In re Ephedra Products Litigation, No. 06-2071 (2d Cir. 2010)

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The court issued a subsequent related opinion or order on February 8, 2011.

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06-2071-cv In re Ephedra Products Litigation 1 UNITED STATES COURT OF APPEALS 2 FOR THE SECOND CIRCUIT 3 August Term, 2007 4 5 6 7 (Argued: November 8, 2007 Final Submission: April 7, 2009 Question Certified: March 17, 2010) 8 ------------------------------------- 9 JOHN GIORDANO, 10 Plaintiff-Appellant, 11 - v - 12 MARKET AMERICA, INC., and THE CHEMINS COMPANY, INC., 13 Defendants-Appellees. 14 ------------------------------------- 15 16 Docket No. 06-2071-cv Before: McLAUGHLIN, CABRANES, and SACK, Circuit Judges. Appeal from a judgment of the United States District 17 Court for the Southern District of New York (Jed S. Rakoff, 18 Judge) in a personal injury action alleging injuries resulting 19 from the ingestion of ephedra. 20 summary judgment to the defendants on statute-of-limitations 21 grounds after concluding that the extended limitations period 22 provided by N.Y. C.P.L.R. § 214-c(4) was inapplicable to the 23 plaintiff's claim because his injuries were not caused by "latent 24 effects" of exposure to ephedra. 25 district court to permit it to determine whether, for purposes of 26 N.Y. C.P.L.R. § 214-c(4), there was a genuine issue of material 27 fact for determination by a trier of fact as to whether The district court granted We remanded the cause to the 1 sufficient technical, scientific, or medical knowledge of the 2 cause of injury had been discovered, identified, or determined 3 during the original three-year limitations period for filing a 4 claim. 5 returned to us. 6 separate questions of New York law, each of which has yet to be 7 addressed by New York courts and involves questions of public 8 policy that New York courts are better situated to resolve than 9 are we. Upon the court's response in the affirmative, the appeal Resolving it now requires answering three We therefore certify the following three questions to 10 the New York Court of Appeals: (1) Are the provisions of N.Y. 11 C.P.L.R. § 214-c(4) providing for an extension of the statute of 12 limitations in certain circumstances limited to actions for 13 injuries caused by the latent effects of exposure to a substance? 14 (2) Can an injury that occurs within 24 to 48 hours of exposure 15 to a substance be considered "latent" for these purposes? 16 What standards should be applied to determine whether a genuine 17 issue of material fact exists for resolution by a trier of fact 18 as to whether "technical, scientific or medical knowledge and 19 information sufficient to ascertain the cause of [the 20 plaintiff's] injury" was "discovered, identified or determined" 21 for N.Y. C.P.L.R. § 214-c(4) purposes? (3) 22 23 24 25 26 BRIAN J. ISAAC, Pollack, Pollack, Isaac & De Cicco, for Sanders, Sanders, Block & Woycik, P.C. (Joseph B. Viener, of counsel), New York, NY, for PlaintiffAppellant. 27 28 29 ANDREW ZAJAC, Fiedelman & McGaw, Jericho, NY, for Defendant-Appellee Market America, Inc. 2 1 2 3 4 5 Edward J. Stolarski, Jr., Wilbraham, Lawler & Buba, Philadelphia, PA, for Defendant-Appellee The Chemins Company, Inc. SACK, Circuit Judge: 6 Plaintiff John Giordano appeals from a judgment of the 7 United States District Court for the Southern District of New 8 York (Jed S. Rakoff, Judge) in a personal injury action filed by 9 Giordano against defendants Market America, Inc., and The Chemins 10 Company, Inc. 11 containing the substance ephedra that the defendants supplied 12 caused his March 1999 cerebral aneurism and subsequent medical 13 events. 14 judgment for the defendants on the grounds that Giordano's 15 lawsuit, filed on July 28, 2003, was barred by the three-year 16 statute of limitations set forth in N.Y. C.P.L.R. § 214. 17 re Ephedra Prods. Liab. Litig., Nos. 04 M.D. 1598, 05 Civ. 1018, 18 2006 WL 944705, at *1, 2006 U.S. Dist. LEXIS 18691, at *1-2 19 (S.D.N.Y. Apr. 10, 2006) ("Ephedra II"). 20 that the one-year extension of the statute of limitations 21 provided for in N.Y. C.P.L.R. § 214-c(4) for situations in which 22 the cause of the injury was not discovered during the original 23 three-year period to file suit was inapplicable because section 24 214-c(4) is limited to latent injuries and that injuries caused 25 by ephedra were not latent. 26 27 Giordano alleges that dietary supplements On April 10, 2006, the district court granted summary See In The court concluded Id. The plaintiff appealed from the district court's judgment and we heard oral argument on November 8, 2007. 3 On 1 August 18, 2008, we remanded for the limited purpose of asking 2 the district court to determine whether a genuine issue of 3 material fact existed as to whether an additional requirement of 4 N.Y. C.P.L.R. § 214-c(4) had been met, namely that Giordano 5 "allege and prove that technical, scientific or medical knowledge 6 and information sufficient to ascertain the cause of his injury 7 had not been discovered, identified or determined" prior to the 8 expiration of the otherwise applicable three-year statute of 9 limitations. See Giordano v. Mkt. Am., Inc., 289 F. App'x 467, 10 469 (2d Cir. 2008) (summary order). 11 response to our question and with expressed doubt as to the 12 standard to be applied under New York law, the district court 13 concluded that under any possible standard there was a genuine 14 issue of material fact as to whether sufficient information had 15 been "discovered, identified or determined" at the relevant time. 16 See In re Ephedra Prods. Liab. Litig., 598 F. Supp. 2d 535, 537 17 (S.D.N.Y. 2009) ("Ephedra III"). 18 On February 24, 2009, in The applicability of N.Y. C.P.L.R. § 214-c(4) to 19 Giordano's claims is now before this Court again. 20 of this issue requires us to answer three separate questions of 21 New York law: (1) Are the provisions of N.Y. C.P.L.R. § 214-c(4) 22 providing for an extension of the statute of limitations in 23 certain circumstances limited to actions for injuries caused by 24 the latent effects of exposure to a substance?; (2) Can an injury 25 that occurs within 24 to 48 hours of exposure to a substance be 26 considered "latent" for these purposes?; (3) What standards 4 The resolution 1 should be applied to determine whether a genuine issue of 2 material fact exists for resolution by a trier of fact as to 3 whether "technical, scientific or medical knowledge and 4 information sufficient to ascertain the cause of [the 5 plaintiff's] injury" was "discovered, identified or determined" 6 for N.Y. C.P.L.R. § 214-c(4) purposes? 7 question requires us to decide both the level of certainty 8 required for knowledge to be deemed "sufficient to ascertain" the 9 cause of an injury, and the community that must possess this Resolving the third 10 knowledge -- that is, whether the knowledge must be reasonably 11 available to a plaintiff and his or her lawyers, or whether it 12 must be reasonably available to the scientific, technical, or 13 medical community. 14 In this instance, the district court found that "some 15 studies suggesting a possible connection between ephedra and 16 injuries similar to Giordano's were published in reputable 17 scientific journals that were publicly available" during the 18 three-year period after discovery of Giordano's injury, but that 19 there was "a lack of awareness of the risks by even the most 20 interested members of the public" during that time. 21 598 F. Supp. 2d at 537 n.1. 22 Ephedra III, The three questions of statutory interpretation raised 23 by this appeal have not been answered conclusively by New York 24 courts. 25 pertaining to how the New York Legislature intended to balance 26 the rights of those suffering personal injuries with the rights They, in turn, implicate questions of public policy 5 1 of defendants and with the need for judicial economy. 2 courts are better situated to answer these questions than are we. 3 We therefore certify them to the New York Court of Appeals. 4 BACKGROUND 5 New York Pursuant to an order of the Judicial Panel on 6 Multidistrict Litigation, see 28 U.S.C. § 1407, the district 7 court that decided this case is charged with managing some 500 8 civil actions, including this one, involving claims of "personal 9 injury or wrongful death caused by dietary supplements containing 10 ephedra." 11 181, 184 (S.D.N.Y. 2005) ("Ephedra I"). 12 containing "ephedrine alkaloids." 13 recently, products containing ephedra were widely used by 14 consumers seeking "weight loss, increased energy and improved 15 athletic performance." 16 In re Ephedra Prods. Liab. Litig., 393 F. Supp. 2d Ephedra is a plant Id. at 185. Until relatively Id.; see also id. at 189 n.4. The Food, Drug, and Cosmetic Act ("FDCA") prohibits 17 "[t]he introduction or delivery for introduction into interstate 18 commerce of any food . . . that is adulterated . . . ." 19 U.S.C. § 331(a). 20 shall be deemed to be adulterated . . . [i]f it is a dietary 21 supplement or contains a dietary ingredient that . . . presents a 22 significant or unreasonable risk of illness or injury . . . ." 23 Id. § 342(f)(1)(A). 24 and Drug Administration ("FDA") effectively banned ephedra by 25 declaring dietary supplements containing ephedrine alkaloids 21 Section 402 of the FDCA provides that a "food On February 11, 2004, the United States Food 6 1 "adulterated" under the FDCA. 2 Declaring Dietary Supplements Containing Ephedrine Alkaloids 3 Adulterated Because They Present an Unreasonable Risk ("FDA Final 4 Rule"), 69 Fed. Reg. 6788 (Feb. 11, 2004). 5 effective on April 12, 2004. 6 See 21 C.F.R. § 119.1; Final Rule This rule became Id. The district court's opinion in Ephedra I granting in 7 part and denying in part motions to exclude expert testimony 8 pursuant to Rule 702 of the Federal Rules of Evidence and Daubert 9 v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), provides 10 background regarding the alleged effects of ephedra. 11 According to the consolidated plaintiffs' experts: 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 [E]phedra can cause injury in susceptible people by increasing their blood pressure and heart rate. . . . [A]n individual's blood pressure and heart rate normally vary over the course of a day, week and season, and . . . the effects of ephedra in an individual also vary over the course of the day in relation to when it was ingested and the individual's metabolism. If ephedra can sometimes be a contributing cause of heart attack, stroke, or sudden death in susceptible people, the injury might be triggered by the coincidence of peak events, such as transient peak blood pressure due to other causes occurring at the same time as peak ephedrine blood level. The longer the duration of repeated exposure, the more likely such coincidence will occur. 30 Ephedra I, 393 F. Supp. 2d at 192 n.8. 31 According to the FDA: 32 33 34 35 36 37 People who use dietary supplements containing ephedrine alkaloids are at increased risk for serious adverse events, including heart attack, stroke, and death. Susceptible individuals (e.g., those with coronary artery disease or heart failure), many of whom may 7 1 2 3 4 5 6 7 8 9 10 11 12 not know they have underlying illnesses, are at increased risk for adverse events because these products can cause abnormal heart rhythms (pro-arrhythmic effect), even when the product is ingested at recommended doses over a short course (one or a few doses). Over longer periods of use, the risk for adverse health effects to the general population, including susceptible individuals, increases further due to a sustained elevation in blood pressure. FDA Final Rule, 69 Fed. Reg. at 6825. 13 Before the district court, all parties 14 15 16 17 18 19 20 21 22 agree[d] that a recommended dose of a product containing ephedra . . . often raises the user's blood pressure and/or heart rate during the first few hours after ingestion, and they agree[d] that any increase maintained over years in a person's usual blood pressure or heart rate significantly increases the risk of cardiac injury and stroke. 23 Ephedra I, 393 F. Supp. 2d at 193-94 (emphasis omitted). 24 The district court also noted in its decision granting 25 summary judgment to the defendants here that "ephedra acts within 26 a few hours to cause a transitory elevation of blood pressure and 27 heart rate and a temporary constriction of certain blood 28 vessels." 29 LEXIS 18691, at *3-*4. 30 Ephedra II, 2006 WL 944705, at *1, 2006 U.S. Dist. For approximately two years, ending on March 15, 1999, 31 Giordano used "ThermoChrome 5000," a dietary supplement 32 containing ephedra. 33 Inc., manufactured ThermoChrome 5000; defendant-appellee Market 34 America, Inc., distributed it. Defendant-Appellee The Chemins Company, 8 1 On March 15, 1999, Giordano suffered a cerebral 2 aneurysm. 3 two strokes on March 17, 1999 -- two days later. 4 with substantial cognitive, motor, and visual deficits. 5 Giordano's physicians were unable to determine the cause of the 6 aneurysm or the strokes. 7 He underwent neurosurgery to repair it, but suffered He was left Nearly four years later, in February 2003, Giordano 8 became aware of news reports that the sudden death of 9 major-league baseball player Steve Bechler might have been linked 10 to his use of an ephedra-based dietary supplement. 11 Giordano's affidavit, these news reports were his first 12 indication that ThermoChrome 5000 may have been a cause of his 13 aneurysm and strokes. 14 According to Some five months later, on July 28, 2003, Giordano 15 instituted this action in New York State Supreme Court. 16 defendants removed it to the United States District Court for the 17 Southern District of New York on the basis of diversity of 18 citizenship. 19 moved for summary judgment on statute-of-limitations grounds. 20 April 10, 2006, the district court granted the summary judgment 21 motions. 22 LEXIS 18691, at *4. 23 See 28 U.S.C. §§ 1332, 1441. The They subsequently On Ephedra II, 2006 WL 944705, at *2, 2006 U.S. Dist. Giordano appealed. After hearing argument on November 8, 2007, we remanded 24 pursuant to the procedures set forth in United States v. 25 Jacobson, 15 F.3d 19, 22 (2d Cir. 1994), for the limited purpose 9 1 of having the district court decide whether a genuine issue of 2 material fact existed as to whether an additional requirement of 3 N.Y. C.P.L.R. § 214-c(4) had been met, namely that the plaintiff 4 "allege and prove that technical, scientific or medical knowledge 5 and information sufficient to ascertain the cause of his injury 6 had not been discovered, identified or determined" prior to the 7 expiration of the otherwise-applicable three-year statute of 8 limitations. 9 district court concluded that such knowledge had been discovered, See Giordano, 289 F. App'x at 469. Had the 10 identified or determined prior to the expiration of the 11 otherwise-applicable statute of limitations, and had we affirmed 12 on that issue on appeal, we would have been in a position to 13 affirm the district court's summary judgment without further 14 addressing the other questions raised on appeal. 15 Although it expressed doubt as to what standard to 16 apply, the district court answered this question in the 17 affirmative under any standard. 18 537. 19 to consider certification to the [New York] Court of Appeals to 20 sort this all out." 21 itself to certify questions to the Court of Appeals, the 22 district court was "bound to follow the interpretation of the 23 Appellate Division in the absence of persuasive evidence that 24 the New York Court of Appeals would rule differently if Ephedra III, 598 F. Supp. 2d at It also suggested that, on further appeal, we might "want Id. at 536-37. 10 Lacking the authority 1 presented with the issue," id. at 537, which the district court 2 did. 3 The defendants now seek review of the district court's 4 findings with respect to the existence of sufficient technical, 5 scientific or medical knowledge to ascertain the cause of injury, 6 and also seek affirmance of the district court's prior holding 7 that N.Y. C.P.L.R. § 214-c(4) was inapplicable because ephedra 8 did not cause any latent injuries. 9 Ltr. Br. at 5-8 (filed Mar. 19, 2009); Appellee Chemins Co. Ltr. See Appellee Market America 10 Br. at 1-5 (filed Mar. 20, 2009). 11 defendants seek certification of these issues to the New York 12 Court of Appeals. 13 8. 14 In the alternative, the See, e.g., Appellee Market America Ltr. Br. at Giordano, conversely, seeks affirmance of the district 15 court's findings with respect to the existence of sufficient 16 knowledge of causation, and reversal of the court's findings 17 regarding latency. 18 Court of Appeals at this time. 19 Appellees' Ltr. Br. at 1-6 (filed Mar. 31, 2009). 20 for resolution of these issues without the further expenditure of 21 time and money with an uncertain result is understandable. 22 23 He opposes certification to the New York See Appellant's Aff. in Opp. to His preference DISCUSSION New York Civil Practice Law and Rules § 214-c(4) 24 extends the statute of limitations for filing a personal injury 25 claim in specified circumstances if the cause of injury was not 26 and could not reasonably have been discovered during the three11 1 year period for filing a claim that is set forth in section 2 214(5). 3 answering three separate questions, the first of which is whether 4 section 214-c(4) is limited to injuries that are "latent." 5 Provided that the answer to that question is in the affirmative, 6 the second question is whether injuries caused by ephedra, which 7 are typically if not universally experienced within twenty-four 8 hours of its ingestion, are or may be "latent" for section 214- 9 c(4) purposes. Applying section 214-c(4) to the facts at hand requires If so, the third question is whether a genuine 10 issue of material fact exists for the trier of fact as to whether 11 technical, medical, or scientific knowledge sufficient to 12 ascertain the cause of Giordano's injury had been discovered, 13 identified, or determined during the otherwise-applicable three- 14 year period. 15 that has not previously been addressed by New York courts. 16 Each of these questions involves an issue of law In addressing the third question, we must take into 17 account that "some studies suggesting a possible connection 18 between ephedra and injuries similar to Giordano's were published 19 in reputable scientific journals that were publicly available" 20 during the three-year period after discovery of Giordano's 21 injury, but that there was "a lack of awareness of the risks by 22 even the most interested members of the public" during that time. 23 Ephedra III, 598 F. Supp. 2d at 537 n.1. 24 The third question is further complicated by two 25 ambiguities regarding the standard that should be used in 26 answering it. First, it is unclear what level of certainty is 12 1 required for knowledge to be "sufficient to ascertain" the cause 2 of an injury. 3 possess this knowledge, i.e., the plaintiff and his or her 4 lawyers, or the scientific, technical, or medical community. Second, it is unclear what relevant group must 5 I. Standard of Review 6 "We review a district court's grant of summary judgment 7 de novo. Summary judgment is warranted only where, construing 8 all the evidence in the light most favorable to the non-movant 9 and drawing all reasonable inferences in that party's favor, 10 there is no genuine issue as to any material fact and the movant 11 is entitled to judgment as a matter of law." 12 Consumer Prods. Mfg. Co., 583 F.3d 92, 96 (2d Cir. 2009) 13 (citations, internal quotation marks, and ellipsis omitted). 14 same standard applies whether summary judgment is granted on the 15 merits or on an affirmative defense such as the statute of 16 limitations. 17 (2d Cir. 1995). 18 appropriate means for disposing of an action that is barred by 19 the statute of limitations, it may not be granted if there is a 20 genuine issue of fact as to when the limitations period began or 21 expired and that fact is material to the question of whether the 22 statute has run. 23 Co.-Conn, 77 F.3d 603, 609 (2d Cir. 1996) (citing 10A Charles 24 Alan Wright et al., Federal Practice and Procedure § 2734, at 25 419, 421 (2d ed. 1983)). 26 II. McBride v. BIC The See Buttry v. Gen. Signal Corp., 68 F.3d 1488, 1492 Although summary judgment may, of course, be an See BellSouth Telecomm., Inc. v. W.R. Grace & New York's Statute of Limitations 13 1 Because our subject-matter jurisdiction rests on 2 diversity of citizenship and Giordano's cause of action arose in 3 New York, we apply New York's substantive law and statute of 4 limitations. 5 (1945); Stuart v. Am. Cyanamid Co., 158 F.3d 622, 626-27 (2d Cir. 6 1998), cert. denied, 526 U.S. 1065 (1999). 7 See Guaranty Trust Co. v. York, 326 U.S. 99, 109-11 New York Civil Practice Law and Rules § 214 sets forth 8 the generally applicable limitations period for personal-injury 9 claims: "[A]n action to recover damages for a personal injury," 10 N.Y. C.P.L.R. § 214(5), "must be commenced within three years," 11 id. § 214, "except as provided in[, inter alia,] section[] 214- 12 c," id. § 214(5). 13 14 Two provisions of section 214-c are relevant here. Section 214-c(2) provides: 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Notwithstanding the provisions of section 214, the three year period within which an action to recover damages for personal injury or injury to property caused by the latent effects of exposure to any substance or combination of substances, in any form, upon or within the body or upon or within property must be commenced shall be computed from the date of discovery of the injury by the plaintiff or from the date when through the exercise of reasonable diligence such injury should have been discovered by the plaintiff, whichever is earlier. Id. § 214-c(2). 29 30 Section 214-c(4) provides: Notwithstanding the provisions of subdivisions two and three[1] of this 1 Section 214-c(3) applies to claims, unlike this one, in which the law requires a "notice of claim [to] be filed or presented within a specified period." N.Y. C.P.L.R. § 214-c(3). It is not relevant to this action. 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 section, where the discovery of the cause of the injury is alleged to have occurred less than five years after discovery of the injury or when with reasonable diligence such injury should have been discovered, whichever is earlier, an action may be commenced or a claim filed within one year of such discovery of the cause of the injury; provided, however, if any such action is commenced or claim filed after the period in which it would otherwise have been authorized pursuant to subdivision two or three of this section the plaintiff or claimant shall be required to allege and prove that technical, scientific or medical knowledge and information sufficient to ascertain the cause of his injury had not been discovered, identified or determined prior to the expiration of the period within which the action or claim would have been authorized and that he has otherwise satisfied the requirements of subdivisions two and three of this section. Id. § 214-c(4). It is undisputed that Giordano did not commence 26 litigation within three years of being exposed to ephedra, and 27 that his suit was thus not commenced within the general 28 limitations period provided by section 214. 29 product containing ephedra for two years up to and likely 30 including March 15, 1999. 31 July 28, 2003, more than three but less than five years later. 32 Moreover, Giordano's claim is not covered by section He ingested the He did not file suit, however, until 33 214-c(2) because he did not assert it within three years of 34 discovering the injury alleged to have been caused by ephedra -- 35 the aneurysm, which occurred on March 15, 1999, and the strokes, 36 which occurred two days thereafter. 37 is whether section 214-c(4), which in certain circumstances 15 The question for us, then, 1 provides for a one-year limitations period running from the date 2 of discovery of the cause of an injury, saves Giordano's claim. 3 Because section 214-c and its subsections provide 4 exceptions to the general statute of limitations, Giordano bears 5 the burden of showing that one of the exceptions applies to his 6 claim. 7 Cir. 2004); Burger v. Union Carbide Corp., 304 A.D.2d 700, 701, 8 758 N.Y.S.2d 381, 383 (App. Div. 2003) (per curiam). 9 See Bano v. Union Carbide Corp., 361 F.3d 696, 710 (2d III. 10 The District Court's Decisions The district court granted summary judgment to the 11 defendants based on its conclusion that the foregoing exceptions 12 to New York's three-year statute of limitations did not apply. 13 Ephedra II, 2006 WL 944705, at *1, 2006 U.S. Dist. LEXIS 18691, 14 at *4. 15 The court determined at the outset that New York courts 16 do not allow equitable tolling of the three-year statute of 17 limitations. 18 18691, at *2-*3 (citing In re N.Y. County DES Litig., 89 N.Y.2d 19 506, 511, 678 N.E.2d 474, 477, 655 N.Y.S.2d 862, 865 (1997)). 20 Consequently, any extension of or exception to the statute of 21 limitations must be found in section 214-c. 22 not take issue with this conclusion. 23 Id., 2006 WL 944705, at *1, 2006 U.S. Dist. LEXIS Id. Giordano does The district court then noted that section 214-c(2), 24 but not section 214-c(4), expressly applies only to injuries 25 caused by the "latent effects" of exposure to a substance. 26 Despite the absence of the term "latent effects" in section 21416 1 c(4), the section governing discovery of the cause of injury more 2 than three but less than five years after discovery of the 3 injury, the district court concluded that that section is also 4 limited to injuries caused by "latent effects." 5 court's conclusion was based primarily on the several references 6 in section 214-c(4) to section 214-c(2), the section containing 7 the latent effects language. 8 U.S. Dist. LEXIS 18691, at *3 (citing Bano, 361 F.3d at 709). 9 The district Id., 2006 WL 944705, at *1, 2006 The district court then concluded as a matter of law, 10 based on the undisputed evidence before it, that ephedra's 11 alleged effects on Giordano were not "latent." 12 observed that Giordano "discovered his stroke immediately upon 13 its occurrence." 14 LEXIS 18691, at *3. 15 admitted at the Daubert hearings in the consolidated cases showed 16 that ephedra's effects were short-term, usually occurring within 17 a few hours of ingestion. 18 Dist. LEXIS 18691, at *3-4. 19 "[t]o hold § 214-c applicable to a stroke allegedly caused by 20 ephedra would effectively eliminate the statute's limitation to 21 'latent effects.'" 22 LEXIS 18691, at *4. 23 First, the court Id., 2006 WL 944705, at *1, 2006 U.S. Dist. Second, the court noted that the evidence Id., 2006 WL 944705, at *1, 2006 U.S. The district court reasoned that Id., 2006 WL 944705, at *1, 2006 U.S. Dist. Rather than decide the latency question unnecessarily, 24 we remanded with instruction to the district court to determine 25 "whether there is a genuine issue of material fact as to whether 26 sufficient scientific or medical knowledge was available to 17 1 Giordano such that he could have ascertained the cause of his 2 injury prior to the expiration of the three-year limitations 3 period provided by section 214-c(2)." 4 at 469. 5 Giordano, 289 Fed. App'x In answering this question in the affirmative, the 6 district court recognized two separate ambiguities in the statute 7 and, as noted, suggested that certification to the New York Court 8 of Appeals -- an approach not available to the district court -- 9 might be appropriate. 10 Ephedra III, 598 F. Supp. 2d at 536-37. First, the court viewed the statute as ambiguous as to 11 whether sufficient knowledge to "ascertain" the cause of an 12 injury requires certainty as to the cause, as suggested by the 13 dictionary definition of the term, or requires "something akin to 14 finding a probable connection," which the court understood to be 15 the way in which the New York Appellate Division, Third 16 Department, had construed the term. 17 Id. at 536. Second, the district court viewed the statute to be 18 ambiguous as to "precisely who has to know what before § 214-c 19 applies." 20 from the face of the statute whether the knowledge of the cause 21 of injury needed to be reasonably available to the scientific and 22 medical communities or reasonably available to the plaintiff. 23 Id. 24 ephedra to injuries similar to Giordano's as early as 1996, but 25 also observed that most lawsuits related to these studies were 26 not filed until after 2002, "suggesting, at least, a lack of Id. at 537 n.1. The court was unable to determine The court recognized that some studies did exist linking 18 1 awareness of the risks by even the most interested members of the 2 public prior to that time." 3 Id. Despite these problematic aspects of the statute, the 4 district court found a genuine issue of material fact as to 5 whether the requisite knowledge existed because "there are 6 genuine issues of material fact remaining to be resolved on 7 virtually any view one takes of the meaning of § 214-c(4)." 8 at 537. 9 10 IV. A. Analysis "Latent Effects" 11 12 Id. 1. The Presence of a Latency Requirement in Section 214-c(4). 13 We find insufficient guidance in the text of section 14 214-c(4), its legislative history, and the New York State case 15 law interpreting it to decide whether there is an implied 16 requirement that injuries be latent in order for the provision to 17 apply. 18 There is indeed support for the district court's 19 conclusion that section 214-c(4) is limited to injuries caused by 20 the "latent effects" of exposure even though that subsection does 21 not expressly use those words. 22 214-c(4) permits an action to be brought if it is 23 "commenced . . . after the period in which it would otherwise 24 have been authorized pursuant to [section 214-c(2)]" and requires 25 the plaintiff to demonstrate that "he has otherwise satisfied the 26 requirements of [section 214-c(2)]." The proviso clause of section 19 N.Y. C.P.L.R. § 214-c(4). 1 If Giordano's injuries were not "caused by the latent effects of 2 exposure" to ephedra, N.Y. C.P.L.R. § 214-c(2), then the terms of 3 section 214-c(2) were never applicable to him: 4 not "otherwise have been authorized pursuant to [section 214- 5 c(2)]" and he cannot be said to have "otherwise satisfied the 6 requirements [of section 214-c(2)]." 7 His action would Id. § 214-c(4). But there are persuasive arguments to the contrary. 8 Latency was expressly made a requirement in section 214-c(2) but 9 omitted from section 214-c(4). As these sections are drafted in 10 largely parallel fashions, with the first relating to discovery 11 of an injury and the second relating to discovery of the cause of 12 an injury, we find it plausible that this omission was 13 intentional. 14 The notion that the legislature intentionally omitted 15 this requirement is consistent with the differing purposes of the 16 subsections. 17 discovered until after the three-year statute of limitations. 18 requirement of latency serves a limiting purpose by eliminating 19 claims where the injury could have been but was not discovered, 20 and in so doing places an added onus on the plaintiff to comply 21 with the otherwise-applicable statute of limitations by timely 22 prosecuting actions based on injuries that are discoverable. 23 Were this requirement not in the statute, courts would presumably 24 be forced to decide cases in which there was a dispute over 25 whether a plaintiff was reasonably diligent in discovering an 26 injury. Section 214-c(2) governs injuries that are not By adding a latency requirement, courts are provided 20 A 1 with more of a bright-line rule that serves the purpose of 2 promoting judicial economy while nonetheless permitting suit to 3 be brought in some circumstances for injuries that were not 4 discoverable within the three-year time period. 5 Section 214-c(4), on the other hand, governs injuries 6 whose causes could not have been reasonably known during the 7 otherwise-applicable three-year time period for filing a claim. 8 In these cases, a requirement of latency does not promote the 9 diligent prosecution of claims. The question under section 214- 10 c(4) is whether sufficient information was available regarding 11 the cause of an injury to reasonably expect the plaintiff to have 12 taken timely legal action. 13 patent is irrelevant to the answer. 14 requirement of section 214-c(2), which prods plaintiffs to be 15 diligent in discovering injuries, a latency requirement would 16 have little effect on the purposes of section 214-c(4) inasmuch 17 as it has little impact on the diligence with which plaintiffs 18 make themselves aware of scientific information concerning the 19 cause of an injury. Whether the injury was latent or In contrast to the latency 20 The New York Court of Appeals is, in our view, the 21 appropriate judicial body to decide, if it chooses to do so, 22 whether there is an implicit latency requirement in section 214- 23 c(4), because the decision requires an analysis of the 24 legislative history, intent of the legislature, and broader 25 purposes of that section. 26 2. The Latency of Ephedra. 21 1 Even were there a latency requirement, we are not 2 entirely persuaded that the purported effects of ephedra are not 3 "latent" within the meaning of section 214-c. 4 relied upon our comment in Bano that "[s]ection 214-c modifies 5 § 214 with respect to a claimed injury that was not discoverable 6 immediately upon its occurrence," Bano, 361 F.3d at 709, to 7 conclude that because Giordano "discovered his stroke immediately 8 upon its occurrence," his injury was not a latent effect of 9 ephedra. The district court Ephedra II, 2006 WL 944705, at *1, 2006 U.S. Dist. 10 LEXIS 18691, at *3. 11 aneurism and strokes2 -- were, as the district court noted, 12 immediately discoverable when they occurred. 13 refers not to a latency period between injury and its discovery, 14 but to "personal injury . . . caused by the latent effects of 15 exposure." 16 testimony indicates that the effects of exposure to ephedra may 17 not have manifested themselves for hours. 18 effects of the exposure -- the aneurysm and strokes -- were 19 discoverable immediately upon their occurrence do not appear to 20 us to matter. 21 ephedra's effects were "latent." 2 The claimed injuries in this case -- the N.Y. C.P.L.R. § 214-c(2). But section 214-c In Giordano's case, expert The fact that the The proper question, we think, is whether Under section 214-c, the term "injury" refers to the manifestation of the harmful effects of exposure to a substance, not the exposure itself. See Sweeney v. Gen. Printing Inc., 210 A.D.2d 865, 865, 621 N.Y.S.2d 132, 133 (App. Div. 1994) ("The wording of CPLR 214-c makes clear that the injury to which it refers is distinct from the actual exposure to the harmful substance, for the injury is, by definition, caused by the latent effects of that exposure, and consequently must be something that occurs later." (citation omitted)). 22 1 Addressing this question, the district court observed: 2 3 4 5 6 7 8 9 10 [R]esearchers in a study of ephedra and stroke admitted into evidence during the Daubert hearings did not consider stroke patients to have been relevantly exposed to ephedra unless they used it within three days before their stroke; indeed, because of ephedra's short-acting properties, the researchers studied strokes that occurred within 24 hours after using ephedra. 11 Ephedra II, 2006 WL 944705, at *1, 2006 U.S. Dist. LEXIS 18691, 12 at *4. 13 between exposure and manifest injury in Bano, where we treated 14 the injury as latent, Bano, 361 F.3d at 709-10, with the time 15 lapse between exposure to ephedra and manifest injury, which 16 appears to be one day, more or less. 17 that the "few weeks" before manifestation of injury in Bano 18 rendered the effect "latent" whereas the approximately twenty- 19 four hours in the present case did not. 20 944705, at *1, 2006 U.S. Dist. LEXIS 18691, at *4. 21 The court compared the time lapse of "a few weeks" The district court decided Ephedra II, 2006 WL But nothing in the text of section 214-c suggests to us 22 that a relatively short period of latency, such as the likely 23 period of time between Giordano's exposure to the ephedra that 24 allegedly caused his injury and the manifestation of the injury 25 itself, is insufficient to invoke section 214-c(4). 26 we assume for this purpose, requires that Giordano's injury be 27 caused by the "latent effects" of exposure to ephedra, but says 28 nothing about the time period that must elapse between exposure 29 and manifestation of injury in order for the effects of exposure 30 to be considered "latent." 23 The statute, 1 Dictionary definitions of "latent" are, not 2 surprisingly, many and various.3 3 seem uniformly to treat "latent" as a term referring to a thing 4 or condition that is present but not evident or manifest. 5 Although the period of time between exposure and the 6 manifestation of injury was relatively short in Giordano's case, 7 it was nonetheless a period of time in which ephedra was present 8 in Giordano's body, but its effects were not evident or manifest. 9 The language of the statute thus suggests that the purported In substance, however, they 10 effects of ephedra may, at least, be "latent," and that section 11 214-c may therefore be applicable. 12 Looking to the legislative purpose for the enactment of 13 section 214-c as part of New York's 1986 tort reform package, the 14 New York Court of Appeals has observed that one "goal of the 15 Legislature in adopting CPLR 214-c was to provide relief to 16 injured New Yorkers whose claims would otherwise be dismissed for 17 untimeliness simply because they were unaware of the latent 18 injuries until after the limitations period had expired." 19 County DES Litig., 89 N.Y.2d at 513-14, 678 N.E.2d at 478, 655 20 N.Y.S.2d at 866 (citations and internal quotation marks omitted). 3 N.Y. They include "Concealed; dormant," Black's Law Dictionary 898 (8th ed. 2004); "Present or potential but not evident or active," The American Heritage Dictionary of the English Language 961 (9th ed. 2009); "Hidden, concealed . . . ; present or existing, but not manifest, exhibited, or developed," 8 The Oxford English Dictionary 680-81 (2d ed. 1989); and "[E]xisting in hidden, dormant, or repressed form but usually capable of being evoked, expressed, or brought to light : existing in posse : not manifest," Webster's Third New International Dictionary of the English Language Unabridged 1275 (2002). 24 1 But in addition to seeking to toll the time period between 2 exposure and manifestation of injury, "the Legislature [also] 3 anticipated and made specific provision for the problem that 4 arises when the plaintiff has discernable bodily symptoms but the 5 toxic etiology of those symptoms has not yet been discovered." 6 Id. at 512, 678 N.E.2d at 477, 655 N.Y.S.2d at 865. 7 Thus, it appears likely to us that by enacting section 8 214-c, the New York legislature sought to address both situations 9 in which injury is not evident immediately upon exposure to a 10 harmful substance and situations in which the cause of physical 11 symptoms cannot be discovered within the otherwise-applicable 12 limitations period. 13 reason why Giordano is not entitled to prove that his injury was 14 caused by the "latent effects" of his exposure to ephedra such 15 that he may invoke section 214-c(4)'s one-year limitation period 16 running from his alleged discovery that ephedra was its cause. 17 In light of these dual goals, we see no Rather than make a definitive decision on this 18 difficult issue of New York law, however, we certify it to the 19 New York Court of Appeals. 20 B. 21 Technical, Scientific, or Medical Knowledge Requirement Even if Giordano surmounts whatever "latency" barriers 22 his invocation of section 214-c(4) may face, to withstand the 23 motion for summary judgment, he must also establish a genuine 24 issue of material fact for the trier of fact to decide as to 25 whether "technical, scientific or medical knowledge and 26 information sufficient to ascertain the cause of his injury had 25 1 not been discovered, identified or determined" prior to the 2 expiration of the three-year limitations period that would 3 otherwise run from the date of discovery of his injury as 4 provided in section 214-c(4). 5 requirement satisfied even though it expressed serious doubt as 6 to what standard it should use in evaluating whether the 7 knowledge or information in question was "sufficient to 8 ascertain" the cause of the injury. 9 expressed its doubt as to both what level of certainty the 10 knowledge or information had to be established, and who was 11 required to possess the knowledge or information. 12 598 F. Supp. 2d at 536-37. 13 The district court found this That is, the district court Ephedra III, Discussing the level of certainty required by the 14 statute, the district court observed an ambiguity as to whether 15 sufficient knowledge to "ascertain" the cause of an injury 16 requires certainty as to cause, as suggested by the dictionary 17 definition of the term, or, alternatively, "something akin to 18 finding a probable connection," which the court understood to be 19 the way in which the New York Appellate Division, Third 20 Department, had construed the term. 21 Burroughs Wellcome Co., 259 A.D.2d 18, 24-25, 696 N.Y.S.2d 587, 22 592 (App. Div. 1999)). 23 required to attain this certainty, the court found the statute 24 ambiguous as to whether the knowledge or information in question 25 needed to be reasonably available to the scientific and medical 26 communities, or reasonably available to the plaintiff and his or Id. at 536 (citing Pompa v. Addressing the question of who was 26 1 her lawyers. 2 has to know what before § 214-c applies"). 3 district court held that there was a genuine issue of material 4 fact as to whether sufficient knowledge existed under any 5 standard. 6 Id. at 537 n.1 (seeking guidance on "precisely who Nevertheless, the Id. at 537. The district court made two findings that render the 7 standard applied relevant to the outcome of the question of 8 sufficient knowledge. 9 studies did exist linking ephedra to injuries similar to On the one hand, the court found that some 10 Giordano's as early as 1996. Id. at 537 n.1. 11 it noted that most lawsuits related to these studies were not 12 filed until after 2002, "suggesting, at least, a lack of 13 awareness of the risks by even the most interested members of the 14 public prior to that time." 15 standard applied could affect the outcome of this case in 16 multiple ways. Id. On the other hand, Under this set of facts, the 17 With regard to who must possess the knowledge, if the 18 statute requires that knowledge of causation must be reasonably 19 available to the scientific community, then sufficient knowledge 20 may have been available as early as 1996, rendering section 214- 21 c(4) inapplicable to Giordano. 22 knowledge of causation be reasonably available to the plaintiff 23 and his or her lawyers, then the district court's finding that 24 most related lawsuits were filed after 2002 may create a genuine 25 issue of fact as to whether the knowledge in question was If, however, the standard is that 27 1 reasonably available during the three-year period following 2 injury and section 214-c(4) may apply. 3 As to the requisite standard of certainty, studies 4 suggesting the relevant causal link between ephedra and the 5 injuries it causes began to appear in 1996, the FDA banned it in 6 2004, and no study has yet confirmed that ephedra causes injuries 7 similar to those suffered by Giordano. 8 Supp. 2d at 192-96. 9 that information suggesting causation be available, then the See Ephedra I, 393 F. In light of these facts, if the standard is 10 information may have been available as early as 1996 and 11 Giordano's claim may be time-barred. 12 information arguably constituting scientific proof of causation 13 be available, then the question is more difficult and later 14 studies or the timing of the FDA's ban may mean the information 15 was available at a later date, in which case Giordano's claims 16 may or may not be time-barred. 17 meaning of the statute and requires that sufficient information 18 to "ascertain" the cause of injury be reasonably available, then 19 the fact that studies have still not conclusively proven that 20 ephedra causes injuries similar to Giordano's may make section 21 214-c(4) inapplicable for that reason. If the standard is that If the standard tracks the plain 22 Although we have in the past attempted to interpret the 23 intention of the New York Legislature in this regard, we have not 24 done so definitively. 25 Corp., 303 F.3d 176, 207 (2d Cir. 2002), cert. denied, 538 U.S. 26 998 (2003) (observing that the New York Legislature likely See, e.g., Freier v. Westinghouse Elec. 28 1 "intended CPLR § 214-c(4) to refer only to scientific knowledge 2 that was 'reasonably available' to the plaintiff"). 3 we recognized that the meaning of "discovered, identified or 4 determined" for the purposes of section 214-c(4) was far from 5 clear. 6 Is 'scientific knowledge' 'determined' -- and if so, does the 7 word 'determined' connote a consensus?"). 8 the New York Court of Appeals for guidance. In Freier, Id. at 206 ("[I]s 'scientific knowledge' 'discovered'? We therefore look to 9 V. Certification to the New York Court of Appeals 10 The local rules of the Second Circuit provide that 11 "[i]f state law permits, the court may certify a question of 12 state law to that state's highest court." 13 also Prats v. Port Auth. of N.Y. & N.J., 315 F.3d 146, 150-51 (2d 14 Cir. 2002). 15 discretionary, see McCarthy v. Olin Corp., 119 F.3d 148, 153 (2d 16 Cir. 1997), but we have recognized at least four factors as 17 relevant in guiding that discretion. 2d Cir. R. 27.2; see Certification to the New York Court of Appeals is 18 First, we have decided certification to be appropriate 19 where the New York Court of Appeals has not spoken clearly on an 20 issue and we are unable to predict, based on other decisions by 21 New York courts, how the Court of Appeals would answer a certain 22 question. 23 (2d Cir. 2009); O'Mara v. Town of Wappinger, 485 F.3d 693, 698 24 (2d Cir. 2007). 25 the three questions certified here. See Kuhne v. Cohen & Slamowitz, LLP, 579 F.3d 189, 198 We have found no conclusive precedents to answer 29 1 Second, we have concluded that certification is 2 appropriate where the "statute's plain language does not indicate 3 the answer." 4 47, 51 (2d Cir. 1992); accord Colavito v. N.Y. Organ Donor 5 Network, Inc., 438 F.3d 214, 229 (2d Cir. 2006). 6 meaning of the statute does not definitively answer any of the 7 three questions certified. 8 of N.Y. C.P.L.R. § 214-c(4), nor does section 214-c(2), which 9 does include an explicit latency requirement, sufficiently define Riordan v. Nationwide Mut. Fire Ins. Co., 977 F.2d Here, the plain Latency is not explicit in the text 10 the term to apply it to the effects of ingesting ephedra. 11 Similarly, it is not clear from the text of section 214-c(4) what 12 level of certainty is required or what group is implicated by the 13 subsection's requirement that sufficient knowledge exist to 14 ascertain the cause of the injury. 15 supports certification. This factor therefore 16 Third, we have thought certification to be appropriate 17 where the decision reflects value judgments and important public 18 policy choices that the New York Court of Appeals is better 19 situated than we are to make. 20 Blue Cross & Blue Shield of N.J., Inc. v. Phillip Morris USA, 21 Inc., 344 F.3d 211, 221 (2d Cir. 2003). 22 issue here directly implicate the New York Legislature's desire 23 to balance, inter alia, a victim's ability to recover for his or 24 her damages, a defendant's ability to live free from fear of 25 litigation, and judicial economy. 26 the New York Legislature created a limited exception to the See Colavito, 438 F.3d at 229; 30 The policy questions at By enacting section 214-c(4), 1 general rule that personal injury cases be brought within three 2 years. 3 and is more competent to interpret the boundaries of that 4 exception. 5 The New York Court of Appeals has more familiarity with The three questions certified are central to the 6 outcome of this case, inasmuch as each is a hurdle that Giordano 7 must overcome in order for section 214-c(4) to apply and his 8 action to be timely, and resolution of each depends upon the 9 guidance we now seek from the New York Court of Appeals. 10 11 The balance of these factors therefore militates in favor of certification in this case. CONCLUSION 12 13 14 15 For the foregoing reasons, we certify the following three questions to the New York Court of Appeals: 1. Are the provisions of N.Y. C.P.L.R. § 214-c(4) 16 providing for an extension of the statute of 17 limitations in certain circumstances limited to 18 actions for injuries caused by the latent effects 19 of exposure to a substance? 20 2. Can an injury that occurs within 24 to 48 hours of 21 exposure to a substance be considered "latent" for 22 these purposes? 23 3. What standards should be applied to determine 24 whether a genuine issue of material fact exists 25 for resolution by a trier of fact as to whether 26 "technical, scientific or medical knowledge and 31 1 information sufficient to ascertain the cause of 2 [the plaintiff's] injury" was "discovered, 3 identified or determined" for N.Y. C.P.L.R. § 214- 4 c(4) purposes? 5 With respect to the last question, we especially seek 6 guidance that will enable us to answer the question of whether 7 sufficient knowledge exists to ascertain a cause of injury where 8 "some studies suggesting a possible connection between ephedra 9 and injuries similar to [the plaintiff's] were published in 10 reputable scientific journals that were publicly available" 11 during the three-year period after the discovery of the 12 plaintiff's injury, but where there was "a lack of awareness of 13 the risks by even the most interested members of the public" 14 during that time. 15 Ephedra III, 598 F. Supp. 2d at 537 n.1. In formulating three specific questions for 16 certification we do not intend to limit the scope of the Court of 17 Appeals' analysis and we invite the Court of Appeals to expand 18 upon or alter these questions as it should deem appropriate. 19 Kirschner v. KPMG LLP, 590 F.3d 186, 195 (2d Cir. 2009). 20 See Pursuant to New York Court of Appeals Rule 500.27 and 21 United States Court of Appeals for the Second Circuit Rule 27.2, 22 it is hereby ORDERED that the Clerk of this Court transmit to the 23 Clerk of the Court of Appeals of the State of New York this 24 opinion as our certificate, together with a complete set of the 25 briefs, appendix, and record filed in this Court by the parties. 26 We direct the parties to bear equally any fees and costs that may 32 1 be imposed by the New York Court of Appeals in connection with 2 this certification. 3 appeal after disposition of this certification by the New York 4 Court of Appeals. This panel will retain jurisdiction of the 33

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