IN RE: Trasylol Products Liability Litigation

MOTION for Summary Judgment and Supporting Memorandum of Law

S.D. Fla.January 22, 2010

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Case No. 1:08-MD-01928-MIDDLEBROOKS/JOHNSON IN RE TRASYLOL PRODUCTS LIABILITY LITIGATION - MDL-1928 This Document Relates to: Melissa Morrill, as personal representative of the Estate of William Cyrus Morrill, III, v. Bayer Pharmaceutical Corp., et al., Case No. 9:08-cv-80424 _____________________________________/ DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT AND SUPPORTING MEMORANDUM OF LAW PLEASE TAKE NOTICE that Defendants Bayer HealthCare Pharmaceuticals Inc. (as successor in interest to Bayer Pharmaceutical Corporation, Bayer HealthCare LLC), Bayer AG, and Bayer Schering Pharma AG (as successor in interest to Bayer Healthcare AG) move for summary judgment on all claims asserted in Plaintiff’s Second Amended Complaint due to plaintiff’s failure to come forward with evidence establishing a genuine issue of material fact as to whether Trasylol caused Decedent’s death. MEMORANDUM OF LAW William Morrill died from ventricular fibrillation and cardiomyopathy just days after suffering a massive heart attack and undergoing his second coronary artery bypass graft surgery (“CABG”) accompanied by a high-risk transmyocardial laser revascularization procedure (“TMR”). Despite the heart attack and subsequent high-risk surgery and despite Mr. Morrill’s pre-existing coronary artery disease, abnormal heart rhythm, chronic obstructive Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 1 of 10 2 pulmonary disease, cirrhosis of the liver, and tobacco abuse, plaintiff Melissa Morrill claims that Trasylol caused Mr. Morrill’s death. Bayer is entitled to summary judgment because plaintiff has no admissible evidence of causation. Bayer already has demonstrated that the opinion of plaintiff’s hired expert must be excluded because the opinion conflicts with Mr. Morrill’s medical records and is not supported by a differential diagnosis. See Bayer’s Motion To Exclude Plaintiff’s Case- Specific Causation And Damages Experts And Memorandum Of Law In Support (the “Daubert Motion”) (Docket Entry 71). Plaintiff has no other evidence of causation. Because proof of causation is an essential element of all of plaintiff’s claims, the Court should dismiss with prejudice plaintiff’s case. BACKGROUND Defendants incorporate by reference pages 2 through 8 of their Daubert Motion, detailing Mr. Morrill’s medical history and Trasylol use. See Daubert Mot. (D.E. 71) at 2-8. SUMMARY JUDGMENT STANDARD Summary judgment should be granted where there is no genuine issue of material fact for trial. Celotex v. Catrett, 477 U.S. 317, 330 (1986); Zivojinovich v. Barner, 525 F.3d 1059, 1066 (11th Cir. 2008). If a plaintiff has no competent evidence to establish an element of her prima facie case, defendants are entitled to summary judgment. Haller v. Astrazeneca Pharms. LP, 598 F. Supp. 2d 1271, 1306 (M.D. Fla. 2009); Colville v. Pharmacia & Upjohn Co., LLC, 565 F. Supp. 2d 1314, 1319 (N.D. Fla. 2008). “Conclusory allegations, evidence that is not significantly probative, and personal opinions will not suffice to defeat a motion for summary Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 2 of 10 3 judgment.” Haller, 598 F. Supp. 2d at 1274; Johnson v. Fleet Fin., Inc., 4 F.3d 946, 949 (11th Cir. 1993). ARGUMENT This case cannot go to trial because plaintiff has no admissible evidence of causation. Plaintiff’s Amended Complaint (D.E. 2-2) asserts four causes of action for wrongful death: (1) negligence; (2) strict liability design defect; (3) strict liability failure to warn; and (4) negligent misrepresentation. Each of these claims requires proof of causation-in-fact. See Rink v. Cheminova, Inc. 400 F.3d 1286, 1295 (11th Cir. 2005) (all products liability claims require proof of causation); accord Allison v. McGhan Med. Corp., 184 F.3d 1300, 1322 (11th Cir. 1999) (negligence); Wolicki-Gables v. Arrow Int’l, Inc., 641 F. Supp. 2d 1270, 1287-88 (M.D. Fla. 2009) (negligence); Colville, 565 F. Supp. 2d at 1320 (strict products liability, design defect, and failure to warn); Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1374 (S.D. Fla. 2007) (negligent misrepresentation). To establish causation-in-fact, plaintiff must prove that “but for” the defendant’s alleged misconduct, plaintiff’s injury would not have occurred. Rink, 400 F.3d at 1295; Christopher v. Cutter Labs., 53 F.3d 1184, 1191 (11th Cir. 1995); Haller, 598 F. Supp. 2d at 1303-1304; Colville, 565 F. Supp. 2d at 1322; Jones v. Utica Mut. Ins., 463 So.2d 1153, 1156 (Fla. 1985). In a products liability action involving a prescription medication, plaintiff must offer expert testimony to establish causation. McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1237 (11th Cir. 2005) (“[t]his type of proof [i.e., specific causation] requires expert testimony”); Kilpatrick v. Breg, Inc., No. 08-10052-CIV, 2009 WL 2058384, at *11 (S.D. Fla. June 25, 2009) Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 3 of 10 4 (J. Moore) (“[i]n the absence of any reliable expert evidence on causation, summary judgment must be granted in favor of [defendant]”). Here, plaintiff has no admissible expert testimony that Trasylol caused Mr. Morrill’s death. Neither of Mr. Morrill’s treating physicians opines that Trasylol caused Mr. Morrill’s death. To the contrary, Mr. Morrill’s cardiac surgeon, Dr. Thomas Kelly, opined that Trasylol did not contribute to Mr. Morrill’s myocardial infarction and arrhythmias that caused his death. Deposition of Thomas Kelly, M.D. (“Kelly Dep.”) (Ex. A) at 8:18-9:11, 86:2-19; see also id. at 83:1-85:10. Instead, Dr. Kelly determined that Mr. Morrill’s postoperative myocardial infarction and ventricular fibrillation (leading to his death) were caused by cardiomyopathy and damage to the heart muscle from the TMR procedure, which necessarily involves damage and death to heart muscle. Id. at 84:16-85:10; see also id. at 86:1-19, 88:10-25. Mr. Morrill’s medical records show that Dr. Kelly and Mr. Morrill’s cardiologist, Dr. Michael Barron, considered several other conditions to be more likely than Trasylol as the cause of Mr. Morrill’s death. These include the risks inherent in a re-do CABG surgery and the TMR procedure, Mr. Morrill’s pre-existing ischemia and myocardial infarction, and his extensive history of significant medical problems, including chronic alcoholism. See id. at 26:20-28:15, 84:16-85:10, 86: 2-19, 88:10-25 (cardiac surgeon, Dr. Kelly); SMH Med. R. (Ex. B) at 763-66 (cardiologist, Dr. Barron). Dr. Kelly’s report after the surgery stated that Mr. Morrill was at high risk of complications due to portal hypertension with left ventricular dysfunction, low ejection fraction (creating a “very weak heart”), chronic obstructive pulmonary disease, hypertension, cirrhosis, and the fact that it was Mr. Morrill’s second CABG surgery. Kelly Dep. (Ex. A) at 80:12-82:1. The autopsy revealed a “large and extensive” myocardial infarction, established cirrhosis, an enlarged spleen, congestive heart failure, a heart more than double the size of a normal heart, and native coronary arteries with extensive arthrosclerosis of nearly 100% Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 4 of 10 5 in some areas. SMH Med. R. (Ex. B) at 976-80 (Autopsy Rep.). Plaintiff conceded that she did not recall anyone ever telling her that Mr. Morrill’s death was caused by or even related to Trasylol. Deposition of Melissa Morrill (Ex. C) at 26:10-22, 27:14-28:5, 202:4-12, 216:21- 217:2. Thus, plaintiff’s causation case rests entirely on the testimony of her hired expert, nephrologist Marc Weinberg, M.D., who proposes a novel theory of causation: Trasylol caused a blood clot to form in Mr. Morrill’s bypass graft, which restricted blood flow to his heart muscle, which in turn caused infarction (death of heart muscle), which caused ventricular fibrillations and arrhythmias, which led to his death. Deposition of Marc Weinberg, M.D. (“Weinberg Dep.”) (Ex. D) at 172:15-20, 174:20-175:3, 202:9-17. This theory is directly contradicted by Mr. Morrill’s autopsy report, which includes an explicit finding of no blood clots in Mr. Morrill’s bypass grafts aside from clots that formed after his death. SMH Med. R. (Ex. B) at 976-80 (Autopsy Rep.). Bayer demonstrated in its Daubert brief that a causation opinion that conflicts with the actual medical record is unreliable and should not be presented to a jury. See Daubert Mot. (D.E. 71) at 13-15. Bayer further demonstrated that Dr. Weinberg’s opinion is inadmissible under Daubert because: (1) as a nephrologist, Dr. Weinberg is not qualified to opine about Mr. Morrill’s cardiac-related death; (2) Dr. Weinberg failed to review important medical records; and (3) Dr. Weinberg failed to consider and rule out other more likely causes of Mr. Morrill’s death. Id. at 11-20. Indeed, Dr. Weinberg admitted that he was unable to rule out Mr. Morrill’s pre- existing conditions and other known risk factors as the cause of his death; nor has Dr. Weinberg tried to assess quantitatively the role of these other causes, as the law requires. Weinberg Dep. (Ex. D) at 72:17-22, 116:7-17, 165:4-14, 170:15-25. See McClain, 401 F.3d at 1253; Allison, 184 F.3d at 1322; Hendrix v. Evenflo Co. Inc., 255 F.R.D. 568, 596 (N.D. Fla. 2009). Bayer’s Daubert Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 5 of 10 6 Motion discusses all of these deficiencies in detail and shows that Dr. Weinberg’s failure to follow scientific method requires exclusion of his opinion. See Daubert Mot. (D.E. 71) at 15-19. Without Dr. Weinberg, plaintiff has no medical evidence of causation. Where, as here, a plaintiff fails to provide admissible expert evidence that the medication at issue caused his or her injuries, the court must enter judgment in the defendant’s favor. See, e.g., Haller, 598 F. Supp. 2d at 1303 n.290 (exclusion of expert testimony is itself a basis for granting summary judgment because plaintiff is unable to establish specific causation); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1167 (S.D. Fla. 1996) (“[w]ithout this [expert] testimony, Plaintiff cannot establish a genuine issue of material fact as to causation, and Upjohn is entitled to summary judgment on this claim”); Chikovsky v. Ortho Pharm. Corp., 832 F. Supp. 341, 346 (S.D. Fla. 1993) (“[w]ithout [expert’s] testimony, the plaintiffs cannot establish a genuine issue of material fact as to causation,” which entitles the defendant “to summary judgment as a matter of law”). CONCLUSION Plaintiff’s “failure to proffer sufficient evidence of causation, an element critical to all of [her] claims, is necessarily fatal to [her] efforts to avoid summary judgment.” Kilpatrick, 2009 WL 2058384, at *11. This Court should enter judgment in Bayer’s favor as to each of the claims set forth in Plaintiff’s Second Amended Complaint. RULE 7.1(A)(3) CERTIFICATION As required by this Court’s Local Rule 7.1(A)(3)(a), counsel for defendants hereby certifies that counsel for the defendants has made reasonable efforts to confer in good Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 6 of 10 7 faith with counsel for all parties who may be affected by the relief sought in the motion, and has been advised that plaintiffs will contest this motion. January 22, 2010 Respectfully submitted, /s/ Barbara Bolton Litten Patricia E. Lowry Florida Bar No. 332569 E-mail: plowry@ssd.com Barbara Bolton Litten Florida Bar No. 91642 E-mail: blitten@ssd.com Guy E. Motzer Florida Bar No. 562467 Email: gmotzer@ssd.com SQUIRE SANDERS & DEMPSEY L.L.P. 1900 Phillips Point West 777 South Flagler Drive West Palm Beach, FL 33401-6198 Telephone: 561-650-7200 Facsimile: 561-655-1509 Philip S. Beck Email: philip.beck@bartlit-beck.com Steven E. Derringer Email: steven.derringer@bartlit-beck.com BARTLIT BECK HERMAN PALENCHAR & SCOTT LLP 54 W. Hubbard Street, Suite 300 Chicago, IL 60603 Telephone: 312-494-4400 Facsimile: 312-494-4440 Eugene A. Schoon Email: eschoon@sidley.com Susan A. Weber Email: saweber@sidley.com Catherine Valerio Barrad Email: cbarrad@sidley.com SIDLEY AUSTIN LLP One South Dearborn Street Chicago, Illinois 60603 Telephone: 312-853-7000 Facsimile: 312-853-73036 Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 7 of 10 8 Susan Artinian Email: sartinian@dykema.com Daniel Stephenson Email: dstephenson@dykema.com DYKEMA GOSSETT PLLC 400 Renaissance Center Detroit, MI 48243 Telephone: 313-268-9788 Facsimile: 313-568-6658 Richard K. Dandrea Email: rdandrea@eckertseamans.com ECKERT SEAMENS CHERIN & MELLOTT, LLC USX Tower, 600 Grant St., 44th Floor Pittsburgh, PA. 15219 Telephone: 412-566-6000 Facsimile: 412-566-6099 Attorneys for Bayer HealthCare Pharmaceuticals Inc., Bayer HealthCare LLC, Bayer AG, and Bayer Schering Pharma AG Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 8 of 10 9 CERTIFICATE OF SERVICE I hereby certify that on January 22, 2010, I electronically filed the foregoing document with the Clerk of the Court using CM/ECF. I also certify that the foregoing document is being served this day on all counsel of record or pro se parties identified on the attached Service List in the manner specified, either via transmission of Notices of Electronic Filing generated by CM/ECF or in some other authorized manner for those counsel or parties who are not authorized to receive electronically Notices of Electronic Filing. /s/ Barbara Bolton Litten Barbara Bolton Litten Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 9 of 10 10 SERVICE LIST In re Trasylol Products Liability Litigation - MDL-1928 Case No. 08-MD-1928-MIDDLEBROOKS/JOHNSON Case No. 9:08-cv-80424 Morrill v. Bayer Pharma. Corp. United States District Court Southern District of Florida James R. Ronca Email: jronca@anapolschwartz.com ANAPOL, SCHWARTZ, WEISS, COHAN, FELDMAN & SMALLEY, P.C. 1710 Spruce Street Philadelphia, PA 19103 Telephone: 215-790-4584 Facsimile: 215-875-7701 Co-Lead Counsel for Plaintiffs Scott A. Love Email: slove@triallawfirm. CLARK, DEAN & BURNETT, G.P. Lyric Center 440 Louisiana Street, Suite 1600 Houston, TX 77002 Telephone: 713-757-1400 Facsimile: 713-759-1217 Co-Lead Counsel for Plaintiffs Theodore Babbitt Email: tedbabbitt@babbitt-johnson.com BABBITT JOHNSON OSBORNE & LECLAINCHE, P.A. 1641 Worthington Road, Suite 100 West Palm Beach, FL 33409 Telephone: 561-684-2500 Facsimile: 561-684-6308 Liaison Counsel for Plaintiffs Neal L. Moskow Email: neal@urymoskow.com URY & MOSKOW, LLC 883 Black Rock Turnpike Fairfield, CT 06825 Telephone: 203-610-6393 Facsimile: 203-610-6399 Federal-State Liaison for Plaintiffs John D. Goldsmith Email: jgoldsmith@trenam.com Amy L. Drushal Email: aldrushal@trenam.com TRENAM KEMKER SCHARF BARKIN FRYE O'NEILL & MULLIS PA 101 E. Kennedy Blvd., Suite 2700 Tampa, FL 33602 Telephone: 813-223-7474 Facsimile: 813-229-6553 Counsel for Plaintiff Melissa Morrill Patricia E. Lowry Florida Bar No. 332569 Email: plowry@ssd.com SQUIRE, SANDERS & DEMPSEY L.L.P. 1900 Phillips Point West 777 South Flagler Drive West Palm Beach, FL 33401-6198 Telephone: 561-650-7200 Facsimile: 561-655-1509 Liaison Counsel for Defendants Case 9:08-cv-80424-DMM Document 74 Entered on FLSD Docket 01/22/2010 Page 10 of 10