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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.

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.

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.

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

Today’s guest post is by Aggie Lee of Tucker Ellis, about a PMA preemption win that she briefed in California.  The medical device is a hemostatic matrix, which is unusual, and this type of device isn’t usually targeted in product liability litigation.  As is always the case, our guest posters are 100% responsible for their submissions, so Aggie deserves all the credit (and any blame) for what follows.

**********

Judge Gonzalo P. Curiel in the Southern District of California has been in the national spotlight since then-candidate Donald Trump questioned his impartiality in the then-pending Trump University lawsuits.  While now-President Trump might not number among his admirers, we like Judge Curiel’s recent contribution to Premarket Approval (PMA) preemption, where he recently dismissed with prejudice all of plaintiffs’ claims in Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017).

But it took a long time and many motions to get there, specifically four complaints, one personal jurisdiction-based motion to dismiss, and three preemption-based motions to dismiss. Defendant Ethicon, Inc., finally prevailed when the Court dismissed Plaintiffs’ Third Amended Complaint with prejudice.

Continue Reading Guest Post – The Matrix Preempted

This is a follow-up to our post last week on the Missouri Supreme Court’s momentous personal jurisdiction decision in State ex rel. Norfolk Southern Railway Co. v. Dolan, ___ S.W.3d ___, 2017 WL 770977 (Mo. Feb. 28, 2017) (“NSRC”).  We stated last week, and we continue to believe, that NSRC will ultimately kill litigation tourism in Missouri.

However, it won’t be easy.  Nothing ever is against the rich and entrenched litigation industry.

As we would expect, the other side is talking out both sides of its mouth about NSRC.

On one hand, in the ongoing legislative push for a statutory fix to the bizarre and unfair way that courts have interpreted Missouri’s venue and joinder rules (see our post here), those supporting the other side of the “v.” are already claiming that the venue/joinder reform bill (H.B. 460 – which will be on the House floor this week) is no longer necessary; that NSRC supposedly “fixed” everything.

On the other hand, and essentially simultaneously, in the multi-plaintiff mass tort litigation that is the main reason tort reform is so desperately needed, they’re doing the opposite –  trying to get around NSRC by claiming “pendent party” jurisdiction as a result of the very same venue/joinder problems that venue/joinder reform and H.B. 460 is intended to fix.

Talk is cheap.  Watch what they do, not what they say.

They can’t have it both ways. In fact, they can’t have it either way.  The plaintiffs’ first position is garbage, and the second is devoid of legal support.

For the reasons stated in our original post, H.B.460 remains necessary after NSRC.  NSRC established that personal jurisdiction over non-resident corporations by non-resident plaintiffs over injuries not arising in Missouri is unconstitutional under the Due Process clause.  There is no general personal jurisdiction because the defendant is not “at home.”  There is no specific personal jurisdiction because out-of-state injuries to out-of-state plaintiffs are not “related to” a defendant’s Missouri activities.  There is no “consent” merely by registering to do business.

But as good as it was, NSRC was not a mass tort case.  Rather, it was an individual litigation tourist plaintiff suing a single non-resident corporation.  NSRC thus had no occasion to address either the 99-plaintiff misjoined tort complaints that have become the bane of Missouri product liability practice or the 99-defendant complaints that are typical of asbestos (and some other) product liability litigation.  Eliminating those abuses are at the core of H.B. 460, meaning that the reforms proposed in H.B. 460 remain every bit as necessary as before.  As we discussed, the court of appeals in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091, at *13 (Mo. App. Nov. 8, 2016), invited the legislature to correct the venue/joinder rules, and that is exactly what H.B. 460 will do.

Continue Reading More on Missouri – What To Expect and Not To Expect After Norfolk Southern v. Dolan

If we’d learned about State ex rel. Norfolk Southern Railway Co. v. Dolan, No. SC95514, slip op. (Mo. Feb. 28, 2017) (“NSRC”), earlier, this would have been a breaking news post – but make no mistake about it, this is big news.  Unanimously, the Missouri Supreme Court has, for all intents and purposes, put an end to Missouri’s notorious litigation tourism industry (about a month before the Legislature would have done the same).

NSRC is a railway accident case, not a product liability action, but the jurisdictional facts are familiar to anyone interested in Missouri jurisdiction and venue issues. An out-of-state litigation-tourist, personal-injury plaintiff sued a large out-of-state corporation in Missouri state court (county not stated, but we can guess) over injuries not suffered in Missouri. NSRC, slip op. at 2-3.  The Missouri Supreme Court made three major rulings:  (1) no general jurisdiction exists over the non-resident corporate defendant because it was not “at home” in Missouri; (2) no specific jurisdiction existed because the litigation tourist’s injuries did not “relate to” the defendant’s Missouri activities; and (3) the defendant’s compliance with the Missouri statute governing corporate registration did not constitute “consent” to general personal jurisdiction.

First, general jurisdiction.  Due process under Daimler AG v. Bauman, 134 S. Ct. 746, 751 (2014), requires that a corporation be “at home” in the state in question.  While the defendant conducted “continuous and systematic” business in Missouri (and in 21 other states), that business “represents a tiny portion of [defendant’s] entire nationwide business.” NSRC, slip op. at 8.  Game over on general jurisdiction . Bauman “observed that finding a corporation at home wherever it does business would destroy the distinction between general and specific jurisdiction.”  Id. at 9.

Continue Reading Litigation Tourism Ended In Missouri

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.”  Taking the alternative design requirement for strict liability as a given, we concentrated in that post on the proposition that an “alternative” design must really constitute a different design for the same product, and not a disguised “stop selling” or “never start selling” claim where the only “alternative” is a different product or, worse, a completely different medical procedure not utilizing that sort of product at all.

Since then, we’ve written about alternative designs several other times, but never comprehensively.

Today, we’re doing something a little different. We’re examining whether an alternative design is also an element of a design-related claim sounding in negligence.  As the rest of this post demonstrates, the overwhelming weight of nationwide precedent established that negligent design claims require the plaintiff to establish the existence of a feasible alternative design the would have prevented the plaintiff’s injuries.

We touched upon the alternative design issue somewhat in our post excoriating the Pennsylvania Supreme Court’s bizarre opinion in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). Lance put the rabbit in the hat and held, for a product allegedly:  (1) “too dangerous to be used by anyone,” and (2) that had been removed from the market by the FDA, a negligent design case could be stated even though the plaintiff didn’t even attempt to prove an alternative design. Id. at 458-60.  What Lance adopted, of course, was a pure “stop selling” claim of the sort preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  “[W]e are convinced that a manufacturer or supplier has a duty to cease further distribution of a product . . . [that] is too dangerous to be used by anyone.” Lance, 85 A.3d at 460.

Generally, in Pennsylvania, negligent design cases have required proof of alternative designs, except in the limited Lance recalled product situation.  “The determination of whether a product was negligently designed turns on whether an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.”  Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38, 64 (3d Cir. 2009) (emphasis original). See, e.g., Kosmack v. Jones, 807 A.2d 927, 931 (Pa. Commw. 2002) (“a plaintiff bears the burden of establishing that there is an alternative design” in negligent design defect cases); Smith v. Yamaha Motor Corp., 5 A.3d 314, 322-23 (Pa. Super. 2010) (requiring proof of alternative design for all-terrain vehicle).

Continue Reading On Alternative Design, Take Two − Negligence

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.

One of us was asked a question the other day that we couldn’t answer immediately.  “Does the learned intermediary rule apply to a physician’s assistant?”  We didn’t remember any cases actually deciding that issue.  So we did what we usually do in that situation and looked at Bexis’ book.  The book has a section (§2.03[2]) titled “Who Is the Learned Intermediary,” which looked like it would cover this subject.  It did, but while it had cases discussing nurses:

Yes: Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1281 (11th Cir. 2002) (applying Georgia law); Walker v. Merck & Co., 648 F. Supp. 931, 934 (M.D. Ga. 1986), aff’d without op., 831 F.2d 1069 (11th Cir. 1987); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93 (Tex. App. 2000); Holley v. Burroughs Wellcome Co., 330 S.E.2d 228, 235-36 (N.C. App. 1985), aff’d, 348 S.E.2d 772 (N.C. 1986); Singleton v. Airco, Inc., 314 S.E.2d 680, 682 (Ga. App. 1984); In re NuvaRing Litigation, 2013 WL 1874321, at *28 (N.J. Super. L.D. April 18, 2013) (applying California law).  No: Mazur v. Merck & Co., 964 F.2d 1348, 1357 (3d Cir. 1992) (a nurse “not authorized to prescribe drugs”) (applying Pennsylvania law); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277 (5th Cir. 1974) (applying Texas law).

Cases discussing optometrists:

No: Prager v. Allergan, Inc., 1990 WL 70875, at *4 (N.D. Ill. May 2, 1990); Bukowski v. CooperVision Inc., 592 N.Y.S.2d 807, 809 (N.Y.A.D. 1993);

Cases discussing pharmacists:

No: Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1387 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987);

A case discussing veterinarians:

Yes: Haste v. American Home Products Corp., 577 F.2d 1122, 1124 (10th Cir. 1978) (applying Wyoming law);

A case discussing physical therapists:

Yes: Seifried v. The Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App. 2013); and

A case discussing medical societies:

No: Davis v. Wyeth Laboratories, 399 F.2d 121, 130 (9th Cir. 1968) (applying Montana law) . . . .

There were no cases specifically addressing P.A. prescriptions and the learned intermediary rule in Bexis’ book.

As an aside, we note that, while the weird case we discussed last week from Washington State, Taylor v. Intuitive Surgical, Inc., ___ P.3d ___, 2017 WL 532497 (Wash. Feb. 9, 2017), wasn’t phrased in such terms, it is effectively a ruling that a hospital can be a learned intermediary.

The only specific mention of physician’s assistants in Bexis’ book was quoting dictum in Perez v. Wyeth Laboratories, Inc., 713 A.2d 520 (N.J. Super. A.D. 1998), that although limited to “physicians” by statute, the learned intermediary rule might also apply to “dentists, optometrists, podiatrists, nurse practitioners, home health care service firms, physician’s assistants, or others similarly permitted to prescribe or administer drugs on a limited basis.” Id. at 522-23 (statutory citations omitted).  That decision was, of course, famously reversed in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 (N.J. 1999), another weird decision that created a “direct to consumer” exception to the learned intermediary rule (since rejected by every other state to consider it), and thus never had to reach the “who is” question.

The next thing we did was to run a ridiculously broad Westlaw search – looking for “learned intermediary” anywhere in the same case as “physician’s assistant”?

Not too bad, this time. Less than 25 cases, including the two Perez decisions.

The most significant case on P.A.s and the learned intermediary rule is Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010).  As we discussed here and here, while Stevens is not overall a favorable decision for defendants, it did reaffirm the learned intermediary rule and extend it to a P.A.-prescribed drug.  Stevens first mentioned the Third Restatement’s version of the learned intermediary rule, Restatement (Third) of Torts, Products Liability §6(d)(1), which describes the rule in terms of warnings “provided to . . . prescribing and other health-care providers.”  247 P.3d at 492 (emphasis added).  The court then discussed the “evolution” of the rule “away from limiting the doctrine’s applicability to the prescribing physician alone.” Id. A P.A. could thus be a “learned intermediary” when fulfilling the “traditional” role of a physician:

The modern healthcare system, however, places far less emphasis on these traditional relationships, and patients today often receive the majority of their care from nurses, nurse practitioners, physicians’ assistants, and physicians other than the prescribing physician.  Appropriately, in situations where the underlying rationale of the doctrine − the traditional doctor-patient relationship − is no longer present, the doctrine has adapted to fit the realities of the situation.

*          *          *          *

[T]he evolution of the doctrine [has been] through an expansion of the possible class of learned intermediaries. This development, likewise spurred by the fact that the medical professionals with whom patients most commonly interact are often no longer primary physicians, has led courts and secondary sources such as the Restatement to suggest that a variety of different healthcare providers may be considered learned intermediaries, depending on the unique facts of the patients’ treatment scenario.

*          *          *          *

We concur with authorities who consider the learned intermediary to be the healthcare professional actually responsible for making decisions related to the patient’s care. . . . [Plaintiff] received much of her treatment from nurses, treating physicians, and nurse practitioners.

Stevens, 247 P.3d at 492-95 (footnote citing many of the cases in Bexis’ book omitted).

Another case applying the learned intermediary rule to a physician’s assistant is Luke v. Family Care & Urgent Medical Clinics, 246 F. Appx. 421 (9th Cir. 2007) (applying Washington law).  The drug in question in Luke was prescribed by a P.A., id. at 423, and but the learned intermediary rule still applied:

[T]he district court properly decided that the [risk at issue] was not material and that the physician’s assistant had no duty to warn [plaintiff] of the danger.  Under Washington law, it would be contradictory to require a pharmacist to warn of the same danger when the “learned intermediary” had no duty to warn.

Id. at 425.

The learned intermediary rule also applied to a physician’s assistant in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying Ohio law) – a case we usually cite for its preemption holdings.  In Yates the prescriber (“Smith”) was a P.A.  Id. at 288.  Without a lot of discussion of Smith’s P.A. status, Yates found the learned intermediary rule applicable:

Smith testified that it is her custom to use her independent medical judgment when prescribing birth control products to patients, and she specifically testified that she discussed the risks and benefits of several different forms of birth control with [plaintiff].  The mere fact that Smith gave [plaintiff] options and a voice in determining which method of birth control would best fit her needs and lifestyle does not remove Smith from her status as a learned intermediary.

Id. at 293.  Without any separate discussion of P.A. status, Czimmer v. Janssen Pharmaceuticals, Inc., 122 A.3d 1043, 1056-58 (Pa. Super. 2015), treated a prescribing P.A. as a learned intermediary.  See also Canady v. Ortho McNeil Pharmaceutical, Inc., 2014 WL 1653349, at *4 (N.D. Ohio April 24, 2014) (applying learned intermediary rule in negligence action over drug prescribed by a P.A.; not applying learned intermediary rule to strict liability, due to peculiar Oregon statute); Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *2-3 (W.D. Tex. June 23, 2011) (applying learned intermediary rule to prescribing P.A. without regard to P.A. status).

As Stevens in particular demonstrates, expanding the learned intermediary rule to non-physicians such as P.A.s is something of a double-edged sword.  On one hand, recognizing non-physicians who prescribe drugs or devices as learned intermediaries precludes plaintiffs from arguing for direct-to-patient warnings.  On the other hand, the rule requires that adequate warnings be given to the learned intermediary – whoever that might be.  Thus, expanding the categories of medical practitioners who qualify as “learned intermediaries” also expands the scope of a defendant’s warning obligations to such practitioners, although not to plaintiffs themselves.  Given the choice between a plaintiff coached to say whatever is necessary to obtain recovery, and a P.A. who usually won’t be in the plaintiff’s back pocket, we’ll take our chances with the P.A.

We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.