August 2010
Authors:
Nicholas P. Vari nick.vari@klgates.com
+1.412.355.8365
Robert M. Seibel robert.seibel@klgates.com
+1.412.355.8259
Contacts:
Charles F. Rysavy charles.rysavy@klgates.com
+1.973.848.4053
Christopher R. Carton christopher.carton@klgates.com
+1.973.848.4052
K&L Gates includes lawyers practicing out of 36 offices located in North America,
Europe, Asia and the Middle East, and represents numerous GLOBAL 500,
FORTUNE 100, and FTSE 100 corporations, in addition to growth and middle market companies, entrepreneurs, capital market participants and public sector entities. For more information, visit www.klgates.com.
Last week, the Pennsylvania Superior Court maintained Pennsylvania’s traditional adherence to the strict liability doctrines set forth in Section 402A of the Restatement
(Second) of Torts, thereby preserving protections traditionally afforded to pharmaceutical product manufacturers facing strict liability claims under
Pennsylvania law. At the same time, however, the court opened the door for a new category of pharmaceutical product liability claims by drawing a distinction between strict liability design defect
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claims under Section 402A of the Restatement (Second) of Torts—which are not actionable against pharmaceutical manufacturers under
Pennsylvania law—and negligent design defect claims under Section 395 of the
Restatement (Second) of Torts, which are.
In Lance v. Wyeth
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, plaintiff Patsy Lance, an Ohio resident, filed suit in a
Pennsylvania state court against drug manufacturer Wyeth after her daughter,
Catherine Ruth Lance, developed hypertension and died in 2004, allegedly as a result of taking the diet drug Redux.
3
Ms. Lance alleged that Wyeth improperly marketed
Redux, improperly tested it, and failed to withdraw it from the market after becoming aware of its allegedly dangerous propensities.
4
Plaintiff’s claims were based upon theories of negligence, strict liability under Section 402A of the
Restatement (Second) of Torts, and strict liability under Section 6 of the Restatement
(Third) of Torts: Products Liability.
Based upon a procedural nuance, without filing an answer to plaintiff’s complaint,
Wyeth moved for summary judgment, arguing essentially that plaintiff did not plead a cognizable personal injury claim, because, under Pennsylvania law, a plaintiff can sustain a product liability claim against a prescription drug manufacturer only by proving that (1) the drug was manufactured improperly or (2) the manufacturer was negligent in providing an improper warning.
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The trial court agreed with Wyeth, and granted summary judgment in its favor, because plaintiff’s product liability claims were based solely upon a design defect theory.
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Pennsylvania law, as embodied in Section 402A, recognizes three types of strict product liability claims: (1) manufacturing defects (where the product was rendered unreasonably dangerous, because it was not manufactured in accordance with its design), (2) design defects (where the product is unreasonably dangerous by design), and (3) warning defects (where a product is rendered unreasonably dangerous, because it lacked a warning that was necessary for its safe use). Here, plaintiff proceeded solely on a design defect theory.
2
3
- - A.2d - -, 2010 WL 2991597, (Pa. Super.), 2010 Pa. Super. 137 (August 2, 2010).
4
2010 UL 2991597 at *1, Slip Op. at p. 2.
5
2010 WL 2991597 at **1-2, Slip Op. at pp. 1-3.
2010 WL 2991597 at **2-3, n. 1; Slip Op. at pp. 4-6.

On appeal, the Superior Court agreed with Wyeth that, in accordance with the Pennsylvania Supreme
Court’s holding in Hahn v. Richter , 673 A.2d 888
(Pa. 1996), and Pennsylvania’s longstanding recognition of Comment k to Section 402A of the
Restatement (Second) of Torts, properly manufactured prescription drugs cannot be deemed defective and unreasonably dangerous under
Pennsylvania law when marketed with appropriate warnings.
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The Superior Court, thus, confirmed that plaintiff could not bring a strict liability design defect claim against Wyeth under Pennsylvania law.
Even though she could not assert a strict liability claim under the facts alleged, however, the Superior
Court concluded that plaintiff did plead a cognizable negligent design defect claim against Wyeth.
7
Relying on the Idaho Supreme Court case of Toner v. Lederle Labs , 732 P.2d 297 (Idaho 1987), and the
California Court of Appeals case of Artiglio v.
Superior Court , 22 Cal. App. 4 th
1388 (Cal. Ct. App.
4 th
Dist. 1994), and citing to the Pennsylvania
Supreme Court’s decision in Phillips v. Cricket
Lighters , 841 A.2d 1000, 1008 (Pa. 2003), the
Superior Court drew a distinction between negligent design defect claims (which focus upon the defendant’s conduct) and strict liability design defect claims (which focus solely upon the condition of the product at the time of sale). In so doing, the court held that Comment k’s reach is limited to strict liability claims; it does not apply to negligence claims.
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As such, the court found that plaintiff had stated a colorable claim for negligent design of a pharmaceutical drug under Section 395 of the
Restatement (Second) of Torts, which does not carve out any exception for pharmaceutical product manufacturers.
The court rejected plaintiff’s remaining arguments, holding that (1) pharmaceutical companies do not have a common law duty to recall a drug, (2)
Pennsylvania law has not recognized an independent cause of action for negligent failure to test a pharmaceutical drug, and (3) Section 6(c) of the
Restatement (Third) of Torts: Products Liability— which permits strict liability design defect claims in limited instances where a reasonable health care provider would not have prescribed the drug to any category of patient—does not create a new cause of action, because Pennsylvania courts have not adopted the Restatement (Third).
As the record stands currently, the Lance opinion may be somewhat theoretical, in that Wyeth has not provided a factual record to support its defenses on the merits to plaintiff’s negligence claim.
Accordingly, when the negligent design defect theory is tested against the contours of all relevant facts, this theory may turn out to be far less expansive than it may appear presently.
Nevertheless, standing alone, Lance is significant in that it illustrates Pennsylvania’s continuing and somewhat rigid adherence to the doctrine of strict liability as set forth in Section 402A of the
Restatement (Second) of Torts, and Pennsylvania’s ongoing rejection of the Restatement (Third) of
Torts: Products Liability. Thus, in its broader sense,
Lance preserves tradition, while providing a new invitation to Pennsylvania’s Supreme Court to revisit the product liability principles contained in the Restatement (Third), which is an issue that the
Court came very close to addressing in 2009. See
Bugosh v. Allen Refractories Co.
, 932 A.2d 901 (Pa.
Super. 2007) appeal dismissed as being improvidently granted in 971 A.2d 1228 (Pa. 2009)
(declining to adopt a portion of the Restatement
(Third) of Torts: Products Liability).
6
2010 WL 2991597 at **3-4, Slip Op. at pp. 7-9. In so holding, the court recognized that this conclusion represents a minority view among the states. 2010 WL2991597 at *4, n.2,
Slip Op. at p. 9, n.2. See also, e.g., Freeman v. Hoffman-La
Roche, Inc.
, 618 N.W.2d 827, 836 (Neb. 2000).
7
2010 WL 2991597 at *5, Slip Op. at pp. 9-10.
8
2010 WL 2991597 at **5-6, Slip Op. at pp. 10-12.
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