Dopson-Troutt v. Novartis Pharms. Corp.

• Decision Date: 23 September 2013
• Docket Number: Case No. 8:06–CV–1708–T–24–EAJ.
• Citation: 975 F.Supp.2d 1209
• Parties: Ruth DOPSON–TROUTT and Frank Troutt, Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.
• Court: U.S. District Court — Middle District of Florida

975 F.Supp.2d 1209

Ruth DOPSON–TROUTT and Frank Troutt, Plaintiffs,

v.NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.

Case No. 8:06–CV–1708–T–24–EAJ.

United States District Court,

M.D. Florida,

Tampa Division.

Sept. 23, 2013.

John Albert Girardi, Girardi & Keese, Los Angeles, CA, John J. Vecchione, Valad & Vecchione, PLLC, Fairfax, VA, Ramon A. Rasco, Steven C. Marks, Podhurst Orseck, PA, Miami, FL, for Plaintiffs.

Katharine R. Latimer, Kirby T. Griffis, Matthew J. Malinowski, Rebecca Anne Womeldorf, Hollingsworth, LLP, Washington, DC, Michael J. Thomas, Pennington, Moore, Wilkinson, Bell & Dunbar, PA, Tallahassee, FL, Susan Kay Spurgeon, Pennington, Moore, Wilkinson, Bell & Dunbar, PA, Tampa, FL, for Defendant.

ORDER

SUSAN C. BUCKLEW, District Judge.

This cause comes before the Court on Defendant Novartis Pharmaceuticals Corporation's Omnibus Motion in Limine. [Doc. 143]. Plaintiffs Ruth Dopson–Troutt and Frank Troutt filed a response in opposition. [Doc. 151]. A hearing on the motion was held after the pretrial conference on September 12, 2013.

I. BACKGROUND FACTS

Plaintiff Ruth Dopson–Troutt was diagnosed with breast cancer, which later metastasized to her hip and pelvic bones. Dr. Arthur Feldman, her oncologist, prescribed Aredia and Zometa, which are bisphosphonate drugs that are produced, sold, and marketed by Defendant Novartis Pharmaceuticals Corporation (“NPC”). From 1999 to 2005, Dopson–Troutt was infused with Aredia and then Zometa, with her last Zometa infusion occurring on May 12, 2005. Dopson–Troutt had her tooth extracted, after which she began experiencing jaw pain caused by osteonecrosis of the jaw (“ONJ”).

In 2006, Dopson–Troutt and her husband brought this action against NPC, alleging that its manufacturing, labeling, marketing, selling, advertising, and distributing of Aredia and Zometa caused their injuries and that NPC failed to, inter alia, adequately warn of the risk of ONJ. This action was transferred to a Multidistrict Litigation Court in the Middle District of Tennessee for consolidated pretrial proceedings with other actions brought against NPC.

In 2012, the case was remanded back to this Court. Jury trial is set to begin on October 21, 2013. Plaintiffs' remaining claims are: negligent failure to warn (count III), breach of express warranty (count IV), and loss of consortium (count VI). [Docs. 1, 138].

II. NPC'S OMNIBUS MOTION IN LIMINEA. EVIDENCE OF PROXIMATE CAUSE

NPC seeks to exclude evidence regarding the possible impact of a proper and adequate warning on a non-prescribing doctor— i.e., another doctor or a “reasonable doctor”—to show proximate cause, arguing that such evidence is irrelevant and inadmissible. Plaintiffs respond that proximate cause can be proven by evidence other than the prescribing doctor's testimony. Further, NPC raises a corollary issue—whether Pennsylvania applies a “heeding presumption” to pharmaceutical failure-to-warn liability cases. NPC argues that a heeding presumption does not apply; Plaintiffs argue that it does. The Court first briefly reviews Pennsylvania's proximate cause requirement in pharmaceutical drug failure-to-warn liability cases, before addressing the parties' heeding presumption and relevancy arguments.

1. Pennsylvania failure-to-warn and proximate cause

In Pennsylvania, a failure-to-warn claim in a pharmaceutical products liability case is governed by the negligence standard set forth in the Restatement (Second) of Torts § 388. See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 890–91 (1996) (citing Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 220 n. 8 (1971)); Lance v. Wyeth, 4 A.3d 160, 165 (Pa.Super.2010). A drug manufacturer is liable only if it failed to exercise reasonable care to inform those, for whose use the pharmaceutical is supplied, of the facts which make the product dangerous. See Lineberger v. Wyeth, 894 A.2d 141, 150 (Pa.Super.2006). The intended user is the prescribing physician—not the patient. Id.

A prescription drug manufacturer's duty to warn therefore runs to the prescribing physician. Id. at 149. The rationale for this rule, known as the learned intermediary doctrine, is that it is the prescribing physician's responsibility to use his or her “own medical judgment, taking into account the data supplied from the drug manufacturer, other medical literature, and any other source available, and weighing that knowledge against the personal medical history of the patient” when deciding whether to prescribe a drug. Id. at 150 (citation and quotation marks omitted). Thus, if a drug manufacturer adequately warned the prescribing physician, the manufacturer is not liable for failure to warn.

However, if the warning is inadequate, a plaintiff must then establish that the inadequate warning was a proximate cause of the plaintiff's injury— i.e., that a proper and adequate warning would have changed the prescribing behavior of the plaintiff's prescribing physician:

In the duty to warn context, assuming that plaintiffs have established both duty and a failure to warn, plaintiffs 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.

Demmler v. SmithKline Beecham Corp., 448 Pa.Super. 425, 671 A.2d 1151, 1155 (1996) (citations and quotations omitted) (“Absent proof that a more thorough or more explicit warning would have prevented Mrs. Demmler's use of Parnate, appellants cannot establish that SmithKline's alleged failure to warn was the proximate cause of Mrs. Demmler's injuries.”).

2. Heeding presumption

NPC argues that Pennsylvania does not apply a “heeding presumption”—a presumption that if an adequate warning had been provided, the user would have read and heeded the warning—to pharmaceutical failure-to-warn cases. If a heeding presumption were to apply, NPC would have the burden to rebut the presumption of proximate cause. Plaintiffs respond that the heeding presumption does apply.

NPC cites to a line of state trial court cases refusing to apply the heeding presumption to pharmaceutical failure-to-warn cases. See Gronniger v. American Home Products Corp., 2005 WL 3766685, at *5–6 (Pa.Com.Pl. Oct. 21, 2005); Leffler v. American Home Products Corp., 2005 WL 2999712, at *5 (Pa.Com.Pl. Oct. 20, 2005); Adams v. Wyeth, 2005 WL 1528656, at *5–6 (Pa.Com.Pl. June 13, 2005). In these cases, the trial court found that Pennsylvania courts only applied the heeding presumption to certain strict liability asbestos claims. See e.g., Gronniger, 2005 WL 3766685, at *5–6;Leffler, 2005 WL 2999712, at *5. The court also reasoned that applying the heeding presumption would conflict with Pennsylvania's framework for pharmaceutical failure-to-warn claims, where the manufacturer's liability is premised on a negligence theory and its duty to warn the learned intermediary.

Those state trial court cases were considered in Fecho v. Eli Lilly and Company, where a federal court sitting in diversity likewise held that Pennsylvania applies no heeding presumption to prescription drug failure-to-warn claims. 914 F.Supp.2d 130, 147 (D.Mass.2012). The Fecho court acknowledged that Pennsylvania asbestos cases have applied the heedingpresumption. However, unlike prescription drug cases, asbestos cases are governed by a strict liability standard and involve no learned intermediary exercising independent judgment; thus, the court found that the reasoning of asbestos cases does not apply to prescription drug cases. Id. at 145–47 (reasoning that Coward v. Owens–Corning Fiberglas Corporation, 729 A.2d 614 (Pa.Super.Ct.1999), and Pavlik v. Lane Ltd./Tobacco Exporters Int'l, 135 F.3d 876 (3rd Cir.1998), do not require applying the heeding presumption in prescription drug cases).

In response, Plaintiffs assert that state trial court cases lack precedential value. However, one of the state trial court cases, Lineberger v. Wyeth, was affirmed on appeal of the trial court's entry of summary judgment in Wyeth's favor on the issue of proximate cause. 2005 WL 1274458, at *4–5 (Pa.Com.Pl. May 23, 2005), aff'd894 A.2d 141 (Pa.Super.2006). Although the appellate court did not expressly hold that Pennsylvania does not apply the heeding presumption to prescription drug cases, it affirmed based on its finding that the record evidence did not create a genuine issue of material fact regarding whether a different warning would have changed the doctor's prescribing methods. Lineberger, 894 A.2d at 149–51.

Further, in arguing that a rebuttable heeding presumption applies in this case, Plaintiffs cite without argument to asbestos strict liability cases, including the very ones considered and rejected by Fecho and the state court trial cases cited by NPC. The Court rejects Plaintiffs' argument and agrees with the analysis set forth in Fecho and the state trial court cases.

Plaintiffs also cite to Wolfe v. McNeil–PPC, Inc., 773 F.Supp.2d 561 (E.D.Pa.2011), a failure-to-warn drug case. However, not only is Wolfe distinguishable from this case—it involved an over-the-counter, not a prescription, drug ¹—the court merely acknowledged that the “Pennsylvania Supreme Court has not ruled on whether a heeding presumption applies in a case such as this” and expressly declined to resolve the issue. Id. at 569.

Finally, Plaintiffs argue that Hahn v. Richter shows that the Pennsylvania Supreme Court has clearly applied the heeding presumption to prescription drug failure-to-warn cases. Plaintiffs' argument rests on select language quoted from the opinion—“where warning is given, the seller may reasonably assume that it will be read and heeded.” Hahn, 673 A.2d at 891. However, this sound bite does not show that the Pennsylvania Supreme Court applied the heeding presumption, or otherwise held that it applies to, pharmaceutical drug failure-to-warn cases. The issue in Hahn was not whether the heeding presumption applied; it was whether the trial...