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., No. 1:13-cv-00144-SJD, slip op. at 18 (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); Johnson v. Wyeth LLC, 2012 WL 1204081, at *1-2 (D. Ariz. April 11, 2012) (testing); Chandler v. Greenstone Ltd., 2012 WL 882756, at *2 (W.D. Wash. March 14, 2012) (reasonableness); 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., No. 1:13-cv-00144-SJD, slip op. at 16-17 (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., No. 1:13-cv-00144-SJD, slip op. at 17 (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); 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); 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., No. 1:13-cv-00144-SJD, slip op. at 17-18 (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.

Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe.  In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs.  When he proposed a song for The Life of Brian,  he ran into resistance.  The song seemed insufficiently catchy.  That song was “Always Look on the Bright Side of Life,” one for the ages.  It manages to be simultaneously profound and absurd.   In honor of Idle, we decided today to discuss a case that is similarly profound and absurd.   The case is New York v. Richard Z., 20 I 7 N. Y. Misc. LEXIS 9 I 8; 20 I 7 N Y Slip Op 30498(U) (Oneida Cty March 9, 2017), and has nothing to do with product liability.  Or does it?

 

Our clients get vilified anytime there is a hint of off label use.  Never mind that off label use can be enormously beneficial for patients.  It can even be the standard of care.  We’ve said that several times and the point is made in Bexis’s book.   But now we have the ultimate proof: in Richard Z, a court ordered prison doctors to make off-label use of a medicine available to a prisoner.  The facts are weird and icky, but the point is nonetheless unmistakable.  The prisoner was apparently in prison for some sort of sexual assault.  The opinion supplies no details, but since the prisoner had been in civil confinement for over nine years, and in prison for 30 years before that, we are guessing he had done something(s) really bad.  It is well known that sexual assaulters have a very high rate of recidivism.  That probably accounts for all those years of civil confinement.      

 

The prisoner wanted to get out of stir, and requested a particular chemical therapy.  That therapy involved an antiandrogen that would substantially reduce his sexual urges, and that has been proven in scientific tests to assist in the reduction of recidivism to less than 3%.  A couple of outside experts supported the chemical treatment, opining that such treatment would likely place the prisoner “at a low risk for future sexual offense recidivism and violent recidivism to the point that he could be released to the community on strict supervision”.   But a prison doctor opposed administering the particular requested/recommended therapy, the use of which for these particular purposes would have been off label.  The prison scheduled an “informed consent” conference relative to the chemical treatment of the prisoner.  The prison doctor elicited responses that suggested the prisoner would be taking the drug under compulsion and that “he would not have chosen to take this medication by himself” and “that he knew he had other choices.”  But to the court it was “abundantly clear” that these responses were “coaxed” from the prisoner via  “a carefully guided inquiry” by the prison doctor in an effort to dissuade the prisoner from taking the off label treatment.  The doctor “was acting according to her own subjective views and beliefs thereby substituting those views and opinions” for the prisoner’s .  It was also clear to the court that the prisoner was intelligent, educated, and engaged, and that he “clearly understands the off-label use of this prescription and its risk.”

 

The court concluded that the prison doctor lacked “experience and training in this area,” had misinterpreted her duties in this case, and that she and the prison were attempting “to avoid compliance with the clear and unequivocal expert opinions.”  The court relied on “many studies that show that antiandrogens greatly assist in repressing sexual urges and allow release of sex offenders safely into the community.”  The prison doctor had “substituted her subjective opinion” for the prisoner’s informed consent, and was “both inexperienced in the field of treating sexual offenders and has not kept current with medical advancements and evolving scientific understanding.”  That evolving scientific understanding supported the off label use of the drug, and denying that off label use to the prisoner would be “precluding him from attaining his liberty.”

 

Off label use was not only permissible, it was ordered. 

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

Last week the Third Circuit overturned the dismissal of thousands of cases in In re: Fosamax Products Liability Litigation, — F.3d –, 2017 WL 1075047 (3rd Cir. Mar. 22, 2017), finding that the trial court had improperly granted summary judgement on preemption grounds by misapplying the Supreme Court’s “clear evidence” standard announced in Wyeth v. Levine. It should come as no surprise that we firmly believe the trial court got it right and have lauded its decision in the past. So, it should be equally unsurprising that the Third Circuit’s abysmal “clear evidence” preemption decision is a front-runner for our list of the ten worst cases for 2017.

Regrettably, since Wyeth v. Levine, successful applications of preemption against warning claims asserted in litigation involving branded drugs have been few and far between. That is due in large measure to the both dauntingly high and utterly ill-defined preemption standard set by the Court in Levine, which requires an intensive fact-based analysis and a powerful regulatory case. So when the standard has been met, it is usually with facts that can hardly be described as equivocal. The district court in In re Fosamax, found as much and therefore a somewhat detailed recitation of the regulatory history is warranted.

Fosamax was approved by the FDA in 1995 for the treatment of osteoporosis in postmenopausal women. In re Fosamax, 2017 WL 1075047 at *4. Over the next 15 years, scientific studies were published concerning a possible link between long-term Fosamax use and atypical femur fractures (“AFF”). Merck kept the FDA aware of these studies and in June 2008, FDA asked Merck and other manufacturers to submit whatever data they had on the issue. Id. at *4-5. In September 2008, Merck submitted a “Prior Approval Supplement” (“PAS”) – the same thing as the “Changes Being Effected” (“CBE”) process discussed in Levine, only involving prior FDA review − seeking FDA approval to add information about AFF to both the Warnings & Precautions and Adverse Reactions sections of the Fosamax label. Because it is important to the arguments and the court’s conclusion, we quote some specific language from the requested change and the FDA’s response. Merck’s proposed language included:

Low-energy fractures of the subtrochanteric and proximal femoral shaft have been reported in a small number of bisphosphonate-treated patients. Some were stress fractures (also known as insufficiency fractures) occurring in the absence of trauma. . . . Patients with suspected stress fractures should be evaluated, including evaluation for known causes and risk factors . . . and receive appropriate orthopedic care. Interruption of bisphosphonate therapy in patients with stress fractures should be considered, pending evaluation of the patient, based on individual benefit/risk assessment.

Id. at *5. In April 2009, the FDA responded that Merck could add the information to the Adverse Reactions section of the label, but as to the Warnings/Precautions section, “more time [was] need[ed] for FDA to formulate a formal opinion on the issue of a precaution around these data.” Id. at *5. In its formal response the FDA wrote:

Identification of “stress fractures” may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature. Discussion of the risk factors for stress fractures is not warranted and is not adequately supported by the available literature and post-marketing adverse event reporting.

Id. at *6.

Almost a year later, the FDA issued a public statement that the data to date “had not shown a clear connection” between Fosamax and a risk of AFF. The FDA commissioned a task force, which after another six months (September 2010) reported a “relationship” between AFF and the class of bisphosphonate drugs, but not anything “proven to be causal.” Id. The FDA responded to the task force’s report with a statement also indicating that causation “is not clear,” and that the Agency was “considering label revisions.” Id. After another month, the FDA announced revised labeling for AFF for this class of drug. Causation was described as “not clear.” Id. at *7. The FDA’s proposed label change stated “[c]ausality has not been established.” Id. In response, Merck proposed adding additional language advising doctors to rule out stress fractures. The FDA ultimately rejected the addition of the term “stress fractures,” finding that the term “represents a minor fracture and this would contradict the seriousness of the atypical femur fractures associated with bisphosphonate use.” Id. The FDA’s approved language, including lack of causality, was added to the Fosamax label in January 2011. Id.

Against this regulatory background, the district court found that the claims of all MDL plaintiffs with injury dates before September 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change – were preempted. Id. at *8. The district court ruled that the regulatory history “provided clear evidence that the FDA would have rejected a stronger Precautions warnings because the FDA did reject a stronger Precautions warning.” Id. at *9.

The Third Circuit clearly saw things differently. On appeal, it considered two questions: What is clear evidence? And who should determine whether clear evidence exists? Id.

As to the first question, and perhaps most significantly, this is the first case formally to make the leap from Levine’s amorphous “clear evidence” requirement for implied preemption of warning claims involving branded drugs, to a “clear and convincing” evidence standard for proof of preemption, which required a “highly probable” result. Our problems with Levine are many, and among them has always been this ill-defined standard. Coupled with the Court’s describing impossibility preemption as a “demanding defense,” district courts knew that the standard was high, but just how high was left completely open-ended and has resulted in a lineage of case law that is highly fact-specific with no clearly established definitions or guidelines.

Despite 8 years of court rulings all over the country using the facts of Levine as a benchmark against which to assess the facts of a given case (if stronger facts than Levine then preemption might be possible, if less than Levine, no preemption), the Third Circuit retroactively undertook to read the Supreme Court’s mind, deciding that what Levine really meant when it used the term “clear evidence” was to announce a standard of proof. Id. at *11. The court parsed the ruling in Levine – that absent clear evidence that the FDA would not have approved the label change, it cannot be ruled that it is impossible for a manufacturer to comply with both federal and state law – into three parts. First, it established the legal rule — a manufacturer is “absolved of state-law liability” where it is impossible to comply with both federal and state law simultaneously (impossibility preemption). Second, it established the factual showing needed to satisfy the legal rule – the FDA would not have approved the label change. Third, it established the standard of proof specifying “how convincing the factual showing must be” – by clear evidence. Id. So, according to the Third Circuit:

The term “clear evidence” therefore does not refer directly to the type of facts that a manufacturer must show, or to the circumstances in which preemption will be appropriate. Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change. The manufacturer must prove that the FDA would have rejected a warning not simply by a preponderance of the evidence, as in most civil cases, but by “clear evidence.”

Id.

The principal problem with this aspect of Fosamax is that it flies in the face of other, binding United States Supreme Court precedent. Because the Third Circuit reached its conclusion without even mentioning the Supreme Court precedent that explicitly rejects any “special burden” in implied preemption cases, one wonders if the Third Circuit went off on its own adventure, beyond the scope of the parties’ briefing. The controlling case is Geier v. American Honda Motor Co., 529 U.S. 861, 872-873 (2000), which held that imposition of any “special burden” on the implied preemption defense both lacks “basis . . . in this Court’s precedents” and creates “practical difficulty by further complicating well-established pre-emption principles.” Geier not only rejected imposition of purported “special burdens” in the implied preemption context, but did so on a stronger set of facts for creating such a burden, where Congress had expressly spoken to preemption with both statutory preemption and savings clauses. In the FDCA, by contrast, Congress was merely silent.

Fosamax thus did just what Geier held was not the law. The Third Circuit determined that when the Court said “clear evidence” it really meant “clear and convincing evidence” as a heightened standard of proof requiring a defendant asserting a preemption defense to prove that it is “highly probable” or “reasonably certain” that the FDA would have rejected a label change. Id. at *12.

The court then moved on to the question of whether deciding what the FDA would have done was a question of law or fact. Disregarding uniform precedent since Levine that has treated the issue as a question of law, the Third Circuit determined it was a question of fact. The court found that none of those other cases explicitly addressed the issue and so could not be the basis for concluding that the “clear evidence” test is a legal question. Id. at *13. But if it sounds like a duck, and walks like a duck . . . . In so ruling, Fosamax violated 3d Cir. I.O.P. 9.1 on a truly epic scale. IOP 9.1 provides:

It is the tradition of this court that the holding of a panel in a precedential opinion is binding on subsequent panels. Thus no subsequent panel overrules the holding in a precedential opinion of a previous panel.

Fosamax conceded that its finding that preemption was a matter of fact for jury consideration was contrary to a number of prior Third Circuit statements, which the panel dismissed as “off-hand.” 2017 WL 1075047 at *12. That is not a legitimate characterization. Relegated to an “e.g.” citation in footnote 106 was the standard of review that controlled in In re Federal-Mogul Global Inc., 684 F.3d 355, 364 n.16 (3d Cir. 2012): “The scope of preemption presents a pure question of law, which we review de novo”; as well as the prior FDCA preemption case, Horn v. Thoratec Corp., 376 F.3d 163, 166 (3d Cir. 2004), which likewise held that preemption was a matter for “plenary review” because “it is a question of law.” But Fosamax ignored a lot more precedent than that, including the en banc decision in Orson, Inc. v. Miramax Film Corp., 189 F.3d 377 (3d Cir. 1999), which held specifically that, because it was not bound by “prior decisions, the court was “free to consider the preemption issue as a matter of law.” Id. at 380. Preemption being a matter of law was plainly the holding of the court in Taj Mahal Travel, Inc. v. Delta Airlines, Inc.:

[Plaintiff] argues that [defendant] waived the preemption defense by not raising it until it moved to dismiss [a different] claim, which occurred [later]. . . . However, the preemption defense is a pure issue of law . . . and could be dispositive. Since the parties have briefed and argued preemption on appeal, we will consider it.

164 F.3d 186, 190 (3d Cir. 1998). See also: South Jersey Sanitation Co. v. Applied Underwriters Captive Risk Assurance Co., 840 F.3d 138, 143 (3d Cir. 2016) (“preemption determinations are questions of law”); Roth v. Norfalco LLC, 651 F.3d 367, 374 (3d Cir. 2011) (“preemption … determinations [a]re based on questions of law”); Elassaad v. Independence Air, Inc., 613 F.3d 119, 124 (3d Cir. 2010) (“[w]e also exercise de novo review of a preemption determination, as it is a question of law”); Deweese v. National Railroad Passenger Corp., 590 F.3d 239, 244 n.8 (3d Cir. 2009) (“a preemption determination . . . is a question of law”; Travitz v. Northeast Dep’t ILGWU Health & Welfare Fund, 13 F.3d 704, 708 (3d Cir. 1994) (“[t]he issue of preemption is essentially legal”); Pennsylvania Medical Society v. Marconis, 942 F.2d 842, 846 (3d Cir. 1991) (“[t]he question of preemption involves an issue of law”); Ayers v. Philadelphia Housing Auth., 908 F.2d 1184, 1188 (3d Cir. 1990) (“we determine that as a matter of law the federal regulations . . . preempt the application of [state law]”) (citations and footnote omitted); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1119 (3d Cir. 1990) (“the question of whether [plaintiff’s] action is pre-empted . . . involves a pure issue of law”). These are not “off-hand” statements or dicta of any sort. Some of them are even West case headnotes. In deciding, after decades of contrary precedent, to convert preemption into a factual issue, Fosamax blatantly disregarded the “tradition” of the Third Circuit and did what panels are forbidden to do by IOP 9.1. We have said many times before that strange things happen in tort preemption cases, but Fosamax goes beyond “strange.” If precedent means anything, this aspect of Fosamax is a lawless decision.

Having decided that preemption doesn’t necessarily have to be a question of law, the court’s next awful conclusion was that juries are to determine what the FDA might have done with a different warning. The court looked at the specific question to be answered under Levine – would the FDA have rejected the label change plaintiffs argue was required – and determined it was the type of fact question that could be decided by a jury. The court’s reasoning was threefold: (1) the question asks about the probability of a future event; (2) the question requires the decision maker to weigh conflicting evidence and draw inferences; and (3) the question requires predicting FDA’s actions which requires assessments of FDA official’s motives and thought processes. All of which the court says are functions left to juries. 2017 WL 1075047 at *15-16. Which leads to the court’s ultimate conclusion that “[a] state-law failure-to-warn claim will only be preempted if a jury concludes it is highly probable that the FDA would not have approved a label change.” Id. at *18. Thus the decision opens the door to dueling FDA experts speculating about how the FDA would have viewed some hypothetical proposed label change, while discovery from actual FDA employees is mostly prohibited. See United States ex rel. Touhy v. Ragen, 340 U.S. 462, 468 (1951); Giza v. HHS, 628 F.2d 748, 751-52 (1st Cir. 1980).

This kind of jury second-guessing creates the kind of practical problems that drove the preemption decision in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (also not cited in Fosamax). It “will dramatically increase the burdens facing potential applicants-burdens not contemplated by Congress,” id. at 350, by encouraging plaintiffs to nit-pick FDA decisions – such as those involving bisphosphonates that we discussed above – without regard to the FDA’s actual decision-making process. It will expose “would-be applicants” to unpredictable civil liability,” id. for doing what the FDA directed them to do. Looking at how the plaintiffs in Fosamax discounted the FDA’s “don’t say that” decision, it is likewise plain that allowing such claims to survive preemption will “also cause applicants to fear that their [interactions with] the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.” Id. at 351. Allowing jury speculation about what the FDA might have done, had it received a different submission from a regulated company is, as a practical matter, no different than allowing the same jury speculation about what the FDA might have done, had it not been “defrauded” in Buckman.

Since the court in Fosamax was no longer addressing a question of law, its role at the summary judgment stage was “therefore limited to determining whether there are genuine issues of material fact that preclude judgment as a matter of law.” Id. at *13. Remember, the court is imposing a heightened standard of proof, so to affirm summary judgment the court concluded it would have to find “that no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff’s proposed atypical-fracture warning had Merck proposed it to the FDA in September 2010.” Id. at *19. Sure sounds like a “special burden” on preemption to us.

What does that mean in the context of Fosamax? Despite the FDA’s rejection of the defendant’s proposal to warn about the particular risk, the court, enforcing the clear and convincing standard against the defendant (preemption being an affirmative defense), holds that plaintiffs can get to the jury on their contention that the FDA’s rejection, after 10 months of review and back-and-forth, was merely a semantic quibble that the defendant could have fixed. See id. at *21 (“a reasonable jury could also conclude that the FDA rejected [defendant’s] proposed warning about femoral fractures in 2009 not because it denied the existence of a causal link between Fosamax and fractures, but because [defendant] repeatedly characterized the fractures at issue as “stress fractures.”). And when you read the court’s view of what Levine requires to get summary judgment, it leaves us very concerned that such a standard will ever be met: “Because the [Levine] test requires the factfinder to speculate about hypothetical scenarios using inferences drawn from historical facts, reasonable jurors could reach a broad range of conclusions.” Id. at *22.

White the Third Circuit claims its adoption of a clear and convincing standard of proof is less than proof beyond a reasonable doubt, id. at *12, the piling of a special burden of proof atop the standard for summary judgment certainly sounds very close to indisputable proof. We used to be concerned that courts would only find “clear evidence” in the context of an outright rejection of a label change. But even that wasn’t enough in Fosamax to allow the court to find that jurors might not differ in their interpretation of that rejection. And it is those differences which bring us back to the fact that this should be a question for the court, not a jury. For a defense like preemption that is equally operative for all plaintiffs, there should be some element of consistency – which will be eradicated if the decision is left to multiple juries to decide. Moreover, deciding federal preemption is an analytical process where legal training adds value and where testing credibility, something usually reserved for a jury, is not as material.

There remain many questions about how this decision and the Fosamax MDL will play out and we’ll be watching it all closely. Definitely more commentary to come.

A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly admonished by the court, the jury changed its mind and returned a verdict for the plaintiff.  We commented fully on the proceedings here, and while we will not repeat all the gory details, trust us, the proceedings were odd.

The Eleventh Circuit has now affirmed the plaintiff’s verdict, and the defendant has valid reasons to be unhappy. Not only did the Eleventh Circuit place its stamp of approval on the do-over verdict, it applied a hopelessly muddled view of comment k.

The case is Christiansen v. Wright Medical Technology, Inc., No. 16-12162, 2017 WL 1046088 (11th Cir. Mar. 20, 2017).  The plaintiff alleged that a defect in the defendant’s metal-on-metal hip replacement device caused him an injury, and he asserted product liability claims governed by Utah law. Id. at *1.  As luck would have it, the case was selected as a “bellwether” trial case in the Conserve Hip Implant MDL, and after a trial that lasted about a week, the jury returned a verdict finding that the product was not defectively designed. Id. The jury also found that the defendant had made negligent misrepresentations and awarded compensatory and punitive damages. Id.

Under Utah law, this is a defense verdict. The Utah Products Liability Statute covers all claims for injuries allegedly caused by defective products, and it requires proof of a product defect.  As a result, once the jury found that the product was not defective, nothing else mattered.  The defendant won.  The court, however, ruled that the verdict was “inconsistent” because the jury found no defect on the one hand, but also found negligent misrepresentation on the other. Id. That is why the court re-instructed the jury, resulting in the second verdict finding a product defect. Id.

The Eleventh Circuit affirmed this result, and its opinion relies on the assumption that the first verdict was “inconsistent.” Id. at **5-7.  But what inconsistency?  The jury made two core findings—no defect and negligent misrepresentation.  Maybe the evidence supported those findings and maybe it did not, but it is very possible for a defendant to make a misrepresentation and also sell a product that is free from design defects.  (There were no manufacturing or warning-based defect claims, in case you were wondering.)  The finding of no defect makes the misrepresentation finding meaningless under Utah law.  They are not “inconsistent.”  The former just deprives the latter of any legal consequence.

For whatever reason, the district judge saw an “inconsistency,” and the Eleventh Circuit deferred. The Eleventh Circuit tries to explain the proceedings in the district court, but in the end, it really did not explain why the initial verdict called for further deliberation.  It seems to have taken that for granted.

There is a second problem with the Eleventh Circuit’s opinion—it declined to apply Utah’s adoption of Comment k and gave a reason that simply does not hold up. Comment k to section 402A of the Restatement (Second) or Torts provides protection against strict liability claims involving “unavoidably unsafe products.”  Nearly all states have adopted some version of Comment k—some apply it on a case-by-case basis; some treat it as an affirmative defense; some apply Comment k as a matter of law in all cases involving prescription medical products, recognizing that all drugs and medical devices have both benefits and risks.

Utah has adopted Comment k, but has placed the burden on the defendant to prove certain elements to invoke Comment k as a defense. However, in cases involving prescription medical products, the Utah Supreme Court has “rejected the case-by-case approach and adopted Comment k as a categorical bar against strict liability.” Id. at **7-8 (quoting Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991)).  Comment k therefore applies in Utah across the board, and the Defendant justifiably argued to the Eleventh Circuit that Comment k applied and that it should result in a judgment for the defense.

The Eleventh Circuit “predicted” Utah law differently. According to the Eleventh Circuit, the Utah Supreme Court applied Comment k to prescription drugs because they are FDA approved. Id. at *8.  It therefore held that the Utah Supreme Court would not apply comment k categorically to medical devices. Id. at **8-9.  It further held that, even if Comment k applied to “FDA-approved medical devices,” the defendant had not carried its burden of proving that the product was FDA approved. Id. at **8-9.

There is so much wrong with this holding. To start, with the Utah Supreme Court having decided that Comment k applies to prescription drugs, there is no basis on which to predict that Utah law would be different for prescription medical devices.  The rationale for applying Comment k is the same—no matter how you design a drug or medical device, there will always be risks. (See here for our research post on comment k, including a 50-state survey.)  In addition, the Eleventh Circuit’s fixation on FDA approval to distinguish prescription drugs from prescription medical devices ignores that the FDA regulates medical devices, too.  It also ignores that drugs are approved for marketing in different ways—some through full-blown new drug applications, some under pre-NDA rules, some through a showing of substantial equivalence, etc.  Comment K applies to all of them, and the Utah Supreme Court has never drawn a distinction.  There is no reason to believe it would draw a distinction between drugs and medical devices because of their respective regulatory pathways either.

Finally, the Eleventh Circuit held that Comment k would not help the defendant in any event because the defendant did not prove that the product was approved by the FDA. This is wrong.  Utah’s version of Comment k requires the defendant to prove certain elements, but FDA approval is not one of them.  Neither the Utah pattern jury instruction nor the instruction given by the district court called for the defendant to prove FDA approval.  Yet, the Eleventh Circuit based its opinion on this purported failure of proof.

We can’t help but consider the possibility that this plaintiff’s judgment had more staying power because it came out of an MDL “bellwether” trial. Maybe.  Maybe not.  It seems to us that if you assume that “bellwether” verdicts actually help the parties value other cases, a defense verdict is as useful as a plaintiff’s verdict.  Both have dollar amounts attached to them, and the number attached to the defense verdict is zero, plus the defendant’s costs.  That should have been the result in Christiansen.

Doctors warn patients and decide which warnings to give. Manufacturers warn doctors and, if a particular doctor already knows a particular risk, it doesn’t even matter—in a court room, that is—whether the manufacturer warned the doctor. That is the interplay between the learned intermediary doctrine and the proximate causation element of a failure to warn claim.

And, in Tomaselli v. Zimmer, Inc., 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017), they came together to hand summary judgment to the defendant manufacturer and distributor. The doctor in Tomaselli surgically implanted a hip repair device into one of his patients to repair the patient’s greater trochanter, part of the femur bone near the hip. Later, one of the device’s cables unwound while inside the patient so that it was laying alongside her femur, causing her some level of pain. The doctor discovered this but, ultimately, recommended to the patient that it not be removed. Thereafter, the patient and her husband sued the manufacturer, the distributor and other defendants.

But they ran into a problem, something that usually isn’t a problem unless you’re in a court room asserting a failure to warn claim. The doctor was very experienced. He had performed more than 5,000 hip surgeries over the course of a 30-year career. He knew things. And one of the things he knew was that cables in hip repair devices can fail:

Based on his experience. . . Dr. Nercessian testified that cable breakage is “a known risk of any wire, any cable,” and that cables tend to break “[b]y reaching and exceeding the maximum fatigue strength of the metal.” Asked whether a cable implanted to repair a greater trochanter fracture may break if the fracture fails to fully heal—a so-called “nonunion”—Dr. Nercessian replied, “Definitely.”

Id. at *1 (citations omitted).

So this doctor knew the risk. That meant that, for purposes of the plaintiffs’ failure to warn claim, it didn’t matter whether the manufacturer had warned the doctor. He already knew. Moreover, this doctor chose, for whatever reason, not to warn this patient about that risk. That didn’t matter either. The doctor’s knowledge of that risk, whether he chose to convey it to his patient or not, cut off proximate causation. Here is the court laying out these principles under New York law:

Under the “informed intermediary” doctrine, a manufacturer “discharges its duty by providing the physician with sufficient information concerning the risks of the device.” Moreover, “where the treating physician is independently aware of potential adverse events, that knowledge is an intervening event relieving the manufacturer of any liability to a patient under the failure to warn theory.” “A physician’s existing awareness of a potential risk or side effect thus severs the causal chain between an allegedly inadequate warning and a plaintiff’s injury.”

Id. at *3 (citations omitted). And, finding no proximate causation, the court granted summary judgment to the manufacturer and distributor on plaintiffs’ failure to warn claim.

A couple of months ago, we reported on the magistrate’s report and recommendation in this case to grant summary judgment against all plaintiff’s claims, which included her failure to warn, design defect and warranty claims. At that time, we seriously doubted that plaintiff would object to the report and recommendation. It was so well-reasoned. You can read our discussion of that report, which was much more detailed, here. As it turns out, plaintiff did object, but only to the failure to warn recommendation. And, as it also turns out, we were right. The report and recommendation was well reasoned. With this decision, the district judge adopted the magistrate’s “thorough and well-reasoned Report in its entirety.”  Id. at *4.  And, now, we can be virtually certain that this is the last we will hear of this case.

 

As we’ve mentioned before, we watch state-law litigation over genetically-modified organisms (“GMOs”) because they tend to produce interesting results on federalism issues such as preemption, since anti-GMO zealots often try to interpose state law to gum up the works of federal regulatory decisions that they don’t like.  Those results are applicable by analogy (at least to our defense-oriented way of thinking) to litigation in our sandbox that attempts to litigate FDA-related issues in the context of product liability litigation.

The recent decision Bader Farms, Inc. v. Monsanto Co., 2017 WL 633815 (E.D. Mo. Feb. 16, 2017), is such an opinion – on the issue of federal question removability to federal court under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308, 314 (2005).  The plaintiffs in Bader Farms brought state-law tort claims alleging that herbicide “drift” had damaged their crops.  The GMO aspect arose because the herbicide was “old” and the defendant had not provided a new type of herbicide to be used on genetically engineered crops.

Genetically engineered crops are “highly regulated” by the federal government.  2017 WL 633815, at *1.  In this case, the agent was a “plant pest” bacterium so-designated by a federal agency going by the interesting acronym “APHIS” – only a one-letter keyboard typo away from “aphid,” which would have other agricultural connotations.

But we digress.

Anyway, APHIS can “allow[] the commercialization and sale” of genetically modified seeds for agricultural use “only after a strenuous investigation process and only based on sound science.”  2017 WL 633815, at *1-2.  According to plaintiffs, herbicides for such GMOs are “custom[arily]” released at the same time as “complete crop system[s].” Id. at *2.  Plaintiffs’ injury claim was based on the allegation that the defendant released seeds for a genetically engineered crop, but did not simultaneously release a new herbicide − resulting in the “old” herbicide being used. Id.

Bader Farms was non-diverse, but the defendant removed it to federal court anyway, alleging Grable-based federal question jurisdiction, id. – something our drug/device clients have also attempted, unfortunately with limited success.  However, in Bader Farm the defendant succeeded and the removal stuck.  The court’s Grable rationale should prove useful to our clients as well.

One count of the plaintiffs’ complaint, for “fraudulent concealment,” “present[ed] a substantial federal question” under Grable.  Id. at *2.  That was all that was necessary to deny remand, whether the other counts were preempted (or not) didn’t matter:

The fraudulent conduct alleged in the petition is that “[defendant] knew of [APHIS’s and others’] ignorance of the truth and intentionally withheld the truth about its product and its risks,” and that “[defendant] intended that [APHIS and others] should act in ignorance in carrying out their…oversight responsibilities.”

Id.  That sure sounds like an allegation of fraud on a federal agency – and indeed the citation of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), in Bader Farms was how we became aware of the decision.

The fraudulent concealment allegation was premised on plaintiffs’ assertion of a duty allegedly owed to the federal agency APHIS. “Plaintiffs must necessarily prove . . . that [defendant] had a duty to inform APHIS regarding the” risk in question.  2017 WL 633815, at *3.  Whether such a duty was owed to a federal agency constituted a substantial federal question justifying removal:

[P]laintiffs cannot dictate what duty was owed to APHIS, nor what kind of information should be material to APHIS’s decisions.  Nor can plaintiffs dictate the criteria under which APHIS was purportedly unable to perform its regulatory duties.

Id.  Rather, “the information [defendant] is required to disclose” was “set out in federal regulations.”  Id. (regulatory citations omitted).

The Buckman citation in Bader Farms did not involve preemption (the court did not have to reach that issue to deny remand), but instead concerned state-law litigation over what duties that the defendant owed to APHIS, the relevant federal regulatory agency.  Buckman held that “whether federal regulatory bodies fulfilled their duties with respect to the entities they regulate is ‘inherently federal in character.’”  2017 WL 633815, at *3 (Buckman citation omitted).  This type of question was both “substantial” and “federal”:

Count VII [for fraudulent concealment] is in a way a collateral attack on the validity of APHIS’s decision to deregulate the new seeds.  Despite plaintiffs’ argument that they are not challenging the agency decision itself, they can only succeed on that count if they establish that the agency decision was incorrect due to defendant’s fraudulent concealment.  Under these circumstances, disposition of Count VII presents a substantial federal question.

Id. (emphasis added).  Since “the outcome of the fraudulent concealment claim necessarily depends on the interpretation and application of the federal regulatory process,” remand was denied solely due to a substantial federal question in that one count.  Id.

An argument similar to Bader Farms can be made in drug/device cases where fraud on the FDA is alleged, even though a preemption defense, by itself, might not be sufficient to support removal.  As in Bader Farms, allegations that information was concealed or withheld from the FDA would require a court in an ostensibly state-law action to decide if the defendant had a duty, under relevant regulations, to supply the information in question and whether the information was “material” under the FDCA scheme.  Likewise, such claims only cause injury if the “agency decision was incorrect” as found by a state-law jury.  Thus, as in Bader Farms the substantial federal question would not be preemption, but rather the scope of disclosure duties owed to the FDA and whether or not those duties were met.  Finally, removability needs nothing more than that agency-fraud-based claim to succeed – whether that claim, or any other pleaded claim, was preempted (or “completely preempted”) isn’t decisive on the removal/remand issue.

Even though Buckman was decided back in 2001, plaintiffs still like to plead fraud on the FDA – even though Buckman preempts such claims.  But the availability of a federal preemption defense alone has not been enough in so many cases to support removal.  Bader Farms shows the value of focusing on a different federal issue, the nature of the duty owed to the FDA, as the substantial federal question.  Nor can plaintiffs “fix” things by amending out the offending count, as removability is determined at the moment of removal.

Now, at least in the Eastern District of Missouri, there is persuasive precedent supporting removal of agency fraud claims as presenting substantial federal questions.

Most of the cases we defend involve claims of inadequate warnings.  What makes a warning inadequate?  Falsehood is the first thing that comes to mind.  But the Pontius Pilate question of “What is truth?” continues to vex.  We have seen very few drug or device labels uttering an affirmative misrepresentation.  More often the complaint is about what the warning did not say, not what it did say.  If John Lennon sang “Gimme Some Truth,” plaintiff lawyers sing (off-key) “gimme some more truth.”  To our ears, it sounds like “gimme some more money.”  Whatever.  Plaintiffs allege that the product label did not disclose all of the serious side effects, or did not recite them with sufficient detail and drama.  There is a hierarchy of warning inadequacy.  A warning can ‘fail’ for any of various reasons.  You pays your money and you takes your choice.  Did the warning:

  • Fail to grab attention?
  • Fail to persuade?
  • Fail to change action?

The last test is a slam dunk.  If the consumer heeded the warning, we wouldn’t be enjoying each other’s company in the courtroom.  There would be no complaint.  Probably.

The first warnings we remember seeing were on cigarette packs.  The United States was the first country to require such warnings.  Back in 1966, the sides of cigarette packs were adorned with the following: “Caution:  Cigarette smoking may be hazardous to your health.”  That warning did not include the word “warning.”  Change came a couple of years later.  In 1970, packs reminded us that the Surgeon General had determined that cigarettes were “dangerous.”  Still later, smokers were treated to rotating warnings.  Some packs warned of cancer, emphysema, heart disease, and pregnancy complications.  Some stated that cigarette smoke contains carbon monoxide.  Some suggested that quitting now could improve one’s health.  And some warned pregnant smokers of possible fetal injury, premature birth, and low birth weight.  We heard that one fellow filed a lawsuit alleging that cigarettes had caused his lung cancer, while also claiming he had not been adequately warned, because he had made a point of buying only the packs that talked about pregnancy complications.  That case proved at least two things:  (a) no matter what, some people will smoke, and (b) no matter what, some people will file silly lawsuits.

Continue Reading Warning: Lawyers May Be Hazardous To Your Health

“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 recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.

Continue Reading What If We Win? Off-Label Promotion & Product Liability

If you have been following along for a while, then you have surely run across our posts making some combination of the following points:  1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture).  One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted.   That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.

The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted.  The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged.  Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection.  Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis.  When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds.  We will address only some of them.

Part of our point here is that the order can matter.  We do not have the briefs, so all we can go off of here is the opinion.  After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this:  “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:

If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.

Id. at *8.  This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary.  Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.

Continue Reading Another Court Tackles Prescription Drug Design Defect