Daniel v. Wyeth Pharmaceuticals Inc.

15 A.3d 909

2011 PA Super 23

Mary DANIEL and Thomas Daniel, Sr., Appellants

v.WYETH PHARMACEUTICALS, INC., Wyeth–Ayerst Pharmaceuticals, Inc., Wyeth–Ayerst International, Inc., Wyeth Laboratories, Inc., Wyeth Pharmaceuticals, Di

v. of Wyeth, Di

v. of American Home Products Corp., Wyeth, Inc. a/k/a American Home Products Corp., Appellees.Mary Daniel and Thomas Daniel, Sr., Appellees

v.Wyeth, Inc., Wyeth Pharmaceuticals, Inc., Wyeth–Ayerst Pharmaceuticals, Inc., Wyeth–Ayerst International, Inc., Wyeth Laboratories, Inc., and Wyeth Pharmaceuticals, Division of Wyeth, Appellants.

Superior Court of Pennsylvania.

Argued Dec. 1, 2009.Filed Feb. 7, 2011.Reargument Denied April 14, 2011.

Mark R. Cuker, Philadelphia, for Daniel, Mary and Thomas.Michael T. Scott, Philadelphia, for Wyeth, et al.BEFORE: DONOHUE, ALLEN and FITZGERALD ^*, JJ.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” ¹) as a hormone replacement drug until 1975, when studies revealed that the use of estrogen was causing endometrial and other below-the-waist cancers. In response, physicians began to prescribe a combination of Premarin and progestin (for endometrial protection).

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:

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 ^TM, 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 ... 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 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.² The FDA did not require, and Wyeth did not include, a prominent “black box” warning of any risks of contracting breast cancer associated with Prempro.³

A comprehensive study of the use of estrogen and progestin in post-menopausal women by the National Institutes of Health (“NIH”) was already underway when the FDA approved Prempro in 1994. Beginning in 1991, one of the areas of inquiry of the Women's Health Initiative (“WHI”) study was the risk of breast cancer from taking estrogen and progestin together. The NIH published the results in July 2002, which included a finding that there was a significant causal link between the combined use of estrogen and progestin and breast cancer. In fact, the NIH noted its study had to be terminated three years prior to its scheduled completion because of an unacceptably high incidence of invasive breast cancer among the participants in its study. In response, Wyeth changed the language on its product information and package inserts for Prempro to include a “black box” warning identifying invasive breast cancer as a risk associated with taking Prempro.

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:

The jury concluded that Wyeth negligently failed to provide proper warnings regarding the risks of breast cancer to [Daniel's] prescribing physician during the time that she took Prempro. The jury further concluded that Wyeth's negligence was a cause of her physician's decision to prescribe Prempro to her, and that Prempro was a factual cause of her injury, specifically breast cancer or its growth. Additionally, the jury found that Wyeth's conduct was sufficient to award punitive damages to [the Daniels].

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 court sealed the amount of punitive damages awarded.

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 ⁴ in April 2007 in which he had recanted his testimony in the case sub judice. The trial court,⁵ after considering Wyeth's supplemental motion, the Daniels' response thereto, and an affidavit from Dr. Layfield, ruled that Dr. Layfield had in fact recanted his testimony and that, if his recanted testimony had been presented to the jury in this case, the jury would likely have reached a different result. Trial Court Opinion, 8/24/08, at 14–18. Concluding that Dr. Layfield's affidavit denying recantation lacked credibility, by order dated August 14, 2007 the trial court granted Wyeth's supplemental motion and ordered a new trial.

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...