DeGidio v. Centocor, Inc. et al

Reply to response to 28 Motion for summary judgment

N.D. OhioAugust 13, 2010

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF OHIO WESTERN DIVISION ANTHONY DeGIDIO, Plaintiff, ) CASE NO. 3:09-CV-0072L ) ) JUDGE JAMES G. CARR ) ) ) ) ) ) ) ) ) v. CENTOCOR, INC., JOHNSON & JOHNSON,ORTHO-McNEIL PHARMACEUTICAL, INC., JOHN DOE MANUFACTURERS A-Z, JOHN DOE DISTRIBUTORS A-Z, RAY MILLER, D.O., AND JANE DOE, Defendants. DEFENDANTS CENTOCOR ORTHO BIOTECH INC., JOHNSON & JOHNSON, AND ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC.'S REPLY TO PLAINTIFF'S OPPOSITION TO DEFENDANTS' MOTION FOR SUMMARY JUDGMENT Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 1 of 21. PageID #: 742 TABLE OF CONTENTS TABLE OF AUTHORITIES..................................................................................................... iii 1. INTRODUCTION AND SUMMARY OF THE ARGUMENTS ............................... i II. PLAINTIFF'S WARNING CLAIMS FAIL AS A MATTER OF LAW BECAUSE PLAINTIFF LACKS EXPERT TESTIMONY TO ESTABLISH THESE CLAIMS. .................................................................................2 III. PLAINTIFF'S WARNING CLAIMS FAIL AS A MATTER OF LAW BECAUSE PLAINTIFF STILL CANNOT SHOW THAT DR. SLEE WOULD HAVE GIVEN A DIFFERENT WARNING SUPPORTED BY THE EVIDENCE......................................................................................................... 4 IV. DEFENDANTS' WARNINGS ARE ADEQUATE AS A MATTER OF LA W BECAUSE THE LABEL SPECIFICALLY AND ACCURA TEL Y DISCLOSES THE TYPE OF PNEUMONIA EXPERIENCED BY PLAINTIFF - INTERSTITIAL PNEUMONITIS. ..................................................... 5 A. The RemicadeCI label warns of the type of pneumonia experienced by Plaintiff..... .... ................................... ............. ......... ......... ........5 B. Plaintiff s criticism of the interstitial pneumonia warning does not create a fact issue. ............................................................................................ 6 C. RemicadeCI's infectious pneumonia and interstitial pneumonia warnings are consistent with Defendants' arguments concerning the adequacy and reasonableness of the warnings given to Plaintiff. ........................................................................................................... 9 V. PLAINTIFF'S FRAUD CLAIM FAILS BECAUSE THE SINGLE FRAUDULENT ACT HE ALLEGES is REFUTED BY THE EVIDENCE, NO OTHER EVIDENCE OF FRAUD is PRESENTED, AND IT is ABROGATED BY THE OPLA. ............................................................lO VI. PLAINTIFF'S "CIVIL CONSPIRACY AND COMMERCIAL BRIBERY" CLAIM FAILS BECAUSE PLAINTIFF HAS NOT ALLEGED THE BASIS OR PROVIDED EVIDENTIARY SUPPORT FOR THIS CLAIM, AND IT is ABROGATED BY THE OPLA. ..........................l i A. Plaintiffs failure to sufficiently allege and support "civil conspiracy and commercial bribery" ............................................................. II B. Abrogation by the OPLA ............................................................................... l2 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 2 of 21. PageID #: 743 VII. PLAINTIFF DOES NOT DISPUTE DEFENDANTS' REQUEST FOR SUMMARY JUDGMENT AS TO PLAINTIFF'S DESIGN DEFECT AND FAILURE TO CONFORM CLAIMS.............................................................. 13 VII1. CONCLUSION.......................................................................................................... i 4 Local Rule 7. i (f) Certification......... ................................... .......................... ............................ i 5 11 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 3 of 21. PageID #: 744 TABLE OF AUTHORITIES Cases Allson v. McGhan Med. Corp. l84 F.3d l300 (11th Cir. 1999) .................................................................................................. 8 Boroffv. Alza Corp., 2010 WL 395211, *7 (N.D. Ohio).............................................................. 13 Brumbaugh v. Sandoz Pharm. Corp. 77 F. Supp. 2d 1153 (D. Mont. 1999)......................................................................................... 8 Caraker v. Sandoz Pharms. Corp. 188 F. Supp. 2d 1026 (S.D. IlL. 2001)......................................................................................... 7 Casey v. Ohio Med. Prods. 877 F. Supp. 1380 (N.D. Cal. 1 995) ........................................................................................... 8 CCB Ohio LLC v. Chemque Inc. 49 F.Supp.2d 757 (S;D. Ohio 2009) ......................................................................................... 12 Celotex Corp. v. Catrett 477 U. S. 317 (1986).................................................................................................................... 1 Crisp v. Stryker Corp., 2010 WL 2076796, *1 FN4, *3 (N.D. Ohio, May 21, 2010) .................. l3 Friedman v. Intervet Inc., 2010 WL 2817257, *6 (N.D. Ohio, July 16,2010) ............................ 13 Glastetter v. Novartis Pharms. Corp. 252 F .3d 986 (8th Cir.200 1) ....................................................................................................... 7 Graham v. Am. Cyanimid Co., 350 F.3d 496,514 (6th Cir. 2003)................................................. 3 In re Bayer AG Sees. Litig., No. 03-Civ-1546 2004 WL 2190357 (S.D.N.Y. Sept. 30,2004)............................................................................ 8 In re Meridia Products Liabilty Litgation 328 F. Supp.2d 791 (N.D. Ohio 2004)........................................................................................ 7 McClain v. Metabolife Int'l, Inc. 401 F.3d 1233 (11 th Cir. 2005) .................................................................................................. 7 Meister v. Med. Eng'g Corp. 267 F.3d 1123 (D.C. Cir. 2001).................................................................................................. 7 Miles v. Raymond Corp. . 612 F.Supp.2d 913 (N.D. Ohio 2009)................................................................................. 13, 14 ii Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 4 of 21. PageID #: 745 Richardson v. Richardson-Merrell, Inc. 493 U.S. 882 (1989)..................................................................................................................... 8 Richardson v. Richardson-Merrell, Inc. 649 F. Supp. 799 (D.D.C. i 986) .................................................................................................8 Richardson v. Richardson-Merrell, Inc. 857 F.2d 823 (D.C. Cir. 1 988) .................................................................................................... 8 Rider v. Sandoz Pharms. Corp. 295 F.3d 1194 (lIth Cir.2002) ................................................................................................... 7 Saari v. Merck & Co., Inc. 961 F. Supp. 387 (N.D.N. Y. 1997)............................................................................................. 8 Saraney v. Tap Pharmaceutical Prod. 2007 WL 148845 ........................................................................................................................ 3 Statutes 2l C. F . R. § 3 l4. 8 0 .. .. .. .. .. . .. .. .. . .. .. . .. .. .. .. . .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .... .. .. .. .. .. .. .. .. .. .. .. . . .. .. .. .. .. .. . ... 8 7 1 Fed. Reg. 3922 ....................... ..................................................................................................... 9 Federal Rule of Civil Procedure 56( c) ............................................................................................ 1 Federal Rule of Civil Procedure 56( e )(2) ..................................................................................... 10 Federal Rule of Civil Procedure 5 6( f) ............................................................................................ 2 iv Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 5 of 21. PageID #: 746 I. INTRODUCTION AND SUMMARY OF THE ARGUMENTS Many of the alleged facts in Plaintiffs Opposition lack evidentiary support, particularly those concerning Plaintiff s attempts to define or explain the medical issues in this case and what various physicians thought, believed, or reviewed when treating or diagnosing Plaintiff. Any such information should be disregarded, as Plaintiff and his counsel are not qualified to explain such matters, nor do they know the thoughts or motives of medical personneL. Indeed, as the non-moving party, Plaintiff must submit evidence under Federal Rule of Civil Procedure 56( c) supporting his position. Celotex Corp. v. Catrett, 477 U.S. 317,324 (1986). Even if such facts are true, however, Plaintiff still cannot refute the arguments Defendants raised in support of their Motion. Plaintiffs Opposition confirms that the interstitial pneumonitis he allegedly experienced was in fact discussed in RemicadeCI's labeling. He contends that the label is inadequate, however, because it "assures" physicians that RemicadeCI does not cause interstitial pneumonitis. Plaintiffs inadequate warning claim fails as a matter of law because (1) he provides no expert support for his claim, (2) the RemicadeCI label warns of Plaintiffs alleged condition, (3) he provides no admissible evidence sufficient to demonstrate a genuine issue of material fact, (4) the plain meaning of the RemicadeCI label refutes his position, (5) the labeling is consistent with regulatory authority and legal precedent, and (6) Plaintiff was provided a reasonable warning under Ohio law. Plaintiffs inadequate warning claim also fails as a matter of law because Dr. Slee, the only intermediary between Defendants and Plaintiff, testified unequivocally that he would not have communicated a waring for interstitial lung disease, and specifically eosinophilic pneumonia ("EP"), even if there was a "known" causal relationship between this condition and RemicadeCI. Furthermore, Dr. Slee, the only expert Plaintiff uses to support his inadequate warning claim, testified that Plaintiffs pneumoma was a rare, idiosyncratic reaction to 1 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 6 of 21. PageID #: 747 RemicadeCI. Plaintiffs questions to Dr. Slee involving a completely unsupported, hypothetical, and ambiguous "significant" causal relationship between RemicadeCI and interstitial lung disease, specifically EP, does not change this reality. Plaintiffs fraud and conspiracy and commercial bribery claims fail because Plaintiff has not alleged the basis for these claims, and canot provide evidence to support them. Furthermore, recent authority from this Court indicates that these claims should be dismissed because they are abrogated by Ohio's Product Liability Act ("OPLA"). Lastly, judgment should be entered in Defendants' favor as to Plaintiffs design defect and failure to conform claims because Plaintiff has not opposed Defendants' request for summary judgment on these claims. Defendants respectfully disagre~ with Plaintiff s characterization of the two-stage dispositive briefing in this case to the extent Plaintiff is using it as an excuse for not having sufficient evidentiary support to substantiate his failure to war claim, especially from outside sources. See Opp. at 1-2. The Cour established a specific discovery deadline for this initial dispositive motion, and Defendants did not seek to limit Plaintiffs discovery efforts during this period. Defendants assume that Plaintiff s reliance on Dr. Slee as his sole expert concerning the product labeling at issue is intentional. Nonetheless, when lacking evidentiary support, a non- moving party should follow the procedures set forth in Federal Rule of Civil Procedure 56(f). II. PLAINTIFF'S WARNING CLAIMS FAIL AS A MATTER OF LAW BECAUSE PLAINTIFF LACKS EXPERT TESTIMONY TO ESTABLISH THESE CLAIMS. Plaintiff has not offered any expert support opining that the RemicadeCI label is inadequate. To survive summary judgment, however, Plaintiff must establish the inadequacy of any warning through expert medical testimony. Saraney v. Tap Pharmaceutical Prod., 2007 WL 148845, *6, FN3 (N.D. Ohio), citing Graham v. Am. Cyanimid Co., 350 F.3d 496, 514 (6th Cir. 2 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 7 of 21. PageID #: 748 2003). Here, Plaintiffs designated expert, Dr. Slee, never once criticized Defendants' label or suggested that it was in any respect inadequate. Thus, as explained in more detail below, Defendants are entitled to sumary judgment on Plaintiffs failure to warn and design defect claims. Plaintiff goes to great lengths to point out Dr. Slee's testimony that the RemicadeCI label does not include the specific terms "non-infectious interstitial lung disease (NILD) and/or EP." Opp. at 20-22. Plaintiff presents this evidence as expert testimony on the "deficiencies in Defendants' warning labeL." Id. at 19. Yet, Dr. Slee did not criticize this fact or even remotely opine that the label should war of eosinophilic pneumonia and/or Plaintiffs latest term of choice, "Non-infectious interstitial lung disease."l To the contrary, Dr. Slee testified unequivocally that, even now, he believes the RemicadeCI labeling adequately wars physicians about the risks of RemicadeCI, and that he does not have any criticism of the labeL. Motion at 7, l4-l5. Moreover, he testified that his understanding of RemicadeCI's risks comes not only from company-provided information, but also his own prescribing experience, American Seminar tapes, attending conferences, participation in two professional organizations, an online drug compendium, and peer review. Motion at 7, citing Slee depo at 44,47,50-51. Thus, the only expert Plaintiff provides to refute Defendants' claim that the RemicadeCI warning is adequate actually agrees with Defendants on this issue, and formed his opinion from many different sources. Furhermore, although Plaintiff argues that even "a cursory review of published literature" demonstrates the need for a warning concerning a "potential" "causal link" 1 Plaintiffs terminology used to describe the condition he alleges should have been contained in the Remicade(ß labeling has changed throughout this litigation. His Complaint focused on the term "acute eosinophilic pneumonia." Presumably because Defendants pointed out that the Remicade(ß label warns about pneumonia, Plaintiffs counsel repeatedly used the phrase "interstitial lung disease and/or EP" while questioning Dr. Slee at his deposition. Now, after Dr. Slee testified that interstitial lung disease and EP can have both infectious and non-infectious etiologies (Motion at 7), Plaintiff argues for the first time that the Remicade(ß label should have warned specifically of "non- infectious interstitial lung disease and/or eosinophilic pneumonitis." Opp. at 3. 3 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 8 of 21. PageID #: 749 between RemicadeCI and NILD and/or EP, Plaintiff has not offered any expert support for this argument either. Accordingly, Plaintiffs lack of supportive expert testimony on the adequacy of Defendants' warning is fatal to his warning and design defect claims, entitling Defendants to judgment as a matter of law. III. PLAINTIFF'S WARNING CLAIMS FAIL AS A MATTER OF LAW BECAUSE PLAINTIFF STILL CANNOT SHOW THAT DR. SLEE WOULD HAVE GIVEN A DIFFERENT WARNING SUPPORTED BY THE EVIDENCE. The testimony of Dr. Slee quoted by Plaintiff does not at all change Dr. Slee's unambiguous testimony that he would not have discussed the risk of "interstitial lung disease, specifically EP" with Plaintiff. Dr. Slee stated definitively that Plaintiff experienced a "rare idiosyncratic reaction and not one that I probably would've entertained in my discussion with the patients." Opp. at 25 (emphasis added). According to Dr. Slee, even if there was a "known relationship" between "RemicadeCI and interstitial lung disease, specifically EP" he would "probably not" communicate that warning to his patients.2 Id. Indeed, Defendants demonstrated in detail how Dr. Slee - who is very knowledgeable of RemicadeCI's risks, and especially various forms of pneumonia - testified that he does not go into detail about different types or causes of pneumonia with his patients, preferring instead to use lay terms and discuss categories of risks. Motion at 7-8, 18. For example, Dr. Slee testified that he . is well aware that lupus is discussed in the RemicadeCI labeling and can cause autoimmune lung disease, but that he does not get into this type of "minutia" with patients. Motion, Exh. B at 219-222. To deal with Dr. Slee's devastating testimony, Plaintiff created a hypothetical at Dr. Slee's deposition in which, (1) RemicadeCI "had been determined to present a "signifcant ris/t' 2 This testimony completely contradicts Plaintiffs statement that Dr. Slee would have warned ofa "known" risk. Opp. at 5. 4 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 9 of 21. PageID #: 750 of causing interstitial lung disease, specifically EP; and (2) such "significant" risk was required to be in "certain medication guides or in the information form, consent form, given to patients." Id. Dr. Slee then pointed out that Plaintiffs counsel presented a new hypothetical before saying that under this different scenario he would discuss such "significant risks" with Plaintiff. Id. Yet Plaintiff has submitted absolutely no admissible evidence whatsoever to show even a "known risk" of interstitial pneumonia beyond that already discussed in the RemicadeCI label, let alone the "significant risk" hypothetically presented to Dr. Slee.3 For example, Plaintiff does not provide any expert testimony concerning the incidence or prevalence of interstitial pneumonia, specifically EP, and no federal regulatory documents concerning such a risk, including any requirement for additional waring. As discussed below, even the five aricles attached to Plaintiffs Opposition - again, without expert support - do not demonstrate, let alone prove, a causal relationship between interstitial pneumonia, specifically EP, and RemicadeCI rising to the level of a "significant risk" with "required" additional warning. Accordingly, Plaintiff cannot meet his burden to show that Dr. Slee would have changed his decision to prescribe RemicadeCI or would have provided the waring Plaintiff argues he should have been given. iv. DEFENDANTS' WARNINGS ARE ADEQUATE AS A MATTER OF LAW BECAUSE THE LABEL SPECIFICALLY AND ACCURATELY DISCLOSES THE TYPE OF PNEUMONIA EXPERIENCED BY PLAINTIFF INTERSTITIAL PNEUMONITIS. A. The RemicadeCI label warns of the type of pneumonia experienced by Plaintiff. Despite the various terminology used by Plaintiff to identify the type of pneumonia he experienced and that allegedly should have been included in the RemicadeCI warnings4, his 3 In his Opposition, Plaintiff unjustifiably referred to his "significant risk" hypothetical as a discussion of an "established risk." Opp. at 26. Plaintiff did not use the term "established" at Dr. Slee's deposition, nor is it accurate or appropriate to broaden the hypothetical's meaning in his Opposition. 4 See FN 1, supra. 5 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 10 of 21. PageID #: 751 Opposition confirms that Defendants did in fact war about the pneumoma he allegedly experienced - interstitial pneumonitis. As Defendants pointed out in their Motion, Dr. Slee testified that the "interstitial pneumonitis" discussed in the RemicadeCI label is the same condition experienced by Plaintiff. 5 Motion at 7. Plaintiff does not dispute that fact, and, actually, acknowledges that this warning deals with non-infectious interstitial lung disease. Opp. at 3, 9, 17. Surely, Plaintiff canot claim that a NILD warning is missing from the label, while simultaneously criticizing the label's discussion ofNILD. B. Plaintiff's criticism of the interstitial pneumonia warning does not create a fact issue. Plaintiff s issue, therefore, is not that Defendants did not warn of the risk of interstitial lung disease, and particularly interstitial pneumonia, but that the warning "assured prescribing physicians that there was no known causal connection between the drug and interstitial lung disease." Opp. at 9. For the following reasons however, this alleged inadequacy does not present a genuine issue of material fact. First, Plaintiff flatly misstates the meaning of the waring, which is copied below: The following adverse events have been reported during post- approval use of REMICADECI ... interstitial pneumonitis/fibrosis . .. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to REMICADECI exposure. This warning plainly does not "assure" either a causal or lack of causal relationship; it simply discloses that interstitial pneumonitis has been reported, and explains the limitations of voluntary case reports. 5Plaintiffrepeatedly claims that Defendants failed to mention Remicade(ß's interstitial pneumonia warning in their Motion. Plaintiff is incorrect, as Defendants discussed the interstitial pneumonia warning on pàges 6, 7, 13, and 14 of their Motion. 6 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 11 of 21. PageID #: 752 Second, adverse event reports cannot reliably establish causation, and therefore canot be used to claim a causal relationship in a warnng labeL. This issue has been resolved in courts throughout the country. See, e.g., In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 808 (N.D. Ohio 2004) (case reports "do not screen out alternative causes for the adverse event and often lack analysis," are "not scientifically valid proof of causation" and are "irrelevant to establish a material issue of fact. "), citing Rider v. Sandoz Pharms. Corp., 295 F .3d 11 94, 11 99 (lIth Cir.2002), Glastetter v. Novartis Pharms. Corp., 252 F .3d 986, 989-90 (8th Cir.2001); McClain v. Metabolife Int'l, Inc., 401 F.3d 1233, 1250 (lIth Cir. 2005) ("Uncontrolled anecdotal information (in FDA adverse event reports) offers one of the least reliable sources to justify opinions about both general and individual causation."); Glastetter, 252 F.3d at 989-90 (8th Cir. 2001) (case reports are "simply a doctor's account of a particular patient's reaction to a drug or other stimulus, accompanied by a description of the relevant surrounding circumstances. Case reports make little attempt to screen out alternative causes for a patient's condition. They frequently lack analysis. And they often omit relevant facts about the patient's condition."); Meister v. Med. Eng'g Corp., 267 F.3d 1123, 1129 (D.C. Cir. 2001) (case reports cannot establish general causation); Caraker v. Sandoz Pharms. Corp., 188 F. Supp. 2d 1026, 1034 (S.D. Il. 2001) ("case reports do not provide reliable foundation for a causation opinion"); Brumbaugh v. Sandoz Pharm. Corp., 77 F. Supp. 2d 1153, 1156-57 (D. Mont. 1999) ("Correlation of two events in time does not necessarily establish causation. That is why anecdotal reports are not generally accepted as reliable scientific evidence to establish causation."); Saari v. Merck & Co., Inc., 961 F. Supp. 387, 394 (N.D.N.Y. 1997) (MedWatch reports are paricularly uileliable because they are merely a compilation of perceived patient reactions that "neither confir(m) nor den(y) that there is any relationship" between alleged 7 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 12 of 21. PageID #: 753 symptoms and a medication); Casey v. Ohio Med. Prods., 877 F. Supp. 1380, 1385 (N.D. Cal. 1995) ("case reports are not reliable scientific evidence of causation, because they simply describ( e) reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group; do not isolate and exclude potentially alternative causes; and do not investigate or explain the mechanism of causation"); see also Allson v. McGhan Med. Corp., 184 F.3d 1300, 13 16 (lIth Cir. 1999); Richardson v. Richardson-Merrell, Inc., 649 F. Supp. 799, 801 n.5 (D.D.C. 1986), aff'd, 857 F.2d 823 (D.C. Cir. 1988), cert. denied, 493 U.S. 882 (1989) (AERs "are neither exceptions to the hearsay rule nor data reasonably relied upon by experts in the field of making determinations of causality."). The FDA likewise recognizes the inherent pitfalls associated with considering adverse event reports as evidence of causation: (O)ne or even many reports of adverse reactions often do not provide sufficient information to confirm that a drug caused the reaction. A reaction may be caused by the suspect drug, another drug that a patient is taking, or the underlying diseases for which the drug was prescribed; it may also be entirely coincidentaL. Dr. Gerald Faich, Adverse Drug Reaction Monitoring, New Eng. J. Med. 314(24) 1589, 1591 (1986); see also In re Bayer AG Sees. Litig., No. 03-Civ-1546, 2004 WL 2190357, at *9 (S.D.N.Y. Sept. 30, 2004) (AERs "may not establish a nexus between a drug and the reported illness") (citing 21 C.F.R. § 3 14.80(a) (2006)). The FDA also cautions against drawing any inference of causation from a count of the number of reports: "For postmarketing reporting, the impetus for reporting, the frequency with which a suspected adverse reaction is reported, and the number of exposures to the drug compared to the number of suspected reactions reported are unkown, making estimation of incidence calculations diffcult." 71 Fed. Reg. 3922, 3950 (Jan. 24, 2006). Indeed, the FDA 8 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 13 of 21. PageID #: 754 views post-marketing reports as "quite subjective and imprecise." See Food and Drug Administration, The Clinical Impact of Adverse Event Reporting at 5 (Oct. 1996), available at http://ww.fda.gov/downloads/Safety/MedWatchlCMI68505.pdf (1ast visited Aug. 13,2010). Thus, Plaintiff cannot create a fact issue with the RemicadeCI waring by attaching or otherwise referencing inadmissible adverse event reports as proof of a causal connection or adverse event frequency - especially without expert support as discussed above. Nor can Plaintiff create a fact issue by claiming that the warning "assures" there is no causal connection when it justifiably states that causation simply cannot be established because of shortcomings inherent to the reports. Accordingly, Defendants warned of the potential risk of Plaintiffs alleged condition - interstitial pneumonitis - in a manner consistent with their regulatory obligations and legal precedent. C. RemicadeCI's infectious pneumonia and interstitial pneumonia warnings are consistent with Defendants' arguments concerning the adequacy and reasonableness of the warnings given to Plaintiff. Plaintiff misses the point when he states that Defendants argue that infectious pneumonia discussed in the RemicadeCI label is the same as the "non-infectious" interstitial pneumonia he contracted. Opp. at 3, 17-18. Defendants never made such a statement. Defendants' point, rather, is that Dr. Slee's warning to Plaintiff - a risk of death from pneumonia - constitutes a reasonable warning under Ohio law. Dr. Slee testified that it is "well known" that interstitial pneumoma, including eosinophilic pneumonia, can be caused by an allergic reaction or infection.6 Motion at 7. Plaintiff does not dispute that he accepted the risk of pneumonia prior to receiving RemicadeCI. Motion at 8; Opp. at 10. Thus, Plaintiff essentially claims that he assumed the risk of death from 6 Once again, Plaintiff cites to Dr. Slee's testimony to support a proposition that is exactly the opposite of what he said. See Opp. at 7-8, claiming that NILD is not caused by infection. 9 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 14 of 21. PageID #: 755 interstitial pneumonia of infectious etiology (the greater risk as evidenced by Defendant's black box pneumonia warning), but did not assume such a risk from interstitial pneumonia of autoimmune etiology. To allow Plaintiffs warning claims to proceed under this novel theory would indeed transfer the analysis of an adequate waring from a focus on the potential side effect to its etiology. There simply is no precedent for this in Ohio. Finally, Plaintiffs portrayal of various physicians being deceived by RemicadeCI's labeling while attempting to diagnose his condition is an inaccurate, completely unsupported, premature, red-herring issue. These physicians do not operate in a vacuum, completely isolated from any source of information beyond the RemicadeCI label, as described by Plaintiff. Plaintiff provides no evidence whatsoever about what these doctors knew, said, or consulted. Even if Plaintiffs story were true, it does not have any bearing on what Plaintiff and Dr. Slee discussed and knew at the time Plaintiff was treated with RemicadeCI, and is therefore irrelevant to the issues ripe for decision in Defendants' Motion. V. PLAINTIFF'S FRAUD CLAIM FAILS BECAUSE THE SINGLE FRAUDULENT ACT HE ALLEGES is REFUTED BY THE EVIDENCE. NO OTHER EVIDENCE OF FRAUD is PRESENTED. AND IT is ABROGATED BY THE OPLA. In support of his fraud claim, Plaintiff merely cites to his Complaint - as he did at his deposition and in his discovery responses. Federal Rule of Civil Procedure 56(e)(2), however, requires a party opposing summar judgment to respond beyond a reliance on his own pleadings and to set forth specific facts showing a genuine issue for triaL. Nonetheless, even Plaintiffs reference to his pleadings demonstrates there is no genuine issue of material fact to support his fraud claim. Specifically, he states that Defendants "failed to disclose the fact that NILD was a known adverse reaction to RemicadeCI therapy." This fact, however, is refuted by the evidence. As explained above, Defendants did in fact warn of NILD when they disclosed the risk of interstitial pneumonitis. See p. 5, supra, showing how Plaintiff 10 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 15 of 21. PageID #: 756 treats the RemicadeCI label's interstitial pneumonitis discussion as a statement about NILD. In response to Defendants' criticism of the lack of detail in Plaintiffs Complaint, Plaintiff claims that he pleaded fraud with paricularity, and provides no other specific facts to support this claim. Missing from his pleadings and Opposition, however, are any allegations of specific fraudulent conduct, including specifically who was involved, where it occurred, when it occurred, or how it occurred. Indeed, Plaintiff was provided with hundreds if not thousands of documents from Defendants and Dr. Slee, and still canot show one instance of fraudulent conduct. This is not surprising, as Plaintiff testified that he could not even remember discussing RemicadeCI with Dr. Slee and had no support for fraud outside the allegations of his Complaint. Motion at 20-22, 24. Finally, Plaintiffs fraud claim is abrogated by the OPLA. Defendants did not previously move to dismiss Plaintiff s fraud claim on this basis because of prior negative precedent. However, two Northern District of Ohio decisions made available after Defendants had researched this issue indicate that fraud claims may be abrogated by the OPLA. See FN 7 and abrogation discussion, pp. 11-13, infra. For all of the above reasons, including those set forth in Defendants' Motion, Plaintiffs fraud claim fails as a matter of law. VI. PLAINTIFF'S "CIVIL CONSPIRACY AND COMMERCIAL BRIBERY" CLAIM FAILS BECAUSE PLAINTIFF HAS NOT ALLEGED THE BASIS OR PROVIDED EVIDENTIARY SUPPORT FOR THIS CLAIM. AND IT is ABROGATED BY THE OPLA. A. Plaintiff's failure to sufficiently allege and support "civil conspiracy and commercial bribery" As with his fraud claim, Plaintiff fails to specifically identify the basis or provide evidentiary support for his "civil conspiracy and commercial bribery" claim. He does not identify who the conspirators are, what they did, where, when, how, etc. Instead, Plaintiff 11 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 16 of 21. PageID #: 757 merely quotes his ambiguous "commercial bribery" allegations from his Complaint. Opp. at 27. Plaintiff further confuses the issue by claiming that Defendants' warnings are "one viable basis" for this claim, while failing to plead in his Complaint or evidence in his Opposition how this is so. Id. at 28. Defendants still cannot make any sense out of this claim, and their Motion has not prompted any futher evidence or explanation from Plaintiff. Consequently, Defendants reiterate that Plaintiffs pleadings are deficient because of his failure to plead and support (1) the "independent unlawful act or tort" forming the basis for this claim, and (2) a cause of action for "commercial bribery" in Ohio that can serve as the requisite unlawful act for a civil conspiracy claim. To the extent the unlawfl act is one of the causes of action forming Plaintiff s Complaint, Defendants request sumary judgment because these claims fail as a matter of law and therefore cannot support a civil conspiracy cause of action. B. Abrogation by the OPLA Plaintiff claims that his civil conspiracy and commercial bribery claim is not abrogated by the OPLA because it "arises out of the fraudulent actions of Defendants relating to RemicadeCI." Opp. at 29, citing CCB Ohio LLC v. Chemque Inc., 49 F.Supp.2d 757, 763-64 (S.D. Ohio 2009). In this Court, however, a common law product liability claim involving fraud may be abrogated by the OPLA. Two recent decisions7 seem to endorse, without qualification, abrogation of any common law product liability claim. See Crisp v. Stryker Corp., 2010 WL 2076796, *1 FN4, *3 (N.D. Ohio, May 21, 2010) (dismissing seven common law product liability claims, including Fraudulent Concealment, Fraudulent Misrepresentation, and Fraud and Deceit, with opportunity to replead, if possible, under an appropriate section of the OPLA); 7 Neither of these two decisions were made available on Westlaw when Defendants researched and briefed their Motion. Westlaw confirmed that Crisp was made available on May 27, 201O,just four days before Defendants filed their Motion, and after Defendants had researched the issue ofOPLA abrogation. See Email from Westlaw, attached as Exh. A. 12 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 17 of 21. PageID #: 758 Friedman v. Intervet Inc., 2010 WL 2817257, *6 (N.D. Ohio, July 16, 2010) ("To be sure, the OPLA preempts all claims that might arise under Ohio common law and statutes."); compare Boroffv. Alza Corp., 2010 WL 395211, *7 (N.D. Ohio) (finding fraudulent misrepresentation claim not abrogated, but citing support from 1998 case that analyzed pre-2005 version of the OPLA), with Miles v. Raymond Corp., 612 F.Supp.2d 913, 923, FN8 (N.D. Ohio 2009) (disapproving reliance on any case that considered prior versions of the OPLA). Defendants contend that the OPLA is clear, contains no qualifications, and hails from a legislative history in which it has been redrafted to be more inclusive in response to judicial limitation. See Miles, 612 F.Supp.2d at 920 ((T)he language of § 2307.71(B) clearly proclaims the legislature's specific intention to eliminate common law product liability causes of action. ... (It) provides a clear and unequivocal statement of the legislature's intent, which must be given effect.). Therefore, the OPLA should abrogate Plaintiffs civil conspiracy and commercial bribery claim regardless of the underlying theory from which Plaintiff claims it arises. Lastly, even if certain common law claims are not abrogated by the statute, Plaintiffs claim should be abrogated because the alleged underlying fraudulent conduct is based on the propriety of Defendants' warnings. See p.10, supra. Under Ohio law, the substance ofthe claim, not the manner in which it is pleaded, determines how it is treated. Miles, 612 F.Supp.2d at 921. Thus, Plaintiff s bald allegations of an "intent to mislead" cannot turn a failure to warn claim into common law fraud. Accordingly, Plaintiffs civil conspiracy and commercial bribery claim amounts to an inadequate warning claim abrogated by the OPLA. VII. PLAINTIFF DOES NOT DISPUTE DEFENDANTS' REQUEST FOR SUMMARY JUDGMENT AS TO PLAINTIFF'S DESIGN DEFECT AND FAILURE TO CONFORM CLAIMS. F or the reasons stated in Defendants' Motion, and because Plaintiff has presented no opposition, Defendants respectfully request summary judgment on Plaintiffs design defect and 13 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 18 of 21. PageID #: 759 failure to conform claims. VIII. CONCLUSION For the reasons stated above and presented in Defendants' Motion, Defendants respectfully request judgment, or dismissal (as appropriate), in their favor as to all of Plaintiffs claims. Isl Justin E. Rice Edward E. Taber (0066707) edward. taberêtuckerellis. com Justin E. Rice (0080587) j ustin.riceêtuckerells. com Tucker Ellis & West LLP 1150 Huntington Building 925 Euclid Avenue Cleveland, OH 44115-1414 Telephone: 216.592.5000 Facsimile: 216.592.5009 Attorneys for Defendants Centocor Ortho Biotech Inc., Johnson & Johnson, and Ortho- McNeil-Janssen Pharmaceuticals, Inc. 14 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 19 of 21. PageID #: 760 LOCAL RULE 7.1(F) CERTIFICATION I certify that that this case has been assigned to the complex track and that it adheres to the page limitations set forth in LR 7.1(f), as modified by this Court in its February 2, 2010 entry. Isl Justin E. Rice Edward E. Taber (0066707) edward. taberêtuckerellis.com Justin E. Rice (0080587) justin.riceêtuckerellis.com Tucker Ells & West LLP 1150 Huntington Building 925 Euclid Avenue Cleveland, OH 44115-1414 Telephone: 216.592.5000 Facsimile: 216.592.5009 Attorneys for Defendants Centocor Ortho Biotech Inc., Johnson & Johnson, and Ortho- McNeil-Janssen Pharmaceuticals, Inc. 15 Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 20 of 21. PageID #: 761 CERTIFICATE OF SERVICE I hereby certify that on August 13, 2010 a copy of the foregoing Defendants Centocor Ortho Biotech Inc., Johnson & Johnson, and Ortho-McNeil-Janssen Pharmaceuticals, Inc.'s Reply to Plaintifts Opposition to Defendants' Motion for Summary Judgment was filed electronically. Notice of this fiing wil be sent to all parties by operation of the Court's electronic filing system. Parties may access this filing through the Court's system. Isl Justin E. Rice Edward E. Taber (0066707) edward. taber(ituckerellis.com Justin E. Rice (0080587) j ustin.rice(ituckerells. com Tucker Ellis & West LLP 1150 Huntington Building 925 Euclid Avenue Cleveland, OH 44115-1414 Telephone: 216.592.5000 Facsimile: 216.592.5009 Attorneys for Defendants Centocor Ortho Biotech Inc., Johnson & Johnson, and Ortho- McNeil-Janssen Pharmaceuticals, Inc. 16 1 1 52469.i Case: 3:09-cv-00721-JGC Doc #: 39 Filed: 08/13/10 21 of 21. PageID #: 762