Toole v. Baxter Healthcare Corporation

• Decision Date: 14 December 2000
• Docket Number: No. 99-15019,99-15019
• Citation: 235 F.3d 1307
• Parties: (11th Cir. 2000) Brenda Griffin TOOLE, Plaintiff-Appellee-Cross-Appellant, v. BAXTER HEALTHCARE CORPORATION, Defendant-Appellant-Cross-Appellee.
• Court: U.S. Court of Appeals — Eleventh Circuit

Page 1307

235 F.3d 1307 (11th Cir. 2000)

Brenda Griffin TOOLE, Plaintiff-Appellee-Cross-Appellant, v. BAXTER HEALTHCARE CORPORATION, Defendant-Appellant-Cross-Appellee.

No. 99-15019.

United States Court of Appeals, Eleventh Circuit.

December 14, 2000.

December 28, 2000.

[Copyrighted Material Omitted]

[Copyrighted Material Omitted]

[Copyrighted Material Omitted] Appeal from the United States District Court for the Northern District of Alabama, (No. 94-13559-CV-P-S), Sam C. Pointer, Jr., Judge.

Before CARNES and BARKETT, Circuit Judges, and POLLAK,^* District Judge.

BARKETT, Circuit Judge:

Baxter Healthcare Corporation ("Baxter") appeals a final judgment based on a jury verdict in favor of Brenda Toole for injuries she suffered as a result of breast implants manufactured by Heyer-Schulte Corporation, Baxter's predecessor corporation.

In 1987, several years after receiving the implants, Ms. Toole began to experience capsular contracture, a hardening of the breast due to scar tissue around the implant compressing down on the implant. Her physician performed a "closed capsulotomy"¹ to correct the contracture. Ms. Toole's pain continued, leading to surgery which revealed that both implants had ruptured. The implants were replaced. Approximately one year after the replacement surgery, Ms. Toole discovered a lump in her breast and was forced to undergo the first of multiple surgical procedures to remove what turned out to be silicone granulomas.² Ms. Toole became increasingly ill, experiencing difficulty concentrating, oral ulcers, hair loss, dry skin, and fatigue. As time passed, she had increasing pain in the form of arthralgias and myalgias. While disagreeing as to the etiology of the disease, the parties do not dispute that her symptoms were real.

Ms. Toole filed this tort action against Baxter.³ Two jury trials were held in this lawsuit. At the first trial, she was awarded $350,000 in compensatory damages and $5,000,000 in punitive damages. Ms. Toole accepted a remittitur of the compensatory damages to $275,000 and punitive damages to $2,000,000, and the trial court denied Baxter's motions for Judgment as a Matter of Law ("JNOV"). After Baxter appealed, this Court found that the evidence presented at the first trial was insufficient to support an award of punitive damages, reversed the compensatory damages based upon an evidentiary issue,⁴ and remanded the case for a new trial. Toole v. McClintock, 999 F.2d 1430 (11th Cir.1993) (hereinafter "Toole I ").

In the second trial, the jury awarded $2,500,000 in compensatory damages and $3,500,000 in punitive damages to Ms. Toole. The trial court granted Baxter's Motion for JNOV as to punitive damages and denied Baxter's Motion for a New Trial on compensatory damages conditioned on Ms. Toole's acceptance of a remittitur of the compensatory damage amount to $1,000,000. Ms. Toole originally rejected the remittitur and the case was restored to the docket for trial. However, prior to trial, Ms. Toole filed, and the trial court granted, a motion to withdraw her earlier rejection of the remittitur and accept the reduced amount of $1,000,000 in compensatory damages. Baxter then filed its "renewed" post-trial motions which were denied. Baxter now appeals those denials, and Ms. Toole cross-appeals the punitive damages issue.

DISCUSSION

Baxter argues on appeal that the judgment against it must be reversed because the trial court: (1) failed to properly instruct the jury on the duties of a medical device manufacturer; (2) erroneously admitted expert testimony that the implants caused Ms. Toole's injury; (3) erroneously admitted evidence of prior complaints against the manufacturer about product failures that Baxter asserts were irrelevant and prejudicial; (4) erred in allowing Ms. Toole to accept a remittitur which she had originally rejected; and (5) once having entered judgment upon Ms. Toole's acceptance of the remittitur, erred in failing to grant Baxter a new trial under F.R.C.P. 60(b) based on intervening scientific and legal developments relating to breast implants. Ms. Toole cross-appeals, claiming that the trial court erred in vacating the award of punitive damages. We address each claim in turn.

1.Evidentiary Rulings

A. Admission of expert witness testimony

Baxter claims that admitting the testimony of Drs. Schneider, Tiliakos, Gaston and Espinosa, each of whom testified to support Ms. Toole's contention that the breast implants that she received caused her disease, constituted an abuse of discretion. Baxter likewise claims that the district court erred in admitting the testimony of Drs. Shanklin, Smalley and Batich, who did not testify to causation directly, but described a disease process based on the human body's reaction to silica and/or the degradation of silicone into silica, which related to the effects of the residual silicone in Ms. Toole's body from the rupturing of her breast implants during the closed capsulotomy.

Ms. Toole first responds that Baxter did not properly preserve this issue, arguing that objections which had been made in limine were not renewed at trial and that objections to certain questions posed to the expert witnesses during trial were insufficient to preserve their Daubert objections. Based on the record, we are satisfied that Baxter appropriately preserved this issue. Baxter submitted three motions in limine, objecting to the expert testimony of Drs. Shanklin, Smalley and Batich, respectively. As to the other experts, Baxter lodged objections in the course of the experts' testimony based on a lack of foundation for the opinion. The district court overruled the objections and admitted the testimony. On this record we are satisfied that the objections were sufficient to preserve the issue.

We review a trial court's evidentiary rulings on the admission of expert witness testimony for abuse of discretion. General Electric Co. v. Joiner, 522 U.S. 136, 142, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 142, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). Scientific evidence or testimony must not only be relevant, but also reliable. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Accordingly, we grant the district court the same broad latitude when deciding how to determine the reliability of expert testimony as it enjoys in determining whether the testimony is reliable. Kumho Tire Co., 526 U.S. at 142, 119 S.Ct. 1167.

Under Federal Rule of Evidence 702 and Daubert, expert testimony is admissible if (1) the expert is qualified to testify competently, (2) the expert has used sufficiently reliable methodology in reaching a conclusion, and (3) the testimony will assist the trier of fact. See City of Tuscaloosa v. Harcros Chems., Inc., 158 F.3d 548, 562 (11th Cir.1998). Based upon their testimony, the trial court found Ms. Toole's expert witnesses to be qualified and their testimony to be sufficiently reliable, as they had conducted research, published in peer-reviewed journals and treated hundreds of patients with silicone gel implants. We have read and carefully considered the testimony of the experts in this case. We are also mindful of the Supreme Court's directive that "it is very much a matter of discretion with the court whether to receive or exclude the evidence," and that an "appellate court will not reverse ... unless the ruling is manifestly erroneous." Joiner, 522 U.S. at 141, 118 S.Ct. 512. Based on our careful review of the testimony presented, we cannot say that the trial court abused its discretion in admitting the expert testimony. See In re Rasbury, 24 F.3d 159, 168 (11th Cir.1994) ("An abuse of discretion standard differs from a de novo standard of review" because "the abuse of discretion standard allows a range of choice for the district court, so long as that choice does not constitute a clear error of judgment.") (citation and internal quotations omitted).

B. Admission of prior complaints into evidence

Baxter also asserts that 92 complaints/reports submitted to Heyer-Schulte from the period 1979-1980 were admitted erroneously into evidence, as only thirteen concerned implants ruptured by a closed capsulotomy. Ms. Toole responds by noting that the admitted complaints were only a subset of the complaints Heyer-Schulte received during the two-year period and only dealt with rupture and bleed-both issues before the jury. Ms. Toole also claims that Baxter previously raised this issue on appeal in Toole I, and their claim was dismissed.

In Toole I, Baxter appealed the trial court's decision to admit 270 complaints into evidence on a number of grounds, including the assertion that the prior complaints were not substantially similar to Ms. Toole's situation. This Court found that this claim of evidentiary error lacked merit. Toole I, 999 F.2d at 1433 n. 7 (vacated and remanded on other grounds). Under the law-of-the-case doctrine, an issue decided at one stage of a case is binding at later stages of the same case. United States v. Escobar-Urrego, 110 F.3d 1556 (11th Cir.1997). Given that Baxter makes the same claim on prior complaints evidence in this case, Baxter's claim is foreclosed. Moreover, we again find that it was not an abuse of discretion for the trial court to admit the prior complaints for the purpose of showing that Baxter had notice of the fragility of its product.

2.Jury instructions on learned intermediary doctrine and duties of manufacturer

Baxter argues that the jury instructions erroneously characterized the applicable law as stating that the manufacturer's duty to warn depends on the knowledge of the patient, rather than on the knowledge of the physician.⁵ We examine jury instructions as a whole to determine whether they fairly and adequately addressed the issue and correctly stated the law. Christopher v. Cutter Laboratories, 53 F.3d 1184, 1190 (11th Cir.1995). "A district court has broad...