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UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA IN RE: LEVAQUIN PRODUCTS LIABILITY LITIGATION, Case No.: MDL 08-1943-JRT

This document relates to: John Schedin v. Johnson & Johnson et al., No. 0:08 cv 5743 JRT

DEFENDANTS’ MOTION IN LIMINE TO EXCLUDE EVIDENCE REGARDING POST-2005 LEVAQUIN® LABELING

INTRODUCTION Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, LLC and Johnson & Johnson Pharmaceutical Research and Development LLC (collectively “Defendants”) submit this memorandum of law in support of their motion in limine to exclude: (1) evidence concerning Levaquin® labeling created, developed or in effect after Plaintiff last received the medicine in February 10, 2005; and (2) any arguments about labeling for Levaquin® that could have been implemented prior to February 10, 2005, which contradict express regulations and decisions made by the United States Food & Drug Administration (“FDA”). Defendants move to exclude all such evidence and arguments because they are irrelevant and inadmissible under the Federal Rules of Evidence and only can serve to confuse and mislead the jury, resulting in undue prejudice to Defendants.

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ARGUMENT Because “[t]he Federal Rules of Evidence govern the admissibility of evidence,” district courts are obligated to evaluate evidence under those rules. Wood v. Valley Forge Life Ins., 478 F.3d 941, 945 (8th Cir. 2007). The Federal Rules of Evidence require the exclusion of evidence concerning Levaquin® created, developed or in effect after February 10, 2005, and arguments that contradict express FDA decision making because: (1) such evidence and arguments are not relevant under Rules 401 and 402; (2) even if such evidence and arguments were relevant, any probative value is outweighed by the danger of unfair prejudice and confusion of the issues under Rule 403; and (3) such evidence and arguments relate to subsequent labeling that are inadmissible subsequent remedial measures under Rule 407. A.

Exclusion Pursuant to Rules 401 and 402 Pursuant to Rule 402, “[e]vidence which is not relevant is not admissible.” Fed.

R. Evid. 402 (2007). To be relevant, evidence must have “any tendency to make the existence of any fact that is of consequence to the determination of an action more probable or less probable than it would be without the evidence.” Fed. R. Evid. 401 (2007); see also Ahlberg v. Chrysler Corp., 481 F.3d 630, 632 (8th Cir. 2007); Skibniewski v. American Home Prods. Corp., 2004 WL 5628157, *4 (W.D.Mo. Apr. 1, 2004) (recognizing a pharmaceutical defendant’s assertion that “only the labeling in effect at the time of Plaintiff’s last prescription is relevant to the adequacy of the warnings” in granting its motion in limine to exclude labels not in effect at the time of 2 ND: 4820-9971-2519

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Plaintiff’s treatment). Any evidence concerning Levaquin® that post-dates Plaintiff’s last ingestion of the medicine – generated by Defendants or FDA – cannot and does not have any impact on the determination of any material issue in this case because post-ingestion evidence fails to make any consequential fact more or less probable. Thus, this evidence is not relevant under Rule 401 and must be excluded under Rule 402. From the time of its initial marketing in December of 1996, Levaquin® was subject to “class labeling” imposed by FDA for all fluoroquinolone antibiotics. (See http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandP roviders/ucm126085.htm; see also Blume Depo. at 33:18-20, 59:18-60:2, 164:7-16.)1 According to one of Plaintiff’s experts, because Levaquin® was subject to class labeling—without FDA’s prior approval or consent—the medicine’s prescribing information could not have been modified and was required to be identical to labeling FDA created for all fluoroquinolones. (Id. at 34:2-36:6, 169:2-19; see also http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116919.htm (“Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language.”)) As of September 2004, FDA had concluded that the “class labeling” for all fluoroquinolones had to state the following in the WARNINGS section of the labeling:

1

Excerpts from the deposition of Cheryl Blume are attached to the Affidavit of Tracy Van Steenburgh (“Van Steenburgh Aff.”) as Exhibit A. 3 ND: 4820-9971-2519

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Tendon Effects: Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulting in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concornitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin. (LEVP1256178)2 This labeling was based on available, reliable information and FDA concluded at the time that this information was adequate to demonstrate that Levaquin® was a safe and effective treatment when used in accordance with the FDA-approved labeling. (Id. at LEVP1256179.) And aside from a “black box” or “boxed warning,” the 2004 Levaquin® tendon warning was the most serious warning available to a manufacturer pursuant to FDA regulations. See 21 C.F.R. § 201.57(e) (1979-2006). This FDA-required labeling was the result of discussions between the agency and the different companies that marketed fluoroquinolones in the United States that started in October 2003. In this regard, in the Spring of 2004 FDA told Defendants that information from an epidemiology study supported by Defendants as well as analysis of several country-specific databases could not be included in the class labeling. This was the labeling in effect when the medicine was prescribed for Plaintiff by Dr. John Beecher in February 2005 and FDA did not request another change to the fluoroquinolone class labeling until May 2006. 2

A copy of document labeled LEVP1256177 - LEVP1256181 is attached to Van Steenburgh Aff. as Exhibit B. 4 ND: 4820-9971-2519

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Evidence concerning Levaquin® disseminated by Defendants after February 10, 2005, is not relevant because Plaintiff’s prescribing physician, Dr. Beecher, who Defendants were charged with warning, could not have seen such material prior to or while he was treating Plaintiff. As Dr. Beecher has testified, the November 2004 Levaquin prescribing information in the package insert (which contained the FDA’s September 2004 class labeling) was available to him when he prescribed Levaquin to Plaintiff. (Beecher Depo., 45:5-46:11, 13.)3 At the time Dr. Beecher decided to prescribe Levaquin®, Plaintiff had been experiencing a persistent respiratory infection, had successfully used Levaquin® in the past and had used Zithromax without success immediately prior to this office visit. (Id. at 27:5-23; 28:13-24.) Dr. Beecher testified he was aware of the risk of tendon rupture from the use of Levaquin® before he prescribed it to Plaintiff. (Id. at 44:4-10.) In addition, Dr. Beecher had prior experiences with Levaquin® therapy in treating other patients and believed the medicine had “value” for the patients to whom he prescribed it. (Id. at 17:18-23, 18:1-3.) Beyond speculation elicited by Plaintiff’s counsel, there is no evidence that Dr. Beecher’s decision-making would have been any different if he had reviewed Levaquin® information disseminated after February 10, 2005. Post-February 10, 2005, Levaquin labeling also is not relevant because warnings contained in labeling cannot be used to establish that a medicine caused an alleged injury.

3

Excerpts from the deposition of Dr. John Beecher are attached to Van Steenburgh Aff. as Exhibit C. 5 ND: 4820-9971-2519

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Thus, any subsequent Levaquin® labeling cannot be relevant to “medical causation” in this case. See 21 C.F.R. § 201.57(e) (“a causal relationship need not have been proved” for approval of a warning in prescribing information); Mensing v. Wyeth, Inc., 588 F.3d 603, 606 (8th Cir. 2009); Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 991 (8th Cir. 2001) (FDA actions may not be used as evidence of causation because “[t]he FDA evaluates pharmaceutical drugs using a different standard than the causation standard at issue in the present case[,]” and the FDA’s decision that a drug “can cause strokes is unreliable proof of medical causation in the present case because the FDA employs a reduced standard (vis-à-vis tort liability) for gauging causation when it decides to rescind drug approval.”); see also Paters v. AstraZeneca LP, 2007 WL 648188, at *4 (7th Cir. Jan. 17, 2007) (“Even if [warnings in a medicine’s package insert] were suggestive of a correlation between [the prescription medicine] and [the alleged injury] . . . a correlation alone is not evidence of causation.”); Lopez v. Wyeth-Ayerst Labs., Inc., 139 F.2d 905, at *2 (9th Cir. 1998) (FDA-required warning could not “be relied upon as evidence of causation.”); Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672, 683 (W.D. Tex 2002) (same). In addition, subsequent Levaquin® information is not relevant to the adequacy of earlier warnings because the adequacy of labeling is based on what is known or knowable at the time particular label warnings were prepared. Karjala v. Johns-Manville Prods. Corp., 523 F.2d 155, 159 (8th Cir. 1975) (to establish a failure to warn claim, Plaintiff must prove that defendant “the manufacturer has failed to give adequate warnings of 6 ND: 4820-9971-2519

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known or knowable dangers”). Moreover, Plaintiff cannot, under Rules 401 and 402, use subsequent information to establish what Defendants knew or should have known before February 2005. See In re Viagara Prods. Liab. Litig., 658 F. Supp. 2d 950, 966 (D. Minn. 2009) (letters FDA sent to a pharmaceutical manufacturer regarding advertisements that did not contain certain risk information for a medicine were irrelevant because the advertisements were not released until after Plaintiffs stopped taking the medicine); Toole v. McClintock, 999 F.2d 1430, 1434 (11th Cir. 1993) (FDA report issued years after Plaintiff’s alleged injury was “irrelevant and inadmissible on what [the manufacturer] knew or should have known about the risks before”); Arnold v. Riddell, Inc., 882 F. Supp. 979, 993 (D. Kan. 1995) (video made six years after Plaintiff’s injury “was not relevant as evidence of warnings available . . . or community expectations” at the time of Plaintiff’s injury). Finally, Plaintiff agrees that Levaquin® information after 2005 is not relevant to this case. In opposing Defendants’ motion to exclude one of his experts, Plaintiff acknowledges that Levaquin® information from 2006 and 2007 is irrelevant because it occurs “long after” the important dates in this litigation. (Pl.’s Opp. re Blume at 18.) Moreover, Plaintiff has acknowledged that his “warnings” expert is not going to testify that Defendants should have implemented a “boxed warning” sooner. (Id. at 42). These pre-trial admissions should preclude Plaintiff from offering post-2005 labeling at trial. See C.H. Robinson Worldwide, Inc. v. Ghirardelli Chocolate Co., 2005 WL 1432199,

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at*2 (D. Minn. May 23, 2005) (proposed witnesses could not offer expert opinions because of earlier concession to limit witnesses’ testimony). 1.

Arguments About Proposed Actions Defendants Should Have Taken That Violate FDA Regulations Are Not Relevant

FDA deemed Defendants’ warning to be adequate as of September 2004 and made no requests for changes in the class labeling for fluoroquinolones until May 2006. Defendants anticipate, however, that Plaintiff will argue that the “boxed warning” label change required by FDA in July 2008 for all fluoroquinolones should have been implemented prior to February 2005. Because this claim contradicts express FDA regulations and specific FDA decisions regarding the labeling for all fluoroquinolones including Levaquin®, the change could not have been implemented by Defendants. Therefore, Plaintiff’s argument is not probative on any issue the jury must decide. See, e.g., In re Viagra Prod. Liab. Litig., 658 F. Supp. 2d 950, 965-66 (D. Minn. 2009). Accordingly, Plaintiff should be precluded from making this argument pursuant to Rules 401, 402 and 403. See, e.g., Skibniewski v. American Home Prods. Corp., 2004 WL 5628157 at *9-12 (W.D. Mo. Apr. 1, 2004). Before addressing the specific reasons why Plaintiff’s “boxed warning sooner” argument should be excluded, it should be noted that FDA’s adequacy of labeling standards are distinct from those upon which a Court or jury relies in tort law. See, e.g., Glastetter, 252 F.3d at 991 (“The FDA evaluates pharmaceutical drugs using a different standard than the causation standard in the present case…The FDA will remove drugs 8 ND: 4820-9971-2519

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from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability. The methodology employed by a government agency results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances.”) (internal citations and quotations omitted); In re Neurontin Mktg., Sales Practices, and Prods. Liab. Litig., 612 F. Supp.2d 116, 136 (D. Mass. 2009) (same). The fact that FDA chose to strengthen the warnings for all fluoroquinolones in 2008 is not evidence that labeling available in 2005 was legally inadequate. This is particularly true here because when it strengthened the warnings for all fluoroquinolones in 2008, FDA specifically said its decision was based on a “new” analysis of the data. See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ 2008/ucm116919.htm (“The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports…The FDA considers this new analysis to be “new safety information” as defined in FDAAA”); see also http://www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm. To the extent Plaintiff wants to argue that a boxed warning should have been instituted prior to July 2008, because Defendants, as a matter of FDA requirements, could not have made the label change Plaintiff wants to argue should have been made, Plaintiff’s arguments are not relevant to any issue the jury must decide. See Soo Line R. R. Co. v. City of St. Paul, __ F. Supp. 2d __, 2010 WL 2540695 at *4 (D. Minn. June 17, 2010). Therefore, Plaintiff should be precluded from advancing it at trial. See Dethmers 9 ND: 4820-9971-2519

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Mfg. Co., Inc. v. Automatic Equip. Mfg. Co., 73 F. Supp. 2d 997, 1004-05 (N.D. Iowa 1999). FDA has had the sole and exclusive authority to institute a boxed warning at all times Levaquin® has been marketed and to decide whether comparative data can be added to WARNINGS statements. A jury simply cannot second guess decisions FDA has made on these issues and impose liability on Defendants for not taking actions FDA would consider to be illegal. a.

No Boxed Warning Sooner

In opposing Defendants’ motion to exclude one of his experts, Cheryl Blume, Plaintiff states that he will not claim that a boxed warning for Levaquin® should have been instituted before July 2008. (Pl.’s Opp. re Blume at 42, 44-45.) Plaintiff should be held to this concession at trial and should be precluded from using subsequent labeling with any witness. See Rattray v. Woodbury County, IA, 614 F.3d 831 (8th Cir. 2010) (plaintiffs denied class certification because of prior concession that there was little risk of inconsistent judgments); see also Whitmore v. O’Connor Mgmt., Inc., 156 F.3d 796, 799-800 (8th Cir. 1998). Even without this admission, Plaintiff could not make a boxed warning sooner argument because it is irrelevant and prohibited by federal law. From the time boxed warnings were first introduced in 1979 into the pharmaceutical regulatory scheme by FDA, it was within FDA’s exclusive judgment both to require a boxed warning and to specify the location where the boxed warning should appear on the label. See 21 C.F.R. § 201.57(e) (1979-2006). Manufacturers never have

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been allowed to institute their own boxed labeling. The 1979 regulation creating “boxed” warnings information for prescriptions medication are clear on this issue: Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based upon clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. If a boxed warning is required, its location shall be specified by the Food and Drug Administration (emphasis added). 21 C.F.R. § 201.80(e). FDA further emphasized this point thirty years ago in public statements made in accordance with its rule-making authority. During the comment period for the new regulation, FDA specifically was asked if a manufacturer could institute a black box warning without prior FDA approval and the FDA confirmed that a manufacturer could not do so: A comment asked whether a manufacturer may include a boxed warning without prior FDA approval and whether FDA would consider the labeler’s desires when specifying the location of boxed warnings in labeling. The Commissioner advises that, to ensure the significance of boxed warnings in drug labeling, they are permitted in labeling only when specifically required by the FDA. 44 Fed. Reg. 37434, 37448 (June 26, 1979) (emphasis added). FDA prohibited boxed warnings, other than those it required, from being unilaterally implemented by manufacturers because FDA was concerned that overuse of a boxed warning could dilute its impact. And because this regulation was adopted after proper notice and comment, it is entitled to substantial deference. See Geier v. American Honda Motor Co., Inc., 529 U.S. 861, 886 (2000); see also Chevron U.S.A., Inc. v. 11 ND: 4820-9971-2519

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Natural Res. Def. Counsel, 467 U.S. 837, 844 (1984); cf. Wyeth v. Levine, 129 S. Ct. 1187, 1204 (2009) (Breyer, J., concurring). Moreover, FDA reiterated its position several years after the 1979 regulations were enacted: “The agency’s policy is to use restraint in requiring warnings to be boxed because overuse of the box will ultimately lead to reducing its effect.” 51 Fed. Reg. 43900, 43902 (Dec. 5, 1986). FDA’s exclusive control over boxed warnings continues to this day. In this regard, public statements by FDA employees have affirmed that “[a] prominently displayed boxed warning, the so-called ‘black box,’ is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury (emphasis added).” Murphy, S., Roberts, R. “Black Box 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk.” 117 J. Allergy Clin. Immunol. 1 at 34;4 see also Lars, Noah. The Imperative to Warn; Disentangling the ‘Right to Know’ from the ‘Need to Know’ about Consumer Product Hazards. 11 Yale J. Reg. 293, 331 (1994) (FDA “has emphasized that, to ensure the significance of boxed warnings in drug labeling, they are permitted in labeling only when specifically required by FDA”). Indeed, only FDA has required a black box warning on a prescription medication since the boxed warning regulation became effective. See, e.g., Beach et al.,

4

A copy of Murphy, S., Roberts, R., Black Box 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk is attached to Van Steenburgh Aff. as Exhibit D. 12

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Black Box Warnings in Prescription Drug Labeling: Results of a Survey of 206 Drugs. 53 Food & Drug L.J. 403 (1998) (evaluating 375 black box warnings imposed by FDA). FDA created class labeling for fluoroquinolones (Blume Depo. at 33:18-20) and Levaquin® always has been subject to fluoroquinolone class labeling (Id. at 59:18-60:2). Any argument that Plaintiff may make that a black box warning should have been issued earlier is irrelevant because a manufacturer cannot change class labeling to add a boxed warning without prior FDA approval. (Id. at 34:2- 36:11.) In the multiple versions of FDA’s class labeling for fluoroquinolones implemented after 1995, FDA never required a boxed warning be added to the fluoroquinolone class labeling until July 2008. (Id. at 50:11-22.) And because FDA did not require a boxed warning for fluoroquinolones including Levaquin® until years after Plaintiff last took the medicine, any “boxed warning sooner” argument, to the extent that Plaintiff makes one, is not admissible pursuant to Rules 403 and 407 in addition to Rules 401 and 402. See, e.g., DeLuryea v. Winthrop Labs., 697 F.2d 222, 229 (8th Cir. 1983). Plaintiff’s experts acknowledge that Defendants could not place a boxed warning in the Levaquin® prescribing information without prior FDA action and admit that FDA never did so prior to July 2008. (Blume Depo. 47:15-19, 49:4-50:8, 50:11-22.) Plaintiff’s experts also acknowledge that a manufacturer cannot change class labeling without prior FDA approval (Id. at 34:24-36:6) and FDA has not added comparative data to the fluoroquinolone class labeling despite possessing the information Plaintiff would have Defendants add. (Id. at 110:19-111:16, 113:19-22.) Based on these admissions, any 13 ND: 4820-9971-2519

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claim by Plaintiff that Defendants could have unilaterally implemented a boxed warning at any time relevant to this case must be rejected. See, e.g., Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189, 1197 (D.N.D. 2002), aff’d, 367 F.3d 1013 (8th Cir. 2004) (claim that prescription medicine should have had black box warning is preempted). Plaintiff’s assertion that his expert may testify that Defendants could have sent a letter to physicians announcing a boxed warning was going to be implemented in the future does not change the analysis. Only FDA can implement a boxed warning and such a warning for all fluoroquinolones was implemented in 2008. Defendants sent a letter to physicians regarding the boxed warning after it was finally approved by FDA. Defendants could not have sent this letter any time before FDA’s July 2008 announcement according to FDA regulations pursuant to Plaintiff’s expert. (Blume Depo. 205:9-16; 206:6-10.) To allow Plaintiff to even suggest an argument that a future boxed warning could have been announced before July 2008 could allow the jury to impose liability on Defendants for failing to announce a warning that could not have been included in the Levaquin® labeling prior to July 2008 as a matter of federal law. This is not a permissible basis upon which the jury can decide liability here. See, e.g., O’Neal v. Smithkline Beecham Corp., 551 F. Supp. 2d 993, 1009 (E.D. Cal. 2008). Thus, any references during trial linked to the current boxed warnings for Levaquin® or a comparative data argument are irrelevant and inadmissible. See, e.g., Id.; Fidelity

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Federal Sav. and Loan Ass’n v. de la Cuesta, 458 U.S. 141, 152 (1982); cf. Wyeth v. Levine, 129 S.Ct. 1187, 1198-99 (2009). The Supreme Court’s decision in Wyeth v. Levine does not alter the analysis on this question because that case turned on the availability of voluntary labeling changes without FDA approval through the “changes being effected” or CBE regulation. 129 S. Ct. at 1199. That option was not available to Defendants here because a manufacturer cannot institute a boxed warning pursuant to the CBE regulation (Blume Depo. 47:1519), or cannot change class labeling through the CBE process (Id. at 34:2-36:11). B.

Rule 403 Mandates Exclusion Rule 403 provides that even if relevant, evidence may be excluded “if its probative

value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury. . . .” Fed. R. Evid. 403 (2007); see also Olson v. Ford Motor Co., 481 F.3d 619, 623 (8th Cir. 2007). The purpose of this rule is to prevent the admission of evidence that may have an “undue tendency to suggest decision on an improper basis, commonly, though not necessarily, an emotional one.” Fed. R. Evid. 403, Adv. Comm. Note; Fireman’s Fund Ins. Co. v. Thien, 63 F.3d 754, 758 (8th Cir. 1995). As demonstrated above, post-February 2005 Levaquin® evidence does not establish any of the elements of Plaintiff’s causes of action and would not provide probative information concerning a relevant issue. Instead of only considering the information that was known and available at the time that Plaintiff received Levaquin®, 15 ND: 4820-9971-2519

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the jury will be faced with materials and information that was not available until after Plaintiff received Levaquin®. This evidence that post-dates the relevant events only will confuse and mislead the jury, resulting in substantial, undue prejudice to Defendants. See Fortune Funding, LLC v. Ceridian Corp., 368 F.3d 985, 990 (8th Cir. 2004) (excluding evidence subsequent to the relevant time frame under Rule 403 as confusing and potentially misleading). Similarly, allowing Plaintiff to advance arguments about steps Defendants should have taken—which Defendants legally could not have taken—will result in substantial undue prejudice to Defendants. See, e.g., Bizzle v. McKesson Corp., 961 F.2d 719, 721 (8th Cir. 1992) (excluding evidence of a subsequent remedial measure as prejudicial under Rule 403). The Eighth Circuit mandates exclusion of evidence and arguments that are prejudicial, confusing or misleading, and allows courts broad authority to do so. See White v. McKinley, 605 F.3d 525, 534 (8th Cir. 2010) (affirming exclusion of unduly prejudicial evidence); Fortune Funding, LLC, 368 F.3d at 990 (“The district court has broad discretion in deciding whether to admit evidence at trial.”) (quoting Jones v. TEK Indus., Inc., 319 F.3d 355, 360 (8th Cir. 2003)). Thus, even if the Court finds postFebruary 2005 evidence and the arguments Plaintiff wants to make based on postFebruary 2005 labeling to be relevant, such evidence still should be excluded pursuant to Rule 403 because the risk of confusion and resulting prejudice far outweighs its scant, if existent, probative value.

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C.

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Rule 407 Mandates Exclusion Federal Rule of Evidence 407, which was amended in 1997 to encompass strict

liability, as well as negligence, claims, states: When, after an injury or harm allegedly caused by an event, measures are taken that, if taken previously, would have made the injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove negligence, culpable conduct, a defect in a product, a defect in a product’s design, or a need for a warning or instruction. This rule does not require the exclusion of evidence of subsequent measures when offered for another purpose, such as proving ownership, control, or feasibility of precautionary measures, if controverted, or impeachment. Fed. R. Evid. 407 (1997); see also Hammes v. Yamaha Motor Corp. U.S.A., Civil File No. 03-6456, 2006 WL 1195907, at *11 (D. Minn. May 4, 2006) (holding that a “subsequent remedial measure” would “not be admissible to prove the existence of a product defect.”); Rowher v. Federal Cartridge Co., No. 03-CV-2872, 2004 WL 2677200, at *5 (D. Minn. Nov. 18, 2004) (ruling that evidence of a subsequent textual change to a product catalog was inadmissible proof that product was defective or unreasonably dangerous). The 1997 Amendments Advisory Committee Note to Rule 407 explains that the amendment “adopt[ed] the view of a majority of the circuits that have interpreted Rule 407 to apply to products liability actions.” Id. Rule 407 is regularly applied to exclude labeling that was in effect after a Plaintiff’s last use of a medicine. See, e.g., DeLuryea, 697 F.2d at 229 (“exhibits, documents, articles, package inserts, and Physicians’ Desk Reference warnings after [the date of Plaintiff’s last use of the medicine]” were inadmissible under Rule 407); Stahl v. 17 ND: 4820-9971-2519

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Novartis Pharms. Corp., 283 F.3d 254, 270 n.10 (5th Cir.), cert. denied, 537 U.S. 824 (2002) (evidence of later package insert could not be considered in evaluating the adequacy of the package insert in effect when Plaintiff used the medicine); Gerber v. Hoffman-LaRoche, Inc., 392 F. Supp. 2d 907, 919 (S.D. Tex. 2005) (excluding a medicine’s subsequent warning label under Rule 407); see also Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 93-94 (2d Cir. 1980); Warner v. Upjohn Co., 628 F.2d 848, 856-58 (4th Cir. 1980), cert. denied, 449 U.S. 1080 (1981). This rule not only applies to the labeling itself, but it applies to correspondence and other communications relating to the subsequent labeling. See DeLuryea, 697 F.2d at 229. Because both Federal Rule of Evidence 407 and federal precedent require that subsequent labeling be excluded, there is no doubt that any Levaquin® labeling disseminated after February 10, 2005, and evidence relating to this subsequent labeling must not be considered in this case. CONCLUSION For all of the foregoing reasons, Defendants respectfully requests that their motion to exclude evidence concerning Levaquin® labeling created, developed in effect after February 10, 2005 and arguments about labeling for Levaquin® which contradict direct express FDA regulations and decisions should be granted.

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NILAN JOHNSON LEWIS PA

By: s/ Tracy J. Van Steenburgh Tracy J. Van Steenburgh #141173 Dana M. Lenahan #0353759 400 One Financial Plaza 120 South Sixth Street Minneapolis, MN 55402 Phone: (612) 305-7500 Fax: (612) 305-7501 Email: [email protected] John Dames William V. Essig Drinker Biddle & Reath LLP 191 N. Wacker, Suite 3700 Chicago, IL 60606 Phone: (312) 569-1497 Fax: (312) 569-3497 Email: [email protected] Email: [email protected] William Robinson LeClair Ryan 1101 Connecticut Avenue NW, Suite 600 Washington, D.C. 20036 Phone: (202) 659-6985 Fax: (202) 775-6405 Email: [email protected] Attorneys for Defendants

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