Cochran v. Wyeth Inc.

• Decision Date: 27 July 2010
• Citation: 3 A.3d 673
• Parties: Nancy COCHRAN, Appellant v. WYETH, INC., Appellee.
• Court: Pennsylvania Superior Court

3 A.3d 673

Nancy COCHRAN, Appellant
v.
WYETH, INC., Appellee.

Superior Court of Pennsylvania.

Argued June 22, 2010.
Filed July 27, 2010.

3 A.3d 674

Howard J. Bashman, Willow Grove, for appellant.

Michael T. Scott, Philadelphia, for appellee.

BEFORE: STEVENS, GANTMAN and ALLEN, JJ.

OPINION BY ALLEN, J.:

¶ 1 In this failure to warn case, we are asked to decide whether a plaintiff can prove proximate causation where a drug manufacturer's warning disclosed a risk of

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injury, the plaintiff sustained that very injury, but the manufacturer failed to disclose another risk of injury which the plaintiff did not sustain. We hold that in these circumstances, a plaintiff cannot prove proximate causation because the non-disclosed risk did not materialize in physical injury.

¶ 2 Nancy Cochran (“Appellant”) appeals from the trial court's order granting summary judgment in favor of Wyeth, Inc. (“Wyeth”). We affirm.

¶ 3 The facts relevant to our disposition are not in dispute and are as follows. From November 1996 to August 1997, Appellant ingested the prescription weight-loss drug dexfenfluramine, which was manufactured by Wyeth and sold under the brand name Redux. Dr. Stephen Anthay, M.D., was the physician who prescribed Redux to Appellant. Wyeth informed Dr. Anthay that Redux may cause primary pulmonary hypertension (“PPH”). Dr. Anthay warned Appellant of the risk of PPH prior to prescribing her Redux. At the time of his decision, however, Dr. Anthay was unaware of the risk that Redux may cause valvular heart disease (“VHD”). In April 2004, Appellant was diagnosed with PPH.

¶ 4 On August 3, 2004, Appellant filed a complaint against Wyeth, asserting that the warnings accompanying Redux were inadequate. Following discovery, on July 28, 2008, Wyeth filed a motion for summary judgment. In this motion, Wyeth claimed that its warnings were sufficient because they informed Dr. Anthay that PPH was a risk of ingesting Redux and Appellant was diagnosed with PPH.

¶ 5 In opposition, Appellant argued that Redux's warnings were faulty because they failed to warn of the danger of VHD. Appellant contended that as early as 1994, Wyeth had reason to suspect that Redux could cause VHD. According to Appellant, Wyeth misrepresented the amount of reports of VHD incidents to the FDA, and failed to alert the medical community of the risk of VHD. Appellant submitted that Dr. Anthay would not have prescribed Redux to her had he been warned that Redux could cause VHD.

¶ 6 In July 2007, the FDA requested Wyeth to issue “black box” warnings detailing the risk of VHD. In September 2007, Wyeth voluntarily withdrew Redux from the market.

¶ 7 On September 4, 2009, the trial court granted summary judgment in favor of Wyeth. The trial court concluded that Wyeth's warnings with regard to PPH were adequate on the basis that Wyeth informed Dr. Anthay that Redux may cause PPH. The trial court further concluded that because Appellant suffered from PPH and not VHD, she could not establish that Wyeth's failure to warn of the risk of VHD was the proximate cause of her particular injury. This appeal ensued.

¶ 8 Appellant raises the following issue for review:

Did the trial court err as a matter of law in granting summary judgment in Wyeth's favor on the issue of proximate causation, where a reasonable jury could easily find based on the evidence of record that [Appellant] would not have sustained serious injuries as a result of ingesting Wyeth's medication had Wyeth provided adequate warnings to [Appellant's] prescribing physician of the actual risks inherent in ingesting that product?

Brief for Appellant at 3.

¶ 9 We review a grant of summary judgment under the following well-settled standards:

Pennsylvania law provides that summary judgment may be granted only in

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those cases in which the record clearly shows that no genuine issues of material fact exist and that the moving party is entitled to judgment as a matter of law. The moving party has the burden of proving that no genuine issues of material fact exist. In determining whether to grant summary judgment, the trial court must view the record in the light most favorable to the non-moving party and must resolve all doubts as to the existence of a genuine issue of material fact against the moving party. Thus, summary judgment is proper only when the uncontraverted allegations in the pleadings, depositions, answers to interrogatories, admissions of record, and submitted affidavits demonstrate that no genuine issue of material fact exists, and that the moving party is entitled to judgment as a matter of law. In sum, only when the facts are so clear that reasonable minds cannot differ, may a trial court properly enter summary judgment.

Wright v. Allied Signal, Inc., 963 A.2d 511, 514 (Pa.Super.2008) (citation omitted).

¶ 10 In support of her sole issue, Appellant maintains that had Dr. Anthay been informed of the risk of VHD, he would not have prescribed her Redux. Appellant reasons that if Dr. Anthay had not prescribed her Redux, she would not have ingested the drug and never would have been diagnosed with PPH. Based on this logic, Appellant proposes that Wyeth's failure to warn of the risk of VHD was the proximate cause of her injury.

¶ 11 Countering, Wyeth asserts that its warnings informed Dr. Anthay that Redux may result in PPH and that Appellant assumed the risk that she may develop PPH. Wyeth argues that even if its warnings with regard to VHD were inadequate, its failure to warn of VHD was not the proximate cause of Appellant's PPH. Wyeth submits that to establish proximate causation, Appellant must prove that its warnings failed to disclose the risk of her particular injury-PPH.

¶ 12 Upon review, we agree with Wyeth.

¶ 13 In cases involving the failure to warn of risks associated with prescription drugs, Pennsylvania applies the learned intermediary doctrine. Simon v. Wyeth Pharms., Inc., 989 A.2d 356, 368 (Pa.Super.2009). Under the learned intermediary doctrine, a manufacturer will be held liable only where it fails to exercise reasonable care to inform a physician of the facts which make the drug likely to be dangerous. Taurino v. Ellen, 397 Pa.Super. 50, 579 A.2d 925, 927 (1990). The manufacturer has the duty to disclose risks to the physician, as opposed to the patient, “because it is the duty of the prescribing physician to be fully aware of (1) the characteristics of the drug he is prescribing, (2) the amount of the drug which can be safely administered, and (3) the different medications the patient is taking.” Id. “It is also the duty of the prescribing physician to advise the patient of any dangers or side effects associated with the use of the drug as well as how and when to take the drug.” Id.

¶ 14 Proximate cause is an essential element in a failure to warn case. Simon, 989 A.2d at 368. A proximate, or legal cause, is defined as a substantial contributing factor in bringing about the harm in question. Whitner v. Von Hintz, 437 Pa. 448, 263 A.2d 889, 893-94 (1970). Assuming that a plaintiff has established both duty and a failure to warn, a plaintiff “must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.”

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Demmler v. SmithKline Beecham Corp., 448 Pa.Super. 425, 671 A.2d 1151, 1155 (1996) (citation omitted). “To create a jury question, the evidence introduced must be of sufficient weight to establish ... some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug.” Id.

¶ 15 Here, in his deposition testimony, Dr. Anthay stated that he would not have prescribed Redux to Appellant had he known of the risk of VHD that the FDA required Wyeth to disclose on a black box warning. R.R. at 589-93. Appellant submits that under Demmler, Dr. Anthay's testimony, standing alone, was sufficient to establish that Wyeth's failure to disclose the risk of VHD proximately caused her PPH. To resolve this matter, we must decide whether the Demmler standard applies to Appellant, vis-à-vis a plaintiff's burden of establishing proximate causation in a failure to warn case. We gauge the Demmler standard in light of the circumstances before us, namely where the manufacturer disclosed a risk of injury, the plaintiff sustained that very injury, but the manufacturer failed to disclose another risk which, if revealed, would have resulted in the physician deciding not to prescribe the drug. Since this issue is unique to Pennsylvania, we turn to the case law from foreign jurisdictions for guidance.

¶ 16 To support her position, Appellants cites Cipollone v. Liggett Group, 1987 WL 14666, 1987 U.S. Dist. Lexis 9936 (D.N.J.1987), aff'd in part and rev'd in part on other grounds in 893 F.2d 541 (3d Cir.1990), later aff'd in part and rev'd in part on other grounds in 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992); Sanderson v. Upjohn Co., 578 F.Supp. 338 (D.Mass.1984); and Dartez v. Fibreboard Corp., 765 F.2d 456, 468 (5th Cir.1985). These cases, however, are distinguishable and/or unpersuasive.

¶ 17 For instance, in Sanderson, the court addressed the adequacy of the drug manufacturer's warning, assessing the duty and breach elements of a failure to warn case. The Sanderson court...