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Handling "bad" company documents: Preventing admission at trial

Sep 1, 2005 | Raleigh, NC

Published in the FDCC Quarterly, Fall 2005. Reprinted with permission from 56 FED'N DEF. & CORP. COUNS. Q 77 (2005). All rights reserved.

By Leslie C. Packer and Wendy Sexton

INTRODUCTION

One of the most powerful evidentiary tools available to plaintiffs is the use of a company's own "bad" documents against it at trial. In this age of technology, "bad" documents are more likely to be accessible because of increased use of computers, e-mail, and the Internet. Requests for production of documents are no longer limited to paper documents; instead, they have been expanded to include e-mail, electronic calendars, draft documents in soft copy form, and computer files. Many of these "bad" documents have never been printed, read, or even disseminated among company employees or executives.

The creation of a "bad" company document happens quickly and easily. An employee writes a quick email to a co-worker. Without understanding the implications of the message, the employee refers to a chart of fatalities associated with a drug as a "death list." Years later, a skilled trial lawyer representing a deceased plaintiff seizes upon this reference. By tying together a few pieces of documentary evidence, the attorney can paint a negative picture of the company - shaded by hues of improper motive, dishonesty, and a sundry list of other items. Admission of this evidence at trial can imply product defect and liability by showing that the company marketed the drug as safe at the same time it maintained a "death list."

Once "bad" company documents are created, they can become powerful weapons in the hands of an adversary. Despite their marginal relevance to the case, these documents are highlighted, enlarged, and mounted for display to jurors, or copied and given to jurors for examination during their deliberations. Given the significance of this dilemma, this article will highlight strategic legal bases for excluding such "bad" corporate documents at trial in drug and medical device cases.

DRUG AND MEDICAL DEVICE ADVERSE EVENT REPORTING

Under the Federal Food, Drug, and Cosmetic Act and its accompanying regulations, drug and medical device manufacturers submit product safety reports to the Federal Drug Administration ("FDA"). Voluntary reports also can be submitted by healthcare professionals, patients, and others.1 One such report includes compilations of anecdotal data regarding alleged drug failures. Typically, these are designated as Adverse Drug Events ("ADEs").2

ADEs should be excluded from evidence at trial because they lack reliability, they lack relevance, and they pose a significant danger of unfair prejudice, issue confusion, and waste of time. ADEs are inherently unreliable because they are based on anecdotal data that cannot be verified. Although rooted in protecting the public health, ADEs at most provide a temporal association between a drug and an unexpected physical reaction.3 Proximity in time, however, simply does not equate with causation. Accordingly, judicial use of such reported information is shielded by statute. Under Section 379v of the United States Code, safety reports and information submitted by any entity pursuant to the Federal Food, Drug, and Cosmetic Act cannot be construed as "an admission that the product involved malfunctioned, caused, or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness."4 Further, the statute specifically allows the submitting entity to deny that the safety report or other reported information constitutes an admission of product defect or causation.

At least one court has recognized that the "most significant analytical defect [of ADEs] is that they don't isolate the investigative effects of alternative causation agents."5 Accordingly, expert opinion testimony on causation, when based on such anecdotal data, has been excluded as insufficiently reliable to satisfy the requirements of Daubert and its progeny.6 Lack of reliability also supports the exclusion of ADEs as inadmissible hearsay evidence. When proffered by an adversary at trial, ADEs constitute nothing more than out-of-court statements offered to prove the truth of the matter, e.g., a product defect or liability. Under the Federal Rules of Evidence, such hearsay is not admissible unless it falls within a recognized exception to the hearsay rule.7

ADEs, however, are unlikely to satisfy the requirements of an exception to the hearsay rule. For example, ADEs do not satisfy the business records exception because they are not made in the regular course of business and are not prepared at or near the time of the event.8 ADEs instead are based on subjective reports of lay persons. There may be a delay of weeks, months, or even years between the time of the unexpected "event" and the report of the event as provided by the patient to a physician. As a result, important details may be innocently omitted or misconstrued without challenge since no independent investigation into the underlying truth of the information is undertaken by any individual or entity. Similarly, ADEs do not satisfy the public records exception because they are not "activities of the office or agency" or "matters observed pursuant to a duty imposed by law."9 ADEs are prepared by private individuals or entities. They are anecdotal reports that are submitted to a public body. Even if certain elements of the business record or public records exceptions could be established, the inherent unreliability of ADEs favors their exclusion due to lack of trustworthiness. Thus, such reports should be excluded as inadmissible hearsay and as inherently unreliable.10

An alternative basis for the exclusion of ADE evidence at trial focuses on its irrelevance and the danger of unfair prejudice, issue confusion, and waste of time.11 The reported adverse events are not relevant when they are not substantially similar to the plaintiff's claimed injury. As a general rule, evidence of previous accidents is not admissible in product liability cases unless it is shown that the previous accident occurred under similar circumstances.12 Even if such reports were deemed relevant, alternative grounds for exclusion exist under Federal Rule 403 because any probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, and waste of time.13 In the medical device context, manufacturers submit Medical Device Reports ("MDRs") regarding incidents of product failure.14 Voluntary reports can be submitted by healthcare professionals and others. Like ADEs, MDRs provide only a temporal association between an individual who receives or uses a medical device and an adverse physical reaction that is reported to a physician. Neither ADEs nor MDRs undergo scientific analysis to isolate and investigate alternative causes of unexpected or adverse physical reactions. The discovery and admissibility of certain MDRs is prohibited by statute. First, the United States Code expressly states that when a hospital, outpatient facility (that is not also a physician's office), ambulatory surgical facility, or nursing home becomes aware of information that reasonably suggests that a medical device may have caused a death or serious injury, the report "shall [not] be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report."15 In addi- addition, federal regulations prohibit disclosure of identifying information contained in voluntary MDRs.16 These statutes have been interpreted to prohibit disclosure of any information obtained from voluntary MDRs or the discovery of other documents that rely on information contained in such reports.17

Certain MDRs fall outside the protection afforded by the Code of Federal Regulations, however. With respect to these reports, the bases for excluding evidence of MDRs at trial parallel those discussed above regarding ADEs.

SUBSEQUENT REMEDIAL MEASURES

From time to time, drug and medical device manufacturers can find themselves "between a rock and a hard place." These businesses strive to develop and manufacture drugs and medical devices that address continuing health conditions and disease. Operating in a constantly changing environment, these drug and medical device manufacturers obtain new safety information about their products nearly every day. At times, new safety information warrants voluntary action to recall a drug or medical device from the market, or to revise package inserts, labels, or dosage levels. Such activities generate documents, conveying this new safety information, that are widely disseminated (both in printed form and on the Internet) to physicians and patients. Recall notices and modifications to package inserts or labels are not "bad" company documents per se. They may constitute evidence that drug and medical device manufacturers continue to evaluate their products, ready to make changes in availability, information, and dosage levels when appropriate. Notwithstanding their salutary effect, in the hands of a skilled adversary, documents resulting from such voluntary conduct may be used at trial to suggest to the jury that the product was defective and inherently dangerous, and that the manufacturer should be held accountable. The Federal Rules of Evidence likewise offer a basis for excluding evidence of recall notices and changes in package inserts, labels, and dosage at trial. Under one such rule, evidence of subsequent remedial measures is not admissible to show "negligence, culpable conduct, a defect in a product, a defect in a product's design, or a need for a warning or instruction."18 Accordingly, when activities that include product recall or label change occur after the plaintiff's injury, documentary evidence of such voluntary activities is inadmissible.19 Nevertheless, timing issues sometimes create obstacles to the admissibility protection offered by Federal Rule of Evidence 407. Thus, it may be necessary to invoke additional grounds for excluding this evidence, such as irrelevance and the danger of unfair prejudice or confusion of the issues.20 Evidence of a voluntary recall or changes to package inserts, labels, or dosage levels is not relevant to assess liability because the issue is properly framed as whether the product was defective at the time it was sold.21 Further, it is likely that the prescribing or implanting physician did not rely on any recall notice or change to a package insert, label, or dosage to obtain information about the product. Rather, physicians commonly rely on published medical literature and presentations at product conferences. When post-sale activities are not relevant to any issue in the case, this evidence is properly excluded under Federal Rule of Evidence 402.22

To the extent that an adversary is able to establish the relevance of post-sale activities, an alternate basis for exclusion of voluntary recalls or changes to package inserts, labels, and dosage levels is available under Federal Rule of Evidence 403.23 The risk that a jury would unfairly use evidence of a voluntary recall as an admission of liability or use evidence of changes to package inserts or labels as evidence of a product defect substantially outweighs any probative value. The potential for unfair prejudice from introduction of this evidence at trial warrants its exclusion.24

DIRECT ADVERTISEMENTS — PRINT, MEDIA, AND THE INTERNET

An adversary also may attempt to admit a company's direct advertising into evidence to show that the company failed to adequately warn the plaintiff about product-related risks. Direct advertising is fertile ground for the creation of "bad" company documents that may be used by a skilled adversary against a product manufacturer at trial. Television advertisements typically are short and use creative metaphors to imply effectiveness. Print advertisements usually include product-related risk information in smaller type, located somewhere other than in the primary advertising space. Even if displayed more prominently, approved summaries of product-related risks may be difficult for the average consumer to understand.

For many years, the learned intermediary doctrine has shielded drug and medical device manufacturers from liability for failure to warn claims.25 Under this doctrine, a drug or medical device manufacturer has a duty to provide product warnings only to the prescribing physician.26 The learned intermediary doctrine is premised upon the physician-patient relationship. Because patients rely on physicians to recommend and select treatment options based upon individual assessments, the physician (and not the manufacturer) is in the best position to warn the patient about any risks associated with the product. At least one state court, however, has carved out a new exception to the learned intermediary doctrine based on the manufacturer's direct advertising. The New Jersey Supreme Court in Perez v. Wyeth Labs., Inc.,27 held that the learned intermediary doctrine did not apply to a drug manufacturer because of its direct advertising activities. Instead, the manufacturer had a direct duty to warn consumers of product-related risks.28 The result of recent challenges to the learned intermediary rule based on direct advertising remains uncertain.29

Notwithstanding increased direct advertising by drug and medical device manufacturers, the learned intermediary doctrine continues to be recognized in the vast majority of jurisdictions.30 Drug and medical device manufacturers should continue to defend against admission of direct advertising into evidence based on irrelevance and the danger of unfair prejudice under the Federal Rules of Evidence.31 Exclusion of such evidence is proper since the communication of warnings to the individual patient is irrelevant when the proper liability analysis applies only to physicians. Given the emergence of an exception to the learned intermediary doctrine, however, other defenses to the admissibility of direct advertising or Internet evidence deserve consideration. First, direct advertising by drug and device manufacturers implicates commercial speech protected by the First Amendment. Furthermore, the implicit authorization for patients to rely on sources other than physicians for product-related risks threatens the patient-physician relationship. Without the involvement of a physician to explain the information and to discuss product-related risks, patients may improperly substitute advertising promises for the judgment of their physicians.32

PETITIONING FOR GOVERNMENT REDRESS

Drug and medical device manufacturers frequently interact to seek redress from the government, including the FDA. Skilled adversaries may seek to admit documentary evidence of these government petitions to show improper conduct or improper motives. Since these efforts by product manufacturers are likely to be chilled if admitted into evidence against them, the balancing test of Federal Rule of Evidence 403 and the Noerr-Pennington doctrine33 favor exclusion of the evidence.

Efforts by a product manufacturer to petition the government are generally immune from antitrust liability under the Noerr-Pennington doctrine. The Noerr-Pennington doctrine was first recognized in Eastern Railroad Presidents' Conference v. Noerr Motor Freight, Inc.,34 and United Mine Workers of America v. Pennington,35 as a limit to the scope of antitrust laws as they affect constitutionally protected speech. The doctrine is intended to remove the chill to free speech posed by the threat of potential liability.36 The doctrine has been applied in contexts other than antitrust, including products liability.37 The Noerr-Pennington doctrine also has been applied in cases involving claims against a drug manufacturer for alleged anticompetitive conduct premised upon government petitioning activity.38

Although not a rule of evidence precluding admissibility, the Noerr-Pennington doctrine buttresses arguments for excluding evidence of government petitioning activities by drug and device manufacturers under Federal Rule of Evidence 403. Despite their marginal relevance to the case, documents regarding these efforts by manufacturers can contribute to an impermissible inference of liability drawn by a jury that implies improper motive or conduct from the evidence. Courts have considered evidence of petitioning activities directed to the government presumptively prejudicial to a defendant's First Amendment rights.39 As such, any probative value that attaches to this evidence is substantially outweighed by the danger of unfair prejudice, confusing the issues, consuming time, or misleading the jury.

DOCUMENTS FROM OTHER LAWSUITS OR CLAIMS

Although not created by companies or company employees, another category of "bad" evidence may include judgments, pleadings, depositions, or other documents drawn from other lawsuits or claims involving a drug or medical device. When discovered by an adversary, such documents may be offered to suggest improperly that the drug or device at issue is defective and caused the alleged injuries because it was found to be defective or the cause of injury in other claims or lawsuits. There exist several bases for excluding these documents. Pleadings and other papers filed in other actions may constitute inadmissible hearsay when offered to prove the truth of the information.40 Furthermore, the documents may not involve identical drugs or devices. The other lawsuits or claims frequently involve vastly different factual situations and issues, especially those regarding causation, exposure, product type, and injury. Thus, the existence, evidence used or outcome of another lawsuit or claim often has no bearing whatsoever on the issues presented in the pending action. In this context, documents from other lawsuits or claims are simply not relevant and should be excluded under Federal Rule of Evidence 401.41

Even if an adversary somehow establishes the relevance of documentary evidence from other lawsuits or claims, exclusion of such evidence is warranted under Federal Rule of Evidence 403.42 When used to show improper conduct, improper motives, product defect, or liability, any probative value that attaches to this evidence is substantially outweighed by the danger of unfair prejudice, confusing the issues, misleading the jury, or undue delay. The admissibility of such documents would be highly prejudicial because such evidence focuses the jury's attention on other alleged misconduct, rather than allowing the jury to determine whether liability is appropriate under the facts of the pending lawsuit.43 The danger of prejudice, confusion of the issues, or misleading the jury is implicated particularly when the prior action was resolved by settlement.44

CONCLUSION

Despite their marginal relevance to the case, preventing the facts contained in "bad" company documents from becoming influential evidence at trial is an uphill battle. After a "bad" company document is admitted into evidence by an adversary, innocuous facts and activities can be developed into compelling evidence of a product defect or grounds for liability against a given manufacturer. Defense counsel must identify and critically examine "bad" company documents as early as possible to identify strategic legal grounds upon which to bar their admission at trial.

FOOTNOTES

  1. U.S. Food and Drug Administration, available at http://www.fda.gov (last visited Sept. 8, 2005).
  2. U.S. Food and Drug Administration, available at http://www.fda.gov/medwatch/report/consumer/consumer.htm (last visited Sept. 8, 2005).
  3. See DeLuca v. Merrell Dow Pharm., 791 F. Supp. 1042, 1050-51 (D.N.J. 1992), aff'd, 6 F.3d 778 (3rdCir. 1993) (recognizing that drug experience reports contain inherent biases and distortions and cannot be used to prove causation); Golod v. Hoffman La Roche, 964 F. Supp. 841, 855-56 (1997) (adverse experience reports were not admissible on issue of causation, but were admissible to show whether drug manufacturer had notice of certain side effects).
  4. 21 U.S.C. ¤ 379v (1997).
  5. Brumbaugh v. Sandoz Pharm. Corp., 77 F. Supp. 2d 1153, 1156 (D. Mont. 1999).
  6. See Caraker v. Sandoz Pharm. Corp., 188 F. Supp. 2d 1026, 1034-35 (S.D. Ill. 2001) (rejecting expert causation opinion testimony to the extent it relied on anecdotal case reports); Glastetter v. Novartis Pharm.Corp., 107 F. Supp. 2d 1015, 1044 (E.D. Mo. 2000), aff'd, 252 F.3d 986 (8th Cir. 2001) (rejecting experts' opinions to the extent that they relied on selective use of statistically insignificant data from case studies);Hollander v. Sandoz Pharm. Corp., 95 F. Supp. 2d 1230, 1236-39 (W.D. Okla. 2000), aff'd, 289 F.3d 1193(10th Cir. 2002) (excluding experts because they did not meet the reliability requirements of Federal Rule 702 and Daubert when based in part on anecdotal case reports); Brumbaugh, 77 F. Supp. 2d at 1155-57(holding that expert causation testimony should be excluded under Federal Rule of Evidence 702 and 703because their opinions, based in part on ADEs, did not have sufficient evidentiary reliability to be admissible);cf. Globetti v. Sandoz Pharm. Corp., 111 F. Supp. 2d 1174, 1177-80 (N.D. Ala. 2000) (finding expert opinions on causation based in part on ADEs and case reports sufficiently reliable under Daubert).
  7. Fed. R. Evid. 802; Rowland v. Am. Gen. Fin., Inc., 340 F.3d 187, 194-95 (4th Cir. 2003) (recognizing that letter was inadmissible hearsay unless it met an exception to the hearsay rule).
  8. See FED. R. EVID. 803(6).
  9. FED. R. EVID. 803(8).
  10. See, e.g., Figueroa v. Boston Scientific Corp., No. 00-CV-7922, 2003 WL 21488012, at * 3, *5 (S.D.N.Y.June 27, 2003) (granting motion in limine to exclude study reporting out-of-court statements obtained by physicians during interviews as unreliable hearsay and double hearsay); cf. Becker v. Nat'l Health Prod.,Inc., 896 F. Supp. 100, 104 (N.D.N.Y. 1995) (holding, without analysis, that FDA complaint reports were admissible hearsay under business record and public records exceptions and that probative value was not substantially outweighed by danger of unfair prejudice).
  11. See FED. R. EVID. 402, 403.
  12. See Barker v. Deere & Co., 60 F.3d 158, 162-63 (3rd Cir. 1995); Rye v. Black & Decker Mfg. Co., 889F.2d 100, 108 (6th Cir. 1989).
  13. See FED. R. EVID. 403.
  14. U.S. Food and Drug Administration, available at http://www.fda.gov/medwatch/report/hcp.htm (lastvisited Sept. 8, 2005).
  15. 21 U.S.C. ¤ 360i (1997).
  16. 21 C.F.R. ¤ 20.63(f) (1995).
  17. See In re Medtronic, Inc., 184 F.3d 807, 808-11 (8th Cir. 1999) (court order compelling disclosure of reports covered by 21 U.S.C. ¤ 360i(b)(3) was improper and violated the statute); Adcox v. Medtronic,Inc., 131 F. Supp. 2d 1070, 1074 (W.D. Ark. 1999) (finding that voluntary MDRs were not discoverable under 21 C.F.R. ¤ 20.63(f)).
  18. FED. R. EVID. 407.
  19. See Chase v. General Motors Corp., 856 F.2d 17, 19-21 (4th Cir. 1988); Werner v. Upjohn Co., 628 F.2d 848, 853-56 (4th Cir. 1980) (evidence of revised drug warning issued after plaintiff's injury was inadmissible under Federal Rule of Evidence 407); Wolf v. Proctor & Gamble Co., 555 F. Supp. 613, 623-24(D.N.J. 1982) (Federal Rule of Evidence 407 barred admission of voluntary recall evidence to show defector causation).
  20. FED. R. EVID. 402, 403.
  21. See Grenada Steel Indus. Inc. v. Alabama Oxygen Co., 695 F.2d 883, 888 (5th Cir. 1983).
  22. See In re Richardson-Merrell, Inc. "Bendectin" Prod. Liab. Litig., 624 F. Supp. 1212, 1239 (S.D. Ohio 1985), aff'd, 857 F.2d 290 (6th Cir. 1986) (evidence of defendant's discontinued sale of Bendectin was not relevant under Federal Rules of Evidence 401 and 402); Occidental v. G.D. Searle & Co., 683 F. Supp. 1579, 1581-82 (D. Minn. 1988) (excluding evidence of manufacturer's voluntary discontinuation of intrauterine device on relevancy grounds); cf., Figueroa v. Boston Scientific Corp., No. 00-Civ-7922, 2003WL 21488012, at * 1, *4-5 (S.D.N.Y. June 27, 2003) (denying motion in limine to exclude evidence of a voluntary recall that occurred before the plaintiff suffered injury from defendant's medical device).
  23. See FED. R. EVID. 403.
  24. See Kociemba, 683 F. Supp. at 1581-82 (granting manufacturer's motion to exclude evidence of a voluntary drug recall because of the danger of unfair prejudice that it would be considered by the jury as an admission of liability); In re Richardson-Merrell, 624 F. Supp. at 1239 (applying Federal Rule of Evidence 403 to manufacturer's withdrawal from intrauterine device market).
  25. Infra note 26.
  26. See Odom v. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) ("[T]he manufacturer's duty to warn extends only to the prescribing physician, who then assumes responsibility for advising the individual patient of risks associated with the drug or device."); Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 811 (5th Cir. 1992) (applying learned intermediary doctrine to acne medication, Accutane); Brooks v.Medtronic, Inc., 750 F.2d 1227, 1231-32 (4th Cir. 1984) (applying learned intermediary doctrine to pacemaker);Willet v. Baxter Int'l Inc., 929 F.2d 1094, 1098 (5th Cir. 1991) (applying learned intermediary doctrine to artificial heart valve); Padgett v. Synthes, Ltd., 677 F. Supp. 1329, 1335 (W.D.N.C. 1988),aff'd, 872 F.2d 418 (4th Cir. 1989) (applying learned intermediary doctrine to compression plate for tibia).
  27. 734 A.2d 1245 (N.J. 1999).
  28. Perez, 734 A.2d at 1257-64; cf. In re Norplant, 165 F.3d 374, 379-80 (5th Cir. 1999) (rejecting proffered"aggressive" direct advertising exception to learned intermediary doctrine and applying doctrine incase to manufacturer of Norplant).
  29. See, e.g., Freeman v. Hoffman-LaRoche, Inc., 618 N.W.2d 827, 841-42 (Neb. 2000) (applying learned intermediary doctrine to failure to warn claim involving acne drug, Accutane); Tracy v. Merrell-Dow Pharm.Inc., 569 N.E.2d 875, 879 (Ohio 1991) (learned intermediary doctrine applied to manufacturer of Nicorette chewing gum).
  30. Tracey Bateman Farrell, Products Liability: Statements in Advertising as Affecting Liability of Manufacturers and Sellers for Injury Caused by Product Other Than Tobacco, 93 A.L.R. 5TH 10 (2004).
  31. FED. R. EVID. 402, 403.
  32. See Swayze v. McNeil Labs. Inc., 807 F.2d 464, 471 (5th Cir. 1987) ("When the physician-patient privilege does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it.").
  33. Infra notes 34, 35.
  34. 365 U.S. 127 (1964).
  35. 381 U.S. 657 (1965).
  36. Fed. Prescription Serv., Inv. v. Am. Pharm. Ass'n, 663 F.2d 253, 262 (D.C. Cir. 1981).
  37. See, e.g., Cipollone v. Liggett Group, Inc., 668 F. Supp. 408 (D.N.J. 1987) (applying the Noerr-Penningtondoctrine in the tobacco products liability context).
  38. See Cheminor Drugs, Ltd. v. Ethyl Corp., 168 F.3d 119, 120-27 (3rd Cir. 1999) (applying Noerr-Pennington doctrine to petitioning activities of ibuprofen manufacturer in antitrust case); Mylan Labs.,Inc. v. Akzo, N.V., 770 F. Supp. 1053, 1063-64 (D. Md. 1991) (finding generic drug manufacturers immunefrom antitrust liability under Noerr-Pennington regarding FDA petitioning activities).
  39. See Feminist Women's Health Ctr., Inc. v. Mohammad, 586 F.2d 530, 543 n.7 (5th Cir. 1978) (recognizing that when evaluating admissibility, evidence of government petitioning efforts should be considered presumptively prejudicial).
  40. See FED. R. EVID. 801; Stevenson v. Hearst Consol. Publ'n, 214 F.2d 902, 907 (2nd Cir.), cert. denied, 348 U.S. 874 (1954).
  41. See FED. R. EVID. 401; see, e.g., Grenier v. Med. Eng'g Corp., 243 F.3d 200, 204-05 (5th Cir. 2001)(refusing to adopt by reference opinion in different action involving a different type of product and different injuries to show existence of defect).
  42. See FED. R. EVID. 403.
  43. See Figueroa v. Boston Scientific Corp., No. 00-CV-7922, 2003 WL 21488012, at *4 (S.D.N.Y. June 27, 2003) (granting motion to exclude evidence of 720 other lawsuits involving same medical implant because any probative value was substantially outweighed by the danger of unfair prejudice, confusion of the issues, and waste of time); Johnson v. Colt Indus. Operating Corp., 797 F.2d 1530, 1534 (10th Cir. 1986) (even if relevant, a judicial opinion concerning the very product at issue performing under similar circumstances was not admissible because the jury would be likely to give it undue weight).
  44. See Wilson v. Bicycle South, Inc., 915 F.2d 1503, 1510 (11th Cir. 1990) (affirming exclusion of evidence of a prior settled claim involving a similar product based on Federal Rule of Evidence 403 considerations);FED. R. EVID. 408 (evidence of an offer to settle or acceptance of such offer "is not admissible to provide liability for or invalidity of the claim or its amount").