FILED

U.S. COURT OF

APPEALS

ELEVENTH CIRCUIT

DEC 14, 2000

THOMAS K. KAHN

 * Honorable Louis H. Pollak, U.S. District Judge for the Eastern District of Pennsylvania,

sitting by designation.

 [PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

__________________________

No. 99-15019

__________________________

D.C. Docket No. 94-13559-CV-P-S

BRENDA GRIFFIN TOOLE,

Plaintiff-Appellee-Cross-Appellant,

versus

BAXTER HEALTHCARE CORPORATION,

Defendant-Appellant–Cross-Appellee.

__________________________

Appeals from the United States District Court

for the Northern District of Alabama

__________________________

(December 14, 2000)

Before CARNES and BARKETT, Circuit Judges and POLLAK,*

 District Judge.

BARKETT, Circuit Judge:

Baxter Healthcare Corporation (“Baxter”) appeals a final judgment based on a
 1

 In performing a closed capsulotomy, the physician attempts to break the scar capsule by

manually exerting direct, extreme pressure upon it. At the time, closed capsulotomy was the

treatment of choice for contracture.

 2

 A granuloma is the human body’s encapsulation of small amounts of a foreign substance, in

this case silicone.

2

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. 
 3

 The original complaint also contained medical malpractice allegations against Ms. Toole’s

physician, but the jury determined that the doctor was not liable.

 4

 This evidentiary issue did not arise in the second trial.

3

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
4

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
5

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
6

testimony for abuse of discretion. General Electric Co. v. Joiner, 522 U.S. 136, 142

(1997); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 142 (1999). Scientific

evidence or testimony must not only be relevant, but also reliable. Daubert v. Merrell

Dow Pharmaceuticals, Inc., 509 U.S. 579, 589 (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.

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
7

ruling is manifestly erroneous.” Joiner, 522 U.S. at 141. 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
 5

 Ms. Toole argues that Baxter did not properly object to the jury instructions on the learned

intermediary doctrine. Although Baxter’s objection was not expressed particularly well, upon

reviewing the trial transcript, we find that the objection was sufficient to preserve the issue for

appeal. 

8

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 discretion in formulating jury instructions. .
9

. . Motions for new trial on the basis of erroneous and prejudicial jury instructions are

committed to the discretion of the trial court and reviewed to ascertain whether there

has been a clear abuse of that discretion.” Id. at 1190 (citations omitted). 

In cases involving complex products, such as those in which pharmaceutical

companies are selling prescription drugs, the learned intermediary doctrine applies.

See Stone v. Smith, Kline & French Labs., 731 F.2d 1575, 1579-1580 (11th Cir.

1984). Under the learned intermediary doctrine, a manufacturer’s duty to warn is

limited to an obligation to advise the prescribing physician of any potential dangers

that may result from the use of its product. Id. This standard is “an understandable

exception to the Restatement’s general rule that one who markets goods must warn

foreseeable ultimate users of dangers inherent in his products.” Id. at 1579 (internal

citation omitted). As such, we rely on the expertise of the physician intermediary to

bridge the gap in special cases where the product and related warning are sufficiently

complex so as not to be fully appreciated by the consumer. In Toole I, we held that

“[u]nder the ‘learned intermediary doctrine,’ the adequacy of Baxter’s warning is

measured by its effect on the physician, . . . to whom it owed a duty to warn, and not

by its effect on Ms. Toole.” 999 F.2d at 1433. 
 6

 Question (1)(a) was as follows: Has Brenda Toole established by a preponderance of the

evidence that she has been injured as a proximate result of . . . Heyer-Schulte’s distributing

breast implants that were unreasonably dangerous for their intended use?

10

Here, in addressing Question (1)(a)6 of the special verdict, the trial court offered

the following instructions with regard to Alabama Extended Manufacturers Liability

Doctrine:

[a] product is considered unreasonably dangerous if it has hazards or

risks that would be unappreciated and unknown by the consumer when

it’s used in its intended manner . . . [a]nd in determining whether

something is unreasonably dangerous, you consider the extent to which

the manufacturer or the distributor was aware of or reasonably should

have been aware of some dangers and hazards that would not have been

known and appreciated by the ordinary consumer. 

The trial court then added:

[i]f there are any, then the manufacturer can, in effect, prevent itself from

being held liable by giving appropriate and adequate warnings of those

risks so that then someone using the product is adequately warned about

the kinds of problems to be expected. 

In the next sentence, the trial court provided the following instruction on the learned

intermediary doctrine and its application to this case:

With products such as breast implants, this obligation of a manufacturer

to give appropriate warnings of things that would not be appreciated by

the consumer may be discharged by giving appropriate warnings to the

physicians who are going to be using the product, taking into account the

type of knowledge that one would expect physicians to have as a result

of their professional training and experience, and providing them with

additional information, supplemental information, that would help those
 7

 Question (1)(c) was as follows: Has Brenda Toole established by a preponderance of the

evidence that she has been injured as a proximate result of . . . Heyer-Schulte’s negligence in the

adequacy of warnings it provided to physicians after February 1981 and before February 1988

about the risk and possible consequences of closed capsulotomies? 

11

physicians to assess the proper use of that product and to understand the

types of risks, if any, that would be associated with that. 

There is no error in these instructions. The learned intermediary doctrine is an

exception to general manufacturer liability law, and we find no abuse of discretion in

outlining general manufacturer’s liability law and then describing the learned

intermediary doctrine. Further, given that the learned intermediary doctrine applies

in cases in which the product is particularly complex, it was not an abuse of discretion

for the trial court to describe such complex products as “things that would not be

appreciated by the consumer.” In examining the jury instructions as a whole, we find

that the jury instructions on Question (1)(a) both fairly stated the issue and correctly

stated the law. 

On Question (1)(c),7

 the negligence claim, the trial court offered the following

instruction:

Negligence is the key in this question. . . that is, did Heyer-Schulte do

something that a reasonable manufacturer would not have done or did it

fail to do something that a reasonable manufacturer would have done

under the same circumstances with respect to warnings to people who

had already gotten breast implants or to their physicians. . . . Did HeyerSchulte fail to do something a reasonable manufacturer would have done
12

under that same or similar circumstances, with respect to giving

warnings to implant recipients or to their physicians concerning possible

risks or consequences of closed capsulotomy?

The instructions to Question (1)(c) followed the jury instructions on the learned

intermediary doctrine. Moreover, the trial judge made two references to the duty to

warn physicians in the instruction on Question (1)(c). Therefore, viewing the

challenged instructions to Question (1)(c) as part of the entire charge, we find no

abuse of discretion on the part of the trial court. Johns v. Jarrard, 927 F.2d 551, 554

(11th Cir. 1991) (quoting National Distillers & Chem. Corp. v. Brad’s Mach. Prod.,

Inc., 666 F.2d 492, 497 (11th Cir. 1982) (“[We] view the challenged instructions as

part of the entire charge, in view of the allegations of the complaint, the evidence

presented, and the arguments of counsel, to determine whether the jury was misled

and whether the jury understood the issues.”) (internal quotations omitted).

3. Acceptance of the previously rejected remittitur

 Baxter next claims that the trial court erred in entering judgment for Ms. Toole

after she previously rejected a remittitur, a new trial was ordered, and four years of

legal and scientific developments created important issues for trial. We review the

trial court’s ruling reinstating the remittitur to determine whether the trial court erred

as a matter of law. Gallimore v. Missouri Pacific R. Co., 635 F.2d 1165 (5th Cir. Unit
 8

 In Bonner v. Prichard, 661 F.2d 1206, 1029 (11th Cir. 1981) (en banc), the Eleventh Circuit

adopted as binding precedent all Fifth Circuit decisions handed down prior to the close of

business on September 30, 1981.

13

A Feb. 1981).8

“There is no sound reason why the court may not reconsider its ruling

(granting) a new trial. . . . Since an order granting a new trial is an interlocutory order,

the district court has plenary power over it and this power to reconsider, revise, alter

or amend the interlocutory order is not subject to the limitations of Rule 59.” Id. at

1171-72 (quoting 6A James W. Moore, Moore’s Federal Practice ¶ 59.13(1), at

59-257 (2d ed. 1979)). See Hardin v. Hays, 52 F.3d 934, 938 (11th Cir. 1995)

(endorsing the holding in Gallimore and the language of Moore’s Federal Practice);

McIsaac v. Didriksen Fishing Corp., 809 F.2d 129, 135 (1st Cir. 1987) (“[t]he trial

court also has discretion to revoke its order for a new trial and reinstate the

judgment.”). In this case, the court’s order for a new trial was an interlocutory order,

and therefore the trial court had the power to revoke it and reinstate the judgment. 

Alternatively, Baxter claims that, even if the district court had the power to

reinstate the remittitur, the exercise of that power was an abuse of discretion, because,

in effect, it allowed Ms. Toole to observe legal and scientific developments over a

four-year period and then accept the remittitur because the developments were adverse
14

to her case. While we agree that an unusually long period of time had elapsed, a

review of the record does not lead us to conclude that accepting the remittitur in 1999

was an abuse of discretion. First, in issuing its final judgment, the trial court noted the

“prolonged period of delay” was “primarily caused by awaiting the completion of

research and depositions of neutral experts appointed by the court.” In addition, Ms.

Toole requested that the district court set a new trial date several years earlier. Based

on the circumstances of this case, including the fact that the delays were not caused

by Ms. Toole, we cannot say that the trial court erred as a matter of law by permitting

her to accept the remittitur in 1999.

4. Rule 60(b) motion

Finally, Baxter argues that newly discovered scientific evidence and legal

developments over the past four years justify a new trial under either Federal Rule of

Civil Procedure 60(b)(2) or 60(b)(6). We review the trial court’s denial of Baxter’s

Rule 60(b) motion for abuse of discretion. Scutieri v. Paige, 808 F.2d 785, 793 (11th

Cir. 1984). 

“A motion for a new trial under Rule 60(b)(2) is an extraordinary motion and

the requirements of the rule must be strictly met.” Id. at 793. In order for the court to

grant such a motion, Baxter must meet the following five-part test: (1) the evidence
15

must be newly discovered since the trial; (2) due diligence on the part of the movant

to discover the new evidence must be shown; (3) the evidence must not be merely

cumulative or impeaching; (4) the evidence must be material; and (5) the evidence

must be such that a new trial would probably produce a new result. Id. Similarly, a

Rule 60(b)(6) motion, by which a court has discretion to grant a new trial for “any

other reason justifying relief from the operation of the judgment,” is intended “only

for extraordinary circumstances.” Frederick v. Kirby Tankships, Inc., 205 F.3d 1277,

1288 (11th Cir. 2000). 

Both parties acknowledge that new scientific evidence is continually emerging.

The science surrounding breast implants is continuing to evolve and will do so even

after this case has concluded. The District of Columbia Court of Appeals has

elucidated the problems presented by new scientific evidence produced after a trial

court judgment: 

Although science is a constantly evolving process, the law depends upon

a high level of certainty once an outcome has been determined. A trial

can be no more than a resolution of an immediate dispute on the basis of

present knowledge; its outcome must turn upon the teachings of science

as understood at the time of trial as best can be discerned through the

presentations of the parties. Where scientific facts are at issue, it is not

unexpected, given the nature of the process, that the passage of time will

bring forth further scientific data and inquiry relating to the ultimate

scientific fact at issue. To reopen the trial’s determination of scientific

truth, however, runs squarely into the fundamental principle of certainty.
 9

 Notwithstanding the Oxendine court’s recognition that “[t]he ends of the litigation process

would be subverted if . . . a jury’s determination of a scientific fact after a full trial . . . could be

the subject of potentially endless re-examination except in the most unusual of circumstances,” 

Id. at 832, the court remanded the case to the trial court for reconsideration. It did so because the

trial court had “refus[ed] to consider at all” the proffered new scientific evidence. Oxendine,

649 A.2d at 832.

 10 Indeed, the fact that the delay in starting a third trial was caused primarily by awaiting the

completion of research and depositions of neutral experts appointed by the court indicates that

the district court was well aware of new developments in this field.

16

Merrell Dow Pharm., Inc. v. Oxendine, 649 A.2d 825, 831 (D.C., 1994).9

For these reasons, we are reluctant to prolong a case that has already been in the courts

for ten years. Nonetheless, we are obliged to review a denial of a Rule 60(b) motion

for abuse of discretion. Although there may be circumstances in which the emergence

of new scientific evidence would warrant a new trial, we find no abuse of discretion

in the district court’s determination to deny this motion. The record reflects sufficient

evidence indicating that the trial court considered the new scientific evidence.10

Morever, while some of this new evidence supports Baxter’s position, the new

evidence is not exclusively in Baxter’s favor. This implicates the requirement under

Rule 60(b)(2) of demonstrating that the new evidence probably would have produced

a different result. See Scutieri, 808 F.2d at 793. Additionally, the new evidence

offered by Baxter would be cumulative or impeaching, which is the type of evidence

for which a Rule 60(b)(2) motion cannot be granted. See Taylor v. Texgas Corp., 831
17

F.2d 255, 259 (11th Cir. 1987). Therefore, we find no abuse of discretion in the

denial of Baxter’s motion under Rule 60(b)(2).

Nor do we find any abuse of discretion in the denial of Baxter’s motion under

Rule 60(b)(6). Although Baxter argues that new or changed circumstances may

justify relief under Rule 60(b)(6), Baxter does not provide evidence of “any other

reason justifying relief” pursuant to Rule 60(b)(6) aside from the new scientific

evidence already addressed under Baxter’s Rule 60(b)(2) motion. This Court has held

that “a Rule 60(b)(6) movant ‘must persuade [the court] that the circumstances are

sufficiently extraordinary to warrant relief.’ Even then, whether to grant the requested

relief is . . . a matter for the district court’s sound discretion.” Booker v. Singletary,

90 F.3d 440, 442 (11th Cir. 1996)(quoting Ritter v. Smith, 811 F.2d 1398, 1401 (11th

Cir.), cert. denied, 483 U.S. 1010 (1987)).

For all of the foregoing reasons, we AFFIRM the district court’s ruling on each

of Baxter’s claims.

5. Cross-appeal on punitive damages

In her cross-appeal, Ms. Toole argues that the trial court erred in deciding that

there was insufficient evidence of wanton conduct for the jury to have awarded

punitive damages. The district court’s grant of a motion for judgment as a matter of
18

law vacating the punitive damage award is reviewed de novo. Snapp v. Unlimited

Concepts, Inc., 208 F.3d 928, 932 (11th Cir. 2000). 

In determining whether there was sufficient evidence of conduct warranting

punitive damages, we apply Alabama substantive law. “Under Alabama law, to award

punitive damages, the jury must have found, by clear and convincing evidence, that

Baxter ‘consciously or deliberately engaged in . . . wantonness . . . with regard to the

plaintiff.’” Toole I, 999 F.2d at 1436 (quoting Ala. Code §§ 6-11-20 (Supp. 1990)).

“Wantonness” under Alabama law is “conduct which is carried on with a reckless or

conscious disregard of the rights and safety of others.” Sears, Roebuck & Co. v.

Harris, 630 So.2d 1018, 1032 (Ala. 1993). 

In Richards v. Michelin Tire Corp., this Court stated that “[w]e have repeatedly

held that the issue of punitive damages should not go to the jury when a manufacturer

takes steps to warn the plaintiff of the potential danger that injured him; such acts bar

a finding of wantonness.” 21 F.3d 1048, 1058 (11th Cir. 1994) (citing Toole I, 999

F.2d at 1436). In Toole I, we found that 

The Heyer-Schulte warning describes the main harms that Ms. Toole has

actually suffered--capsular contracture, rupture, and granuloma–and the

warning forecasted the way she came to suffer these harms--“treat[ment

of] capsule firmness by forceful external stress.” More could have been

done or said, but Heyer-Schulte did not exhibit indifference toward

safety. Baxter's conduct shows regard for recipients of its implants and
19

cannot be viewed as “wanton.” We conclude that there was insufficient

evidence of wantonness in this case to permit the jury to award punitive

damages. 

Toole I, 999 F.2d at 1436.

On review of the record, we reaffirm our earlier view that while Heyer-Schulte

could have done or said more, it did not exhibit wantonness as defined by Alabama

law. Moreover, because essentially the same punitive damage case was presented at

the second trial, Ms Toole’s claim has been foreclosed by our earlier decision. See

Burger King Corp. v. Pilgrim’s Pride Corp., 15 F.3d 166, 169 (11th Cir.1994) (under

law of the case doctrine, “findings of fact and conclusions of law by an appellate court

are generally binding in all subsequent proceedings in the same case in the trial or on

a later appeal.”) (citations omitted). Therefore, we affirm the district court’s order

granting Baxter’s Motion for JNOV vacating the punitive damages.

Accordingly, the district court’s rulings in all respects are

AFFIRMED.