Case Information
IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Caroline Polt and Monica Polt, : CIVIL ACTION individually and as co- : NO. 16-2362 executors of the estate of :
Joanne Polt, deceased, :
:
Plaintiffs, :
v. :
:
Sandoz, Inc., :
:
Defendant. :
M E M O R A N D U M
EDUARDO C. ROBRENO, J. May 26, 2020
Table of Contents
I. INTRODUCTION ............................................. 2 II. FACTUAL BACKGROUND ....................................... 3 III. LEGAL STANDARD ........................................... 6 IV. DISCUSSION ............................................... 7
A. Sandoz’s Motion for Summary Judgment ..................... 7 1. Preemption ............................................. 8 2. State Law Duty ........................................ 12 i. Pennsylvania’s Policy Against Expanding Tort Liability ... 14 ii. The FDA Regulations Exception .......................... 16 iii. Negligence Per Se ...................................... 20
3. Breach of Duty ........................................ 24 B. The Polts’ Cross-Motions for Partial Summary Judgment ... 24 V. CONCLUSION .............................................. 25
I. INTRODUCTION
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. II. FACTUAL BACKGROUND
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” 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” 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.
III. LEGAL STANDARD
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.,
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.,
Fed. R. Civ. P. 56).
The standard for summary judgment is identical when
addressing cross-motions for summary judgment. Lawrence v. City
of Philadelphia,
IV. DISCUSSION
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 Sandoz, as a generic manufacturer, to use the brand-name manufacturer’s warning label. As to the third, that Sandoz failed to warn consumers directly, it is preempted because it is not cognizable under state tort law in that Pennsylvania has adopted the learned intermediary doctrine, which applies without exception here.
1. Preemption Two of the Polts’ three claims are preempted. The claim
that Sandoz did not provide any warning to physicians is not preempted. But the claim that Sandoz did not provide an adequate warning to physicians and the claim that Sandoz did not provide a medication guide to consumers are barred by implied preemption.
Under the Supremacy Clause of Article VI of the United
States Constitution, federal law preempts state law in three
ways: express preemption, implied preemption, and field
preemption. Hillsborough Cty. v. Automated Med. Labs., Inc.,
Drug product liability claims are not preempted by express
or field preemption. There is no express preemption clause in
the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§
301 et seq., that applies to prescription drugs. Riegel v.
Medtronic, Inc.,
But the FDCA may preempt a drug product liability claim by
one of the two types of implied preemption: obstruction or
impossibility. Wyeth v. Levine,
The claim that Sandoz did not provide any warnings at all
to physicians is not preempted. This claim is not preempted
because there is no conflict between federal and state law in
that both require drug manufacturers to provide the warning
label to physicians. See Eckhardt v. Qualitest Pharm., Inc.,
But the claim that Sandoz provided an inadequate warning to
physicians is preempted by implied preemption through
impossibility. It is well-settled that a claim based on a
generic manufacturer’s inadequate warning label is preempted by
impossibility preemption because a generic manufacturer, under
the FDA’s sameness requirement, cannot unilaterally change a
drug’s warning label. PLIVA, Inc. v. Mensing,
(2011). [3] Here, the Polts’ claim that the warning label did not adequately warn physicians is preempted because it was impossible for Sandoz to both change the label to make it adequate under state law and comply with FDA regulations requiring the generic manufacturer’s label to be identical to the brand-name manufacturer’s label.
And finally, the claim that Sandoz did not provide warnings
directly to consumers—in the form of medication guides—is
preempted by implied preemption through obstruction. A state
law claim that is parallel to an FDA requirement obstructs
federal law if the claim is dependent on the federal
requirement, but it does not obstruct federal law if it is
independent of the federal requirement. See In re Orthopedic
Bone Screw Prods. Liab. Litig.,
Therefore, in this case, whether the Polts’ medication guide claim is preempted depends upon what duty to warn Pennsylvania law imposes on drug manufacturers. It is to that question that the Court now turns.
2. State Law Duty
In Pennsylvania, when the “drug was available only upon
prescription of a duly licensed physician, the warning required
is not to the general public or to the patient, but to the
prescribing doctor.” Incollingo v. Ewing,
Bolubasz,
374, 378 (Pa. Super. Ct. 1987)). And this “[learned
intermediary doctrine] is strictly applied by Pennsylvania
courts.” Colacicco v. Apotex, Inc.,
Other jurisdictions have adopted “limited exceptions to the
learned intermediary doctrine” for (1) vaccines, (2) oral
contraceptives, (3) contraceptive devices, (4) drugs marketed to
consumers directly, (5) drugs that are over-promoted, and (6)
drugs that are removed from the market. Vitanza v. Upjohn Co.,
The Polts do not contend that a recognized exception applies in this case. Instead, they ask the Court to craft a new exception, under Pennsylvania law, based on FDA regulations. The Court will reject this suggestion for three reasons: (1) it would break new ground and significantly expand liability under Pennsylvania law; (2) even if adopted, it would be inapplicable in this case; and (3) it would be a misuse of negligence per se, which does not operate to create a new duty.
i. Pennsylvania’s Policy Against Expanding Tort Liability
An expansion of tort liability in this case would break
with Pennsylvania’s stated policy. Where “there [is] no
reported decision by the Pennsylvania Supreme Court or any other
Pennsylvania court addressing the precise issue before [the
Court], it [is] the duty of the District Court to predict how
the Pennsylvania Supreme Court would [rule] if presented with
this case.” Nationwide Mut. Ins. Co. v. Buffetta,
1992) (quoting McKenna v. Ortho Pharmaceutical Corp., 622 F.2d
657, 663 (3d Cir. 1980)). And in making this prediction,
“[f]ederalism concerns require that [federal courts] permit
state courts to decide whether and to what extent they will
expand state common law.” City of Philadelphia v. Lead Indus.
Ass'n, Inc.,
Pennsylvania courts have generally “expressed reluctance to
judicially expand tort liability on public policy grounds as
such is properly the role of the legislature.” Excavation
Techs., Inc. v. Columbia Gas Co. of Pennsylvania,
Therefore, under the facts of this case, the Court will decline the invitation to alter Pennsylvania’s social policy calculus as it relates to the liability of manufacturers engaged in the sale of prescription drugs. The crafting of an exception to the learned intermediary doctrine, if one is to be crafted at all, is best left to the legislature and Pennsylvania courts. ii. The FDA Regulations Exception
Even if Pennsylvania were to adopt an FDA regulations exception, this exception, as it exists in all but one of the few jurisdictions that have adopted it, would not apply in this case. An FDA regulations exception would be an extension of the contraceptives exception. It would only be available where, in addition to regulations mandating direct-to-consumer warnings, it is foreseeable that a physician would not play the traditional learned intermediary role. This was not foreseeable here, so an FDA regulations exception would not apply in this case.
The ordinary FDA regulations exception requires some fact
that undermines the rationale behind the learned intermediary
protect it from excess lest it becomes unworkable and alas, we find it
replaced with something far less desirable.” (quoting City of Philadelphia v.
Lead Indus. Ass'n, Inc.,
FDA regulations mandating direct-to-consumer warnings are
not by themselves sufficient for the FDA regulations exception
[8]
For any exception, there must be some fact that undermines the
rationale of the doctrine for the exception to apply. See Incollingo v.
Ewing,
374, 379 (5th Cir. 1999). So, in practice, the FDA regulations exception requires more than FDA regulations; it requires that a learned intermediary foreseeably would not play the traditional role in prescribing the drug.
Assuming Pennsylvania would adopt the FDA regulations exception, [12] it would similarly only apply the exception where it was foreseeable that a learned intermediary would not weigh the risks and benefits before prescribing the drug. Two cases illustrate this point.
First, the Third Circuit held in Mazur v. Merck & Co. that
an exception to the learned intermediary doctrine would apply
where it was foreseeable that a physician would not weigh the
risks and benefits before prescribing the drug.
Second, the Pennsylvania Superior Court in Taurino v. Ellen
held that an exception to the doctrine did not apply where it
was not foreseeable that the drug would be dispensed without a
physician’s prescription.
This case is like Taurino, and it is unlike Mazur and the few cases finding a contraceptive exception. It was not foreseeable that the amiodarone would be administered without a learned intermediary weighing the risks and benefits. Indeed, there were at least three physicians that prescribed the drug to Joanne Polt after considering the risks and benefits of the drug. And the Polts point to nothing that made it foreseeable that the drug would be dispensed without a physician’s considered prescription. Thus, following the reasoning of Taurino, Mazur, and the contraceptive exception cases, an FDA regulations exception would not apply in this case.
iii. Negligence Per Se
The doctrine of negligence per se does not create new duties; rather, a claim alleging negligence per se must be based on a preexisting duty. And because the learned intermediary doctrine applies here and an exception does not, Sandoz had no duty to directly warn consumers. Thus, there is no preexisting duty on which to base a negligence per se medication guide claim.
It is true that, although the FDCA does not create a
private cause of action, a violation of the FDCA can form the
basis for a negligence per se claim. Cabiroy v. Scipione, 767
A.2d 1078, 1081 (Pa. Super. Ct. 2001). That being said, where
there is no preexisting tort duty, negligence per se does not
operate to impose a new duty. In re Orthopedic Bone Screw Prod.
Liab. Litig.,
Courts in Pennsylvania have only found a negligence per se
claim based on the FDCA where the learned intermediary doctrine
was not implicated. In Stanton v. Astra Pharm. Prods., Inc.,
the Third Circuit found a negligence per se claim where the drug
manufacturer failed to comply with adverse effects reports
regulations requiring reports to the FDA.
The Polts argue that their negligence per se claim is properly based on a general duty to warn. This argument fails because the learned intermediary doctrine specifically defines the drug manufacturers’ duty to warn more narrowly.
Pennsylvania courts have consistently held that the drug manufacturers’ duty is defined by the learned intermediary doctrine and that they have no duty to warn consumers directly. [17] Further, the policy behind the doctrine shows that it defines the drug manufacturers’ duty to warn such that a medication guide claim is not cognizable here. In adopting the doctrine, Pennsylvania has expressed the policy that the physician should be a gatekeeper: the physician, not the manufacturer, decides whether to prescribe drugs and explains the risks to consumers. [18] In other words, the Polts merely attempt to expand failure to warn liability and abrogate the learned intermediary doctrine under the guise of negligence per se. [19]
Therefore, there is no cognizable negligence per se claim for the failure of Sandoz to provide a medication guide to Joanne Polt.
3. Breach of Duty
Last, the only claim that is not preempted—i.e., the claim
that the physicians did not receive a warning at all—fails
because there is no genuine dispute that the physicians received
warnings that told them of the risks of amiodarone. The Polts
contend that there is a genuine dispute of fact as to whether
the physicians were warned because Dr. Cox claimed to not know
that amiodarone was a drug of last resort and that it was not
approved to treat non-life-threatening atrial fibrillation. But
the drug manufacturer must “inform a physician of the facts
which make the drug likely to be dangerous.” Cochran v. Wyeth,
Inc.,
B. The Polts’ Cross-Motions for Partial Summary Judgment The Polts’ cross-motions for partial summary judgment are denied for the same reason that Sandoz’s motion is granted: the drug manufacturers do not have a duty to warn consumers directly. The Polts’ cross-motion for partial summary judgment on the learned intermediary doctrine fails because neither an abandonment of nor an exception to the doctrine is appropriate here. The Polts’ cross-motion for partial summary judgment on the adequacy of the warning fails because it assumes that Sandoz has a duty to warn consumers directly, but this assumption is incorrect.
In sum, it is not for the Court to locate a new exception to the learned intermediary doctrine where the state courts have found none. And in any event, an exception based on the FDA’s medication guide regulations, even if the Pennsylvania Supreme Court were to adopt it, would not apply here because it was foreseeable that Joanne Polt would consume the drug following her physician’s considered prescription.
V. CONCLUSION
For the foregoing reasons, Sandoz’s Motion for Summary Judgment will be granted and the Polts’ Cross-Motions for Summary Judgment will be denied. An appropriate Order follows.
Notes
[1] Prescribing a medication for off-label use means to prescribe it to
treat an illness other than the illness it was approved to treat. See In re
Schering Plough Corp. Intron/Temodar Consumer Class Action,
[2] Medication guides are paper handouts that the FDA requires to accompany certain medications. See FDA, Medication Guides (Jan. 3, 2020), https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm (last visited May 21, 2020).
[3] See also In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No.
II),
[4] Compare Buckman Co. v. Plaintiffs' Legal Comm.,
[5] See Moore v. Zydus Pharm. (USA), Inc.,
[6] At most they argue that there is an analogy here to the direct-to- consumer advertising exception. But this argument fails because even if Pennsylvania were to adopt the direct-to-consumer advertising exception, the
[7] See Charles Shaid of Pennsylvania, Inc. v. George Hyman Const. Co., 947 F. Supp. 844, 855 (E.D. Pa. 1996) (“A sound and viable tort system—generally what we now have—is a valuable incident of our free society, but we must
[9] See Edwards v. Basel Pharm.,
[10] See also Odgers v. Ortho Pharm. Corp.,
[11] See In re Norplant Contraceptive Prod. Liab. Litig.,
[12] That is not to say Pennsylvania would adopt this exception—in fact, the
Superior Court might have already implicitly rejected this exception. See
Taurino v. Ellen,
[13] Other courts have rejected an FDA regulation exception based on the
medication guide requirement. See Small v. Amgen, Inc.,
[14] See Cuyler v. United States,
[15] See Lance v. Wyeth,
[16] The Superior Court also found negligence per se applied to a violation
of the FDCA in In re Reglan/Metoclopramide Litig., where the defendant failed
to update the label as required by the FDA.
[17] See Stange v. Janssen Pharm., Inc.,
[18] See Coyle,
[19] See Strayhorn v. Wyeth Pharm., Inc.,
[20] It is irrelevant that Dr. Cox did not testify that he unequivocally
understood the warning because the adequacy of the warning is not at issue
since a claim that the warning was inadequate is preempted. See PLIVA, Inc.
v. Mensing,
[21] To the extent the Polts seek to establish liability for the alleged inadequacy of the warning to physicians, this claim is preempted. And to the extent they argue that the physicians were not given the required warnings, this argument is refuted by the evidence: Dr. Cox’s testimony—which is the only testimony the Polts point to as creating a dispute of fact that warnings were given—shows that Dr. Cox received the warnings about the risks of amiodarone because he knew of the risk of pulmonary toxicity.