Marianne Chapman v. The Procter & Gamble Distributing, LLC

Marianne and Daniel Chapman appeal summary judgment for The Proctor & Gamble Distributing, LLC and The Proctor & Gamble Manufacturing Company (collectively “P&G”) in their products liability case concerning Fixodent, a denture adhesive. We affirm.

I. FACTUAL AND PROCEDURAL BACKGROUND

Marianne Chapman suffers from myelo-pathy, a neurological condition or spinal-cord disorder that affects the upper and lower extremities. She developed a number of neurological symptoms from April 2006 through January 2009.1 The Chap-mans maintain Marianne Chapman’s symptoms were caused by zinc-induced, copper-deficiency myelopathy (“CDM”) from her use of two to four 68-gram tubes of Fixodent denture adhesive each week for eight years. P&G counters that the testimony of the Chapmans’ experts should not be admitted, because their methodologies are unreliable and do not substantiate the conclusion that Fixodent caused Marianne Chapman’s CDM.

While zinc is an essential element for human growth, it is not found separately in nature but occurs in various compounds, such as zinc acetate and zinc sulfate. In 1990, P&G reformulated Fixodent to include a calcium-zinc compound to improve its adhesion. The calcium-zinc compound in Fixodent is less bioavailable than other zinc compounds, like zinc acetate.2 A case report in 2008 hypothesized zinc in denture adhesives may lead to copper deficiency, which could cause neurologic injury. S.P. Nations, et al., Denture Cream: An Unusual Source of Excess Zinc, Leading to Hypocupremia and Neurologic Disease, 71 Neurology 639 (2008). Thereafter, various individuals filed lawsuits nationwide against GlaxoSmithKline (“GSK”), manufacturer of Poligrip, and P&G, manufacturer of Fixodent.

The Chapmans originally filed their case in Florida state court on April 1, 2009, against P&G, which removed it to federal court in the Southern District of Florida on diversity jurisdiction.3 On June 9, 2009, the United States Judicial Panel on Multidistrict Litigation (“MDL”) trans*1301ferred these similar cases against GSK and P&G to Judge Cecilia M. Altonaga in the Southern District of Florida for coordinated pretrial proceedings. In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga. Following the conclusion of pretrial proceedings, the individual MDL plaintiffs had the right to transfer their cases back to their respective district courts. Because this case was the only one filed in the Southern District of Florida, it provided the judge with jurisdiction to proceed to trial.

The Chapmans sought to prove causation primarily through four expert witnesses.4 Dr. George J. Brewer, Dr. Joseph R. Landolph, and Dr. Ebbing Lautenbach would have testified generally whether Fixodent could cause CDM. Dr. Steven A. Greenberg would have testified Marianne Chapman’s mye-lopathy specifically was caused by her use of Fixodent. P&G moved to exclude the Chapmans’ expert testimony under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Briefing, supplemental briefing, and a hearing addressed the issues raised by P&G’s motions. On June 13, 2011, one week before trial was to begin on June 20, 2011, the district judge issued a comprehensive order granting P&G’s motions to exclude the Chapmans’ expert testimony. In re Denture Cream Prods. Liab. Litig., 795 F.Supp.2d 1345 (S.D.Fla.2011).

A. First Appeal

1. District Court

At the previously scheduled calendar call on June 14, 2011, the parties discussed with the judge the best route to this court to decide whether the judge’s Daubert order was correct — interlocutory appeal or summary judgment. P&G argued the other MDL eases should be “stayed pending the appeals,” because “it would make no sense for the parties to be litigating anything in those cases while the issues that are set forth squarely in the Court’s order yesterday are addressed by the 11th Circuit.” Hr’g Tr., June 14, 2011, at 6:3-10. The judge commented it would be “futile” and “a waste of everyone’s resources” to have full briefing on summary judgment “just so [the parties] could get to the 11th Circuit on the correctness of [her] decision on the Daubert motions.” Id. at 7:8-12. Instead, the judge suggested the parties “consent to an entry of judgment with the right to appeal the adverse Daubert ruling.” Id. at 7:13-14.

On June 16, 2011, the judge held a scheduling conference to discuss further the proper way to get her Daubert decision before this court. The judge recognized “the problem is how do you get [the Daubert order] to the Appellate Court [because] you can’t ... appeal ... a Daubert ruling. You need a final order.” Hr’g Tr., June 16, 2011, at 6:21-23. She suggested “the way to do it is to have me enter judgment against [the Chapmans] with the understanding of the parties that you are reserving your right to appeal ... my adverse ruling on Daubert, but you need a final order.” Id. at 7:5-8. Since both parties wanted the Daubert order reviewed by this court, the judge ordered the parties to “present to [her] a proposed order that contemplates” an appealable final judgment. Id. at 9:10-13.

*1302On June 23, 2011, the parties submitted a Joint Stipulation of Dismissal with Prejudice, agreeing to “1) the entry of judgment against [the Chapmans] on all claims alleged against [P&G]; and, 2) the entry of dismissal with prejudice on all [the Chap-mans’] claims alleged against [P&G].” Jt. Stip. of Dismissal at 1-2. The joint stipulation provided “the parties recognize that this stipulation is in the best interest of all parties and judicial economy” and expressly reserved the Chapmans’ right to appeal to this court. Id. at 2. In accordance with the joint stipulation, the judge entered final judgment on June 24, 2011, and the Chapmans timely appealed.

2. Court of Appeals

This court recognized “our jurisdiction ‘must be both (1) authorized by statute and (2) within constitutional limits.’ ” Chapman v. Proctor & Gamble Distrib., LLC, No. 11-13371 at 2 (11th Cir. Jan. 4, 2012) (per curiam) (quoting OFS Fitel, LLC v. Epstein, Becker & Green, P.C., 549 F.3d 1344, 1355 (11th Cir.2008)). While the district judge’s order was final under 28 U.S.C. § 1291, “to be within constitutional limits,” it had to be “ ‘adverse as to the final judgment’ ... to satisfy the Article III case or controversy requirement.” Id. (quoting OFS Fitel, 549 F.3d at 1356). We noted “three ‘distinct factual ingredients that are critical to the adverseness issue.’ ” Id. (quoting OFS Fitel, 549 F.3d at 1357). Those factual requirements are: (1) the appealed order was “ ‘case-disposi-tive because it foreclosed plaintiff from presenting the expert testimony required to prove [the cause of action], which was a core element in all of its claims,”’ (2) “plaintiffs attorney ‘candidly informed the district court of the impact of its sanctions ruling on the plaintiffs case,’” and (3) “ ‘importantly, the district court ... agreed with plaintiffs counsel’s suggestion that the [appealed] ruling was case-disposi-tive.’ ” Id. (alterations omitted) (quoting OFS Fitel, 549 F.3d at 1357, 1358).

We concluded the Chapmans did not meet the second and third OFS Fitel requirements. Although the parties had informed the district judge her Daubert order might be dispositive, the Chapmans “also argued that they could still muster enough evidence to prove causation at trial even without the expert testimony, specifically by presenting testimony from treating doctors.” Id. at 3. Not only did the Chapmans fail “ ‘candidly’ ” to inform the judge of the consequence of the Daubert order, but also they “disputed that it was dispositive.” Id. (quoting OFS Fitel, 549 F.3d at 1357). “Regarding the third requirement, we determined the district judge’s dismissal was not case-dispositive. It was unclear whether the interlocutory appeal from the Daubert order excluding the Chapmans’ expert witnesses was “the only basis for dismissal, or if the Chap-mans could otherwise have proceeded to trial and proved causation despite the exclusion, as they initially conte[nd]ed.” Id. at 3-4. In addition, the Chapmans’ representation that it was undisputed that the Daubert order was case-dispositive was belied by their persistently “claiming that the order was not case-dispositive.” Id. at 4. Accordingly, we dismissed the appeal of the Daubert order for lack of standing, because the Chapmans were not adverse to the final judgment. Id.

B. Second Appeal

Following dismissal of the Chapmans’ first appeal by this court, the district judge granted their motion to vacate the stipulated final judgment under Federal Rule of Civil Procedure 60(b). P&G then moved for summary judgment, which the Chap-mans opposed, and P&G replied. Because the district judge had determined none of the Chapmans’ proffered experts qualified *1303as experts under Daubert, P&G maintained the Chapmans could not use treating physicians as experts at trial. Since these doctors had never been designated as experts, the judge determined they were not qualified to testify regarding general or specific causation of Marianne Chapman’s CDM. Accordingly, she granted P&G’s summary judgment motion and entered final judgment. The Chapmans appealed, which is the case we now decide. We necessarily first must address the merits of the district judge’s Daubert order, because it is incorporated by reference in the Chapmans’ opposition to P&G’s summary judgment motion,5 and the parties’ first appeal to this court was dismissed for lack of jurisdiction without addressing the merits of the Daubert order.

II. DISCUSSION

A. Daubert Analysis

1. Distinguishing Z)cm6eri-Applieable Cases

For analyzing cases involving alleged toxic substances, we have delineated two categories. McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1239 (11th Cir.2005). The first category consists of “cases in which the medical community generally recognizes the toxicity of the [substance] at issue” to “eaus[e] the injury plaintiff alleges.” Id.; Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183, 1196 (11th Cir.2010). In this category are “toxins like asbestos, which causes asbestosis and mesothelioma; silica, which causes silicosis; and cigarette smoke, which causes cancer.” McClain, 401 F.3d at 1239. For judicial economy, federal courts need not consider expert opinions for diagnoses “medical doctors routinely and widely recognize as true, like cigarette smoking causes lung cancer and heart disease, too much alcohol causes cirrhosis of the liver, and ... the ingestion of sufficient amounts of arsenic causes death.” Id. at 1239 n. 5. In cases where the cause and effect or resulting diagnosis has been proved and accepted by the medical community, federal judges “need not undertake an extensive Daubert analysis on the general toxicity question.”6 Id. at 1239.

In contrast, the second category contains cases, where the medical community generally does not recognize the substance in question as being toxic and having caused plaintiffs alleged injury. Id. These cases require a two-part Daubert analysis, comprised of (1) general causation, “whether the [substance] can cause the harm plaintiff alleges,” id., and (2) specific causation, whether experts’ methodology determines the substance “caused the plaintiffs specific injury,” Hendrix, 609 F.3d at 1196 (citing McClain, 401 F.3d at 1239). For cases in category two, a district judge “must assess the reliability of the expert’s opinion on general, as well as specific, causation.” Id. (first emphasis added). The two categories economize the time of a trial judge, who “does not need to waste time with a Daubert hearing ‘where the reliability of an expert’s methods is properly taken for granted, and to require *1304appropriate proceedings in the less usual or more complex cases where cause for questioning the expert’s reliability arises,”’ McClain, 401 F.3d at 1239 n. 5 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 1176, 143 L.Ed.2d 238 (1999)).

The Chapmans represent the district judge should have analyzed this case under McClain category one, because there is a general consensus in the medical community that ingestion of zinc causes CDM. They cite medical textbooks and journals as well as their experts7 and those of P&G, who have recognized an association between excess zinc and copper deficiency. See Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1199 (11th Cir.2002) (“[Wjhile they may support other proof of causation, case reports alone ordinarily cannot prove causation.”). But they fail to show that the zinc compound in Fixodent is in McClain category one of medically accepted, cause-and-effect toxins, such as asbestos causing asbestosis and cigarette smoking causing lung cancer and heart disease. Id. at 1239 & n. 5. P&G notes: “Millions of consumers have regularly used Fixodent for decades without complaint. Nevertheless, [the Chapmans] claim that Fixodent is toxic because it contains zinc in a calcium-zinc compound — even though zinc is undeniably an essential nutrient the body must have to function properly.” Appellees’ Br. at 1; see Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1257 (11th Cir.2010) (per curiam) (recognizing in a products liability case that two-thirds of patients who took an antipsychotic prescription drug, Seroquel, did not experience weight gain, which plaintiff alleged was the cause of her diabetes). Therefore, the district judge properly determined that Fixodent, containing zinc, was in McClain category two and conducted the requisite Daubert review of proffered expert testimony, which included a thorough hearing and consideration of “thousands of pages of filings by the parties, including the experts’ reports and depositions, and scientific literature.” In re Denture Cream Prods. Liab. Litig., 795 F.Supp.2d at 1348.

2. Daubert Review for Reliability of Expert Testimony

Under Federal Rule of Evidence 702, expert testimony is admissible if (1) the expert is qualified to testify regarding the subject of the testimony; (2) the expert’s methodology is “sufficiently reliable as determined by the sort of inquiry mandated in Daubert”; and (3) the expert’s testimony will assist the trier of fact in understanding the evidence or determining a fact at issue. United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir.2004) (en banc) (citation and internal quotation marks omitted). In considering the proffered expert testimony, a trial judge is mindful “[t]he burden of establishing qualification, reliability, and helpfulness rests on the proponent of the expert opinion.” Id. To determine the reliability and relevance of proffered expert testimony, the judge performs a “gatekeeping” function. Daubert, 509 U.S. at 589 n. 7, 113 S.Ct. at *13052795 n. 7; see Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1342 (11th Cir.2003) (recognizing “one maybe considered an expert but still offer unreliable testimony”). We review a district judge’s exclusion of expert testimony only for abuse of discretion. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 141-43, 118 S.Ct. 512, 517, 139 L.Ed.2d 508 (1997). The “considerable leeway” accorded to a district judge, Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. at 1176, requires us to defer to the judge’s decision on expert testimony, “unless it is manifestly erroneous.” Rink v. Cheminova, Inc., 400 F.3d 1286, 1291 (11th Cir.2005) (citation and internal quotation marks omitted). This deferential abuse-of-discretion standard is applied stringently, even if a decision on expert testimony is “outcome determinative.”8 Gen. Elec. Co., 522 U.S. at 142-43, 118 S.Ct. at 517; United States v. Brown, 415 F.3d 1257, 1266 (11th Cir.2005).

The Daubert Court identified four factors to guide district judges in assessing the reliability of an individual expert’s methodology:

(1) whether the expert’s methodology has been tested or is capable of being tested; (2) whether the theory or technique used by the expert has been subjected to peer review and publication; (3) whether there is a known or potential error rate of the methodology; and (4) whether the technique has been generally accepted in the relevant scientific community.

United Fire & Cas. Co. v. Whirlpool Corp., 704 F.3d 1338, 1341 (11th Cir.2013) (per curiam) (citing Daubert, 509 U.S. at 593-94, 113 S.Ct. at 2796-97). These factors are not “a definitive checklist or test,” Daubert, 509 U.S. at 593, 113 S.Ct. at 2796, and Daubert considerations are “applied in case-specific evidentiary circumstances,” Brown, 415 F.3d at 1266. “[T]he trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable.” Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. at 1176.

While the inquiry is “a flexible one,” the focus “must be solely on principles and methodology, not on the conclusions that they generate." Daubert, 509 U.S. at 594-95, 113 S.Ct. at 2797 (emphasis added); see McDowell v. Brown, 392 F.3d 1283, 1298 (11th Cir.2004) (recognizing a trial judge “should meticulously focus on the expert’s principles and methodology, and not on the conclusions that they generate”). “But conclusions and methodology are not entirely distinct from one another”; neither Daubert nor Federal Rule of Evidence 702 requires a trial judge “to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.” Gen. Elec. Co., 522 U.S. at 146, 118 S.Ct. at 519. Instead, the judge “is free to ‘conclude that there is simply too *1306great an analytical gap between the data and the opinion proffered.’ ” Hendrix, 609 F.3d at 1194 (quoting Gen. Elec. Co., 522 U.S. at 146, 118 S.Ct. at 519); see McDowell, 392 F.3d at 1299 (noting “there is no fit where a large analytical leap must be made between the facts and the opinion,” such as proffering animal studies concerning a type of cancer in mice to establish a different cancer in humans (citing Gen. Elec. Co., 522 U.S. at 146, 118 S.Ct. at 519)). The district judge has “the task of ensuring that an expert’s testimony both rests on a reliable foundation and is relevant to the task at hand.” Daubert, 509 U.S. at 597, 113 S.Ct. at 2799.

As gatekeeper for the expert evidence presented to the jury, the judge “must do a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.” Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1335 (11th Cir.2010) (citation and internal quotation marks omitted). It is “proper” and “necessary” for the trial judge “to focus on the reliability” of a proffered expert’s “sources and methods.” Id. at 1336. Under Daubert, the “district judge asked to admit scientific evidence must determine whether the evidence is genuinely scientific, as distinct from being unscientific speculation offered by a genuine scientist.” Allison v. McGhan Med. Corp., 184 F.3d 1300, 1316-17 (11th Cir.1999) (citation and internal quotation marks omitted).

a. General Causation

General causation refers to the “general issue of whether a substance has the potential to cause the plaintiffs injury.” Guinn, 602 F.3d at 1248 n. 1. The district judge consolidated her consideration of the proffered testimonies of Dr. Brewer, Dr. Landolph, and Dr. Lauten-bach regarding general causation. Neither the judge nor the parties questioned that these three experts were qualified to testify based on their credentials, the first part of the Rule 702 test for admission of expert testimony. Frazier, 387 F.3d at 1260. The judge, however, determined that their methodologies were not sufficiently reliable to satisfy part two of the test and therefore would not assist the trier of fact in understanding the evidence, part three of the test. Id. We must review the judge’s analysis that caused her to reach that conclusion.

At the outset, the judge placed this case in McClain category two, where “the medical community does not generally recognize the agent as both toxic and causing the injury plaintiff alleges.” McClain, 401 F.3d at 1239. To establish generally “Fix-odent is capable of causing a myelopathy,” the Chapmans proffered the testimonies of three experts. In re Denture Cream Prods. Liab. Litig., 795 F.Supp.2d at 1350. “Dr. Brewer would testify ‘that zinc containing Fixodent denture adhesives are a health hazard and capable of causing severe hematological and neurological injury.’ ” Id. at 1350-51 (quoting Brewer Report). “Dr. Landolph would testify ‘that long-term use of Fixodent (containing 1.69% zinc) will result in ... neurotoxic, neurologic, and hematologic consequences.’ ” Id. at 1351 (quoting Landolph Report). Dr. Lautenbach would testify “that there is ‘an association between Fixo-dent and myeloneuropathy’ and he would ‘consider the myeloneuropathy as a “probable” reaction related to denture adhesive use.’ ” Id. (quoting Lautenbach Report).

The judge reviewed reliable methodologies, including dose-response relationship, epidemiological evidence, background risk of the disease, physiological processes involved, and clinical studies. Id. at 1351-*130757. The judge determined the Chapmans’ experts did not satisfy any of these recognized methodologies. Failure to satisfy any of the four reliability factors recognized in Daubert is sufficient to preclude the testimony of any of the general causation experts from testifying at trial. 509 U.S. at 593-94, 113 S.Ct. at 2796-97. Recognizing all substances potentially can be toxic, the judge noted “ ‘the relationship between dose and effect (dose-response relationship) is the hallmark of basic toxicology,’ ” and “ ‘is the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect.’ ”9 In re Denture Cream Prods. Liab. Litig., 795 F.Supp.2d at 1351-52 (quoting McClain, 401 F.3d at 1242). The judge noted, however, neither the Chap-mans’ general-causation experts “nor the articles on which they rely determine how much Fixodent must be used for how long to increase the risk of a copper-deficiency, or for how long a copper-deficiency must persist before an individual is at an increased risk of developing a myelopathy.” Id. at 1352. Similarly, the judge recognized “[ejpidemiology is the ‘best evidence of causation’ ” in cases involving toxic substances. Id. at 1354 (quoting Kilpatrick, 613 F.3d at 1337 n. 8). But she determined the Chapmans’ “experts have no analytical epidemiological evidence on which to base their inference of causation.”10 Id.

The judge further noted “[bjackground risk of disease ‘is the risk a plaintiff and other members of the general public have of suffering the disease or injury that plaintiff alleges without exposure to the drug or chemical in question.’ ” Id. at 1355 (quoting McClain, 401 F.3d at 1243). While “ ‘[a] reliable methodology should take into account the background risk,’ ” the judge found the Chapmans’ “causation experts uniformly testified that they did not know the background risk of copper-deficiency myelopathy,” which was “a serious methodological deficiency.”11 Id. (al*1308teration in original) (quoting McClain, 401 F.3d at 1243). The judge explained:

[T]he question of background risk is important because it could be coincidence that any particular denture-cream user h