OPINION BY DONOHUE, J.:
Appellants, Mary Daniel ("Daniel") and Thomas Daniel, Sr. ("Daniel, Sr.," collectively, the "Daniels"), appeal from the trial court's orders granting motions for a new trial on liability issues and for judgment notwithstanding the verdict ("JNOV") on punitive damages. Appellee, Wyeth Pharmaceuticals, Inc., et al. ("Wyeth"), cross-appeals four rulings of the trial court. For the reasons set forth herein, we reverse the trial court's order granting Wyeth's post-trial motion for a new trial and reinstate the jury's verdict on compensatory damages. We likewise reverse the trial court's grant of JNOV on punitive damages and reinstate the jury's verdict awarding punitive damages. Wyeth's cross-appeal is denied.
This case arises from Daniel's use of a drug manufactured by Wyeth known as Prempro. Prempro is a combination of two drugs: estrogen and progestin. Physicians regularly prescribed estrogen (sold by Wyeth as "Premarin"
In 1983, Wyeth sought FDA approval for the sale of a single pill containing both estrogen and progestin. In its initial application, Wyeth did not propose to do any new studies, instead relying on then-available studies regarding the efficiency and safety of the two drugs in combination. The FDA denied the application, advising Wyeth that existing studies were inadequate. In 1991 the FDA approved Wyeth's proposal to conduct clinical trials of the combination drug (known as the "Prem-Pack Protocols"). After these clinical trials were completed, the FDA approved the sale of the one pill combination drug named Prempro. In so doing, the FDA required Wyeth to make various disclosures on its product information and package inserts, including the following warning on Prempro's information sheet:
Physicians' Desk Reference 1999, Notes of Testimony ("N.T."), 1/17/07 (Afternoon Session ("AS")), at 26-29; Wyeth's Motion for Summary Judgment Based on the Learned Intermediary Doctrine, Exhibit C.
On June 30, 2004, the Daniels, residents of the state of Arkansas, filed a complaint in the Court of Common Pleas of Philadelphia County, alleging that in 1999 Daniel's doctor, John Haggard, M.D., prescribed for her a hormone therapy drug, Prempro, manufactured by Wyeth. Complaint, ¶ 2-3. Daniel further alleged that she continued to ingest Prempro until August 9, 2001, at which time she was diagnosed with breast cancer (moderately differentiated invasive ductal carcinoma, extending to one margin) and had to undergo surgery and chemotherapy as a result. Id. at ¶ 4. Daniel asserted claims against Wyeth for negligence, breach of express warranty, and fraud, and Daniel, Sr. asserted a claim for loss of consortium. Id. at ¶ 7.
After a four week trial, on January 29, 2007 the jury awarded the Daniels $1,681,650 in compensatory damages ($1,000,000 to Daniel, $500,000 to Daniel, Sr., and $181,650 in delay damages). The trial court summarized the jury's findings as follows:
Trial Court Opinion, 4/23/07, at 1-2.
On January 30, 2007, Wyeth filed a motion for JNOV on the availability of punitive damages which, after hearing oral argument, the trial court granted. When the Daniels indicated that they intended to appeal this ruling, the trial court conducted a brief jury trial with the same jury so that this Court would not have to remand the case for re-trial in the event of a reversal. The parties presented additional evidence, including information regarding Wyeth's net worth, and the jury returned an award of punitive damages (which the trial court then formally struck, in accordance with its JNOV ruling). At Wyeth's request, and in order not to prejudice the jury in another case being tried at the same time in another courtroom, the trial
On February 1, 2007, Wyeth filed a motion for post-trial relief on causation issues. On February 8, 2007, Wyeth filed a second motion for post-trial relief on other liability issues. By orders dated April 23, 2007, the trial court denied both of these motions and issued a written opinion in support of the grant of Wyeth's motion for JNOV on punitive damages. On June 14, 2007, the Daniels filed a notice of appeal from the trial court's grant of JNOV on punitive damages, and on June 15, 2007 Wyeth filed two notices of cross-appeal from the trial court's April 23, 2007 orders denying its motions for post-trial relief.
On May 14, 2007, Wyeth filed a supplemental motion for post-trial relief seeking a new trial based upon after-discovered evidence. Specifically, Wyeth claimed that Dr. Lester Layfield, one of the expert witnesses whose testimony the Daniels offered at trial (through the reading a portion of his deposition), had given a deposition in another case
On September 18, 2007, the Daniels filed a second notice of appeal, this one including both the trial court's grant of JNOV on punitive damages and the grant of Wyeth's motion for a new trial. Wyeth promptly filed another notice of cross-appeal. This Court thereafter dismissed both the Daniels' initial notice of appeal and Wyeth's initial cross-appeals as moot, leaving as pending the Daniels' second appeal and Wyeth's second cross-appeal. This Court initially issued an order sua sponte dismissing Wyeth's second cross-appeal, but by order dated October 26, 2009 this Court reinstated said cross-appeal.
The Daniels present the following issues for our consideration in this appeal:
Appellants' Brief at 3.
In its cross-appeal, Wyeth raises the following four issues for our review:
Appellee's Brief at 2-3.
With respect to the Daniels first issue on appeal, our standard of review
The legal requirements for the grant of a new trial based upon after-discovered evidence are well established: the evidence must have been discovered after the trial and must be such that it could not have been obtained at the trial by reasonable diligence, must not be cumulative or merely impeach credibility, and must be such as would likely compel a different result. Stern, 509 Pa. at 264-65, 501 A.2d at 1382; Hornick v. Bethlehem Mines Corp., 310 Pa. 225, 228, 165 A. 36, 37 (1933). Our Supreme Court has expanded the basis for granting a new trial to include cases involving recanted testimony. Township of Perkiomen v. Mest, 513 Pa. 598, 603, 522 A.2d 516, 519 (1987); Blake v. Marinelli, 357 Pa. 314, 317, 53 A.2d 550, 552 (1947).
In this case, the trial court found that Dr. Layfield had recanted his opinion regarding the cause of Daniel's cancer by the time of trial, and that Daniel nevertheless presented his testimony (by way of the reading of his deposition) without informing anyone of the recantation. Trial Court Opinion, 9/24/08, at 9-11. Specifically, based upon a small portion of Dr. Layfield's deposition testimony, the trial court found that he "testified that the use of Prempro caused any cancerous lesions that may not have advanced to cancerous lesions, to proliferate to cancer." Id. at 9. At his subsequent deposition in the Zandi case four months later, however, the trial court decided that Dr. Layfield "testified that he no longer held that opinion and would not be able to testify linking Daniel's cancer with the use of Prempro as he had done at his earlier deposition in the Daniel's case because of the short term duration of time in which she took Prempro." Id. As a result, the trial court ruled that Dr. Layfield had recanted the opinion he provided in his Daniels' deposition (and which was later read to the jury), that this recantation could not have been discovered by Wyeth upon reasonable diligence, that it was not cumulative or for purposes of impeachment, and would likely to have compelled a different result in the Daniels' trial. Id. at 11.
Based upon our review of the record on appeal, the trial court's finding that Dr. Layfield recanted his testimony in the Zandi deposition was based upon an incomplete consideration of Dr. Layfield's testimony in this case. Dr. Layfield testified that he is an anatomic pathologist and was initially hired in connection with the Daniels' litigation for two purposes: (1) to perform a "Ki-67"
Id. at 94.
The trial court relied exclusively on this testimony in deciding that Dr. Layfield subsequently recanted in the Zandi deposition. This testimony, taken alone, does appear to indicate that Dr. Layfield was of the opinion that Daniel's ingestion of Prempro caused a premalignant lesion to proliferate and, after mutations, become cancerous. Dr. Layfield's testimony, however, did not end with these two questions and answers. In fact, in response to the very next question, he agreed that he could not testify that Daniel did not already have a cancerous tumor when she began taking Prempro:
Id. at 94-95.
Moreover, on cross-examination, Dr. Layfield further clarified his lack of certainty with respect to the cause of Daniel's breast cancer:
Id. at 108-109.
Finally, Dr. Layfield testified that he was familiar with the results of the WHI study and agreed that this study showed no statistical increase in breast cancer until the patient had taken Prempro for four to five years:
Id. at 108-109.
Taken as a whole, then, Dr. Layfield's deposition testimony—all of which was read to the jury—may fairly be summarized as follows:
At his deposition in the Zandi case four months later, Dr. Layfield was asked about his prior testimony in the Daniels' case. The record does not reflect that he reviewed (or was asked to review) the transcript of his deposition in the Daniel's case. He nevertheless offered the following testimony:
Zandi case at 150-52.
Comparing Dr. Layfield's Zandi testimony with his deposition testimony read to the jury in this case, it is clear that there was no recantation. To the contrary, the testimony in both depositions was remarkably consistent. In both instances, he testified that that the short duration of her use of Prempro precluded any use of the
The trial court's attempts to distinguish Dr. Layfield's testimony at the two depositions reflects a failure to read the entirety of the testimony at either deposition. The trial court points out that "Dr. Layfield does not reconcile his Daniel testimony that it was at most a `possibility' that Daniel already had a late-stage lesion when she started taking hormone therapy to believing it was `more likely than not.'" Trial Court Opinion, 9/24/08, at 13. In the Daniel deposition, however, Dr. Layfield described all three potential conditions at the time she began taking Prempro as "possibilities," not just the "late stage lesions" (which the trial court apparently thought referred to occult cancers). In the Zandi deposition, Dr. Layfield made clear that by "late stage lesions" he was referring to "atypical intraductal hyperplasia or ductal carcinoma in situ," and not pre-existing cancer (although shortly thereafter he included "preexisting cancer" as a third possibility). In both depositions, Dr. Layfield consistently and without exception refused to opine that either of the three possible conditions existed at the time Daniel began to take Prempro—only that it had to be one of the three. As a result, there was nothing for Dr. Layfield to reconcile.
Similarly, the trial court also noted that "[Dr. Layfield] does not reconcile the trial testimony that hormone therapy caused the transformation of a pre-existing, nonmalignant lesion to invasive cancer with his Zandi testimony that, at most, hormone therapy caused an already existing cancerous tumor to `grow[ ] a little faster.'" Id. Again, however, reviewing the entirety of Dr. Layfield's testimony as read to the jury, he simply did not testify that the ingestion of Prempro caused a pre-malignant lesion to proliferate into a cancerous tumor. Instead, he testified that this was merely one possibility (among the three expressly specified). If this was not entirely clear to the jury during the reading of Dr. Layfield's testimony, counsel for Wyeth emphasized it during closing arguments: "And that's why Dr. Layfield, himself, after all of this testing, said I can't exclude the possibility that she had an occult or hidden breast cancer on the earlier occasion before she ever took hormone therapy." N.T., 1/25/07 (AS), at 120.
Finally, the trial court found that "Dr. Layfield's affidavit does not explain why he was unable to appear live at the Daniel trial," and that "Although Dr. Layfield confirmed in the Zandi deposition that he had informed Plaintiff's counsel of his revised opinion, he subsequently denies that any conversations took place." Trial Court Opinion, 9/24/08, at 12-13. Dr. Layfield's decision not to appear in person to testify at the Daniels' trial was, of course, not Dr. Layfield's but rather that of counsel for the Daniels, and the reason for not doing so is plain from both deposition transcripts—Dr. Layfield repeatedly made clear that he could not offer any expert opinion on causation to a reasonable degree of medical certainty, since he could not opine as to whether Daniel had an occult cancer, a DCIS, or an atypical hyperplasia
For these reasons, we reverse the trial court's order dated August 24, 2007 granting Wyeth a new trial. As explained hereinabove, we conclude that no basis exists in the record on appeal to support Wyeth's contention that Dr. Layfield recanted his testimony in this case in his subsequent deposition in the Zandi case. Contrary to Wyeth's contentions in its supplemental motion for post-trial relief, no "fraud on the court" took place here and a new trial should not have been granted on this basis.
Accordingly, we will proceed to consider the issues raised in Wyeth's cross-appeal. For its first issue, Wyeth contends it is entitled to a new trial because the trial court erred in permitting the Daniels to introduce evidence of subsequent remedial measures in the form of warnings that post-dated Daniel's use of the drug to prove negligence. Wyeth argues that "post-use, post-injury, post-WHI warnings were inadmissible pursuant to Pa. R. Evid. 403 and 407, as well as case law interpreting those rules." Brief of Appellees at 31.
We conclude that Wyeth failed to preserve this issue for appeal. In its appellate brief, Wyeth notes that it filed a motion in limine objecting to "any use of post-use labeling, but the motion was denied." Id. at 30. Our review of the record reflects a different history on this point. During pre-trial argument on Wyeth's motion in limine on January 3, 2007, counsel for the Daniels argued that they intended to use the post-WHI label (hereinafter, the "2005 label") for the limited purpose of showing proximate causation. Specifically, counsel for the Daniels represented that if Wyeth had done the necessary studies on the cancer risk posed by Prempro earlier, the warning label that Daniel's doctor (Dr. Hubbard) saw before prescribing the drug to her would have looked substantially similar to the 2005 label (i.e., with a "black box that has the definitive language"). N.T., 1/3/07 (AS), at 79. In response, counsel for Wyeth contended that Dr.
The trial court apparently agreed with Wyeth's recommendation, as it entered an order dated January 11, 2007 granting Wyeth's motion in limine in part. In a handwritten notation on the order, the trial court indicated that "Plaintiff may use the 2005 label in presenting its case and has presented evidence from a doctor as to whether or not it would have made a difference." Order Regarding Wyeth's Motion in Limine No. 10 at 1. While this handwritten notation is not the model of clarity, in the context in which it was entered, it is clear that the Daniels' use of the 2005 label was limited to causation testimony by Dr. Hubbard, and only after he testified that a "black box" label would have made a difference to him. With this limited exception, the trial court's decision to otherwise grant the motion in limine clearly reflects that any other use of the 2005 label, including any attempt to use it to prove negligence, was prohibited.
On appeal, Wyeth does not seem to take issue with the trial court's decision to allow the use of the 2005 label in connection with Dr. Hubbard's testimony. To the contrary, in its appellate brief Wyeth points out that "Daniel did not even call Dr. Haggard to testify at trial and, in his deposition, did not ask him whether the post-use labeling would have altered his prescribing of the drug for her." Brief of Appellees at 33. In any event, we do not conclude that the trial court's decision to allow the use of the 2005 label for the limited purpose of demonstrating proximate causation through Dr. Hubbard's testimony was error.
Instead, Wyeth contends that "counsel's rationale was a pretext for placing the two warnings side by side in order to argue from the contrast that the earlier breast cancer warning was inadequate." Brief of Appellees at 33. In this regard, Wyeth identifies four occasions on which counsel for the Daniels used the 2005 label to prove negligence by demonstrating the inadequacy of the prior label, including during the testimony of Dr. Michael Dey, Cheryl Blume, Ph.D, and in both opening and closing arguments. N.T. 1/9/07 (AS) at 40, 52-54; 1/10/07 (AS) at 56-62;
To the extent that counsel for the Daniels used the 2005 label in attempts to prove Wyeth's negligence in this case, this use was prohibited by the trial court when it granted Wyeth's motion in limine in part. As such, a timely and contemporaneous objection was required to provide the trial court with an immediate opportunity to issue an appropriate ruling.
For its second issue presented in its cross-appeal, Wyeth argues that the trial court erred in not granting its motion for judgment notwithstanding the verdict ("JNOV") on proximate causation. Wyeth contends that the Daniels did not present any evidence that a different breast cancer warning would have caused Dr. Haggard not to proscribe Prempro for her. Brief of Appellees at 34. The parties here agree that to prove proximate causation under the learned intermediary doctrine in this case, Daniels needed to present sufficient evidence to establish "a reasonable inference that Dr. Haggard would have changed his prescribing decision" if presented with an adequate warning. Brief of Appellees at 35; Reply Brief of the Appellants at 27.
Our standard of review for an order denying judgment notwithstanding the verdict is whether there was sufficient competent evidence to sustain the verdict. Whitaker v. Frankford Hosp. of City of Philadelphia, 984 A.2d 512, 517 (Pa.Super.2009). With respect to questions of law, our scope of review is plenary. Underwood ex rel. Underwood v. Wind, 954 A.2d 1199, 1206 (Pa.Super.2008). Any conflict in the evidence must be resolved in favor of the verdict winner's favor. Eichman v. McKeon, 824 A.2d 305, 311 (Pa.Super.), appeal denied, 576 Pa. 712, 839 A.2d 352 (2003). If any basis exists upon which the jury could have properly made its award, then we must affirm. Griffin v. University of Pittsburgh Medical Center-Braddock Hosp., 950 A.2d 996, 999 (Pa.Super.2008), appeal denied, 601 Pa. 680, 970 A.2d 431 (2009).
In Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d 356 (Pa.Super.2009), this Court reaffirmed that proximate cause is an essential element in failure to warn cases involving prescription medications. Id. at 368. Pennsylvania law requires that
In failure to warn cases involving pharmaceutical drugs,
Taurino v. Ellen, 397 Pa.Super. 50, 579 A.2d 925, 927 (1990), appeal denied, 527 Pa. 603, 589 A.2d 693 (1991) (quoting Makripodis by Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 361 Pa.Super. 589, 523 A.2d 374, 378 (1987)).
At trial in the case sub judice, Dr. Haggard testified that it was his practice when prescribing hormone therapy drugs to engage in a discussion of the benefits and the risks with the patient, and to allow the patient to make the final decision on whether to take the drugs. N.T., 1/17/07 (AS), at 25. Dr. Haggard further testified that when he prescribed Prempro to Daniel, he warned her of certain risks (e.g., headaches, nausea, vaginal bleeding), but not of the risk of cancer. Id. at 10, 17. He stated that in his view the physician's package insert did not, at the time he prescribed Prempro to Daniel, provide him with any basis to conclude that the drug posed any significant risk of breast cancer
Daniel testified that Dr. Haggard never informed her of the risk of breast cancer from taking Prempro, and that if she had known of the risk of breast cancer associated with Prempro, she would not have taken the drug—even if Dr. Haggard had recommended it. N.T., 1/17/07 (MS), at 28-29. Daniel also testified that she read the warnings on the patient information sheets that accompanied her monthly supply of Prempro pills, and that nothing contained therein made her believe that taking the drug would cause her to develop breast cancer. Id. at 32. She emphasized that if any of these information sheets had contained a "black box" warning about breast cancer, she would not have taken the drugs. Id.
In Simon, this Court reversed a trial court's grant of JNOV on proximate causation in a failure to warn case involving HRT medications (including Prempro). Reviewing testimony in that case substantially similar in all material respects to that presented here, we determined that sufficient evidence existed to permit the jury to believe the testimony of the plaintiff's doctors "that they would have permitted [plaintiff] to decide, based on the cancer risk that the WHI study revealed, whether to accept prescriptions for HRT." Id. at 375. We concluded that the jury in Simon was entitled to believe the plaintiff's testimony that "based upon the WHI study findings, she would not have utilized HRT once her doctors communicated the information they presently share with patients regarding breast cancer risks." Id. Accordingly, viewing the evidence in the light most favorable to the verdict winner and giving the plaintiff every reasonable inference of fact, this Court concluded that the plaintiff in that case had sustained her burden of proof on proximate causation and that it was error to grant JNOV on that issue. Id. at 376.
Based upon our review of the testimony of record here as well as our reasoning in Simon, we conclude that the trial court did not err in refusing to grant JNOV in favor of Wyeth on the proximate causation issue. Sufficient evidence of record exists in this case permitting the jury to find that if Wyeth had issued adequate warnings regarding the risk of breast cancer, Dr. Haggard would have altered his prescribing practices for Prempro (by specifically advising Daniel of the risk of breast cancer), and Daniel's injury would have been avoided since Daniel would have declined the prescription.
For its third issue presented in its cross-appeal, Wyeth argues that the trial court erred in not granting JNOV in its favor because the Daniels did not offer any expert medical testimony that Wyeth's warnings to physicians were not adequate. Wyeth contends that the only expert witness who opined that Wyeth's labeling inadequately warned physicians of the risk of breast cancer from Prempro was Cheryl Blume, Ph.D. As Wyeth points out, Dr. Blume is not a medical doctor, has never practiced medicine, and has no medical specialty relevant here to the use of HRT drugs, including neither gynecology nor oncology. Brief of Appellees at 37.
Rule 702 of the Pennsylvania Rules of Evidence provides no particular rules for the qualification of experts. Instead,
Wyeth relies primarily upon two decisions from this Court in support of its position that Pennsylvania law requires that only physicians may opine as to the adequacy of a drug's warning. First, in Demmler v. SmithKline Beecham Corp. we stated that "[g]enerally, expert medical testimony is required to determine whether the drug manufacturer's warning to the medical community is adequate because prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect." Id. at 1152. We find Wyeth's reliance on Demmler in this regard to be unpersuasive for two reasons. First, to the extent that this quoted language in Demmler purports to require that only medical experts may testify regarding the adequacy of drug labeling, it is mere obiter dicta, as the issue of whether a physician must testify regarding the adequacy of drug label warnings was never at issue in that case. In Demmler, a physician testified on behalf of plaintiff regarding the alleged inadequacy of the drug label, and thus whether the issue of whether only a physician could do so never arose for our consideration. Id.
Second, the quoted language in Demmler only requires that a plaintiff offer the testimony of a "medical expert" on the adequacy of warning labels, and does not specify that the medical expert be a licensed physician. Sufficient evidence of record existed to permit the trial court to find that Dr. Blume qualified as a satisfactory "medical expert," as that term was used in Demmler. Her testimony disclosed that she had a Bachelors degree in Biology and a Doctoral degree in Medical Pharmacology and Toxicology. N.T., 1/10/07 (MS), at 36. Dr. Blume further testified that in her twenty-year career as an executive with a major pharmaceutical company (Mylan Laboratories), she had been responsible for securing FDA approval of over 100 prescription drugs, and that her responsibilities included revising drug labels in light of post-marketing safety signals. Id. at 38-42. Based upon this testimony, the trial court aptly noted that as a "labeling expert," Dr. Blume was arguably "more qualified than a doctor who deals very marginally with these issues." N.T., 1/18/07 (AS), at 83.
Wyeth also relies upon Dion v. Graduate Hospital of University of Pennsylvania, 360 Pa.Super. 416, 520 A.2d 876 (1987), in which we affirmed a trial court's grant of a non-suit because the plaintiff did not introduce expert testimony on the adequacy of the drug's warning label, and, in general, "only physicians or others with similar education and experience regarding prescription drugs would be qualified to testify as to the adequacy of the warning." Id. at 879 (emphasis added). Rather than requiring a physician to provide such expert testimony, in Dion this Court expressly recognized that any expert "with similar education and experience" to a physician is qualified to opine on the adequacy of a drug's warning label. Based upon her qualifications as set forth, the trial court did not err in finding that Dr. Blume was qualified to offer testimony regarding the adequacy of Wyeth's warning label in this case.
As explained hereinabove, our standard of review when reviewing the denial of a motion for JNOV, we must view the evidence in the light most favorable to the verdict winner and give that party the benefit of every reasonable inference arising therefrom. Furthermore, in so doing we must reject all unfavorable testimony and inferences and carefully avoid the substitution of our judgment for that of the finder of fact. Given this standard of review, we conclude that the Daniels presented sufficient evidence that the short term use of Prempro increases the risk of breast cancer.
For example, the Daniels introduced the testimony of Dr. Donald Austin, an epidemiologist, who opined that in some women the effects from Prempro would be seen within months rather than years:
N.T., 1/16/07 (AS), at 11.
Dr. Elizabeth Naftalis, a surgeon specializing in breast cancer, served as the Daniels' primary causation witness, offering both general causation opinions as well as specific ones related to Daniel's breast cancer. For her general causation opinions, Dr. Naftalis expressly agreed with the opinion of Dr. Graham Colditz, a cancer researcher from Harvard University, that Prempro may promote abnormal cells into breast cancer within six months to one year. N.T., 1/17/07 (MS), at 41. She also testified that she relied upon an epidemiological study performed by Dr. Peter Ravdin, which reported that after the number of women taking the combination of estrogen and progestin decreased sharply in July 2002 (after publication of the WHI study), the number of breast cancer cases reported over the next six to eighteen months (through the end of 2003) was 15,000 less than expected. N.T., 1/12/07 (AS), at 9.
In addition, with respect to Daniel specifically, Dr. Naftalis testified affirmatively that Daniel's 18-month use of Prempro caused her breast cancer:
N.T., 1/12/07 (AS), at 73-74. Dr. Naftalis also testified that relied in part on the Ki-67 tests performed by Dr. Layfield. N.T., 1/12/07 (MS), at 97, 107 ("The evidence clearly points to the fact that her intake of combination hormone therapy caused her breast cancer in this particular case.").
We recognize that on cross-examination these experts conceded significant points, including the general lack of published and peer-reviewed studies demonstrating a statistically significant increase in the risk of contracting breast cancer after taking Prempro for less than two years.
Finally, we turn to the trial court's grant of Wyeth's JNOV motion on the availability of punitive damages in this case. The trial court ruled in Wyeth's favor for two reasons. First, the trial court found "no evidence from which a reasonable juror could find reckless and outrageous conduct, allowing all inferences in favor of the plaintiffs." Trial Court Opinion, 4/23/07, at 2. Second, the trial court ruled that federal constitutional law precludes a state court from awarding punitive damages based on out-of-state conduct (in this case, events occurring in Arkansas). Id. at 5 (quoting BMW of North America, Inc. v. Gore, 517 U.S. 559, 116 S.Ct. 1589, 134 L.Ed.2d 809 (1996)). We address these two points in turn.
Both the Daniels and Wyeth agree that the appropriate legal standard for evaluating an award of punitive damages in Pennsylvania is set forth in Hutchison ex rel. Hutchison v. Luddy, 582 Pa. 114, 870 A.2d 766 (2005).
Id. at 121-24, 870 A.2d at 771-72 (citations and footnotes omitted); see also Phillips, 584 Pa. at 188, 883 A.2d at 445 (2005) ("[P]unitive damages are an `extreme remedy' available only in the most exceptional circumstances."); Doe v. Wyoming Valley Health Care System, Inc., 987 A.2d 758, 768 (Pa.Super.2009).
Based upon this legal standard, the trial court granted Wyeth's JNOV motion, finding as follows:
Trial Court Opinion, 4/23/07, at 4. As explained in detail above, we review the trial court's grant of JNOV to determine whether there was sufficient competent evidence to sustain the jury's verdict. Brown v. Progressive Insurance Co., 860 A.2d 493, 497 (Pa.Super.2004) (citing Birth Center v. St. Paul Companies, Inc., 567 Pa. 386, 397, 787 A.2d 376, 383 (2001)), appeal denied, 582 Pa. 714, 872 A.2d 1197 (2005). To affirm a grant of JNOV, the evidence must be "such that no reasonable minds could disagree that the moving party is entitled to relief." Northeast Fence & Iron Works, Inc. v. Murphy Quigley Co., Inc., 933 A.2d 664, 668 (Pa.Super.2007), appeal denied, 596 Pa. 755, 947 A.2d 737 (2008).
Based upon our review of the record on appeal, we conclude that the trial court's finding that there was "simply no evidence that Wyeth knew that additional studies were necessary given the great body of scientific literature on hormone replacement therapy" was in error. The Daniels presented expert testimony and documentary evidence that Wyeth knew as early as the middle 1970s of the potential risk of breast cancer associated with the use of estrogen. In 1975, researchers proved that the use of estrogen substantially increased the risk of endometrial cancer by triggering receptors responsive to the hormone. According to Dr. Blume, these receptors are located not only in the endometrial lining of the uterus but also in other tissues of the female body, including in particular the breast. N.T. 1/10/07 (MS), at 56-57. According to Dr. Blume, given the discovery that receptors in the endometrial lining were hormone sensitive, Wyeth should have been on notice that studies were needed to assess the impact of hormone drugs on the tissues of the breast. Id.
Dr. Blume further testified that in a 1976 internal memorandum, Wyeth researchers recognized a "valid concern as to whether or not the use of exogenous estrogen leads to the increase of the incidence of breast cancer." Id. at 73. Dr. Blume described this internal memorandum as a "red flag," since in it Wyeth's researchers acknowledged "the possible role of estrogen and the combination of estrogen and progestin in the etiology of the triggering of breast cancer." Id. at 76
The record does not reflect Wyeth, despite acknowledging the existence of unanswered questions regarding possible links between the use of estrogen (independently or in combination with progestins), undertook any studies on these issues at this time. In this regard, Dr. Blume noted that in a 1977 internal memorandum, Wyeth researchers concluded that "[m]any practicing gynecologists are introducing sequential progestins into their estrogen replacement regimens in postmenopausal women." Id. at 81. The memo further acknowledged that the number of "published, well-designed studies" on the combined use of estrogen and progestin "is small or practically non-existent." Id. at 82.
In 1983, Wyeth applied to the FDA for approval to sell estrogen and progestin together in "convenience packaging" (dubbed the "Prem-Pack"). Wyeth proposed to do so based upon existing safety studies, but the FDA declined, advising
In 1990, Drs. Andrew Glass and Robert Hoover published a study of their conclusions after reviewing a large data base maintained by Kaiser-Permanente, an insurance carrier on the west coast that also operates cancer treatment centers. Based upon their review of this data base, which tracked the health of women from 1960 to 1985, Drs. Glass and Hoover reported a 130% increase in hormone positive breast cancers in menopausal women in the United States over that period of time. Id. at 113-116. Dr. Blume testified that Wyeth had a contract with Kaiser for use of its data base, and thus could have performed similar studies on the rise in the number of breast cancer cases during the same period of time when the use of drug hormones (many of which were manufactured and sold by Wyeth) had steadily increased. Id. at 117-118.
Contrary to the trial court's findings, a jury could reasonably find that Wyeth knew that additional studies were required to understand the possible association between its products and breast cancer in menopausal women. In this regard, we also find that the trial court's reliance on Wyeth's compliance with the FDA's testing and labeling requirements was misplaced. In Phillips v. Cricket Lighters, 584 Pa. 179, 883 A.2d 439 (2005), our Supreme Court ruled that compliance with industry and governmental safety standards "does not, standing alone, automatically insulate a defendant from punitive damages." Id. at 191, 883 A.2d at 447. Moreover, Dr. Blume testified that the FDA's testing and labeling requirements were the "minimum standards" for a drug company, and that nothing prevents drug companies from conducting additional studies if safety concerns arise either before or after FDA approval. N.T. 1/10/07 (MS), at 48-50.
Wyeth argues that its compliance with the FDA's testing requirements, including the clinical trials (the "Prem-Pack Protocols") it conducted prior to receiving FDA approval to sell Prempro in 1994, preclude any finding that it acted with reckless indifference. Wyeth points out that federal law required the FDA to obligate drug manufacturers to conduct "adequate tests by all methods reasonably applicable" to establish a drug's safety before giving its approval. Appellee's Brief at 50 (citing 21 U.S.C. § 355(d)). We disagree. It was for the jury to decide whether Wyeth had performed adequate testing of its product before marketing it for sale. To this end, the jury was within its province to determine whether the Prem-Pack Protocols, which lasted for only one year and involved only 1,700 women, constituted adequate safety testing. The Daniels introduced testimony from Dr. Blume that the Prem-Pack Protocols were inadequate in this regard because of their purpose and scope. N.T. 1/10/07 (AS), at 52.
In sum, sufficient evidence of record exists to support a jury's finding that from the middle 1970s and forward, Wyeth knew or strongly suspected that hormone replacement therapy increased the risk of breast cancer in post-menopausal women
We turn then to the trial court's legal conclusion that federal constitutional law precluded an award of punitive damages in this case. The trial court found that "Pennsylvania may not use punitive damages to punish Wyeth for any conduct— lawful or not—that occurred in Arkansas." Trial Court Opinion, 4/23/07, at 5. Elaborating on this finding, the trial court concluded as follows:
Id.
The trial court cites to BMW of North America, Inc. v. Gore, 517 U.S. 559, 116 S.Ct. 1589, 134 L.Ed.2d 809 (1996), as authority for its conclusions. In BMW, the United States Supreme Court addressed a case in which an Alabama purchaser of a new automobile brought suit in state court against the out-of-state manufacturer of the vehicle, based upon the failure to disclose to the purchaser that the car had been repainted prior to delivery to correct minor damages. Id. at 562, 116 S.Ct. 1589. At trial, the manufacturer acknowledged that it had a policy since 1983 of not advising dealers or customers of fixing minor repairs if the cost of the repairs did not exceed three percent of the vehicle's suggested retail price. Id. at 562, 116 S.Ct. 1589. The jury agreed with the purchaser that this policy constituted common law fraud awarded $4,000 in compensatory damages.
With respect to the purchaser's claim for punitive damages, he introduced evidence that pursuant to its policy of non-disclosure, the manufacturer had sold 983 cars nationwide refinished in accordance with its nondisclosure policy, including 14 in Alabama. Id. at 564, 116 S.Ct. 1589. The manufacturer argued that the refinished cars it sold were of equal value to those with original factory finishes, and also pointed out that its nondisclosure policy for repairs under 3% of the car's value was expressly permitted by statute in at least
Focusing in part on the varying statutory provisions in other states, the U.S. Supreme Court reversed. The Court acknowledged that different states may provide differing protections for purchasers of automobiles, resulting in "a patchwork of rules representing the diverse policy judgments of lawmakers in 50 states." Id. at 570, 116 S.Ct. 1589. Because no state may force its policy choices on neighboring states, the Court concluded that "a State may not impose economic sanctions on violators of its laws with the intent of changing the tortfeasors' lawful conduct in other states." Id. at 572, 116 S.Ct. 1589. Alabama's authority to award punitive damages was limited to its own interest in "protecting its own consumers and its own economy," and thus it did not have the power "to punish BMW for conduct that was lawful where it occurred and that had no impact on Alabama or its residents." Id. at 573, 116 S.Ct. 1589.
Wyeth contends that State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408, 123 S.Ct. 1513, 155 L.Ed.2d 585 (2003), also supports the trial court's decision here. In State Farm, the driver of a vehicle was permanently injured and his passenger killed in an automobile accident in Utah that witnesses and investigators all attributed to an unsafe passing maneuver by another driver (Campbell, insured by State Farm). Id. at 412-13, 123 S.Ct. 1513. State Farm decided to contest liability at trial and refused offers to settle the case for the policy limit of $50,000. Id. at 413, 123 S.Ct. 1513. A jury determined that Campbell was 100% negligent and awarded over $185,000 in compensatory damages. Id.
Campbell thereafter filed suit in Utah state court against State Farm, alleging bad faith, fraud, and intentional infliction of emotional distress. Id. at 414, 123 S.Ct. 1513. At trial, Campbell introduced evidence that State Farm's conduct in taking the case to trial was part of a national scheme to meet corporate fiscal goals by capping payouts on claims. Id. at 415, 123 S.Ct. 1513. The jury awarded Campbell $2.6 million in compensatory damages and $145 million in punitive damages. Id. at 415, 123 S.Ct. 1513. Although the trial court reduced the damages to $1 million and $25 million, respectively, the Utah Supreme Court reinstated the $145 million punitive damages award. Id. at 415, 123 S.Ct. 1513.
The U.S. Supreme Court reversed, in part based upon the Utah Supreme Court's express acknowledgement that the punitive damages award was intended to punish State Farm for unlawful conduct outside the state of Utah, i.e., for its national scheme to meet corporate goals:
Id. at 421-22, 123 S.Ct. 1513.
In our view, neither BMW nor State Farm imposes any constitutional limitation on an award of punitive damages against Wyeth, since in both cases the limitations
In the present case, the trial court erred by confusing conduct relevant to the award of compensatory damages with the conduct relevant to assessing punitive damages. While it is true that Daniel resided in Arkansas and obtained and ingested Wyeth's drug in Arkansas after her Arkansas doctor received and communicated the contents of Wyeth's warning labels there, this conduct is relevant principally, if not exclusively, to the Daniels' claims for compensatory damages. In contrast, all of Wyeth's conduct relevant to the jury's assessment of the award of punitive damages occurred in Pennsylvania. Wyeth is a Pennsylvania corporation with its principal place of business in King of Prussia. N.T., 1/9/07 (MS), at 59.
For these reasons, the trial court's order dated August 24, 2007 granting Wyeth's post-trial motion for a new trial is hereby
FITZGERALD, J. files a Concurring Opinion.
CONCURRING OPINION BY FITZGERALD, J.:
After a review of the certified record
I write separately to note my concern that the majority's seeming emphasis on where the conduct warranting punitive damages originated shifts the focus away from whether the harmful conduct was directed to the injured plaintiff or to non-parties, such as all "post-menopausal women," or non-Pennsylvania consumers. See generally Philip Morris USA v. Williams, 549 U.S. 346, 353-55, 127 S.Ct. 1057, 1063-64, 166 L.Ed.2d 940, 948-49 (2007);
Also, in its Ra.R.A.P. 1925(b) statement, Wyeth raised two issues relating to the provisional second stage of the trial during which the jury determined the amount of the punitive damage award: (1) whether the trial court had subject matter jurisdiction to hold the proceeding after granting the motion for JNOV, (2) whether the amount of punitive damages awarded by the jury could be reinstated if this Court were to reverse the trial court's grant of JNOV, since the trial court denied certain of Wyeth's proposed jury instructions regarding the proper method of computation of a punitive damage award (including instructions regarding the relationship between punitive and compensatory damages, the bar to punishment for out-of-state conduct, the bar to punishment for unlawful conduct, and the relevance of Wyeth's financial condition). See Wyeth's Statement of Matters Complained of on Appeal at 3-4 (issues 8 and 9). With respect to this second issue, Wyeth stated that "[t]he Court's refusal to give these instructions left the jury with an incomplete, misleading, and unfairly prejudicial account of the law of punitive damages. Therefore, a new trial on the amount of punitive damages as well as the other issues would still be required." Id. (issue 9).
Wyeth did not include either of these issues in the "Statement of Questions Involved" section of its appellate brief, however, and did not thereafter mention them in the "Argument" section of the brief. Accordingly, these issues are waived for purposes of appeal. See, e.g., Mooney v. Greater New Castle Development Corp., 510 Pa. 516, 524 n. 4, 510 A.2d 344, 348 n. 4, cert. denied, 479 U.S. 915, 107 S.Ct. 317, 93 L.Ed.2d 290 (1986); Dickens v. Barnhart, 711 A.2d 513, 515 n. 5 (Pa.Super.), appeal denied, 556 Pa. 709, 729 A.2d 1129 (1998).
Pa.R.E. 407.
In their appellate briefs filed with this Court, however, both the Daniels and Wyeth insist that the principles in Hutchison should guide our analysis. Brief of Appellants' at 46; Brief of Appellee at 47-48. Accordingly, we will proceed on that basis, in part because neither party has challenged any aspect of the jury charge. In this regard, we note that the record on appeal does not contain either the points for charge submitted by the parties or the transcript of the oral argument on January 30, 2007 prior to the trial court's grant of Wyeth's JNOV motion. As such, our understanding of the trial court's decision for charging the jury as it did on punitive damages and/or the legal standards on which it initially based its decision to grant Wyeth's JNOV motion, is lacking. In its written opinion supporting its decision, however, the trial court cites to, and relies upon, Hutchison.
In this regard, we note that both the Daniels and Wyeth agree that Pennsylvania law applies with regard to the availability of punitive damages in this case, as both strongly urged the application of the legal standards set forth by our Supreme Court in Hutchison ex rel. Hutchison v. Luddy, 582 Pa. 114, 870 A.2d 766 (2005). Brief of Appellants' at 46; Brief of Appellee at 47-48.
