Court Opinion

ID: 771568
Source: CourtListenerOpinion
Date Created: 2012-04-18 10:53:22+00
Date Added: 2024-06-11T17:55:58.393555
License: Public Domain

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:

1
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.

2
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
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 ").

4
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

5
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

6
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.

7
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.

8
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.

9
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).

10
B. Admission of prior complaints into evidence

11
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.

12
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.

13
2.Jury instructions on learned intermediary doctrine and duties of manufacturer

14
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.... 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).

15
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.

16
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:

17
[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:

18
[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.

19
In the next sentence, the trial court provided the following instruction on the  learned intermediary doctrine and its application to this case:

20
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 physicians to  assess the proper use of that product and to understand the types of risks, if  any, that would be associated with that.

21
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.

22
On Question (1)(c),7 the negligence claim, the trial court offered the following  instruction:

23
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 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?

24
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)).

25
3.Acceptance of the previously rejected remittitur

26
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 A Feb.1981).8

27
"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. Hayes, 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.

28
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 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

29
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.1987).

30
"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 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).

31
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:

32
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.

33
Merrell Dow Pharm., Inc. v. Oxendine, 649 A.2d 825, 831 (D.C., 1994).9

34
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  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).

35
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, 107 S.Ct. 3242, 97 L.Ed.2d 747 (1987)).

36
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

37
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 law vacating the punitive damage award is reviewed de novo. Snapp v.  Unlimited Concepts, Inc., 208 F.3d 928, 932 (11th Cir.2000).

38
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).

39
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

40
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 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.

41
Toole I, 999 F.2d at 1436.

42
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.

43
Accordingly, the district court's rulings in all respects are

44
AFFIRMED.

NOTES:

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

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.

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.

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.

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?

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?

8
 In Bonner v. Prichard, 661 F.2d 1206, 1209 (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.

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.