, Inc., 2006 WL 6225071 (D.D.C. Sept. 26, 2006) (minute order); Barnes v. EBI Medical Systems, Inc., 2001 WL 36105533 (Vir. Cir. Spotsylvania Co. Jan. 26, 2001) (legal opinion; lack of qualifications; no foundation; speculation).

Cases Excluding Dr. Parisian’s Opinions That The Defendant Violated FDA Regulations: Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 934 (D. Minn. 2014) (legal conclusions that the defendant “violated the law”); Rowland v. Novartis Pharmaceuticals Corp., 9 F. Supp.3d 553, 561-62 (W.D. Pa. 2014) (conclusions about regulatory compliance); Monroe v. Novartis Pharmaceuticals Corp., 2014 WL 12586426, at *3-4 (S.D. Ohio Sept. 15, 2014) (regulatory compliance; conclusions of law); Stanley v. Novartis Pharmaceuticals Corp., 2014 WL 12573393, at *4 (C.D. Cal. May 6, 2014) (legal conclusions; regulatory compliance); Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1046-47 (D. Minn. 2013) (compliance generally); Stambolian v. Novartis Pharmaceuticals Corp., 2013 WL 6345566, at *9 (C.D. Cal. Dec. 6, 2013) (legal conclusions); Mathews v. Novartis Pharmaceuticals Corp., 2013 WL 5780415, at *24 (S.D. Ohio Oct. 25, 2013) (legal conclusions); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013) (compliance with regulations); Taylor v. Novartis Pharmaceuticals Corp., 2013 WL 5118945, at *7 (S.D. Fla. April 22, 2013) (allowed to testify only after disclaiming compliance opinions); Chiles v. Novartis Pharmaceuticals Corp., 923 F. Supp.2d 1330, 1333 (M.D. Fla. 2013) (legal conclusions); Dopson-Troutt v. Novartis Pharmaceuticals Corp., 2013 WL 1344755, at *3 (M.D. Fla. April 2, 2013) (compliance with regulation predicated on “causal relationship”; legal conclusions); Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 1278089, at *2-3 (M.D. Fla. March 28, 2013) (compliance with regulation predicated on “causal relationship”; legal conclusions); Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012) (legal conclusions); Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *9-10 (C.D. Cal. Nov. 2, 2012) (compliance with regulations, legal conclusions generally); Lyman v. Pfizer, Inc., 2012 WL 2971550, at *6 (D. Vt. July 20, 2012) (legal conclusions); Baldonado v. Wyeth, 2012 WL 2921026, at *2-3 (N.D. Ill. July 17, 2012) (sandbagging; untimeliness); Barnes v. Orthofix International NV, 2012 WL 1931224, at *5 (W.D. Wash. May 23, 2012) (legal conclusions); Pritchett v. I-Flow Corp., 2012 WL 1059948, at *6- (D. Colo. March 28, 2012) (unqualified to give legal conclusions; invades role of judge and jury); Hines v. Wyeth, 2011 WL 2680842, at *5-6 (S.D.W. Va. July 8, 2011) (conclusory), order clarified on reconsideration, 2011 WL 2730908 (S.D.W. Va. July 13, 2011); In re Heparin Products Liability Litigation, 2011 WL 1059660, at *8 (N.D. Ohio March 21, 2011) (as to reasonableness of compliance); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007) (legal conclusion; improper foundation); Lillebo v. Zimmer, Inc., 2005 WL 388598, at *4-5 (D. Minn. Feb. 16, 2005) (FDA legal requirements and compliance); Oakberg v. Zimmer, Inc., 2004 WL 5503779, at *2 (D. Mont. Nov. 23, 2004) (content, application, or violation of FDA regulations; FDA regulatory clearance or reporting requirements), aff’d in pertinent part, reversed in part on other grounds, 211 F. Appx. 578, 580 (9th Cir. 2006); Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 2300222 (N.J. Super. Law Div. April 30, 2010) (legal opinions).

Cases Excluding Dr. Parisian’s Opinions About Regulatory Issues in Other Countries: In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 477 (S.D.N.Y. 2016). Note:  This was also one of the reasons for Dr. Parisian’s total exclusion in In re Trasylol Products Liability Litigation, 709 F. Supp.2d 1323, 1336 (S.D. Fla. 2010).

Cases Excluding Dr. Parisian’s Testimony Concerning Risks of Other Drugs: Jones v. Novartis Pharmaceuticals Corp., ___ F. Supp.3d ___, 2017 WL 372246, at *15 (N.D. Ala. Jan. 26, 2017); Rheinfrank v. Abbott Laboratories, Inc., 2015 WL 13022172, at *10 (S.D. Ohio Oct. 2, 2015), aff’d, ___ F. Appx. ___, 2017 WL 680349 (6th Cir. Feb. 21, 2017); In re Fosamax Products Liability Litigation, 924 F. Supp.2d 477, 495-96 (S.D.N.Y. 2013).

Cases Excluding Dr. Parisian’s Testimony About Pharmaceutical Industry Standards: In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 478 (S.D.N.Y. 2016) (alternative designs); Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 935 (D. Minn. 2014); Gilliland v. Novartis Pharmaceuticals Corp., 2014 WL 11581411, at *1 (S.D. Iowa July 30, 2014); Bartoli v. Novartis Pharmaceuticals Corp., 2014 WL 1515870, at *6 (M.D. Pa. April 17, 2014) (ethical standards; no expertise); In re Fosamax Products Liability Litigation, 924 F. Supp.2d 477, 496-97 (S.D.N.Y. 2013) (use of “Dear Doctor” letters; opinions contrary to learned intermediary rule); Taylor v. Novartis Pharmaceuticals Corp., 2013 WL 5118945, at *7 (S.D. Fla. April 22, 2013) (no expertise); Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012) (NDA approval, pharmacovigilence and monitoring of clinical trials; no expertise); Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *13 (C.D. Cal. Nov. 2, 2012) (unqualified); Okuda v. Pfizer Inc., No. 1:04-CV-00080, slip op. at 1-2 (D. Utah July 6, 2012); Johnson v. Wyeth LLC, 2012 WL 1204081, at *1-2 (D. Ariz. April 11, 2012) (testing); Romero v. Wyeth Pharmaceuticals, Inc.,2012 WL 12905978, at *4-5 (E.D. Tex. Apr. 26, 2012) (testing, legal conclusions, conclusory); Chandler v. Greenstone Ltd., 2012 WL 882756, at *2 (W.D. Wash. March 14, 2012) (reasonableness); Lea v. Wyeth LLC, 2011 WL 13143427, at *5-6 (E.D. Tex. Oct. 6, 2011) (testing, conclusory, personal opinions); Deutsch v. Novartis Pharmaceuticals Corp., 768 F. Supp. 2d 420, 468 (E.D.N.Y. 2011) (no expertise); Cross v. Wyeth Pharmaceuticals, Inc., 2011 WL 3498305, at *5 (M.D. Fla. Aug. 10, 2011) (industry custom and practice); Rivera Adams v. Wyeth, 2010 WL 5072061, at *3 (D.P.R. Dec. 3, 2010) (industry standard of care); Ingram v. Wyeth, 2010 WL 5663003, at *3 (E.D. Ark. Sept. 16, 2010) (conclusory; speculative); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007) (legal conclusion); Oakberg v. Zimmer, Inc., 2004 WL 5503779, at *2 (D. Mont. Nov. 23, 2004) (marketing and advertising; warnings), aff’d in pertinent part, reversed in part on other grounds, 211 F. Appx. 578, 580 (9th Cir. 2006); Linsley v. C.R. Bard, Inc., 2000 WL 343358, at *4-5 (E.D. La. March 30, 2000) (adequacy of warning).

Cases Excluding Dr. Parisian’s Testimony Concerning Medical Issues:

Jones v. Novartis Pharmaceuticals Corp., ___ F. Supp.3d ___, 2017 WL 372246, at *9-12 (N.D. Ala. Jan. 26, 2017) (“causal association”; how prescribers would respond to warnings; notice of risk); In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 475-76 (S.D.N.Y. 2016) (medical risks; medical causation; “causal association”); In re Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306, 1335-36 (N.D. Ga. 2015) (medical causation); Rheinfrank v. Abbott Laboratories, Inc., 2015 WL 13022172, at *9 (S.D. Ohio Oct. 2, 2015) (medical state of the art), aff’d, ___ F. Appx. ___, 2017 WL 680349, at *10 (6th Cir. Feb. 21, 2017); Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 934-35 (D. Minn. 2014) (medical causation; “regulatory causation”); Rowland v. Novartis Pharmaceuticals Corp., 9 F. Supp.3d 553, 562 (W.D. Pa. 2014) (“regulatory causation” ; how prescribers would respond to warnings); Monroe v. Novartis Pharmaceuticals Corp., 2014 WL 12586426, at *3 (S.D. Ohio Sept. 15, 2014) (“regulatory causation”); Gilliland v. Novartis Pharmaceuticals Corp., 2014 WL 11581411, at *1 (S.D. Iowa July 30, 2014) (medical or regulatory causation); Kirchman v. Novartis Pharmaceuticals Corp., 2014 WL 12617778, at *5 (M.D. Fla. May 22, 2014) (“regulatory causation”); Stanley v. Novartis Pharmaceuticals Corp., 2014 WL 12573393, at *4-5 & n.4 (C.D. Cal. May 6, 2014) (“regulatory causation”; response of prescribers to different warnings); Bartoli v. Novartis Pharmaceuticals Corp., 2014 WL 1515870, at *6 (M.D. Pa. April 17, 2014) (unqualified); Chiles v. Novartis Pharmaceuticals Corp., 923 F. Supp.2d 1330, 1333-34 (M.D. Fla. 2013) (“regulatory causation”; medical causation); Stambolian v. Novartis Pharmaceuticals Corp., 2013 WL 6345566, at *9, 11 (C.D. Cal. Dec. 6, 2013) (causal connection; how prescribers would respond to warnings); Mathews v. Novartis Pharmaceuticals Corp., 2013 WL 5780415, at *24 (S.D. Ohio Oct. 25, 2013) “regulatory causation”); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013) (medical causation; adequacy of warnings); Taylor v. Novartis Pharmaceuticals Corp., 2013 WL 5118945, at *8-9 (S.D. Fla. April 22, 2013) (medical causation; adequacy of warnings, monitoring of clinical trials); Dopson-Troutt v. Novartis Pharmaceuticals Corp., 2013 WL 1344755, at *3 (M.D. Fla. April 2, 2013) (“regulatory causation”; “causal association”); Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013) (medical causation); Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012) (medical causation); Jenkins v. Novartis Pharmaceuticals Corp., 2012 WL 6213494, at *7 (E.D. Tenn. Dec. 13, 2012) (mechanisms of medical causation); Hill v. Novartis Pharmaceuticals Corp., 2012 WL 5451809, at *2 (E.D. Cal. Nov. 7, 2012) (medical causation and diagnosis); Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *10, 12-14 (C.D. Cal. Nov. 2, 2012) (“causal association,” how doctors react to labeling, conduct of clinical trials, other drugs, events postdating exposure); Winter v. Novartis Pharmaceuticals Corp., 2012 WL 827305, at *5 (W.D. Mo. March 8, 2012) (medical causation); Brown v. Novartis Pharmaceuticals Corp., 2012 WL 9082913, at *5 (Mag. E.D.N.C. Jan. 9, 2012), adopted in pertinent part, 2012 WL 9082901 (E.D.N.C. Sept. 20, 2012) (medical causation, diagnosis, medical testimony generally); Forman v. Novartis Pharmaceuticals Corp., 794 F. Supp. 2d 382, 384 (E.D.N.Y. 2011) (medical causation); Deutsch v. Novartis Pharmaceuticals Corp., 768 F. Supp.2d 420, 469 (E.D.N.Y. 2011) (not qualified to diagnose disease); In re Heparin Products Liability Litigation, 2011 WL 1059660, at *8 (N.D. Ohio March 21, 2011) (medical or physiological causation); In re Human Tissue Products Liability Litigation, 582 F. Supp. 2d 644, 665-71 (D.N.J. 2008) (possible methods of transmitting several diseases; speculation; unqualified); Oakberg v. Zimmer, Inc., 2004 WL 5503779, at *2 (D. Mont. Nov. 23, 2004) (medical causation), aff’d in pertinent part, reversed in part on other grounds, 211 F. Appx. 578, 580 (9th Cir. 2006); Linsley v. C.R. Bard, Inc., 2000 WL 343358, at *4-5 (E.D. La. March 30, 2000) (medical causation; adequacy of warning to physician); Meng v. Novartis Pharmaceuticals Corp., 2012 WL 9083477, at *1 (N.J. Super. L.D. Aug. 8, 2012) (medical causation); Meng v. Novartis Pharmaceuticals Corp., No. 2012 WL 9083474, at *1 (N.J. Super. L.D. Aug. 8, 2012) (medical causation); see Anderson v. Frank, 2009 WL 5172680 (Pa. C.P. Philadelphia Co. Dec. 15, 2009) (imposing sanctions because Dr. Parisian was not an “appropriate licensed professional” eligible to testify in medical malpractice case).

Cases Excluding Dr. Parisian’s Testimony About Corporate Intent/Motive/State Of Mind/Ethics: Jones v. Novartis Pharmaceuticals Corp., ___ F. Supp.3d ___, 2017 WL 372246, at *12-13 (N.D. Ala. Jan. 26, 2017); In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 479-80 (S.D.N.Y. 2016); Rheinfrank v. Abbott Laboratories, Inc., 2015 WL 13022172, at *9 (S.D. Ohio Oct. 2, 2015), aff’d, ___ F. Appx. ___, 2017 WL 680349 (6th Cir. Feb. 21, 2017); Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 935 (D. Minn. 2014) (“implied coercion” of physicians); Bartoli v. Novartis Pharmaceuticals Corp., 2014 WL 1515870, at *6 (M.D. Pa. April 17, 2014); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013); Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012); Hill v. Novartis Pharmaceuticals Corp., 2012 WL 5451809, at *2 (E.D. Cal. Nov. 7, 2012); Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *13 (C.D. Cal. Nov. 2, 2012);  Okuda v. Pfizer Inc., No. 1:04-CV-00080, slip op. at 2 (D. Utah July 6, 2012); Romero v. Wyeth Pharmaceuticals, Inc.,2012 WL 12905978, at *6 (E.D. Tex. Apr. 26, 2012); Johnson v. Wyeth LLC, 2012 WL 1204081, at *3 (D. Ariz. April 11, 2012); Pritchett v. I-Flow Corp., 2012 WL 1059948, at *6 (D. Colo. March 28, 2012); Chandler v. Greenstone Ltd., 2012 WL 882756, at *1 (W.D. Wash. March 14, 2012); Winter v. Novartis Pharmaceuticals Corp., 2012 WL 827305, at *5 (W.D. Mo. March 8, 2012); Deutsch v. Novartis Pharmaceuticals Corp., 768 F. Supp.2d 420, 467 (E.D.N.Y. 2011); Lea v. Wyeth LLC, 2011 WL 13143427, at *7 (E.D. Tex. Oct. 6, 2011); Hines v. Wyeth, 2011 WL 2680842, at *7 (S.D.W. Va. July 8, 2011), order clarified on reconsideration, 2011 WL 2730908, at *2 (S.D.W. Va. July 13, 2011); In re Heparin Products Liability Litigation, 2011 WL 1059660, at *8 (N.D. Ohio March 21, 2011); In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334, at *13 (N.D. Ohio May 4, 2010); In re Fosamax Products Liability Litigation, 645 F. Supp.2d 164, 192 (S.D.N.Y. 2009); Reece v. Astrazeneca Pharmaceuticals, LP, 500 F. Supp. 2d 736, 744-46 (S.D. Ohio 2007) (advisability of tests; warnings needed for particular medical conditions; lack of methodology); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *8 (D. Minn. June 29, 2007); Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 2300222 (N.J. Super. Law Div. April 30, 2010); Singh v. Edwards Lifesciences Corp., 2008 WL 5758387, ¶ELS 6 (Wash. Super. Snohomish Co. Jan. 31, 2008).

Cases Excluding Dr. Parisian’s Narrative Testimony: In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 478, 481 (S.D.N.Y. 2016); Rheinfrank v. Abbott Laboratories, Inc., 2015 WL 13022172, at *9 (S.D. Ohio Oct. 2, 2015), aff’d, ___ F. Appx. ___, 2017 WL 680349 (6th Cir. Feb. 21, 2017); In re Fosamax Products Liability Litigation, 924 F. Supp.2d 477, 497 (S.D.N.Y. 2013); Pritchett v. I-Flow Corp., 2012 WL 1059948, at *7 (D. Colo. March 28, 2012); Hines v. Wyeth, 2011 WL 2680842, at *7 (S.D.W. Va. July 8, 2011), order clarified on reconsideration, 2011 WL 2730908, at *2 (S.D.W. Va. July 13, 2011); In re Heparin Products Liability Litigation, 2011 WL 1059660, at *8 (N.D. Ohio March 21, 2011); In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334, at *13 (N.D. Ohio May 4, 2010); In re Fosamax Products Liability Litigation, 645 F. Supp.2d 164, 192 (S.D.N.Y. 2009); Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 2300222 (N.J. Super. Law Div. April 30, 2010).

Cases Excluding Dr. Parisian’s Testimony Criticizing Medical Literature: Bartoli v. Novartis Pharmaceuticals Corp., 2014 WL 1515870, at *6 (M.D. Pa. April 17, 2014) (ghostwriting; funding); Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 935 (D. Minn. 2014) (ghostwriting); Hill v. Novartis Pharmaceuticals Corp., 944 F. Supp.2d 943, 952 (E.D. Cal. 2013) (ghostwriting); Stambolian v. Novartis Pharmaceuticals Corp., 2013 WL 6345566, at *9-10 (C.D. Cal. Dec. 6, 2013); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013) (ghostwriting); Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012) (ghostwriting); Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *14 (C.D. Cal. Nov. 2, 2012) (ghostwriting); Deutsch v. Novartis Pharmaceuticals Corp., 768 F. Supp.2d 420, 468-69 (E.D.N.Y. 2011) (ghostwriting; funding; personal opinion); In re Fosamax Products Liability Litigation, 645 F. Supp.2d 164, 191 (S.D.N.Y. 2009) (ghostwriting).

Cases Excluding Dr. Parisian’s Testimony Criticizing the FDA: Monroe v. Novartis Pharmaceuticals Corp., 2014 WL 12586426, at *4 (S.D. Ohio Sept. 15, 2014).

Got any others – particularly slip opinions (like the Rheinfrank decision we discovered when writing this post)?  We suspect there are probably others out there.  Send them to us, and we’ll get the word out.

“The facts and data considered by the witness . . . .” That is what expert witnesses must disclose to the other side after forming their opinions, although the rule was not always this way.  Before 2010, you had to disclose “the data or other information” considered by an expert.  But for many that was too broad, potentially encompassing attorney thoughts or impressions.  So the committee changed the rule, and we now have the “facts and data” standard.  As the committee explained, “The refocus on ‘facts or data’ is meant to limit disclosure to material of a factual nature by excluding theories or mental impressions of counsel.”  Rule 26(a)(2)(B)(ii) advisory committee note to 2010 amendment.  We wrote on the 2010 changes to Rule 26 here.

Your work product is therefore somewhat safer from disclosure than it once was, but if an expert considered “facts and data,” those facts and data must be disclosed. That is the lesson of In re Benicar (Olmesartan) Products Liability Litigation, No. 15-2606, 2017 WL 970263 (D.N.J. Mar. 13, 2017), where an MDL judge ordered the plaintiffs to produce medical records upon which their experts had relied.

The records at issue appear to have involved patients other than the plaintiffs, which we guess is why the production of medical records was the least bit controversial.  As it turned out, those other patients’ records became discoverable when two experts considered them in forming their opinions.  One, for example, reviewed the charts of certain patients and relied on them in reaching his ultimate conclusions. Id. at *3.  The other similarly confirmed that his review of a number of patient charts “contributed to his thinking.” Id.

Continue Reading All Things “Considered”: Plaintiffs’ Experts Ordered To Produce Patient Records

We loved La La Land.   We were enchanted by the colors and the music and the dancing.  We were transported by the dreams-come-true and saddened by the could-have-beens.  We disappeared into the characters’ world for two hours and were not ready when the lights came up.   For us, it was the epitome of a movie experience, and we were thrilled – momentarily – when it was announced as Best Picture.  But, as all who witnessed Oscargate (and anyone who didn’t spend the last week in a submarine) can attest, simply saying it didn’t make it so.

Last week, in Bowersock, et al. v. Davol, Inc. and C.R. Bard, Inc., 2017 WL 711849 (S.D. Ind. Feb. 23, 2017) the United States District Court for the Southern District of Indiana reached the same conclusion, excluding the plaintiffs’ experts in a hernia mesh case.  The plaintiffs claimed that a component of the defendants’ hernia mesh patch – a polyethylene terephthalate ring – perforated the intestines of the plaintiffs’ decedent, ultimately resulting in sepsis and death.

An autopsy was performed and concluded that the decedent’s small bowel and colon were intact, without perforation. But the hernia mesh patch was not retrieved from the decedent’s body before she was buried, so, seven years later (!!!), the plaintiffs had the body exhumed so the patch could be retrieved and analyzed, after which they submitted the reports of two causation experts – a surgeon and a biomedical engineer – to opine that components of the mesh patch caused the decedent’s injuries.

The Surgeon

The plaintiffs’ first expert, a general and gastrointestinal surgeon who used the defendants’ patch in his own practice, reviewed the patch explanted from the decedent’s exhumed body. He opined that the ring, though not broken, had buckled, creating a sharp edge that rubbed against the decedent’s bowel and perforated it.

Continue Reading Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

That’s Engle v. Liggett Group, Inc., 945 So. 2d 1246 (Fla. 2006), the most bizarre use of res judicata that we’ve ever seen – giving preclusive effect to a class action verdict despite also finding that the class was not certifiable.  Anyway, continuing in the tradition of unusual, pro-plaintiff results from the Florida Supreme Court (but not necessarily the district courts of appeals), we have two more to discuss.

First, since we blogged about the preemption result in Charles v. Southern Baptist Hospital, Inc., 178 So.3d 102 (Fla. App. 2015), we feel we ought to warn you that the favorable preemption decision was reversed late last month by the Florida Supreme Court.  Charles v. Southern Baptist Hospital, Inc., ___ So.3d ___, 2017 WL 411333 (Fla. Jan. 31, 2017).  Basically, the court held that the provisions of the federal Patient Safety and Quality Improvement Act (“PSQI”), didn’t preempt (expressly or impliedly) an unusual Florida constitutional provision (called “Amendment 7”) granting patients (read:  plaintiff lawyers) access to “adverse medical incidents” – even though these incidents were compiled and provided to PSQI evaluation committees in accordance with the statute.  Anything that had been initially created for any other purpose couldn’t qualify as protected “patient safety work product” under the PSQI.  2017 WL 411333, at *8.  The statute provided:

Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.

42 U.S.C. §299b-22(a)-(b).  Tort litigation was not mentioned in subsection (c), but the court in Charles grabbed a “rule of construction” from elsewhere in the statute, and used that to create an exception to confidentiality that Congress has not seen fit to create in subsection (c).  Charles has a lot of mumbo-jumbo about not reading statutes in “isolation” and giving “every portion” meaning, 2017 WL 411333, at *4-5, but none of that can hide that the decision ignored the “notwithstanding any other provision” language and used something other than “subsection (c)’ to create a huge hole in confidentiality that Congress did not authorize.

That’s one.

In In re Amendments To Florida Evidence Code, ___ So.3d ___, 2017 WL 633770 (Fla. Feb. 16, 2017), the same court showed the same lack of respect for the state legislature that Charles had shown to the United States Congress.  In 2013, the legislature passed a statute to replace the prior Frye-based analysis of expert testimony with that of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).  2017 WL 633770, at *2-3.  In re Amendments refused to amend the Florida Rules of Evidence to comply with this legislative directive.  This result followed a narrow 16-14 vote to that effect by a rules committee (no doubt packed, like Pennsylvania’s, with plaintiff-side members).  Id. at *1.

The reason for refusing to follow the Legislature’s directive was as bizarre as Engle – that Daubert may well be unconstitutional:

[T]he Committee and commenters who support the recommendation raised what we consider “grave constitutional concerns.”  Those concerns include undermining the right to a jury trial and denying access to the courts.  While the Court does not address the constitutionality of a statute or proposed rule within the context of a rules case, the fact that there may be “grave concerns about the constitutionality of the amendment” has been a basis previously for the Court not adopting an amendment to the Evidence Code. . . .  [W]e decline to adopt the Daubert Amendment to the extent that it is procedural, due to the constitutional concerns raised, which must be left for a proper case or controversy.

In re Amendments, 2017 WL 633770, at *3.  The court cited no precedent at all for this jaw-dropping proposition.  Daubert – a United States Supreme Court decision – has been around, now, since 1993.  The Federal Rules of Evidence (Rule 702) have been amended to conform to Daubert.  As the dissent points out, no court anywhere has ever declared Daubert unconstitutional before:

[T]he United States Supreme Court decided Daubert in 1993, and the standard has been routinely applied in federal courts ever since.  The clear majority of state jurisdictions also adhere to the Daubert standard.  In fact, there are 36 states that have rejected Frye in favor of Daubert to some extent.  Has the entire federal court system for the last 23 years as well as 36 states denied parties’ rights to a jury trial and access to courts?  Do only Florida and a few other states have a constitutionally sound standard for the admissibility of expert testimony?  Of course not.

In re Amendments, 2017 WL 633770, at *6 (dissenting opinion).  The dissent cited two cases directly rejecting this sort of constitutional challenge to Daubert. Id. (citing Junk v. Terminix International Co., 628 F.3d 439, 450 (8th Cir. 2010), and E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 558 (Tex. 1995)).  That’s two more cases than the majority cited.  It’s also probably the tip of the iceberg.  The relevant West keynote for Junk is #24, and for Robinson is #8.  According to Westlaw, these two keynotes, between them, have been cited by 97 other cases.

We agree with the dissent in In re Amendments – the proposition that, after a quarter century, Daubert is unconstitutional is absurd.

Not only absurd, but utterly unsupported by precedent.

Fish rot from the head, and there is currently something very rotten in the State of Florida.

Last week three of our posts dealt with Daubert issues.  That was not intentional.  Chalk it up to coincidence.  Or was it?  We are not especially superstitious, but maybe the passing last week of the great “Professor” Irwin Corey had something to do with the Daubert eruption.  Corey was a comedian who pretended to be “the world’s foremost authority”.  As if to parody the parade of plaintiff experts in mass tort cases, Prof. Corey would enter the stage wearing an academic robe, awkwardly look around at the crowd and down at his sneakers, begin with the word “However,” and then proceed to spout gibberish and vague Big Ideas that made no sense.  (This is not the first time in this blog that we have cited the wisdom of Prof. Corey.)  Corey was 102 years old.  He was doing comedy into his 90s, and consistently made more sense than most plaintiff regulatory or causation expert witnesses.  Catch his act on Youtube.  You will find it more enlightening than any plaintiff expert, or even most court opinions discussing the Daubert test.

As if to trumpet one final honor to Prof. Corey, we have a wonderful, clear, compelling Daubert opinion.  This one, Nease v. Ford Motor Co., No. 15-1950 (4th Cir. Feb. 1, 2017), has nothing to do with drugs or devices.  However, [we normally hate starting a sentence with that word, but if it was good enough for Prof. Corey, who are we to stand on ceremony?], the Nease case contains reasoning and language you might want to cite against the next plaintiff exercise in pretentious hokum. That the opinion comes out of the Fourth Circuit is both important and, for the most part, expected.  There are a couple of mass torts in the Fourth Circuit, and the effect of the Nease opinion can only be beneficent.  The Fourth Circuit has long had a reputation for having smart judges who follow the law.  (That being said, we nearly wept over the poor reasoning in the Fourth Circuit’s Cisson decision.)  In this season of judicial nominations by a new administration, we will hear a lot about how judges should decide, rather than create, the law.  The Fourth Circuit has not had a lot of judges posing as philosopher kings.  They actually tend to follow precedent.  We have it on good authority that when the DOJ had an internal debate about where to bring the 9/11 prosecutions – whether S.D.N.Y. (World Trade Center) or E.D.Va. (Pentagon) would be better for the government – the winning argument for E.D.Va. was based not on the pluses or minuses of the district court (or jury pool), but on whether the government would rather face the inevitable appeal in the Second Circuit or the Fourth Circuit.  There was a perception that the Second Circuit was more capable of activism, lenience, and surprise, none of which was particularly welcome under such circumstances.

If you like to see the law interpreted and applied, rather than created, the Fourth Circuit is usually a good forum.  That was certainly true in Nease.   The plaintiff in Nease claimed serious injuries from an accident allegedly caused by a defect in the speed control system of the plaintiff’s pickup truck.  The plaintiff offered the testimony of an electrical engineering expert who maintained that the speed control cable in the truck was susceptible to getting stuck while the throttle was in the open position, thus preventing the driver from being able to slow the vehicle down.  The defendant filed a Daubert motion, challenging the plaintiff expert’s methodology. The district court (S.D.W.Va.) denied the Daubert motion, waved the expert’s testimony along to the jury, and the jury returned a verdict for the plaintiff on strict liability and awarded more than three million dollars.

Continue Reading Fourth Circuit Vigorously Applies Daubert

A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court.  In addition to that, this blogger’s mother grew up on a farm in Douglas County, Nebraska.  It was a lovely 80-acre parcel terraced into a gentle slope leading down to the Platte River.  The Platte River is a shallow meandering river—a mile wide at the mouth and six inches deep, as some Nebraskans like to say—and it flows from west to east, eventually emptying into the Missouri River, and then on to the great Mississippi.  It forms the western boundary of Douglas County.

The Platte River is no use as a commercial waterway, but because of the gradual slope of the Platte River Valley, it has been a highway into the Rocky Mountains for hundreds of years. Traders established trails through the Valley, followed by wagon trains carrying settlors and ultimately surveyors for the Trans-Continental Railroad.  When the Trans-Continental Railroad was built, the government’s policy toward public lands was one of disposition.  The government therefore divided parcels along the railroad’s route into 160-acre tracts and gave every other parcel to the railroad companies, with the government keeping the rest for sale to other private landowners.  This checkerboard land ownership pattern persists to this day.  We have not done the research, but we would wager a bushel of corn that some grantee around the turn of the twentieth century split his 160-acre grant in half and sold it to our great grandfather—resulting in our lovely 80-acre farm in Douglas County.

The Douglas County judge who decided Freeman v. Hoffman La Roche, Inc., No. CI 10-9312802, 2017 WL 385440 (Dist. Ct. Neb. Jan. 23, 2017), may or may not live within view of the Platte River, but she produced an extraordinarily exacting Daubert order that came to the correct result—the exclusion of causation opinion because the expert had not applied a reliable methodology.  The plaintiff alleged that her Accutane use resulted in Crohn’s disease, which the defendants contested.

The battle came down to experts, and it is clear that this case is not the first rodeo for these experts or the lawyers. The plaintiff’s causation expert was Dr. David Sachar, who has been a plaintiffs’ expert for 15 years.  He offered the opinion that Accutane caused the plaintiff’s Crohn’s disease, but he did not follow any accepted scientific method.  Instead, he purported to rely on “lines of evidence” to draw his conclusions.

What are “lines of evidence”? Well, it’s not all that clear to us, but the expert identified nine categories of information:  (1) Animal studies; (2) class effect; (3) biological plausibility; (4) dose relationship; (5) clinical studies; (6) adverse event and challenge/de-challenge/re-challenge reports; (7) the defendants’ internal documents; (8) published medical literature; and (9) epidemiological studies. Id. at *8.  This list looks good on its face, but it does not disclose a scientific method, let alone application of a scientific method to draw a valid conclusion. Put another way, this expert was probably able to produce a nice long report—assuming that expert reports are required and/or permitted under Nebraska procedure.  But a long-winded report is not necessarily good science.

Continue Reading Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy.  Perhaps because of the inherent sympathy for the plaintiff (offspring), it seems that plaintiffs in birth defect cases get extra chances to prove that have enough science to support their claims.  Science in this area is undoubtedly complicated.  For one thing, while ontogeny does not always recapitulate phylogeny, fetal development of placental mammals (of which humans are a relatively recently evolved species) varies, so extrapolation from animal studies on teratogenic effects is even harder than with studies of direct effects on animals.  For another, ethical considerations generally preclude prospective clinical trials designed to study teratogenic effects.  FDA’s treatment of drug labeling on the risks of teratogenic effects has reflected some of this dynamic.

Litigations pursuing birth defect claims seem to follow their own dynamic.  Despite the oft-cited caution from Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996), that “the courtroom is not the place for scientific guesswork, even of the inspired sort.  Law lags science; it does not lead it,” it often seems like cases are pursued before there is science to support them, particularly if specificity of drug, dosage, and injury is going to be required.  This may be due to the impact of statutes of limitations.  It may also be because some courts are lenient on admissibility of causation evidence and there can be years from filing a case a case until Daubert (or equivalent) motions are decided.  Another dynamic seems to be that the only proof as to whether the plaintiff’s mother took the drug during the relevant time can be her word, unless the plaintiff’s expert can argue that the birth defect can itself count as proof of exposure.  We also sometimes see that general causation can be a harder concept for courts to understand than it should be.

Looking through our particular lens, we see all of this in K.E. v. Glaxosmithkline LLC, No. 3:14-cv-1294(VAB), 2017 U.S. Dist. LEXIS 13705 (D. Conn. Feb. 1, 2017), a case that came to the correct result—causation opinions excluded—but took an overly charitable route in arriving there.  The case alleged that maternal use of the defendant’s SSRI during the first trimester of her pregnancy with plaintiff in 2001 caused him to develop a bicuspid aortic valve and accompanying regurgitation.  The plaintiff was diagnosed with a bicuspid aortic valve in September 2010 (after evaluation following his father’s diagnosis with his own heart condition), by which time the drug’s label had been revised to reflect the pregnancy category D—“adverse reaction data from investigational or marketing experience or studies [of the drug] in humans”—and the manufacturer had sent a dear healthcare provider letter describing the basis for the change. Id. at **16-18.  The purported prescribing physician testified that he would not have prescribed the drug to a patient whom he suspected was pregnant or recommended it for a pregnant woman based on the label as it was in 2001. Id. at **16-17.  We say “purported prescribing physician” because he denied prescribing the drug to plaintiff’s mother until after the plaintiff was born, which is what his records and pharmacy records—but not plaintiff’s mother’s testimony—showed. Id. at **9-12.  More on that later.  After the bicuspid valve diagnosis, plaintiff’s records suggested that his mother had used the drug during pregnancy and his mother—plaintiff was still a minor—thought that there was a relationship.  This was reinforced by a lawyer advertisement on television trolling for plaintiffs and she contracted and signed up with a law firm to pursue a lawsuit over plaintiff’s bicuspid aortic valve by September 2011. Id. at **18-19.  Even though the statute of limitations in Connecticut for claims like this was two years, plaintiff waited until late July 2014—close to four years after the diagnosis—to sue.  Within a year—pretty fast for such cases—the manufacturer moved to exclude plaintiff’s sole causation expert and for summary judgment on statute of limitations, lack of causation, and other problems with plaintiff’s proof.  The decision we are discussing followed more than eighteen months later.

Continue Reading Unreliable Expert Causation Evidence Ends Birth Defect Case

We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work. Rather than merely count whether there are enough other experts out there who seem to be saying something similar to what the proffered expert would say, judges under Daubert must act as gatekeepers who scrutinize the reliability of the expert’s methods. Such an effort burns up pages, time, and calories. Is it any wonder that judicial opinions that simply wave junk science along to the jury, with the usual suggestion that cross-examination and juror common sense will separate the wheat from the chaff, are pretty short, whereas those judicial opinions that really test experts under Daubert and find them wanting can be as long as a Victor Hugo novel?

Recently, Judge Hopkins of the Northern District of Alabama issued a 119-page opinion throwing out a lot of plaintiff expert opinions in Jones v. Novartis Pharmaceuticals Corp., 2017 WL 372246 (N.D. Ala. Jan. 26, 2017). We read all 119 pages, so you don’t have to, though the opinion is clear and pleasant enough. It is definitely no Les Miserables. Indeed, any sense of misery vanished when we saw a heading early on in the opinion entitled “General Requirements – Judge as Gatekeeper.”

The plaintiff in the Jones case alleged that she experienced an atypical femur fracture (“AFF”) as a result of her treatment with a prescription osteoporosis medication, Reclast. The plaintiff proffered a variety of expert opinions. The ubiquitous Dr. Suzanne Parisian submitted the usual magnum opus about how the drug had a “causal association”with the AFFs, how the defendant was on notice of that fact, and how the defendant violated much of the Federal Register and slapped on an inadequate label, There were also two retained and two nonretained medical experts who would opine on medical causation.

The Jones court began by observing that, like Caesar’s Gaul, a Daubert analysis is divided into three parts: (1) whether the expert is qualified, (2) whether the expert’s methodology is reliable, and (3) whether the expert’s opinion would help the jury in determining scientific or technical issues. The Jones court also emphasized that the proponent of the expert bears the burden of satisfying this test. The existence of that burden should, by itself, prevent courts from issuing perfunctory blessings of junk science. But, too often, it does not.

Continue Reading Reclast Plaintiff Experts Hobbled by Daubert