OPINION BY BOWES, J.:
Elizabeth Coleman and her husband, Patricia Medwid and her husband, Mary Weinberger, Judy A. Reed and her husband, Kathleen Taw Stephenson and her husband, Diane Morales, Vicki Lenzi and her husband, Zanda Schirn and her husband, Peggy Fleming-Crain, Nancy Honaker and her husband, Virginia Hansen, Hazel Blaylock, Graciana Manalo and her husband, and Carol J. Hess (collectively referred to as Appellants herein) appeal from the various orders granting summary judgment in favor of Wyeth Pharmaceuticals, Inc. and the other Wyeth parties, and in some cases Pharmacia Upjohn (hereinafter collectively referred to as Appellees). The appeals have been consolidated for purposes of our review. After careful consideration, we reverse the trial court's orders granting summary judgment.
All husband litigants have asserted claims for loss of consortium. For ease of reference, "Appellants" will refer to wife-Appellants unless otherwise noted.
Ms. Coleman filed her action against Wyeth Pharmaceuticals, Inc., Wyeth-Ayerst Pharmaceuticals, Inc., Wyeth Ayerst International, Inc., Wyeth Laboratories, Inc., Wyeth Pharmaceuticals, Wyeth, Inc., Pharmacia Up-john, Inc. a/k/a Pharmacia Upjohn Company, and Pfizer, Inc. Pfizer was dismissed by stipulation in December 2006 because it did not manufacture or sell Provera until it acquired Pharmacia Upjohn, Inc. and Pharmacia Upjohn Company in 2003. Wyeth-Ayerst Pharmaceuticals, Inc. and Wyeth Laboratories, Inc. are non-existent entities. Wyeth Pharmaceuticals, Inc. is the successor to these entities. For the sake of brevity, the Wyeth and Upjohn entities are referred to herein as simply "Wyeth" and "Upjohn."
Overview
Appellants are fourteen post-menopausal women who were diagnosed with breast cancer between 1998 and 2002. Prior to their diagnoses, Appellants' physicians prescribed hormone replacement therapy ("HRT" or "HT"), comprising estrogen and progestin in combination, to relieve symptoms associated with menopause such as hot flashes, irritability, and vaginal atrophy. Upjohn manufactured and distributed Provera, a synthetic progestin, until 1995 when it merged with Pharmacia to form the Pharmacia Up-john entities. Premarin, a conjugated estrogen drug, and Prempro, a combination of Premarin and a progestin that is the chemical equivalent of Provera, were manufactured and distributed by Wyeth. The combination of estrogen and progestin was used by all Appellants because they had intact uteri and estrogen alone was found to cause endometrial cancer. These appeals arise from Appellants' claims that the pharmaceutical companies failed to adequately warn their physicians that HRT therapy caused or increased the risk of breast cancer.
Appellants Elizabeth and Joe Coleman commenced their lawsuit against Appellees on June 28, 2004, alleging negligent failure to warn, fraud, breach of express warranty, loss of consortium, and a violation of corporate responsibilities. On September 24, 2007, after completion of some discovery, Appellees filed motions for summary judgment asserting that the statute of limitations on the claims began to run on October 20, 2000, when Ms. Coleman was diagnosed with breast cancer. Appellees argued that Ms. Coleman's lawsuit was barred by Pennsylvania's two-year statute of limitations set forth in 42 Pa.C.S. § 5524(2). That statute provides:
Virtually identical allegations were made by the remaining Appellants herein.
The following actions and proceedings must be commenced within two years:
(1) An action for assault, battery, false imprisonment, false arrest, malicious prosecution or malicious abuse of process.
(2) An action to recover damages for injuries to the person or for the death of an individual caused by the wrongful act or neglect or unlawful violence or negligence of another.
(3) An action for taking, detaining or injuring personal property, including actions for specific recovery thereof.
(4) An action for waste or trespass of real property.
(5) An action upon a statute for a civil penalty or forfeiture.
(6) An action against any officer of any government unit for the nonpayment of money or the nondelivery of property collected upon on execution or otherwise in his possession.
(7) Any other action or proceeding to recover damages for injury to person or property which is founded on negligent, intentional, or otherwise tortious conduct or any other action or proceeding sounding in trespass, including deceit or fraud, except an action or proceeding subject to another limitation specified in this subchapter.
(8) An action to recover damages for injury to a person or for the death of a person caused by exposure to asbestos shall be commenced within two years from the date on which the person is informed by a licensed physician that the person has been injured by such exposure or upon the date on which the person knew or in the exercise of reasonable diligence should have known that the person had an injury which was caused by such exposure, whichever date occurs first.
42 Pa.C.S. § 5524.
Ms. Coleman countered that the facts concerning the cause of her cancer were not known or knowable prior to the publication of the Women's Health Initiative ("WHI") study on July 9, 2002, and that the discovery rule operated to toll the limitations period until that time. The National Institutes of Health ("NIH") commissioned the WHI study to examine whether HRT decreased the risk of cardiovascular disease in post-menopausal women. The study was halted prematurely because an unusually high number of women who were taking HRT medications for purposes of the study developed breast cancer. The WHI study was the first large randomized study establishing a link between HRT medications and breast cancer. Consequently, its report was widely publicized. The trial court rejected Ms. Coleman's position and granted summary judgment for Appellees, holding that the discovery rule was inapplicable and that the two-year statute of limitations barred her claim. Coleman Opinion, 9/24/07, at 25.
The Coleman opinion and reasoning was subsequently adopted by the trial court in each of the remaining thirteen cases consolidated herein. Moreover, commencing with Appellant Medwid, the trial court held that the statute of limitations barred the action on an additional basis: that a response to Fact Sheet Question XI constituted a judicial admission, conclusively establishing that Ms. Medwid knew by June 1998 that there was a correlation between her breast cancer and her use of HRT drugs. The same finding was subsequently made in the Weinberger, Reed, Stephenson, Morales, Lenzi, Schirn, Fleming-Crain, Honaker, Hansen, Blayloch, and Manolo cases. In Hess, there was no Fact Sheet response that could be construed as a judicial admission because Ms. Hess indicated that she did not recall what she was told.
Fact Sheets are form discovery documents utilized in mass tort litigation. Appellants herein were required to complete Fact Sheets upon filing their actions in the Court of Common Pleas of Philadelphia County.
While substantial discovery was completed in Coleman prior to the entry of summary judgment, virtually no discovery had been undertaken in the remaining cases, other than the completion of Fact Sheets. As the Coleman opinion served as the template for the remaining cases, we focus initially on the facts therein and then turn our attention to issues common to all. To the extent that the remaining cases present unique facts or legal issues, we address them individually.
Questions Presented on Appeal
The following issues have been raised for our review:
1. Did the trial court err in holding that whether to apply the discovery rule to postpone the accrual of the statute of limitations applicable to plaintiffs' claims in these 14 cases did not present a question of fact for the jury to decide — notwithstanding Pennsylvania's strong preference for jury resolution of the discovery rules application; the absence of any developed factual record in 13 of these 14 cases; and the existence of genuine issues of material fact governing the discovery rule's application in all 14 cases?
2. Did the trial court err in holding on summary judgment that the statute of limitations applicable to plaintiffs' claims began to run — and in certain of these cases had in fact expired — before generally accepted scientific proof became available which was necessary to establish that ingesting defendants' combination hormone therapy drugs caused breast cancer?
The issues have been renumbered for the convenience of the Court.
Appellants' Consolidated Brief at 4.
In their first issue, Appellants contend that the trial court erred and abused its discretion in granting summary judgment on the basis of the statute of limitations because there were genuine issues of fact as to when they should have realized the causal connection between HRT and their breast cancer. In asserting such error, they contend that the trial court failed to view the record in the light most favorable to the non-moving party, Appellants herein, and to draw all reasonable inferences in their favor. Appellants argue that their actions were not time-barred for two reasons: 1) the discovery rule tolled the limitations period until July 9, 2002, the date that they had reason to believe there was a causal connection between HRT medications and breast cancer, and 2) their causes of action did not accrue until July 9, 2002, because, until then, they could not maintain an action to a successful conclusion.
Our standard of review on an appeal from the grant of a motion for summary judgment is well-settled:
A reviewing court may disturb the order of the trial court only where it is established that the court committed an error of law or abused its discretion. As with all questions of law, our review is plenary.
In evaluating the trial court's decision to enter summary judgment, we focus on the legal standard articulated in the summary judgment rule. Pa.R.C.P. 1035.2. The rule states that where there is no genuine issue of material fact and the moving party is entitled to relief as a matter of law, summary judgment may be entered. Where the non-moving party bears the burden of proof on an issue, he may not merely rely on his pleadings or answers in order to survive summary judgment. Failure of a non-moving party to adduce sufficient evidence on an issue essential to his case and on which he bears the burden of proof establishes the entitlement of the moving party to judgment as a matter of law. Lastly, we will review the record in the light most favorable to the non-moving party, and all doubts as to the existence of a genuine issue of material fact must be resolved against the moving party.
ADP, Inc. v. Morrow Motors Inc., 969 A.2d 1244, 1246 (Pa.Super. 2009) (quoting
Shepard v. Temple University, 948 A.2d 852, 856 (Pa.Super. 2008)).
Our Supreme Court recently cautioned that "the function of the summary judgment proceedings is to avoid a useless trial but is not, and cannot, be used to provide for trial by affidavits or trial by depositions." Stimmler v. Chestnut Hill Hospital, 602 Pa. 539, 981 A.2d 145 (2009). The Court emphasized that in considering such a motion, a lower court must thoroughly examine the whole record to determine whether there is a genuine issue as to any material fact, with all doubts as to the existence of a genuine issue resolved against the moving party. Id. at 154.
The trial court granted summary judgment on Appellants' negligent failure-to-warn claims based upon the expiration of the two-year statute of limitations for personal injury actions and the inapplicability of the discovery rule. Coleman Order, 9/24/07. The Judiciary Code, 42 Pa.C.S. § 5502(a), sets forth the general rule for the statute of limitations:
The time within which a matter must be commenced under this chapter shall be computed, except as otherwise provided by subsection (b) or any other provision of this chapter, from the time the cause of action accrued, the criminal offense was committed or the right of appeal arose.
Actions or proceedings to recover damages for injury to person founded on negligent conduct must be commenced within two years, as measured from the time the cause of action accrued. See 42 Pa.C.S. § 5524(7), supra, n. 4. It is undisputed that none of Appellants instituted suit within two years of the diagnosis of her breast cancer; however, all filed suit within two years of the publication of the WHI study on July 9, 2002.
The Discovery Rule
Appellants allege that the trial court erred in granting summary judgment on the inapplicability of the discovery rule, holding as a matter of law that no reasonable jury could find that they initiated suit within two years from when they knew or should have known that Appellees' drugs caused their breast cancer. Appellants' brief at 28. Where, as here, there is conflicting evidence of when Appellants knew or reasonably should have known that their injuries resulted from the negligent conduct of Appellees, Appellants contend the applicability of the discovery rule is a jury question. Moreover, Appellants argue that there is sufficient evidence of record from which a jury could reasonably conclude that they neither knew nor should have known, despite reasonable diligence, that Appellees' combination hormone therapy caused their breast cancer until the WHI study was published on July 9, 2002. Thus, they urge us to hold that the discovery rule tolls the statute of limitations until that date. We agree and find our decision in Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d 356 (Pa.Super. 2009) to be controlling on this issue.
We recognize that the Simon decision was handed down after the trial court's decision in this matter.
In Pennsylvania, there are two well-recognized legal constructs that toll the running of the statute of limitations: the discovery rule and the doctrine of fraudulent concealment. While Appellants argued below that both were applicable herein, on appeal they have chosen to rely solely on the discovery rule as the basis for reversal.
The discovery rule is a "judicially created device which tolls the running of the applicable statute of limitations until the point where the complaining party knows or reasonably should know that he has been injured and that his injury has been caused by another party's conduct." Crouse v. Cyclops Industries, 560 Pa. 394, 745 A.2d 606, 611 (2000). In Fine v. Checcio, 582 Pa. 253, 870 A.2d 850 (2005), our Supreme Court affirmed the applicability of the discovery rule in cases involving latent injuries or instances where the causal connection between an injury and another's conduct was not apparent. Accord Wilson v. El-Daief, 600 Pa. 161, 964 A.2d 354, 361-62 (2009). Our high court has looked favorably on "tying commencement of the limitations period to actual or constructive knowledge of at least some form of significant harm and of a factual cause linked to another's conduct, without the necessity of notice of the full extent of the injury, the fact of actual negligence, or precise cause." Wilson, supra at 364.
Recognizing that a plaintiffs awareness of an injury and its cause is fact-intensive, our courts have held that ordinarily this is an issue "best determined by the collective judgment, wisdom and experience of jurors." Crouse, supra at 611 (quoting White v. Owens-Corning Fiberglas Corp., 546 Pa. 648, 683 A.2d 885 (1996)). Fine, supra. It is the factfinder who must focus on whether the plaintiff was reasonably diligent in discovering his injury and that it was caused by a third party. Even though this is an objective standard, it is to be applied with reference to individual characteristics. Wilson, supra; Crouse, supra. Our courts maintain that the standard "is sufficiently flexible . . . to take into account the differences between persons and their capacity to meet certain situations and the circumstances confronting them at the time." Burnside v. Abbott Laboratories, 351 Pa.Super. 264, 505 A.2d 973, 988 (1985). Where there are factual and credibility determinations to be made regarding the reasonable diligence of the plaintiff, that issue should be submitted to the finder of fact. Crouse, supra; Fine, supra.
The common thread in our jurisprudence, as articulated in Crouse, Fine, and Wilson is the recognition that at some point, a plaintiff should become sufficiently aware of his injury and that it was caused by another to trigger or "awaken inquiry." Hayward v. Medical Center of Beaver County, 530 Pa. 320, 608 A.2d 1040, 1043 (1992). Knowledge of an injury alone is not sufficient to trigger such inquiry. One must have some reason to suspect that the injury was caused by a third party to impose a duty to investigate further. Where the injury is one that may result from nontortious conduct, such as a disease, that point may be difficult to discern without resolving factual issues. Subjective differences among persons and the situations in which they find themselves are relevant in making that determination.
In Fine, supra, the plaintiff suffered facial numbness following wisdom tooth extraction. The record revealed that the condition could have been a temporary physical consequence of the surgery or a manifestation of Fine's injury, a permanent condition that resulted from underlying nerve damage. We refused to apply the discovery rule, holding that Fine knew when the surgery ended that he was hurt, and that he was experiencing unexpected numbness. The Supreme Court reversed, recognizing that
until conflicts in the record were resolved and inferences from relevant facts were drawn, the issue of whether Fine knew, or should have known through the diligence that a reasonable person would have exercised under the circumstances, that the numbness he was experiencing . . . was a manifestation of injury, as, opposed to, or in addition to, the typical condition that dental surgery produces, remained disputed.
Id. at 862. In refusing to apply the discovery rule in that situation, the Court held that we had erroneously undertaken "the fact resolution and inference-drawing functions" when our proper role was to decide whether there was an issue to be tried. It is only when "reasonable minds would not differ in finding that a party knew or should have known on the exercise of reasonable diligence of his injury and its cause" that a court may determine that the discovery rule does not apply as a matter of law.
Id. at 858 (quoting
Hayward, supra at 1043.)
More recently, in Simon v. Wyeth Pharmaceuticals, Inc., supra, at 365-366, we examined the discovery rule, and specifically the reasonable diligence component, in the context of an HRT case:
If the injured party could not ascertain when he was injured and by what cause within the limitations period, "despite the exercise of reasonable diligence," then the discovery rule is appropriate.
Pocono International Raceway, Inc. v. Pocono
Produce, Inc., 503 Pa. 80,
468 A.2d 468, 471 (1983). The test is objective but takes into account individual capacities and society's expectations of "attention, knowledge intelligence and judgment" for citizens to protect their own interests.
Fine,
supra at 858. The party who invokes the discovery rule has the burden of proving its applicability by establishing he acted with reasonable diligence in determining the fact and cause of his injury but was unable to ascertain it.
Weik v. Estate of
Brown, 794 A.2d 907, 909 (Pa.Super. 2005) (citing
Fine, supra at 858).
This determination is a factual one as to whether the party, despite the exercise of reasonable diligence, was unaware of his injury and unable to determine its cause.
Id. Where the rule's application involves a factual determination regarding whether the plaintiff exercised due diligence in discovering his injury, the jury must decide whether the rule applies.
Crouse v. Cyclops Industries, 560 Pa. 394,
745 A.2d 606 (2000).
We reversed JNOV for Upjohn entered on statute of limitations grounds in Simon because we found sufficient competent evidence of record to support the jury's finding that Ms. Simon's cause of action accrued when the WHI study was published on July 9, 2002. Until that time, Ms. Simon had no reason to suspect a link between her use of HRT and breast cancer. Simon, supra at ¶ 26.
The trial court, in granting summary judgment herein, held that Ms. Coleman "failed to provide sufficient evidence that she did not know nor reasonably could have known that HRT could cause breast cancer before the WHI study." Coleman Opinion, 9/24/07, at 25-26. It also found that she "failed to exercise the level of diligence that a reasonable person would employ under the facts of her case and therefore, has failed to establish that she falls within the exception of the discovery rule." Id. at 10. In the view of the trial court, there was no factual issue for the jury since Ms. Coleman "failed to make even a single attempt" to investigate her injury. Id. In essence, the trial court concluded that reasonable minds could not differ in finding that Ms. Coleman knew or should have known, with the exercise of reasonable diligence, of her injury and its cause, and the discovery rule did not therefore apply.
An understanding of the state of medical warnings regarding HRT therapy during the relevant time period is fundamental to our analysis of the trial court's ruling because the application of the discovery rule involves issues of Appellants' constructive and actual knowledge of a causal relationship between HRT therapy and breast cancer. We begin our inquiry with the physician-labeling information published annually in the Physicians' Desk Reference ("PDR") and patient package inserts for the medications at issue.
The FDA-approved physician labeling information that was provided in 1992 with Premarin, Wyeth's estrogen, identified a potential risk of endometrial cancer with estrogen-only therapy. Regarding breast cancer risk, the label stated:
Some studies have suggested a possible increased incidence of breast cancer in those women on estrogen therapy taking higher doses for prolonged periods of time. The majority of studies, however, have not shown an association with the usual doses used for estrogen replacement therapy.
Physicians' Desk Reference, 1992; Weinberger Brief in Opposition to Wyeth's Motion for Summary Judgment, Exhibit 10. The patient package insert for Premarin at the same time dismissed any association between estrogen and breast cancer, except perhaps with long-term use at higher dosages, stating:
Cancer of the breast. The majority of studies have shown no association with the usual dose used for estrogen replacement therapy and breast cancer. Some studies have suggested a possible increased incidence of breast cancer in those women taking estrogens for prolonged periods of time and especially if higher doses are used.
Id.
The 1992 PDR listing for Provera, Upjohn's progestin-only drug, contained the following warning:
Beagle dogs treated with medroxyprogesterone acetate [the active ingredient in Provera] developed mammary nodules some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules in the drug-treated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. Their significance with respect to humans has not been established.
As to Prempro, the combined estrogen-progestin medication, the 1998 PDR stated, "unopposed estrogen therapy has been associated with an increased risk of endometrial adenocarcinoma," but the "resuits of clinical studies indicate that the addition of a progestin to an estrogen replacement cycle . . . reduces the incidence of endometrial hyperplasia and the attendant risk of adenocarcinoma in women with intact uteri." Coleman Brief in Opposition to Wyeth's Motion for Summary Judgment, Exhibit F. Under "Contraindications," the 1998 PDR listing for Prempro advised that:
Estrogens/progestin combined should not be used in women under any of the following conditions or circumstances:
1. Known or suspected pregnancy, including for missed abortion or as a diagnostic test for pregnancy (see Boxed Warning). Estrogen or progestin may cause fetal harm when administered to a pregnant woman.
2. Known or suspected cancer of the breast.
3. Known or suspected estrogen-dependent neoplasia.
4. Undiagnosed abnormal genital bleeding;
5. Active or past history of thrombophlebitis, thrombolic disorders, or stroke.
1. Liver dysfunction or disease.
Id. The information described as "WARNINGS" stated as follows:
ALL WARNINGS BELOW PERTAIN TO THE USE OF THIS COMBINATION PRODUCT.
Based on experience with estrogens and /or progestins:
1.
Induction of malignant neoplasms
Breast cancer. Some studies have reported a moderately increased risk of breast cancer (relative risk of 1.3 to 2.0) in those women on estrogen replacement therapy taking higher doses, or in those taking lower doses for prolonged periods of time, especially in excess of 10 years. The majority of studies, however, have not shown an association in women who have ever used estrogen replacement therapy. The effect of added progestins on the risk of breast cancer is unknown, although a moderately increased risk in those taking combination estrogen/progestin therapy has been reported. Other studies have not shown this relationship. In a one year clinical trial of PREMPRO, PREMPHASE and Premarin alone, 5 new cases of breast cancer were detected among 1377 women who received the combination treatments, while no new cases were detected among 347 women who received Premarin alone. The overall incidence of breast cancer in this clinical trial does not exceed that expected in the general population.
In the three year clinical Postmenopausal Estrogen Progestin Intervention (PEPI) trial of 875 women to assess differences among placebo, unopposed Premarin, and three different combination hormone therapy regimens, one (1) new case of breast cancer was detected in the placebo group (n=174), one in the Premarin group alone (n=175), none in the continuous Premarin plus continuous medroxyprogesterone acetate group (n=174), and two (2) in the continuous Premarin plus cyclic medroxyprogesterone acetate group (n=174).
Women on hormone replacement therapy should have regular breast examinations and should be instructed in breast self-examination, and women over the age of 50 should have regular mammograms.
Physicians' Desk Reference, 1998; Coleman Brief in Opposition to Wyeth's Motion for Summary Judgment, Exhibit F. There was mention in the 1998 PDR of an increase in pancreatic islet cell tumors and a decreased incidence of spontaneous mammary gland tumors in female rats with
Prempro.
Id. The 1998 PDR for Prempro contained a warning regarding the beagle dog study, providing:
Beagle dogs treated with MPA [medroxyprogesterone, the active ingredient in Provera] developed mammary nodules, some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules in the drug-treated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. It is known that progestogens stimulate synthesis and release of the growth hormone in dogs. The growth hormone, along with the progestogen, stimulates mammary growth and tumors. In contrast, growth hormone in humans is not increased, nor does growth hormone have any significant mammotrophic role. Therefore, the MPA-induced increase of mammary tumors in dogs probably has no significance to humans. No pancreatic tumors occurred in dogs.
Id. The 2000 PDR contained virtually identical language regarding Prempro.
The 1998 package insert for Prempro under "Risks of Estrogens and/or Progestins," provided:
Cancer of the breast. Most studies have not shown a higher risk of breast cancer in women who have used estrogens. However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogens for long periods of time (especially more than 10 years), or who used high doses for shorter periods. The effects of added progestin on the risk of breast cancer are unknown. Some studies have reported a somewhat increased risk, even higher than the possible risk associated with estrogen alone. Others have not. Regular breast examinations by a health professional and monthly self-examination are recommended for all women. Regular mammograms are recommended for all women over 50 years of age.
Wyeth's Reply in Further Support of Its Motion for Summary Judgment Based on the Statute of Limitations, 3/29/07, at Exhibit A.
Thus, the literature distributed to physicians and patients through 2000 did not causally link HRT therapy with breast cancer. The reported studies involving women were inconclusive. Studies conducted on rats and beagle dogs were dismissed as being of little or no significance to humans.
The certified record herein contains articles that appeared in the popular print media in the late 1990s, including an article authored by Susan Love, a breast cancer specialist, entitled, "Estrogen Therapy: Should You or Shouldn't You?," in the February 1997 issue of Good Housekeeping. Wyeth's Supplemental Brief in Further Support of its Motion for Summary Judgment Based on the Statute of Limitations (Coleman), Exhibit 1. The article addressed estrogen therapy and its risks and alluded to contradictory medical advice and doctor confusion. In an article appearing in the June 19, 1997 issue of USA Today, it was explained that if a woman had a budding cluster of estrogen-dependent breast cancer cells, estrogen replacement could promote the tumor's growth. Id. at Exhibit 2. A Newsweek article appearing in the June 30, 1997 issue touted the benefits of estrogen therapy for heart, skin, and bones, but cautioned against long-term use of estrogen. Id. at Exhibit 3. A December 23, 1997 New York Times article recited that women doctors were more likely to use HRT despite studies suggesting a link with a higher incidence of breast cancer. Id. at Exhibit 5. An article in the Arkansas Democrat Gazette appearing on January 27, 2000, explained the dilemma, noting that "[s]ome previous studies have linked estrogen supplements, either alone or in combination with progestin, with higher risks of breast cancer. Other research has found no increased risk." Id. at Exhibit 10.
Reference is made in the record to an article appearing in the Journal of the American Medical Association ("JAMA ") in January 2000 discussing three studies: the Breast Cancer Detection Demonstration Project ("BCDDP"), the National Health and Nutrition Examination Study ("NHANES"), and the Iowa Women's Health Study. Coleman's Brief in Support of Motion for Reconsideration, Exhibit 18. The studies were characterized as showing "different conclusions and reaffirming the majority of data that have not shown an association between hormone use and overall increased breast cancer risk in most women." Id. The JAMA article heralded that, "More definitive information is anticipated at the conclusion in 2006 of the National Institutes of Health: Women's Health Initiative, the largest prospective clinical trial of postmenopausal women and estrogen use — " Id.
On July 9, 2002, the WHI study was made public. This document was the first large randomized study establishing a definitive causal link between combined estrogen and progestin in healthy post-menopausal women and breast cancer. Journal of the American Medical Association, "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women." It was touted to be the "biggest bombshell in the history of HRT." Sari Harrar, HRT: Answers, Not Panic; Breast Cancer. Heart attacks. Stroke. And — Surprise! — A Window of Safety. Vol. 54 Prevention 46 (October 1, 2002). Coleman Brief in Opposition to Wyeth's Motion for Summary Judgment Based on the Statute of Limitations, Exhibit I (hereinafter "Coleman Brief). The study was halted three years early because results indicated that the risks of taking HRT medications clearly outweighed the benefits. The study found that HRT did not protect against heart disease or Alzheimer's, as advertised; rather, it increased the risk of developing invasive breast cancer. The study acknowledged, however, that further research was needed to determine whether different dosages and combinations impacted breast cancer.
Alice Park, What Did the Study Show?, 160 Time Mag. 38 (July 22, 2002), Coleman Brief, Exhibit A.
We have reviewed the record, which is replete with articles, product labeling information, physician resources, and excerpts from expert testimony proffered by Appellees and plaintiffs in other litigation involving HRT medications. The patient package inserts either do not mention or largely dismiss a connection between breast cancer and HRT medications. The physicians' product labeling information during the relevant time period offered no conclusive connection or specifically down-played a causal link. Articles in popular magazines alluded to a possible correlation but acknowledged that no reliable studies confirmed one. Wyeth's expert in another HRT case, Nelson v. Wyeth et at, 2007 Phila.Ct.Com.Pl. LEXIS 316 (2007), Raquel D. Arias, M.D., opined that when she reviewed the literature in its totality, it showed "no cause association" between hormone therapy and breast cancer. Coleman's Brief in Opposition to Summary Judgment, Exhibit P. The record herein contains numerous excerpts, submitted by Appellants, from Appellees' expert reports in other cases, such as the report of Gretchen M. Ahrendt, M.D., FAC.S., to the effect that "HT is not a cause of breast cancer," (Manalo Brief in Opposition to Wyeth's Motion for Summary Judgment, Exhibit 6 at 2) and the fact that "a breast cancer is ER+ and PR+ does not mean that HT has any effect on that cancer." Id. at 4.
After reviewing the record in Coleman in light of the above facts, we conclude that there are genuine issues of material fact for the jury. Ms. Coleman's diagnosis of breast cancer did not automatically place her on notice that her injury was caused by a third party. In fact, one could reasonably conclude, based upon the record before us, that diagnosis would not likely trigger inquiry into a third-party cause of her injury. There are factual inconsistencies as to what Ms. Coleman was told and by whom and what was generally known and understood about HRT and breast cancer. We hold that until these conflicts are resolved and inferences are drawn from relevant facts by the factfinder, the determination of what Ms. Coleman knew or should have known with reasonable diligence under the circumstances remains a matter of dispute as in Fine, supra. Those factual determinations and inferences drawn by the trial court were erroneously undertaken.
Viewed in the light most favorable to Ms. Coleman, the non-moving party, the facts of record reveal that she was prescribed Premarin and Provera from November 1991 through November 1998 by Dr. Haynes Jackson and his son, Dr. Haynes Jackson, Jr. Thereafter, in November of 1998, Dr. David Greathouse prescribed first a combipatch, a patch worn on the skin that released estrogen and progestin, and then Prempro. In April 2000, following a hysterectomy, Dr. Greathouse prescribed Premarin. Coleman Short Form Complaint ¶ 3. On or about October 20, 2000, Ms. Coleman was diagnosed with infiltrating ductal carcinoma in her right breast. Id. at ¶ 4. Ms. Coleman averred that she "first learned that her injuries described herein were related to the ingestion of an HT medication on or about July 9, 2002." Id. at ¶ 4(a).
Dr. Jackson, Jr. testified at his deposition that he would routinely discuss risks and benefits of HRT medications with his patients, but he had no recollection of such a discussion with Ms. Coleman. Deposition, Haynes Jackson, Jr. M.D., 11/18/05, Exhibit "B" at 58. The information Dr. Jackson typically shared at that time was "simply that it was an unresolved issue in dispute. There were some studies to suggest possible breast protection and some studies to suggest increased risk, and it was an unsettled issue." Id. at 33. When he ceased treating Ms. Coleman in 1998, it was Dr. Jackson's opinion that whether or not breast cancer was related to hormone therapy was still a matter in dispute. Id. at 57-58.
Dr. Greathouse testified that, "I would have, you know, discussed the possibility of DVT, stroke, and perhaps even made a mention of there being a possible concern of breast cancer." Deposition, David Greathouse, M.D. 11/09/05 at 110-111. He had no independent recollection of any conversation with Ms. Coleman regarding the risks of hormone therapy generally or breast cancer specifically. His records were devoid of any mention of such a discussion. Id. at 113. Dr. Greathouse added, "And if she [Ms. Coleman] were to say under oath that I never specifically discussed breast cancer risks with her with regard to Prempro, then all I would have to say to that is that's possible." Id. at 153. Dr. Greathouse denied that he became more focused on the link between hormone therapy and breast cancer after the WHI report was issued in 2002, insisting that it only provided "more clarity of what those risks are." Id. at 112. However, he later admitted that the WHI impacted the way he counseled patients prior to prescribing HRT medications; that post WHI he was conscious about using the lowest effective dose for the shortest duration. Id. at 129-132. While unsure if the study affected his prescribing practices, Dr. Greathouse acknowledged that after the revelations of the WHI, he recommended that his patients periodically cease such therapy due to his concern over the risks of long-term use. Id. at 133-136. He noted that his counseling at the time of the deposition in 2005 differed from his counseling in March 1999 because he knew something that he did not know then: that there is no cardio benefit from the medications and that there is an increased risk in combination usage. Id. at 137. Prior to the WHI study, it was common practice to prescribe HRT prophylactically for women entering menopause and today, as a rule, he would not do so. Id. at 141.
Ms. Coleman testified that neither Dr. Jackson, Jr. nor Dr. Greathouse ever advised her that HRT caused or increased the risk of breast cancer. Deposition, E. Coleman, 10/19/05, at 15. She deferred to the doctor who was knowledgeable of the risks as, "I'm not a pharmacist or a doctor so I have no way of knowing." Id. at 16. "He prescribed it so I took it." Id. Ms. Coleman stated that she scanned the product insert that came with the prescription looking for side effects, admitting that, "lots of it I do not understand." Id. at 18. She did not recall reading anything about cancer in the information provided by Appellees prior to 2000. Id. at 22. When Dr. Greathouse prescribed Prempro in March 1999, she scanned its information pack. Id. at 34. At the time of her deposition, Ms. Coleman had no recollection of what Dr. Greathouse told her about Prempro except that it was one pill. Id. at 35.
The physicians' knowledge and what they communicated to their patients, Appellants herein, is relevant at this juncture in determining whether Appellants knew or should have known of a causal connection between their ingestion of HRT medications and their breast cancer for purposes of application of the discovery rule. At trial, the physicians' understanding of the warnings provided by the manufacturers becomes the focus as the "learned intermediary" doctrine provides that the manufacturer of a prescription drug must direct warnings to the prescribing physician, not to the patient. Taurino v. Ellen, expansive meaning, that is, one or some indiscriminately of whatever kind" (internal quotation marks omitted)); Fleck v. KDI Sylvan Pools Inc., 981 F.2d 107, 115 (3d Cir. 1992) ("The word `any' is generally used in the sense of `all' or `every' and its meaning is most comprehensive." (internal quotation marks and citation omitted)).
Second, and critically, the Court noted that the FBSA contains a savings clause which states that "[c]ompliance with this chapter or standards, regulations, or orders prescribed under this chapter does not relieve a person from liability at common law or under State law." Sprietsma, 537 U.S. at 59, 123 S.Ct. 518 (citing 46 U.S.C. § 4311(g)). The Court reasoned that such a clause "`assumes that there are some significant number of commonlaw liability cases to save [and t]he language of the pre-emption provision permits a narrow reading that excludes common-law actions.'" Id. at 63, 123 S.Ct. 518 (quoting Geier v. Am. Honda Motor Co., 529 U.S. 861, 867-68, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000)). Indeed, in Geier, the Court also relied heavily on the presence of a savings clause to read common law claims out of a preemption provision superseding state "standard[s]." See 529 U.S. at 867-68, 120 S.Ct. 1913. Importantly, there is no parallel savings clause in the Act, nor any similar indication that Congress intended to save any common law claims.
Third, the Sprietsma Court reasoned that:
[B]ecause "a word is known by the company it keeps,"
Gustafson v. Alloyd Co., 513 U.S. 561, 575,
115 S.Ct. 1061,
131 L.Ed.2d 1 (1995), the terms "law" and "regulation" used together in the preemption clause indicate that Congress
pre-empted only positive enactments. If "law" were read broadly so as to include the common law, it
might also be interpreted to include regulations, which would render the express reference to "regulation" in the pre-emption clause superfluous.
Id. at 63, 123 S.Ct. 518 (emphasis added). While this observation provided additional justification for Sprietsma's narrow construction of the FBSA's preemption clause, we are not convinced that, on its own, this reasoning — using the word "might" — could justify completely excluding common law claims from the scope of the Act's preemption clause. "[O]ur hesitancy to construe statutes to render language superfluous does not require us to avoid surplusage at all costs." United States v. Atl. Research Corp., 551 U.S. 128, 137, 127 S.Ct. 2331, 168 L.Ed.2d 28 (2007). Moreover, given the tentative nature of Sprietsma's superfluity point — using the word "might" — as well as the key differences we have identified between the FBSA and the Act, we hold that Sprietsma does not control here. If Sprietsma does not control, we are still left to determine whether the Act's preemption clause encompasses common law claims. Having found no clear congressional intent on the face of the statute, we turn to the legislative history of the Act. Medtronic, 518 U.S. at 485-86, 116 S.Ct. 2240 (noting that, to divine Congressional intent as to the scope of a preemption clause, a court may look to the legislative history and purpose of the statute as a whole). The Part C preemption provision, upon which Part D's preemptive force relies, was created in 1997. See 42 U.S.C. § 1395w-26(b)(3) (1997). That provision was largely similar to the current preemption provision, and also used the phrase "any State law or regulation." Id. Pursuant to this former version of the statute, CMS promulgated the following interim final rule in 1998:
The Medicare Part C preemption provision created in 1997 read:
In general
The standards established under this subsection shall supersede any State law or regulation (including standards described in subparagraph (B)) with respect to Medicare + Choice plans which are offered by Medicare + Choice organizations under this part to the extent such law or regulation is inconsistent with such standards.
(B) Standards specifically superseded
State standards relating to the following are superseded under this paragraph:
(i) Benefit requirements.
(ii) Requirements relating to inclusion or treatment of providers.
(iii) Coverage determinations (including related appeals and grievance processes).
42 U.S.C. § 1395w-26(b)(3)(1997).
(a) General preemption. Except as provided in paragraph (b) of this section, the rules, contract requirements, and standards established under this part supersede any State laws, regulations, contract requirements, or other standards that would otherwise apply to M + C organizations and their M + C plans only to the extent that such State laws are inconsistent with the standards established under this part.
42 C.F.R. § 422.402(a) (1998). In CMS's request for comments on this interim final rule, the Secretary stated that neither the statute nor the regulation "preempt[ed] State remedies for issues other than coverage under the Medicare contract (i.e. tort claims or contract claims under State law are not preempted)." 63 Fed.Reg. 34968, 35013 (June 26, 1998). Subsequently, in promulgating the final version of the rule in 2000, the Secretary noted the following comment:
Comment: A commenter asked that we revisit our position that State tort or contract remedies may be available to
beneficiaries whose coverage determination dispute goes through the Medicare appeals process. This commenter believes that coverage determination cases are contract disputes, and therefore should be the sole province of the Medicare appeals process.
65 Fed.Reg. 40170, 40261 (June 29, 2000). In response, CMS retreated from its former position that "tort claims or contract claims under State law are not preempted":
Response: In some cases, a case that is cast as a State contract claim may amount to a claim that services are covered under an organization's M + C contract. We agree with the commenter that in that case, the claim would be preempted. However, there are other tort or State contract law, or consumer protection-based claims that would be entirely independent of the issue of whether services are required under M + C provisions.
Id. Obviously, CMS's revised interpretation of the preemption clause admits that some common law claims may be preempted. While we emphasize that the Secretary's interpretation of the statute does not speak to congressional intent, it is important in helping to divine Congress's subsequent intent when it amended the Part C preemption clause in December 2000 and again in 2003 when it passed the Medicare Modernization Act. Because, as early as June 2000, the Secretary had interpreted the phrase "any State law or regulation" to include some common law claims, we may reasonably presume that Congress was aware of that interpretation while crafting the two subsequent amendments to the Part C preemption provision. See Abebe v. Gonzales, 493 F.3d 1092, 1101 (9th Cir. 2007) ("Congress is presumed to be familiar with the background of existing law when it legislates. . . ."). In fact, it is well established that "`Congress is presumed to be aware of an administrative or judicial interpretation of a statute and to adopt that interpretation when it re-enacts a statute without change.'" Forest Grove Sch. Dist. v. T.A., ____ U.S. ___, 129 S.Ct. 2484, 2492, 174 L.Ed.2d 168 (2009) (quoting Lorillard v. Pons, 434 U.S. 575, 580, 98 S.Ct. 866, 55 L.Ed.2d 40 (1978)). Thus, as there were no contrary administrative interpretations and no federal court had yet confronted the issue, we also may presume that Congress adopted CMS's interpretation in leaving the statutory language unchanged. Thus, we conclude that Congress intended the Part C preemption provision — as incorporated into Part D — to preempt at least some common law claims.
Again, in enacting Title VI of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Pub.L. No. 106-554, 114 Stat. 2763, Congress amended subsection (B) of § 1395w-26(b)(3) by adding the following italicized words:
(B) Standards specifically superseded State standards relating to the following are superseded under this paragraph:
(i) Benefit requirements (
including cost-sharing requirements).
(ii) Requirements relating to inclusion or treatment of providers.
(iii) Coverage determinations (including related appeals and grievance processes).
(iv) Requirements relating to marketing materials and summaries and schedules of benefits regarding a Medicare + Choice plan.
CMS's interpretations of the Part D preemption provision, while requiring no deference, further bolster our conclusion. See Wyeth v. Levine, ____ U.S. ___, 129 S.Ct. 1187, 1201, 173 L.Ed.2d 51 (2009) ("While agencies have no special authority to pronounce on preemption absent delegation by Congress, they do have a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." (internal quotation marks and citations omitted)). In the proposed rulemaking pronouncements following the Act's enactment, CMS noted, "We continue to believe that generally applicable State tort, contract, or consumer protection law would not be preempted under [the Act]." 69 Fed.Reg. 46866, 46913 (Aug. 3, 2004). That position attracted a number of critical comments, and CMS responded by retreating from that position in the pronouncements on the final rule, declaring that "all State standards, including those established through case law, are preempted to the extent they specifically would regulate MA plans, with exceptions of State licensing and solvency laws." 70 Fed.Reg. at 4665 (emphasis added). In other words, CMS's latest position on the "any State law or regulation" language of the preemption clause is that it includes a subspecies of common law causes of action — here, those common law causes of action specifically applicable to Part D plans. Again, while CMS's position does not bind this court, we note that it accords with our reading of the Part D preemption provision.
For example, "[a] commenter expressed concern that while State contract and tort law principals [sic] may have general application, State standards developed through case law based on interpretations of State contract and tort law may be specific to health plans, and may apply State standards that would otherwise be preempted under Section 232(a) of the [Act]." 70 Fed.Reg. 4588, 4665 (Jan. 28, 2005).
In its amicus brief to this court, CMS took the position that, under Sprietsma, the Act's express preemption provision does not contemplate common law claims (although such claims can, argued CMS, be impliedly preempted). We accord that position no deference here. See United States v. Trident Sea-foods Corp., 60 F.3d 556, 559 (9th Cir. 1995) ("No deference is owed when an agency has not formulated an official interpretation of its regulation, but is merely advancing a litigation position.").
Having concluded that some common law claims fall within the ambit of the Act's preemption clause, the remaining question is whether the Uhms' fraud and fraud in the inducement claims do. The Uhms allege that Humana made misrepresentations "that were material to the subject transactions" and that Humana "knew of the false representations of fact and intentionally entered into contracts with Plaintiffs and Class members with knowledge of these misrepresentations." For substantially similar reasons as those discussed in reference to the Uhms' state consumer protection claims, these common law claims are preempted.
In the same way that an action brought under the auspices of a state consumer protection statute would be inconsistent with those standards established under the Act, so too could these tort actions pose such a problem. Indeed, the Supreme Court has indicated, and we agree, that both positive state enactments and liability under state common law may be inconsistent with standards imposed by federal statutes. See Geier, 529 U.S. at 868, 120 S.Ct. 1913 (considering whether "standards imposed in common-law tort actions, as well as standards contained in state legislation or regulations" might interfere with standards imposed by the National Traffic and Motor Vehicle Safety Act). Cf. Riegel, 552 U.S. at 323-24, 128 S.Ct. 999 ("In Lohr, five Justices concluded that common-law causes of action for negligence and strict liability do impose `requirement[s]' and would be preempted by federal requirements" under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (citing Lohr, 518 U.S. at 512, 116 S.Ct. 2240)).
Here, in order to determine whether Humana committed a fraud or fraud in the inducement, a court would necessarily need to determine whether the written and oral statements were misleading. See W. Coast, Inc. v. Snohomish Cnty., 112 Wash. App. 200, 48 P.3d 997, 1000 (2002) ("The nine elements of intentional misrepresentation, or fraud, are: (1) representation of an existing fact; (2) materiality; (3) falsity; (4) the speaker's knowledge of its falsity; (5) intent of the speaker that it should be acted upon by the plaintiff; (6) plaintiffs ignorance of its falsity; (7) plaintiffs reliance on the truth of the representation; (8) plaintiffs right to rely upon the representation; and (9) damages suffered by the plaintiff."); Pedersen v. Bibioff, 64 Wash. App. 710, 828 P.2d 1113, 1120 (1992) ("Fraud in the inducement . . . is fraud which induces the transaction by misrepresentation. . . ."). Were a state court to determine that Humana's marketing materials constituted misrepresentations resulting in fraud or fraud in the inducement, it would directly undermine CMS's prior determination that those materials were not misleading and in turn undermine CMS's ability to create its own standards for what constitutes "misleading" information about Medicare Part D. Thus, the Uhms' fraud and fraud in the inducement claims must be preempted. (4) Preemption of Claims Against Humana, Inc.
We emphasize that this holding does not mean that all common law fraud and fraud in the inducement claims would be preempted under the Act. The preemption inquiry turns on the specific allegations forming the basis of those claims, not their labels.
The Uhms argued in their motion for reconsideration that regardless of whether the Act preempts their claims against Humana Health Plan, Inc., their claims against Humana, Inc., are not preempted because Humana, Inc., is not a CMS-approved PDP sponsor, and the Act's preemption provision applies only to PDP sponsors. Humana, Inc., argues that preemption under the statute is determined by whether federal standards exist with respect to the prescription drug plan, not by the identity of the defendant. We assess this argument with respect to the claims against Humana Health Plan, Inc., that we have found preempted — the fraud and consumer protection claims — and conclude that the Uhms' claims against Humana, Inc., are also preempted.
To recall, the Act's preemption provision provides:
The standards established under this part shall supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to [PDPs] which are offered by [Part D sponsors] under this part.
42 U.S.C. § 1395w-26(b)(3); see also 42 C.F.R. § 423.440(a) (2005). See 42 U.S.C. § 1395w-l 12(g) (providing that "[t]he provisions of sections 1395w-24(g) and 1395w-26(b)(3) of this title shall apply with respect to PDP sponsors and prescription drug plans under this part in the same manner as such sections apply to MA organizations and MA plans under part C of this subchapter").
Section 1395w-26(b)(3) provides that standards preempt state laws with respect to PDPs; the language about PDP sponsors modifies or describes what a PDP is — it does not shift the locus of preemption from the prescription drug plan to the sponsor. Here, the fraud and consumer protection claims against Humana, Inc., are entirely derivative of its relationship with Humana Health Plan, Inc. The Uhms allege that Humana, Inc., participated alongside its subsidiary Humana Health Plan, Inc., in marketing the PDP. As we discussed above, the conduct underlying these allegations is directly governed by federal standards. Therefore the Uhms' state law claims, with respect to the PDP, are preempted. This case does not require us to consider whether allegations related to a third party's involvement with a PDP that differ from those alleged here might be preempted under the Act.
III. CONCLUSION
Because the Uhms' state consumer protection claims and fraud claims fall within the ambit of the federal standards provided for in the Act and its implementing regulations, those claims are preempted. Because the breach of contract and unjust enrichment claims fall squarely within the Act's exhaustion provision, the district court lacked jurisdiction over those claims. Accordingly, the judgment of the district court is AFFIRMED.