Lead Opinion
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.
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.
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.
The Chapmans sought to prove causation primarily through four expert witnesses.
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.
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.,
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,
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
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.,
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,
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 experts
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,
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.,
While the inquiry is “a flexible one,” the focus “must be solely on principles and methodology, not on the conclusions that they generate." Daubert,
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.,
a. General Causation
General causation refers to the “general issue of whether a substance has the potential to cause the plaintiffs injury.” Guinn,
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,
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-
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,
[T]he question of background risk is important because it could be coincidence that any particular denture-cream user has a myelopathy or copper-deficiency myelopathy. Some people use denture cream and some people have a myelopa-thy; it is possible (and depending on the incidence of myelopathies, likely) that some denture-cream users have an idiopathic myelopathy simply due to the background distribution of that disease. Without a baseline, any incidence may be coincidence.
Id. at 1356. The judge concluded the absence of background risk of disease was “a substantial weakness” in the Chapmans’ experts’ general-causation reasoning. Id.
Given the deposition admissions of Dr. Brewer, Dr. Lautenbach, and Dr. Lan-dolph regarding their lack of knowledge of dose-response, epidemiological evidence, and background risk of disease, methodologies this circuit has recognized as indispensable to proving the effect of an -ingested substance, we conclude that the testimonies of these proffered experts could not establish general causation of myelopathy by Fixodent. Because these experts have failed to demonstrate the primary methods for proving the zinc in Fixo-dent causes myelopathy, their secondary methodologies, including plausible explanations, generalized case reports, hypotheses, and animal studies are insufficient proof of general causation. This latter evidence could mislead the jury by causing it to consider testimony that was insufficient by recognized primary methodologies to prove using Fixodent causes myelopa-thy. As gatekeeper for the evidence presented to the jury, the judge did not abuse her discretion or commit manifest injustice by precluding the testimonies of Dr. Brewer, Dr. Lautenbach, and Dr. Landolph as experts on general causation.
b. Specific Causation
“Specific causation refers to the issue of whether the plaintiff has demonstrated that the substance actually caused injury in her particular case.” Guinn,
While differential diagnosis as a scientifically accepted methodology meets the Daubert guiding factors for district judges in deciding reliability,
Marianne Chapman’s medical history included neurological ailments that occurred before and after her Fixodent use.
A reliable differential analysis requires an expert to “compile a comprehensive list of hypotheses that might explain” a plaintiffs condition. Hendrix,
Significantly, after concluding his report on Marianne Chapman, Dr. Greenberg performed an additional, reasonable test on her to determine if she had arterial venous malformation in her thoracic spinal cord. The judge found Dr. Greenberg’s “failure to perform a test he considered reasonable before opining on the cause of Ms. Chapman’s disease shows a lack of methodological rigor in reaching the diagnosis in his report,” because he “did not consider the possibility of an idiopathic cause for Ms. Chapman’s myelopathy.” In re Denture Cream Prods. Liab. Litig.,
Obviously, there were numerous potential causes for Marianne Chapman’s CDM that Dr. Greenberg did not analyze or consider. The district judge determined “Dr. Greenberg’s differential diagnosis is not reliable as a matter of law in the Eleventh Circuit because he ruled-in and considered an etiology — Fixodent-induced copper-deficiency myelopathy- — that has not been established to cause Ms. Chapman’s disease.” In re Denture Cream Prods. Liab. Litig.,
c. Exclusion of Other Expert Testimony
Because the judge determined neither the general nor specific-causation experts had proffered testimony that would prove the zinc in Fixodent had caused Marianne Chapman’s CDM, she also excluded the testimonies of Dr. Wogalter and Dr. Yon Frunhofer, whose testimonies were premised on the toxicity of Fixodent. In re Denture Cream Prods. Liab. Litig.,
In short, taking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it. Hypotheses are verified by testing, not by submitting them to lay juries for a vote. It may very well be that Fixodent in extremely large doses over many years can cause copper deficiency and neurological problems, but the methodology [the Chapmans’] experts have used in reaching that conclu*1312 sion will not reliably produce correct determinations of causation.
Id. The proposed testimony of Dr. Raffa concerned P&G’s assets, which related to the punitive damages claim. Consequently, the judge precluded the proffered testimonies of these experts based on Rule 702 relevancy. We conclude there was no abuse of discretion or manifest injustice in granting P&G’s motions preventing the testimonies of these three experts for the Chapmans.
B. Summary Judgment
After this court dismissed the parties’ first appeal for lack of jurisdiction, based on our conclusion the Chapmans did not consider the district judge’s Daubert order case-dispositive, the judge granted their Federal Rule of Civil Procedure 60(b) motion for relief from the final judgment. Thereafter, P&G moved for summary judgment and argued the Chapmans did not have an admissible expert witness to establish general or specific causation. In opposition, the Chapmans argued they had alternative expert witnesses to testify at trial, irrespective of the district judge’s Daubert order. Concluding under the governing law the Chapmans had no experts to prove their products liability case alleging Fixodent was the cause of Marianne Chapman’s CDM, the district judge granted summary judgment to P&G and entered final judgment.
The Chapmans’ notice of appeal states they are appealing the summary judgment order and final summary judgment entered on July 81, 2012, “as well as all orders and rulings that produced that final judgment,” including the order granting P&G’s motions to exclude the testimony of the Chapmans’ seven general and specific expert witnesses. Notice of Appeal (Aug. 27, 2012). We have considered fully the district judge’s thorough Daubert order, which eliminated the Chapmans’ expert witnesses, and concluded it was decided correctly under the controlling law. We now address the summary judgment order the Chapmans have appealed in conjunction with the Daubert order.
We review a district judge’s granting summary judgment de novo. Williams v. Mast Biosurgery USA, Inc.,
The Chapmans opposed summary judgment for lack of expert witnesses following the Daubert order for three reasons: (1) their expert, Dr. Joseph Prohaska, a biochemistry professor at the University of Minnesota Medical School, could testify at trial, because P&G had not contested his proffered testimony; (2) they could call P&G experts and witnesses to testify that excessive ingestion of zinc can lead to copper deficiency, which can cause CDM; and (3) Marianne Chapman’s treating physicians for her neuropathy could testify regarding causation. Because of the Chapmans’ “periodic and contradictory insistence on having enough evidence to proceed to trial,” the judge analyzed the merits of P&G’s motion to -make her decision “perfectly clear” for this court.
On appeal, the Chapmans challenge both the district judge’s Daubert order and summary judgment granted to P&G, because the cumulative effect of these orders eliminated all potential causation experts the Chapmans had proffered. Their arguments for alternative expert witnesses are combined in the Chapmans’ initial and reply briefs with their Daubert arguments, regarding their contention the district judge erred in disqualifying their original causation experts. See, e.g., Appellants’ Br. at 18 n. 5, 22-23, 25, 30-31, 40, 43, 44-46, 47, 48-49, 50, 56, 60; Appellants’ Reply Br. at 4 n. 1, 6, 8, 11, 14, 16-17, 18, 21, 22, 24, 30. The alternative expert witnesses the Chapmans propounded following the Daubert order and precluded by summary judgment granted to P&G necessarily had to satisfy the same Daubert review standards to testify concerning causation for the Chapmans to prove their case that Fixodent caused Marianne Chapman’s CDM.
The Chapmans discuss Dr. Pro-haska
In addition, the judge explained the Chapmans “cannot create a triable issue of fact as to causation” with P&G experts and witnesses, who have not submitted the requisite epidemiological or clinical reports. Summ. J. Order at 9. Expert witnesses, who are expected to testify at trial, must be identified in the Joint Pretrial Stipulation and must meet the procedural requirements of Federal Rule of Civil Procedure 26(a)(2), including time designations for supplying disclosures and reports, regarding expert testimony to be given. The Chapmans proposed their ability to use P&G experts and witnesses at trial almost six months after the judge’s scheduled January 24, 2011, deadline for identifying experts, making complying with the procedural timely notice and disclosure requirements of Rule 26(a)(2), including reports of testimony, impossible.
Even if the Chapmans had satisfied the procedural requirements of Rule 26(a)(2) to use P&G experts and witnesses to testify for them at trial, the district judge concluded the Chapmans could not prove their case with them. P&G’s experts had “reached the conclusion that Fixodent does not cause CDM.”
At a status conference the day after issuance of the Daubert order, the Chap-mans’ counsel argued for the first time they still could try to prove causation through “treating experts who have opined [Marianne Chapman’s] condition was caused by her use of Fixodent that were not the subject of the Daubert motion.” Hr’g Tr., June 14, 2011, at 7:21-8:1 (emphasis added). In recasting Marianne Chapman’s treating physicians as “treating experts,” the Chapmans sought to have these doctors testify concerning their personal treatment of Marianne Chapman as well as their view of the cause of her CDM. The judge, however, explained in her summary judgment order that treating physicians, who diagnosed Marianne Chapman’s CDM, are fact and not expert witnesses.
III. CONCLUSION
To prove Fixodent caused Marianne Chapman’s CDM, the Chapmans were required to have Demheri-qualified, general and specific-causation-expert testimony that would be admissible at trial to avoid summary judgment. Guinn,
AFFIRMED.
Notes
. These symptoms included loss of feeling in her hands and feet, a progressive gait ataxia that caused her to trip when walking in the dark and subsequently confined her to bed, a burning pain in her hands and feet requiring opiod management, blood dyscrasias with anemia and neutropenia (low red and white blood-cell counts), and subacute bilateral asymmetric wrist and finger drop in both hands, limiting her ability to extend her fingers and thumbs. In re Denture Cream Prods. Liab. Litig.,
. The zinc in Fixodent enters a user's digestive tract, when food is chewed and swallowed. The absorption of zinc occurs in the small intestine, where the Chapmans contend it blocks copper assimilation into the body, resulting in CDM. Bioavailability refers to accessibility to metabolic and physiological body processes, while dissociation references how a compound separates into component parts under particular conditions.
.The Chapmans' Amended Complaint, filed on November 9, 2009, contains seven causes of action, including state-law claims: (1) strict products liability, (2) negligence, (3) intentional misrepresentation, (4) breach of express warranty, (5) implied warranty, (6) violation of the Florida Deceptive and Unfair
. P&G also sought to exclude the testimonies of three additional experts for the Chapmans: Dr. Frederick Raffa, Dr. J. Anthony Von Fraunhofer, and Dr. Michael S. Wogalter.
. In their opposition to P&G's summary judgment motion, the Chapmans stated: "Plaintiffs explicitly reserve their right to appeal this Court's June 13, 2011 decision and preserve all arguments previously set forth in opposition to Defendants' Daubert motions. All such arguments are hereby incorporated herein by reference.” Chapmans’ Opp’n to P&G’s Summ. J. Mot. at 7 n. 11.
. The focus for cases in the first category is "individual causation to plaintiff” — "was plaintiff exposed to the toxin, was plaintiff exposed to enough of the toxin to cause the alleged injury, and did the toxin in fact cause the injury?” McClain,
. For example, the Chapmans quote from the report of their only expert unchallenged by P&G in the Daubert proceedings, Dr. Joseph Prohaska, that "it is well understood in the scientific community that excess zinc can result in low plasma copper.” Appellants’ Br. at 31 n. 8 (citation, internal quotation marks, and alteration omitted). The Chapmans, however, did not advance Dr. Prohaska with their other seven proffered experts they argued could establish general and specific causation, all of whom the district judge disqualified in her Daubert order. Moreover, Dr. Prohaska was limited by his report to opining on "the hematological changes associated with copper deficiency as well as the impact
. We have ‘'explained] why it is difficult to persuade a court of appeals to reverse a district court's judgment on Daubert grounds[,] ... where the abuse of discretion standard thrives.” United States v. Brown,
. The judge quoted the deposition testimonies of the three general-causation experts to show their inability to state the Fixodent dosage to put an individual at risk of developing myelo-pathy:
Dr. Brewer:
Q. Have you ever determined the dose of Fixodent necessary to consistently place individuals into a negative copper balance?
A. Experimentally, no.
Dr. Lautenbach:
Q. Now, do you know how much below normal ... serum copper has to be and for how long before you have myelopathies?
A. I don't know.
Dr. Landolph:
Q. So no studies have been done to determine how low the copper must be in the serum and for how long to cause myelopa-thy?
A. I had not seen such a precise curve....
In re Denture Cream Prods. Liab. Litig.,
. The judge supported the lack of epidemiological evidence with Dr. Lautenbach’s deposition testimony:
Q. To the best of your knowledge, there are no controlled population-based epide-miologic studies testing whether there is an association between denture adhesive and the development of hematologic or neuro-logic disease. Correct?
A. That’s correct.
In re Denture Cream Prods. Liab. Litig.,
. The Chapmans’ general-causation experts testified concerning the lack of background risk of CDM at their respective depositions:
Dr. Brewer:
Q. Do you know the incidence of myelo-neuropathies in the United States?
A. No.
Q. Do you know the incidence of myelo-neuropathies, myelopathies, or myeloneuro-pathies [sic] amount uses of zinc-containing denture adhesives in the United States?
A. No.
*1308 Dr. Lautenbach:
Q. Do you know what the incidence of myelopathy is in the general population?
A. I don't. I’m not sure it’s been well defined.
Dr. Landolph:
Q. You are unable to give me a number setting forth the incidence of myeloneuro-pathy among users of zinc containing denture adhesives in the United [S]tates, correct?
A. That's correct, the precise number, I don’t have that data.
In re Denture Cream Prods. Liab. Litig.,
. Marianne Chapman’s medical history reveals she had experienced neurologic ailments in her childhood, long before her Fixo-dent use began in 2001. Matthew E. Fink (P&G expert) Report at 4-5. As a child, she had suffered frequent migraine headaches and was treated for unexplained foot and ankle pain. Id. at 4. She was evaluated during her teen years for pain from her shoulder through her leg. Id. After a series of recurrent falls, some of which resulted in hospitalization, she complained of pain in her lower extremities, numbness, and decreased sensation. Id. at 5. In adulthood, before her use of Fixodent, Marianne Chapman was diagnosed with hereditary hemorrhagic telangiectasia, a genetic disorder often accompanied with spinal cord, neurologic ailments. Marianne Chapman Dep. at 39:20-25; Fink Report at 16.
. Marianne Chapman’s husband first “diagnosed” her medical ailments as the result of her ingestion of zinc by researching the issue on the Internet. See Daniel Chapman Dep. at 57:15-24 ("A. I looked up her symptoms and I learned about zinc poisoning. Q. Now, pri- or to the time when you did that, had anybody suggested to you that it could be zinc poisoning? A. No. Q. So are you the first person that thought Marianne Chapman, your wife, might have zinc poisoning? A. Yes.”); Marianne Chapman Dep. at 111:13-25 ("When did it first come to your attention that there might be some nerve problems that could result from the zinc in Fixodent or other dental adhesives? ... A. In the beginning of '09 when my husband was looking up neuro-pathy, the browser log popped up with all different types of neuropathy, links to neuro-pathy and possible causes of neuropathy. And that's when he had brought it to my attention that the zinc in the denture cream could cause neuropathy.”); Greenberg Report at 6 (noting Marianne Chapman and her husband "became concerned about the possibility of zinc poisoning after research on the Internet”).
.After Marianne Chapman began using Fixodent, she again complained of pain in her lower extremities. Marianne Chapman Dep. 12:25-13:14. She was diagnosed with and treated for vitamin B12 deficiency, which has been associated with myelopathy. Fink Report at 14; Greenberg Dep. 75:1-9. Following brief improvement, her neurologic ailments returned in 2006, when she experienced burning and numbness in her legs, poor balance, and the eventual loss of motor control in her right hand. Fink Report at 14-15. In 2006, Marianne Chapman also developed anemia (low red blood cells) and neutropenia (low white blood cells). Green-berg Report at 5 (Table 3). She had normal red and white blood-cell measurements in May and November 2006, while she continued to use Fixodent; her neutropenia normalized permanently in September 2008, before she stopped using Fixodent in 2009. Id.; Fink Report at 15.
. Ten months after Marianne Chapman stopped using Fixodent, she reported worsening hand weakness and wrist drop. Fink Report at 15. Two years after she ceased using Fixodent, in 2011, she had a recurrence of a neurological problem, a positive Rom-berg sign of unsteady balance with her eyes closed, which was not present in 2010. Green-berg Report at 7; Fink Report at 13.
. P&G contended to the district judge that Dr. Greenberg also should have considered other hereditary and acquired diseases that could have caused Marianne Chapman’s mye-lopathy, including adrenomyeloneuropathy, complicated hereditary spastic paraplegia, Charcot-Marie-Tooth disease, hereditary motor and sensory neuropathy Type V, subtypes of spinocerebeller atrophy, hereditary ataxia with neuropathy, vitamin E deficiency, Sjo-gren’s syndrome, sarcoidosis, HTLV-1, neuro-mylitis optica, and multiple-vitamin-deficiency syndrome. In re Denture Cream Prods. Liab. Litig.,
. Procedurally, this case has been appealed from the district judge’s order granting summary judgment to P&G. Her Daubert order, excluding the Chapmans’ general and specific-causation experts, alone could not have provided the procedural basis for appellate jurisdiction, because it was not a final order. Consequently, the Chapmans have incorporated the judge’s Daubert order in their appeal of summary judgment granted to P&G to have this court review the merits of the Daubert order. The Chapmans’ reasons for appealing summary judgment granted to P&G were raised before the district judge and decided in her order. The Chapmans’ opposition to P&G’s summary judgment motion consisted of their proposing alternative experts for trial testimony, while the Daubert order had addressed and excluded their general and specific-causation experts. To the extent the Chapmans have appealed the same reasons for opposing P&G's summary judgment mo
.Because of the Chapmans’ joining in the interlocutory appeal purporting to be a final judgment and her granting the Rule 60(b) motion, the judge was inclined to grant P&G’s motion for summary judgment based on judicial estoppel under New Hampshire v. Maine,
. The Chapmans argue Dr. Prohaska's Report states his “unchallenged opinion [by P&G] that zinc excess causes copper deficiency and that copper deficiency caused [Marianne] Chapman’s hematological symptoms.” Appellants’ Br. at 18 n. 5.
. In their initial brief, the Chapmans argue P&G pre-litigation studies, demonstrating the bioavailability of zinc after ingestion, would support their position:
Plaintiffs’ experts relied on three internal P&G studies demonstrating that a large*1314 percentage of the Fixodent used by denture wearers is ultimately ingested into the body and that the zinc in Fixodent, once ingested, is highly bioavailable in the small intestine, ultimately being absorbed into the bloodstream and leading to elevated serum zinc levels. In 1993, P&G performed a study of 10 actual denture wearers "to obtain data on the quantity of Zinc ions ingested by the study subjects following daily administration of the maximum recommended amount of [denture] adhesive paste.” P&G Clinical Study Report No. 003793, at 5 (Sept. 1993) ("1993 Study”). Even when the study subjects were instructed to apply only half of the label’s recommended amount of adhesive, P&G found that the studied users ingested approximately 50% of the Fixodent applied. [Footnote 17 to this sentence states: "At that rate, someone like Ms. Chapman would ingest 247 mg of zinc daily (approximately 10 times the threshold for causing hypocupre-mia).”]
Moreover, P&G internal studies dating back more than two decades have demonstrated that, once ingested, most of the elemental zinc dissociates from the Fixodent polymer and becomes free-floating in the intestines, where it affects copper metabolism. First, in 1989, prior to the introduction of Fixodent, P&G conducted a “zinc dissociation experiment” in which it mixed Fixodent with laboratory-simulated saliva, gastric fluid, and intestinal proteins. P&G calculated that "nearly 100% [of the zinc] dissociated (96.6%)” from its polymer when mixed with the simulated gastric fluid. P&G Report on Zinc Dissociation Experiment at 5 (July 1989). P&G further recognized that the zinc ions would bind with proteins in the small intestine, the precise mechanism by which zinc interferes with copper absorption (binding to metallothion-ein).
Subsequently, in 1994, P&G performed an "[i]n vitro dialysis study” to further analyze the bioavailability of Fixodent. Consistent with its 1989 study, P&G found that 83.3% of the zinc in Fixodent became bioa-vailable when the denture cream was mixed with simulated gastric fluid (compared to 93% for zinc salt). P&G Dialysis Study on Denture Adhesives at 2 (Nov. 1994). The researchers responsible for the 1994 study noted that, "if the adhesive is ingested, ... the majority of [the zinc will] be released” into the body, and as P&G had found the previous year, users ingest almost all of the Fixodent that they apply. As Dr. Brewer stated in his report, P&G's own studies provide reliable evidence that the zinc in Fixodent can, if the adhesive is consumed, "caus[e] copper depletion and its clinical manifestations.” Brewer Rep. 9 & n. 14.
In excluding Plaintiffs' general-causation experts, the district court never mentioned these studies or explained why they were not reliable in demonstrating the bioavaila-bility of zinc in Fixodent. The court thus erred by failing to do the kind of "exacting analysis of the proffered expert's methodology” that Daubert requires. That error was critical: given that it is well settled that zinc can cause CDM, P&G's own internal studies showing that Fixodent is ingested, and that when ingested exposes users to bioavailable zinc, constitute reliable evidence that zinc in Fixodent generally can cause CDM.
Appellants’ Br. at 44-46 (alterations and ellipsis in original) (some citations omitted).
. Because the Chapmans had waited six months after the court-imposed deadline for naming expert witnesses before proffering P&G’s experts to testify for them at trial, the district judge recognized that they were procedurally barred from using these alternative witnesses at trial. We are not saying parties may not use opposing parties’ experts to prove their case at trial as a general proposition. We are recognizing that all experts, regardless of which party secured their services, must meet the qualifications established by Daubert and the procedural requirements of Rule 26(a)(2).
. For example, P&G expert, Dr. Timothy R. Koch, plainly disagreed with the Chapmans’ general causation theory and stated: “It’s my position, based on an independent review of the literature [and] based upon my own practice and experience, that there’s not a sufficient amount of medical and scientific information and evidence available to support the statement that zinc induces myelopathy.” Koch Dep. at 67:9-17. Similarly, the district judge noted the Chapmans contended P&G expert, Dr. Lara W. Katzin, "confirmed that zinc-induced CDM should be considered in the differential etiology for Ms. Chapman’s condition,” but failed to square that statement with the judge’s discussion of Eleventh Circuit law stating general causation cannot be proved by differential diagnosis, "a necessary element of their claims.” Summ. J. Order at 9 (citing McClain,
. A treating physician providing lay testimony can testify narrowly, limited to personal knowledge resulting from providing medical care, involving consultation, examination, or treatment of a patient plaintiff. See United States v. Henderson,
Concurrence Opinion
concurring:
Given the “due deference” that the abuse of discretion standard embodies, see Gall v. United States,
Specifically, I would not suggest, as the court does in dictum, that the district court could have properly prevented the Chap-mans from relying on Procter & Gamble’s own experts. The district court addressed the Chapmans’ reliance on some of the defense experts on the merits and did not exclude those experts under Rule 26 of the Federal Rules of Civil Procedure. So there is no need to hypothesize about how we would rule if the district court had decreed that such reliance by the Chap-mans was procedurally improper. Moreover, P&G does not assert Rule 26 on appeal, and some cases hold that, because there is no surprise or prejudice, a party is permitted to use and rely on the expert testimony presented by the opposing party. See, e.g., Nat’l Railroad Passenger Corp. v. Certain Temporary Easements,
In closing, I recognize that the district court at times used language which might be seen as opining on the ultimate persuasiveness of the theories advanced by the Chapmans’ experts. But given its numerous accurate statements of the correct standard under Daubert v. Merrell Dow Pharmaceuticals, Inc.,
