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Windy City Litigation Management a TRIAL.COM Litigation Management SuperCourse June 15, 2012 - The Metropolitan Club - Willis Tower - Chicago, IL PROGRAM COURSEBOOK

Defending Product and Service Providers Overseas Joseph Krasovec Schiff Hardin (Chicago, IL) jkrasovec@schiffharin.com 312.258.5639 http://www.schiffhardin.com/attorneys/attorney-search/krasovec-iii-joseph-j Defending Product and Service Providers Overseas Joseph Krasovec and Brian O. Watson As U.S. companies expand their global footprint, conduct in other countries can fuel, or lead to, litigation here. Manufacturing processes and incidents occurring in foreign countries, violations of foreign standards and documents generated by overseas affiliates can become fodder for, if not the centerpiece of, claims brought in the United States. This piece sets forth strategies and tactics to increase the likelihood that what happens overseas stays there. Faced with possible overseas evidence introduced in their domestic litigation, companies should set out early to prevent or minimize its impact using three steps: (1) refuse or limit its production as beyond the scope of permissible discovery; (2) preclude it from becoming evidence at trial; and (3) prepare to minimize its impact as evidence at trial. The bottom-line risk of overseas evidence is real in each case because its discovery and admissibility are within every trial court s discretion. Generally, trial courts will permit discovery of some overseas records because, as a practical matter, liberal discovery rules make it difficult for companies to resist production entirely. At trial, however, most courts conclude that records about foreign standards are inadmissible, although foreign product models themselves can be admitted. Therefore, companies should develop a plan early in litigation to put any possible overseas evidence in its proper context at trial. I. REFUSE OR LIMIT PRODUCTION OF OVERSEAS RECORDS AS BEYOND THE SCOPE OF PERMISSIBLE DISCOVERY. Plaintiff s lawyers have recently expanded the scope of the discovery they are seeking to include foreign records. The discovery process therefore offers the first line of defense against the inappropriate use of overseas evidence domestically. Companies should consider all discovery tools to refuse or limit production of overseas records as beyond the scope of permissible discovery. These include refusing or limiting discovery on possession, custody, or control grounds; relevance grounds; and burdensome grounds. As a practical matter, however, liberal discovery rules and corporate interconnectedness often make it difficult for companies to prevent production of foreign records entirely, notwithstanding the significant burdens and marginal (if any) relevance of this discovery. A. OVERSEAS RECORDS ARE OUTSIDE POSSESSION, CUSTODY, OR CONTROL. Under Rule 34(a) of the Rules of Civil Procedure, companies must produce during discovery those documents, electronically stored information, or things in their possession, custody, or control. Fed. R. Civ. P. 34(a). Absent actual possession or actual custody, the issue becomes control over the foreign records. Through a very fact specific inquiry into the relationship between a company and its foreign affiliates, the foreign records may (or may not) be considered under the control of the company and therefore discoverable information. Importantly, the party seeking production must establish the company s control over the information sought. SEC v. Credit Bancorp., Ltd., 194 F.R.D. 469, 472 (S.D.N.Y. 2000). In general, courts have defined control as the legal right to obtain the documents requested upon demand. E.g., Alexander v. FBI, 194 F.R.D. 299, 301 (D.D.C. 2000); Cochran Consulting, -- 28 --

Inc. v. Uwatec USA, Inc., 102 F.3d 1224, 1233 (Fed. Cir. 1996) ( The word control includes not merely physical possession, but also legal control. Thus, a court may properly order a party to produce information beyond its possession, so long as it has a legal right to gain possession. (citations omitted)). But determining if a party has control is a very fact specific inquiry. Pitney Bowes, Inc. v. Kern Int l, 239 F.R.D. 62, 66 (D. Conn. 2006). For this very fact specific inquiry, Gerling Int l Ins. Co. v. C.I.R., 839 F.2d 131, 140 41 (3d Cir. 1988), is cited most often to provide a framework. See, e.g., U.S. Int l Trade Comm n v. ASAT, Inc., 411 F.3d 245, 254 (D.C. Cir. 2005) (citing Gerling for control analysis); Kestrel Coal Pty. Ltd. v. Joy Global, Inc., 362 F.3d 401, 405 (7th Cir. 2004) (same); Camden Iron & Metal, Inc. v. Marubeni Am. Corp., 138 F.R.D. 438, 441 42 (D.N.J. 1991) (same). To create its framework, Gerling established four general principles, each depending on the relationship between the company and its affiliate possessing the records. First, Gerling held that a corporate party has no duty to produce absent control over the records possessed by its affiliates. 839 F.2d at 140 (emphasis added and citations omitted). Yet, the physical location of the records is irrelevant, including whether or not the records are in the territorial jurisdiction. Id. (citations omitted). Second, Gerling concluded when the corporate party is the parent of a subsidiary possessing the records, control will exist if the subsidiary acts as a direct instrumentality of and in direct cooperation with its parent corporation, and where the properties and affairs of the two [were]... inextricably confused as to a particular transaction. Id. (citation omitted). In particular, control will likely exist if the parent has the power to elect a majority of the board of directors of the subsidiary. Id. (citations omitted). Third, when the corporate party is the subsidiary of a parent corporation possessing the records, Gerling found control to exist if: 1) the alter ego doctrine warranted piercing the corporate veil ; 2) the subsidiary was an agent of the parent in the transaction giving rise to the lawsuit ; 3) the relationship is such that the agent-subsidiary can secure documents of the principal-parent to meet its own business needs and documents helpful for use in litigation ; 4) there is access to documents when the need arises in the ordinary course of business ; or 5) the subsidiary was a marketer and servicer of the parent s product... in the United States. ASAT, Inc., 411 F.3d at 254 (outlining the five grounds from Gerling). Fourth and finally, Gerling decided when the corporate party is the sister corporation under common control and another sister corporation possesses the records, control will exist only where the sister corporation was found to be the alter ego of the litigating entity,... or where the litigating corporation had acted with its sister in effecting the transaction giving rise to suit and is litigating on its behalf. 839 F.2d at 141 (citations omitted). In terms of the specific facts applied to the Gerling framework, courts have therefore considered whether: the affiliates are wholly-owned; the affiliates have different places of incorporation; the affiliates have independent decisionmaking power over their day-to-day operations; the affiliates have separate finances; the affiliates have the power to elect a majority of their board of directors; the affiliates share corporate directors, officers, and executive and administrative personnel; the affiliates operate as a single functional unit in all aspects of the business; the affiliates could secure documents that are helpful for use in the litigation; the affiliates obtain and use the information in the normal course of their business; the information is readily accessible in the normal course of the affiliates businesses; the information is commonly accessible in document storage systems or computer networks; and the affiliates access to the information is necessary to their business. When considering the production of overseas records, companies should first determine whether the records are outside their possession, custody, or control under the foregoing analytical framework. B. PRODUCTION OF OVERSEAS RECORDS IS BURDENSOME. Even if foreign records fall within a company s possession, custody, or control, production may be too burdensome and exceed a point of diminishing -- 29 --

returns for permissible discovery. See Fed. R. Civ. P. 26(b)(2) (limit extent of discovery if the burden or expense of the proposed discovery outweighs its likely benefit ); Fed. R. Civ. P. 26(c)(1) (issue protective order if undue burden or expense ); Manual for Complex Litigation 11.443 (4th ed. 2009) (with respect to document production, the court should... ensure that the burdens are fairly allocated and prevent indiscriminate, overly broad, or unduly burdensome demands ). While companies should assess on a case-by-case basis whether and what foreign records should be produced, they should also actively resist a global production of foreign files. Now is the time to frame the issues for judges who might otherwise be inclined to permit broad discovery. Put simply, the foreign records are of limited relevance and their wholesale production would be highly burdensome. For example, In re Gadolinium-Based Contrast Agents denied plaintiffs request that General Electric Healthcare produce all foreign labels, chemistry reviews conducted at the request of foreign agencies or communicated to foreign agencies, and causation analyses conducted in foreign countries. The Gadolinium court limited discovery instead to the 5 bellwether countries for labels [and causation studies] going back no further than January 1, 2000. See Order, In re Gadolinium-Based Contrast Agents Prods. Liab. Litig., MDL No. 1909, slip op. at 3 4 (N.D. Ohio Aug. 18, 2008). Similarly, In re NuvaRing limited foreign discovery to European Union custodians, matching the scope of a prior state court order. See Order, In re NuvaRing Prods. Liab. Litig., No. 4:08-md-1964, slip op. at 1 (E.D. Mo. Dec. 4, 2009). In re Seroquel allowed foreign discovery when plaintiffs pursued a narrowed request for [n]otes regarding contacts with any foreign regulatory authority [in six countries]. In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769, 2008 WL 508391, at *1, 2 3 (M.D. Fla. Feb. 21, 2008). The court granted plaintiffs request, but only to the extent the information [wa]s located in the United States and kept in electronic form. Id. C. OVERSEAS RECORDS ARE NOT REASONABLY CALCULATED TO LEAD TO RELEVANT EVIDENCE. Foreign discovery is not only burdensome (and in some cases, cumulative and duplicative), it may ultimately add little to no value in the trial of plaintiff s case. Most compellingly, the court in Harrison v. Wyeth Laboratories explained that: Each government must weigh the merits of permitting the [product] s use and the necessity of requiring a warning. Each makes its own determination as to the standards of degree of safety and duty of care. This balancing of the overall benefits to be derived from a product s use with the risk of harm associated with that use is peculiarly suited to a forum of the country in which the product is to be used. Each country has its own legitimate concerns and its own unique needs.... 510 F. Supp. 1, 4 5 (E.D. Pa. 1980) (Weiner, J.) (dismissing case on forum non conveniens grounds where foreign regulatory standards regarding drug safety were at issue, and finding [q]uestions as to the safety of drugs marketed in a foreign country are properly the concern of that country ), aff d, 676 F.2d 685 (3d Cir. 1982). However, courts have not excluded foreign records uniformly from discovery. In allowing overseas discovery, In re Gadolinium-Based Contrast Agents concluded that evidence of foreign regulatory events that bear upon [defendant] s knowledge of [the product] s safety risks and its post-marketing surveillance efforts may be admissible. In re Gadolinium-Based Contrast Agents Prods. Liab. Litig., No. 1:08-GD-50000, 2010 WL 1796334, at *17 (N.D. Ohio May 4, 2010). Likewise, In re Seroquel permitted foreign discovery and noted information that foreign regulators communicated to [defendant] regarding [the product] s safety profile, such testimony may be admissible. In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769, 2009 WL 3806436, at *5 (M.D. Fla. July 20, 2009) (emphasis original). II. PRECLUDE OVERSEAS RECORDS FROM BECOMING EVIDENCE AT TRIAL. When overseas records are discoverable, they nevertheless may not be admissible at trial. Indeed, motion practice during discovery allows the trial court to understand early on the basis of a parties ultimate objection to the admissibility of foreign records at trial. Pretrial motions, however, are the best time to point out all the reasons that the records are not proper evidence for trial in a domestic courtroom. For example, plaintiffs in product liability actions may try to offer foreign standards or product models to -- 30 --

show that: (1) reasonable alternative designs existed; (2) the company had knowledge of an alternative design or potential defect; (3) the company failed to warn the consumer of non-obvious hazards learned of overseas; or (4) the company breached its duty of care. Accordingly, companies should move in limine to exclude the foreign records on several bases: (1) relevance under Federal Rule of Evidence 402; (2) unfairly prejudicial, confusing, or misleading under Federal Rule of Evidence 403; (3) hearsay under Federal Rule of Evidence 802; and (4) standards for limiting expert testimony under Federal Rules of Evidence 701 through 703 and Daubert. As discussed below, Federal Rule of Evidence 403 ultimately provides the strongest basis for companies to exclude foreign records. Rule 403, of course, excludes otherwise relevant information if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence. Indeed, foreign records are in many ways the perfect illustration of Rule 403, both in terms of their being unduly prejudicial and in promoting undue delay in having to put them in context, or explain their meaning. Foreign records can also be highly prejudicial as they are used to suggest that companies failed to apply the same standards domestically as they do in foreign countries, or that the companies failed to disclose information here which was learned overseas. Plaintiffs lawyers can comb through foreign discovery for the single country in which an arguably heightened warning was given, and efforts to put that country s warning into context still may not cure this prejudice. See, e.g., Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478, 1479 (E.D. Okla. 1997) (finding U.S. warning called for [c]lose supervision of high-risk patients... [during] initial drug therapy, while the German warning required continuous monitoring and suggested additional sedative therapy ); Axen v. Am. Home Prods. Corp., 974 P.2d 224, 242 (Or. Ct. App. 1999) (finding manufacturer failed to change its labeling even though... it was aware that its Canadian counterpart had been required to change its labeling to clarify the danger of vision loss ). The prejudice is enhanced by the challenge in producing witnesses who can testify in a United States courtroom about the foreign evidence. For instance, while a plaintiff might be allowed to introduce this evidence through expert testimony, or by prevailing on a court s liberal standards for allowing any corporate document to be used against a company, that company may be hard-pressed to produce company witnesses who can explain the foreign evidence to an American jury. In the same vein, foreign evidence promotes mini-trials on extraneous issues. While a plaintiff s lawyer may quickly, and misleadingly, suggest that a company hid a foreign labeling change from American consumers, it may take complicated regulatory testimony to explain why a foreign label change is irrelevant and involves standards inapplicable in the United States. But even after this explanation, the taint from the plaintiff lawyer s superficial argument if it was good enough for [insert country], it should have been good enough for [Mr. and Mrs. Plaintiff] will likely persist. The decisions on overseas evidence show evolving approaches by courts in handling the issue of admissibility. It is therefore hard to argue acrossthe-board principles. The following summarizes the decisions as they have unfolded over time. Two Minnesota opinions during the 1980s lead the way on admissibility of foreign standards and product models. In Tews v. Husqvarna, Inc., plaintiff offered expert testimony on Swedish standards for chain saws to imply that the Swedish defendant company should have followed Swedish, rather than American, regulations for saws sold in this country. 390 N.W.2d 363, 366 (Minn. App. 1986). The Minnesota trial court allowed testimony about the foreign design, while excluding the foreign legal standards, and was affirmed on appeal: [T]he trial court did not err in excluding testimony concerning the legal requirements for chain brakes in foreign jurisdictions. The court admitted testimony on current chain saw technology from around the world, but explained that while technology available in other jurisdictions is relevant, legal standards in other jurisdictions are not.... We cannot say that the trial court abused its discretion in excluding this evidence. Id. at 367. The Minnesota appellate court had rejected evidence of foreign standards previously for press brakes on prejudice grounds. Buzzell v. Bliss, 358 N.W.2d 695, 699 (Minn. App. 1984) ( [I]ts probative value was outweighed by its potential to confuse or mislead the jury. ). -- 31 --

The chain saw issue in Tews reached the federal courts in Deviner v. Electrolux Motor, AB, 844 F.2d 769 (11th Cir. 1988). The Deviner trial court concluded that Swedish Standards are not relevant in a U.S. product liability case involving a saw sold in the U.S. in 1981. Id. at 771 n.3. The Eleventh Circuit affirmed and determined that [t]he District Court s desire to avoid confusing the jury with Swedish law and statistics cannot rightly be described as abuse of discretion, when the issues aris[e] under Alabama and federal law. Id. at 773. A few years later, the Sixth Circuit followed Deviner in holding expert testimony about foreign safety mandates should be excluded. Hurt v. Coyne Cylinder Co., 956 F.2d 1319, 1327 (6th Cir. 1992). The Hurt court offered little analysis, concluding simply that foreign legal standards have been found excludable [in Deviner], and we will follow that holding. Id. In Jones v. Lederle Laboratories, a court in the Second Circuit applied a similar principle to a design defect case, holding as a matter of law that a vaccine approved in Japan but not in the United States could not qualify as an alternative design : The evidence is essentially uncontested that defendant could not have produced and marketed the safer [Japanese] vaccine that plaintiff s experts say would have avoided [plaintiff s] injuries. Once this conclusion is reached, there is nothing left to the case. The warnings were adequate. The production was not defective it was in accordance with the design. No safer alternative design was available.... No basis for liability has been shown. 785 F. Supp. 1123, 1127 (E.D.N.Y. 1992), aff d, 982 F.2d 63 (2d Cir. 1992). But soon after Hurt and Jones, the Texas Court of Appeals held that foreign designs were relevant to the plaintiff s design defect case. Cantrell v. Hennessey Ind., Inc., 829 S.W.2d 875, 877 (Tex. App. 1992). When plaintiff offered a European model of defendant s tire-changing machine, which contained a pressurelimiting device, as evidence that the alternative design was technically feasible and available years before the allegedly defective American product was manufactured, the Cantrell court concluded that: Whether a safer design suitable for one machine is adaptable to another is a question of feasibility to be decided by the trier of fact, not a question to be resolved in ruling on discovery requests. Evidence of the actual use of, or availability of practical, safer alternatives is therefore relevant. Id. (citations omitted). In line with Cantrell, Sherry v. Massey Ferguson, Inc. admitted foreign design evidence where the defendant manufactured two different tractors one model with a passenger seat that was sold in Europe, and an American model without a passenger seat. No. 1:96-CV-76, 1997 WL 480893, at *1 (W.D. Mich. June 5, 1997). The Sherry court admitted photographs illustrating the European tractor designs and explained the purported difference between foreign standards and product designs: In both Hurt and Deviner, the courts held that the district court did not err by refusing to admit evidence of foreign legal standards because evidence of such foreign requirements could lead to jury confusion. Neither case, however, held foreign legal standards were inadmissible as a matter of law, merely that declining to admit such evidence did not constitute an abuse of discretion. Neither case addressed whether the evidence was admissible on an issue such as feasibility. Moreover, in Deviner, the court expressly based its decision on the potential for jury confusion concerning the appropriate legal standard. While I agree that evidence of European legal standards and requirements... will unnecessarily confuse the jury, plaintiffs have not at this time sought to introduce foreign legal standards. Instead, plaintiffs contend that evidence of foreign tractor design is relevant to the feasibility of alternate tractor designs, and potentially to defendants knowledge of such alternate designs. Evidence that an alternate tractor design was in production at the time of the subject tractor s manufacture unquestionably is relevant to the feasibility of plaintiffs design theory. Advertisement of such alternate designs may also be relevant to defendants knowledge of such alternatives. Id. at *1; see also Tobin v. SmithKline Beecham Pharms., No. 00-cv-0025, 2001 WL 36102165, at *1 -- 32 --

(D. Wyo. May 18, 2001) ( [F]oreign product labeling evidence relevant since it may potentially demonstrate the defendant s knowledge of potential side effects resulting from the ingestion of Paxil. The foreign labeling evidence may also demonstrate the adequacy of the warning provided by the defendant to customers in the United States. ). In yet another farm equipment case, Blevins v. New Holland N.A., Inc. denied defendant s motion in limine to exclude foreign safety standards or tests performed in the furtherance of such standards. 128 F. Supp. 2d 952, 959 (D.W.V. 2001). The Blevins court held the evidence was relevant to an allegedly negligent design of the guarding on a hay baler: Id. Both engineering principles and human nature transcend national boundaries, and thus under certain circumstances proof of foreign standards may be relevant and helpful to a jury in determining the issues. In In re Rezulin, a defendant sought to exclude all evidence, expert or otherwise, on the subject of foreign regulatory actions. In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 552 (S.D.N.Y. 2004). The Rezulin court disagreed and found no legal basis upon which now to rule, as urged by [defendant], that testimony regarding foreign regulatory actions is irrelevant as a matter of law in a United States products liability case governed by American law. The authorities cited by the defendants do not stand for this broad proposition, but rather reflect decisions by various courts to exercise their discretion, in particular cases, to admit or exclude testimony on foreign standards or practices. Id. at 553. A few years later, in a failure to warn context, the Sixth Circuit found plaintiffs could not use a foreign regulatory decision to create a triable issue on the adequacy of a United States drug s label: Plaintiffs also allege that the warning label for [the drug s] European equivalent contains more detailed instructions for the treating physician. Citing no authority, Plaintiffs argue that the difference in instructions creates a triable issue of fact. We disagree. American regulators have different priorities and deal with often more diverse populations than their European counterparts.... Plaintiffs have failed to make a showing of inadequacy such that a reasonable jury could find for the nonmoving party. Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861, 867 (6th Cir. 2006); see also In re Vioxx, 448 F. Supp. 2d 741, 748 (E.D. La. 2006) (dismissing a foreign plaintiffs suit over foreign drugs taken in foreign countries, and finding [a]n American jury would also have no good means of evaluating whether a given foreign label or marketing scheme was adequate ). Next in Katzenmeier v. Blackpowder Products, Inc., an Iowa District court decided (and the Eighth Circuit affirmed) that European gun standards should be excluded. The district court concluded that: [T]his case is governed by domestic law standards concerning which it is undisputed there is no government or industry standard or procedure.... Evidence of stricter... European laws and regulations is likely to confuse and mislead the jury to defendants unfair prejudice. Katzenmeier, No. 4:06-cv-00169-RAW, 2008 WL 8586676, at *2 (S.D. Iowa Nov. 25, 2008). The Eighth Circuit affirmed, adding that evidence of foreign regulations in a case governed by domestic law has been found excludable because it likely leads to confusion of the jury. Katzenmeier v. Blackpowder Products, Inc., 628 F.3d 948, 950 n.4 (8th Cir. 2010) (citations omitted). The issue of foreign regulation came up next in the drug context when a Federal court excluded foreign regulatory activity because allowing the admission of evidence of foreign regulatory actions, in a case that is governed by domestic law, would likely cause jury confusion. In re Baycol Prods. Liab. Litig., 532 F. Supp. 2d 1029, 1054 (D. Minn. 2007). The same result was reached in In re Viagra Products Liability Litigation, 658 F. Supp. 2d 950 (D. Minn. 2009). Relying on Baycol, the Viagra court held that plaintiffs expert testimony about foreign regulatory conclusions was both irrelevant and confusing: The Court finds that any discussion of foreign regulatory actions is irrelevant to the current litigation and should therefore be excluded.... Further, the Court finds that to the extent that foreign regulatory information is relevant, its probative value is substantially outweighed -- 33 --

by the danger of unfair prejudice, confusion of the issues, or misleading the jury. 658 F. Supp. 2d at 965 66. Similarly, In re Seroquel concluded that evidence of foreign regulatory non-approval was inadmissible: The foreign [drug] labels and the foreign regulatory actions have no relevance to Plaintiffs main case. More importantly, whatever minimal relevance the foreign regulatory actions might have is clearly overwhelmed by the likelihood of jury confusion.... Plaintiffs approach of allowing the evidence of foreign regulations and dispositions as to [the drug] which the Court views as akin to evidence of foreign legal standards even with Plaintiffs proposed limiting instruction, will not alleviate the risk of jury confusion. In re Seroquel Prods. Liab. Litig., 06-md-1769, 2009 WL 223140, at *5 6 (M.D. Fla. Jan. 30, 2009). The In re Seroquel court also adopted a magistrate s conclusion that even if foreign regulatory actions could be relevant to notice, they were prejudicial and inordinately time consuming. Id. (citing In re Seroquel Prods. Liab. Litig., 601 F. Supp. 2d 1313 (M.D. Fla. 2009)). Without the necessary context, the jury might be tempted to defer to the negative decisions of... foreign regulators concerning the drug. 601 F. Supp. 2d at 1318. Indeed, providing context to explain foreign evidence was also a waste of time because this evidence would result in a series of mini-trials regarding the grounds for the decisions and the regulatory schemes of the three foreign countries involved. This would confuse the jury and waste everyone s time. Id. Last year, in Hogan v. Novartis Pharmaceuticals Corp., a District Court found I do not see the relevance of foreign regulatory actions and materials. No. 06-cv- BMC-RER, 2011 WL 1533467, at *13 (E.D.N.Y. April 24, 2011). And then, Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc. agreed in a case involving an allegedly defective child seat that foreign standards are irrelevant and prejudicial: Evidence of foreign labeling requirements is inherently prejudicial and presents a substantial risk of jury confusion. Plaintiff has also failed to show that [defendant s] obligations under Canadian law are relevant here. As Plaintiff observes, [defendant] simply placed whatever labels conformed to the location where the [products] were sold. Standing alone, this difference in American and Canadian labeling requirements does not speak to the wisdom or safety of the product s design. No. 07-cv-4029, 2011 WL 3740472 (E.D. Pa. Aug. 25, 2011). The foregoing cases, though somewhat patchwork, indicate that the most effective strategy in precluding the admission of foreign designs and standards is to focus on the dissimilarities between the legal and regulatory requirements in the foreign country and those applicable in the United States. This strategy includes establishing a foundation, through testing or with an expert s opinion, that a product made to the foreign standard would not comply with the standard applicable in the United States. Without such evidence or opinion, features on overseas products are far more likely to be admissible as alternate designs. III. PREPARE TO MINIMIZE THE IMPACT OF OVERSEAS RECORDS AS EVIDENCE AT TRIAL. Of course, trial courts have wide discretion when it comes to the admission of evidence, so despite all the best efforts to prevent overseas records from becoming evidence, they may still be admitted. Consequently, litigants should prepare early in litigation to minimize the impact of overseas records as evidence at trial. In particular, companies should develop both the people and the theme to explain the foreign evidence. Possible witnesses include company representatives and experts to place the evidence in context with the actual issues at trial. For instance, a warning may use different language simply because the foreign standard requires it. Or, a product design may simply provide the features required by an overseas standard, custom or manner of usage that is not present in this country. The company has to explain that just because something is done differently overseas does not mean that what is done or produced here is defective, or sub-standard. Different does not mean defective or negligent. Admitting this evidence at trial, however, often requires significant advanced planning. The proper witnesses (whether fact or expert) have to be disclosed on a timely basis and their testimony preserved so it can be admitted at trial. This should not wait until the eve of trial. If an affiliate company s employee must be deposed, help from in-house personnel with the -- 34 --

business relationship with the affiliate may be needed to secure a de bene esse deposition. Anticipating early on in the litigation the need to explain something produced from an overseas parent, subsidiary or affiliate corporation is essential. With the proper theme and plan, you can prevent negative overseas evidence from becoming the centerpiece of your trial. -- 35 --

About Joseph J. Krasovec, III Partner Schiff Hardin Chicago, IL 312.258.5639 jkrasovec@schiffhardin.com Joseph J. Krasovec concentrates his practice on the defense of manufacturers in product liability matters. He also represents a variety of businesses in commercial disputes. He practices in state and federal courts, at the trial and appellate levels. Mr. Krasovec has managed cases from the beginning of the discovery phase, through trial, and to the appellate level. He also is experienced in structuring settlements in cases involving multiple parties and complex issues. In addition to trying cases in courtrooms around the country, Mr. Krasovec also counsels manufacturers in the product development phase regarding potential liability considerations, advising them on product labeling, instructions, testing and design. Specifically, Mr. Krasovec serves as national product liability counsel for two large consumer product manufacturers. He has worked with manufacturers of such products as: Juvenile products, including child car seats, swings, playyards and strollers Air compressors Power and hand tools, including saws, lathes, dust collectors and hydraulic lift jacks Corded window coverings Gas barbecue grills Commercial printing presses Hot beverage dispensers Portable camping heaters Electric switches Pill manufacturing equipment Awards and Honors Leading Lawyer Commercial Litigation; Product Liability Defense, Illinois Leading Lawyers Network Education Northwestern University School of Law (J.D., 1989) University of Denver(B.S., Finance, cum laude, 1986) -- 36 --