Polt v. Sandoz, Inc.

Decision Date26 May 2020
Docket NumberCIVIL ACTION NO. 16-2362
Citation462 F.Supp.3d 557
Parties Caroline POLT and Monica Polt, individually and as co-executors of the estate of Joanne Polt, deceased, Plaintiffs, v. SANDOZ, INC., Defendant.
CourtU.S. District Court — Eastern District of Pennsylvania

Anthony S. Pinnie, Kenneth R. Schuster and Associates, Media, PA, Edward Kirksey Wood, Jr., Wood Law Firm LLC, Birmingham, AL, Justin L. Williams, Nathaniel Joseph Clark, Patrick Ryan Williams, Williams Attorneys PLLC, Jack Edward Urquhart, The Snapka Law Firm, Corpus Christi, TX, Jay C. English, English Law Group PLLC, Dallas, TX, for Plaintiffs.

Christiana Jacxsens, Sara K. Thompson, Irvin Hernandez, Lori G. Cohen, Greenberg Traurig, LLP, Atlanta, GA, Elizabeth Ross Hadley, Greenberg Traurig LLP, Austin, TX, Gregory E. Ostfeld, Greenberg Traurig LLP, Chicago, IL, Gregory T. Sturges, Michael D. Lipuma, Greenberg Traurig LLP, Philadelphia, PA, Stephen Todd Fowler, Greenberg Traurig LLP, Washington, DC, for Defendant.


Eduardo C. Robreno, J.

Table of Contents


A. Sandoz's Motion for Summary Judgment ...563
1. Preemption...564
2. State Law Duty...565
i. Pennsylvania's Policy Against Expanding Tort Liability ...566
ii. The FDA Regulations Exception...567
iii. Negligence Per Se...569
3. Breach of Duty...571
B. The Polts' Cross-Motions for Partial Summary Judgment ...571



Caroline and Monica Polt, individually and as co-executrixes of the estate of Joanne Polt, (hereinafter "the Polts") bring this action against Sandoz, Inc., (hereinafter "Sandoz") claiming that its failure to directly warn their mother Joanne Polt about the risks associated with taking the drug it manufactured caused her death. The Polts claim that, under Pennsylvania law, Sandoz owed a duty to Joanne Polt to deliver to her a medication guide accompanying the drug, in accordance with FDA regulations. Sandoz responds that a claim for failure to warn a consumer directly is preempted by federal law. The issue is whether Pennsylvania recognizes an independent cause of action for failure to warn a consumer directly of the risks associated with the medically prescribed drug. If, indeed, there is this duty to warn under Pennsylvania law, the claim is not preempted. If there is no such duty, then the claim is preempted.

The Court concludes that the Polts' claim is preempted. Under the learned intermediary doctrine, a drug manufacturer has no duty to warn the consumer directly about the risks associated with its drug when it had warned the consumer's physicians. In this case, Sandoz warned Joanne Polt's physicians. And neither an exception to nor an abandonment of the learned intermediary doctrine, which has been strictly and consistently applied in Pennsylvania for fifty years, is appropriate in this case.


The Polts' mother, decedent Joanne Polt, died from pulmonary fibrosis. She had taken Sandoz's drug, amiodarone, over a five-year period. The FDA approved amiodarone as a drug of last resort to treat life-threatening ventricular fibrillation and ventricular tachycardia. But physicians sometimes prescribed it "off-label"1 to treat non-life-threatening atrial fibrillation. In Joanne Polt's case, she was prescribed the drug for atrial fibrillation, an off-label use. After five years of amiodarone use, she was diagnosed with pulmonary fibrosis. Pulmonary fibrosis is a disease associated with pulmonary toxicity, a known adverse side effect of amiodarone. Joanne Polt died shortly after this diagnosis.

Sandoz is a generic manufacturer of amiodarone and provides to physicians the same warning label as is provided by the brand-name manufacturer of amiodarone. As a generic manufacturer, under FDA regulations, Sandoz has a duty of sameness, which means that its warning label for amiodarone must be the same as the brand-name manufacturer's warning label. Sandoz complied with this duty. And this amiodarone warning label includes a warning of the risk of pulmonary toxicity.

Sandoz is also required by FDA regulations to warn consumers directly. In addition to the warning label given to physicians, it must provide pharmacies with "medication guides"2 to give directly to consumers. The Polts contend that Sandoz did not comply with these FDA medication guide regulations.

The Polts also contend that Sandoz failed to provide a warning to Joanne Polt's physicians. At least three different physicians provided care to Joanne Polt, but the Polts only point to the testimony of Dr. Cox, her cardiologist, as creating a dispute of fact on this issue. Dr. Cox testified that he was aware that amiodarone could lead to pulmonary toxicity. But he was not aware that amiodarone was a drug of last resort. And he was not aware that it was only approved by the FDA to treat ventricular tachycardia and ventricular fibrillation. Dr. Cox was also not aware that a medication guide was required for amiodarone, and he testified that a medication guide provided to Joanne Polt, but not to him, would have assisted him in conveying information about the drug.

The Polts brought this action for wrongful death, alleging negligent failure to warn, negligence per se, and negligent marketing. Sandoz moved to dismiss all counts on preemption grounds, and this Court granted the motion as to the negligent marketing count, but denied the motion as to the negligent failure to warn and negligence per se counts. This Court reasoned that the Polts might be able to defeat preemption if they could show that the negligent failure to warn and negligence per se claims are based on state tort law imposing a duty on the manufacturer to warn consumers directly, but could not show that the negligent marketing claim was based on anything other than the federal regulations. Following extensive discovery, the parties now bring motions for summary judgment, mainly contesting whether the negligent failure to warn and negligence per se claims are based on state tort law independent of federal law. The parties do not dispute that Pennsylvania substantive law applies.

Sandoz and the Polts also submitted motions in limine seeking to exclude expert testimony, but the Court need not rule on these motions because, in accordance with the suggestion of the parties, it is not necessary to do so to resolve the motions for summary judgment. Thus, only Sandoz's motion for summary judgment and the Polts' two cross-motions for partial summary judgment are discussed below.


Summary judgment is appropriate if there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). "A motion for summary judgment will not be defeated by ‘the mere existence’ of some disputed facts, but will be denied when there is a genuine issue of material fact." Am. Eagle Outfitters v. Lyle & Scott Ltd., 584 F.3d 575, 581 (3d Cir. 2009) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). A fact is "material" if proof of its existence or nonexistence might affect the outcome of the litigation, and a dispute is "genuine" if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson, 477 U.S. at 248, 106 S.Ct. 2505.

The Court views the facts in the light most favorable to the nonmoving party. "After making all reasonable inferences in the nonmoving party's favor, there is a genuine issue of material fact if a reasonable jury could find for the nonmoving party." Pignataro v. Port Auth. of N.Y. & N.J., 593 F.3d 265, 268 (3d Cir. 2010). While the moving party bears the initial burden of showing the absence of a genuine issue of material fact, meeting this obligation shifts the burden to the nonmoving party, who must "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 250, 106 S.Ct. 2505 (quoting Fed. R. Civ. P. 56).

The standard for summary judgment is identical when addressing cross-motions for summary judgment. Lawrence v. City of Philadelphia, 527 F.3d 299, 310 (3d Cir. 2008). When confronted with cross-motions for summary judgment, "[t]he court must rule on each party's motion on an individual and separate basis, determining, for each side, whether a judgment may be entered in accordance with the Rule 56 standard." Schlegel v. Life Ins. Co. of N. Am., 269 F. Supp. 2d 612, 615 n.1 (E.D. Pa. 2003) (quoting 10A Charles A. Wright, Arthur R. Miller & Mary Kay Kane, Federal Practice and Procedure § 2720 (3d ed. 1998) ).


The application of the learned intermediary doctrine resolves the core of all the summary judgment motions in favor of Sandoz. Under this doctrine, Sandoz's state law tort duty is to warn physicians, not the ultimate consumers. While the Polts argue for an exception to the learned intermediary doctrine, none is available under the facts of this case. And the Court will not ignore or abandon this doctrine, which is firmly established in Pennsylvania.

A. Sandoz's Motion for Summary Judgment

The Polts bring three claims, under failure to warn and negligence per se theories: (1) Sandoz failed to warn physicians at all, (2) Sandoz failed to adequately warn physicians, and (3) Sandoz failed to directly warn consumers in accordance with FDA medication guide regulations. The third claim is the true crux of the dispute, and the other two claims are peripheral contentions, argued half-heartedly and as alternatives.

And while their third claim merits a robust discussion of the issues involved, all three claims decidedly fail. As to the first, that Sandoz failed to warn physicians at all, although it is not preempted, it fails because there is no genuine dispute that the physicians were aware of the risk of pulmonary toxicity. As to the second, that Sandoz failed to adequately warn physicians, it is preempted because federal law requires...

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