[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
FILED
__________________________ U.S. COURT OF
APPEALS
No. 99-15019 ELEVENTH CIRCUIT
__________________________ DEC 14, 2000
THOMAS K. KAHN
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
*
Honorable Louis H. Pollak, U.S. District Judge for the Eastern District of Pennsylvania,
sitting by designation.
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.
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
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
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
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
4
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
5
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
6
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
7
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. .
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
. . 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.
9
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
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
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 Heyer-
Schulte fail to do something a reasonable manufacturer would have done
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
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
12
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
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
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
14
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.
15
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
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
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
17
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
18
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.
19