Anne Ruggiero v. Warner-Lambert Co., 424 F.3d 249 (2d Cir. 2005). · Go Syfert
Anne Ruggiero v. Warner-Lambert Co., 424 F.3d 249 (2d Cir. 2005). Cases Citing This Book View Copy Cite
Quick Summary

An expert using differential diagnosis to rule out other potential causes must also rule in the suspected cause using scientifically valid methodology to establish general causation.

In a product liability action alleging a diabetes medication caused the plaintiff's husband's death, the district court granted summary judgment after excluding expert testimony on general causation. The expert relied solely on a differential diagnosis to attribute the injury to the drug without independent scientific evidence that the drug was capable of causing the condition. The court addresses whether a differential diagnosis alone satisfies the reliability requirements of Federal Rule of Evidence 702 for establishing general causation. Applying the Daubert standard, the court holds that while differential diagnosis may support specific causation, it does not necessarily support general causation because it assumes the remaining cause is capable of causing the injury. The expert must rule in the suspected cause using scientifically valid methodology. The court affirms the exclusion of the testimony and the summary judgment.

271 citation events (271 in the last 25 years) across 38 distinct courts.
Treatment trajectory · 2005 → 2026 · click a year to view as-of
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Cited for
At page 252 District court discretion to consider arguments in reply briefs60 citing casesholding that the district court had discretion to consider an issue first raised in reply papers3 citing courts put it this way · 59 listed here
  • Escobar v. Ludington, No. 1:22-cv-08434 (S.D.N.Y. Sept. 4, 2024). 3 cites
    ([I]t is hard for [the plaintiff] to claim unfair prejudice now, because she could have claimed surprise in the district court and sought to file a responsive sur-reply.)
  • Allah, No. 9:23-cv-00785 (N.D.N.Y. Sept. 28, 2026). 2 cites
    Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 252 (2d Cir. 2005).
  • United States v. Premises, Bldgs., Appurtenances, Improvements, & Real Prop. Located at 3242 Daansen Road, Walworth, No. 1:25-cv-00459 (W.D.N.Y. Sept. 18, 2026).
    Co., 611 F. Supp. 2d 373, 375 (S.D.N.Y. 2009), aff’d, 374 F. App’x 71 (2d Cir. 2010) (citing Ruggiero v. Warner- Lambert Co., 424 F.3d 249, 252 (2d Cir. 2005)).
  • Quinn v. City of New York, No. 24-2682 (2d Cir. Jan. 21, 2026).unpublished
    (district court did not err in considering issue of general causation, which defendants did not “expressly” raise in summary-judgment opening papers but did raise in reply papers, where plaintiff’s “opposition papers cit…)
  • Adamson, No. 1:24-cv-05235 (S.D.N.Y. Sept. 4, 2025).
    The Government first observed that “this Court ‘is free to disregard argument[s] raised for the first time in reply papers.’” Id. at 1 (citing Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 252 (2d Cir. 2005)).
  • Arthur v. Orchestrate Bus. LLC, No. 1:24-cv-02985 (S.D.N.Y. Aug. 1, 2025).
    June 19, 2023) (citing Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 252 (2d Cir. 2005)).
  • Rouviere v. Depuy Orthopaedics, Inc., No. 1:18-cv-04814 (S.D.N.Y. June 12, 2025).
    Even assuming Plaintiff’s contentions were untimely, see United States v. Pepin, 514 F.3d 193 , 203 n.13 (2d Cir. 2008) (observing that courts “generally do not consider issues raised in a reply brief for the first time” because the nonmov…
  • Siracusa v. New Hyde Park-Garden City Union Free Sch. Dist., No. 2:24-cv-01002 (E.D.N.Y. Aug. 19, 2024).
    (noting that “the district court had discretion to consider” an argument first made in a reply brief)
  • New York State Firearms Ass'n v. Chiumento, No. 6:23-cv-06524 (W.D.N.Y. May 2, 2024).
    Mgmt., L.P. v. Vitek, No. 20-3406, 2022 WL 3970920 , at *1 (2d Cir. Sept. 1, 2022) (citing Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 252 (2d Cir. 2005)) (“The district court has discretion to consider arguments made and evidence submit…
  • Starlink Logistics, Inc. v. ACC, LLC, No. 1:18-cv-00029 (M.D. Tenn. May 1, 2024).
    (noting that the district court has discretion to consider arguments first raised in reply papers)
Show 49 more citing cases
At page 254 Evaluating differential diagnosis for causation opinions50 citing cases“where an expert employs differential diagnosis to 'rule out' other potential causes for the injury at issue, he must also 'rule in' the suspected cause, and do so using scientifically valid methodology.”6 citing courts quote it · 47 listed here
  • Henry Sims, Jr. v. Kia Motors of Am., I, 839 F.3d 393 (5th Cir. 2016).published 4 cites
    (Where an expert employs differential diagnosis to ‘rule out’ other potential causes for the injury at issue, he must also ‘rule in’ the suspected cause, and do so using ‘scientifically valid methodology’)
  • Junk v. Terminix Int'l Co., 577 F. Supp. 2d 1086 (S.D. Iowa 2008).published 2 cites
    (A differential diagnosis is a ‘a patient-specific process of elimination.... ’)
  • Josepha W. Austin v. Monsanto Co., No. 2:23-cv-00272 (D. Vt. Dec. 1, 2025). 2 cites
    Ruggiero, 424 F.3d at 251.
  • State v. Darryl Nieves, 345 A.3d 1127 (N.J. 2025).published
    Ante at ___ (slip op. at 49). 34 This means that SBS/AHT is a differential diagnosis, which we have previously defined as “a patient-specific process of elimination that medical practitioners use to identify the ‘most likely’ cause of a se…
  • Brown v. Abbott Labs., Inc., No. 1:22-cv-02001 (N.D. Ill. Oct. 23, 2025).
    Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 904 (7th Cir. 2007) (citing Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir. 2005)).
  • Raymond v. Mitchell, No. 9:18-cv-01467 (N.D.N.Y. June 11, 2024). 2 cites
    Differential Diagnosis "A differential diagnosis is a patient-specific process of elimination that medical practitioners use to identify the most likely cause of a set of signs and symptoms from a list of possible causes." Ruggiero v. Warn…
  • MacSwan v. Merck & Co., No. 1:20-cv-01661 (W.D.N.Y. June 14, 2023). 2 cites
    Although Dr. Morhaim testified that a partial denture could cause gum tissue to separate from the jawbone and that “[s]moking plays a contributing role in any dental infection[,]” (Doc. 30-2 at 96), beyond noting that a denture could be a…
  • Tardif v. City of New York, No. 1:13-cv-04056 (S.D.N.Y. June 17, 2022).
    “A differential diagnosis is ‘a patient- specific process of elimination that medical practitioners use to identify the most likely cause of a set of signs and symptoms from a list of possible causes.’” Ruggiero v. Warner-Lambert Co., 424…
  • Deutsch ex rel. Est. of Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420 (E.D.N.Y. 2011).published
  • Derienzo v. Metro. Transp. Auth., 694 F. Supp. 2d 229 (S.D.N.Y. 2010).published
Show 37 more citing cases
At page 253 Evaluating expert testimony under Daubert and Rule 70231 citing cases“as the supreme court explained in daubert, rule 702 requires the district court to ensure that 'any and all scientific testimony or evidence admitted is not only relevant, but reliable.”2 citing courts quote it
  • McFee v. BJ's Wholesale Club, Inc., No. 1:21-cv-03087 (E.D.N.Y. Aug. 25, 2025).
    When an expert’s opinion is “based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Souza v. Exotic Island E…
  • Shariff v. Goord, No. 6:05-cv-06504 (W.D.N.Y. Apr. 28, 2025).
    When an expert opinion is “based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v. Warner- Lamber…
  • B & R Supermarket, Inc. v. Visa, Inc., No. 1:17-cv-02738 (E.D.N.Y. Sept. 20, 2024).
    When an expert’s opinion is based on data or methodologies “that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v. Warner-Lambert Co., 42…
  • Raymond v. Mitchell, No. 9:18-cv-01467 (N.D.N.Y. June 11, 2024). 2 cites
    Differential Diagnosis "A differential diagnosis is a patient-specific process of elimination that medical practitioners use to identify the most likely cause of a set of signs and symptoms from a list of possible causes." Ruggiero v. Warn…
  • Comfortex Co. v. Xcel Brands, Inc., No. 1:21-cv-07326 (S.D.N.Y. Mar. 25, 2024).
    “As the Supreme Court explained in Daubert, Rule 702 requires the district court to ensure that ‘any and all scientific testimony or evidence admitted is not only relevant, but reliable.’” Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 253…
  • Lane v. Am. Airlines, Inc., No. 1:18-cv-06110 (E.D.N.Y. Mar. 20, 2024).
    When an expert’s opinion is based on data or methodologies “that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v. Warner-Lambert Co., 42…
  • Cargo Logistics Int'l, LLC v. Overseas Moving Specialists, Inc., 723 F. Supp. 3d 212 (E.D.N.Y. 2024).published
    When an expert’s opinion is based on data or methodologies “that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v. Warner-Lambert Co., 42…
  • Silva v. Heil, Inc., 692 F. Supp. 3d 29 (E.D.N.Y. 2023).published
    When an expert’s opinion is based on data or methodologies “that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v. Warner-Lambert Co., 42…
  • Anthem, Inc. v. Express Scripts, Inc., 660 F. Supp. 3d 169 (S.D.N.Y. 2023).published
    “As the Supreme Court explained in Daubert, Rule 702 requires the district court to ensure that ‘any and all [expert] testimony or evidence admitted is not only relevant, but reliable.’” Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 253 (2…
  • Suazo v. Ocean Network Express (North Am.), Inc., No. 1:20-cv-02016 (S.D.N.Y. Mar. 2, 2023).
    “As the Supreme Court explained in Daubert, Rule 702 requires the district court to ensure that ‘any and all scientific testimony or evidence admitted is not only relevant, but reliable.’” Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 253…
Show 21 more citing cases
At page 255 Exclusion of expert testimony based on inadequate data and methodology16 citing casesaffirming the district court’s grant of summary judgment in favor of defendant on the ground that plaintiff’s expert failed to submit competent evidence to show, as a matter of general causation, that the product can cause the alleged harm1 citing court put it this way
  • Sw. Payroll Serv., Inc. v. Pioneer Bancorp, Inc., No. 1:19-cv-01349 (N.D.N.Y. Sept. 9, 2026).
    "Accordingly, 'nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.'" Id. (citation omitted).3 "Consequently…
  • Rutledge v. Walgreen Co., 182 F.4th 168 (2d Cir. 2026).published
    Consequently, “when an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v.…
  • Rutledge v. Walgreen Co., No. 24-916(L); 24-2594 (2d Cir. July 13, 2026).published
    Accordingly, “nothing in either Daubert 18 or the Federal Rules of Evidence requires a district court to admit opinion evidence 19 that is connected to existing data only by the ipse dixit of the expert.” Id. 20 Consequently, “when an expe…
  • Ctr. for Indep. of the Disabled v. Metro. Transp. Auth., No. 1:17-cv-02990 (S.D.N.Y. Nov. 9, 2023).
    Thus, “when an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the 2 exclusion of that unreliable opinion testimony.” Ruggiero v. Warner…
  • Ctr. for Indep. of the Disabled v. Metro. Transp. Auth., No. 1:17-cv-02990 (S.D.N.Y. Sept. 6, 2023).
    Thus, “when an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Ruggiero v. Warner-…
  • White Buffalo Env't, Inc. v. Hungry Horse, LLC, No. 1:21-cv-00175 (D.N.M. Mar. 22, 2023).
    Lasker, Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702, 57 Wm. & Mary L. Rev. 1 , 32 (2015)(“Bernstein & Lasker”)(“[W]hen an expert opinion is based on data, a methodology, or studies that are simply inadequate to suppo…
  • Delgado v. Universal Beauty Prods., Inc., No. 2:17-cv-03245 (E.D.N.Y. Sept. 21, 2022).
    (affirming the district court’s grant of summary judgment in favor of defendant on the ground that plaintiff’s expert failed to submit competent evidence to show, as a matter of general causation, that the product can ca…)
  • Capri Sun GmbH v. Am. Beverage Corp., 595 F. Supp. 3d 83 (S.D.N.Y. 2022).published
    Dr. Steckel’s report thus does not fall below the minimum requirement for admissibility in this Circuit: that its data and methodology are “simply inadequate to support the conclusions reached,” Ruggiero v. Warner-Lambert Co., 424 F.3d 249…
  • JP Riggs, No. 21-20380 (Bankr. D. Conn. Dec. 10, 2021).
    To be admissible, an expert opinion “requires some explanation as to how the expert came to his conclusion and what methodologies or evidence substantiate that conclusion.” Riegel v. Medtronic, Inc., 451 F.3d 104, 127 (2d Cir. 2006). “[W]h…
  • In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164 (S.D.N.Y. 2009).published
Show 6 more citing cases
At page 251 Defining differential diagnosis in medical context6 citing cases
Retrieving the full opinion text from the archive…
Anne RUGGIERO, Individually and as Representative of the Estate of Albert Ruggiero, Plaintiff-Appellant,
v.
WARNER-LAMBERT COMPANY and Parke Davis, Defendants-Appellees
249.
Court of Appeals for the Second Circuit.
Sep 16, 2005.
Published opinion
424 F.3d 249
2005 U.S. App. LEXIS 19899
Ronald R. Benjamin, Law Office of Ronald R. Benjamin, Binghamton, NY, for Appellant., David Klingsberg, Kaye Scholer LLP, New York, N.Y. (Bert L. Slonim and Steven Glickstein, on the brief), for Appellees.
Jacobs, Parker, Hurd.
Cited by 177 opinions  |  Published
Pinpoint authority: bottom 53%
DENNIS JACOBS, Circuit Judge.

Plaintiff Anne Ruggiero appeals from a judgment entered by the United States District Court for the Southern District of New York (Kaplan, /.), dismissing on summary judgment a complaint alleging that her husband’s cirrhosis and death were caused by Rezulin, a diabetes medication manufactured and sold by defendants Warner-Lambert Co. and Parke Davis (“Defendants”). The ground for dismissal was that Ruggiero failed to produce sufficient evidence that Rezulin was capable of causing or exacerbating cirrhosis (so-called “general” causation). On appeal, Ruggiero argues principally that [i] the ruling on general causation was error because that issue was first raised in Defendants’ summary-judgment reply papers, and is a subject of on-going consolidated proceedings in the multi-district litigation (“MDL”) of which Ruggiero’s case is part; and [ii] medical expert evidence attributing Mr. Ruggiero’s cirrhosis and death to Rezulin was erroneously ruled inadmissible. For the following reasons, we affirm.

BACKGROUND

Albert Ruggiero was diagnosed with Type-II diabetes in 1982, and in May 1997, he began taking Rezulin, a diabetes medication manufactured and sold by Defendants. His death on August 24, 1998 was attributed to liver failure caused by cirrhosis. On March 21, 2000, Defendants halted distribution of Rezulin at the request of the Food and Drug Administration, in light of concerns that the drug caused increased liver toxicity.

Anne Ruggiero commenced this product-liability action, claiming that Rezulin caused Albert’s cirrhosis. The case was added to the “[m]ore than one thousand” Rezulin-related cases consolidated for pretrial proceedings in the Southern District of New York, before Judge Kaplan. In re Rezulin Prods. Liab. Litig. (MDL No. 1848), 223 F.R.D. 109, 111 (S.D.N.Y.2004). Defendants subsequently moved for summary judgment in Ruggiero’s individual case.

The district court granted summary judgment, holding that Ruggiero produced insufficient evidence of “general” causation, i.e., evidence that Rezulin is capable of causing or exacerbating cirrhosis of the liver. [1] Specifically, the court ruled that the sole evidence of general causation submitted by Ruggiero — the expert opinion of Dr. Douglas T. Dietrich — was inadmissible (as to that issue) under Fed R. Evid. 702 (“Testimony by Experts”) and Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The court reasoned that “Dr. Dietrich was unable to point to any studies or, for that matter, anything else that suggested that cirrhosis could be caused or exacerbated by Rezulin.” Dr. Dietrich’s opinion rested on a review of Albert’s medical records and a “differential diagnosis,” i e., a patient-specific process of ruling out potential causes of an illness as unlikely, until one cause remains. [2] The court con-[*252] eluded that this approach did not provide a reliable basis for Dr. Dietrich’s opinion that Rezulin is capable of causing or exacerbating cirrhosis.

DISCUSSION

We review the grant of summary judgment de novo. See Anthony v. City of New York, 339 F.3d 129, 134 (2d Cir.2003). A ruling as to the admissibility of expert evidence is reviewed for abuse of discretion. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 142-43, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) (“On a motion for summary judgment .... the question of admissibility of expert testimony ... is reviewable under the abuse-of-discretion standard.”).

I

As a threshold matter, Ruggiero claims that the district court should not have reached the issue of general causation.

First, she argues that the issue was first raised in Defendants’ summary-judgment reply papers. See, e.g., Playboy Enters., Inc. v. Dumas, 960 F.Supp. 710, 720 n. 7 (S.D.N.Y.1997) (“Arguments made for the first time in a reply brief need not be considered by a court.”). Assuming that is so, the district court had discretion to consider it. See Bayway Ref. v. Oxygenated Mktg. & Trading, 215 F.3d 219, 226 (2d Cir.2000) (reviewing for abuse of discretion district court’s decision to rely on evidence submitted with moving party’s reply papers).

Defendants’ moving papers did not argue expressly in terms of general causation. However [i] the motion was cast in terms of the broader and subsuming argument that Ruggiero could not “establish the essential element of causation”; [ii] a declaration appended to the moving papers noted that “[tjhere are no scientific studies in the medical literature that conclude Rezulin can cause cirrhosis”; and [iii] Ruggiero’s opposition papers cited as a genuine issue of material fact “[wjhether or not there are scientific studies in the medical literature that conclude Rezulin can cause liver failure such as caused decedent Albert Ruggiero’s death.” Under the circumstances, Ruggiero cannot claim that she was blindsided by Defendants’ reliance on general causation or that she was prejudiced by the district court’s consideration of that issue. [3] In any event, it is hard for Ruggiero to claim unfair prejudice now, because she could have claimed surprise in the district court and sought to file a responsive sur-reply. [4]

[*253] Second, Ruggiero argues that the district court should not have considered the issue of general causation because that issue [i] is being litigated by the “Plaintiffs Executive Committee” in the consolidated MDL proceedings and [ii] implicates the law-of-the-case doctrine by reason of a previous contrary decision in those consolidated proceedings (or somewhere else). Even assuming that the law-of-the-case doctrine would apply, Ruggiero’s brief directs us to no such contrary ruling.

In any event, we decline to consider the merits of this argument because Ruggiero failed to present it to the district court. Id. We have discretion to consider issues that a party failed to raise in the district court, see Booking v. Gen. Star Mgmt. Co., 254 F.3d 414, 418-19 (2d Cir.2001), but we decline to do so here. For the reasons stated above, there is no good excuse for Ruggiero’s failure to bring this complaint to the district court’s attention; and we are most hesitant to consider it in the first instance, given the unmatched expertise Judge Kaplan has acquired while presiding over the Rezulin MDL over the past five years.

II

The district court granted summary judgment to Defendants on the ground that Ruggiero submitted no admissible evidence to show, as a matter of general causation, that Rezulin can cause or exacerbate cirrhosis of the liver. Her only submission arguably on point was the expert opinion of Dr. Dietrich, who concluded with reasonable medical certainty that “Albert Ruggiero’s liver disease was caused by his taking Rezulin.” The district court ruled it inadmissible under the standards set out in Fed.R.Evid. 702 and Daubert.

Rule 702 states:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

As the Supreme Court explained in Dau-bert, Rule 702 requires the district court to ensure that “any and all scientific testimony or evidence admitted is not only relevant, but reliable.” 509 U.S. at 589, 113 S.Ct. 2786. As to reliability, “Daubert enumerated a list of factors that, while not constituting a ‘definitive checklist or test,’ a district court might consider ...; whether a theory or technique has been and could be tested, whether it had been subjected to peer review, what its error rate was, and whether scientific standards existed to govern the theory or technique’s application or operation.” Nimely v. City of New York, 414 F.3d 381, 397 (2d Cir.2005) (quoting Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786). “[W]hen an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 266 (2d Cir.2002).

A district court’s decision as to how the reliability of expert testimony should[*254] be determined, as well as the ultimate decision as to whether that testimony is reliable, are reviewed for abuse of discretion. See Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); see also Joiner, 522 U.S. at 142-43, 118 S.Ct. 512 (abuse-of-discretion standard persists at summary judgment stage).

Judge Kaplan applied the Daubert factors and concluded that there was no reliable basis for Dr. Dietrich’s opinion that Rezulin could cause or exacerbate cirrhosis of the liver: “Dr. Dietrich was unable to point to any studies or, for that matter, anything else that suggested that cirrhosis could be caused or exacerbated by Rezulin.” The judge further concluded that insofar as Dr. Dietrich’s opinion relied on a differential diagnosis, that technique was insufficiently reliable to support the opinion as to general causation (though it might suffice to support an opinion that a drug shown to be capable of causing the condition likely did so in a particular case).

We see no error. A differential diagnosis is “a patient-specific process of elimination that medical practitioners use to identify the ‘most likely’ cause of a set of signs and symptoms from a list of possible causes.” Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387, 1413 (D.Or.1996); Hines v. Consol. Rail Corp., 926 F.2d 262, 270 n. 6 (3d Cir.1991) (defining “differential diagnosis” as a “process whereby medical doctors experienced in diagnostic techniques provide testimony countering other possible causes ... of the injuries at issue”). As the district court observed, this method does not (necessarily) support an opinion on general causation, because, like any process of elimination, it assumes that “the final, suspected ‘cause’ remaining after this process of elimination must actually be capable of causing the injury.” Cavallo v. Star Enter., 892 F.Supp. 756, 771 (E.D.Va. 1995), aff'd on this ground, rev’d on other grounds, 100 F.3d 1150 (4th Cir.1996); Hall, 947 F.Supp. at 1413 (noting that a differential diagnosis “assumes that general causation has been proven for the list of possible causes it eliminates”). Where an expert employs differential diagnosis to “ ‘rule out’ other potential causes” for the injury at issue, he must also “ ‘rule in’ the suspected cause,” and do so using “scientifically valid methodology.” Id. Here, Dr. Dietrich may have used a differential diagnosis to rule out competing causes of cirrhosis without establishing that Rezulin is among them.

We cannot say that a differential diagnosis may never provide a sufficient basis for an opinion as to general causation. There may be instances where, because of the rigor of differential diagnosis performed, the expert’s training and experience, the type of illness or injury at issue, or some other case-specific circumstance, a differential diagnosis is sufficient to support an expert’s opinion in support of both general and specific causation. Cf. McCulloch v. H.B. Fuller Co., 61 F.3d 1038, 1043-44 (2d Cir.1995) (district court did not abuse discretion in ruling that opinion on causation was admissible, where opinion was based on care and treatment of plaintiff, medical history, pathological studies, product’s safety data sheet, reference to scientific and medical treatises, expert’s training and experience, as well as differential diagnosis). The district judge has broad discretion in determining whether in a given case a differential diagnosis is enough by itself to support such an opinion. [5]

[*255] As a final matter, Ruggiero — relying on language in McCulloch — argues that any fault in Dr. Dietrich’s use of a differential diagnosis goes to weight, not admissibility. After the McCulloch Court reviewed a number of factors underlying the opinion of the plaintiffs expert, the Court stated that “[disputes as to the strength of his credentials, faults in his use of differential etiology as a methodology, or lack of textual authority for his opinion, go to the weight, not the admissibility, of his testimony.” Id. at 1044. Ruggiero is over-reading that passage. The opinion had held, supra, that the district court did not abuse its discretion in ruling that the expert’s opinion in that case was admissible; in the quoted passage, the Court was merely signaling that any remaining objection as to the expert’s credentials or methodology was for the consideration of the jury. In any event, Ruggiero’s reading of McCulloch is precluded by the Supreme Court’s subsequent decision in Joiner. In Joiner, the Court held that “conclusions and methodology are not entirely distinct from one another,” and that “[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.” 522 U.S. at 146, 118 S.Ct. 512. Following Joiner, we held that “when an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 266 (2d Cir.2002). In light of Joiner and Amorgi-anos, Ruggiero’s reliance on McCulloch is unpersuasive.

❖ * * sji * *

We have considered Ruggiero’s remaining arguments and find each to be without merit. The judgment of the district court is affirmed.

1

. General causation bears on whether the type of injury at issue can be caused or exacerbated by the defendant's product. “Specific" causation bears on whether, in the particular instance, the injury actually was caused or exacerbated by the defendant's product. See Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 268 (2d Cir.2002).

2

. The district court assumed for the purpose of analysis that Dietrich relied on a differential diagnosis but noted that "it was not really clear” that he did so.

3

. See, e.g., Bayway, 215 F.3d at 227 (district court properly relied on evidence submitted with moving party’s reply, where, inter alia, record showed that opposing party knew such evidence could refute its claim but “chose not to introduce any evidence” of its own); Cifarelli v. Village of Babylon, 93 F.3d 47, 53 (2d Cir.1996) (district court properly relied on evidence submitted with defendants' summary-judgment reply, where record showed that plaintiff "was fully aware prior to the defendants’ reply of” the issue to which evidence pertained); Bridgeway Corp. v. Citibank, 201 F.3d 134, 140 (2d Cir.2000) (district court's sua sponte grant of summary judgment neither surprised nor prejudiced losing party where, inter alia, party had previously claimed that it had introduced sufficient evidence concerning the very issue on which the court based its decision).

4

. See, e.g., Bayway, 215 F.3d at 227 (district court properly considered evidence submitted with plaintiff's reply brief where, inter alia, defendant "did not move the district court for leave to file a surreply to respond”); Bridgeway Corp. v. Citibank, 201 F.3d 134, 140 (2d Cir.2000) (plaintiff was not prejudiced by district court’s sua sponte grant of summary judgment where, inter alia, plaintiff "did not, before the district court, raise any objections based on lack of notice. Nor did it subsequently seek to introduce additional evidence that might have convinced the district court[*253] to change its position.”); cf. Gwozdzinsky v. Magten Asset Mgmt. Corp., 106 F.3d 469, 472 (2d Cir.1997) ("[A]bsent manifest injustice or a showing of extraordinary need, we will not decide an issue on appeal not first presented to the district court.”).

5

. On this score, the district court indicated that even if a differential diagnosis could be probative of general causation in an appropriate case, it was not so here:

[*255] It is not at all clear ... that a district court lacks discretion to conclude in an individual case that an expert's opinion as to general causation based on an unreliable differential diagnosis must be received in evidence.
This case illustrates the fundamental problem with differential diagnosis .... The doctor has not offered any reliable basis for concluding that Rezulin is capable of causing the cirrhosis that caused the liver failure that resulted in Mr. Ruggiero’s death. In other words, he has offered no reliable ground upon which Rezulin may be “ruled in" as a plausible cause of the cirrhosis.