J-A21017-20

NON-PRECEDENTIAL DECISION - SEE SUPERIOR COURT I.O.P. 65.37

JANNINE ZITNEY AND STEVE ZITNEY 

Appellants

v.

WYETH LLC., WYETH 

PHARMACEUTICALS, INC.MORTON 

GROVE PHARMACEUTICALS, INC., 

TEVA PHARMACEUTICALS USA, INC., 

A.K.A IVAX PHARMACEUTICALS, 

PLIVA, INC., BARR 

PHARMACEUTICALS, LLC., A.K.A 

BARR PHARMACEUTICALS, INC FK., 

BARR LABORATORIES, INC., 

DURAMED PHARMACEUTICALS, INC., 

QUALITEST PHARMACEUTICALS, 

INC., VINTAGE PHARMACEUTICALS, 

LLC., GENERICS BIDO I., LLC, 

INDIVIDUAL, A.K.A QUALIITEST 

PHARMACEUTICALS., HARVARD 

DRUG GROUP, LLC, A.K.A MAJOR 

PHARMACEUTICALS, INC., 

PHARMACEUTICAL ASSOCIATES, 

INC., BEACH PRODUCTS, INC., 

UNITED RESEACH LABORATORIES, 

INC., MUTUAL PHARMACEUTICAL 

COMPANY, INC., SILARX 

PHARMACEUTICALS, INC., SANDOZ, 

INC., ANIP ACQUISITION COMPANY, 

A.K.A A&I PHARMACEUTICALS, A.K.A 

ANI PHARMACEUTICALS, A.K.A ANIP 

PHARMACEUTICALS, WATSON 

LABORATORIES, INC., ACTAVIS 

ELIZABETH LLC, INDIVIDUAL, A.K.A 

PUREPAC PHARMACEUTICALS DBA., 

APP PHARMACEUTICALS LLC., A.K.A 

ABRAXIS PHARMACEUTICALS DBA., 

AMNEAL PHARMACEUTICALS, LLC., 

BEDFORD LABORATORIES, HOSPIRA 

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 3369 EDA 2019
J-A21017-20

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INC., MCKESSON CORPORATION, 

INDIVIDUALLY, A.K.A NORTHSTAR 

RX, LLC DBA., NORTHSTAR RX LLC, 

RUGBY LABORATORIES, INC., 

NORBROOK INC. USA, SMITH & 

NEPHEW, INC., VISTAPHARM, INC., 

ROXANE LABORATORIES, INC., 

INDIV THE CORPORATION TRUST 

COMPANY, USL PHARMA, INC., PAR 

PHARMACEUTICAL INC., HALSEY 

DRUG, LLC INDIVIDUALLY, A.K.A 

HALSEY DRUG CO INC, DBA., 

SUPERPHARM, INC., PACO 

PHARMACEUTICAL SERVICES, INC., 

SCHERING CORPORATION, IVAX 

PHARMACEUTICALS, INC., GOLDLINE 

LABORATORIES INC., INDIVI, A.K.A 

IVAX PHARMACEUTICALS DBA., 

BRISTOL MYERS SQUIBB CO., A.K.A 

APOTHECON INC DBA., APOTHECON, 

INC., PFIZER, INC., INVAMED, INC., 

KING PHARMACEUTICALS, INC., 

A.K.A A.L. PHARMA INC FKA., A.K.A 

ALPHARMA INC DBA., A.K.A 

ALPHARMA-BARRE NATIONAL., 

RICHMOND PHARMACEUTICALS, 

INC., KAREN TOBIN, M.D., SCHWARZ 

PHARMA, INC., ALAVEN 

PHARMACEUTICAL LLC., BAXTER 

HEALTHCARE CORPORATION., AND 

WOCKHARDT USA.

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Appeal from the Order Entered October 16, 2019

In the Court of Common Pleas of Philadelphia County Civil Division at 

No(s): No. 110204100

BEFORE: LAZARUS, J., DUBOW, J., and FORD ELLIOTT, P.J.E.

MEMORANDUM BY DUBOW, J.: FILED OCTOBER 19, 2020

Jannine Zitney (“Mrs. Zitney”) and Steve Zitney (“Mr. Zitney”) 

(collectively, “Appellants”), appeal from the October 16, 2019 Orders entered 
J-A21017-20

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in the Philadelphia County Court of Common Pleas granting summary 

judgment in favor of Appellees, PLIVA, Inc. (“PLIVA”) and Teva 

Pharmaceuticals USA, Inc. (“Teva”) (collectively, “Appellees”). After careful 

review, we affirm.

Background

Wyeth, LLC (“Wyeth”) manufactures the drug Reglan. Teva and PLIVA1

manufacture Reglan’s generic equivalent, metoclopramide. In the 1980s, the 

Food and Drug Administration (“FDA”) approved Reglan and metoclopramide

for the treatment of chronic digestive disorders. Physicians also used 

metoclopramide “off-label”2to treat nausea associated with a range of 

illnesses, including migraines. Since the 1980s, Reglan’s label contained a 

warning that its use was associated with an increased risk of tardive 

dyskinesia.3

In July 2004, Wyeth updated the Reglan label to include language 

indicating that metoclopramide should not be used for longer than 12 weeks. 

In June 2005, Teva sought FDA approval to update its metoclopramide label 

____________________________________________

1 PLIVA is a wholly-owned subsidiary of Teva.

2 The term “off-label” refers to the use of a FDA-approved drug for an 

unapproved use. 

3 Tardive dyskinesia is a neurological disorder characterized by involuntary 

movements of the face and jaw.
J-A21017-20

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to mirror the Reglan label. On January 17, 2017, the FDA approved Teva’s 

label update.4 

In early 2010, the Philadelphia County Court of Common Pleas formed 

the Reglan/metoclopramide mass tort litigation. See In Re 

Reglan®/metoclopramide Litigation, January Term 2010 No. 1997, Case 

Management Order 1, docketed on February 16, 2010. Pursuant to Case 

Management Order 1, a Master Long-Form Complaint was filed asserting 

allegations common to all plaintiffs in the litigation. See Case Management 

Order 1 at § III(A). Thereafter, the trial court required each individual plaintiff 

to file only a case-specific short-form Complaint, which incorporated by 

reference the Master Long-Form Complaint and set forth the factual 

circumstances unique to that individual plaintiff. See id. at § III(C).

The Instant Litigation

Mrs. Zitney has suffered from debilitating migraine headaches for more 

than forty years. Between 2004 and 2009, Dr. Karen Tobin, Mrs. Zitney’s 

neurologist, prescribed metoclopramide to treat the nausea associated with 

Mrs. Zitney’s migraines. Dr. Tobin instructed Mrs. Zitney to take 

metoclopramide on an as-needed basis. Mrs. Zitney’s pharmacist dispensed 

metoclopramide manufactured by PLIVA on four occasions from October 31, 

2004, to December 4, 2006. The pharmacist also dispensed metoclopramide 

____________________________________________

4 The record is unclear as to when PLIVA updated its label to conform to the 

July 2004 Reglan label.
J-A21017-20

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manufactured by Teva on four occasions between December 28, 2007, and 

November 21, 2008.

In December 2009, Mrs. Zitney complained of an eye twitch to Dr. Tobin. 

Additionally, on multiple occasions starting in 2009, Mrs. Zitney complained 

of muscle spasms in her back and neck. Dr. Vernon Neppe, a 

neuropsychiatrist, opined that Appellant suffers from tardive dyskinesia 

caused by her metoclopramide use.5 

On February 28, 2011, Appellants commenced this action by filing a 14-

count short-form Complaint against 50 defendants. Appellant’s claims 

included: (1) strict liability failure to warn; (2) strict liability design defect; (3) 

negligence; (4) negligence per se; (5) fraud and intentional 

misrepresentation; (6) constructive fraud; (7) breach of implied warranty; (8) 

unfair trade practices; (9) unjust enrichment; (10) negligent 

misrepresentation; (11) civil conspiracy; (12) loss of consortium; (13) gross 

negligence/malice; and (14) punitive damages. See Complaint, 2/28/11. By 

January 2019, all defendants other than PLIVA and Teva had settled with 

Appellants or had been dismissed from the case.

____________________________________________

5 Dr. Neppe examined and observed Mrs. Zitney, reviewed the video of her 

deposition to observe her symptoms over a period of hours, and reviewed her 

medical and pharmacy records. He opined to a reasonable medical probability 

that Mrs. Zitney’s metoclopramide exposure caused her movement disorder. 

See Motion for Summary Judgment, 4/25/19, at 4.
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On April 3, 2019, the trial court granted partial summary judgment in 

favor of Teva on the basis of federal preemption as to Appellants’ claims for:

(1) strict liability failure to warn; (2) strict liability design defect; (3) fraud 

and intentional misrepresentation; (4) constructive fraud; (5) breach of 

implied warranty; (6) unfair trade practices, and (7) negligent 

misrepresentation.6

On April 25, 2019, Appellants filed a Motion for Partial Summary 

Judgment asserting that they were entitled to judgment as a matter of law 

against Teva on Appellants’ failure to warn claim. In particular, Appellants 

argued that Teva was negligent because it failed to inform Dr. Tobin about the 

July 2004 updates to the Reglan label and the corresponding updates to its

metoclopramide label through a “Dear Health Care Provider” (“DHCP”) letter. 

See Motion for Summary Judgment, 4/25/19, at 7; Letter Brief, 7/10/19, at 

¶ 13. Stated differently, Appellants based their failure to warn claim on the 

manner in which Appellees notified Dr. Tobin of the warnings, not on the 

warnings themselves. 

On June 3, 2019, PLIVA filed a Motion for Summary Judgment in which 

it argued that it was entitled to judgment as a matter of law on all of 

Appellants’ claims. Two days later, on June 5, 2019, Teva filed a similar 

Motion for Summary Judgment. 

____________________________________________

6 PLIVA did not seek summary judgment on the basis of federal preemption.
J-A21017-20

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On July 10, 2019, Appellants filed a “Reply Brief in Support of 

[Appellants’] Motion for Summary Judgment; Response Brief to Defendant’s 

Motion for Summary Judgment on Preemption, State Duty to Warn and 

Causation; and [Appellants’] Response to Defendant’s Motion to Strike 

Testimony of Vernon Neppe, M.D., Ph.D.” Reply Brief, 7/10/19. On July 25, 

2019, Appellees’ filed a Reply in support of their Motions for Summary 

Judgment. 

After considering the Motions filed by the parties, the trial court 

concluded that Pennsylvania law does not impose a duty on drug 

manufacturers to convey safety warnings in any manner other than by 

including them in a product’s package insert shipped with the product. 

Consequently, it found that because PLIVA and Teva had undisputedly 

complied with that mandate, they had not breached their duty to warn 

Appellant by not providing Dr. Tobin with a DHCP letter. Therefore, on October 

16, 2019, the trial court entered Orders granting PLIVA’s and Teva’s Motions 

for Summary Judgment and dismissing Appellants’ claims against them with 

prejudice. 

This timely appeal followed. Both Appellants and the trial court have 

complied with Pa.R.A.P. 1925.

Appellants raise the following issue on appeal:

[D]oes a prescription drug manufacturer’s duty to provide product 

warnings extend to doctors who foreseeably rely on a 

manufacturer’s product information when prescribing a 

medication, even if the prescription was filled with the generic 

version of the prescribed?
J-A21017-20

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Appellants’ Brief at 4.

Appellants challenge the trial court’s Orders granting summary 

judgment in favor of PLIVA and Teva. Our Supreme Court has clarified our 

role as the appellate court as follows: 

On appellate review, then, an appellate court may reverse a grant 

of summary judgment if there has been an error of law or an 

abuse of discretion. But the issue as to whether there are no 

genuine issues as to any material fact presents a question of law, 

and therefore, on that question our standard of review is de novo. 

This means we need not defer to the determinations made by the 

lower tribunals. To the extent that this Court must resolve a 

question of law, we shall review the grant of summary judgment 

in the context of the entire record. 

Summers v. Certainteed Corp., 997 A.2d 1152, 1159 (Pa. 2010) (citations 

and quotation omitted).

A trial court may grant summary judgment “only in those cases where 

the record clearly demonstrates that there is no genuine issue of material fact 

and that the moving party is entitled to judgment as a matter of law.” Id.

(citation and quotation omitted); see also Pa.R.C.P. No. 1035.2(1). “When 

considering a motion for summary judgment, the trial court must take all facts 

of record and reasonable inferences therefrom in a light most favorable to the 

non-moving party.” Summers, supra at 1159 (citation omitted). “In so 

doing, the trial court must resolve all doubts as to the existence of a genuine 

issue of material fact against the moving party, and, thus, may only grant 

summary judgment where the right to such judgment is clear and free from 

all doubt.” Id. (citation and internal quotation marks omitted).
J-A21017-20

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The party moving for summary judgment bears the burden of showing 

that no genuine issue of material doubt exists and that it is entitled to 

judgment as a matter of law. Ford v. American States Ins. Co., 154 A.3d 

237, 244 (Pa. 2017). 

Appellants claim the trial court erred in finding that Appellees had not 

breached their duty to warn Appellants of the dangers of metoclopramide. 

Appellant’s Brief at 13-15. Appellants assert that Appellees’ conduct fell short 

of Pennsylvania law requiring drug manufacturers to provide warnings and 

related prescribing information to physicians because Appellees did not convey 

the required safety information directly to Dr. Tobin through a DHCP Letter. 

Id. Appellants further argue that the trial court erred in concluding that, by 

updating their drug labels, Appellees’ had adequately warned Dr. Tobin of the 

dangers posed by metoclopramide. Id. at 15-18. Last, Appellants aver that 

entry of summary judgment was inappropriate because whether PLIVA and 

Teva breached their duty to notify Dr. Tobin of metoclopramide’s known risks

is a question of fact for the jury and not a question of law for the court to 

decide. Id. at 24-26.

“[W]here the adequacy of warnings associated with prescription drugs 

is at issue, the failure of the manufacturer to exercise reasonable care to warn 

of dangers, i.e., the manufacturer’s negligence, is the only recognized basis 

of liability.” Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996). 

With respect to negligence, a plaintiff in a products liability case must 

show that: (1) the product was defective; (2) the defect caused the plaintiff’s 
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injury; and (3) the defect existed at the time the product left the 

manufacturer. Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 

1153-54 (Pa. Super. 1996). “A product may be deemed defective if it lacks 

adequate warnings or instructions necessary for safe use of the product.” Id.

at 1154 (citation omitted). However, a pharmaceutical product, when 

“accompanied by proper directions and warning, is not defective, nor is it 

unreasonably dangerous.” Id. (citing Restatement (Second) of Torts, § 402A, 

Comment k).

“Pennsylvania applies the learned intermediary doctrine to claims for 

failure to warn involving pharmaceutical drugs.” Simon v. Wyeth 

Pharmaceuticals, Inc., 989 A.2d 356, 368 (Pa. Super. 2009). Under the 

learned intermediary doctrine, drug manufacturers must direct required drugsafety warnings to physicians, and not to patients. Id. See also Dion v. 

Graduate Hosp. of Univ. of. Penna. 520 A.2d 876, 879 (Pa. Super. 1987) 

(noting that “where the drug is 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.”) “Thus, in an action against a drug 

manufacturer based upon inadequate warnings, the issue to be determined is 

whether the warning, if any, that was given to the prescribing physicians was 

proper and adequate.” Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 

909, 924 (Pa. Super. 2011) (citations and quotation omitted).

As noted above, Appellants do not dispute that the contents of the 

Reglan and metoclopramide labels were adequate to satisfy Appellees’ duty to 
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warn. Instead, citing the learned intermediary doctrine’s requirement that 

pharmaceutical companies direct drug warnings to physicians and not to the 

general public, Appellants challenge the trial court’s conclusion that by merely 

including warning labels containing warnings about metoclopramide’s safety 

in the drugs’ packaging, Appellees had satisfied their legal duty to warn. In 

support of this claim, Appellants baldly assert, without citation to any 

authority, that the learned intermediary doctrine imposes upon Appellees a 

duty to warn Dr. Tobin individually through a DHCP letter of the risks posed 

by Mrs. Zitney’s use of metoclopramide. 

In explaining its conclusion that Appellees were entitled to judgment as 

a matter of law, the trial court noted as follows:

Here, [Appellants] do not argue Teva or PLIVA distributed their 

metoclopramide without the FDA approved label. Similarly, 

[Appellants] conceded the contents of [Appellees’] warnings was 

proper and adequate. Accordingly, since Teva and PLIVA 

distributed their metoclopramide with labels containing warnings 

that [Appellants] concede are sufficient, [Appellees] have fulfilled 

their duty to warn under Pennsylvania law. 

Trial Ct. Op. at 10.

We agree with the trial court. Moreover, and contrary to Appellants’ 

claim, Pennsylvania law does not impose on drug manufacturers a duty to 

send DHCP letters to prescribing physicians like Dr. Tobin. Because 

Pennsylvania law does not impose upon Appellees the heightened duty 

advocated by Appellants, and because Appellants conceded that Appellees 

fulfilled their duty to provide content-appropriate warning labels in their 

metoclopramide packaging, the trial court properly found that Appellees had 
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not breached their duty to Appellants. Accordingly, Appellees were entitled to 

judgment as a matter of law and the trial court, therefore, did not err in 

entering summary judgment in favor of Appellees.

7

Orders affirmed.

Judgment Entered.

Joseph D. Seletyn, Esq.

Prothonotary

Date: 10/19/20

____________________________________________

7 With respect to Appellants’ contention that whether PLIVA and Teva 

breached their duty to notify Dr. Tobin of metoclopramide’s known risks is a 

question of fact for the jury and not a question of law for the court to decide, 

this Court’s review of the record indicates that Appellants failed to preserve 

this issue before the trial court and, instead, raised this issue for the first time 

on appeal. See Pa.R.A.P. 302 (“Issues not raised in the lower court are waived 

and cannot be raised for the first time on appeal.”) They have, therefore, 

waived this claim. Moreover, it is axiomatic that whether the law imposes a 

duty on a defendant is a question of law. See Truax v. Roulhac, 126 A.3d. 

991, 1000 (Pa. Super. 2015) (“While the existence of a duty is a question of 

law, whether there has been a neglect of such duty is generally for the jury.”). 

Thus, even if Appellants had not waived this claim, it would fail.