Dopson-Troutt v. Novartis Pharmaceuticals Corp.

975 F. Supp. 2d 1209, 2013 WL 5330463, 2013 U.S. Dist. LEXIS 135834
District Court, M.D. Florida·Decided September 23, 2013·No. Case No. 8:06-CV-1708-T-24-EAJ·Published·Cited by 1 cases

Opinion

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 LI-MINE

A. 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 [1212]*1212supplied, 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 plaintiffs injury — ie., that a proper and adequate warning would have changed the prescribing behavior of the plaintiffs 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 eases have applied the heed[1213]*1213ing presumption. 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.

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Dopson-Troutt v. Novartis Pharmaceuticals Corp., 975 F. Supp. 2d 1209, 2013 WL 5330463, 2013 U.S. Dist. LEXIS 135834 (M.D. Fla. 2013).

975 F. Supp. 2d 1209 (Dopson-Troutt v. Novartis Pharmaceuticals Corp.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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