184 F.3d 1300 (11th Cir. 1999), 99-8053, Allison v McGhan Medical Corp.

Docket Nº99-8053.
Citation184 F.3d 1300
Party NameCatherine "Kip" ALLISON, Plaintiff-Appellant, v. McGHAN MEDICAL CORPORATION and Minnesota Mining & Manufacturing Company (3M), Defendants-Appellees.
Case DateAugust 18, 1999
CourtUnited States Courts of Appeals, United States Court of Appeals (11th Circuit)

Page 1300

184 F.3d 1300 (11th Cir. 1999)

Catherine "Kip" ALLISON, Plaintiff-Appellant,

v.

McGHAN MEDICAL CORPORATION and Minnesota Mining & Manufacturing Company (3M), Defendants-Appellees.

No. 99-8053.

United States Court of Appeals, Eleventh Circuit

August 18, 1999

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Appeals from the United States District Court for the Northern District of Georgia. (No. 93-CV-2051-RLV), Robert L. Vining, Jr., Judge.

Before COX, Circuit Judge, FAY, Senior Circuit Judge, and NANGLE[*], Senior District Judge.

NANGLE, Senior District Judge:

Catherine "Kip" Allison sought recovery in district court for injuries allegedly suffered from breast implants manufactured by McGhan Medical Corporation and Minnesota Mining & Manufacturing Company ("3M/McGhan"). She asserted claims in negligence, fraud/misrepresentation and strict liability/failure to warn. After holding a three day Daubert hearing, the district court ruled inadmissible Allison's proffered expert testimony on causation. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The district court granted summary judgment on the fraud/misrepresentation claims for failure to plead with particularity and to establish a prima facie case, and on the strict liability claim because Georgia's statute of repose had run. Because of Allison's inability to establish liability without the experts, the district court granted final summary judgment to 3M/McGhan on the remaining negligence and failure to warn claims. After careful but deferential review, we conclude that the district court's Daubert rulings were correct. Because the court properly excluded the expert testimony, we affirm its grant of summary judgment on the negligence claims. We additionally affirm summary judgment on Allison's other claims.

I. Background

In December 1979, at age 21, Kip Allison decided to get cosmetic silicone breast implants. She discussed her decision with her parents and a cousin who had implants. She also discussed the various associated risks of the implant surgery with her plastic surgeon, Dr. Harvey Weiss, although the parties dispute the contents of this discussion. Dr. Weiss implanted a double lumen design,1 manufactured by 3M/McGhan. After complications from the initial surgery developed, the left implant was replaced in December 1980 by a model also manufactured by 3M/McGhan. (Appellant's Br. at 3.)

In 1986 Allison was diagnosed with Hashimoto's thyroiditis (diffuse infiltration of the thyroid gland with white blood cells, resulting in diffuse goiter).2 In 1987, Allison was diagnosed with Type I diabetes mellitus.3 She also began experiencing

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debilitating fatigue, joint, muscle and nerve pain. In 1992 Dr. Bruce Bode, an endocrinologist, tested Allison for antinuclear antibodies and found that she had an extremely high titer of 1:5120.4 Bode referred Allison to Dr. Sam Schatten, a rheumatologist, who diagnosed her with Sjogren's syndrome5 and fibromyalgia.6 Dr. Schatten reported to Dr. Bode that he did not believe that Allison's breast implants were a source of her medical problems. (Appellees' Br. at 10-11.) Although Allison does not contend that her diabetes, thyroiditis, or neuropathies were caused or exacerbated by the implants, the parties dispute the degree of debilitation caused by Allison's diabetes, which 3M/McGhan alleges was severe. (Appellant's Reply Br. at 20; Appellees' Br. at 9-10, 14; see also Bode Dep. at 16, 22, 39-40 (describing Allison's diabetes as chronically poorly controlled, aggravated by bulimia, and contributing to her chronic fatigue); Schatten Dep. vol. I at 33 (describing onset of symptoms of daily temperature, fatigue, malaise and chills at age sixteen and arising from diabetes.))

Throughout 1992 Allison worsened, and although no one determined the cause of her ailments, she decided to have her implants removed at Dr. Bode's recommendation. (Bode Dep. at 60.) Dr. Philip Beegle, a plastic surgeon, performed the explantation surgery in February 1993. The pathology report stated that the outer shell of one implant was collapsed and the other contained minimal saline. Neither implant showed a loss of integrity of the inner lumen containing the silicone gel.7 The implants were photographed and subsequently destroyed. After removal of the implants, Allison's non-diabetic symptoms improved. Her ANA levels steadily declined to a level of 1:80 in October 1997. Allison reported dramatic reduction of joint and muscle pain, and less fatigue. (Appellant's Br. at 5; Appellees' Br. at 8.) Dr. Schatten again evaluated Allison in 1993, shortly after the implants were removed. He did not change his former opinion, but advised Allison that she needed psychiatric help. (Id. at 11.)

Allison filed her complaint in September 1993 in the Northern District of Georgia seeking compensation for injuries allegedly caused by defectively manufactured breast implants. The case was transferred to the Northern District of Alabama as part of In re Silicone Gel Breast Implants Products Liability Litigation, 793 F.Supp. 1098 (J.P.M.L.1992), before the Honorable Sam Pointer, Jr. for pretrial disposition in multidistrict proceedings. The case was later remanded to the Northern District of Georgia.

After remand, Allison stated orally to the court that she was proceeding on

Page 1306

claims of strict liability, negligence, misrepresentation and fraud. To establish causation in the negligence claim, Allison proposed testimony from three physicians, Drs. Eric Gershwin, Douglas Shanklin and Sam Schatten. The district court, in accordance with the Supreme Court's mandate for federal judges to exercise gatekeeping functions to determine the reliability and relevance of scientific evidence, held a Daubert hearing. The court heard three days of evidence and argument from both sides and waded through literally volumes of paper of the documentary record on the science related to breast implants. After consideration of this evidence, the court granted 3M/McGhan's motions to exclude the expert causation witnesses on the basis that their testimony lacked reliability and relevance under Daubert. The court dismissed Allison's claims for local injuries and strict liability due to Georgia's ten year statute of repose.8 The court additionally barred the claims for fraud/misrepresentation and failure to warn. Because causation is an essential element in the negligence claim, and Allison was unable to prove causation without the experts, the court subsequently granted final summary judgment to 3M/McGhan on all remaining claims. Allison appeals.

II. Standards of Review

We review the district court's grants of partial summary judgment and summary judgment de novo, reviewing all facts and reasonable inferences in the light most favorable to the nonmoving party, and applying the same standard as the district court. Rodgers v. Singletary, 142 F.3d 1252, 1253 (11th Cir.1998); Hale v. Tallapoosa County, 50 F.3d 1579, 1581 (11th Cir.1995). A grant of summary judgment is appropriate "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). "If the record presents factual issues, the court must not decide them; it must deny the motion and proceed to trial." Clemons v. Dougherty County, Ga., 684 F.2d 1365, 1369 (11th Cir.1982). A grant of summary judgment may be upheld on any basis supported by the record. Fitzpatrick v. City of Atlanta, 2 F.3d 1112, 1118 (11th Cir.1993).

The Court reviews rulings on the admissibility of expert testimony for abuse of discretion. General Elec. Co. v. Joiner, 522 U.S. 136, 138-39, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). This deferential standard is not relaxed even though a ruling on the admissibility of expert evidence may be outcome-determinative. Id., 522 U.S. at 142-43, 118 S.Ct. 512. "Cases arise where it is very much a matter of discretion with the court whether to receive or exclude the evidence; but the appellate court will not reverse in such a case, unless the ruling is manifestly erroneous." Id. (quoting Spring Co. v. Edgar, 99 U.S. 645, 25 L.Ed. 487 (1878)); see also N.V. Maatschappij Voor Industriele Waarden v. A.O. Smith Corp., 590 F.2d 415, 418 (1978) (pointing out that Rule 702, although broadening "the range of admissible expert testimony," does not alter the "manifestly erroneous" standard of review). The burden of laying the proper foundation for the admission of the expert testimony is on the party offering the expert, and admissibility must be shown by a preponderance of the evidence. Daubert, 509 U.S. at 592 n. 10, 113 S.Ct. 2786 (citing Bourjaily v. United States, 483 U.S. 171, 175-76, 107 S.Ct. 2775, 97 L.Ed.2d 144 (1987)).

III. Analysis

A. Strict Liability/Failure to Warn

The district court properly granted summary judgment on the strict liability claims. The court found that the claims were barred under Georgia's ten year statute of repose which states:

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No action shall be commenced pursuant to this subsection with respect to an injury after ten years from the date of the first sale for use or consumption of the personal property causing or otherwise bringing about the injury.

O.C.G.A. § 51-1-11(b)(2). Subsection (c) provides an exception to the above:

The limitation of paragraph (2) of subsection (b) of this Code section regarding bringing an action within ten years from the date of the first sale for use or consumption of personal property shall also apply to the commencement of an action claiming negligence of a manufacturer as the basis of liability, except an action seeking to recover from a...

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517 practice notes
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    • United States
    • Federal Cases United States Bankruptcy Courts Third Circuit
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    ...to consistently reject individual case reports as a reliable basis for medical causation opinions. See Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir.1999); Hollander v. Sandoz Pharm. Corp., 95 F.Supp.2d 1230 (W.D.Okla.2000), aff'd in pertinent part, 289 F.3d 1193 (10th Cir.), cert. ......
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    ...Pharm. USA, Inc., No. 17-CV-61800, 2017 WL 5971720 (S.D. Fla. Dec. 1, 2017) ................. 5 Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir. 1999) ............................................ Bains LLC v. Arco Prod. Co., Div. of Atl. Richfield Co., 405 F.3......
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    • Federal Cases United States District Courts 11th Circuit Middle District of Alabama
    • January 12, 2001
    ...of Evidence. See Bennett v. PRC Public Sector, Inc., 931 F.Supp. 484, 490 (S.D.Tex.1996) ( Rule 701). Cf. Allison v. McGhan Med. Corp., 184 F.3d 1300, 1312 (11th Cir.1999) (Rule 702). Rule 701 of the Federal Rules of Evidence, which took effect in December 2000, provides that a witness, who......
  • 248 B.R. 583 (Bkrtcy.N.D.Ala. 2000), 99-04505-TBB-13, In re Greene
    • United States
    • Federal Cases United States Bankruptcy Courts Eleventh Circuit
    • May 18, 2000
    ...As a consequence, no further consideration of this argument is necessary. It fails at this time. See Allison v. McGhan Medical Corp., 184 F.3d 1300 (11th Cir.1999); Arrington v. Cobb County, 139 F.3d 865, 875 (11th Cir.1998); Warrior Tombigbee Trans. Co. v. M/V Nan Fung, 695 F.2d 1294, 1296......
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498 cases
  • 355 B.R. 462 (Bkrtcy.D.Del. 2006), 01-01139, In re W.R. Grace &Co.
    • United States
    • Federal Cases United States Bankruptcy Courts Third Circuit
    • December 14, 2006
    ...to consistently reject individual case reports as a reliable basis for medical causation opinions. See Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir.1999); Hollander v. Sandoz Pharm. Corp., 95 F.Supp.2d 1230 (W.D.Okla.2000), aff'd in pertinent part, 289 F.3d 1193 (10th Cir.), cert. ......
  • 822 F.Supp.2d 1263 (S.D.Fla. 2011), 09-61652-CIV, MDS (Canada), Inc. v. Rad Source Technologies, Inc.
    • United States
    • Federal Cases United States District Courts 11th Circuit United States District Courts. 11th Circuit. Southern District of Florida
    • September 30, 2011
    ...the proper foundation for the admission of the expert testimony is on the party offering the expert." Allison v. McGhan Med. Corp., 184 F.3d 1300, 1306 (11th Cir.1999) (citing Page 1319 Daubert, 509 U.S. at 592 n. 10, 113 S.Ct. 2786). " The proponent of the expert testimony carrie......
  • In re Testosterone Replacement Therapy Products Liability Litigation, 042318 ILNDC, MDL 2545
    • United States
    • Federal Cases United States District Courts 7th Circuit United States District Court (Northern District of Illinois)
    • April 23, 2018
    ...Pharm. USA, Inc., No. 17-CV-61800, 2017 WL 5971720 (S.D. Fla. Dec. 1, 2017) ................. 5 Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir. 1999) ............................................ Bains LLC v. Arco Prod. Co., Div. of Atl. Richfield Co., 405 F.3......
  • 131 F.Supp.2d 1265 (M.D.Ala. 2001), Civ. A. 99-D-286, KW Plastics v. United States Can Co.
    • United States
    • Federal Cases United States District Courts 11th Circuit Middle District of Alabama
    • January 12, 2001
    ...of Evidence. See Bennett v. PRC Public Sector, Inc., 931 F.Supp. 484, 490 (S.D.Tex.1996) ( Rule 701). Cf. Allison v. McGhan Med. Corp., 184 F.3d 1300, 1312 (11th Cir.1999) (Rule 702). Rule 701 of the Federal Rules of Evidence, which took effect in December 2000, provides that a witness, who......
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6 firm's commentaries
  • Prescription Medical Product Causation – Expert Required – Part One
    • United States
    • Mondaq United States
    • August 14, 2019
    ...through human experience. Thus, medical expert testimony was essential to prove causation in this case. Allison v. McGhan Medical Corp., 184 F.3d 1300, 1320 (11th Cir. 1999) (applying Georgia law). See Thurmond v. Bayer Healthcare Pharmaceuticals, Inc., 649 F. Appx. 1003, 1006, n.1 (11th Ci......
  • Prescription Medical Product Causation – Expert Required
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    • LexBlog United States
    • August 12, 2019
    ...through human experience. Thus, medical expert testimony was essential to prove causation in this case. Allison v. McGhan Medical Corp., 184 F.3d 1300, 1320 (11th Cir. 1999) (applying Georgia law). See Thurmond v. Bayer Healthcare Pharmaceuticals, Inc., 649 F. Appx. 1003, 1006, n.1 (11th Ci......
  • Differential Diagnosis – Sometimes Best Isn’t So Good
    • United States
    • LexBlog United States
    • May 7, 2009
    ...“points to the temporal association. . ., which has been held to be insufficient proof of causation”); Allison v. McGhan Medical Corp., 184 F.3d 1300, 1321 (11th Cir. 1999) (“mere coincidence of temporality” held a “questionable” basis for an expert opinion); Kennedy v. Collagen Corp., 161 ......
  • The Use And Misuse Of Expert Testimony In Bad Faith Actions
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    • JD Supra United States
    • May 8, 2013
    ...had not personally been involved in a similar subrogation issue. Similarly, in City of Hobbs v. Hartford 6 Allison v. McGhan Med. Corp., 184 F.3d 1300, 1306 (11th Cir. 1999). ~ See, e.g., Talking Walls, Inc. v. Hartford Cas. Ins. Co., 2005 WL 6011243 (N.D. Fla. July 5, 2005); Currie v. Chev......
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