IN RE: Trasylol Products Liability Litigation

MOTION in Limine to Exclude Evidence and Argument Regarding Alleged Off-Label Promotion of Trasylol

S.D. Fla.February 16, 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: Anna Bryant v. Bayer Corp. et al., Case No. 9:08-cv-80868 Melissa Morrill v. Bayer Corp. et al., Case No. 9:08-cv-80424 Naguib Bechara, et al., v. Bayer Corp., et al., Case No. 9:08-cv-80776 ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) DEFENDANTS’ MOTION IN LIMINE TO EXCLUDE EVIDENCE AND ARGUMENT REGARDING ALLEGED OFF-LABEL PROMOTION OF TRASYLOL Defendants move in limine to request that plaintiffs be precluded from offering evidence, testimony, or argument about alleged “off-label” promotion of Trasylol for surgeries that have no bearing on the “on-label” surgeries at issue in these cases. See Fed. R. Evid. 401- 403. INTRODUCTION Bayer anticipates that plaintiffs will seek to spend a significant amount of time at trial addressing Bayer’s supposed promotion of Trasylol for various “off-label” uses (such as orthopedic surgery) or the extent of off-label usage of Trasylol—both of which have no bearing on the “on-label” use at issue in these cases. The term “off-label” use refers to a prescribing physician’s decision to use an FDA-approved pharmaceutical for an indication not identified in the product’s FDA-approved Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 1 of 9 2 labeling. Under federal law, the FDA generally prohibits manufacturers from promoting unapproved uses of prescription drugs, but does not restrict actual off-label uses by health care providers as part of the practice of medicine. See, e.g., Ortho Pharm. Corp. v. Cosprophar, Inc., 32 F.3d 690, 692 (2d Cir. 1994) (“FDA permits doctors to prescribe drugs for ‘off-label use”); WLF v. Kessler, 880 F. Supp. 26, 28 n.1 (D.D.C. 1995) (“‘Off-label’ usage refers to the use of a drug or device in a manner not approved by the FDA and not set forth in the product’s labeling materials. While manufacturers may not themselves promote such uses, it is not unlawful for doctors to employ or prescribe medical products for ‘unapproved’ uses”) (internal quotation omitted); see generally Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (“‘off-label’ usage of medical devices (use of a device for some other purpose than that for which it has been approved by the FDA) is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine”).1 FDA has, however, crafted safe-harbors for manufacturers to disseminate information about off- label uses of approved pharmaceuticals. These include continuing medical education, reprints of medical or scientific articles, non-promotional scientific exchange, and responses to unsolicited requests for off-label information. Issues of off-label use and promotion are not at issue in these cases. At the time of each of these surgeries, FDA had approved Trasylol for use in “patients undergoing cardiopulmonary bypass [‘CPB’] in the course of coronary artery bypass graft surgery [‘CABG’].” Trasylol U.S. Package Insert (Jan. 2003) (Ex. A). Each of the plaintiffs in these 1 Provided that a medical professional complies with state law medical practice standards— including the use of due care—he or she may depart from the uses set forth in the FDA-approved labeling. Indeed, off-label uses can even represent the standard of care in various medical fields. See, e.g., 63 Fed. Reg. 31143, 31153 (June 8, 1998) (“FDA has long recognized that in certain circumstances, new (off-label) uses of approved products are appropriate, rational, and accepted medical practice. There are important off-label uses of approved products.”). Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 2 of 9 3 cases was treated with Trasylol for this purpose.2 Plaintiff Anna Bryant underwent CABG surgery with CPB in March 2006. See Bryant Compl. ¶ 23. William Morrill, plaintiff’s decedent in the Morrill action, underwent CABG surgery with CPB in October 2003. See Morrill Compl. ¶ 16; Deposition of Dr. Thomas Kelly at 55-57 (Ex. B). Plaintiff Naguib Bechara underwent CABG surgery with CPB in December 2004. See Bechara Compl. ¶ 4; Deposition of Dr. Thomas Pfeffer at 37 (Ex. C). Thus, these cases involve “on-label” uses. ARGUMENT Even though there was no off-label use of Trasylol at issue in these cases, it appears that plaintiffs intend to present evidence and argument regarding off-label use and supposed off-label promotion of Trasylol. See, e.g., Plaintiff Anna Bryant’s Designation of Case-Specific Exhibits (D.E. 4150), Schedule B, No. 77 (exhibit related to the use of Trasylol in liver transplant surgery); id., No. 297 (emails concerning research on Trasylol off-label use in CABG surgery without CPB). Any such evidence or argument should be precluded. First, evidence or argument about off-label promotion or use of Trasylol is wholly irrelevant to the on-label issues in these cases. See Fed. R. Evid. 401-402. Plaintiffs’ claims do not arise from off-label use of Trasylol, but from surgeries in which Trasylol was used within the approved labeling. Nevertheless, plaintiffs’ designations and questions at depositions suggest that they may seek to present argument and evidence regarding various off-label uses and supposed off-label promotion of Trasylol that have no bearing on the on-label uses at issue in these cases. Any argument that Bayer promoted Trasylol for off-label uses, or evidence 2 In addition to its FDA-approved usage, as part of the practice of medicine, surgeons have used Trasylol in procedures for which it was not labeled, such as orthopedic surgeries, aortic valve replacement surgeries, and CABG surgery without cardiopulmonary bypass (“off-pump” CABG). None of these uses is implicated here. Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 3 of 9 4 purportedly in support of such arguments, has no relevance to plaintiffs’ claims and should not be allowed. Fed. R. Evid. 402. Second, evidence or argument about off-label use or supposed off-label promotion of Trasylol would mislead the jury and confuse the issues by suggesting, contrary to the evidence, that these cases involve off-label use or that plaintiffs’ physicians were influenced by marketing or promotional materials that have nothing to do with these on-label cases. A detour on such irrelevant matters would expend considerable Court and jury time not only in considering plaintiffs’ affirmative presentation, but also in light of the legal and factual context Bayer would then be required (and entitled) to present in response. Especially in view of the limits of the trial calendar, there is no justification for spending this time and effort on irrelevant, collateral matters. It is clear that plaintiffs seek to argue about alleged off-label promotion and usage only to try to suggest that Bayer violated federal law addressing what companies may say about so-called “off-label” uses of their products or otherwise to intimate that Bayer was engaged in inappropriate conduct. See generally American Home Assurance Co. v. Merck & Co., 462 F. Supp. 2d 435, 446 (S.D.N.Y. 2006) (excluding evidence regarding conduct by Merck not at issue in the case because “the only possible purpose for offering such evidence would be to generally prejudice the fact finder against Merck through insinuations that it is a careless corporate citizen.”). For example, at depositions, plaintiffs’ counsel have asked questions about the extent of Bayer’s knowledge of off-label use and tried to imply that there is something wrong with the extent of that use. Not only is this entire line of evidence and argument completely irrelevant to these cases, but it also would waste an enormous amount of time and inevitably confuse the jury and cause unfair prejudice to Bayer. Accordingly, it should be excluded. Fed. R. Evid. 403. Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 4 of 9 5 CONCLUSION For these reasons, defendants request that the Court preclude plaintiffs from offering evidence, testimony, or argument relating to any alleged off-label promotion or usage of Trasylol. 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 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. February 16, 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 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 Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 5 of 9 6 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: 312-853-7036 Rebecca K. Wood Email: rwood@sidley.com Richard H. Menard, Jr. Email: rmenard@sidley.com Adam C. Doverspike Email: adoverspike@sidley.com SIDLEY AUSTIN LLP 1501 K Street, NW Washington, DC 20005 Telephone: 202-736-8000 Facsimile: 202-736-8711 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 SEAMANS CHERIN & MELLOTT, LLC USX Tower, 600 Grant St., 44th Floor Pittsburgh, PA. 15219 Telephone: 412-566-6000 Facsimile: 412-566-6099 Attorneys for Bayer Corporation, Bayer HealthCare Pharmaceuticals Inc., and Bayer Schering Pharma AG Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 6 of 9 7 CERTIFICATE OF SERVICE I hereby certify that on February 16, 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-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 7 of 9 8 SERVICE LIST In re Trasylol Products Liability Litigation – MDL-1928 Case No. 08-MD-1928-MIDDLEBROOKS/JOHNSON 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.com 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 and Counsel for Plaintiff Anna Bryant Joseph A. Osborne Email: jaosborne@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 Counsel for Plaintiffs Bechara & Saad David Matthews Email: dmatthews@thematthewslawfirm.com MATTHEWS & ASSOCIATES 2905 Sackett Street Houston, TX 77098 Telephone: 713-222-8080 Facsimile: 713-535-7184 Attorneys for Plaintiff Anna Bryant Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 8 of 9 9 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 Michael T. Gallagher Email: rebeccam@gld-law.com THE GALLAGHER LAW FIRM 2095 Sackett Street Houston, TX 77098 Telephone: 713-222-8080 Facsimile: 713-222-0066 Counsel for Plaintiff Naguib Bechara 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 Tim K. Goss Email: goss39587@aol.com Tamara L. Banno Email: tbanno@tlb-law.com FREESE &GOSS PLLC 3031 Allen Street Suite 100 Dallas, TX 75204 Telephone: 214-761-6610 Facsimile: 214-761-6688 Counsel for Plaintiff Naguib Bechara Case 9:08-cv-80868-DMM Document 123 Entered on FLSD Docket 02/16/2010 Page 9 of 9